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Federal Housing Finance Agency.
Final rule.
Section 1209 of the Housing and Economic Recovery Act of 2008 (HERA) amended section 26 of the Federal Home Loan Bank Act (Bank Act) to permit any Federal Home Loan Bank (Bank) to merge with another Bank with the approval of its board of directors, its members, and the Director of the Federal Housing Finance Agency (FHFA). This final rule establishes the conditions and procedures for the consideration and approval of voluntary Bank mergers.
The final rule is effective on December 28, 2011.
John P. Foley, Senior Financial Analyst, Policy and Program Development,
The 12 regional Banks are instrumentalities of the United States organized under the Bank Act.
Section 1209 of HERA added new paragraphs (b)(1) and (b)(2) to section 26 of the Bank Act to address voluntary mergers of Banks. Section 26(b)(1) authorizes any Bank to merge voluntarily with another Bank with the approval of the Director of FHFA (Director) and the boards of directors of the Banks involved in the merger. Section 26(b)(2) requires FHFA to promulgate regulations establishing the conditions and procedures for the consideration and approval of voluntary mergers, including approval by Bank members.
As required by section 26(b)(2), the final rule establishes the conditions and procedures for the consideration and approval of voluntary mergers of Banks. The rule does not relate to liquidations, reorganizations, conservatorships, or receiverships undertaken by the Director pursuant to the authority set forth at section 26(a) of the Bank Act and section 1367 of the Federal Housing Enterprises Financial Safety and Soundness Act of 1992 (Safety and Soundness Act).
On November 26, 2010, FHFA published in the
The proposed rule would have established procedures for Banks to follow in order to consummate a merger, including: Execution of a written merger agreement that has been authorized by each merging Bank's board of directors; joint submission of a merger application to FHFA by the merging Banks; preliminary approval of the terms of the merger by the Director; ratification of the merger by the merging Banks' member institutions; and final approval by the Director. In developing the proposed rule, FHFA looked for guidance to governance practices that are common under general principles of corporate law, disclosure practices that are required under the federal securities laws, and the approval standards required under federal banking laws relating to mergers of insured depository institutions.
Section 1313 of the Safety and Soundness Act, as amended by HERA, requires the Director, when promulgating regulations relating to the Banks, to consider the following differences between the Banks and the Enterprises (Fannie Mae and Freddie Mac) with respect to the Banks' cooperative ownership structure; mission of providing liquidity to members; affordable housing and community development mission; capital structure; and joint and several liability.
FHFA received six comment letters in response to the proposed rule. All twelve Banks jointly submitted one
FHFA considered all of the comments in developing the final rule, which establishes merger conditions and procedures that are substantially similar to those that were proposed, except that the two-step preliminary/final FHFA approval process embodied in the proposed rule has been replaced with a single-step approval in the final version, as suggested by some commenters. FHFA has made a number of minor revisions to the rule in order to address concerns raised by commenters, as well as to provide greater clarity. Specific comments, FHFA's responses, and changes adopted in the final rule are described in greater detail below in the sections describing the relevant rule provisions.
Proposed § 1278.1 set forth definitions of terms used in proposed part 1278. With two minor exceptions, all of these definitions have been adopted as proposed and are set forth in § 1278.1 of the final rule. A definition for the term “Financial Statements” has been added to the final rule to refer to statements of condition, income, capital, and cash flows, with explanatory notes, in such form as the Banks are required to include in their filings made under the Securities and Exchange Act of 1934 (Exchange Act).
Section 1278.2 of the proposed rule would have authorized any two or more Banks to merge, provided that they satisfied the various procedural and substantive requirements of proposed part 1278 relating to the merger agreement, merger application, approval by the Director, ratification by the members, and final consummation of the merger. Proposed § 1278.1 defined the words “merge” and “merger” broadly to include not only a traditional merger (where one surviving entity absorbs another disappearing entity), but also a consolidation, a purchase and assumption transaction, and any other type of business combination that could occur between or among Banks. The intent behind proposed § 1278.2 was to permit each Bank wide latitude to pursue beneficial business combinations with other Banks, subject to the proviso that any such combination could be consummated only with the express approval of the Director, obtained in accordance with the conditions and procedures set forth in proposed part 1278. The Banks expressed support for the broad definition of “merge” and “merger,” and no commenters opposed the definition, which the final rule retains without change.
In the final rule, the introductory paragraph of § 1278.2 has been revised to make clear that the provisions of part 1278 apply only to voluntary mergers undertaken pursuant to section 26(b) of the Bank Act.
Section 1278.3 of the proposed rule would have required that any merger of Banks be consummated only pursuant to a written merger agreement meeting the requirements of paragraphs (a) and (b) of that section, which addressed the authorization of the agreement by the Constituent Banks' boards of directors and the contents of the agreement, respectively.
Specifically, proposed § 1278.3(a) would have required that a merger agreement be authorized by the affirmative vote of a simple majority of a quorum of the board of directors of each Constituent Bank at a meeting on the record and that it be executed by authorized signing officers of each Constituent Bank. FHFA requested comment upon whether a standard other than a majority vote of a quorum of the boards of directors would be appropriate. The Banks opposed the imposition of a regulatory standard for board authorization of a merger agreement, preferring instead that each Bank be permitted to establish board voting requirements under its bylaws, which they asserted is consistent with the approach taken by most state corporation statutes. One commenter questioned the sufficiency of a simple majority of a quorum of the board of directors to authorize a merger agreement, and advocated that the final rule instead require a supermajority of the full board of each Constituent Bank.
As discussed in the proposed rule, section 26(b) of the Bank Act, while requiring a board vote as part of the merger process, does not address specific requirements with respect to such a vote. Although the absence of statutory requirements would allow FHFA to include in the final rule either of those suggestions, FHFA has decided to retain this provision as proposed. As a matter of policy, FHFA believes that a uniform standard for board authorization is preferable to allowing each Bank to set its own approval standard. Unlike general business corporations, all of the Banks are very similar in business model and operations, as governed by the Bank Act and the regulations adopted thereunder, and they were created to further uniform purposes. Given those circumstances, FHFA believes that each Bank should also be subject to the same approval standards in determining whether to enter into a merger agreement. In addition, FHFA has concluded that the appropriate uniform standard is one that corresponds with the manner in which board decisions currently are made under the bylaws of all of the Banks—that is, by vote of a majority of a quorum of the board.
Proposed § 1278.3(b) addressed the minimum content for a merger agreement. It would have required generally that the agreement set forth all material terms and conditions of the merger, and would have further required that the agreement include provisions addressing nine specified matters. FHFA proposed to require agreement on those matters early in the merger process because, in the agency's judgment, they would be the central issues to be negotiated between Constituent Banks under most merger scenarios, and are matters of major regulatory concern to the agency. The nine matters enumerated in the proposed rule were: (1) The proposed Effective Date of the merger; (2) the proposed organization certificate and bylaws of the Continuing Bank; (3) the proposed capital structure plan for the Continuing Bank; (4) the proposed size and structure of the board of directors for the Continuing Bank; (5) the formula to be used to exchange the stock of the Constituent Banks for the stock of the Continuing Bank; (6) any conditions that must be satisfied prior to the Effective Date of the proposed merger; (7) a statement of any representations or warranties; (8) a description of any legal opinions or rulings; and (9) a statement that the board of directors of a Constituent Bank can terminate the merger agreement before the Effective Date upon a determination that certain events have occurred. FHFA's intent in including these provisions in the proposed rule was to ensure that a merger agreement reflects the understandings that the Banks have reached with respect to each of these critical matters. The agency did not intend to require that the documents that may be necessary to implement these understandings be prepared at the same time as the merger agreement.
FHFA received a number of comments regarding the nine specific matters to be addressed in a merger agreement. The agency has made some minor revisions to § 1278.3(b) in response to some of these comments, which are discussed below, and has also made a few minor wording changes for greater clarity and consistency.
Paragraph (1) of proposed § 1278.3(b) would have required that a merger agreement set forth the proposed Effective Date of the merger. In the proposed rule, the term “Effective Date” was defined as the date on which the Constituent Banks consummate the merger, or, in the case of a merger encompassing two or more component transactions, the date on which the relevant Constituent Banks consummate each component transaction. As discussed below, § 1278.7 has been revised in order to provide greater specificity as to the time that the organization certificate of the Continuing Bank, and consequently the consummation of the merger, becomes legally effective. In conjunction with this change, the definition of “Effective Date” has been revised to refer to the date on which the organization certificate of the Continuing Bank (or Banks) becomes effective as provided under § 1278.7. As stated in the
In the final rule, paragraph (1) of § 1278.3(b) has been revised to require that, in addition to the proposed Effective Date, the merger agreement set forth the proposed acquisition date for purposes of accounting for the transaction under GAAP, if that date is to be different from the Effective Date. Under GAAP, a business combination is recorded as of the “acquisition date.” Thus, among other things, the fair value of the assets acquired, liabilities assumed, and consideration exchanged is measured as of that date. The acquirer also begins to consolidate the acquired entity's financial position, results of operations, and cash flows as of that date. Under GAAP, the “acquisition date” is considered to be the date on which the acquirer obtains control of the acquiree. Typically, this would be the date on which the acquirer legally transfers the consideration, acquires the assets, and assumes the liabilities of the acquiree—
Paragraphs (2) and (3) of proposed § 1278.3(b) would have required that a merger agreement describe, respectively, the proposed organization certificate and bylaws, and the proposed capital structure plan, for the Continuing Bank. In their joint comment letter, the Banks stated that the rule should not require descriptions of these items, but should instead require the items to be attached to the merger agreement. FHFA has considered this suggestion, but has decided to adopt these requirements in their proposed form. In all cases, the types of material understandings that are required to be addressed in the merger agreement must precede the preparation of the detailed documents that are intended ultimately to implement those understandings. Although, in practice, the Constituent Banks may choose to negotiate the specifics of the capital structure plan, organization certificate, and bylaws prior to executing a final merger agreement, FHFA can discern no compelling reason to require these documents to be prepared contemporaneously with the agreement. In a legal sense, the understandings memorialized in the merger agreement will determine the scope and content of these implementing documents. FHFA believes that the better approach is the one embodied in the proposed rule, which requires that the merger agreement reflect the material understandings that the Banks have reached with respect to each of these matters. That approach allows the Banks the opportunity to prepare related documents contemporaneously with the merger agreement if they so desire, but also affords them the flexibility to agree in principle as part of the merger agreement how certain matters, such as the organization certificate, bylaws, or capital structure plan, are to be addressed, but leave the drafting of those documents to a later date.
The final rule requires that a merger agreement set forth all material terms and conditions of the merger. As
Proposed § 1278.3(b)(4) would have required that a merger agreement address the proposed size and structure of the board of directors for the Continuing Bank. The proposed rule also requested comments on how best to address the transition from the separate boards of the Constituent Banks to the combined board of the Continuing Bank, and the manner in which FHFA should establish the size and composition of the board for the Continuing Bank. In their joint comment letter, the Banks requested that Constituent Banks be permitted to include in either a merger agreement or a merger application their proposals as to the size and composition of the board immediately following the merger, and as to the gradual reduction in size of the board over time through FHFA's annual designation of Bank directorships process. The Banks opposed the imposition of any requirement to provide a detailed long-term plan regarding such matters as the number and composition of board committees and the responsibilities to be delegated to those committees, stating that they wish to preserve the flexibility to allow more detailed governance matters to evolve over time. Another commenter also agreed that any reduction in post-merger directorships should be a gradual process effected through the annual designation process.
FHFA has considered these comments and has decided to carry over the language of proposed § 1278.3(b)(4) without change. Final § 1278.3(b)(4) allows the Banks some flexibility with respect to the level of detail that must be included in the merger agreement. At a minimum, the merger agreement must include the Banks' proposal for the size and composition of the board of directors,
Ultimately, the size and composition of the board of the Continuing Bank will be determined by the Director. Section 7 of the Bank Act generally requires the Director to establish the size and structure of the board of directors of each Bank and gives the Director additional discretion to adjust the board size in connection with any Bank merger.
Proposed § 1278.3(b)(7) would have required that a merger agreement contain a statement of the representations or warranties, if any, made or to be made by any Constituent Bank, or its officers, directors, or employees. In their joint letter, the Banks requested clarification that any representations and warranties made by Bank officers, directors, or employees would not be signed in their individual capacities, but on behalf of their respective Banks. The proposed provision was not intended to require that any individual or Bank make any particular representations or warranties in connection with a merger, or to address the capacity in which any individual might make such representations or warranties. Instead, it was intended merely to require that the merger agreement set forth any representations or warranties made by any of the parties in connection with the merger. In recognition of the fact that the parties to the merger agreement will be the Constituent Banks as corporate entities, and in order to avoid any implication that Banks directors, officers, or employees should be making representations or warranties in their individual capacities, as opposed to doing so as a representative of his or her Bank, FHFA has revised § 1278.3(b)(7) in the final rule to remove the reference to Banks' “officers, directors, or employees.” Thus, the text of final § 1278.3(b)(7) requires that the merger agreement include “a statement of the representations or warranties, if any, made or to be made by any Constituent Bank.”
Section 1278.3(b)(8) of the proposed rule would have required that a merger agreement describe any legal opinions or rulings that have been obtained or furnished by any party in connection with the proposed merger. In their joint comment letter, the Banks stated that if legal opinions are required in connection with a merger, they are frequently conditions to consummation and, therefore, are not available until after the merger agreement is signed. Consequently, the Banks suggested that FHFA modify the provision to require that a merger agreement include descriptions of any legal opinions that are required to be obtained as a condition to the consummation of the merger, as well as those that have already been completed at the time the agreement is executed. The Banks further suggested that the rule require that a merger agreement describe any accounting opinions obtained or furnished in connection with the merger. FHFA has accepted both of these suggestions and has revised final § 1278.3(b)(8) to require that a merger agreement describe the legal or accounting opinions or rulings, if any, that are required to be obtained or furnished by any party in connection with the proposed merger.
Section 1278.3(b)(9) of the proposed rule would have required that a merger agreement contain a statement that the board of directors of a Constituent Bank may terminate the agreement before the Effective Date of the merger upon a determination by the Bank, with the concurrence of FHFA, that: (i) The information disclosed to members contained material errors or omissions; (ii) material misrepresentations were
In the final rule, FHFA has removed the requirement for FHFA concurrence with a termination decision, but has otherwise retained the substance of the proposed provision. The intent behind the proposed requirement of FHFA concurrence was primarily to aid FHFA in carrying out its supervisory duties, and to a lesser extent, to decrease the likelihood of a Bank alleging the existence of fraud as a pretext for terminating a merger agreement. FHFA acknowledges that the language of the proposed rule lacked standards for the agency's concurrence, and thus could be construed as authorizing it to compel an unwilling Bank to consummate a merger that the statutory regime intends to be voluntary, even if one of the Banks has concluded that grounds for termination exist, although such a result was not intended.
As in the proposed rule, final § 1278.3(b) states that a written merger agreement must set forth all material terms and conditions of the merger, including, “without limitation,” provisions addressing each of the matters enumerated in paragraphs (b)(1) through (b)(9). While, under paragraph (b)(9), the Constituent Banks are required to include within the merger agreement a provision authorizing a Bank to terminate the agreement for the reasons enumerated in the regulation, nothing in the language of § 1278.3 precludes the Banks from including in the agreement other grounds for termination that may be agreed upon by the respective boards and, in the case of a termination occurring after the member votes, by the members themselves. Thus, to the extent that Banks wish to include within a merger agreement provisions specifying additional grounds for termination of the agreement, they are free to do so under the final rule.
Section 1278.4 of the proposed rule addressed the application process to be followed in order to obtain FHFA approval for any merger of Banks. Proposed § 1278.4(a) would have required that the Constituent Banks submit to FHFA a merger application addressing all material aspects of the merger including, at a minimum: (1) A written statement summarizing the material features of the proposed merger and addressing certain enumerated issues; (2) a copy of the executed merger agreement and certified copies of the board resolutions authorizing the merger agreement; (3) a copy of the proposed organization certificate of the Continuing Bank; (4) a copy of the proposed bylaws of the Continuing Bank; (5) a copy of the proposed capital structure plan of the Continuing Bank; (6) the most recent annual audited financial statements for each Constituent Bank; and (7) pro forma financial statements for the Continuing Bank. No commenter objected to these proposed application requirements, but there were several comments regarding particular aspects of the requirements. Section 1278.4(a) of the final rule retains the proposed requirements, with some minor revisions as noted below.
As a general matter, the Banks expressed concern over the treatment of confidential commercial information that may be included in a merger application and requested that the final rule permit the submission of confidential information in a separate binder, specify that such information is exempt from disclosure under the Freedom of Information Act (FOIA), and give examples of types of information that would be considered confidential. FHFA has adopted only the first of these suggestions. The introductory clause of final § 1278.4(a) has been revised to include a new sentence specifying that a Bank may submit separately any portions of the merger application that it believes contain confidential or privileged trade secrets or commercial or financial information, and that such information will be handled in accordance with FHFA's FOIA regulations set forth at 12 CFR part 1202.
The procedures for the handling of information submitted to FHFA that the submitter believes to be confidential commercial information protected from FOIA disclosure under 5 U.S.C. 552(b)(4) and 12 CFR 1202.4(a)(4) are set forth in 12 CFR 1202.8. Section 1202.8(b) specifies that submitters of commercial information should use good-faith efforts to designate, by appropriate markings, either at the time of submission or at a reasonable time thereafter, those portions of the information they deem to be protected. Once so designated, such information may be released only pursuant to the procedures set forth in 12 CFR 1202.8(c) through (i), which provides in most cases for prior notice to the submitter and an opportunity for the submitter to object to the release of the information. Because the handling of confidential commercial information is addressed directly by FHFA's FOIA regulations, FHFA has declined to address separately in final part 1278 the FOIA status of any materials or information submitted as part of the merger application process.
With regard to the contents of the merger application, proposed § 1278.4(a)(1) would have required a written statement including: (i) A summary of the material features of the proposed merger; (ii) the reasons for the proposed merger; (iii) the effect of the proposed merger on the Constituent Banks and their members; (iv) the planned Effective Date of the merger; (v) a summary of the material features of any related transactions and the bearing that the consummation of, or failure to consummate, the related transactions is expected to have upon the merger; (vi) the names of the persons proposed to serve as directors and senior executive officers of the Continuing Bank; (vii) a description of all proposed material operational changes; (viii) information demonstrating that the Continuing Bank will comply with all applicable capital requirements after the Effective Date; (ix) a statement explaining all officer and director indemnification provisions; and (x) an undertaking that the Constituent Banks will continue to disclose all material information, and update all items, as appropriate. The topics required to be addressed in the application statement under § 1278.4(a)(1) of the final rule are substantially the same as those that were proposed, although the final version reflects a few minor additions and clarifications.
The first of these appears in paragraph (a)(1)(iv), which has been revised to require the statement to include, in addition to the proposed Effective Date: the Record Date established by each Constituent Bank's board of directors for purposes of determining the rights of member institutions to participate in the merger ratification vote (discussed in detail below); and the GAAP acquisition
Second, paragraph (a)(1)(vi), which as proposed would have required the names of the persons to serve as directors and senior officers of the Continuing Bank, has been revised to require the Banks also to include in the merger application information regarding their proposal for the ultimate size and composition of the board of directors,
Third, paragraph (a)(1)(vii), which in its proposed form would have required that the application statement address any staff reductions as part of a discussion of anticipated material operational changes, has been revised to require that the statement address such reductions only to the extent such information is known. This revision was made in response to the Banks' comment that it may be more prudent to defer decisions about specific reductions in staff until after the merger has occurred and management of the Continuing Bank has assessed its staffing needs and that, therefore, the Banks should not be required to provide such specific information at the time the merger application is filed. The fourth revision appears in paragraph (a)(1)(x), and is meant to clarify that the Constituent Banks' undertaking to update “all items,” as appropriate, applies specifically to items required to be included in the merger application.
FHFA has declined to make a requested change to proposed paragraph (a)(1)(vi), which would have required that the merger application set forth the names of the persons proposed to serve as directors and senior executive officers of the Continuing Bank. In their joint comment letter, the Banks expressed concern that the identity of the directors and senior executive officers of the Continuing Bank may not yet be determined at the time that the merger application is submitted, and requested that the rule permit this information to be added later as a supplement to the application. Although FHFA believes that the better practice would be for the Banks to file a complete merger application as a single submission, the rule does not require the Banks to do so, and therefore would allow the Banks to file portions of the required materials as a supplement to their initial merger application. Thus, if the Constituent Banks have not reached agreement as to the identity of the persons who will serve as directors and senior executives of the Bank when they initially file the merger application, they may submit this information as a supplement to the initial merger application. However, if they choose to do so, FHFA will not deem the application to be complete, and the time periods for FHFA review prescribed under § 1278.5 will not commence, until all information required by the final rule has been submitted. Corporate governance of the Continuing Bank is a critical issue, and the Director must know the identity of these individuals in order to determine whether the Continuing Bank will have adequate managerial resources—a factor that the Director is required to consider as part of the decision to approve or deny a merger request under § 1278.5(a).
Paragraphs (2) through (7) of proposed § 1278.4(a) addressed the additional items to be included as part of the merger application. Paragraph (a)(2) would have required that a merger application include a copy of the executed merger agreement, accompanied by a certified copy of the resolution of the board of directors of each Constituent Bank authorizing the execution of the merger agreement. In addition, paragraphs (a)(3) through (a)(5) would have required the Banks to provide, respectively, copies of the proposed organization certificate, the proposed bylaws, and the proposed capital structure plan of the Continuing Bank. These paragraphs have been carried over unchanged in the final rule. As discussed previously, if the items addressed in paragraphs (a)(3) through (a)(5) have already been attached to the merger agreement, additional copies need not be provided so long as the application makes clear that they are so attached.
Proposed paragraph (a)(6) would have required that the Banks include as part of a merger application the most recent annual audited financial statements for each Constituent Bank. In the final rule, this provision has been revised to require that the Banks also provide their quarterly financial statements for the current year-to-date. The most current available financial information for each of the Constituent Banks will obviously be a critical element of the official record to be reviewed by the Director, and the omission of this requirement from the proposed rule was an oversight. As mentioned above, FHFA also has added a definition of the term “Financial Statements” to § 1278.1 to clarify that these are to comprise statements of condition, income, capital, and cash flows, with explanatory notes, in such form as the Banks are required to include in their filings made under the Exchange Act.
Paragraph (a)(7) of proposed § 1278.4 would have required the Banks to include as part of a merger application pro forma financial statements for the Continuing Bank in such form as would be required to be included in the Disclosure Statement that the Banks must provide to their members in connection with the member vote under proposed § 1278.6—
In their joint comment letter, the Banks asserted that Regulation S-X
Having concluded that the Form S-4 requirements are the appropriate template upon which to base the requirements for the Disclosure Statement under part 1278, and given the detailed nature of the Form (including the SEC regulations cross-referenced), FHFA has further concluded that it is best to minimize any variations therefrom with respect to the Disclosure Statement requirements. Accordingly, the final rule continues to require only that the pro forma statements included in the Disclosure Statement correspond with those that would be required under the Form S-4. If a Constituent Bank and its attorneys and accountants conclude that the Form S-4 would require inclusion of only historical pro forma information in a particular case, then it should provide that information in the Disclosure Statement.
However, in order to approve any merger application under § 1278.5 of the final rule, the Director must be provided with information to establish that the Continuing Bank will be viable and will be able to serve its members effectively immediately following the merger and for some period thereafter. The agency also recognizes that the longer the time period covered by a pro forma forecast, the less accurate the forecast is likely to be. With this in mind, the agency has decided to revise § 1278.4(a)(7) to require the Banks to include forward looking pro forma financial statements for the Continuing Bank for each of at least two years following the date of the most recently filed quarterly statement of condition for the Constituent Banks. In order to establish a baseline for these forecasts, final paragraph (a)(7) also requires that the merger application include pro forma financial statements for the Continuing Bank as of the date of the most recently filed quarterly statement of condition for the Constituent Banks. FHFA requires Banks to provide two-year forward looking pro forma statements when they apply for approval of amendments to their capital structure plans,
Section 1278.4(b) of the proposed rule would have authorized FHFA to require the Constituent Banks to submit any additional information that the agency determined was necessary to assess a particular merger. Under the proposed rule, if the agency had determined a merger application to be complete under § 1278.4(c), FHFA could have required the Constituent Banks to submit additional information only with respect to matters derived from or prompted by the materials already submitted, or matters of a material nature that were not reasonably apparent previously. Under proposed § 1278.4(b), FHFA would have been permitted to use a Constituent Bank's failure to provide the required information in a timely manner as grounds to deny a merger application. No commenters objected to these provisions and § 1278.4(b) has been adopted as proposed.
Section 1278.4(c) of the proposed rule addressed the timing for determining whether a merger application is complete. As proposed, FHFA would have had 30 days after the receipt of a merger application to determine whether it was complete or whether any additional information was required. The proposed rule would have required FHFA to inform the Constituent Banks in writing if the agency determined that an application was complete and that it had all information necessary to evaluate the proposed merger, and also if it determined that an application was incomplete or that it required additional information. In the latter case, FHFA would have been required to specify the number of days within which the Constituent Banks must provide any additional information or materials, and within 15 days of receipt of such information or materials, to again determine whether a merger application is complete and so inform the Banks. Again, no commenters objected to this provision and it has been adopted as proposed.
Under the proposed rule, the review and approval of a merger by the Director would have been a two-step process. The first step, addressed by proposed § 1278.5, would have encompassed a review of all substantive aspects of a proposed merger, followed by either a preliminary approval or a denial of the merger application. Merger transactions that had been granted preliminary approval, and which had been ratified by the members of each Constituent Bank, would then have been subject to a final review and approval under § 1278.7 of the proposed rule. At the final review step, the Director would have been permitted to deny final approval of a merger only for limited reasons.
The Banks opposed this two-step process as being overly lengthy and burdensome. They recommended that the rule be revised to provide for a process similar to that which they asserted is employed by the federal depository institution regulators—
Final § 1278.5(a), which establishes standards for approving a merger, has been adopted as proposed and provides that, in deciding whether to approve or deny a merger application, the Director must take into consideration the financial and managerial resources of each of the Constituent Banks, the future prospects of the Continuing Bank, and the effect of the proposed merger on the safety and soundness of the Continuing Bank and the Bank System. These standards are similar to those used by the federal depository institution regulators in considering mergers and acquisitions of federally insured depository institutions.
Section 1278.5(b) of the proposed rule addressed procedural aspects of the merger application process. As proposed, § 1278.5(b) would have permitted the Director 30 days after determining the merger application to be complete to consider the information and materials provided in the application and either grant or deny preliminary approval of the merger. The
In the final rule, § 1278.5(b) has been revised, and a new § 1278.5(c) has been added, to reflect the new one-step approval process. Final § 1278.5(b) continues to require that, within 30 days of FHFA's determination that a merger application is complete, the Director either approve or deny the merger application. This section has been revised to provide that an approval of a merger application may include any conditions the Director determines to be appropriate. While FHFA has not included in the final rule a requirement that the Banks must submit their Disclosure Statements to the agency for review prior to sending the document to their members, the Director will have the ability to require such a review as a condition of approval.
Final § 1278.5(b) also provides that, in every case, approval will be conditioned on each Constituent Bank demonstrating that it has obtained the members' ratification of the merger agreement in accordance with the requirements of § 1278.6 by submitting to FHFA: (1) A certified copy of the members' resolution ratifying the merger agreement, on which the members cast their votes; and (2) a certification of the member vote from the Bank's corporate secretary or from an independent third party. These materials, as well as any others necessary to prove that all conditions of approval have been met, must be provided to FHFA before the Director may effect the consummation of the merger by accepting the organization certificate of the Continuing Bank under § 1278.7 of the rule (discussed below).
Final § 1278.5(c) contains the same notice requirements that appeared in § 1278.5(b) of the proposed rule. Thereunder, FHFA must provide written notice to each Constituent Bank, as well as to each other Bank and the Office of Finance, in the case of either an approval or a denial. As in the proposed rule, a notice of approval must set forth any conditions to that approval and a notice of denial must state the reasons for the denial.
Section 1278.6 of the proposed rule addressed the requirements for the ratification of a merger agreement by vote of the Constituent Banks' member institutions. This section has been adopted substantially as proposed, with the exceptions discussed below.
Proposed § 1278.6(a) would have required that no merger of Banks be consummated unless the merger agreement had been ratified by the members of each Constituent Bank in a voting process meeting the requirements of paragraphs (a)(1) through (a)(4) of that section. As proposed, paragraph (a)(1) would have required that each Constituent Bank deliver a ballot and a Disclosure Statement to each of its members. As defined in § 1278.1 of the proposed rule, a Disclosure Statement would have been required to contain all of the items that the Constituent Bank providing the statement would be required to include in a Form S-4 Registration Statement promulgated by the SEC under the Securities Act of 1933 (or any successor form promulgated by the SEC governing disclosure required for securities issued in business combination transactions) when prepared as a prospectus as directed in Part I of the Form. In addition, proposed paragraph (a)(1) would have required that the Disclosure Statement establish a closing date for the Bank's receipt of completed ballots that was no earlier than 30 days after the date that the ballot and Disclosure Statement were delivered to its members.
In the final rule, paragraph (a)(1) has been revised slightly to require that the enumerated items be delivered to “each institution that was a member as of the Record Date,” as opposed to merely “its members.” This change was made to reflect the fact that the eligibility of an institution to participate in the merger vote is to be determined as of the record date established by the Constituent Bank's board of directors (discussed in more detail below) and that, consequently, it is the institutions that are so eligible that must receive the ballot and the Disclosure Statement.
In addition, the definition of “Disclosure Statement” has been modified slightly in the final rule. In their joint comment letter, the Banks agreed that the Form S-4 is a useful and widely-accepted model for comprehensive shareholder disclosure in a merger transaction. However, the Banks asserted that a number of the Form S-4 requirements are clearly not applicable to the Banks, and requested that the rule make clear that the Form S-4 prospectus information needs to be included only to the extent applicable. Similarly, the Banks asserted that, pursuant to various statutory provisions and SEC no-action letters, the Banks are not required to comply with certain requirements that would otherwise apply in the preparation of their Annual Reports on Form 10-K. They requested that the rule also make clear that, to the extent that these Form 10-K requirements are also Form S-4 requirements, these items need not be included in the Disclosure Statement.
FHFA recognizes that, due to the unique corporate and capital structure of the Banks, certain items regarding the Banks or the transactions that are required to be disclosed in the Form S-4 will be inapplicable. The agency also recognizes that the Banks have been exempted by statute and through SEC no-action letters from a number of disclosure requirements that would otherwise be applicable. The Form S-4 and the SEC regulations that are cross-referenced therein make clear in several places that information need only be furnished to the extent appropriate.
In discussing proposed § 1278.6 in the Supplementary Information to the proposed rule, FHFA stated that, under the terms of the Form S-4, the Banks would be permitted to supply much of the required information through incorporation by reference of their Form 10-Ks and other periodic SEC filings. The Banks supported this option, but pointed out that the incorporation by reference into a Form S-4 is permitted under the SEC's regulatory authority, which would not extend to the Disclosure Statement. They therefore
Paragraph (a)(2) of proposed § 1278.6 addressed the voting rights of shareholders of the Constituent Banks and the requirements for the casting of ballots. With respect to the latter, proposed paragraph (a)(2) would have required that each voting entity cast all of its votes either for or against the ratification of the merger agreement or to abstain with respect to all of its votes, and that each entity's vote be made by resolution of its governing body, either authorizing the specific vote or delegating to an individual the authority to vote. Both of these requirements, which mirror requirements that apply to the election of Bank directors, have been carried over unchanged in the final rule.
However, the approach to the determination of the voting rights of each member of a Constituent Bank in a vote to ratify a merger agreement has been modified from that which appeared in the proposed rule. As proposed, paragraph (a)(2) stated that each member of each Constituent Bank would be entitled to cast the same number of votes that the member may cast in that year's election of Bank directors. By statute, in the election of Bank directors, a member is entitled to cast one vote for each share of Bank stock the member was required to hold as of the record date (set by statute at December 31 of the prior year in the case of elections for Bank directors
Most commenters supported tying members' merger voting rights closely to those that apply to the election of Bank directors, although one requested that the rule permit each Bank to amend its bylaws to govern members' merger voting rights in a way that the Bank's board believes is appropriate. One commenter expressly supported the application of the cap on the number of shares that a member may vote, explaining that this will ensure that small members will continue to have a voice in Bank governance. Another commenter supported the voting cap in theory, but opined that in the case of a district-wide merger vote the cap should be applied uniformly for all of the members within the Bank's district and not on a state-by-state basis, as is done in the case of the election of directors.
FHFA has considered these comments and believes, on balance, that the requirements for the merger voting process should be closely tied to those that are established by statute for the election of Bank directors. This is because the voting process enshrined in the Bank Act is the only manifestation of general Congressional intent on the subject of member voting, and because it is consistent with the cooperative structure of the Bank System and will reduce the possibility that a few large stockholders will control the outcome of a vote on a merger. However, in the light of the comments received, the agency has reconsidered the application of the vote cap and has determined that because a merger ratification vote would be a district-wide “at large” election, the cap on the number of votes that may be cast by a member institution should be calculated based upon the average number of shares held by all members in the Bank's district, as opposed to the average number held by all members within the state in which that member institution is located.
FHFA recognizes that this will result in certain large Bank members being eligible to cast more or fewer votes—in some cases by significant margins—than the member would be eligible to cast in the election of directors. However, it is the agency's view that, as a matter of equity and appropriate corporate governance, the final rule should not permit a result where one Bank member is authorized to vote a materially different number of shares than another similarly-sized member that is located within a different state in the same Bank district. Therefore, paragraph (a)(2) has been revised in the final rule to provide that each member of each Constituent Bank shall be entitled to cast one vote for each share of Bank stock that the member was required to own as of the Record Date, provided that the number of votes that any member may cast shall not exceed the average number of shares of Bank stock required to be held by all members of that Bank, calculated on a district-wide basis, as of the Record Date.
In the Supplementary Information to the proposed rule, FHFA explained that the effect of applying the statutory and regulatory requirements governing the election of Bank directors to the merger ratification vote is that not all Bank stock would carry the right to vote in such an election. For example, stock controlled by a non-member institution as a result of the acquisition of a Bank member, and stock held by a member in excess of the statutory cap applicable to that member's state, could not be voted in a director election and, therefore, could not have been voted in a merger election under the proposal. In their joint comment letter, the Banks expressed concern about both of those examples, pointing out that the long-standing policy of both FHFA and the former Federal Housing Finance Board (Finance Board) has been that: (1) If a non-member institution acquires a Bank member after the record date, but prior to the election, the acquiring non-member may vote the acquired member's shares, despite the fact that it is not a Bank member; and (2) if a member that is subject to the statutory cap in a particular state acquires another member in the same state subsequent to the record date, but prior to the election, the acquiring member is permitted to cast the eligible votes for the acquired member, as well as its own votes, in that year only.
FHFA did not intend to imply in the Supplementary Information to the proposed rule that these policies would not apply also to a merger vote under part 1278. The counter-examples given by the Banks apply to particular situations that may occur due to the fact that voting rights are determined as of the record date (December 31 in the case of director elections), whereas the vote itself may not occur until many months later. During the interim, stock that is eligible to be voted by a member as of the record date may be transferred to another entity—which could be a member or non-member—through the acquisition of the member by the other entity. In these cases, the acquiring entity may vote the shares that were deemed eligible as of the record date as the successor to the disappearing member. Because these voting rights are those of the disappearing member, the status of the acquirer as a non-member or the fact the acquirer may be a member whose own voting power is limited by the vote cap have no bearing
Paragraph (a)(3) of proposed § 1278.6 addressed the Constituent Banks' handling of ballots and the determination of the results of the ratification vote. It would have prohibited each Constituent Bank from reviewing any ballot until after the closing date of the election, counting any ballot received after the closing date, or disclosing how any member voted, while requiring each to tabulate the ballots immediately after the closing date and to retain all ballots for at least two years after the date of the election. Importantly, as proposed, paragraph (a)(3) provided that a merger agreement would be considered to be ratified if a majority of votes cast in the election have been cast in favor of the merger. One commenter, while otherwise supporting the parallel to the director election process, advocated requiring the approval of a supermajority of members for any proposed merger. FHFA has declined to adopt that suggestion because it interprets section 26(b) of the Bank Act as having the purpose of facilitating the ability of the Banks to voluntarily merge, and the imposition of a supermajority requirement would not further that purpose. Accordingly, paragraph (a)(3) has been adopted as proposed.
Paragraph (a)(4) of proposed § 1278.6 would have required that, within 10 calendar days of the election closing date, a Constituent Bank deliver to its members, to each Constituent Bank with which it proposes to merge, and to FHFA a statement of: the total number of eligible votes; the number of members voting in the election; and the total number of votes cast both for and against ratification of the merger agreement, as well as those that were eligible to be cast by members that abstained and by members who failed to return completed ballots. No commenters objected to any aspect of this provision, and it has been adopted as proposed.
Section 1278.6(b) of the proposed rule stated that, in connection with a proposed merger, no Bank, or any director, officer, or employee thereof, shall make any statement, written or oral, which, at the time and in the light of the circumstances under which it is made, is false or misleading with respect to any material fact, or which omits to state any material fact necessary in order to make the statement not false or misleading, or necessary to correct any earlier statement that has become false or misleading. No commenter objected to this provision, and it has also been adopted as proposed.
Section 1278.7 of the final rule governs the process for the consummation of a merger after the members of each Constituent Bank have voted to ratify the merger agreement. As proposed, § 1278.7 would have governed the second step of the preliminary/final approval process that was provided for in the proposed rule. The proposed provision would have required that the Director grant a second, final, approval prior to consummation of the merger, and would have provided the Director with limited authority to deny approval of the merger in cases where: the member vote was not carried out in accordance with the requirements of § 1278.6; one or more Constituent Banks failed to fulfill a condition of the preliminary approval; or an event had occurred since the time of the preliminary approval that would have had a significant adverse impact on the future viability of the Continuing Bank.
For the reasons discussed above, the final rule now requires only one approval by the Director to be obtained, prior to the member votes under § 1278.6. However, because this approval is conditional, § 1278.7 has been retained in revised form as a procedural mechanism to ensure that the merger cannot be consummated until the Director has received satisfactory evidence that the conditions of the approval have been met. Section 1278.7 has also been revised to provide for greater certainty as to the time that the merger becomes effective.
Section 1278.7(a) of the final rule addresses the materials that the Constituent Banks are required submit after their respective member institutions have voted to ratify the merger. Final § 1278.7(a)(1) requires that the Constituent Banks submit to FHFA evidence acceptable to the Director that all conditions imposed in connection with the approval of the merger application have been satisfied, which shall in all cases include for each Bank a certified copy of its members' resolution ratifying the merger agreement and a certification of the member votes from the corporate secretary or from an independent third party. Final § 1278.7(a)(2) requires that the Constituent Banks also submit an organization certificate for the Continuing Bank, “in such form as FHFA may specify” that has been executed by the individuals who will constitute the board of directors of the Continuing Bank. Although FHFA currently has no regulations or guidelines governing the form of a Bank's organization certificate, final § 1278.4(a)(3) requires that the Constituent Banks submit a proposed organization certificate as part of the merger application, and the agency anticipates that it will provide appropriate guidance as to the form and content of the final certificate as part of the merger approval process.
Final § 1278.7(b) governs the method of acceptance and timing of the effectiveness of the Continuing Bank's organization certificate. Under the proposed rule, after obtaining the Director's final approval, the Constituent Banks would have been required to submit to FHFA an organization certificate for the Continuing Bank and, upon its acceptance by the agency, the corporate existence of the Continuing Bank would have commenced “as of the Effective Date.” This approach lacked clarity in a number of respects. First, as discussed above, the proposed rule defined “Effective Date” to mean “the date on which the Constituent Banks consummate the merger,” but left unclear what actions were required for the Banks to consummate the merger. In addition, while the proposed rule would have required FHFA to provide notice of its final approval to all of the Banks, it neither specified any particular overt action to be taken by FHFA to signify “acceptance” of the Continuing Bank's organization certificate, nor provided for any prior or subsequent notice of the fact or timing of such acceptance, or of
Final § 1278.7(b) is intended to provide the specificity that the proposed rule lacked. It states that, upon determining that all conditions of the Director's approval have been satisfied and that the organization certificate has been properly executed and is in the required form, the Director shall accept the organization certificate by endorsing it with the date of acceptance and the Effective Date. Paragraphs (1) and (2) of § 1278.7(b) govern the method by which the Director shall determine the Effective Date. If the merger agreement states a proposed Effective Date (whether expressed in terms of a specific date or a specific number of days after a particular event) and that date has not passed, the Director shall establish that date as the Effective Date. If the merger agreement sets forth a proposed range of dates within which the Effective Date may occur (
Final §§ 1278.7(c)(1) and (2) provide that, after the Director has accepted the organization certificate as provided under § 1278.7(b), the Continuing Bank shall, as of the commencement of the Effective Date specified on the certificate, become or remain a body corporate (depending on the type of transaction) operating under such organization certificate with all powers granted to a Bank under the Bank Act, and shall succeed to all rights, titles, powers, privileges, books, records, assets, and liabilities of the Constituent Bank or Banks, as provided in the merger agreement. In the proposed rule, § 1278.7(b) stated that, after acceptance of the organization certificate, the Continuing Bank would “be a body corporate operating under the new organization certificate.” The Banks expressed concern about this phrasing because they believed that such language may imply that a new corporate entity has been formed even in the case of a traditional merger (where an existing Bank absorbs a disappearing Bank). In response, FHFA has specifically provided in final § 1278.7(c) that, after acceptance of the organization certificate, the Continuing Bank shall “become or remain a body corporate (depending on the type of transaction) operating under such organization certificate.” This phrasing is intended to address both those business combinations where the Continuing Bank is a continuation of one of the existing Constituent Banks, as well as those where the Continuing Bank is considered to be an entirely new entity. Regardless of the form of the transaction, FHFA will not consider the merger to have been legally consummated until the new or revised organization certificate becomes effective.
In addition, final § 1278.7(c)(3) provides that the corporate existence of any Constituent Bank that is not a Continuing Bank shall cease as of the Effective Date of the organization certificate of the Continuing Bank, except as provided in the merger agreement. The latter clause is intended to provide for those cases in which it may be useful or necessary for a disappearing Constituent Bank to continue in existence for a short period following the consummation of a merger—for example, where a “shell” Bank that has transferred its territory and most of its assets and liabilities to another Bank may need time wind down its affairs, or where the disappearing Bank is being acquired by two or more other Banks and the transactions are not to be consummated simultaneously. Section 25 of the Bank Act provides that each Bank shall have succession until dissolved by the Director (or by Act of Congress) and final § 1278.7(c)(3) is intended to make clear that the Director's approval of the merger application and endorsement of the new organization certificate are sufficient to dissolve any non-Continuing Banks without further action in cases where the merger agreement does not provide for the temporary continuation of a disappearing Constituent Bank. In the case of a shell Bank that is winding down its affairs, the Director will issue a separate order of dissolution at the appropriate time. Under the rule, any Constituent Bank that is a party to a merger (as that term is broadly defined in the rule) that continues in existence after the consummation of the merger without specific provision for its eventual disposition (either through dissolution or another merger) will be considered to be a Continuing Bank and will be subject to all applicable requirements.
Final § 1278.7(d) provides that, after the Director accepts the organization certificate for the Continuing Bank, FHFA shall provide prompt written notice of that fact to the Constituent Banks, as well as to each other Bank and the Office of Finance. This notice must include the date of acceptance and the Effective Date of the organization certificate for the Continuing Bank.
The final rule does not contain any collections of information pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The final rule applies only to the Banks, which do not come within the meaning of small entities as defined in the Regulatory Flexibility Act (RFA).
Banks, banking, Federal home loan banks, mergers.
For the reasons stated in the Supplementary Information, the Federal Housing Finance Agency hereby amends chapter XII of title 12 of the Code of Federal Regulations by adding new part 1278 to subchapter D to read as follows:
12 U.S.C. 1432(a), 1446, 4511.
(1) A merger of one or more Banks into another Bank;
(2) A consolidation of two or more Banks resulting in a new Bank;
(3) A purchase of substantially all of the assets, and assumption of substantially all of the liabilities, of one or more Banks by another Bank or Banks; or
(4) Any other business combination of two or more Banks into one or more resulting Banks.
Any two or more Banks may merge voluntarily under authority of section 26(b) of the Bank Act, provided that each of the following requirements has been satisfied:
(a) The Constituent Banks have executed a written merger agreement that satisfies all requirements of § 1278.3;
(b) The Constituent Banks have jointly filed a merger application with FHFA that satisfies all requirements of § 1278.4;
(c) The Director has approved the merger application in accordance with the requirements of § 1278.5;
(d) The members of each Constituent Bank have ratified the merger agreement as provided under § 1278.6; and
(e) The Director has determined that the Constituent Banks have satisfied all conditions imposed in connection with the approval of the merger application, and has accepted the properly executed organization certificate of the Continuing Bank, as provided under § 1278.7.
A merger of Banks under the authority of § 1278.2 shall require a written merger agreement that:
(a) Has been authorized by the affirmative vote of a majority of a quorum of the board of directors of each Constituent Bank at a meeting on the record and has been executed by authorized signing officers of each Constituent Bank; and
(b) Sets forth all material terms and conditions of the merger, including, without limitation, provisions addressing each of the following matters—
(1) The proposed Effective Date and the proposed acquisition date for purposes of accounting for the transaction under GAAP, if that date is to be different from the Effective Date;
(2) The proposed organization certificate and bylaws of the Continuing Bank;
(3) The proposed capital structure plan for the Continuing Bank;
(4) The proposed size and structure of the board of directors for the Continuing Bank;
(5) The formula to be used to exchange the stock of the Constituent Banks for the stock of the Continuing Bank, and a provision prohibiting the issuance of fractional shares of stock;
(6) Any conditions that must be satisfied prior to the Effective Date, which must include approval by the Director and ratification by the members of the Constituent Banks;
(7) A statement of the representations or warranties, if any, made or to be made by any Constituent Bank;
(8) A description of the legal or accounting opinions or rulings, if any, that are required to be obtained or furnished by any party in connection with the proposed merger; and
(9) A statement that the board of directors of a Constituent Bank may terminate the merger agreement before the Effective Date upon a determination that:
(i) The information disclosed to members contained material errors or omissions;
(ii) Material misrepresentations were made to members regarding the impact of the merger;
(iii) Fraudulent activities were used to obtain members' approval; or
(iv) An event occurred subsequent to the members' vote that would have a significant adverse impact on the future viability of the Continuing Bank.
(a)
(1) A written statement that includes—
(i) A summary of the material features of the proposed merger;
(ii) The reasons for the proposed merger;
(iii) The effect of the proposed merger on the Constituent Banks and their members;
(iv) The proposed Effective Date, the proposed acquisition date for purposes of accounting for the transaction under GAAP, if that date is to be different from the Effective Date (including the reasons for designating a different acquisition date), and the Record Date established by each Constituent Bank's board of directors;
(v) If the Constituent Banks contemplate that the proposed merger will be one of two or more related transactions, a summary of the material features of any related transactions and the bearing that the consummation of, or failure to consummate, the related transactions is expected to have upon the proposed merger;
(vi) If not addressed by the merger agreement, the Banks' proposal for the ultimate size and composition of the board of directors for the Continuing Bank and their plan for reducing the board to its ultimate size and composition, as well as the names of the persons proposed to serve as directors and senior executive officers of the Continuing Bank immediately after the merger;
(vii) A description of all proposed material operational changes including, but not limited to, reductions in the existing staffs of the Constituent Banks (to the extent such information is known), whether and how Bank operations will be combined, and whether any Constituent Bank will continue to operate as a branch of the Continuing Bank;
(viii) Information demonstrating that the Continuing Bank will comply with all applicable capital requirements after the Effective Date;
(ix) A statement explaining all officer and director indemnification provisions; and
(x) An undertaking that the Constituent Banks will continue to disclose all material information, and update all items of the application, as appropriate;
(2) A copy of the executed merger agreement and a certified copy of the resolution of the board of directors of each Constituent Bank authorizing the merger agreement;
(3) A copy of the proposed organization certificate of the Continuing Bank;
(4) A copy of the proposed bylaws of the Continuing Bank;
(5) A copy of the proposed capital structure plan of the Continuing Bank;
(6) The most recent annual audited Financial Statements, and any interim quarterly financial statements for the year-to-date, for each Constituent Bank; and
(7) Pro forma Financial Statements for the Continuing Bank as of the date of the most recent statement of condition supplied under paragraph (a)(6) of this section, and forecasted pro forma Financial Statements for each of at least two years following such date.
(b)
(c)
(1) If FHFA determines that the application is complete and that it has all information necessary to evaluate the proposed merger, it shall so inform the Constituent Banks in writing.
(2) If FHFA determines that the application is incomplete, or that it requires additional information in order to evaluate the application, it shall so inform the Constituent Banks in writing, and shall specify the number of days within which the Constituent Banks must provide any additional information or materials. Within 15 days of receipt of the additional information or materials, FHFA shall inform the Constituent Banks in writing whether the merger application is complete.
(a)
(b)
(1) A certified copy of the members' resolution ratifying the merger agreement, on which the members cast their votes; and
(2) A certification of the member vote from the Bank's corporate secretary or from an independent third party.
(c)
(a)
(1)
(i) A ballot that permits the member to vote for or against the ratification of the merger agreement, or to abstain from such vote; and
(ii) A Disclosure Statement that establishes a closing date for the Bank's receipt of completed ballots that is no earlier than 30 days after the date that the ballot and Disclosure Statement are delivered to its members.
(2)
(3)
(4)
(i) The total number of eligible votes;
(ii) The number of members voting in the election; and
(iii) The total number of votes cast both for and against ratification of the merger agreement, as well as those that were eligible to be cast by members that abstained and by members who failed to return completed ballots.
(b)
(a)
(1) Evidence acceptable to the Director that all conditions imposed in connection with the approval of the merger application under § 1278.5 have been satisfied, including the items specified in §§ 1278.5(b)(1) and (2); and
(2) An organization certificate for the Continuing Bank, in such form as FHFA may specify, that has been executed by the individuals who will constitute the board of directors of the Continuing Bank.
(b)
(1) The proposed Effective Date set forth in the merger agreement or, if the merger agreement expresses the proposed Effective Date in terms of a range of dates, a date within the applicable range of dates; or
(2) If the proposed Effective Date set forth in the merger agreement has passed, the earlier of:
(i) The 10th business day following the date of acceptance of the organization certificate by the Director; or
(ii) The last business day preceding any date specified in the merger agreement by which the merger agreement will terminate if the merger has not become effective.
(c)
(1) The Continuing Bank shall become or remain a body corporate (depending on the type of transaction) operating under such organization certificate with all powers granted to a Bank under the Bank Act;
(2) The Continuing Bank shall succeed to all rights, titles, powers, privileges, books, records, assets, and liabilities of the Constituent Banks, as provided in the merger agreement; and
(3) The corporate existence of any Constituent Bank that is not a Continuing Bank shall cease, unless otherwise provided in the merger agreement.
(d)
Federal Aviation Administration (FAA), DOT.
Final rule; correction
This action corrects a final rule published by the FAA in the
Effective date 0901 UTC, December 15, 2011. The Director of the Federal Register approves this incorporation by reference action under 1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
Paul Gallant, Airspace, Regulations and ATC Procedures Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591;
On September 19, 2011, the FAA published a final rule in the
Area Navigation Routes are published in paragraph 2006 of FAA Order 7400.9V, dated August 9, 2011, and effective September 15, 2011, which is incorporated by reference in 14 CFR
Accordingly, pursuant to the authority delegated to me, the coordinates for the CANDR waypoint as published in the
On page 57905, line 38, Remove “CANDR, NJ WP (lat. 40°57′59″ N., long. 74°57′29″ W.)”and insert “CANDR, NJ WP (lat. 40°58′16″ N., long. 74°57′35″ W.)
Federal Aviation Administration (FAA), DOT.
Final rule.
This action amends Class D and Class E airspace at Baltimore, MD, as the Martin Non-Directional Beacon (NDB) has been decommissioned and new Standard Instrument Approach Procedures have been developed at Martin State Airport. This action also updates the geographic coordinates of the Baltimore VORTAC and makes a minor adjustment to the geographic coordinates of the airport. This action enhances the safety and airspace management of Instrument Flight Rules (IFR) operations at the airport.
Effective 0901 UTC, February 9, 2012. The Director of the
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.
On August 31, 2011, the FAA published in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 amends Class D airspace and Class E surface airspace and Class E airspace designated as an extension to Class D surface area. Airspace reconfiguration is necessary due to the decommissioning of the Martin NDB and cancellation of the NDB approach, and for continued safety and management of IFR operations at the airport. The geographic coordinates for the Baltimore VORTAC and Martin State Airport also are adjusted to coincide with the FAA's aeronautical database.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends controlled airspace at Martin State Airport, Baltimore, MD.
Airspace, Incorporation by reference, Navigation (Air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from the surface to and including 2,500 feet MSL within a 5.2-mile radius of Martin State Airport and within 4.4 miles each side of a 14.7-mile radius arc of the Baltimore VORTAC extending clockwise from the Baltimore VORTAC 030° radial to the VORTAC 046° radial, excluding that airspace within the Washington Tri-Area Class B
Within a 5.2-mile radius of Martin State Airport and within 4.4 miles each side of a 14.7-mile radius arc of the Baltimore VORTAC extending clockwise from the Baltimore VORTAC 030° radial to the VORTAC 046° radial, excluding that airspace within the Washington Tri-Area Class B airspace area and Restricted Areas R-4001A and R-4001B when they are in effect. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.
That airspace extending upward from the surface within 4 miles each side of a 134° bearing from Martin State Airport extending from the 5.2-mile radius of Martin State Airport to 9.2 miles southeast of the airport, excluding that airspace within the Washington Tri-Area Class B airspace area and Restricted Areas R-4001A and R-4001B when they are in effect. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action amends Class E Airspace at Luray, VA, to accommodate the new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures serving Luray Caverns Airport. This action enhances the safety and airspace management of Instrument Flight Rules (IFR) operations within the National Airspace System. This action also makes a minor adjustment to the geographic coordinates of the airport.
Effective 0901 UTC, February 9, 2012. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.
On August 22, 2011, the FAA published in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 amends Class E airspace extending upward from 700 feet above the surface at Luray, VA, to provide the controlled airspace required to accommodate the new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures developed for Luray Caverns Airport. This action also adjusts the geographic coordinates of the airport to be in concert with the FAAs aeronautical database. This action is necessary for the safety and management of IFR operations at the airport.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends controlled airspace at Luray Caverns Airport, Luray, VA.
Airspace, Incorporation by reference, Navigation (Air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 14.5-mile radius of Luray Caverns Airport.
Coast Guard, DHS.
Notice of temporary deviation from regulations.
The Commander, Thirteenth Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the South 11th Street (“Murray Morgan”) Bridge across City Waterway also known as the Thea Foss Waterway, mile 0.6, at Tacoma, WA. The deviation is necessary to perform extensive maintenance and repair work on the bridge, including but not limited to removal and replacement of the roadway surface and the underlying steel stringer substructure as part a major bridge rehabilitation project. This deviation allows the bridge to remain in the closed position during construction activities.This deviation is effective from 8 a.m. on November 14, 2011 through 6 p.m. April 30, 2012.
Documents mentioned in this preamble as being available in the docket are part of docket USCG-2011-1068 and are available online by going to
If you have questions on this rule, call or email the Bridge Administrator, Coast Guard Thirteenth District; telephone (206) 220-7282 email
The City of Tacoma has requested to place the South 11th Street “Murray Morgan” Bridge in the closed or down position and to not open the bridge for vessel traffic to facilitate a major rehabilitation project on the bridge. The South 11th Street Bridge crosses City Waterway mile 0.6 at Tacoma, WA. The South 11th Street Bridge is also known as the Murray Morgan Bridge and City Waterway is also known as Thea Foss Waterway. The South 11th Street Bridge is a vertical lift bridge. During this deviation the bridge will be placed in the close or down position. There will be a debris containment system attached to the underside of the bridge for the duration of construction activities. A minimum vertical clearance of 57 feet above mean high water will be provided beneath the bridge and the attached debris containment system, at all time during the deviation period. Vessels which do not require a bridge opening may continue to transit beneath the bridge during this closure period. Under normal operations the bridge operates under 33 CFR 117.1061 which requires a two hour notice for an opening and allows the bridge to not open during morning and afternoon rush hours. This current deviation states the lift span of the 11th Street South Bridge (Murray Morgan Bridge) across City Waterway (Thea Foss Waterway), mile 0.6, need not open from 8 a.m. November 14, 2011 through 6 p.m. April 30, 2012; except as otherwise outlined in this article and through ongoing coordination with waterway users. The bridge will be able to open during this maintenance period for emergent situations provided 12 hours of advance notification of an opening is given. The bridge will be placed in the open position: November 24-27, 2011; December 24, 2011 through January 1, 2012, and either April 14-15, 2012 or April 21-22, 2012, to be coordinated with the local waterway users. The bridge will also be opened during an additional weekend in January, February, and March to be determined in coordination with local waterway users.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone on the Illinois River near Morris, Illinois. This zone is intended to restrict vessels from a portion of the Illinois River due to the Truman-Hobbs alteration of the Elgin Joliet & Eastern Railroad Drawbridge. This temporary safety zone is necessary to protect the surrounding public and vessels from the hazards associated with the removal of the Elgin Joliet & Eastern Railroad Drawbridge's old bridge piers and pier protection cells.
This rule is effective in the CFR from November 28, 2011 until December 9, 2011. It is effective for purposes of enforcement from 7 a.m. on November 16, 2011 until 7 a.m. on December 9, 2011.
Documents indicated in this preamble as being available in the docket are part of docket USCG-2011-1058 and are available online by going to
If you have questions on this temporary rule, contact or email BM1 Adam Kraft, U.S. Coast Guard Sector Lake Michigan, at (414) 747-7148 or
The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when an agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because there is insufficient time for the Coast Guard to wait for a notice and comment period to run. The Coast Guard only recently learned that the bridge project described below will take longer than previously planned and consequently, will continue beyond the expiration of the Coast Guard safety zone previously established. Thus, waiting for a notice and comment period to run would be impracticable and contrary to the public interest in that it would prevent the Coast Guard from protecting the public and vessels on navigable waters from the hazards associated with this ongoing bridge construction project.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Truman-Hobbs alteration of the Elgin Joliet & Eastern Railroad Drawbridge, which consists of the removal of the bridges old piers and pier protection cells had originally scheduled to finish by November 16, 2011. However, it has fallen behind schedule and will now go until December 9, 2011. The falling debris associated with the removal of the bridge's piers and protection cells poses a serious risk of injury to persons and property. As such, the Captain of the Port, Sector Lake Michigan, has determined that the alteration project of the Elgin Joliet & Eastern Railroad Drawbridge poses significant risks to public safety and property and that a safety zone is necessary.
Because of the aforementioned hazards, the Captain of the Port, Sector Lake Michigan, has determined that a safety zone is necessary to protect people and vessels. The safety zone will encompass all U.S. navigable waters of the Illinois River in the vicinity of the Elgin Joliet & Eastern Railroad Drawbridge between Mile Marker 270.1 and Mile Marker 271.5 of the Illinois River in Morris, IL. [DATUM: NAD 83].
All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port, Sector Lake Michigan, or his or her designated representative. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port, Sector Lake Michigan, or his or her designated representative. The Captain of the Port, Sector Lake Michigan, or his or her designated representative may be contacted via VHF-FM Channel 16 or at (414) 747-7182.
We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.
This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone around the bridge project will be relatively small and exist for relatively short duration. Thus, restrictions on vessel movement within that particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port or his or her designated representative.
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule will have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
This rule will affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor on a portion of the Illinois River at various times between 7 a.m. on November 16, 2011 and 7 a.m. on December 9, 2011.
This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This rule will only be enforced while unsafe conditions exist. Recreational Vessel traffic will be minimal due to the time of year and Commercial traffic is well aware of this project since it has been active since October 6, 2011. This rule will simply extend the duration of the safety zone that originally was set to expire at 7 a.m. on November 16, 2011.
In the event that this temporary safety zone affects shipping, commercial vessels may request permission from the Captain of The Port, Sector Lake Michigan, or his or her designated representative to transit through the safety zone. The Captain of the Port or his or her representative can be contacted via VHF-FM Channel 16 or at (414) 747-7182. The Coast Guard will give notice to the public via a Broadcast to Mariners that the regulation is in effect.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-(888) 734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule will not affect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not concern an environmental risk to health or risk to safety that may disproportionately affect children.
This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
We have analyzed this proposed rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction. This rule involves the establishment of a safety zone and is therefore categorically excluded under paragraph 34(g) of the Instruction.
A final environmental analysis checklist and categorical exclusion determination are available in the docket where indicated under
Harbors, Marine Safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(1) In accordance with the general regulations in § 165.23 of this part, entry into, transiting, or anchoring within this safety zone is prohibited unless authorized by the Captain of the Port, Sector Lake Michigan, or his or her designated representative.
(2) This safety zone is closed to all vessel traffic, except as may be permitted by the Captain of the Port, Sector Lake Michigan, or his or her on-scene representative.
(3) The “designated representative” of the Captain of the Port, Sector Lake Michigan, is any Coast Guard commissioned, warrant, petty officer, or District 8 Bridge Branch Member who has been designated by the Captain of the Port, Sector Lake Michigan, to act on his or her behalf. The designated representative of the Captain of the Port, Sector Lake Michigan, will be reachable via VHF-FM Channel 16 or by calling (414) 747-7182.
(4) Vessel operators desiring to enter or operate within the safety zone shall contact the Captain of the Port, Sector Lake Michigan, or his or her designated representative to obtain permission to do so. The Captain of the Port, Sector Lake Michigan, or his or her designated representative may be contacted via VHF Channel 16 or at (414) 747-7182. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the Captain of the Port, Sector Lake Michigan, or his or her designated representative.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing four temporary safety zones during New Year's Eve fireworks displays on certain navigable waterways in Naples, St. Petersburg, Cape Coral, and Sarasota, Florida. These safety zones are necessary to protect the public from the hazards associated with launching fireworks over navigable waters of the United States. Persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within any of the four safety zones unless authorized by the Captain of the Port St. Petersburg or a designated representative.
This rule is effective from 7 p.m. on December 31, 2011 until 1 a.m. on January 1, 2012.
Documents indicated in this preamble as being available in the docket are part of docket USCG-2011-0958 and are available online by going to
If you have questions on this temporary final rule, call or email Marine Science Technician First Class Nolan L. Ammons, Sector St. Petersburg Prevention Department, Coast Guard; telephone (813) 228-2191, email
The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the Coast Guard did not receive necessary information regarding the fireworks displays until October 6, 2011. As a result, the Coast Guard did not have sufficient time to publish an NPRM and to receive public comments prior to the fireworks displays. Any delay in the effective date of this rule would be contrary to the public interest because immediate action is needed to minimize potential danger to the public during the fireworks displays.
The legal basis for the rule is the Coast Guard's authority to establish regulated navigation areas and other limited access areas: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.
The purpose of the rule is to protect the public from the hazards associated with the launching of fireworks over navigable waters of the United States.
Multiple fireworks displays are planned for New Year's Eve celebrations throughout the Captain of the Port St. Petersburg Zone. The fireworks will be launched from land, piers, or barges. Whether launched from land, pier, or barge, such fireworks will explode over navigable waters of the United States.
The Coast Guard is establishing four temporary safety zones for New Year's Eve fireworks displays on navigable waters of the United States that are located in the Captain of the Port St. Petersburg Zone. The safety zones are listed below.
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Persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within any of the safety zones unless authorized by the Captain of the Port St. Petersburg or
We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.
Executive Orders 13563, Regulatory Planning and Review, and 12866, Improving Regulation and Regulatory Review, direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a significant regulatory action under section 3(f) of Executive Order 12866. Accordingly, the Office of Management and Budget has not reviewed this regulation under Executive Order 12866.
The economic impact of this rule is not significant for the following reasons: (1) The safety zones will be enforced for only six hours; (2) vessel traffic in the areas will be minimal during the enforcement periods; (3) although persons and vessels will not be able to enter, transit through, anchor in, or remain within any of the safety zones without authorization from the Captain of the Port St. Petersburg or a designated representative, they may operate in the surrounding areas during the enforcement periods; (4) persons and vessels may still enter, transit through, anchor in, or remain within the safety zones during the enforcement periods if authorized by the Captain of the Port St. Petersburg or a designated representative; and (5) the Coast Guard will provide advance notification of the safety zones to the local maritime community by Local Notice to Mariners and Broadcast Notice to Mariners.
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule may affect the following entities, some of which may be small entities: The owners or operators of vessels intending to enter, transit through, anchor in, or remain within any of the four safety zones established by this regulation during the respective enforcement period. For the reasons discussed in the Regulatory Planning and Review section above, this rule will not have a significant economic impact on a substantial number of small entities.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process.
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-(888) 734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or Tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.
This rule does not have Tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and
We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction. This rule involves establishing four temporary safety zones, as described in paragraph 34(g) of the Instruction, that will be enforced for a total of six hours. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.
(a)
(1)
(2)
(3)
(4)
(b)
(c)
(1) All persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the regulated areas unless authorized by the Captain of the Port St. Petersburg or a designated representative.
(2) Persons and vessels desiring to enter, transit through, anchor in, or remain within any of the regulated areas may contact the Captain of the Port St. Petersburg by telephone at (727) 824-7524, or a designated representative via VHF radio on channel 16, to request authorization. If authorization to enter, transit through, anchor in, or remain within any of the regulated areas is granted by the Captain of the Port St. Petersburg or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port St. Petersburg or a designated representative.
(3) The Coast Guard will provide notice of the regulated areas by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.
(d)
Environmental Protection Agency (EPA).
Direct final rule.
EPA is taking direct final action to approve several State Implementation Plan (SIP) revisions submitted by the South Carolina Department of Health and Environmental Control (SC DHEC). These revisions establish reasonably available control technology (RACT) requirements for the three major sources located in the portion of York County, South Carolina that is within the bi-state
This rule is effective on January 27, 2012 without further notice, unless EPA receives relevant adverse comment by December 28, 2011. If EPA receives such comment, EPA will publish a timely withdrawal in the
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2010-0017 and EPA-R04-OAR-2010-0018, by one of the following methods:
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Zuri Farngalo, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Zuri Farngalo may be reached by phone at (404) 562-9152 or by electronic mail address
On April 30, 2004, EPA designated the bi-state Charlotte Area as a moderate nonattainment area with respect to the 1997 8-hour ozone National Ambient Air Quality Standard (NAAQS).
Section 183(e) of the CAA directs EPA to: (1) List for regulation those categories of products that account for at least 80 percent of the VOC emissions, on a reactivity-adjusted basis, from consumer and commercial products in ozone nonattainment areas; and (2) divide the list of categories to be regulated into four groups. EPA published the initial list in the
The primary purpose of the CTGs is to satisfy the requirement in CAA section 182(b)(2) that states adopt RACT rules for all areas designated nonattainment for ozone and classified as moderate or above. The three parts to the section 182(b)(2) RACT requirement are: (1) RACT for sources covered by an existing CTG (
A CTG is a guidance document issued by EPA which, in combination with CAA section 182(b)(2), triggers a responsibility for states to submit RACT rules for stationary sources of VOC that are covered by the CTG as part of their SIPs. EPA defines RACT as “the lowest emission limit that a particular source is capable of meeting by the application of control technology that is reasonably available considering technological and economic feasibility.” 44 FR 53761 (September 17, 1979). Each CTG includes a “presumptive norm” or “presumptive RACT” that EPA believes satisfies the definition of RACT.
If a state submits a RACT rule that is consistent with the presumptive RACT, the state does not need to submit additional support to demonstrate that the rule meets the CAA's RACT requirement. However, if the state decides to submit an alternative emission limit or level of control for a source or source category for which there is a presumptive RACT, the state must submit independent documentation as to why the rule meets the statutory RACT requirement.
Section 182(b)(2) of the CAA addresses moderate and above areas for the 1-hour ozone standard. Further clarification of the RACT requirements for areas classified as moderate or above for the 1997 8-hour ozone NAAQS is provided in EPA's regulations. Specifically, 40 CFR 51.912, entitled “What requirements apply for reasonably available control technology (RACT) and reasonably available control measures (RACM) under the 8-hour NAAQS?” provides the pertinent RACT requirements for areas classified as moderate or above for the 1997 8-hour ozone NAAQS, stating:
(1) For each area subject to subpart 2 in accordance with 51.903 of this part and classified moderate or higher, the State shall submit a SIP revision that meets the nitrogen oxides (NO
(2) The State shall submit the RACT SIP for each area no later than 27 months after designation for the 8-hour ozone NAAQS, except that for a State subject to the requirements of the Clean Air Interstate Rule, the State shall submit NO
(3) The State shall provide for implementation of RACT as expeditiously as practicable but no later than the first ozone season or portion thereof which occurs 30 months after the RACT SIP is due.
The CTGs established by EPA are guidance to the states and provide recommendations only. A state can develop its own strategy for what constitutes RACT for the various CTG categories, and EPA will review that strategy in the context of the SIP process and determine whether it meets the RACT requirements of the CAA and its implementing regulations. If no major sources of VOC or NO
CTGs that were established in 1978 ultimately were required to be adopted by the States by 1990 (see schedule below for details). CAA Section 182(b)(2) provides that a CTG issued after 1990 must specify the date by which a state must submit a SIP revision in response to the CTG. States were required to have the pre-1990 CAA CTG categories and post-1990 CAA CTG categories for applicable areas addressed in their SIPs according to the following schedule:
Following the April 2004 designation of the bi-state Charlotte Area as a moderate ozone nonattainment area, South Carolina had until June 15, 2007, to submit an attainment demonstration, RACT submission (addressing the applicable CTG), and a reasonable further progress plan for the Rock Hill-
South Carolina provided SIP revisions addressing Groups I and II CTG, on August 31, 2007. Subsequent to South Carolina's August 31, 2007, SIP revision, South Carolina provided SIP revisions to address Group III CTG on February 23, 2009, and Group IV CTG on July 9, 2009, for the Rock Hill Fort-Mill Area. Today's action relates to South Carolina's SIP revisions for the Rock Hill-Fort Mill Area regarding Groups, I, II, III and IV CTG requirements, and South Carolina's RACT demonstration for major non-CTG sources in the Rock Hill-Fort Mill Area.
As part of its analysis to support the negative declarations for Groups I, II, III and IV CTG, South Carolina reviewed its permits files and emissions inventory information. After this review, South Carolina determined that there are no stationary sources or emitting facilities located in Rock Hill-Fort Mill Area that are subject to Groups I, II, III and IV CTG. In accordance with CAA requirements, South Carolina prepared SIP revisions with these negative declarations and provided the public with an opportunity to review and provide comment regarding South Carolina's analyses. EPA has reviewed South Carolina's SIP revisions in support of the negative declarations for Groups I, II, III and IV CTG, and has concluded that the Rock Hill-Fort Mill Area in York County, South Carolina has met all the statutory and regulatory requirements for making a negative declaration regarding Groups I, II, III and IV CTG. Further, EPA has determined that South Carolina's August 31, 2007, February 23, 2009, and July 7, 2009, SIP revisions meet the applicable requirements of the CAA and EPA regulations.
With regard to RACT for non-CTG sources, South Carolina identified three major non-CTG sources within the Rock Hill-Fort Mill Area subject to RACT requirements. The three sources are Bowater, Inc., Cytec Carbon Fibers, LLC, and Georgia Pacific Wood Products, LLC. South Carolina determined what constitutes RACT for these facilities using the top-down process used for prevention of significant deterioration and nonattainment new source review. The top-down process provides that all available control technologies be ranked in descending order of control effectiveness. The most stringent technology is analyzed based on the following criteria: Technical considerations, along with energy, environmental, and economic impact. After this analysis is complete a determination is made as to whether the technology is achievable. The most stringent technology may be eliminated in this fashion and then the next most stringent alternative is considered, and so on.
A report submitted by the three facilities concluded that emission control devices would not be economically feasible, and thus, that RACT for these facilities should consist only of work practice requirements. SC DHEC evaluated the RACT analyses submitted by the three facilities which are further discussed below.
Bowater Coated Paper Division (Bowater) produces bleached pulp and paper products and is a major source for both NO
Cytec Carbon Fibers LLC (Cytec) is a title V facility that operates a carbon fiber manufacturing process and is a major source for NO
Georgia Pacific—Catawba Hardboard Plant is a major source for VOC but not for NO
Pursuant to section 110 of the CAA, EPA is approving the revision to South Carolina's SIP revisions addressing negative declarations for applicability of Groups I, II, III and IV CTG for the Rock Hill-Fort Mill Area; and concerning the RACT requirements related to the 1997 8-hour ozone NAAQS for the Rock Hill-Fort Mill Area which is the portion of York County, South Carolina that is included in the bi-state Charlotte-Gastonia-Rock Hill 1997 8-hour ozone nonattainment area. EPA has evaluated South Carolina's August 31, 2007, February 23, 2009, and July 9, 2009, SIP revisions, and has determined that they meet the applicable requirements of the CAA and EPA regulations, and are consistent with EPA policy for negative declarations for Groups I, II, III and IV CTG, and for RACT.
On March 12, 2008, EPA issued a revised ozone NAAQS. See 73 FR 16436. EPA subsequently announced a reconsideration of the 2008 NAAQS, and proposed new 8-hour ozone NAAQS in January 2010. See 75 FR 2938. In September 2011, EPA withdrew the proposed reconsidered NAAQS and began implementation of the 2008 NAAQS. The current action, however, is being taken to address requirements under the 1997 ozone NAAQS. Requirements for the bi-state Charlotte Area under the 2008 NAAQS will be addressed in the future.
EPA is publishing this rule without prior proposal because the Agency views this as a non-controversial amendment and anticipates no adverse comments. However, in the proposed rules section of this
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 27, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of
Environmental protection, Air pollution control, Intergovernmental relations, Incorporation by reference, Ozone, Nitrogen Dioxides, Reporting and recordkeeping requirements, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(e) * * *
Federal Communications Commission.
Final rule; announcement of effective date.
In this document, the Commission announces that the Office of Management and Budget (OMB) has approved, for a period of three years, the information collection requirements contained in a final rule published July 27, 2011. The information collection requirements were approved on February 7, 2011, and November 17, 2011, by OMB.
The amendments to 47 CFR 73.624(g), published at 76 FR 44821, July 27, 2011, are effective on November 28, 2011.
For additional information contact Cathy Williams on (202) 418-2918 or via email to:
This document announces that on February 7, 2011 and November 17, 2011, OMB approved, for a period of three years, the information collection requirements contained in 47 CFR 73.624(g). The Commission publishes this document to announce the effective date of this rule section. See, In the Matter of Amendment of Parts 73 and 74 of the Commission's Rules to Establish Rules for Digital Low Power Television, Television Translator, and Television Booster Stations and to Amend Rules for Digital Class A Television Stations, MB Docket No. 03-185; FCC 11-110, 76 FR 44821, July 27, 2011.
As required by the Paperwork Reduction Act of 1995, (44 U.S.C. 3507), the Commission is notifying the public that it received OMB approval on February 7, 2011 and November 17, 2011, for the information collection requirements contained in 47 CFR 73.624(g). Under 5 CFR part 1320, an
No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a valid OMB Control Number.
The OMB Control Number is 3060-0906 and the total annual reporting burdens for respondents for this information collection are as follows:
Section 73.624(g) also adds a new group of respondents to this collection (namely, “low power television, TV translator, and Class A television station DTV stations operating pursuant to STA”). The Commission has also revised FCC Form 317 and its instructions to indicate that low power television, TV translator, and Class A television station DTV stations operating pursuant to STA are required to file FCC Form 317 (which includes reporting their ancillary and supplementary services, making the required payment to the Commission, and retaining the appropriate records).
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Final rule.
This rule increases the rail equipment accident/incident reporting threshold from $9,400 to $9,500 for certain railroad accidents/incidents involving property damage that occur during calendar year 2012. This action is needed to ensure that FRA's reporting requirements reflect cost increases that have occurred since the reporting threshold was last published in December of 2010.
This regulation is effective January 1, 2012.
Kebo Chen, Staff Director, U.S. Department of Transportation, Federal Railroad Administration, Office of Safety Analysis, RRS-22, Mail Stop 25, West Building 3rd Floor, Room W33-314, 1200 New Jersey Ave. SE., Washington, DC 20590 (telephone (202) 493-6079); or Gahan Christenson, Trial Attorney, U.S. Department of Transportation, Federal Railroad Administration, Office of Chief Counsel, RCC-10, Mail Stop 10, West Building 3rd Floor, Room W31-204, 1200 New Jersey Ave. SE., Washington, DC 20590 (telephone (202) 493-1381).
A “rail equipment accident/incident” is a collision, derailment, fire, explosion, act of God, or other event involving the operation of railroad on-track equipment (standing or moving) that results in damages to railroad on-track equipment, signals, tracks, track structures, or roadbed, including labor costs and the costs for acquiring new equipment and material, greater than the reporting threshold for the year in which the event occurs. 49 CFR 225.19(c). Each rail equipment accident/incident must be reported to FRA using the Rail Equipment Accident/Incident Report (Form FRA F 6180.54). 49 CFR 225.19(b) and (c). As revised, effective in 1997, paragraphs (c) and (e) of 49 CFR 225.19 provide that the dollar figure that constitutes the reporting threshold for rail equipment accidents/incidents will be adjusted, if necessary, every year in accordance with the procedures outlined in appendix B to part 225 to reflect any cost increases or decreases.
Approximately one year has passed since the rail equipment accident/incident reporting threshold was revised. 75 FR 75911 (December 7, 2010). Consequently, FRA has recalculated the threshold, as required by § 225.19(c), based on increased costs for labor and increased costs for equipment. FRA has determined that the current reporting threshold of $9,400, which applies to rail equipment accidents/incidents that occur during calendar year 2011, should increase by $100 to $9,500 for equipment accidents/incidents occurring during calendar year 2012, effective January 1, 2012. The specific inputs to the equation set forth in appendix B (
Where:
In this rule, FRA has recalculated the monetary reporting threshold based on the formula discussed in detail and adopted, after notice and comment, in the final rule published December 20, 2005, 70 FR 75414. FRA has found that both the current cost data inserted into this pre-existing formula and the original cost data that they replace were obtained from reliable Federal government sources. FRA has found that this rule imposes no additional burden on any person, but rather provides a benefit by permitting the valid comparison of accident data over time. Accordingly, finding that notice and comment procedures are either impracticable, unnecessary, or contrary to the public interest, FRA is proceeding directly to the final rule.
This rule has been evaluated in accordance with existing policies and procedures, and determined to be non-significant under both Executive Order 12866 and 13563 in addition to DOT policies and procedures (44 FR 11034 (Feb. 26, 1979)).
The Regulatory Flexibility Act of 1980 (5 U.S.C. 601-612) requires a review of proposed and final rules to assess their impact on small entities, unless the Secretary certifies that the rule will not have a significant economic impact on a substantial number of small entities. Pursuant to Section 312 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), FRA has issued a final policy that formally establishes “small entities” as including railroads that meet the line-haulage revenue requirements of a Class III railroad. 49 CFR part 209, app. C. For other entities, the same dollar limit in revenues governs whether a railroad, contractor, or other respondent is a small entity.
About 721 of the approximately 754 railroads in the United States are considered small entities by FRA. FRA certifies that this final rule will have no significant economic impact on a substantial number of small entities. To the extent that this rule has any impact on small entities, the impact will be neutral or insignificant. The frequency of rail equipment accidents/incidents, and therefore also the frequency of required reporting, is generally proportional to the size of the railroad. A railroad that employs thousands of employees and operates trains millions of miles is exposed to greater risks than one whose operation is substantially smaller. Small railroads may go for months at a time without having a reportable occurrence of any type, and even longer without having a rail equipment accident/incident. For example, current FRA data indicate that 3,000 rail equipment accidents/incidents were reported in 2006, with small railroads reporting 379 of them. Data for 2007 show that 2,694 rail equipment accidents/incidents were reported, with small railroads reporting 368 of them. Data for 2008 show that 2,478 rail equipment accidents/incidents were reported, with small railroads reporting 296 of them. In 2009, 1,905 rail equipment accidents/incidents were reported, and small railroads reported 272 of them. In 2010, 1,888 rail equipment accidents/incidents were reported, with small railroads reporting 258 of them. On average for those five calendar years, small railroads reported about 13% (ranging from 12% to 14%) of the total number of rail equipment accidents/incidents. FRA notes that these data are accurate as of the date of issuance of this final rule, and are subject to minor changes due to additional reporting. Absent this rulemaking (
There are no new information collection requirements associated with this final rule. Therefore, no estimate of a public reporting burden is required.
Executive Order 13132, entitled, “Federalism,” signed on August 4, 1999, requires that each agency “in a separately identified portion of the preamble to the regulation as it is to be issued in the Federal Register, provide[] to the Director of the Office of Management and Budget a federalism summary impact statement, which consists of a description of the extent of the agency's prior consultation with State and local officials, a summary of the nature of their concerns and the agency's position supporting the need to issue the regulation, and a statement of the extent to which the concerns of the State and local officials have been met * * *.” This rulemaking action has been analyzed in accordance with the principles and criteria contained in Executive Order 13132. This rule will not have a substantial direct effect on States, on the relationship between the National Government and the States, or on the distribution of power and the responsibilities among the various levels of government, as specified in the Executive Order 13132. Accordingly, FRA has determined that this rule will not have sufficient federalism implications to warrant consultation with State and local officials or the preparation of a federalism assessment. Accordingly, a federalism assessment has not been prepared.
FRA has evaluated this regulation in accordance with its “Procedures for Considering Environmental Impacts” (FRA's Procedures) (64 FR 28545 (May 26, 1999)) as required by the National Environmental Policy Act (42 U.S.C. 4321
Pursuant to Section 201 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 2 U.S.C. 1531), each Federal agency “shall, unless otherwise prohibited by law, assess the effects of Federal regulatory actions on State, local, and Tribal governments, and the private sector (other than to the extent that such regulations incorporate requirements specifically set forth in law).” Section 202 of the Act (2 U.S.C. 1532) further requires that “before promulgating any general notice of proposed rulemaking that is likely to result in the promulgation of any rule that includes any Federal mandate that may result in expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of [$140,800,000 or more (as adjusted for inflation)] in any one year, and before promulgating any final rule for which a general notice of proposed rulemaking was published, the agency shall prepare a written statement” detailing the effect on State, local, and Tribal governments and the private sector. The final rule will not result in the expenditure, in the aggregate, of $140,800,000 or more in any one year, and thus preparation of such a statement is not required.
Executive Order 13211 requires Federal agencies to prepare a Statement of Energy Effects for any “significant energy action.” 66 FR 28355 (May 22, 2001). Under the Executive Order, a “significant energy action” is defined as any action by an agency (normally published in the
Anyone is able to search the electronic form of all our comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
Investigations, Penalties, Railroad safety, Reporting and recordkeeping requirements.
In consideration of the foregoing, FRA amends part 225 of chapter II, subtitle B of title 49, Code of Federal Regulations, as follows:
49 U.S.C. 103, 322(a), 20103, 20107, 20901-02, 21301, 21302, 21311; 28 U.S.C. 2461, note; and 49 CFR 1.49.
(c)
(e) The reporting threshold is $6,700 for calendar years 2002 through 2005, $7,700 for calendar year 2006, $8,200 for calendar year 2007, $8,500 for calendar year 2008, $8,900 for calendar year 2009, $9,200 for calendar year 2010, $9,400 for calendar year 2011 and $9,500 for calendar year 2012. The procedure for determining the reporting threshold for calendar years 2006 and beyond appears as paragraphs 1-8 of appendix B to part 225.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to supersede an existing airworthiness directive (AD) that applies to certain Model 737-300, -400, and -500 series airplanes. The existing AD currently requires repetitive external detailed inspections or non-destructive inspections to detect cracks in the fuselage skin along the chem-mill steps at stringers S-1 and S-2R, between station (STA) 400 and STA 460, and repair if necessary. Since we issued that AD, we have received reports of additional crack findings of the fuselage skin at the chem-mill steps. This proposed AD would add inspections for cracking in additional fuselage skin locations, and repair if necessary. This proposed AD would also reduce the inspection thresholds and repetitive intervals for certain airplanes. We are proposing this AD to detect and correct fatigue cracking of the fuselage skin panels at the chem-mill steps, which could result in sudden fracture and failure of the fuselage skin panels, and consequent rapid decompression of the airplane.
We must receive comments on this proposed AD by January 12, 2012.
You may send comments by any of the following methods:
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•
•
•
For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone (206) 544-5000, extension 1; fax (206) 766-5680; email
You may examine the AD docket on the Internet at
Wayne Lockett, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton, Washington 98057-3356; phone: (425) 917-6447; fax: (425) 917-6590; email:
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
On September 11, 2008, we issued AD 2008-19-03, Amendment 39-15670 (73 FR 56958, October 1, 2008), for certain Model 737-300, -400, and -500 series airplanes. That AD requires repetitive external detailed inspections or non-destructive inspections to detect cracks in the fuselage skin along the chem-mill steps at stringers S-1 and S-2R, between STA 400 and STA 460, and repair if necessary. That AD resulted from reports of cracks in the fuselage skin common to stringers S-1 and S-2R, between STA 400 and STA 460. We issued that AD to detect and correct fatigue cracking of the fuselage skin panels at the chem-mill steps, which could result in sudden fracture and failure of the fuselage skin panels, and consequent rapid decompression of the airplane.
Since we issued AD 2008-19-03, Amendment 39-15670 (73 FR 56958, October 1, 2008), we received reports of new findings of cracking in the fuselage skin at the chem-mill steps adjacent to the Air Traffic Control antenna. One reported crack was on the inboard side of S-2R at STA 451; the crack measured one inch long. That airplane had accumulated 52,207 total flight cycles. Another reported crack was on the left-hand side of stringer S-1 at STA 431. That airplane had accumulated 43,565 total flight cycles. Other cracks were located on the left-hand side of stringer S-1, between STA 400 and STA 460 on certain airplanes. The cause of the cracking was fatigue due to high-tension stresses and local bending at the edge of the chem-mill pockets of the bonded skin. It was also determined that the detailed inspection alone (one method required by the existing AD) is not adequate to detect the cracking.
We reviewed Boeing Alert Service Bulletin 737-53A1293, Revision 1,
Boeing Alert Service Bulletin 737-53A1293, Revision 1, dated July 7, 2010, adds an ultrasonic phased array inspection to the options for non-destructive inspections (NDI) specified in Boeing Alert Service Bulletin 737-53A1293, dated August 13, 2008, and combines the detailed inspection and the NDI in lieu of doing either Option 1 (a detailed inspection) or Option 2 (an NDI). Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011, clarifies repair instructions for specific findings.
The initial inspection compliance times range between the following, depending on configuration: (1) Before the accumulation 33,000 total flight cycles, or within 500 flight cycles after the date on this service bulletin, whichever is later; and (2) before the accumulation of 35,000 total flight cycles, or within 1,800 flight cycles after the date on this service bulletin, whichever is later.
The repetitive inspection intervals range between 500 and 2,400 flight cycles, depending on the inspection option and configuration.
We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of these same type designs.
This proposed AD would retain certain requirements of AD 2008-19-03, Amendment 39-15670 (73 FR 56958, October 1, 2008). This proposed AD would also require accomplishing the actions specified in Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011, except as discussed under “Differences Between the AD and the Service Information.”
Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011, specifies contacting the manufacturer for instructions on how to repair a certain condition, but this AD requires repairing that condition in one of the following ways:
• Using a method that we approve; or
• Using data that meet the certification basis of the airplane, and that have been approved by an Authorized Representative for the Boeing Commercial Airplanes Delegation Option Authorization Organization whom we have authorized to make those findings.
The post-repair inspection specified in Tables 4 and 6 of paragraph 1.E., “Compliance,” of Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011, is not required by this proposed AD.
We consider this proposed AD interim action. If final action is identified later, we might consider further rulemaking then.
We estimate that this proposed AD affects 596 airplanes of U.S. registry.
We estimate the following costs to comply with this proposed AD:
We have received no definitive data that would enable us to provide a cost estimate for the on-condition actions specified in this proposed AD.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in subtitle VII, part A, subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that the proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by removing airworthiness directive (AD) 2008-19-03, Amendment 39-15670 (73 FR 56958, October 1, 2008), and adding the following new AD:
(a) The FAA must receive comments on this AD action by January 12, 2012.
(b) This AD supersedes AD 2008-19-03, Amendment 39-15670 (73 FR 56958, October 1, 2008).
(c) This AD applies to Model 737-300, -400, and -500 series airplanes, certificated in any category; as identified in Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011.
(d) Joint Aircraft System Component (JASC)/Air Transport Association (ATA) of America Code 53, Fuselage.
(e) This AD was prompted by reports of additional crack findings of the fuselage skin at the chem-mill steps. We are issuing this AD to detect and correct fatigue cracking of the fuselage skin panels at the chem-mill steps, which could result in sudden fracture and failure of the fuselage skin panels, and consequent rapid decompression of the airplane.
(f) Comply with this AD within the compliance times specified, unless already done.
(g) At the applicable times specified in paragraph 1.E., “Compliance,” of Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011, except as provided by paragraph (j) and (k) of this AD: Do both a detailed inspection and a nondestructive inspection (NDI) (medium frequency eddy current, magneto optical imaging, C-scan, or ultrasonic phased array) to detect cracks in the fuselage skin along the chem-mill steps at stringers S-1 and S-2R, between station (STA) 400 and STA 460, in accordance with the Accomplishment Instructions of Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011. Repeat the applicable inspections thereafter at intervals not to exceed those specified in paragraph 1.E., “Compliance,” of Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011.
(h) If any crack is found during any inspection required by paragraph (g) of this AD, before further flight, repair in accordance with the Accomplishment Instructions of Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011; except as provided by paragraph (i) of this AD. Installation of a repair that meets the conditions specified in paragraph 1.E., “Compliance,” of Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011, terminates the repetitive inspections required by paragraph (g) of this AD for the repaired area only.
(i) If any crack is found during any inspection required by paragraph (g) of this AD and Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011, specifies to contact Boeing for repair: Before further flight, repair using a method approved in accordance with the procedures specified in paragraph (n) of this AD.
(j) Where Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011, specifies a compliance time relative to the date on that service bulletin, this AD requires compliance within the specified compliance time after the effective date of this AD.
(k) Where the Condition column of paragraph 1.E., “Compliance,” of Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011, specifies a condition based on whether an airplane has or has not been inspected, this AD bases the condition on whether an airplane has or has not been inspected as of the effective date of this AD.
(l) The post-repair inspection specified in Tables 4 and 6 of paragraph 1.E., “Compliance,” of Boeing Service Bulletin 737-53A1293, Revision 2, August 10, 2011, is not required by this AD.
The damage tolerance inspections specified in Tables 4 and 6 of paragraph 1.E., “Compliance,” of Boeing Service Bulletin 737-53A1293, Revision 2, August 10, 2011, may be used in support of compliance with section 121.1109(c)(2) or 129.109(c)(2) of the Federal Aviation Regulations (14 CFR 121.1109(c)(2) or 14 CFR 129.109(c)(2)).
(m) Actions done before the effective date of this AD in accordance with Boeing Alert Service Bulletin 737-53A1293, Revision 1, July 7, 2010, are acceptable for compliance with the corresponding actions required by this AD.
(n)(1) The Manager, Seattle ACO, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in the Related Information section of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair required by this AD if it is approved by the Boeing Commercial Airplanes ODA that has been authorized by the Manager, Seattle ACO to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane.
(4) AMOCs approved for AD 2008-19-03, Amendment 39-15670 (73 FR 56958, October 1, 2008), are approved as AMOCs for the corresponding requirements in this AD.
(o) For more information about this AD, contact Wayne Lockett, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton, Washington 98057-3356; phone: (425) 917-6447; fax: (425) 917-6590; email:
(p) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone (206) 544-5000, extension 1; fax (206) 766-5680; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all Empresa Brasileira de Aeronautica S.A. (EMBRAER) Model ERJ 190 airplanes. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:
It has been found the occurrence of damage on the rod end of the Main Landing Gear (MLG) retraction actuator. The ANAC [Agência Nacional de Aviação Civil] is issuing this AD to prevent breakage of the MLG retracting actuator rod, which may result in MLG extension with no hydraulic damping and consequent damage to the locking mechanism and collapse of the MLG.
The proposed AD would require actions that are intended to address the unsafe condition described in the MCAI.
We must receive comments on this proposed AD by January 12, 2012.
You may send comments by any of the following methods:
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For service information identified in this proposed AD, contact Empresa Brasileira de Aeronautica S.A. (EMBRAER), Technical Publications Section (PC 060), Av. Brigadeiro Faria Lima, 2170-Putim-12227-901 São Jose dos Campos-SP-BRASIL; telephone +55 12 3927-5852 or +55 12 3309-0732; fax +55 12 3927-7546; email
You may examine the AD docket on the Internet at
Cindy Ashforth, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425) 227-2768; fax (425) 227-1149.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The Agencia Nacional De Aviacao Civil—Brazil (ANAC), which is the airworthiness authority for Brazil, has issued Brazilian Airworthiness Directive 2011-02-01, dated February 12, 2011 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:
It has been found the occurrence of damage on the rod end of the Main Landing Gear (MLG) retraction actuator. The ANAC [Agência Nacional de Aviação Civil] is issuing this AD to prevent breakage of the MLG retracting actuator rod, which may result in MLG extension with no hydraulic damping and consequent damage to the locking mechanism and collapse of the MLG.
EMBRAER has issued Service Bulletin 190-32-0036, dated October 4, 2010; and Service Bulletin 190-32-0037, dated October 6, 2010. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.
We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a Note within the proposed AD.
Based on the service information, we estimate that this proposed AD would affect about 73 products of U.S. registry.
In addition, we estimate that any necessary follow-on actions would take about 6 work-hours and require parts costing $0, for a cost of $510 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. We have no way of determining the number of products that may need these actions.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by adding the following new AD:
(a) We must receive comments by January 12, 2012.
(b) None.
(c) This AD applies to Empresa Brasileira de Aeronautica S.A. (EMBRAER) Model ERJ 190-100 STD, -100 LR, -100 ECJ, and -100 IGW airplanes; and Model ERJ 190-200 STD, -200 LR, and -200 IGW airplanes; certificated in any category; all serial numbers.
(d) Air Transport Association (ATA) of America Code 32: Landing Gear.
(e) The mandatory continuing airworthiness information (MCAI) states:
It has been found the occurrence of damage on the rod end of the Main Landing Gear (MLG) retraction actuator. The ANAC [Agência Nacional de Aviação Civil] is issuing this AD to prevent breakage of the MLG retracting actuator rod, which may result in MLG extension with no hydraulic damping and consequent damage to the locking mechanism and collapse of the MLG.
(f) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
(g) Within 30 days after the effective date of this AD, do a one-time general visual inspection to determine if part number (P/N) 190-70980-403 is installed on the left-hand and right-hand MLG retraction actuator. A review of airplane maintenance records is acceptable in lieu of this inspection if the part number of the MLG retraction actuator can be conclusively determined from that review.
For the purpose of this AD, a general visual inspection (GVI) is: “A visual examination of an interior or exterior area, installation or assembly to detect obvious damage, failure or irregularity. This level of inspection is made from within touching distance, unless otherwise specified. A mirror may be necessary to enhance visual access to all exposed surfaces in the inspection area. This level of inspection is made under normally available lighting conditions such as daylight, hangar lighting, flashlight or droplight, and may require removal or opening of access panels or doors. Stands, ladders or platforms may be required to gain proximity to the area being checked.”
(1) No further action is required by paragraph (g) of this AD if no MLG retraction actuator having P/N 190-70980-403 is found.
(2) If any MLG retraction actuator having P/N 190-70980-403 is found, do a GVI of the actuator and bolt (P/N 2821-0028) for discrepancies (such as cracks, damage, and movement between the actuator rod end and shock strut lug of the MLG retraction actuator), in accordance with “Part I” of the Accomplishment Instructions of EMBRAER Service Bulletin 190-32-0036, dated October 4, 2010, within the applicable compliance time specified in paragraphs (g)(2)(i) and (g)(2)(ii) of this AD. Repeat the inspection, thereafter, at intervals not to exceed 3,500 flight cycles, until the actions required by paragraph (j) of this AD are done.
(i) For any MLG retraction actuator that has accumulated fewer than 3,500 total flight cycles as of the effective date of this AD, do the GVI of the actuator before the accumulation of 4,500 total flight cycles on the MLG retraction actuator.
(ii) For any MLG retraction actuator that has accumulated 3,500 total flight cycles or more as of the effective date of this AD, do the GVI of the actuator within 1,000 flight cycles after the effective date of this AD.
(h) If any discrepancy is found during any inspection required by paragraph (g)(2) of this AD, including any movement between the actuator rod-end and shock strut lug, before further flight, replace the MLG retraction actuator, and as applicable the anti-rotation pin and the attachment bolt, in accordance with “Part II” and “Part III,” as applicable, of EMBRAER Service Bulletin 190-32-0036, dated October 4, 2010; except where EMBRAER Service Bulletin 190-32-0036, dated October 4, 2010, specifies to contact the manufacturer, before further flight repair in accordance with a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, or Agência Nacional de Aviação Civil (or its delegated agent).
(i) Before any MLG retraction actuator having P/N 190-70980-403 accumulates
(j) For all actuators: Within 20,000 flight cycles or within 96 months after the effective date of this AD, whichever occurs first, do the replacement and modification, as applicable, in accordance with “Part III” of EMBRAER Service Bulletin 190-32-0037, dated October 6, 2010. Doing the actions in this paragraph is a terminating action for the requirements specified in paragraphs (g), (h), and (i) of this AD.
This AD differs from the MCAI and/or service information as follows: Brazilian Airworthiness Directive 2011-02-01, dated February 12, 2011, requires replacing the MLG retraction actuator, and as applicable, the anti-rotation pin and attachment bolt within the next 500 flight cycles if any discrepancy is found. However, if any discrepancy is found, this AD requires replacing the MLG retraction actuator, and as applicable, the anti-rotation pin and attachment bolt, before further flight.
(k) The following provisions also apply to this AD:
(1)
(2)
(l) Refer to MCAI Brazilian Airworthiness Directive 2011-02-01, dated February 12, 2011; EMBRAER Service Bulletin 190-32-0036, dated October 4, 2010; and EMBRAER Service Bulletin 190-32-0037, dated October 6, 2010; for related information.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to supersede two existing airworthiness directives (AD) that apply to Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. The first existing AD currently requires, for certain airplanes, repetitive inspections of the Station (STA) 348.2 frame to detect cracking under the stop fittings and intercostal flanges at stringers S-14L, S-15L, and S-16L, and corrective action if necessary. The second existing AD currently requires repetitive inspections to detect cracking of the intercostal webs, attachment clips, and stringer splice channels, and corrective action if necessary. Since we issued those ADs, we have received reports of cracking of the STA 348.2 frame above the two outboard fasteners attaching the frame inner chord and door stop fittings, and in the outboard chord at stringer S-16L. We have also received reports of missing fasteners in the STA 348.2 frame inner chord. This proposed AD would require additional airplanes to do the inspection for cracking under the stop fittings; extend the repetitive interval for certain airplanes; add a one-time inspection to detect missing fasteners; and update or add certain inspection and repair instructions. This proposed AD would also require, for certain airplanes, repetitive inspections of the cargo barrier net fitting for cracking and repair if necessary. This proposed AD would also add, for certain airplanes, repetitive inspections for cracking of the S-15L aft intercostal, and repair if necessary. We are proposing this AD to detect and correct fatigue cracking of the intercostals on the forward and aft sides of the forward entry door cutout, which could result in loss of the forward entry door and rapid decompression of the airplane.
We must receive comments on this proposed AD by January 12, 2012.
You may send comments by any of the following methods:
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•
•
•
For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P. O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone (206) 544-5000, extension 1; fax (206) 766-5680; email
You may examine the AD docket on the Internet at
Alan Pohl, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton, Washington 98057-3356;
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
On April 20, 2004, we issued AD 2004-09-09, Amendment 39-13598 (69 FR 23646, April 30, 2004), for all Boeing Model 737-200C series airplanes. That AD requires repetitive inspections of the Station (STA) 348.2 frame to detect cracking under the stop fittings and intercostal flanges at Stringers S-14L, S-15L, and S-16L; and corrective action if necessary. That AD resulted from a report of cracks in the STA 348.2 frame on a Boeing Model 737-200C series airplane. We issued that AD to detect and correct fatigue cracking of the intercostals on the forward and aft sides of the forward entry door cutout, which could result in the loss of the forward entry door and rapid decompression of the airplane.
On July 23, 2009, we issued AD 2009-16-14, Amendment 39-15987 (74 FR 38901, August 5, 2009), for certain Boeing Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. That AD requires repetitive inspections of the intercostal webs, attachment clips, and stringer splice channels for cracks; and corrective action if necessary. That AD resulted from reports of fatigue cracks on several Boeing Model 737-200 series airplanes. We issued that AD to detect and correct fatigue cracking of the intercostals on the forward and aft sides of the forward entry door, which could result in loss of the forward entry door and rapid decompression of the airplane.
Since we issued AD 2004-09-09, Amendment 39-13598 (69 FR 23646, April 30, 2004), we have received reports of cracking above the two outboard fasteners attaching the frame inner chord and door stop fitting of the STA 348.2 frame at S-15L. The cracking was reported on seven airplanes that had accumulated between 19,185 and 64,800 flight cycles (AD 2004-09-09 applies only to Model 737-200C airplanes). Cracking has also been found in the outboard chord at S-16L. In addition, we have received reports of 10 airplanes with missing fasteners in the STA 348.2 frame inner chord at S-7L through S-15L.
In addition, the requirement to inspect the intercostal on the aft side at S-14L to S-16L is common to both AD 2004-09-09, Amendment 39-13598 (69 FR 23646, April 30, 2004), and AD 2009-16-14, Amendment 39-15987 (74 FR 38901, August 5, 2009). Service history indicates that the repetitive inspection interval of 6,000 flight cycles for that area, as required by AD 2009-16-14, Amendment 39-15987 (74 FR 38901, August 5, 2009), is adequate to ensure continued operational safety. The repetitive interval required by AD 2004-09-09, Amendment 39-13598 (69 FR 23646, April 30, 2004), is 4,500 flight cycles.
Boeing Commercial Airplanes has received a Organization Designation Authorization (ODA). We have revised paragraph (h) of this proposed AD to delegate the authority to approve an alternative method of compliance for any repair required by this AD to the Boeing Commercial Airplanes ODA rather than a Designated Engineering Representative (DER).
We reviewed Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010. The procedures in Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010, differ from those in 737-53A1204, Revision 1, dated March 26, 2007 (the appropriate source of service information for AD 2009-16-14 (74 FR 38901, August 5, 2009)), as follows:
• Repetitive detailed and high frequency eddy current (HFEC) inspections for cracking of the S-15L aft intercostal between body station (BS) 348.2 and BS 360 and a detailed inspection of the cargo barrier net fitting at the intercostal are added for Model 737-200C airplanes.
• New repair instructions are added for cracking found at the S-14L, S-15L, and S-16L intercostals. The repair includes either doing actions specified in Boeing Alert Service Bulletin 737-53A1240, Revision 1, dated June 29, 2010 (described below), or, if a crack is at the S-15L aft intercostal or the damage at other intercostal locations is outside certain parameters covered in Boeing Alert Service Bulletin 737-53A1240, Revision 1, Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010, specifies contacting Boeing for repair instructions.
We also reviewed Boeing Alert Service Bulletin 737-53A1240, Revision 1, dated June 29, 2010. The procedures in Boeing Alert Service Bulletin 737-53A1240, Revision 1, dated June 29, 2010, differ from those in Boeing Alert Service Bulletin 737-53A1240, dated April 10, 2003 (the appropriate source of service information for AD 2004-09-09, Amendment 39-13598 (69 FR 23646, April 30, 2004)), as follows:
• All Model 737-100, -200, -300, -400, and -500 series airplanes (i.e., line numbers 1 through 3132) are added to the effectivity. For these airplanes, the service bulletin specifies procedures for inspecting under the stop fitting by doing HFEC and surface eddy current inspections for cracking of the frame, HFEC inspections for cracking of the reinforcement angle and shear web, and doing a detailed inspection for cracking of the STA 348.2 frame outer chord, inner chord, and reinforcement angle, and corrective actions if necessary. The corrective actions include replacing certain cracked parts with new parts, and if a crack is found in the frame outer chord, contacting Boeing for repair instructions and doing the repair.
• For Model 737-200C airplanes, the repetitive interval for the HFEC inspection of the STA 348.2 frame is extended from 4,500 flight cycles to 6,000 flight cycles.
• For Model 737-100, -200, -300, -400, and -500 series airplanes, a one-time detailed inspection is added to detect missing fasteners of the STA 348.2 frame inner chord at S-7L through S-15L. If any fastener is missing, the service bulletin specifies to contact Boeing for repair instructions.
• For all airplanes, intercostal inspections for cracking between STA 348.2 and STA 360 are now specified in Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010. Previously, for the intercostals at S-14 through S-16L, this inspection was common to both Boeing Alert Service Bulletin 737-53A1204 and Boeing Alert Service Bulletin 737-53A1240 for Model 737-200C airplanes.
• For Group 3 airplanes, instructions are added for repair of the STA 348.2 frame inner chord, reinforcement angle, and shear web; and of the door stop intercostals at S-14L through S16L.
We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This proposed AD would retain certain requirements of AD 2004-09-09, Amendment 39-13598 (69 FR 23646, April 30, 2004) and AD 2009-16-14, Amendment 39-15987 (74 FR 38901, August 5, 2009). This proposed AD would add airplanes to the applicability for the HFEC inspection for cracking of the stop fittings at the shear web at STA 348.2 frame; extend the repetitive interval for the HFEC inspection of the STA 348.2 frame for Model 737-200C airplanes; add an inspection to detect missing fasteners of the STA 348.2 frame inner chord; and update or add certain inspection and repair instructions. This proposed AD would also require accomplishing the actions specified in the service information described previously.”
Since those ADs were issued, the AD format has been revised, and certain paragraphs have been rearranged. As a result, the corresponding paragraph identifiers have changed in this proposed AD, as listed in the following tables:
We estimate that this proposed AD affects 581 airplanes of U.S. registry.
We estimate the following costs to comply with this proposed AD:
We estimate the following costs to do any necessary repairs that would be required based on the results of the proposed inspections. We have no way of determining the number of aircraft that might need these repairs:
According to the manufacturer, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in subtitle VII, part A, subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by removing airworthiness directive (AD) 2004-09-09, Amendment 39-13598 (69 FR 23646, April 30, 2004), and AD 2009-16-14, Amendment 39-15987 (74 FR 38901, August 5, 2009), and adding the following new AD:
(a) The FAA must receive comments on this AD action by January 12, 2012.
(b) This AD supersedes AD 2004-09-09, Amendment 39-13598 (69 FR 23646, April 30, 2004); and AD 2009-16-14, Amendment 39-15987 (74 FR 38901, August 5, 2009).
(c) This AD applies to all The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500 series airplanes, certificated in any category.
(d) Joint Aircraft System Component (JASC)/Air Transport Association (ATA) of America Code 53, Fuselage.
(e) This AD was prompted by reports of cracking of the STA 348.2 frame above the two outboard fasteners attaching the frame inner chord and door stop fittings, and in the outboard chord at stringer S-16L. We have also received reports of missing fasteners in the STA 348.2 frame inner chord. We are issuing this AD to detect and correct fatigue cracking of the intercostals on the forward and aft sides of the forward entry door cutout, which could result in loss of the forward entry door and rapid decompression of the airplane.
(f) Comply with this AD within the compliance times specified, unless already done.
(g) For Model 737-200C series airplanes: Except as provided by paragraph (h) of this AD, prior to the accumulation of 46,000 total flight cycles, or within 2,250 flight cycles after June 4, 2004 (the effective date of AD 2004-09-09, Amendment 39-13598 (69 FR 23646, April 30, 2004)), whichever occurs later, do detailed and eddy current inspections of the STA 348.2 frame for cracking under the stop fittings and intercostal flanges at Stringers 14L, 15L, and 16L by accomplishing paragraphs 3.A. and 3.B.1. through 3.B.7. of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1240, dated April 10, 2003, or by accomplishing Part 1 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1240, Revision 1, dated June 29, 2010. Do the actions in accordance with Boeing Alert Service Bulletin 737-53A1240, dated April 10, 2003; or Revision 1, dated June 29, 2010. Any applicable repair must be accomplished prior to further flight. Repeat the inspections thereafter at intervals not to exceed 6,000 flight cycles. As of the effective date of this AD, only Boeing Alert Service Bulletin 737-53A1240, Revision 1, dated June 29, 2010, may be used.
(h) If any crack is found during any inspection required by paragraph (g) of this AD, and Boeing Alert Service Bulletin 737-53A1240, dated April 10, 2003; or Revision 1, dated June 29, 2010; specifies to contact Boeing for appropriate action: Before further flight, repair in accordance with a method approved by the Manager, Seattle Aircraft Certification Office (ACO), FAA; or using a method approved in accordance with the procedures specified in paragraph (t) of this AD.
(i) For all Model 737-100, -200, -200C, -300, -400, and -500 series airplanes, as identified in Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007: Before the accumulation of 15,000 total flight cycles, or within 4,500 flight cycles after November 1, 2005 (the effective date of AD 2005-20-03, Amendment 39-14296 (70 FR 56361, September 27, 2005)), whichever occurs later: Do the inspections required by paragraphs (k) and (l) of this AD.
(j) For all Model 737-200C series airplanes, as identified in Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007: Before the accumulation of 15,000 total flight cycles, or within 4,500 flight cycles after September 9, 2009 (the effective date of AD 2009-16-14, Amendment 39-15987 (74 FR 38901, August 5, 2009)), whichever occurs later, do the inspection required by paragraph (m) of this AD.
(k) For Group 1 airplanes identified in Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007: Perform a detailed inspection for cracking of the intercostal web, attachment clips, and stringer splice channels; and a high frequency eddy current (HFEC) inspection for cracking of the stringer splice channels located forward and aft of the forward entry door; and do all applicable corrective actions before further flight; in accordance with Parts 1 and 2 of the Work Instructions of Boeing Special Attention Service Bulletin 737-53-1204, dated June 19, 2003; or Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007; or in accordance with Parts 1, 2, 4, and 5 of the Work Instructions of Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010. After September 9, 2009 and until the effective date of this AD, Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007; or Revision 2, dated June 24, 2010; may be used. As of the effective date of this AD, only Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010, may be used.
(l) For Group 2 cargo airplanes identified in Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007: Perform a detailed inspection for cracking of the intercostal webs and attachment clips located forward of the forward entry door, and do all applicable corrective actions before further flight, in accordance with Part 3 of the Work Instructions of Boeing Special Attention Service Bulletin 737-53-1204, dated June 19, 2003; or Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007; or in accordance with Part 3 of Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010. After September 9, 2009 and until the effective date of this AD, Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007; or Revision 2, dated June 24, 2010; may be used. As of the effective date of this AD, only Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010, may be used.
(m) For Group 2 cargo airplanes identified in Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007: Perform a detailed inspection for cracking of the intercostal webs and attachment clips located aft of the forward entry door, and do all applicable corrective actions before further flight, in accordance with Part 4 of the Work Instructions of Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007; or in accordance with Part 3 of Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010. As of the effective date of this AD, only Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010, may be used.
(n) Repeat the inspections required by paragraphs (k), (l), and (m) of this AD thereafter at intervals not to exceed 6,000 flight cycles after the previous inspection, or within 3,000 flight cycles after September 9, 2009, whichever occurs later.
(o) Do the actions required by paragraphs (i), (j), (k), (l), (m), and (n) of this AD by accomplishing all the applicable actions specified in the Accomplishment Instructions of Boeing Special Attention Service Bulletin 737-53-1204, dated June 19, 2003; Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007; or Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010; except as provided by paragraphs (o)(1) and (o)(2) of this AD. After September 9, 2009, and until the effective date of this AD, Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007; or Revision 2, dated June 24, 2010; may be used. As of the effective date of this AD, only Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010, may be used.
(1) Where Boeing Special Attention Service Bulletin 737-53-1204, dated June 19, 2003; Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007; or Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010; specifies to contact Boeing for repair instructions: Before further flight, repair using a method approved in accordance with the procedures specified in paragraph (t) of this AD.
(2) Where Boeing Special Attention Service Bulletin 737-53-1204, dated June 19, 2003; or Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007; specifies a compliance time relative to the date of a service bulletin, this AD requires compliance relative to September 9, 2009. Where Boeing Special Attention Service Bulletin 737-53-1204, dated June 19, 2003; or Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007; specifies a compliance time relative to the date of the initial release of the service bulletin, this AD requires compliance relative to November 1, 2005 (the effective date of AD 2005-20-03, Amendment 39-14296 (70 FR 56361, September 27, 2005)).
(p) For Groups 2 and 3 airplanes identified in Boeing Alert Service Bulletin 737-53A1240, Revision 1, dated June 29, 2010: Within 4,500 flight cycles after the effective date of this AD, do a detailed inspection to detect missing fasteners of the STA 348.2 frame, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1240, Revision 1, dated June 29, 2010, except as required by paragraph (r) of this AD. If any fastener is missing, before further flight, repair using a method approved in accordance with the procedures specified in paragraph (t) of this AD.
(q) For Groups 2 and 3 airplanes identified in Boeing Alert Service Bulletin 737-53A1240, Revision 1, dated June 29, 2010: Before the accumulation of 15,000 total flight cycles or within 4,500 flight cycles after the effective date of this AD, do HFEC and surface eddy current inspections for cracking of the frame, HFEC inspections for cracking of the reinforcement angle and shear web, and a detailed inspection for cracking of the STA 348.2 frame outer chord, inner chord, and reinforcement angle, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1240, Revision 1, dated June 29, 2010, except as required by paragraph (r) of this AD. If any crack is found during any inspection required by this paragraph, before further flight, do all applicable corrective actions in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1240, Revision 1, dated June 29, 2010, except as required by paragraph (r) of this AD, and except where that service bulletin specifies to contact Boeing, before further flight, repair using a method approved in accordance with the procedures specified in paragraph (t) of this AD. Repeat the inspections thereafter at intervals not to exceed 6,000 flight cycles.
(r) Where Boeing Alert Service Bulletin 737-53A1240, Revision 1, dated June 29, 2010, specifies that for the instructions identified in paragraph 3.B., Work Instructions, and the Figure(s) which give the recommended sequence of steps, the sequence of the steps to do the service bulletin can be changed; the requirements in this AD do not allow the sequence of the steps to be changed.
(s) For Group 2 airplanes identified in Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010: Before the accumulation of 15,000 total flight cycles, or within 4,500 flight cycles after the effective date of this AD, whichever occurs later, do initial detailed and HFEC inspections for cracking of the S-15L aft intercostal between BS 348.2 and BS 360, and do a detailed inspection of the cargo barrier net fitting at the intercostal, in accordance with Figure 3 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010. If any cracking is found, before further flight repair using a method approved in accordance with the procedures specified in paragraph (t) of this AD. Repeat the inspections at intervals not to exceed 6,000 flight cycles.
(t)(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, it may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4) AMOCs approved for AD 2004-09-09, Amendment 39-13598 (69 FR 23646, April 30, 2004), are approved as AMOCs for the corresponding requirements of this AD.
(5) AMOCs approved for AD 2009-16-14, Amendment 39-15987 (74 FR 38901, August 5, 2009), are approved as AMOCs for the corresponding requirements of this AD.
(u) For more information about this AD, contact Alan Pohl, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle ACO, 1601 Lind Avenue SW., Renton, Washington 98057-3356; phone (425) 917-6450; fax (425) 917-6590; email:
(v) For service information identified in this AD, contact Boeing Commercial Airplanes,
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 707-100 long body, -200, -100B long body, and -100B short body series airplanes; Model 707-300, -300B, -300C, and -400 series airplanes; and Model 720 and 720B series airplanes. For certain airplanes, this proposed AD would require using redefined flight cycle counts, determining the type of material of the horizontal stabilizer, rear spar, upper chords, and lower chords on the inboard and outboard ends of the rear spar; repetitively inspecting for cracking of the horizontal stabilizer components; and repairing or replacing the chord, or modification of chord segments made from 7079 aluminum, if necessary. For all airplanes, this proposed AD would require inspecting certain structurally significant items, and repairing discrepancies if necessary. This proposed AD was prompted by reports of stress corrosion cracking in the chord segments made from 7079 aluminum in the horizontal stabilizer rear spar, and fatigue cracking in the chord segments made from 7075 aluminum. We are proposing this AD to detect and correct stress corrosion and/or fatigue cracking in the horizontal stabilizer, which could compromise the structural integrity of the stabilizer.
We must receive comments on this proposed AD by January 12, 2012.
You may send comments by any of the following methods:
•
•
•
•
For service information identified in this proposed AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone (206) 544-5000, extension 1; fax (206) 766-5680; email
You may examine the AD docket on the Internet at
Berhane Alazar, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, Washington 98057-3356; phone: (425) 917-6577; fax: (425) 917-6590, email:
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We have received numerous reports of stress corrosion cracking in the chord segments made from 7079 aluminum in the Model 707 horizontal stabilizer rear spar. 7079 aluminum is known to be susceptible to stress corrosion cracking. Development of stress corrosion cracking was slowed by the accomplishment of the actions specified in Boeing 707 Service Bulletin 3356, Revision 2, dated December 12, 1991; and Boeing 707 Service Bulletin 3381, Revision 2, dated January 31, 1991.
In addition, we have received three reports of fatigue cracking in the upper chords of the horizontal stabilizer rear spar near the side of the body. These chords are made from 7075 aluminum. In all three cases, the actions specified in Boeing 707/720 Service Bulletin A3313, Revision 1, dated May 27, 1977, had been incorporated. The fatigue cracking in either 7075 or 7079 material configuration has occurred early in the life of the modified structure. The fatigue cracks were generated by frequent training flights that included multiple touch-and-go cycles, which are most prevalent with military operators. These conditions, if not corrected, could result in stress corrosion and/or fatigue cracking in the horizontal stabilizer, which could compromise the structural integrity of the stabilizer.
Parts made from 7079 aluminum have also been discovered on airplanes that were not originally delivered with those parts. Therefore, to adequately address the stress corrosion cracking in the chord segments in the rear spar of the horizontal stabilizer, it is necessary to determine the chord configuration on the airplane. Furthermore, it is also necessary to carefully maintain a record of that configuration until all chord segments of the rear spar of the horizontal stabilizers that are made from 7079 aluminum have been removed from the fleet. Since horizontal stabilizers can be swapped, it is also necessary to implement the inspections for early fatigue cracking on all airplanes, regardless of their current usage.
We have reviewed Boeing 707 Alert Service Bulletin A3515, dated December
Boeing 707 Alert Service Bulletin A3515 describes procedures for the following actions:
• Counting flight-cycles to determine the compliance times.
• Determining the type of material of the horizontal stabilizer, rear spar, upper chords, and lower chords on the inboard and outboard ends of the rear spar.
• Repetitive special detailed inspections for cracking of the upper chord on the inboard end of the rear spar of the left and right side horizontal stabilizers.
• Repetitive high frequency eddy current inspections for cracking of the web flanges of the upper and lower chords of the rear spar of the left and right side horizontal stabilizers between stabilizer stations 92.55 and 272.55 for 7079 aluminum components.
• Repetitive low frequency eddy current inspections for cracking of the forward skin flanges of the upper and lower chords of the rear spar in the left and right side horizontal stabilizers from stabilizer stations -13.179 to 272.55 (for lower chords) and 92.55 to 272.55 (for upper chords) for 7079 aluminum components.
• Repetitive special detailed inspections for cracking of the upper chord of the inboard side of the rear spar in the left and right side horizontal stabilizers from stabilizer station -13.179 to 92.55 for 7079 aluminum components.
• Replacing certain chord components made from 7079 aluminum.
• Corrective actions, including replacing the chord(s) with a new chord and contacting Boeing for repair instructions and doing the repair.
Boeing 707 Alert Service Bulletin A3516 specifies one-time inspections of certain structurally significant items, and provides procedures for counting flight cycles for determining the compliance times for the inspections.
We issued AD 85-12-01, Amendment 39-5073 (50 FR 26690, June 28, 1985), for Model 707 and 720 airplanes, as revised (AD 85-12-01 R1, Amendment 39-5439 (51 FR 36002, October 8, 1986). That AD requires structural inspections and repairs or replacement on certain high time airplanes that have exceeded their fatigue design life.
We are proposing this AD because we evaluated all relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of these same type designs. This proposed AD would require accomplishing the actions specified in the service information described previously, except as discussed below. The requirements of this proposed AD do not affect the requirements of AD 85-12-01 R1, Amendment 39-5439 (51 FR 36002, October 8, 1986).
Paragraph (i) of this proposed AD specifies determining the material of the structural components of the horizontal stabilizer in accordance with Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007. That service bulletin also specifies that this action be repeated. We have determined that accomplishing this action one time only will provide an adequate level of safety, provided that the component material is determined before further flight on any replaced horizontal stabilizer.
Paragraph (i) of this proposed AD specifies a special detailed inspection of the upper chords, in accordance with Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007. That service bulletin specifies a compliance time of 180 days or 500 flight cycles (after the date on the service bulletin). This proposed AD, however, would remove the 500-flight-cycle compliance time to ensure that no airplane is unintentionally grounded, because it is possible an operator might exceed the flight-cycle grace period specified in paragraph (i) of this proposed AD before completing the inspection for chord material specified in paragraph (h) of this proposed AD. Similarly, paragraph (k) of this proposed AD removes the 250- and 1000-flight-cycle compliance times (specified in Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007) for the initial inspection. This proposed AD would require these inspections within 180 days after the effective date of the AD.
Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007, specifies to contact the manufacturer for instructions on how to repair certain conditions, but this proposed AD would require repairing those conditions in one of the following ways:
• Using a method that we approve; or
• Using data that meet the certification basis of the airplane, and that have been approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) whom we have authorized to make those findings.
We consider this proposed AD interim action. If final action is later identified, we might consider further rulemaking then.
We estimate that this proposed AD would affect 10 airplanes of U.S. registry. The following table provides the estimated costs for U.S. operators to comply with this proposed AD.
We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this proposed AD.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866,
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
3. Will not affect intrastate aviation in Alaska, and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
You can find our regulatory evaluation and the estimated costs of compliance in the AD Docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by adding the following new AD:
(a) We must receive comments by January 12, 2012.
(b) This AD affects AD 85-12-01, Amendment 39-5073 (50 FR 26690, June 28, 1985), as revised by AD 85-12-01 R1, Amendment 39-5439, (51 FR 36002, October 8, 1986).
(c) This AD applies to The Boeing Company Model 707-100 long body, -200, -100B long body, and -100B short body series airplanes; Model 707-300, -300B, -300C, and -400 series airplanes; and Model 720 and 720B series airplanes; certificated in any category; as identified in Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007, and Boeing 707 Alert Service Bulletin A3516, dated April 4, 2008.
(d) Air Transport Association (ATA) of America Code 55: Stabilizers.
(e) This AD was prompted by reports of stress corrosion cracking in the chord segments made from 7079 aluminum in the horizontal stabilizer rear spar, and fatigue cracking in the chord segments made from 7075 aluminum. The Federal Aviation Administration is issuing this AD to detect and correct stress corrosion and/or fatigue cracking in the horizontal stabilizer, which could compromise the structural integrity of the stabilizer.
(f) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
(g) Flight cycles, as used in this AD, must be counted as defined in Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007 (for Model 707 airplanes); or Boeing 707 Alert Service Bulletin A3516, dated April 4, 2008 (for Model 707 airplanes, and Model 720 and 720B series airplanes).
(h) For airplanes identified in Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007: At the earlier of the times specified in paragraphs (h)(1) and (h)(2) of this AD, determine the type of material of the horizontal stabilizer, rear spar, upper chords, and lower chords on the inboard and outboard ends of the rear spar, in accordance with Part 2 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007.
(1) Within 180 days after the effective date of this AD.
(2) Before further flight after any horizontal stabilizer is replaced after the effective date of this AD.
(i) For airplanes with horizontal stabilizer components made from 7075 aluminum, as determined during the inspection required by paragraph (h) of this AD: Within 180 days after the effective date of this AD, and before further flight after any replacement of the horizontal stabilizer, do a special detailed inspection for cracking of the upper chord on the inboard end of the rear spar in the left and right side horizontal stabilizers, from stabilizer station −13.179 to 92.55, in accordance with Part 3 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007. Repeat the inspections thereafter at intervals not to exceed 500 flight cycles, and before further flight after any replacement of the horizontal stabilizer, except as provided by paragraph (j) of this AD. If any cracking is found, before further flight, either repair the cracking in accordance with Part 3 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007, except as required by paragraph (n) of this AD; or replace the chord with a new chord, in accordance with Part 6 of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007.
For the purposes of this AD, a special detailed inspection is “an intensive examination of a specific item, installation, or assembly to detect damage, failure, or irregularity. The examination is likely to make extensive use of specialized inspection techniques and/or equipment. Intricate cleaning and substantial access or disassembly procedure may be required.
(j) For airplanes on which the chord is replaced with a new chord in accordance with Part 6 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007: Within 4,000 flight cycles after the chord replacement, do the inspections required by paragraph (i) of this AD, and repeat the inspections thereafter at the times specified in paragraph (i) of this AD.
(k) For airplanes with horizontal stabilizers that have components of the chords of the rear spar made from 7079 aluminum, as determined during the inspection required by paragraph (h) of this AD: Within 180 days after the effective date of this AD, do the actions required by paragraphs (k)(1), (k)(2), and (k)(3) of this AD, and repeat those actions at the applicable intervals specified in paragraphs (k)(1), (k)(2), and (k)(3) of this AD.
(1) Do a special detailed inspection for cracking of the upper chord of the inboard side of the rear spar in the left and right side horizontal stabilizers from stabilizer station −13.179 to 92.55, in accordance with Part 3 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007. Repeat the inspection thereafter at intervals not to exceed 250 flight cycles or 180 days, whichever occurs first. If any cracking is found during any inspection required by this paragraph, before further flight, either repair the cracking, in accordance with Part 3 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007, except as required by paragraph (n) of this AD; or replace the chord with a new chord, in accordance with Part
(2) Do a high frequency eddy current inspection for cracking of the web flanges of the upper and lower chords of the rear spar in the left and right side horizontal stabilizers from stabilizer stations 92.55 to 272.55, in accordance with Part 4 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007. Repeat the inspection thereafter at intervals not to exceed 1,000 flight cycles or 180 days, whichever occurs first. If any cracking is found during any inspection required by this paragraph, before further flight, do the actions specified in paragraph (k)(2)(i) or (k)(2)(ii) of this AD.
(i) Determine whether the cracking meets the limits specified in Part 4 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007, and whether a previous repair has been done; determine if all 7079 upper and lower chord segments installed on the horizontal stabilizer have had the Part II, Group 1, Preventative Modification specified in Boeing 707 Service Bulletin 3356 done; and do all applicable repairs and modifications, in accordance with Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007. Do the actions required by this paragraph in accordance with Part 4 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007, except as required by paragraph (n) of this AD. Do all applicable repairs and modifications before further flight.
(ii) Replace the chord with a new chord, in accordance with Part 6 of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007.
(3) Do low frequency eddy current (LFEC) inspections for cracking of the forward skin flanges of the upper and lower chords of the rear spar in the left and right side horizontal stabilizers from stabilizer stations −13.179 to 272.55 (for lower chords) and 92.55 to 272.55 (for upper chords), in accordance with Part 5 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007. Repeat the inspections thereafter at intervals not to exceed 1,000 flight cycles or 180 days, whichever occurs first. If any cracking is found during any inspection required by this paragraph, before further flight, do the actions specified in either paragraph (k)(3)(i) or paragraph (k)(3)(ii) of this AD.
(i) Repair cracking, and determine whether all 7079 upper and lower chord segments installed on the horizontal stabilizer have had the Part II—Preventative Modification specified in Boeing 707 Service Bulletin 3381 done, and do all applicable modifications, in accordance with Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007. Do the actions required by this paragraph in accordance with Part 5 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007, except as required by paragraph (n) of this AD. Do all applicable modifications before further flight.
(ii) Replace the chord with a new chord, in accordance with Part 6 of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007.
(l) For airplanes identified in Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007, with horizontal stabilizers that have rear spar chord components made from 7079 aluminum and have not had embodied the modification of Part II of Boeing 707 Service Bulletin 3381, dated July 25, 1980; or Revision 1, dated July 31, 1981: Before further flight after determining the type of material in accordance with paragraph (h) of this AD, modify all 7079 chord segments still installed on the horizontal stabilizer, in accordance with Part 5 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007; or replace the chord, in accordance with Part 6 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007.
(m) For all airplanes: Within 180 days or 1,000 flight cycles after the effective date of this AD, whichever occurs first, do the inspections of the applicable structurally significant items specified in and in accordance with the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3516, dated April 4, 2008. If any cracking is found, before further flight, repair in accordance with the procedures specified in paragraph (q) of this AD. The inspections required by AD 85-12-01 R1, Amendment 39-5439 (51 FR 36002, October 8, 1986), are still required, except, as of the effective date of this AD, the flight-cycle interval for the repetitive inspections specified in paragraph 1.E., “Compliance,” of Boeing 707 Alert Service Bulletin A3516, dated April 4, 2008, must be counted in accordance with the requirements of paragraph (g) of this AD.
(n) If any cracking is found during any inspection required by this AD, and Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007, specifies to contact Boeing for appropriate action: Before further flight, repair the cracking using a method approved in accordance with the procedures specified in paragraph (q) of this AD.
(o) Where Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007, specifies that operators “refer to” NDT procedures, the procedures must be done in accordance with the service information identified in paragraphs (o)(1), (o)(2), and (o)(3) of this AD, as applicable.
(1) Subject 51-00-00, “Structures-General,” Figure 20, “Electrical Conductivity Measurement for Aluminum,” of Part 6-Eddy Current, of the Boeing 707/720 Nondestructive Test Manual, Document D6-48023, Revision 118, dated July 15, 2011.
(2) Subject 55-10-07, “Horizontal Stabilizer,” of Part 6-Eddy Current, of the Boeing 707/720 Nondestructive Test Manual, Document D6-48023, Revision 118, dated July 15, 2011.
(3) Subject 51-01-00, “Orientation and Preparation for Testing” of Part 1-General, of the Boeing 707/720 Nondestructive Test Manual, Document D6-48023, Revision 118, dated July 15, 2011.
(p) As of the effective date of this AD, no person may install any horizontal stabilizer assembly with any chord segment having a part number other than that identified in paragraph 2.C.2. of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007, on any airplane.
(q)(1) The Manager, Seattle Aircraft Certification Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in the Related Information section of this AD Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(r) For more information about this AD, contact Berhane Alazar, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, Washington 98057-3356; phone: (425) 917-6577; fax: (425) 917-6590; email:
(s) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P. O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone (206) 544-5000, extension 1; fax (206) 766-5680; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend Class E airspace at Hastings, NE. Additional controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures (SIAP) at Hastings Municipal Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) operations for SIAPs at the airport.
Comments must be received on or before January 12, 2012.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You must identify the docket number FAA-2011-0499/Airspace Docket No. 11-ACE-10, at the beginning of your comments. You may also submit comments through the Internet at
Scott Enander, Central Service Center, Operations Support Group, Federal Aviation Administration, Southwest Region, 2601 Meacham Blvd., Fort Worth, TX 76137;
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2011-0499/Airspace Docket No. 11-ACE-10.” The postcard will be date/time stamped and returned to the commenter.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see
Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking (202) 267-9677, to request a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
This action proposes to amend Title 14, Code of Federal Regulations (14 CFR), part 71 by amending Class E airspace extending upward from 700 feet above the surface to accommodate new standard instrument approach procedures at Hastings Municipal Airport, Hastings, NE. Controlled airspace is needed for the safety and management of IFR operations at the airport.
Class E airspace areas are published in Paragraph 6005 of FAA Order 7400.9V, dated August 9, 2011 and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document would be published subsequently in the Order.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore, (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend controlled airspace at Hastings Municipal Airport, Hastings, NE.
Airspace, Incorporation by reference, Navigation (Air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
1. The authority citation for part 71 continues to read as follows:
49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9V, Airspace Designations and Reporting Points, dated August 9, 2011, and effective September 15, 2011, is amended as follows:
That airspace extending upward from 700 feet above the surface within a 7.2-mile radius of Hastings Municipal Airport, and within 2 miles each side of the 150° bearing from the airport extending from the 7.2-mile radius to 10.4 miles southeast of the airport.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to establish Class E airspace at Boyne City, MI. Controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures (SIAP) at Boyne City Municipal Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) operations for SIAPs at the airport.
Comments must be received on or before January 12, 2012.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You must identify the docket number FAA-2011-0828/Airspace Docket No. 11-AGL-16, at the beginning of your comments. You may also submit comments through the Internet at
Scott Enander, Central Service Center, Operations Support Group, Federal Aviation Administration, Southwest Region, 2601 Meacham Blvd., Fort Worth, TX 76137;
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2011-0828/Airspace Docket No. 11-AGL-16.” The postcard will be date/time stamped and returned to the commenter.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see
Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking (202) 267-9677, to request a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
This action proposes to amend Title 14, Code of Federal Regulations (14 CFR), part 71 by establishing Class E airspace extending upward from 700 feet above the surface for new standard instrument approach procedures at Boyne City Municipal Airport, Boyne City, MI. Controlled airspace is needed for the safety and management of IFR operations at the airport.
Class E airspace areas are published in Paragraph 6005 of FAA Order 7400.9V, dated August 9, 2011 and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document would be published subsequently in the Order.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore, (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish controlled airspace at Boyne City Municipal Airport, Boyne City, MI.
Airspace, Incorporation by reference, Navigation (Air).
In consideration of the foregoing, the Federal Aviation Administration
1. The authority citation for part 71 continues to read as follows:
49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9V, Airspace Designations and Reporting Points, dated August 9, 2011, and effective September 15, 2011, is amended as follows:
That airspace extending upward from 700 feet above the surface within a 9.9-mile radius of Boyne City Municipal Airport, and within 2 miles each side of the 080 degree bearing from the airport extending from the 9.9-mile radius to 11.9 miles east of the airport.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to establish restricted area airspace within the Devils Lake Military Operations Area (MOA), overlying Camp Grafton Range, in the vicinity of Devils Lake, ND. The new restricted areas would permit realistic training in modern tactics to be conducted at Camp Grafton Range while ensuring the safe and efficient use of the National Airspace System (NAS) in the Devils Lake, ND, area. Unlike restricted areas which are designated under Title 14 Code of Federal Regulations (14 CFR) part 73, MOAs are not rulemaking airspace actions. However, since the proposed restricted areas overlap the Devils Lake East MOA, the FAA is including a description of the Devils Lake East MOA change in this NPRM. The MOA change described herein will also be published in the National Flight Data Digest (NFDD).
Comments must be received on or before January 12, 2012.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, M-30, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-0001;
Colby Abbott, Airspace, Regulations and ATC Procedures Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591;
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (FAA Docket No. FAA-2011-0117 and Airspace Docket No. 09-AGL-31) and be submitted in triplicate to the Docket Management System (see
Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2011-0117 and Airspace Docket No. 09-AGL-31.” The postcard will be date/time stamped and returned to the commenter.
All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see
Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, for a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
Resulting from the 2005 Base Realignment and Closure Commission decisions, Grand Forks AFB was selected for a mission change from its existing aerial refueling mission to an emerging unmanned aerial system (UAS) mission. To accommodate this mission change, the United States (U.S.) Air Force is establishing an operational MQ-1, Predator, squadron at Hector International Airport, ND, with eight Predator aircraft being located at Grand Forks AFB. The launch and recovery operations and maintenance support activities for these aircraft will be accomplished at Grand Forks AFB. Additionally, the U.S. Air Force is
The UAS aircraft programmed to arrive at Grand Forks AFB will have mission and training requirements that include employing Intelligence/Reconnaissance/Surveillance, Close Air Support, and Time Sensitive Targeting tactics. Predator laser training will be accomplished at Camp Grafton Range near Devils Lake, ND. Since the Predator onboard laser system is not eye-safe, its use during training must be contained within restricted area airspace. Restricted areas are regulatory airspace areas that are designated under 14 CFR part 73 rulemaking procedures to contain activities that may present a hazard to nonparticipating aircraft. No person may operate an aircraft within a restricted area without the advance permission of the using or controlling agency.
With the emerging UAS mission at Grand Forks AFB and associated laser training requirements at Camp Grafton Range, the existing R-5401 restricted area surrounding the range is inadequate to satisfy laser training requirements for realistic mission profiles above 5,000 feet mean sea level (MSL). In order to fully exploit the capabilities of today's UAS aircraft and provide the essential training that replicates the conditions that are encountered during wartime deployments today, it is necessary to expand the restricted airspace around Camp Grafton Range. The U.S. Air Force has proposed the FAA establish restricted areas surrounding Camp Grafton Range and R-5401 to enable realistic UAS mission profiles above 5,000 feet MSL to contain the hazardous non-eye safe laser training.
The proposed restricted areas would be established within the existing Devils Lake East MOA and would also extend beyond the MOA's southern boundary approximately 10 NM at the furthest point. Additionally, the Devils Lake East and Devils Lake West MOAs and the existing air traffic control assigned airspaces associated with the MOAs would be retained to support integrated training activities; thus, allowing Predator crews to train for real world mission scenarios with other manned aircraft. To prevent confusion and conflict of having the proposed restricted areas and the existing MOA active in the same airspace at the same time, the Devils Lake East MOA would be amended to exclude R-5401 and the proposed restricted areas when they are active.
MOAs are nonregulatory airspace areas that are established administratively and published in the NFDD. MOAs are established to separate or segregate non-hazardous military flight activities from aircraft operating in accordance with instrument flight rules (IFR), and to advise pilots flying under visual flight rules (VFR) where these activities are conducted. IFR aircraft may be routed through an active MOA only when air traffic control can provide approved separation from the MOA activity. VFR pilots are not restricted from flying in an active MOA, but are advised to exercise caution while doing so. Normally, MOA proposals are not published in an NPRM, but are advertised for public comment through a nonrule circular distributed by an FAA Service Center office to aviation interests in the affected area. When a nonrulemaking action is an integral part of a rulemaking action, FAA procedures allow for the nonrulemaking proposal to be included in the NPRM. Since R-5401 and the proposed restricted areas R-5402, R-5403A, R-5403B, R-5403C, R-5403D, R-5403E, and R-5403F all infringe on the Devils Lake East MOA, the FAA is including a description of the Devils Lake East MOA amendment in this NPRM. Comments on the proposed MOA change may also be submitted as indicated above in the “Comments Invited” section of this NPRM.
The FAA is proposing to amend the Devils Lake East MOA legal description to exclude that airspace within the proposed restricted areas R-5402, R-5403A, R-5403B, R-5403C, R-5403D, R-5403E, and R-5403F, which overlaps airspace within the MOA, when any of the restricted areas are active, respectively. The intent would be to exclude the restricted areas individually only as they are activated. Additionally, the Devils Lake East MOA amendment will retain and move the R-5401 exclusionary language contained in the altitude information of the legal description to the boundaries information. Except for moving the R-5401 exclusion information, the altitude and time of use descriptions for Devils Lake East MOA will remain unchanged. This proposed amendment will prevent airspace conflict with the overlapping existing and proposed restricted areas.
By removing the current boundaries and altitudes descriptions and substituting the following:
The FAA is proposing to amend 14 CFR part 73 to expand the vertical and lateral limits of restricted area airspace over Camp Grafton Range to contain hazardous non-eye safe laser training operations by an emerging UAS mission at Grand Forks Air Force Base (AFB), transforming the range into a viable non-eye safe laser training location. Camp Grafton Range currently is surrounded by R-5401; however, the lateral boundaries and altitude are insufficient to contain the laser training mission profiles and tactics flown today in combat operations. This proposal would supplement R-5401 and establish additional restricted areas, R-5402, R-5403A, R-5403B, R-5403C, R-5403D, R-5403E, and R-5403F, to provide the vertical and lateral tactical maneuver airspace needed for UAS target acquisition prior to attack, and to contain the non-eye safe laser during laser target designation training operations from medium to high altitudes.
The proposed restricted area R-5402 boundary, described in the regulatory text, would be defined by a 7 nautical mile (NM) radius around the center of R-5401, with the northern boundary adjusted to lie along the 47°45′00″ N latitude. The proposed restricted area altitude would be upward from 500 feet above ground level to, but not including 10,000 feet MSL. This new restricted area would provide a pathway for the non-eye safe laser beam to transit from the proposed R-5403A, R-5403B, or R-5403C (described below) through the existing R-5401 and onto Camp Grafton Range.
The proposed restricted areas R-5403A, R-5403B, and R-5403C would share the same lateral boundaries, overlying R-5402 and layered in ascending order. The northern boundary of these R-5403 areas, as described in the regulatory text, would share the same northern boundary as R-5402, the 47°45′00″ N latitude. The western boundary would lie approximately 14 NM west of R-5402 along the 99°15′00″ W longitude and the eastern boundary would lie approximately 7 NM east of
The proposed restricted areas R-5403D, R-5403E, and R-5403F would also share the same lateral boundaries, adjacent to and southeast of R-5403A, R-5403B, and R-5403C, and also layered in ascending order. The northern boundary of these R-5403 areas, as described in the regulatory text, would share the same southern boundary of R-5403A, R-5403B, and R-5403C. The western boundary point would reach to the 99°15′00″ W longitude and the eastern boundary would lie along the 98°15′00″ W longitude. Finally, the southern boundary would be established to lie along the 47°30′00″ N latitude. The proposed restricted area altitudes, in ascending order, would be defined upward from 10,000 feet MSL to, but not including 12,000 feet MSL for R-5403D; upward from 12,000 feet MSL to, but not including 14,000 feet MSL for R-5403E; and upward from 14,000 feet MSL to, but not including Flight Level (FL) 180 for R-5403F. The additional lateral and vertical limits provided by these proposed restricted areas, in conjunction with R-5401, R-5402, R-5403A, R-5403B, R-5403C, and Camp Grafton Range, would establish the maneuvering airspace, standoff target acquisition, and hazardous non-eye safe laser employment training completely within restricted airspace, as noted above.
Restricted areas R-5402, R-5403A, R-5403B, R-5403C, R-5403D, R-5403E, and R-5403F will all be designated as “joint-use” airspace. This means that, during periods when any of the restricted airspace areas are not needed by the using agency for its designated purposes, the airspace will be returned to the controlling agency for access by other NAS users. The Minneapolis Air Route Traffic Control Center is the controlling agency for the proposed restricted areas.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this proposed regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish restricted airspace at Camp Grafton Range near Devils Lake, ND, to enhance safety and accommodate essential military training.
This proposal will be subjected to an environmental analysis in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” prior to any FAA final regulatory action.
Airspace, Prohibited Areas, Restricted Areas.
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 73 as follows:
1. The authority citation for part 73 continues to read as follows:
49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
2. § 73.54 is amended as follows:
Federal Trade Commission (FTC or Commission).
Advance notice of proposed rulemaking and public meeting announcement.
The Commission seeks comment on disclosures to help consumers, distributors, contractors, and installers easily determine whether a specific furnace, central air conditioner, or heat pump meets the applicable new Department of Energy efficiency standard for the regions where it will be installed. The Commission seeks comment on the content, location, and format of such disclosures. As part of this effort, the Commission staff will hold a public meeting with the Department of Energy to discuss possible disclosures.
Comments must be received by January 10, 2012. The public meeting will be held on December 16, 2011.
Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the
Hampton Newsome, Attorney, (202) 326-2889, Division of Enforcement, Federal Trade Commission, 600 Pennsylvania Avenue NW., Washington, DC 20580.
The Commission seeks comment on new labeling requirements and other disclosures for residential furnaces, central air conditioners, and heat pumps (
To facilitate the development of such disclosures, the Commission seeks comment on their appropriate content, location, and format. After considering comments, the Commission will publish specific proposed requirements for comment and then publish final disclosure requirements as amendments to the Commission's Appliance Labeling Rule (16 CFR Part 305).
The Commission's Appliance Labeling Rule, issued pursuant to the Energy Policy and Conservation Act (EPCA),
The EnergyGuide labels for heating and cooling equipment contain two key disclosures: (1) The product's efficiency
The Rule also requires manufacturers to provide distributors and installers with energy information about their furnaces, central air conditioners, and heat pumps in paper or electronic form (including internet-based access).
On June 27, 2011,
To promote
To help consumers and businesses determine whether a product conforms with the regional standards promulgated by DOE, EISA directs the FTC to develop new disclosures for furnaces, central air conditioners, and heat pumps. Specifically, the law requires the Commission to “determine the appropriate 1 or more methods for disclosing information so that consumers, distributors, contractors, and installers can easily determine whether a specific piece of equipment that is installed in a specific building is in conformance with the regional standard that applies to the building.”
The content of the new disclosures must help consumers and industry members avoid installing equipment in violation of regional standards. The Commission seeks suggestions for the best disclosure content to meet this goal. For example, such disclosures could simply explain that a particular product may or may not be installed in certain regions:
•
Federal law prohibits installation of this unit in Alabama, Arizona, Arkansas, California, Delaware, Florida, Georgia, Hawaii, Kentucky, Louisiana, Maryland, Mississippi, New Mexico, Nevada, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, or the District of Columbia.
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Federal law prohibits installation of this unit in Arizona, California, New Mexico, or Nevada.
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Federal law prohibits the installation of this unit in Alaska, Colorado, Connecticut, Idaho, Illinois, Indiana, Iowa, Kansas, Maine, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New York, North Dakota, Ohio, Oregon, Pennsylvania Rhode Island, South Dakota, Utah, Vermont, Washington, West Virginia, Wisconsin, or Wyoming.
•
Federal law allows installation of this unit in any U.S. state.
Comments should also address the location and format for the required disclosures. For instance, the EnergyGuide label could be revised to include information about whether a specific piece of equipment meets standards for installation in a specific region. Alternatively, the manufacturer could provide the required disclosures through other means such as product nameplates, product packaging, brochures, user manuals, Web sites, or online databases. Such alternative methods might provide more space than the EnergyGuide labels for the disclosure of detailed compliance information. The disclosure format could also involve a combination of these approaches. For example, the Energy Guide label could include a QR (Quick Response) scan code to provide mobile phone access to an online database containing detailed product information in addition to disclosures on the label or elsewhere. The EPA recently adopted such an approach for new fuel economy labels on automobiles.
The Commission seeks general comments on potential disclosure methods to help consumers, distributors, contractors, and installers easily determine whether residential heating and cooling equipment meets applicable regional efficiency standards. The Commission invites interested persons to submit written comments on any issue of fact, law or policy that may bear upon the FTC's current labeling requirements. Please provide details to support your comments. We encourage commenters to consider the questions below when preparing comments.
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
The Commission invites interested persons to submit written comments on any issue of fact, law, or policy that may bear upon the proposals under consideration. Please include explanations for any answers provided, as well as supporting evidence where appropriate. After examining the comments, the Commission will determine whether to issue specific amendments.
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before January 10, 2012. Write “Regional Labeling for Heating and Cooling Equipment, (16 CFR Part 305) (Project No. P114202)” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at
Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, such as anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which is obtained from any person and which is privileged or confidential,” as provided in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online, or to send them to the Commission by courier or overnight service. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “Regional Labeling for Heating and Cooling Equipment, (16 CFR Part 305) (Project No.114202)” on your comment and on the envelope, and mail or deliver it to the following address: Federal Trade Commission, Office of the Secretary, Room H-113 (Annex H), 600 Pennsylvania Avenue NW., Washington, DC 20580. If possible, submit your paper comment to the Commission by courier or overnight service.
Visit the Commission Web site at
The Commission and DOE staff have scheduled a public meeting to give interested parties an opportunity to provide their views on potential FTC disclosures and the DOE enforcement plan related to new regional standards for furnaces, central air conditioners, and heat pumps. The public meeting will be held on December 16, 2011 at DOE. DOE will provide details regarding time, location, attendance and participation at the meeting.
By direction of the Commission.
Internal Revenue Service (IRS), Treasury.
Notice of proposed rulemaking.
This document contains proposed regulations regarding the definition of an “interest in a limited partnership as a limited partner” for purposes of determining whether a taxpayer materially participates in an activity under section 469 of the Internal Revenue Code (Code). These proposed regulations affect individuals who are partners in partnerships.
Written or electronic comments and requests for a public hearing must be received by February 27, 2012.
Send submissions to: CC:PA:LPD:PR (REG-109369-10), Room 5203, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand-delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to: CC:PA:LPD:PR (REG-109369-10), Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue NW., Washington, DC, or sent electronically, via the Federal eRulemaking Portal at
Concerning the proposed regulations, Michala Irons, (202) 622-3050; concerning submissions of comments and requests for public hearing, Oluwafunmilayo Taylor, (202) 622-7180 (not toll free numbers).
Section 469(a)(1) limits the ability of certain taxpayers to deduct losses from passive activities. Section 469(b) permits passive losses disallowed in one year to be carried over to the next year. Section 469(c)(1) provides that a passive activity means any activity which involves the conduct of any trade or business, and in which the taxpayer does not materially participate. Section 469(h)(1) provides that a taxpayer shall be treated as materially participating in an activity only if the taxpayer is involved in the operations of the activity on a basis which is regular, continuous, and substantial. The Treasury Department and the IRS promulgated temporary regulations under section 469 in 1988. See TD 8175, 53 FR 5686 (February 25, 1988). Section 1.469-5T(a) provides that an individual taxpayer shall be treated as materially participating in an activity for the taxable year if and only if:
(1) The individual participates in the activity for more than 500 hours during such year;
(2) The individual's participation in the activity for the taxable year constitutes substantially all of the participation in such activity of all individuals (including individuals who are not owners of interests in the activity) for such year;
(3) The individual participates in the activity for more than 100 hours during the taxable year, and such individual's participation in the activity for the taxable year is not less than the participation in the activity of any other individual (including individuals who are not owners of interests in the activity) for such year;
(4) The activity is a significant participation activity (within the meaning of § 1.469-5T(c)) for the taxable year, and the individual's aggregate participation in all significant participation activities during such year exceeds 500 hours;
(5) The individual materially participated in the activity (determined without regard to § 1.469-5T(a)(5)) for any five taxable years (whether or not consecutive) during the ten taxable years that immediately precede the taxable year;
(6) The activity is a personal service activity (within the meaning of § 1.469-5T(d)), and the individual materially participated in the activity for any three taxable years (whether or not consecutive) preceding the taxable year; or
(7) Based on all of the facts and circumstances (taking into account the rules in § 1.469-5T(b)), the individual participates in the activity on a regular, continuous, and substantial basis during such year.
Section 469(h)(2) presumptively treats losses from interests in limited partnerships as passive. Section 469(h)(2) provides that, except as provided in regulations, no interest in a limited partnership as a limited partner shall be treated as an interest with respect to which a taxpayer materially participates. Section 1.469-5T(e)(2) permits an individual taxpayer to establish material participation in a limited partnership but constrains the individual taxpayer to only three of the seven regulatory tests in § 1.469-5T(a), (§ 1.469-5T(a)(1), (a)(5), or (a)(6)).
Section 1.469-5T(e)(3)(i) generally provides that a partnership interest shall be treated as a limited partnership interest if (A) such interest is either designated as a limited partnership interest in the limited partnership agreement or the certificate of limited partnership, without regard to whether the liability of the holder of such interest for obligations of the partnership is limited under applicable State law; or (B) the liability of the holder of such interest for obligations of the partnership is limited, under the law of the State in which the partnership is organized, to a determinable fixed amount (for example, the sum of the holder's capital contributions to the partnership and contractual obligations to make additional capital contributions to the partnership). However, even if the interest is characterized as a limited partnership interest under § 1.469-5T(e)(3)(i), an exception under § 1.469-5T(e)(3)(ii) applies if the individual is a general partner in the partnership at all times during the partnership's taxable year ending with or within the individual's taxable year (or portion of the partnership's taxable year during which the individual (directly or indirectly) owns such limited partnership interest) (the “general partner exception”). If the general partner exception applies, the limited partnership interest will not be treated as such for the year in which the individual taxpayer is a general partner in the partnership. This allows the individual taxpayer to demonstrate material participation through any of the seven regulatory tests in § 1.469-5T(a).
Courts have concluded, in certain instances, that the holder of a limited liability company (LLC) interest is not treated as holding an interest in a limited partnership as a limited partner for purposes of applying the section 469 material participation tests. In
The proposed regulations provide that an interest in an entity will be treated as an interest in a limited partnership under section 469(h)(2) if (A) the entity in which such interest is held is classified as a partnership for Federal income tax purposes under § 301.7701-3; and (B) the holder of such interest does not have rights to manage the entity at all times during the entity's taxable year under the law of the jurisdiction in which the entity was organized and under the governing agreement. Rights to manage include the power to bind the entity. The proposed regulations provide rules concerning an interest in a limited partnership based on the purposes for which section 469 was enacted, and the manner in which the provision is structured and operates within the Code. Accordingly, the rules concerning an interest in a limited partnership in the proposed regulations are provided solely for purposes of section 469 and no inference is intended that the same rules would apply for any other provisions of the Code requiring a distinction between a general partner and a limited partner.
In
The regulations are proposed to apply to taxable years beginning on or after the date of publication of the Treasury decision adopting these regulations as final regulations in the
It has been determined that this notice of proposed rulemaking is not a significant regulatory action as defined in Executive Order 12866, as supplemented by Executive Order 13563. Therefore, a regulatory assessment is not required. It has also been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to this regulation, and because the regulation does not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Code, these regulations will be submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.
Before these proposed regulations are adopted as final regulations, consideration will be given to any written (a signed original and eight (8) copies) or electronic comments that are submitted timely to the IRS. All comments will be available for public inspection and copying. A public hearing will be scheduled if requested in writing by any person that timely submits written comments. If a public hearing is scheduled, notice of the date, time, and place for the public hearing will be published in the
The principal author of these proposed regulations is Michala Irons, Office of the Associate Chief Counsel (Passthroughs and Special Industries). However, other personnel from the Treasury Department and the IRS participated in their development.
Income taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 1 is proposed to be amended as follows:
26 U.S.C. 7805 * * *
1. Revising the entries for § 1.469-5(a), (b), (c), (d), and (e).
2. Removing the entries for § 1.469-5T(e)(1), (e)(2), and (e)(3).
The revisions read as follows:
(a) through (d) [Reserved].
(e) Treatment of an interest in a limited partnership as a limited partner.
(1) In general.
(2) Exceptions.
(3) Interest in a limited partnership as a limited partner.
(i) In general.
(ii) Individual holding an interest other than an interest in a limited partnership as a limited partner.
(4) Effective/applicability date.
(a) through (d) [Reserved].
(e)
(i) The individual's share of any income, gain, loss, deduction, or credit from such activity that is attributable to an interest in a limited partnership as a limited partner; and
(ii) Any gain or loss from such activity recognized upon a sale or exchange of such an interest.
(2)
(3)
(A) The entity in which such interest is held is classified as a partnership for Federal income tax purposes under § 301.7701-3; and
(B) The holder of such interest does not have rights to manage the entity at all times during the entity's taxable year under the law of the jurisdiction in which the entity is organized and under the governing agreement.
(ii)
(4)
(e)
(f)
Financial Crimes Enforcement Network, Treasury (“FinCEN”), Treasury.
Notice of proposed rulemaking.
In a notice of finding published elsewhere in this issue of the
Written comments on the notice of proposed rulemaking must be submitted on or before January 27, 2012.
You may submit comments, identified by RIN 1506-AB16, by any of the following methods:
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•
The FinCEN regulatory helpline at (800) 949-2732 and select Option 6.
On October 26, 2001, the President signed into law the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001 (the “USA PATRIOT Act”), Public Law 107-56. Title III of the USA PATRIOT Act amends the anti-money laundering provisions of the Bank Secrecy Act (“BSA”), codified at 12 U.S.C. 1829b and 1951-1959, and 31 U.S.C. 5311-5314, and 5316-5332, to promote the prevention, detection, and prosecution of international money laundering and the financing of terrorism. Regulations implementing the BSA appear at 31 CFR Chapter X. The authority of the Secretary of the Treasury (the “Secretary”) to administer the BSA and its implementing regulations has been delegated to the Director of FinCEN.
Section 311 of the USA PATRIOT Act (“section 311”) added section 5318A to the BSA, granting the Secretary the authority, upon finding that reasonable grounds exist for concluding that a foreign jurisdiction, institution, class of transaction, or type of account is of “primary money laundering concern,” to require domestic financial institutions and financial agencies to take certain “special measures” against the primary money laundering concern. Section 311 identifies factors for the Secretary to consider and Federal agencies to consult before the Secretary may conclude that a jurisdiction, institution, class of transaction, or type of account is of primary money laundering concern. The statute also provides similar procedures,
Taken as a whole, section 311 provides the Secretary with a range of options that can be adapted to target specific money laundering and terrorist financing concerns most effectively. These options give the Secretary the authority to bring additional pressure on those jurisdictions and institutions that pose money laundering threats. Through the imposition of various special measures, the Secretary can gain more information about the jurisdictions, institutions, transactions, or accounts of concern; can more effectively monitor the respective jurisdictions, institutions,
Before making a finding that reasonable grounds exist for concluding that a jurisdiction is of primary money laundering concern, the Secretary is required to consult with both the Secretary of State and the Attorney General. The Secretary is also required by section 311, as amended,
• Evidence that organized criminal groups, international terrorists, or entities involved in the proliferation of weapons of mass destruction or missiles, have transacted business in that jurisdiction;
• The extent to which that jurisdiction or financial institutions operating in that jurisdiction offer bank secrecy or special regulatory advantages to nonresidents or nondomiciliaries of that jurisdiction;
• The substance and quality of administration of the bank supervisory and counter-money laundering laws of that jurisdiction;
• The relationship between the volume of financial transactions occurring in that jurisdiction and the size of the economy of the jurisdiction;
• The extent to which that jurisdiction is characterized as an offshore banking or secrecy haven by credible international organizations or multilateral expert groups;
• Whether the United States has a mutual legal assistance treaty with that jurisdiction, and the experience of United States law enforcement officials and regulatory officials in obtaining information about transactions originating in or routed through or to such jurisdiction; and
• The extent to which that jurisdiction is characterized by high levels of official or institutional corruption.
If the Secretary determines that reasonable grounds exist for concluding that a jurisdiction is of primary money laundering concern, the Secretary must determine the appropriate special measure(s) to address the specific money laundering risks. Section 311 provides a range of special measures that can be imposed individually, jointly, in any combination, and in any sequence.
• Whether similar action has been or is being taken by other nations or multilateral groups;
• Whether the imposition of any particular special measures would create a significant competitive disadvantage, including any undue cost or burden associated with compliance, for financial institutions organized or licensed in the United States;
• The extent to which the action or the timing of the action would have a significant adverse systemic impact on the international payment, clearance, and settlement system, or on legitimate business activities involving the particular jurisdiction; and
• The effect of the action on United States national security and foreign policy.
Today, as detailed elsewhere in this part,
As a result of that finding, and based upon the additional consultations and the consideration of all relevant factors discussed in the finding and in this notice of proposed rulemaking, the Director of FinCEN has determined that reasonable grounds exist for the imposition of the fifth special measure authorized by section 5318A(b)(5).
The United Nations Security Council has adopted multiple resolutions imposing sanctions on Iran for its refusal to comply with international nuclear obligations and proliferation sensitive activities, including United Nations Security Council resolutions (“UNSCRs”) 1696,
Iran's serious deficiencies with respect to anti-money laundering/countering the financing of terrorism (“AML/CFT”) controls have long been highlighted by numerous international bodies and government agencies. Starting in October 2007, the Financial Action Task Force (“FATF”) has issued a series of public statements expressing its concern that Iran's lack of a comprehensive AML/CFT regime represents a significant vulnerability within the international financial system. The statements further called upon Iran to address those deficiencies with urgency, and called upon FATF-member countries to advise their institutions to conduct enhanced due diligence with respect to the risks associated with Iran's deficiencies.
The FATF has been particularly concerned with Iran's failure to address the risk of terrorist financing, and starting in February 2009, the FATF called upon its members and urged all jurisdictions to apply effective counter-measures to protect their financial sectors from the terrorist financing risks emanating from Iran.
The FATF's most recent statement in October 2011 reiterated, with a renewed urgency, its concern regarding Iran's failure to address the risk of terrorist financing and the serious threat this poses to the integrity to the international financial system.
Although none of these actions to sanction Iran prohibit domestic financial institutions and agencies from opening or maintaining a correspondent account for or on behalf of any financial institution in Iran, or require the type of special due diligence outlined in this proposed rulemaking, FinCEN encourages other countries or multilateral groups to take similar action based on the findings contained in this rulemaking.
The fifth special measure sought to be imposed by this rulemaking would prohibit covered financial institutions from opening and maintaining correspondent accounts for, or on behalf of, Iranian banking institutions. As a corollary to this measure, covered financial institutions also would be required to take reasonable steps to apply special due diligence, as set forth below, to all of their correspondent accounts to help ensure that no such account is being used indirectly to provide services to an Iranian banking institution. FinCEN does not expect the burden associated with these requirements to be significant given that U.S. financial institutions have long been subject to sanctions regulations prohibiting the provision of correspondent account services for banking institutions in Iran. There is a minimal burden involved in transmitting a one-time notice to certain correspondent account holders concerning the prohibition on indirectly providing services to Iranian banking institutions. In addition, U.S. financial
Banking institutions in Iran generally are not major participants in the international payment system and are not relied upon by the international banking community for clearance or settlement services. Additionally, given the preexisting OFAC and international sanctions on Iran and certain Iranian banking institutions, it is unlikely that these new measures or the timing of the new measures will have a significant impact on the international payment, clearance, and settlement system. Financial transactions between the United States and Iran pertaining to licensed agricultural and medical exports to Iran, as well as other licensed transactions or transactions exempted or not prohibited from the scope of OFAC sanctions, may continue under the rule as proposed.
The exclusion from the U.S. financial system of jurisdictions that serve as conduits for significant money laundering activity, for the financing of terrorism or weapons of mass destruction or their delivery systems, and for other financial crimes enhances U.S. national security by making it more difficult for terrorists and money launderers to access the substantial resources of the U.S. financial system. To the extent that this action serves as an additional tool in preventing Iran from accessing the U.S. financial system, the proposed action supports and upholds U.S. national security and foreign policy goals. More generally, the imposition of the fifth special measure would complement the U.S. Government's worldwide efforts to expose and disrupt international money laundering and terrorist financing.
Therefore, pursuant to the finding of the Director of FinCEN that Iran is a jurisdiction of primary money laundering concern, and after conducting the required consultations and weighing the relevant factors, FinCEN has determined that reasonable grounds exist for imposing the fifth special measure authorized by 31 U.S.C. 5318A(b)(5) against Iran.
The proposed rule would prohibit covered financial institutions from establishing, maintaining, or managing in the United States any correspondent account for, or on behalf of, banking institutions in Iran. As a corollary to this prohibition, covered financial institutions would be required to apply special due diligence to their correspondent accounts to guard against their improper indirect use by Iranian banking institutions. At a minimum, that special due diligence must include two elements. First, a covered financial institution must notify those correspondent account holders that the covered financial institution knows or has reason to know provide services to Iranian banking institutions, that such correspondents may not provide Iranian banking institutions with access to the correspondent account maintained at the covered financial institution. Second, a covered financial institution must take reasonable steps to identify any indirect use of its correspondent accounts by Iranian banking institutions, to the extent that such indirect use can be determined from transactional records maintained by the covered financial institution in the normal course of business. A covered financial institution should take a risk-based approach when deciding what, if any, additional due diligence measures it should adopt to guard against the improper indirect use of its correspondent accounts by Iranian banking institutions, based on risk factors such as the type of services it offers and the geographic locations of its correspondents.
Section 1010.657(a)(1) defines the term “correspondent account” by reference to the definition contained in 31 CFR 1010.605(c)(1)(ii). Section 1010.605(c)(1)(ii) defines a correspondent account to mean:
• An account established to receive deposits from, or make payments or other disbursements on behalf of, a foreign bank, or handle other financial transactions related to the foreign bank.
In the case of a U.S. depository institution, this broad definition includes most types of banking relationships between a U.S. depository institution and a foreign bank that are established to provide regular services, dealings, and other financial transactions including demand deposit, savings deposit, or other transaction or asset accounts, and credit accounts or other extensions of credit.
In the case of securities broker-dealers, futures commission merchants, introducing brokers in commodities, and investment companies that are open-end companies (mutual funds), we are using the same definition of “account” for purposes of this rule as was established in the final rule implementing section 312 of the USA PATRIOT Act.
Section 1010.657(a)(2) of the proposed rule defines “covered financial institution” with the same definition used in the final rule implementing section 312 of the USA PATRIOT Act,
• An insured bank (as defined in section 3(h) of the Federal Deposit Insurance Act (12 U.S.C. 1813(h));
• A commercial bank;
• An agency or branch of a foreign bank in the United States;
• A federally insured credit union;
• A credit union;
• A savings association;
• A corporation acting under section 25A of the Federal Reserve Act (12 U.S.C. 611);
• A trust bank or trust company that is federally regulated and is subject to an anti-money laundering program requirements;
• A broker or dealer in securities registered, or required to be registered,
• A futures commission merchant or an introducing broker registered, or required to be registered, with the Commodity Futures Trading Commission under the Commodity Exchange Act (7 U.S.C. 1
• A private banker; and
• A mutual fund.
Section 1010.657(a)(3) of the proposed rule defines a foreign bank as that term is defined in 1010.100(u). An Iranian banking institution shall mean any foreign bank chartered by Iran, including any branches, offices, or subsidiaries of such bank operating in any jurisdiction, and any branch or office within Iran of any foreign bank licensed by Iran. In addition, the Central Bank of Iran (Bank Markazi Iran),
A covered financial institution should take commercially reasonable measures to determine whether it maintains a correspondent account for an Iranian banking institution, including a branch, office, or subsidiary of an Iranian banking institution.
For purposes of complying with the proposed rule's prohibition on the opening or maintaining of correspondent accounts for, or on behalf of, Iranian banking institutions, FinCEN expects that a covered financial institution will take such steps that a reasonable and prudent financial institution would take to protect itself from loan fraud or other fraud or loss based on misidentification of a person's status.
Section 1010.657(b)(1) of the proposed rule requires all covered financial institutions to terminate any correspondent account that is established, maintained, administered, or managed in the United States for, or on behalf of, Iranian banking institutions, provided that the account is not blocked under any Executive Order issued pursuant to the International Emergency Economic Powers Act (50 U.S.C. 1701
As a corollary to the prohibition on maintaining correspondent accounts directly for Iranian banking institutions, proposed section 1010.657(b)(2) requires a covered financial institution to apply special due diligence to its correspondent accounts
Notice: Pursuant to U.S. regulations issued under section 311 of the USA PATRIOT Act, 31 CFR 1010.657, we are prohibited from establishing, maintaining, administering or managing a correspondent account for, or on behalf of, an Iranian banking institution or any of its subsidiaries. The regulations also require us to notify you that you may not provide an Iranian banking institution or any of its subsidiaries with access to the correspondent account you hold at our financial institution other than for the purpose of processing transactions that are authorized, exempt, or not prohibited pursuant to any Executive Order issued under the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.) or 31 C.F.R. Chapter V. If we become aware that an Iranian banking institution or any of its subsidiaries is indirectly using the correspondent account you hold at our financial institution for transactions other than those specified above, we will be required to take appropriate steps to prevent such access, including terminating your account.
The purpose of the notice requirement is to help ensure cooperation from correspondent account holders in denying Iranian banking institutions access to the U.S. financial system. However, FinCEN does not require or expect a covered financial institution to obtain a certification from any of its correspondent account holders that indirect access will not be provided in order to comply with this notice requirement. Instead, methods of compliance with the notice requirement could include, for example, transmitting a one-time notice by mail, fax, or email to certain of the covered financial institution's correspondent account customers, informing them that they may not provide Iranian banking institutions with access to the covered financial institution's correspondent account, or including such information in the next regularly occurring transmittal from the covered financial institution to those correspondent account holders. FinCEN specifically solicits comments on the form and scope of the notice that would be required under the rule. FinCEN also requests comment as to whether a one-time notice will be sufficient to ensure cooperation from correspondent account holders in denying Iranian banking institutions access to the financial system, as well as the incremental costs that financial institutions would incur if this rule required an annual notice.
A covered financial institution also would be required under this rulemaking to take reasonable steps to identify any indirect use of its correspondent accounts by Iranian
Notifying certain correspondent account holders and taking reasonable steps to identify any indirect use of its correspondent accounts by Iranian banking institutions in the manner discussed above are the minimum due diligence requirements under the proposed rule. Beyond these minimum steps, a covered financial institution should adopt a risk-based approach for determining what, if any, additional due diligence measures it should implement to guard against the improper indirect use of its correspondent accounts by Iranian banking institutions, based on risk factors such as the type of services it offers and the geographic locations of its correspondent account holders.
A covered financial institution that obtains knowledge that a correspondent account is being used by a foreign bank to provide indirect access to an Iranian banking institution must take all appropriate steps to prevent such indirect access, including the notification of its correspondent account holder per section 1010.657(b)(2)(i)(A) and, where necessary, terminating the correspondent account. However, this provision does not require financial institutions to prevent indirect access to correspondent accounts when such access is necessary to conduct transactions involving Iranian banking institutions that are: (1) Authorized pursuant to Executive Orders issued under IEEPA or pursuant to 31 CFR Chapter V, including transactions authorized by the Office of Foreign Assets Control; (2), exempted from the prohibitions of such authority; or (3) not prohibited by such authority.
A covered financial institution may afford the foreign bank a reasonable opportunity to take corrective action prior to terminating the correspondent account. Should the foreign bank refuse to comply, or if the covered financial institution cannot obtain adequate assurances that Iranian banking institutions will no longer be able to improperly access the correspondent account, the covered financial institution must terminate the account within a commercially reasonable time. This means that the covered financial institution should not permit the foreign bank to establish any new positions or execute any transactions through the account, other than those necessary to close the account. A covered financial institution may reestablish an account closed under the proposed rule if it determines that the account will not be used to provide improper indirect access to an Iranian banking institution. FinCEN specifically solicits comments on the requirement under the proposed rule that covered financial institutions prevent improper indirect access to Iranian banking institutions, once such indirect access is identified.
Section 1010.657(b)(3) of the proposed rule clarifies that the rule does not impose any reporting requirement upon any covered financial institution that is not otherwise required by applicable law or regulation. A covered financial institution must, however, document its compliance with the requirement that it notify those correspondent account holders that the covered financial institution knows or has reason to know provide services to Iranian banking institutions, that such correspondents may not provide Iranian banking institutions with improper access to the correspondent account maintained at the covered financial institution.
FinCEN invites comments on all aspects of the proposal to prohibit the opening or maintaining of correspondent accounts for or on behalf of Iranian banking institutions, and specifically invites comments on the following matters:
1. The form and scope of the notice to certain correspondent account holders that would be required under the rule and whether a one-time notice will be sufficient to ensure cooperation from correspondent account holders in denying Iranian banking institutions access to the financial system, and the incremental costs that financial institutions would incur if this rule required an annual notice;
2. The appropriate scope of the proposed requirement for a covered financial institution to take reasonable steps to identify any indirect use of its correspondent accounts by Iranian banking institutions;
3. The appropriate steps a covered financial institution should take once it identifies an indirect use of one of its correspondent accounts by an Iranian banking institution; and
4. The impact of the proposed special measure upon legitimate transactions with Iran involving, in particular, U.S. persons and entities; foreign persons, entities, and governments; and multilateral organizations doing legitimate business with persons or entities operating in Iran.
It is hereby certified that this proposed rule will not have a significant economic impact on a substantial number of small entities. Given that U.S. financial institutions have long been subject to sanctions regulations prohibiting the provision of correspondent account services for banking institutions in Iran, FinCEN assesses that the prohibition on maintaining such accounts will not have a significant impact on a substantial number of small entities. In addition, all U.S. persons, including U.S. financial institutions, currently must exercise some degree of due diligence in order to comply with various legal requirements. The tools used for such purposes, including commercially available software used to comply with the economic sanctions programs administered by OFAC, can easily be modified to monitor for the use of correspondent accounts by Iranian banking institutions. Thus, the special due diligence that would be required by this rulemaking—
The collection of information contained in this proposed rule is being submitted to the Office of Management
The collection of information in this proposed rule is in 1010.657(b)(2)(i) and 1010.657(b)(3)(i). The notification requirement in 1010.657(b)(2)(i) is intended to ensure cooperation from correspondent account holders in denying Iranian banking institutions access to the U.S. financial system. The information required to be maintained by 1010.657(b)(3)(i) will be used by federal agencies and certain self-regulatory organizations to verify compliance by covered financial institutions with the provisions of 31 CFR 1010.657. The class of financial institutions affected by the notification requirement is identical to the class of financial institutions affected by the recordkeeping requirement. The collection of information is mandatory.
FinCEN specifically invites comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the mission of FinCEN, including whether the information shall have practical utility; (b) the accuracy of FinCEN's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information required to be maintained; (d) ways to minimize the burden of the required collection of information, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to maintain the information.
The proposed rule is not a significant regulatory action for purposes of Executive Order 12866, “Regulatory Planning and Review.”
Administrative practice and procedure, Banks and banking, Brokers, Counter-money laundering, Counter-terrorism, Foreign banking, Iran.
For the reasons set forth in the preamble, chapter X of title 31 of the Code of Federal Regulations is proposed to be amended as follows:
1. The authority citation for chapter X is amended to read as follows:
12 U.S.C. 1829b and 1951-1959; 31 U.S.C. 5311-5314, 5316-5332 Title III, secs. 311, 312, 313, 314, 319, 326, 352, Pub. L. 107-56, 115 Stat. 307.
2. Subpart F of Chapter X is amended by adding new § 1010.657 under the undesignated center heading “SPECIAL DUE DILIGENCE FOR CORRESPONDENT ACCOUNTS AND PRIVATE BANKING ACCOUNTS” to read as follows:
(a)
(1)
(2)
(3)
(4)
(i) Any foreign bank chartered by Iran, including any branches, offices, or subsidiaries of such bank operating in any jurisdiction, and any branch or office within Iran of any foreign bank licensed by Iran;
(ii) The Central Bank of Iran (Bank Markazi Iran); and
(iii) Any foreign bank of which more than 50 percent of the voting stock or analogous interest is owned by two or more foreign banks chartered by Iran.
(5)
(b)
(1)
(2)
(i) A covered financial institution shall apply special due diligence to its correspondent accounts that is reasonably designed to guard against their improper indirect use by Iranian banking institutions. At a minimum, that special due diligence must include:
(A) Notifying those correspondent account holders that the covered financial institution knows or has reason to know provide services to Iranian banking institutions, that such correspondents generally may not provide Iranian banking institutions with access to the correspondent account maintained at the covered financial institution; and
(B) Taking reasonable steps to identify any indirect use of its correspondent accounts by Iranian banking institutions, to the extent that such indirect use can be determined from transactional records maintained in the covered financial institution's normal course of business.
(ii) A covered financial institution shall take a risk-based approach when deciding what, if any, other due diligence measures it should adopt to guard against the improper indirect use of its correspondent accounts by Iranian banking institutions.
(iii) A covered financial institution that obtains knowledge that a correspondent account is being used by the foreign bank to provide indirect access to an Iranian banking institution, shall take all appropriate steps to prevent such indirect access, including the notification of its correspondent account holder under paragraph
(3)
(i) A covered financial institution is required to document its compliance with the notice requirement set forth in paragraph (b)(2)(i)(A) of this section.
(ii) Nothing in this section shall require a covered financial institution to report any information not otherwise required to be reported by law or regulation.
Environmental Protection Agency (EPA).
Proposed rule.
EPA is proposing to approve several State Implementation Plan (SIP) revisions submitted by the South Carolina Department of Health and Environmental Control (SC DHEC). These revisions establish reasonably available control technology (RACT) requirements for the three major sources located in the portion of York County, South Carolina that is within the bi-state Charlotte-Gastonia-Rock Hill, North Carolina-South Carolina 1997 8-hour ozone nonattainment area that either emit volatile organic compounds, nitrogen oxides or both. The bi-state Charlotte-Gastonia-Rock Hill 1997 8-hour ozone nonattainment area is hereinafter referred to as the “bi-state Charlotte Area.” In addition, South Carolina's SIP revisions include negative declarations for certain source categories for which EPA has control technique guidelines, meaning that SC DHEC has concluded that no such sources are located in that portion of the nonattainment area. EPA has evaluated the proposed revisions to South Carolina's SIP, and has preliminarily concluded that they are consistent with statutory and regulatory requirements and EPA guidance.
Written comments must be received on or before December 28, 2011.
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2010-0017 and EPA-R04-OAR-2010-0018 by one of the following methods:
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Please see the direct final rule which is located in the Rules section of this
Zuri Farngalo, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Zuri Farngalo may be reached by phone at (404) 562-9152 or by electronic mail address
On March 12, 2008, EPA issued a revised ozone NAAQS. See 73 FR 16436. EPA subsequently announced a reconsideration of the 2008 NAAQS, and proposed new 8-hour ozone NAAQS in January 2010. See 75 Fr 2938. In September 2011, EPA withdrew the proposed reconsidered NAAQS and began implementation of the 2008 NAAQS. The current action, however, is being taken to address requirements under the 1997 ozone NAAQS for a portion of York County, South Carolina. Requirements for the bi-state Charlotte Area under the 2008 NAAQS will be addressed in the future.
For additional information see the direct final rule which is published in the Rules Section of this
Federal Communications Commission.
Proposed rule.
In this document, the Federal Communications Commission seeks comment on a request by certain private parties, identified below, that the Commission authorize voluntary asymmetric digital sideband power for
Comments for this proceeding may be filed on or before December 19, 2011 and reply comments may be filed on or before January 3, 2012.
You may submit comments, identified by MM Docket No. 99-325, by any of the following methods:
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Peter H. Doyle, Chief, Media Bureau, Audio Division, at (202) 418-2700; Susan Crawford, Ann Gallagher, or Charles Miller, Media Bureau, Audio Division, at (202) 418-2700.
This is a summary of a Public Notice released by the Media Bureau on November 1, 2011. The full text of this document is available for public inspection and copying during regular business hours in the Commission's Reference Information Center, Portals II, 445 12th Street SW., Room CY-A257, Washington, DC 20554. The complete text of this document also may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., Portals II, 445 12th Street SW., Room CY-B402, Washington, DC 20554, telephone (202) 488-5300, facsimile (202) 488-5563 or via email
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• Copies of the reports and any subsequently filed documents in this matter may be obtained electronically at
• Alternate formats of this Public Notice (computer diskette, large print, audio recording or Braille) are available to persons with disabilities by contacting the Consumer and Governmental Affairs Bureau at (202) 418-0530 or (202) 418-7365 (TTY).
On October 4, 2011, representatives of iBiquity Digital Corporation (iBiquity) and National Public Radio, Inc. (NPR) met with Media Bureau staff to discuss the possibility of permitting FM stations to operate with unequal digital sideband power levels. Concurrently, iBiquity filed a technical report that discusses the field performance of asymmetric digital sideband operation by FM stations. On October 24, 2011, NPR filed a report describing the results of field testing of asymmetric FM digital sidebands used in conjunction with the testing of newly-developed technology for reducing the peak-to-average power ratio in digital transmitters. Based on these reports, iBiquity and NPR requested that the Commission authorize voluntary asymmetric digital sideband power for FM stations. On November 1, 2011, the Media Bureau released the “November 1, 2011,
The iBiquity and NPR request and the iBiquity and NPR technical studies are available electronically from the Commission's Electronic Comment Filing System under MM Docket No. 99-235 at
The Public Notice tentatively concludes that it would be expedient to modify Form 335-FM (OMB control number 3060-1034), currently used for Digital Notifications, to accommodate requests for increased digital power and/or operation with asymmetric digital sideband power. The Public Notice also seeks comment on the process by which FM stations engaging in such operations would notify the Commission and how such notifications would be maintained in the Commission's electronic databases. Thus, the proposal under consideration may result in a new or revised information collection requirement being adopted by the Commission when the final rules are adopted. If the Commission adopts any new or revised information collection requirement, the Commission will publish a separate notice in the
This proceeding will be treated as a “permit-but-disclose” proceeding subject to the “permit-but-disclose” requirements under § 1.1206(b) of the Commission's rules (47 CFR 1.1206(b)).
As required by the Regulatory Flexibility Act of 1980, as amended (RFA), 5 U.S.C. 603, the Commission has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed. Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments on the proposed rule as provided in the “Dates” paragraph of the item. The Commission will send a copy of the proposed rule, including this IRFA, to the Chief Counsel for Advocacy of the Small Business Administration (SBA). In addition, the proposed rule and IRFA (or summaries thereof) will be published in the
This document seeks comment on the iBiquity and NPR request that the Commission authorize voluntary asymmetric digital sideband power for FM stations. Currently, FM stations may operate only with equal power levels on the upper and lower primary digital sidebands. In the
Early experience with FM IBOC operation showed the one-percent digital power level to be insufficient to replicate analog coverage areas. In response to a request from a group of broadcasters, the Media Bureau issued its January 29, 2010,
A significant number of FM stations are currently precluded from taking advantage of the full 10 dB digital power increase permitted by the
The authority for this proposed rulemaking is contained in sections 1, 2, 4(i), 301, 302, 303, 307, 308, and 309(j) of the Communications Act of 1934, as amended, 47 U.S.C. 151, 152, 154(i), 301, 302, 303, 307, 308, and 309(j).
The RFA directs the Commission to provide a description of and, where feasible, an estimate of the number of small entities that will be affected by the proposed rules. The RFA generally defines the term “small entity” as encompassing the terms “small business,” “small organization,” and “small governmental entity.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.
In the
Non-super-powered FM stations requesting authorization to operate with digital ERP between −14 dBc and −10 dBc, or super-powered FM stations requesting digital ERP in excess of −20 dBc are required to file an informal request using the Engineering STA Form prior to commencement of the increased power FM digital operation. Licensees submitting such a request must use the simplified method set forth in the January 29, 2010,
The proposed rule changes may, in some cases, impose different reporting or recordkeeping requirements on FM radio stations, insofar as they would allow certain licensees to voluntarily operate with asymmetric digital sideband power. However, the information that would be reported is already familiar to broadcasters, and is similar to the current IBOC digital operation notification or authorization reporting requirements, so any additional burdens would be minimal. The Public Notice tentatively concludes that it would be expedient to modify Form 335-FM, currently used for Digital Notifications, to accommodate requests for increased digital power and/or operation with asymmetric digital sideband power.
The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities (5 U.S.C. 603(b)).
Operation of hybrid digital facilities by Commission licensees and permittees is voluntary. Likewise, use of asymmetric FM digital sideband powers would be limited to those licensees and permittees expressly seeking authorization for such operation. The proposal to permit use of asymmetric FM digital sideband powers thus would not impose any additional burden on FM broadcasters. In fact, for those FM broadcasters that choose to operate hybrid FM facilities, the proposal would confer a benefit. Currently, a significant number of FM stations are precluded from operating maximum permissible hybrid FM digital facilities. This occurs in the case of an FM station operating hybrid digital facilities that has a nearby FM station on one, but not both, of its two first-adjacent channels, thus limiting allowable digital power in both sidebands to a level that protects the sole limiting station. By permitting asymmetric FM digital sideband operation, such a station could increase to maximum permissible digital power on the sideband opposite the limiting FM station, thus achieving improved digital facilities and signal coverage. Because operation under the proposed rule is voluntary, and would only be undertaken by licensees and permittees that would realize a benefit from such operation, consideration of alternatives was not required.
None.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Notice of regulatory review; Request for comments.
NHTSA seeks comments on the economic impact of its regulations on small entities. As required by Section 610 of the Regulatory Flexibility Act, we are attempting to identify rules that may have a significant economic impact on a substantial number of small entities. We also request comments on ways to make these regulations easier to read and understand. The focus of this notice is rules that specifically relate to school buses and other buses.
You should submit comments early enough to ensure that Docket Management receives them not later than January 27, 2012.
You may submit comments [identified by DOT Docket ID Number NHTSA-2011-0160] by any of the following methods:
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Juanita Kavalauskas, Office of Regulatory Analysis, Office of Regulatory Analysis and Evaluation, National Highway Traffic Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590 (telephone (202) 366-2584, fax (202) 366-3189).
Section 610 of the Regulatory Flexibility Act of 1980 (Pub. L. 96-354), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), requires agencies to conduct periodic reviews of final rules that have a significant economic impact on a substantial number of small business entities. The purpose of the reviews is to determine whether such rules should be continued without change, or should be amended or rescinded, consistent with the objectives of applicable statutes, to minimize any significant economic impact of the rules on a substantial number of such small entities.
The Department of Transportation (DOT) published its Semiannual Regulatory Agenda on November 22, 1999, listing in Appendix D (64 FR 64684) those regulations that each operating administration will review under section 610 during the next 12 months. Appendix D contained DOT's 10-year review plan for all of its existing regulations. On November 24, 2008, NHTSA published in the
The National Highway Traffic Safety Administration (NHTSA, “we”) has divided its rules into 10 groups by subject area. Each group will be reviewed once every 10 years, undergoing a two-stage process—an Analysis Year and a Review Year. For purposes of these reviews, a year will coincide with the fall-to-fall publication schedule of the Semiannual Regulatory Agenda. The newly revised 10-year plan will assess years 9 and 10 of the old plan in years 1 and 2 of the new plan. Year 1 (2008) began in the fall of 2008 and will end in the fall of 2009; Year 2 (2009) will begin in the fall of 2009 and will end in the fall of 2010; and so on.
During the Analysis Year, we will request public comment on and analyze each of the rules in a given year's group to determine whether any rule has a significant impact on a substantial number of small entities and, thus, requires review in accordance with section 610 of the Regulatory Flexibility Act. In each fall's Regulatory Agenda, we will publish the results of the analyses we completed during the previous year. For rules that have subparts, or other discrete sections of rules that do have a significant impact on a substantial number of small entities, we will announce that we will be conducting a formal section 610 review during the following 12 months.
The section 610 review will determine whether a specific rule should be revised or revoked to lessen its impact on small entities. We will consider: (1) The continued need for the rule; (2) the nature of complaints or comments received from the public; (3) the complexity of the rule; (4) the extent to which the rule overlaps, duplicates, or conflicts with other federal rules or with state or local government rules; and (5) the length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule. At the end of the Review Year, we will publish the results of our review. The following table shows the 10-year analysis and review schedule:
During Year 4, we will continue to conduct a preliminary assessment of the following: 49 CFR 571.131, 571.217, 571.220, 571.221, and 571.222.
We are seeking comments on whether any requirements in 49 CFR 571.131, 571.217, 571.220, 571.221, and 571.222 have a significant economic impact on a substantial number of small entities. “Small entities” include small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations under 50,000. Business entities are generally defined as small businesses by Standard Industrial Classification (SIC) code, for the purposes of receiving Small Business Administration (SBA) assistance. Size standards established by SBA in 13 CFR 121.201 are expressed either in number of employees or annual receipts in millions of dollars, unless otherwise specified. The number of employees or annual receipts indicates the maximum allowed for a concern and its affiliates to be considered small. If your business or organization is a small entity and if any of the requirements in 49 CFR 571.131, 571.217, 571.220, 571.221, and 571.222 have a significant economic impact on your business or organization, please submit a comment to explain how and to what degree these rules affect you, the extent of the economic impact on your business or organization, and why you believe the economic impact is significant.
If the agency determines that there is a significant economic impact on a substantial number of small entities, it will ask for comment in a subsequent notice during the Review Year on how these impacts could be reduced without reducing safety.
Executive Order 12866 and the President's memorandum of June 1, 1998, require each agency to write all rules in plain language. Application of the principles of plain language includes consideration of the following questions:
• Have we organized the material to suit the public's needs?
• Are the requirements in the rule clearly stated?
• Does the rule contain technical language or jargon that is not clear?
• Would a different format (grouping and order of sections, use of headings, paragraphing) make the rule easier to understand?
• Would more (but shorter) sections be better?
• Could we improve clarity by adding tables, lists, or diagrams?
• What else could we do to make the rule easier to understand?
If you have any responses to these questions, please include them in your comments on this document.
In conjunction with our section 610 reviews, we will be performing plain language reviews over a ten-year period on a schedule consistent with the section 610 review schedule. We will review 49 CFR 571.131, 571.217, 571.220, 571.221, and 571.222 to determine if these regulations can be reorganized and/or rewritten to make them easier to read, understand, and use. We encourage interested persons to submit draft regulatory language that clearly and simply communicates regulatory requirements, and other recommendations, such as for putting information in tables that may make the regulations easier to use.
Your comments must be written and in English. To ensure that your comments are correctly filed in the Docket, please include the docket number of this document in your comments.
Your comments must not be more than 15 pages long. (49 CFR 553.21.) We established this limit to encourage you to write your primary comments in a concise fashion. However, you may attach necessary additional documents to your comments. There is no limit on the length of the attachments.
Please submit two copies of your comments, including the attachments, to Docket Management at the address given above under
Please note that pursuant to the Data Quality Act, in order for substantive data to be relied upon and used by the agency, it must meet the information quality standards set forth in the OMB and DOT Data Quality Act guidelines. Accordingly, we encourage you to consult the guidelines in preparing your comments. OMB's guidelines may be accessed at
If you wish Docket Management to notify you upon its receipt of your comments, enclose a self-addressed, stamped postcard in the envelope containing your comments. Upon receiving your comments, Docket Management will return the postcard by mail.
If you wish to submit any information under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Chief Counsel, NHTSA, U.S. Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590. In addition, you should submit two copies, from which you have deleted the claimed confidential business information, to Docket Management at the address given above under
We will consider all comments that Docket Management receives before the close of business on the comment closing date indicated above under
You may read the comments received by Docket Management at the address given above under
You may also see the comments on the Internet. To read the comments on the Internet, take the following steps:
(1) Go to the Federal Docket Management System (FDMS) at
(2) FDMS provides two basic methods of searching to retrieve dockets and docket materials that are available in the system: (a) “Quick Search” to search using a full-text search engine, or (b) “Advanced Search,” which displays various indexed fields such as the docket name, docket identification number, phase of the action, initiating office, date of issuance, document title, document identification number, type of document,
(3) You may download the comments. However, since the comments are
Please note that even after the comment closing date, we will continue to file relevant information in the Docket as it becomes available. Further, some people may submit late comments. Accordingly, we recommend that you periodically check the Docket for new material.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
90-day petition finding, request for information, and initiation of status review.
We, NMFS, announce a 90-day finding on a petition to list the scalloped hammerhead shark (
Information and comments on the subject action must be received by January 27, 2012.
You may submit comments, information, or data, identified by “NOAA-NMFS-2011-0261” by any one of the following methods:
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•
Instructions: All comments received are a part of the public record and may be posted to
Maggie Miller, NMFS, Office of Protected Resources, (301) 427-8403.
On August 14, 2011, we received a petition from WildEarth Guardians and Friends of Animals to list the scalloped hammerhead shark (
Section 4(b)(3)(A) of the ESA of 1973, as amended (16 U.S.C. 1531
Under the ESA, a listing determination may address a species, which is defined to also include subspecies and, for any vertebrate species, any DPS that interbreeds when mature (16 U.S.C. 1532(16)). A joint NMFS-U.S. Fish and Wildlife Service (USFWS) (jointly, “the Services”) policy clarifies the agencies' interpretation of the phrase “distinct population segment” for the purposes of listing, delisting, and reclassifying a species under the ESA (61 FR 4722; February 7, 1996). A species, subspecies, or DPS is “endangered” if it is in danger of extinction throughout all or a significant portion of its range, and “threatened” if it is likely to become endangered within the foreseeable future throughout all or a significant portion of its range (ESA sections 3(6) and 3(20), respectively, 16 U.S.C. 1532(6) and (20)). Pursuant to the ESA and our implementing regulations, we determine whether species are threatened or endangered based on any one or a combination of the following five section 4(a)(1) factors: (1) The present or threatened destruction, modification, or curtailment of habitat or range; (2) overutilization for commercial, recreational, scientific, or educational purposes; (3) disease or predation; (4) inadequacy of existing regulatory mechanisms; and (5) any other natural or manmade factors affecting the species' existence (16 U.S.C. 1533(a)(1), 50 CFR 424.11(c)).
ESA-implementing regulations issued jointly by NMFS and USFWS (50 CFR 424.14(b)) define “substantial information” in the context of reviewing
Judicial decisions have clarified the appropriate scope and limitations of the Services' review of petitions at the 90-day finding stage, in making a determination that a petitioned action “may be” warranted. As a general matter, these decisions hold that a petition need not establish a “strong likelihood” or a “high probability” that a species is either threatened or endangered to support a positive 90-day finding.
We evaluate the petitioners' request based upon the information in the petition including its references and the information readily available in our files. We do not conduct additional research, and we do not solicit information from parties outside the agency to help us in evaluating the petition. We will accept the petitioners' sources and characterizations of the information presented if they appear to be based on accepted scientific principles, unless we have specific information in our files that indicates the petition's information is incorrect, unreliable, obsolete, or otherwise irrelevant to the requested action. Information that is susceptible to more than one interpretation or that is contradicted by other available information will not be dismissed at the 90-day finding stage, so long as it is reliable and a reasonable person would conclude it supports the petitioners' assertions. In other words, conclusive information indicating the species may meet the ESA's requirements for listing is not required to make a positive 90-day finding. We will not conclude that a lack of specific information alone negates a positive 90-day finding if a reasonable person would conclude that the unknown information itself suggests an extinction risk of concern for the species at issue.
To make a 90-day finding on a petition to list a species, we evaluate whether the petition presents substantial scientific or commercial information indicating the subject species may be either threatened or endangered, as defined by the ESA. First, we evaluate whether the information presented in the petition, along with the information readily available in our files, indicates that the petitioned entity constitutes a “species” eligible for listing under the ESA. Next, we evaluate whether the information indicates that the species faces an extinction risk that is cause for concern; this may be indicated in information expressly discussing the species' status and trends, or in information describing impacts and threats to the species. We evaluate any information on specific demographic factors pertinent to evaluating extinction risk for the species (
Information presented on impacts or threats should be specific to the species and should reasonably suggest that one or more of these factors may be operative threats that act or have acted on the species to the point that it may warrant protection under the ESA. Broad statements about generalized threats to the species, or identification of factors that could negatively impact a species, do not constitute substantial information indicating that listing may be warranted. We look for information indicating that not only is the particular species exposed to a factor, but that the species may be responding in a negative fashion; then we assess the potential significance of that negative response.
Many petitions identify risk classifications made by non-governmental organizations, such as the International Union on the Conservation of Nature (IUCN), the American Fisheries Society, or NatureServe, as evidence of extinction risk for a species. Risk classifications by other organizations or made under other Federal or state statutes may be informative, but the classification alone may not provide the rationale for a positive 90-day finding under the ESA. For example, as explained by NatureServe, their assessments of a species' conservation status do “not constitute a recommendation by NatureServe for listing under the U.S. Endangered Species Act” because NatureServe assessments “have different criteria, evidence requirements, purposes and taxonomic coverage than government lists of endangered and threatened species, and therefore these two types of lists should not be expected to coincide” (
The scalloped hammerhead shark is a circumglobal species that lives in coastal warm temperate and tropical seas. It occurs over continental and insular shelves, as well as adjacent deep waters, but is seldom found in waters cooler than 22 °C (Compagno, 1984; Schulze-Haugen
In the western Atlantic Ocean, the scalloped hammerhead range extends from the Northeast coast of the United States (from New Jersey to Florida) to Brazil, including the Gulf of Mexico and Caribbean Sea. In the eastern Atlantic, it can be found from the Mediterranean Sea to Namibia. Populations in the Indian Ocean are found in the following locations: South Africa and the Red Sea to Pakistan, India, and Myanmar, and in the western Pacific the scalloped hammerhead can be found from Japan and China to New Caledonia, including throughout the Philippines, Indonesia, and off Australia. Distribution in the eastern Pacific Ocean extends from the coast of southern California (U.S.), including the Gulf of California, to Ecuador and possibly Peru (Compagno, 1984), and off waters of Hawaii (U.S.) and Tahiti.
The general life history pattern of the scalloped hammerhead shark is that of a long lived (oldest known sharks of both sexes aged at 30.5 years; Piercy
The oldest aged scalloped hammerhead sharks had lengths of 241 cm (females) and 234 cm (males) (Piercy
The scalloped hammerhead shark is viviparous (
The scalloped hammerhead shark is a high trophic level predator (Cortés, 1999) and opportunistic feeder, with a diet that includes a wide variety of teleosts, cephalopods, crustaceans, and rays (Compagno, 1984).
We evaluated the information provided in the petition and readily available in our files to determine if the petition presented substantial scientific or commercial information indicating that the petitioned action may be warranted. The petition contains information on the species, including the taxonomy, species description, geographic distribution, habitat, population status and trends, and factors contributing to the species' decline. The petition states that the primary threat to the scalloped hammerhead shark is exploitation by fishing, with the ongoing practice of “finning” of particular concern. The petitioners also assert that the lack of adequate regulatory protection programs worldwide, as well the species' biological constraints, increase the susceptibility of the scalloped hammerhead shark to exploitation and extinction. Although data are not available to determine the actual number or size of the global population of scalloped hammerhead sharks, the information from our files and from the petitioners' references suggest that the scalloped hammerhead underwent significant range-wide declines from historical abundance levels (Feretti
According to the petition, at least three of the five causal factors in section 4(a)(1) of the ESA are adversely affecting the continued existence of the scalloped hammerhead shark, specifically: (B) Overutilization for commercial, recreational, scientific, or educational purposes; (D) inadequacy of existing regulatory mechanisms; and (E) other natural or manmade factors affecting its continued existence. In the following sections, we use the information presented in the petition and in our files to determine whether the petitioned action may be warranted. We consider the global population of scalloped hammerhead sharks and will revisit the question of DPSs during a status review, if necessary. We summarize our analysis and conclusions regarding the information presented by the petitioner and in our files on the specific ESA section 4(a)(1) factors affecting the species' risk of global extinction below.
Information from the petition and in our files suggests that the primary threat to the scalloped hammerhead shark is from fisheries. We refer to the U.S. and Palau CITES (2010) proposal to list
Scalloped hammerhead sharks are both targeted and taken as bycatch in many global fisheries (
In the United States, scalloped hammerhead sharks are mainly caught as bycatch in longline and coastal gillnet fisheries and are known to suffer high mortality from capture. In the northwest Atlantic, on-line mortalities (for all age groups) were estimated at 91.4 percent and 93.8 percent (Mejuto
According to the CITES proposal, overutilization of scalloped hammerheads has also been documented off the coast of Belize, leading to an observed decline in the abundance and size of hammerheads and prompting a halt in the Belize-based shark fishery. However, fishing pressure on hammerheads still continues as a result of Guatemalan fishermen entering Belizean waters (CITES, 2010). Further south, in Brazil, declines between 60 and 90 percent of adult female scalloped hammerheads have been reported from 1993 to 2001 using CPUE data, while the abundance of neonates has significantly decreased over the past 10 years (CITES, 2010). In inshore waters, neonates are heavily targeted by coastal gillnets and recreational fisheries, and are also caught as bycatch in shrimp and pair trawls (CITES, 2010). Further offshore, catches of scalloped hammerheads have been documented as incidental take in other directed fisheries, such as a tuna fishery based in Santos City, São Paulo State, Brazil, where data has revealed a decline in these incidental catch weights, from 290 t in 1990 to 59 t in 1996 (Amorim
In the Pacific Ocean, juvenile scalloped hammerheads are targeted mainly in directed fisheries but also taken as bycatch by shrimp trawlers and coastal teleost fisheries. Importance of scalloped hammerheads in fishery landings appears to vary by region, from 11.9 percent of the total catch from El Salvador (number of individuals (n)=412; 1991-1992) to 36 percent from the Gulf of Tehauntepec, Mexico (n=8,659; 1996-1998), and ranging from 6 percent (n=339) to 74 percent (n=800) of the total catch off different parts of Guatemala (1996-1999) (CITES, 2010). In Ecuador, landings of hammerhead sharks have decreased since 1996, with a 51 percent decline in artisanal fishery landings between 2004 and 2006 in the Port of Manta, an area where artisanal and drift-net fleets account for 80 percent of shark landings in Ecuador (CITES, 2010).
In the Indian Ocean, pelagic sharks, including the scalloped hammerhead, are targeted in various fisheries, including semi-industrial, artisanal, and recreational fisheries. Countries that fish for sharks include: Egypt, India, Iran, Oman, Saudi Arabia, Sudan, United Arab Emirates, and Yemen, where the probable or actual status of the shark populations is unknown, and Maldives, Kenya, Mauritius, Seychelles, South Africa, and United Republic of Tanzania, where the actual status of the shark population is presumed to be fully to over exploited (Young, 2006). We conclude that the information in the petition and in our files suggests that fisheries may be impacting the continued existence of the scalloped hammerhead.
The petition asserts that the inadequacy of existing Federal, state, or international regulatory mechanisms require that the scalloped hammerhead shark be listed under the ESA. The petition contends that the lack of specific regulations for the scalloped hammerhead has failed to prevent large population declines of the shark species. However, the latest stock assessment for the northwestern Atlantic scalloped hammerhead shark population estimated that a total allowable catch (TAC) of 2,853 scalloped hammerhead sharks per year (or 69 percent of the 2005 catch) would allow a 70 percent probability of rebuilding to MSY in 10 years (Hayes
In addition, the petition asserts that there is little international regulation of fishing or trading to protect scalloped hammerheads; however, in 2010, the International Commission for the Conservation of Atlantic Tunas (ICCAT) developed recommendations 10-07 and 10-08, which specifically prohibit the retention, transshipping, landing, sorting, or selling of hammerhead sharks, other than bonnethead sharks, caught in association with ICCAT fisheries. The ICCAT is responsible for the conservation of tuna and tuna-like species in the Atlantic Ocean and adjacent seas and its recommendations are binding to Contracting Parties (of which there are 48, including the United States), unless Parties object pursuant to the treaty. On April 29, 2011, NMFS proposed and on August 29, 2011, finalized the implementation of these recommendations, which affect the U.S. commercial HMS pelagic
The petition notes that finning bans are a common form of shark management regulation and have been adopted by 19 countries, including Mexico, Costa Rica, and Chile, but argues that many of these bans contain loopholes that allow for the continued removal of shark fins at sea. It is important to note that the petition does not provide information that some countries and management bodies are working to address these issues, including the United States and the European Union (EU). In fact, on January 4, 2011, the 2010 U.S. Shark Conservation Act was signed. This legislation requires that all sharks caught in U.S. waters, with an exemption for smooth dogfish, be landed with fins naturally attached, effectively ending the practice of removing fins at sea in the United States (Pub. L. 111-348). However, even with the increase and strengthening of finning bans, the lack of internationally enforced catch limits or trade regulations allows for the continued and unregulated fishing of scalloped hammerheads in international waters. In 2010, the United States and Palau proposed to list
The petition contends that “biological vulnerability” in the form of long gestation periods, late maturity, large size, and documented schooling behavior, is affecting the species' ability to recover from exploitation. However, a recent ecological risk assessment for pelagic sharks found that scalloped hammerheads ranked among the less vulnerable species in terms of its biological productivity and susceptibility to the pelagic longline fisheries in the Atlantic Ocean (Cortés
The petition also asserts that “human population growth” may pose a serious threat to the scalloped hammerhead population. However, broad statements about generalized threats to the species do not constitute substantial information indicating that listing may be warranted. Although the petition presents information that the human population may be expanding, it does not provide information indicating an increase in fishing pressure on scalloped hammerhead sharks due specifically to this human population growth, or information that scalloped hammerhead sharks are responding in a negative fashion to human population growth.
We conclude that the petition presents substantial scientific or commercial information indicating that a combination of two of the section 4(a)(1) factors: Overutilization for commercial, recreational, scientific, or educational purposes, and inadequate existing regulatory mechanisms, may be causing or contributing to an increased risk of extinction for the scalloped hammerhead shark.
After reviewing the information contained in the petition, as well as information readily available in our files, and based on the above analysis, we conclude the petition presents substantial scientific information indicating the petitioned action of listing the scalloped hammerhead shark as threatened or endangered may be warranted. Therefore, in accordance with section 4(b)(3)(B) of the ESA and NMFS' implementing regulations (50 CFR 424.14(b)(2)), we will commence a status review of the species. During our status review, we will first determine whether the species is in danger of extinction (endangered) or likely to become so (threatened) throughout all or a significant portion of its range. If it is not, then we will consider whether the populations identified by the petitioner meet the DPS policy criteria, and if so, whether any of these are threatened or endangered. We now initiate this review, and thus, the scalloped hammerhead shark is considered to be a candidate species (69 FR 19975; April 15, 2004). Within 12 months of the receipt of the petition (August 14, 2012), we will make a finding as to whether listing the species (or any identified DPSs) as endangered or threatened is warranted as required by section 4(b)(3)(B) of the ESA. If listing the species (or any identified DPSs) is found to be warranted, we will publish a proposed rule and solicit public comments before developing and publishing a final rule.
To ensure that the status review is based on the best available scientific and commercial data, we are soliciting information on whether the scalloped hammerhead shark is endangered or threatened. Specifically, we are soliciting information in the following areas: (1) Historical and current distribution and abundance of this species throughout its range; (2) historical and current population trends; (3) life history in marine environments; (4) shark fin trade data; (5) any current or planned activities that may adversely impact the species; (6) ongoing or planned efforts to protect and restore the species and their habitats; (7) population structure information, such as genetics data; and (8) management, regulatory, and enforcement information. We request that all information be accompanied by: (1) Supporting documentation such as
A complete list of references is available upon request from NMFS Protected Resources Headquarters Office (see
The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB),
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Animal and Plant Health Inspection Service, USDA.
Notice of a proposed new system of records; request for comment.
The Animal and Plant Health Inspection Service proposes to add a system of records to its inventory of records systems subject to the Privacy Act of 1974, as amended. The system of records being proposed is the APHIS Animal Health Surveillance and Monitoring System, USDA-APHIS-15. This notice is necessary to meet the requirements of the Privacy Act to publish in the
Although the Privacy Act requires only that the portion of the system which describes the “routine uses” of the system be published for comment, we invite comment on all portions of this notice.
You may submit comments by either of the following methods:
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Dr. Diane Sutton, Senior Staff Veterinarian,
The Privacy Act of 1974, as amended (5 U.S.C. 552a), requires agencies to publish in the
The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) is proposing to add a new system of records, entitled APHIS Animal Health Surveillance and Monitoring System (AHSM), that will be used to maintain records of activities conducted by the agency pursuant to its mission and responsibilities authorized by the Animal Health Protection Act (7 U.S.C. 8301
APHIS' Veterinary Services (VS) program will use the AHSM to collect, manage, and evaluate animal health data for disease control and surveillance programs. The AHSM will assist APHIS in obtaining and analyzing relevant epidemiological information, identifying appropriate response tactics, and effectively responding to an animal disease event in the United States. It will also allow us to identify and notify the owners of animals that have been or may have been exposed in an animal disease event. The AHSM may also be used to document animal health program results to justify expenditures and compile statistical data about animal disease control or surveillance programs.
The AHSM contains modules for the Veterinary Services Laboratory Submissions (VSLS), the National Poultry Improvement Plan (NPIP), and the Mobile Information Management system (MIM).
The AHSM contains personally identifiable information about the individual listed as the contact person for the location where the animals subject to animal disease control or surveillance programs are maintained and the owner of animals involved with animal disease control or surveillance programs. Such information includes name; mailing and physical address, including city, county, State, postal code, and latitude/longitude coordinates; telephone number; email address; and any animal, sample, or location identification numbers associated with the person. The system also contains information about APHIS employees, cooperators, and contractors who are directly involved in animal disease control or surveillance program activities such as name, home and work address, home and work email addresses, telephone number(s), and any assigned identification numbers.
APHIS may routinely share data in the AHSM with certain Federal and State animal health officials or Federal or State wildlife agencies for assistance in conducting, managing, and analyzing animal disease or surveillance programs, and monitoring animal diseases including those related to wildlife, feral animals, or alternative livestock. Data may also be shared with Federal or State agencies involved with public health such as the Departments of Homeland Security and Health and Human Services for the purposes of zoonotic disease surveillance or control activities. APHIS may also share data in the AHSM with the public through a Web site that lists participants in voluntary animal disease certification or quality assurance programs, and lists individuals or entities not in compliance with animal disease regulations. APHIS may also use the Web site to notify individuals who may have acquired exposed or potentially exposed animals when other means of contact are unavailable.
Other routine uses of this information include releases related to investigations pertaining to violations of law or related to litigation. A complete listing of the routine uses for this system is included in the accompanying document that is published along with this notice.
The proposed information collection requests associated with this system have been approved by or submitted for approval by the Office of Management and Budget under the Paperwork Reduction Act.
Chief Information Officer, U.S. Department of Agriculture, 1400 Independence Ave. SW., Washington, DC 20250.
A report on the new system of records, required by 5 U.S.C. 552a(r), as implemented by Office of Management and Budget Circular A-130, was sent to the Chairman, Committee on Homeland Security and Governmental Affairs, United States Senate; the Chairman, Committee on Oversight and Government Reform, House of Representatives; and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget.
APHIS Animal Health Surveillance and Monitoring System, USDA-APHIS-15.
None.
The AHSM is a Web-based system hosted at secure and geographically dispersed locations. A backup copy of the data is maintained at a secure U.S. government facility.
Individuals who are listed as the contact person for the location where the animals subject to animal disease control or surveillance programs are maintained; owners of animals involved with animal disease control or surveillance programs; dealers, agents, and brokers of animals; owners or operators of animal product processing, slaughter, or rendering establishments; accredited veterinarians; contractors; cooperators; and certain APHIS employees.
For the individuals listed as the contact person for the location where the animals subject to animal disease control or surveillance programs are maintained; owners of animals involved with animal disease control or surveillance programs; dealers, agents, and brokers of animals; or owners or operators of animal product processing, slaughter, or rendering establishments; the following information will be retained: Name; address, including city, county, State, postal code, and latitude/longitude coordinates; e-mail address; telephone number; operation type; species and breed of animals maintained; and data necessary for managing and analyzing animal disease control or surveillance programs and monitoring diseases related to wildlife, feral animals, or alternative livestock. The information retained for APHIS employees, cooperators, and contractors
Animal Health Protection Act (7 U.S.C. 8301
APHIS Veterinary Services (VS) program uses the AHSM to collect, manage, and evaluate animal health data for disease management and surveillance programs.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, records maintained in the system may be disclosed outside USDA as follows:
(1) To certain Federal and State animal health officials to conduct, analyze, and report on the progress of animal disease control or surveillance programs;
(2) To Federal and State wildlife agencies for assistance in managing and analyzing animal disease control or surveillance programs and monitoring diseases related to wildlife, feral animals, or alternative livestock;
(3) To Federal or State agencies involved with public health such as the Departments of Homeland Security and Health and Human Services for the purposes of zoonotic disease surveillance or control activities;
(4) To the public through a public Web site which lists participants in voluntary animal disease certification or quality assurance programs and documents compliance with such programs; lists individuals not in compliance with animal disease regulations; and notifies individuals who may have acquired exposed or potentially exposed animals when other means of contact are unavailable;
(5) To the appropriate agency, whether Federal, State, local, or foreign, charged with responsibility of investigating or prosecuting a violation of law or of enforcing, implementing, or complying with a statute, rule, regulation, or order issued pursuant thereto, of any record within this system when information available indicates a violation or potential violation of law, whether civil, criminal, or regulatory in nature, and either arising by general statute or particular program statute, or by rule, regulation, or court order issued pursuant thereto;
(6) To the Department of Justice when the agency, or any component thereof, or any employee of the agency in his or her official capacity, or any employee of the agency in his or her individual capacity where the Department of Justice has agreed to represent the employee, or the United States, in litigation, where the agency determines that litigation is likely to affect the agency or any of its components, is a party to litigation or has an interest in such litigation, and the use of such records by the Department of Justice is deemed by the agency to be relevant and necessary to the litigation; provided, however, that in each case, the agency determines that disclosure of the records to the Department of Justice is a use of the information contained in the records that is compatible with the purpose for which the records were collected;
(7) For use in a proceeding before a court or adjudicative body before which the agency is authorized to appear, when the agency, or any component thereof, or any employee of the agency in his or her official capacity, or any employee of the agency in his or her individual capacity where the agency has agreed to represent the employee, or the United States, where the agency determines that litigation is likely to affect the agency or any of its components, is a party to litigation or has an interest in such litigation, and the agency determines that use of such records is relevant and necessary to the litigation; provided, however, that in each case, the agency determines that disclosure of the records to the court is a use of the information contained in the records that is compatible with the purpose for which the records were collected;
(8) To appropriate agencies, entities, and persons when the agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; the agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, a risk of identity theft or fraud, or a risk of harm to the security or integrity of this system or other systems or programs (whether maintained by the agency or another agency or entity) that rely upon the compromised information; and the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the agency's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm;
(9) To contractors and other parties engaged to assist in administering the program. Such contractors and other parties will be bound by the nondisclosure provisions of the Privacy Act. This routine use assists the agency in carrying out the program, and thus is compatible with the purpose for which the records are created and maintained;
(10) To USDA contractors, partner agency employees or contractors, or private industry employed to identify patterns, trends or anomalies indicative of fraud, waste, or abuse; and
(11) To the National Archives and Records Administration or to the General Services Administration for records management inspections conducted under 44 U.S.C. 2904 and 2906.
None.
Records are maintained on magnetic tape and optical disk. Backup media is taken weekly to an offsite storage facility and stored on tape.
Records are retrieved primarily by first or last name, address, or phone number of the individual listed as the contact person for the location where the animal(s) subject to animal disease control or surveillance programs are maintained or the owner of animals involved with animal disease control or surveillance programs; and by animal, flock, herd, or premises numbers. However, under this system records can be retrieved by any of the categories that have been recorded.
The AHSM security plan includes management, operational, and technical controls to prevent misuse of data by system users. These controls include the use of role-based security and access rights, network firewalls, and requiring all users to obtain a government-issued login. Access to the system is monitored by USDA officials to ensure authorized and appropriate use of the data.
Individual electronic records are retained within the system for 150 years from the last date of creation, edit, or access of the records. Incremental and full system tape backups are retained for 1 month.
Associate Deputy Administrator, National Animal Health Policy and
Any individual may request general information regarding this system of records or information as to whether the system contains records pertaining to him/her from the system manager at the address above. All inquiries pertaining to this system should be in writing, must name the system of records as set forth in the system notice, and must contain the individual's name, telephone number, address, and email address.
Any individual may obtain information from a record in the system that pertains to him or her. Requests for hard copies of records should be in writing, and the request must contain the requesting individual's name, address, name of the system of records, timeframe for the records in question, any other pertinent information to help identify the file, and a copy of his/her photo identification containing a current address for verification of identification. All inquiries should be addressed to the Freedom of Information and Privacy Act Staff, Legislative and Public Affairs, APHIS, 4700 River Road Unit 50, Riverdale, MD 20737-1232.
Any individual may contest information contained within a record in the system that pertains to him/her by submitting a written request to the system manager at the address above. Include the reason for contesting the record and the proposed amendment to the information with supporting documentation to show how the record is inaccurate.
Information in this system comes primarily from the customers, including the individuals listed as the contact person for the location where the animals subject to animal disease control or surveillance programs are maintained, and the owners of animals involved with animal disease control or surveillance programs. Such information may be supplemented by information from other USDA agencies such as the Food Safety and Inspection Service, Farm Service Agency, APHIS' Wildlife Services, or from State veterinary health officials and animal testing laboratories.
Employee, cooperator, and contractor information is obtained primarily from the employee, cooperator, or contractor.
None.
Grain Inspection, Packers and Stockyards Administration, USDA.
Notice of advisory committee meeting.
Pursuant to the Federal Advisory Committee Act, this constitutes notice of the upcoming meeting of the Grain Inspection, Packers and Stockyards Administration (GIPSA) Grain Inspection Advisory Committee (Advisory Committee). The Advisory Committee meets twice annually to advise the GIPSA Administrator on the programs and services that GIPSA delivers under the U.S. Grain Standards Act. Recommendations by the Advisory Committee help GIPSA better meet the needs of its customers who operate in a dynamic and changing marketplace.
December 6, 2011, 8 a.m. to 4:30 p.m.; and December 7, 2011, 8 a.m. to 3:30 p.m.
The Advisory Committee meeting will take place at the Embassy Suites Hotel-Portland Downtown, 319 SW Pine Street, Portland, Oregon, 97204.
Requests to orally address the Advisory Committee during the meeting or written comments may be sent to: Administrator, GIPSA, U.S. Department of Agriculture, 1400 Independence Avenue SW., STOP 3601, Washington, DC 20250-3601. Requests and comments may also be faxed to (202) 690-2173.
Terri L. Henry by phone at (202) 205-8281 or by email at
The purpose of the Advisory Committee is to provide advice to the GIPSA Administrator with respect to the implementation of the U.S. Grain Standards Act (7 U.S.C. 71-87k). Information about the Advisory Committee is available on the GIPSA Web site at
The agenda will include an overview of Federal Grain Inspection Service operations, updated tonnage fee projections, international programs, sorghum odor, moisture measurement, and the quality management program.
For a copy of the agenda please contact Terri L. Henry by phone at (202) 205-8281 or by email at
Public participation will be limited to written statements unless permission is received from the Committee Chairperson to orally address the Advisory Committee. The meeting will be open to the public.
Persons with disabilities who require alternative means of communication of program information or related accommodations should contact Terri L. Henry at the telephone number listed above.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the Connecticut Advisory Committee to the Commission will be held at the Legislative Building, Hearing Group Room 3C, 210 Capitol Avenue, Hartford, CT 06106, and will convene at 9:30 a.m. on Tuesday, December 6, 2011. The purpose of the briefing meeting is to discuss police practices and the changing demographics in Connecticut. The purpose of the planning meeting is to plan future activities.
Members of the public are entitled to submit written comments. The comments must be received in the regional office by Friday, January 6, 2012. Comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 624 9th Street NW., Suite 740, Washington, DC 20425, faxed to (202) 376-7548, or emailed to
Hearing-impaired persons who will attend the meeting and require the services of a sign language interpreter should contact the Regional Office at least ten (10) working days before the scheduled date of the meeting.
Records generated from this meeting may be inspected and reproduced at the
The meeting will be conducted pursuant to the provisions of the rules and regulations of the Commission and FACA.
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
Copies of the above information collection proposal can be obtained by calling or writing Diana Hynek, Departmental Paperwork Clearance Officer, (202) 482-0266, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Economic Development Administration, Department of Commerce.
Notice and opportunity for public comment.
Pursuant to Section 251 of the Trade Act of 1974, as amended (19 U.S.C. 2341
Any party having a substantial interest in these proceedings may request a public hearing on the matter. A written request for a hearing must be submitted to the Trade Adjustment Assistance for Firms Division, Room 7106, Economic Development Administration, U.S. Department of Commerce, Washington, DC 20230, no later than ten (10) calendar days following publication of this notice.
Please follow the requirements set forth in EDA's regulations at 13 CFR 315.9 for procedures to request a public hearing. The Catalog of Federal Domestic Assistance official number and title for the program under which these petitions are submitted is 11.313, Trade Adjustment Assistance for Firms.
The Materials Processing Equipment Technical Advisory Committee (MPETAC) will meet on December 12, 2011, 9 a.m., Room 3884, in the Herbert C. Hoover Building, 14th Street between Pennsylvania and Constitution Avenues NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration with respect to technical questions that affect the level of export controls applicable to materials processing equipment and related technology.
1. Opening remarks and introductions.
2. Presentation of papers and comments by the Public.
3. Discussion on proposals from last and for next Wassenaar Meeting.
4. Report on proposed and recently issued changes to the Export Administration Regulations.
5. Other business.
6. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3).
The open session will be accessible via teleconference to 20 participants on a first come, first serve basis. To join the conference, submit inquiries to Ms. Yvette Springer at
A limited number of seats will be available for the public session. Reservations are not accepted. To the extent that time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate the distribution of public presentation materials to the Committee members, the Committee suggests that presenters forward the public presentation materials prior to the meeting to Ms. Springer via email.
The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on November 21, 2011, pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. app. 2 § 10(d)), that the portion of the meeting dealing with matters the premature disclosure of which would be likely to frustrate significantly implementation of a proposed agency action as described in 5 U.S.C. 552b(c)(9)(B) shall be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3). The remaining portions of the meeting will be open to the public. For more information, call Yvette Springer at (202) 482-2813.
The Emerging Technology and Research Advisory Committee (ETRAC) will meet on December 14 and 15, 2011, 8:30 a.m., Room 3884, at the Herbert C. Hoover Building, 14th Street between Pennsylvania and Constitution Avenues NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration on emerging technology and research activities, including those related to deemed exports.
1. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3).
1. ETRAC Member Discussion Emerging Technology Analysis; and Impact of Export Controls on the conduct of U.S. science and technology activities in the United States.
2. Public Comments.
The open sessions will be accessible via teleconference to 20 participants on a first come, first serve basis. To join the conference, submit inquiries to Ms. Yvette Springer at
A limited number of seats will be available for the public session. Reservations are not accepted. To the extent that time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate the distribution of public presentation materials to the Committee members, the Committee suggests that presenters forward the public presentation materials prior to the meeting to Ms. Springer via email.
The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on November 21, 2011, pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended, that the portion of the meeting dealing with matters which would be likely to frustrate significantly implementation of a proposed agency action as described in 5 D.S.C. 552b(c) (9) (B) shall be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)1 and 10(a) (3). The remaining portions of the meeting will be open to the public.
For more information, call Yvette Springer at (202) 482-2813.
Import Administration, International Trade Administration, Department of Commerce.
Lilit Astvatsatrian or Trisha Tran, AD/CVD Operations, Office 4, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230;
On October 25, 2011, the Department of Commerce (“Department”) published in the
However, pursuant to our
This correction is published in accordance with sections 751(h) and 777(i) of the Tariff Act of 1930, as amended.
Import Administration, International Trade Administration, Department of Commerce.
Joshua Morris at (202) 482-1779; AD/CVD Operations, Office 1, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230.
On September 2, 2011, the Department of Commerce (“the Department”) published a notice announcing the opportunity to request an administrative review of the countervailing duty order on narrow woven ribbons with woven selvedge (“ribbons”) from the People's Republic of China (“PRC”) covering the period of September 1, 2010, through December 31, 2010.
Pursuant to 19 CFR 351.213(d)(l), the Secretary will rescind an administrative review, in whole or in part, if the party that requested a review withdraws the request within 90 days of the date of publication of the notice of initiation of the requested review. On November 2, 2011, Dongfang withdrew its request for review within the 90-day period. Therefore, in response to Dongfang's timely withdrawal request, and as no other party requested a review, the Department is rescinding this administrative review.
The Department will instruct U.S. Customs and Border Protection (“CBP”) to assess countervailing duties on all appropriate entries. For Dongfang, countervailing duties shall be assessed at rates equal to the cash deposit of estimated countervailing duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). The Department intends to issue appropriate assessment instructions to CBP 15 days after the date of publication of this notice of rescission of administrative review.
This notice serves as a final reminder to parties subject to administrative protective order (“APO”) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.
This notice of rescission is issued and published in accordance with sections 751(a)(l) and 777(i)(l) of the Tariff Act, as amended, and 19 CFR 351.213(d)(4).
National Institute of Standards and Technology, Department of Commerce.
Notice of open meeting.
The National Construction Safety Team (NCST) Advisory Committee (Committee), will hold a meeting via teleconference on Wednesday, December 21, 2011 from 3 p.m. to 5 p.m. Eastern Time. The primary purpose of this meeting is to discuss the NCST Advisory Committee's draft annual report to Congress. A copy of the draft report will be posted on the NCST Advisory Committee's web site at
The NCST Advisory Committee will hold a meeting via teleconference on Wednesday, December 21, 2011, from 3 p.m. until 5 p.m. Eastern Time.
Questions regarding the meeting should be sent to the Disaster and Failure Studies Program Director, National Institute of Standards and Technology, 100 Bureau Drive, Mail Stop 8611, Gaithersburg, Maryland 20899-8611. For instructions on how to participate in the meeting, please see the
Mr. Eric Letvin, Disaster and Failure Studies Program Director, National Institute of Standards and Technology, 100 Bureau Drive, Mail Stop 8611, Gaithersburg, Maryland 20899-8611. Mr. Letvin's email address is
The NCST Advisory Committee was established pursuant to Section 11 of the National Construction Safety Team Act (15 U.S.C. 7301
Pursuant to the Federal Advisory Committee Act, 5 U.S.C. app., notice is hereby given that the NCST Advisory Committee will hold a meeting via teleconference on Wednesday, December 21, 2011, from 3 p.m. until 5 p.m. Eastern Time. There will be no central meeting location. Interested members of the public will be able to participate in the meeting from remote locations by calling into a central phone number. The primary purpose of this meeting is to discuss the NCST Advisory Committee's draft annual report to Congress. A copy of the draft report will be posted on the NCST Advisory Committee's web site at
Individuals and representatives of organizations who would like to offer comments and suggestions related to the NCST Advisory Committee's affairs are invited to request detailed instructions by contacting Eric Letvin on how to dial in from a remote location to participate in the meeting. Eric Letvin's email address is
All participants in the meeting are required to pre-register. Anyone wishing to participate must register by 5 p.m. Eastern Time on Monday, December 19, 2011, in order to be included. Please submit your name, email address, and phone number to Eric Letvin. After registering, participants will be provided with detailed instructions on
National Institute of Standards and Technology, Department of Commerce.
Notice of open meeting.
The Advisory Committee on Earthquake Hazards Reduction (ACEHR or Committee), will hold a meeting via teleconference on Tuesday, December 20, 2011 from 11 a.m. to 1 p.m. Eastern Time. The primary purpose of this meeting is to develop an outline for the Committee's draft annual report to the NIST Director. Any draft meeting materials will be posted on the NEHRP Web site at
The ACEHR will hold a meeting via teleconference on Tuesday, December 20, 2011, from 11 a.m. until 1 p.m. Eastern Time.
Questions regarding the meeting should be sent to National Earthquake Hazards Reduction Program Director, National Institute of Standards and Technology, 100 Bureau Drive, Mail Stop 8604, Gaithersburg, Maryland 20899-8604. For instructions on how to participate in the meeting, please see the
Dr. Jack Hayes, National Earthquake Hazards Reduction Program Director, National Institute of Standards and Technology, 100 Bureau Drive, Mail Stop 8604, Gaithersburg, Maryland 20899-8604. Dr. Hayes' email address is
The Committee was established in accordance with the requirements of Section 103 of the NEHRP Reauthorization Act of 2004 (Public Law 108-360). The Committee is composed of 12 members appointed by the Director of NIST, who were selected for their technical expertise and experience, established records of distinguished professional service, and their knowledge of issues affecting the National Earthquake Hazards Reduction Program. In addition, the Chairperson of the U.S. Geological Survey (USGS) Scientific Earthquake Studies Advisory Committee (SESAC) serves in an ex-officio capacity on the Committee. The Committee assesses:
• Trends and developments in the science and engineering of earthquake hazards reduction;
• The effectiveness of NEHRP in performing its statutory activities (improved design and construction methods and practices; land use controls and redevelopment; prediction techniques and early-warning systems; coordinated emergency preparedness plans; and public education and involvement programs);
• Any need to revise NEHRP; and
• The management, coordination, implementation, and activities of NEHRP.
Background information on NEHRP and the Advisory Committee is available at
Pursuant to the Federal Advisory Committee Act, 5 U.S.C. app., notice is hereby given that the ACEHR will hold a meeting via teleconference on Tuesday, December 20, 2011, from 11 a.m. until 1 p.m. Eastern Time. There will be no central meeting location. Interested members of the public will be able to participate in the meeting from remote locations by calling into a central phone number. The primary purpose of this meeting is to develop an outline for the Committee's draft annual report to the NIST Director. Any draft meeting materials will be posted on the NEHRP Web site at
Individuals and representatives of organizations who would like to offer comments and suggestions related to the Committee's affairs are invited to request detailed instructions by contacting Michelle Harman on how to dial in from a remote location to participate in the meeting. Michelle Harman's email address is
All participants of the meeting are required to pre-register. Anyone wishing to participate must register by close of business Wednesday, December 14, 2011, in order to be included. Please submit your name, email address, and phone number to Michelle Harman. After registering, participants will be provided with detailed instructions on how to dial in from a remote location in order to participate. Michelle Harman's email address is
National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before January 27, 2012.
Direct all written comments to Diana Hynek, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW, Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection
This request is for extension of a currently approved information collection.
NOS Office of Coast Survey manages the Certification Requirements for Distributors of NOAA Electronic Navigational Charts (NOAA ENCs®). The certification allows entities to download, redistribute, repackage, or in some cases reformat, official NOAA ENCs and retain the NOAA ENC's official status. The regulations for implementing the Certification are at 15 CFR part 995.
The recordkeeping and reporting requirements of 15 CFR part 995 form the basis for this collection of information. This information allows the Office of Coast Survey to administer the regulation, and to better understand the marketplace resulting in products that meet the needs of the customer in a timely and efficient manner.
Responses from the Certified ENC Distributors are all electronic and sent via email. All distributors have an Excel spreadsheet which they submit for the twice-yearly report.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information;
(c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings.
The Mid-Atlantic Fishery Management Council (Council) and its Mid-Atlantic Monkfish Subcommittee will hold public meetings.
The meetings will be held Tuesday, December 13 through Thursday, December 15, 2011. See
The meetings will be held at Kingsmill, 1010 Kingsmill Road, Williamsburg, VA 23185; telephone: (757) 253-1703.
Dr. Christopher Moore, Executive Director, Mid-Atlantic Fishery Management Council; telephone: (302) 674-2331 ext. 255.
Agenda items by day for the Council's Committees and the Council itself are:
On Tuesday, December 13, the Mid-Atlantic Monkfish Subcommittee will discuss issues and concerns unique to the Mid-Atlantic Monkfish fishery and potential management solutions. The Council will receive presentation on the CIE Review of the June 2012 Excessive Shares Workshop and followed by Council discussion on next steps. Kris Ohleth will provide the Council with a presentation on the Atlantic Wind Connection Project. The Council will receive a presentation from Chris Boelke and Lou Chiarella of the NMFS Habitat Division. The Council will discuss and identify the next steps related to the
On Wednesday, December 14, the Council in conjunction with the ASMFC's Summer Flounder, Scup, and Black Sea Bass Boards will review the Scientific and Statistical Committee's (SSC) and the associated Monitoring Committee's and Advisory Panel's specification recommendations and adopt 2012 commercial and recreational harvest levels and commercial management measures for summer flounder and scup, and finalize recreational management measures for summer flounder, scup, and black sea bass. The Council will review alternatives to address spatial and regional management of the black sea bass recreational fishery and discuss potential complimentary action by the Council and ASMFC Board related to Amendment 17 to the Summer Flounder, Scup, and Black Sea Bass FMP.
On Thursday, December 15, the Council will present the Ricks E Savage Award. The Council will receive a presentation by Ingrid Biedron of Cornell University on Fishery Management Councils: Decision-making, Communication, and Social Factors Associated with Ecosystem-based Fisheries Management. The Council will hold its regular Business Session to approve the October 2011 minutes and address any outstanding actions from the October 2011 meeting, review and approve SOPPs, review and approve 5-year research plan, receive Organizational Reports, Liaison Reports, the Executive Director's Report, the Science Report, Committee Reports, and any continuing and/or new business.
Although non-emergency issues not contained in this agenda may come before these groups for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), those issues may not be the subject of formal action during these meetings. Actions will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notification of U.S. fishing opportunity.
NMFS announces a U.S. fishing opportunity for 1,000 mt yellowtail flounder in Division 3LNO of the Northwest Atlantic Fisheries Organization (NAFO) Regulatory Area during 2011. This action is necessary to make available this U.S. fishing opportunity on an equitable basis.
Expressions of interest regarding NAFO Division 3LNO yellowtail flounder will be accepted through December 13, 2011. Fishing operations must take place during 2011.
Expressions of interest regarding NAFO Division 3LNO yellowtail flounder should be made in writing to Patrick E. Moran in the NMFS Office of International Affairs, at 1315 East-West Highway, Silver Spring, MD 20910 (
Information relating to NAFO fish quotas, NAFO Conservation and Enforcement Measures, and the High Seas Fishing Compliance Act (HSFCA) Permit is available from Douglas Christel, at the NMFS Northeast Regional Office at 55 Great Republic Drive, Gloucester, MA 01930 (
Patrick E. Moran, (301) 427-8370.
NAFO has established and maintains conservation measures in its Regulatory Area that include one effort limitation fishery as well as fisheries with total allowable catches (TACs) and member nation quota allocations. The principal species managed are cod, flounder, redfish, American plaice, halibut, hake, capelin, shrimp, skates and squid. The United States currently receives no yellowtail flounder allocation from NAFO. However, as the result of a bilateral arrangement with Canada, the United States may request a transfer of up to 1,000 mt of NAFO Division 3LNO yellowtail flounder from Canada's quota allocation for use by U.S. vessels during 2011, or any succeeding year through 2017. In January 2011, this fishing opportunity was announced in the
Expressions of interest to fish 1,000 mt of yellowtail flounder in NAFO Division 3LNO will once again be considered from U.S. vessels in possession of, or eligible for, a valid HSFCA permit, which is available from the NMFS Northeast Regional Office (see
Note that vessels issued valid HSFCA permits under 50 CFR part 300 are exempt from multispecies permit, mesh size, effort-control, and possession limit restrictions, specified in 50 CFR 648.4, 648.80, 648.82 and 648.86, respectively, while transiting the U.S. exclusive economic zone (EEZ) with multispecies on board the vessel, or landing multispecies in U.S. ports that were caught while fishing in the NAFO Regulatory Area, provided:
1. The vessel operator has a letter of authorization issued by the Regional Administrator on board the vessel;
2. For the duration of the trip, the vessel fishes, except for transiting purposes, exclusively in the NAFO Regulatory Area and does not harvest fish in, or possess fish harvested in, or from, the U.S. EEZ;
3. When transiting the U.S. EEZ, all gear is properly stowed in accordance with one of the applicable methods specified in § 648.23(b); and
4. The vessel operator complies with the HSFCA permit and all NAFO conservation and enforcement measures while fishing in the NAFO Regulatory Area.
Relevant NAFO Conservation and Enforcement Measures include, but are not limited to, maintenance of a fishing logbook with NAFO-designated entries; adherence to NAFO hail system requirements; presence of an on-board observer; deployment of a functioning, autonomous vessel monitoring system; and adherence to all relevant minimum size, gear, bycatch, and other requirements. Further details regarding these requirements are available from the NMFS Northeast Regional Office, and can also be found in the current NAFO Conservation and Enforcement Measures on the Internet (see
In the event that no adequate expressions of interest in harvesting NAFO Division 3LNO yellowtail flounder during 2011 are made on behalf of U.S. vessels, expressions of interest will be considered from U.S. processors and other fishing interests intending to make use of a Canadian vessel under a chartering arrangement. Under the bilateral arrangement with Canada, the United States may enter into a chartering (or other) arrangement with a Canadian vessel to harvest the transferred yellowtail flounder. Prior notification to the NAFO Executive Secretary is necessary in this case. Expressions of interest from U.S. processors and other fishing interests intending to make use of a Canadian vessel under chartering arrangements should provide the following information: the name and registration number of the intended vessel; a copy of the charter; a detailed fishing plan, and a written letter of consent from the Department of Fisheries and Oceans, Canada. In addition, expressions of interest using a Canadian vessel under charter should be accompanied by a detailed description of anticipated benefits to the United States. Such benefits might include, but are not limited to, the use of U.S. processing facilities/personnel; the use of U.S. fishing personnel; marketing of the product in the United States; other specific positive effects on U.S. employment; evidence that fishing by the Canadian vessel will actually take place; and any available documentation of the physical characteristics and economics of the fishery for future use by the U.S. fishing industry.
Any Canadian vessel wishing to enter into a chartering arrangement with the United States must be in full current compliance with the requirements outlined in the NAFO Convention and Conservation and Enforcement Measures including, but not limited to, submission of the following reports to the NAFO Executive Secretary: provisional monthly catches within 30 days following the calendar month in which the catches were made; observer reports within 30 days following the completion of a fishing trip; and an annual statement of actions taken in order to comply with the NAFO Convention; and notification to NMFS of the termination of the charter fishing activities. Furthermore, the United States may also consider the vessel's previous compliance with NAFO bycatch, reporting and other provisions, as outlined in the NAFO Conservation and Enforcement Measures, before entering into a chartering arrangement. More details on NAFO requirements are available from NMFS (see
In the event that multiple expressions of interest are made by U.S. fishing vessels, processors, or interests to fish for NAFO Division 3LNO yellowtail in 2011, the information submitted regarding benefits to the United States will be used in making a selection. After reviewing all requests for allocations submitted, NMFS may decide not to grant any allocations if it is determined that no requests meet the criteria described in this notice. Once a decision has been made regarding the disposition of the fishing opportunity, NMFS will immediately take appropriate steps to notify all applicants and will contact Canada and NAFO to take appropriate action. If the 3LNO yellowtail flounder transferred from Canada is awarded to a U.S. vessel or a specified chartering operation during 2011, it may not be transferred without the express, written consent of NMFS.
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed additions to the Procurement List.
The Committee is proposing to add products and a service to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Committee for Purchase From People Who Are Blind or Severely Disabled, Jefferson Plaza 2, Suite 10800, 1421 Jefferson Davis Highway, Arlington, Virginia, 22202-3259.
Patricia Briscoe,
This notice is published pursuant to 41 U.S.C. 47(a) (2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the products and service listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. If approved, the action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the products and service to the Government.
2. If approved, the action will result in authorizing small entities to furnish the products and service to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the products and service proposed for addition to the Procurement List.
Comments on this certification are invited. Commenters should identify the statement(s) underlying the certification on which they are providing additional information.
The following products and service are proposed for addition to Procurement List for production by the nonprofit agencies listed:
Defense Logistics Agency, Department of Defense (DoD).
Notice to amend a system of records.
The Defense Logistics Agency is proposing to amend a system of records notice in its existing inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.
The proposed action will be effective without further notice on December 28, 2011 unless comments are received which would result in a contrary determination.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
Ms. Jody Sinkler, DLA FOIA/Privacy Act Office, Headquarters, Defense Logistics Agency, ATTN: DGA, 8725 John J. Kingman Road, Suite 1644, Fort Belvoir, VA 22060-6221, or by phone at (703) 767-5045.
The Defense Logistics Agency's system of records notices subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the
The specific changes to the record system being amended are set forth below followed by the notice, as amended, published in its entirety. The proposed amendment is not within the purview of subsection (r) of the Privacy Act of 1974 (5 U.S.C. 552a), as amended, which requires the submission of new or altered systems reports.
Government Telephone Use Records (August 7, 2009, 74 FR 39652).
Delete entry and replace with “Records are located at System Engineering and Network Services (J6FIS), Defense Logistics Agency Headquarters, 8725 John J. Kingman Road, Stop 6220, Fort Belvoir, VA 22060-6221, and at the telephone control offices of the DLA Primary Level Field Activities. Official mailing addresses are published as an appendix to DLA's compilation of systems of records notices.”
Add “BlackBerry devices” to entry.
Add “and wireless devices” to first paragraph.
Delete entry and replace with “Records are stored on paper.”
Delete second sentence from entry.
Delete entry and replace with “Staff Director, System Engineering and Network Services (J6FIS), Defense Logistics Agency Headquarters, 8725 John J. Kingman Road, Stop 6220, Fort Belvoir, VA 22060-6221, and the Telecommunications Control Officers of DLA Primary Level Field Activities. Official mailing addresses are published as an appendix to DLA's compilation of systems of records notices.”
Delete entry and replace with “Individuals seeking to determine whether information about themselves is contained in this system should address written inquiries to the DLA FOIA/Privacy Act Office, Headquarters, Defense Logistics Agency, ATTN: DGA, 8725 John J. Kingman Road, Suite 1644, Fort Belvoir, VA 22060-6221.
Individuals need to provide their full name and the DLA facility or activity where employed at the time the records were created or processed.”
Delete entry and replace with “Individuals seeking access to information about themselves contained in this system should address written inquiries to the DLA FOIA/Privacy Act Office, Headquarters, Defense Logistics Agency, ATTN: DGA, 8725 John J.
Individuals need to provide their full name and the DLA facility or activity where employed at the time the records were created or processed.”
Delete entry and replace with “The DLA rules for accessing records, for contesting contents, and appealing initial agency determinations are contained in 32 CFR part 323, or may be obtained from the DLA FOIA/Privacy Act Office, Headquarters, Defense Logistics Agency, ATTN: DGA, 8725 John J. Kingman Road, Suite 1644, Fort Belvoir, VA 22060-6221.”
Government Telephone Use Records.
Records are located at System Engineering and Network Services (J6FIS), Defense Logistics Agency Headquarters, 8725 John J. Kingman Road, Stop 6220, Fort Belvoir, VA 22060-6221, and at the telephone control offices of the DLA Primary Level Field Activities. Official mailing addresses are published as an appendix to DLA's compilation of systems of records notices.
DLA employees, military members, contractors, and individuals authorized to use government telephone systems, including wireless devices such as cellular telephones, pagers, BlackBerry devices, and telecommunications devices for the deaf or speech impaired and wireless air cards. The records also cover individuals who have been issued telephone calling cards.
The records include individual's name and physical location; duty telephone, cell, and pager numbers; billing account codes; government issued telephone calling card account number; equipment and calling card receipts and turn-in documents; device serial numbers; and details of telephone use to include dates and times of telephone calls made or received, numbers called or called from, city and state, duration of calls, and assessed costs.
10 U.S.C. 133, Under Secretary of Defense for Acquisition, Technology, and Logistics; 44 U.S.C. 3501 et seq., Federal Information Policy; Committee on National Security Systems Directive No. 900, Governing Procedures of the Committee on National Security Systems promulgated pursuant to 47 U.S.C. 901
Records are maintained to verify that telephones and wireless devices are used for official business or authorized purposes; to identify inappropriate calls and the persons responsible, and to collect the costs of those calls from those responsible. These records may be used as a basis for disciplinary action against offenders.
Records are also maintained to ensure proper certification and payment of bills; to safeguard telecommunications assets; for internal management control; for reporting purposes; and to forecast future telecommunications requirements and costs. Statistical data, with all personal identifiers removed, may be used by management officials for purposes of conducting studies, evaluations, and assessments.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974 these records may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
Information may be released to telecommunications service providers to permit servicing the account.
The DoD “Blanket Routine Uses” also apply to this system of records.
Records are stored on paper.
Records are retrieved by individual's name, billing account code, or telephone number.
Access to the data is limited to those who require the records in the performance of their official duties. Physical entry is restricted by the use of locks, guards, and administrative procedures. Employees are periodically briefed on the consequences of improperly accessing restricted databases or records.
Records are destroyed when 3 years old. Initial telephone use reports may be destroyed earlier if the information needed to identify abuse has been captured in other records.
Staff Director, System Engineering and Network Services (J6FIS), Defense Logistics Agency Headquarters, 8725 John J. Kingman Road, Stop 6220, Fort Belvoir, VA 22060-6221, and the Telecommunications Control Officers of DLA Primary Level Field Activities. Official mailing addresses are published as an appendix to DLA's compilation of systems of records notices.
Individuals seeking to determine whether information about themselves is contained in this system should address written inquiries to the DLA FOIA/Privacy Act Office, Headquarters, Defense Logistics Agency, ATTN: DGA, 8725 John J. Kingman Road, Suite 1644, Fort Belvoir, VA 22060-6221.
Individuals need to provide their full name and the DLA facility or activity where employed at the time the records were created or processed.
Individuals seeking access to information about themselves contained in this system should address written inquiries to the DLA FOIA/Privacy Act Office, Headquarters, Defense Logistics Agency, ATTN: DGA, 8725 John J. Kingman Road, Suite 1644, Fort Belvoir, VA 22060-6221.
Individuals need to provide their full name and the DLA facility or activity where employed at the time the records were created or processed.
The DLA rules for accessing records, for contesting contents, and appealing initial agency determinations are contained in 32 CFR part 323, or may be obtained from the DLA FOIA/Privacy Act Office, Headquarters, Defense Logistics Agency, ATTN: DGA, 8725 John J. Kingman Road, Suite 1644, Fort Belvoir, VA 22060-6221.
Data is supplied by the telephone user, telecommunications service providers, and DLA management.
None.
Office of the Secretary, Department of Defense.
Notice of updated mental health rates for Fiscal Year 2012.
This notice provides the updated regional per-diem rates for low-volume mental health providers; the update factor for hospital-specific per-diems; the updated cap per-diem for high-volume providers; the beneficiary per-diem cost-share amount for low-volume providers; and, the updated per-diem rates for both full-day and half-day TRICARE Partial Hospitalization Programs for Fiscal Year 2012.
TRICARE Management Activity (TMA), Medical Benefits and Reimbursement Branch, 16401 East Centretech Parkway, Aurora, CO 80011-9066.
Elan Green, Medical Benefits and Reimbursement Branch, TMA, telephone (303) 676-3907.
The final rule published in the
Partial hospitalization rates for full-day and half-day programs also will be updated by 3.0 percent for Fiscal Year 2012.
The cap amount for high-volume hospitals and units also will be updated by the 3.0 percent for Fiscal Year 2012.
The beneficiary cost share for low-volume hospitals and units also will be updated by the 3.0 percent for Fiscal Year 2012.
Per 32 CFR 199.14, the same area wage indexes used for the CHAMPUS Diagnosis-Related Group (DRG)-based payment system shall be applied to the wage portion of the applicable regional per-diem for each day of the admission. The wage portion shall be the same as that used for the CHAMPUS DRG-based payment system. For wage index values greater than 1.0, the wage portion of the regional rate subject to the area wage adjustment is 68.8 percent for Fiscal Year 2012. For wage index values less than or equal to 1.0, the wage portion of the regional rate subject to the area wage adjustment is 62 percent.
Additionally, 32 CFR 199.14, requires that hospital specific and regional per-diems shall be updated by the Medicare update factor for hospitals and units exempt from the Medicare prospective payment system.
The following reflect an update of 3.0 percent for Fiscal Year 2012.
The following reflect an update of 3.0 percent for Fiscal Year 2012 for the partial hospitalization rates.
The above rates are effective for services rendered on or after October 1, 2011.
Department of Defense.
Office of the Secretary, Department of Defense (DoD).
Notice of DRG revised rates.
This notice describes the changes made to the TRICARE DRG-based payment system in order to conform to changes made to the Medicare Prospective Payment System (PPS).
It also provides the updated fixed loss cost outlier threshold, cost-to-charge ratios and the data necessary to update the FY 2012 rates.
TRICARE Management Activity (TMA), Medical Benefits and Reimbursement Systems, 16401 East Centretech Parkway, Aurora, CO 80011-9066.
Mark A. Jacobs, Medical Benefits and Reimbursement Systems, TMA, telephone (303) 676-3802.
Questions regarding payment of specific claims under the TRICARE DRG-based payment system should be addressed to the appropriate contractor.
The final rule published on September 1, 1987 (52 FR 32992) set forth the basic procedures used under the CHAMPUS DRG-based payment system. This was subsequently amended by final rules published August 31, 1988 (53 FR 33461), October 21, 1988 (53 FR 41331), December 16, 1988 (53 FR 50515), May 30, 1990 (55 FR 21863), October 22, 1990 (55 FR 42560), and September 10, 1998 (63 FR 48439).
An explicit tenet of these final rules, and one based on the statute authorizing the use of DRGs by TRICARE, is that the TRICARE DRG-based payment system is modeled on the Medicare PPS, and that, whenever practicable, the TRICARE system will follow the same rules that apply to the Medicare PPS. The Centers for Medicare and Medicaid Services (CMS) publishes these changes annually in the
In addition, this notice updates the rates and weights in accordance with our previous final rules. The actual changes we are making, along with a description of their relationship to the Medicare PPS, are detailed below.
Following is a discussion of the changes CMS has made to the Medicare PPS that affect the TRICARE DRG-based payment system.
Under both the Medicare PPS and the TRICARE DRG-based payment system, cases are classified into the appropriate DRG by a Grouper program. The Grouper classifies each case into a DRG on the basis of the diagnosis and procedure codes and demographic information (that is, sex, age, and discharge status). The Grouper used for the TRICARE DRG-based payment system is the same as the current Medicare Grouper with two modifications. The TRICARE system has replaced Medicare DRG 435 with two age-based DRGs (900 and 901), and has implemented thirty-four (34) neonatal DRGs in place of Medicare DRGs 385 through 390. For admissions occurring on or after October 1, 2001, DRG 435 has been replaced by DRG 523. The TRICARE system has replaced DRG 523 with the two age-based DRGs (900 and 901). For admissions occurring on or after October 1, 1995, the CHAMPUS grouper hierarchy logic was changed so the age split (age <29 days) and assignments to MDC 15 occur before assignment of the PreMDC DRGs. This resulted in all neonate tracheostomies and organ transplants to be grouped to MDC 15 and not to DRGs 480-483 or 495. For admissions occurring on or after October 1, 1998, the CHAMPUS grouper hierarchy logic was changed to move DRG 103 to the PreMDC DRGs and to assign patients to PreMDC DRGs 480, 103 and 495 before assignment to MDC 15 DRGs and the neonatal DRGs. For admissions occurring on or after October 1, 2001, DRGs 512 and 513 were added to the PreMDC DRGs, between DRGs 480 and 103 in the TRICARE grouper hierarchy logic. For admissions occurring on or after October 1, 2004, DRG 483 was deleted and replaced with DRGs 541 and 542, splitting the assignment of cases on the basis of the performance of a major operating room procedure. The description for DRG 480 was changed to “Liver Transplant and/or Intestinal Transplant”, and the description for DRG 103 was changed to “Heart/Heart
The MS-DRG system consolidated the 43 pediatric CMS DRGs that were defined based on age less than or equal to 17 into the most clinically similar MS-DRGs. In the CMS Inpatient Prospective Payment System final rule for MS-DRGs, CMS stated for the Medicare population these pediatric CMS DRGs contained a very low volume of patients. At the same time, Medicare encouraged private insurers and other non-Medicare payers to make refinements to MS-DRGs to better suit the needs of the patients they serve. Consequently, TRICARE finds it appropriate to retain the pediatric CMS-DRGs for our population. TRICARE is also retaining the TRICARE-specific DRGs for neonates and substance use.
TRICARE retained the MS-DRG numbering system for FY09 and those TRICARE-specific DRGs were assigned available, blank DRG numbers unused in the MS-DRG system. We refer the reader to
For FY09, TRICARE used the MS-DRG v26.0 pre-MDC hierarchy, with the exception that MDC 15 is applied after DRG 011-012 and before MDC 24.
For FY 10, there were no additional or deleted DRGs.
For FY 11, DRG 009 was deleted; DRGs 014 and 015 were added.
For FY 12, the added DRGs and deleted DRGs are the same as those included in CMS' final rule published on August 18, 2011 (76 FR 51476-51846). That is, DRG 015 is deleted; DRGs 016 and 017 are being added.
TRICARE will continue to use the same wage index amounts used for the Medicare PPS. TRICARE will also duplicate all changes with regard to the wage index for specific hospitals that are re-designated by the Medicare Geographic Classification Review Board. In addition, TRICARE will continue to utilize the out commuting wage index adjustment.
TRICARE is adopting CMS' percentage of labor related share of the standardized amount. For wage index values greater than 1.0, the labor related portion of the Adjusted Standardized Amount (ASA) shall equal 68.8 percent. For wage index values less than or equal to 1.0 the labor related portion of the ASA shall continue to equal 62 percent.
TRICARE will update the adjusted standardized amounts according to the final updated hospital market basket used for the Medicare PPS for all hospitals subject to the TRICARE DRG-based payment system according to CMS's August 18, 2011, final rule. For FY 2012, the market basket is 3.0%. Medicare applied reductions to the market basket in FY 2012, with an adjustment of 1.0 percentage point for economy-wide productivity and less 0.1 percentage point for hospitals in all areas. However, these reductions do not apply to TRICARE.
Since TRICARE does not include capital payments in our DRG-based payments (TRICARE reimburses hospitals for their capital costs as reported annually to the contractor on a pass through basis), we will use the fixed loss cost outlier threshold calculated by CMS for paying cost outliers in the absence of capital prospective payments. For FY 2012, the TRICARE fixed loss cost outlier threshold is based on the sum of the applicable DRG-based payment rate plus any amounts payable for Indirect Medical Education (IDME) plus a fixed dollar amount. Thus, for FY 2012, in order for a case to qualify for cost outlier payments, the costs must exceed the TRICARE DRG base payment rate (wage adjusted) for the DRG plus the IDME payment plus $21,482 (wage adjusted). The marginal cost factor for cost outliers continues to be 80 percent.
The FY 2012 TRICARE National Operating Standard Cost as a Share of Total Costs (NOSCASTC) used in calculating the cost outlier threshold is 0.919. TRICARE uses the same methodology as CMS for calculating the NOSCASTC; however, the variables are different because TRICARE uses national cost to charge ratios while CMS uses hospital specific cost to charge ratios.
Passage of the MMA of 2003 modified the formula multipliers to be used in the calculation of the indirect medical education IDME adjustment factor. Since the IDME formula used by TRICARE does not include disproportionate share hospitals (DSHs), the variables in the formula are different than Medicare's, however; the percentage reductions that will be applied to Medicare's formula will also be applied to the TRICARE IDME formula. The multiplier for the IDME adjustment factor for TRICARE for FY 2012 is 1.02.
For FY 2012 TRICARE is adopting CMS' expanded post acute care transfer policy according to CMS' final rule published August 18, 2011.
While CMS uses hospital-specific cost to charge ratios, TRICARE uses a national cost to charge ratio. For FY 2012, the cost-to-charge ratio used for the TRICARE DRG-based payment system for acute care hospitals and neonates will be 0.3460. This shall be used to calculate the adjusted standardized amounts and to calculate cost outlier payments, except for children's hospitals. For children's hospital cost outliers, the cost-to-charge ratio used is 0.3757.
The updated rates and weights are accessible through the Internet at
Department of the Army, DoD.
Notice of open meeting.
Pursuant to the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Sunshine in the Government Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150, the following meeting notice is announced:
Individuals submitting a written statement must submit their statement to the Designated Federal Officer at the following address:
The Designated Federal Officer will review all timely submissions with the U.S. Army War College Subcommittee Chairperson, and ensure they are provided to members of the U.S. Army War College Subcommittee before the meeting that is the subject of this notice. After reviewing the written comments, the Chairperson and the Designated Federal Officer may choose to invite the submitter of the comments to orally present their issue during an open portion of this meeting or at a future meeting.
The Designated Federal Officer, in consultation with the U.S. Army War College Subcommittee Chairperson, may, if desired, allot a specific amount of time for members of the public to present their issues for review and discussion by the U.S. Army War College Subcommittee.
Defense Acquisition Regulations System, Department of Defense (DoD).
Notice and request for comments.
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), DoD announces the proposed extension of a public information collection requirement and seeks public comment on the provisions thereof. DoD invites comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility; (b) the accuracy of the estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology. The Office of Management and Budget (OMB) has approved this information collection for use through November 30, 2012. DoD proposes that OMB extend its approval for use for three additional years beyond the current expiration date.
DoD will consider all comments received by January 27, 2012.
You may submit comments, identified by OMB Control Number 0704-0246, using any of the following methods:
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•
Comments received generally will be posted without change to
Ms. Meredith Murphy, telephone (703) 602-1302; facsimile (703) 602-0350. The information collection requirements addressed in this notice are available on the World Wide Web at:
Paper copies are available from Ms. Meredith Murphy, OUSD(AT&L)DPAP(DARS), 3060 Defense Pentagon, Room 3B855, Washington, DC 20301-3060.
This requirement provides for the collection of information related to providing Government property to contractors; contractor use and management of Government property;
a. DFARS 245.302(1)(i) requires contractors to request and obtain contracting officer approval before using Government property on work for foreign governments and international organizations.
b. DFARS subpart 245.70, Plant Clearance Forms, prescribes the requirements for the use of the following forms:
(1)
(2)
(3)
(4)
(i) Downgrade useable property to scrap.
(ii) Abandonment or destruction.
(iii) Noncompetitive sale of surplus property.
(iv) Other disposal actions.
(5)
c. In addition, the following DD forms are prescribed in the clause at DFARS 252.245-7004, Reporting, Reutilization, and Disposal (AUG 2011):
(1)
(2)
Department of Defense (DoD).
Notice and request for comments.
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), DoD announces the proposed extension of a public information collection requirement and seeks public comment on the provisions thereof. DoD invites comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility; (b) the accuracy of the estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology. The Office of Management and Budget (OMB) has approved this information collection requirement for use through April 30, 2012. DoD proposes that OMB extend its approval for use for three additional years beyond the current expiration date.
DoD will consider all comments received by January 27, 2012.
You may submit comments, identified by OMB Control Number 0704-0187, using any of the following methods:
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•
•
•
Comments received generally will be posted without change to
Dr. Laura Welsh, Defense Acquisition Regulations System, OUSD(AT&L)DPAP/DARS, Room 3B855, 3060 Defense Pentagon, Washington, DC 20301-3060. Telephone 703-602-0326; facsimile 703-602-0350. The information collection requirements addressed in this notice are available on the World Wide Web at:
• Determine whether to provide precious metals as Government-furnished material;
• Determine an entity's eligibility for award of a contract due to ownership or control by the government of a terrorist country;
• Determine an entity's eligibility for award of a contract under a national
• Determine whether there is a compelling reason for a contractor to enter into a subcontract in excess of $30,000 with a firm, or subsidiary of a firm, that is identified in the List of Parties Excluded from Federal Procurement and Nonprocurement as being ineligible for award of Defense subcontracts because it is owned or controlled by the government of a terrorist country;
• Evaluate claims of indemnification for losses or damages occurring under a research and development contract; and
• Keep track of radio frequencies on electronic equipment under research and development contracts so that the user does not override or interfere with the use of that frequency by another user.
This information collection pertains to information, as required in DFARS parts 208, 209, 235, and associated clauses in part 252 that an offeror must submit to DoD in response to a request for proposals or an invitation for bids or a contract requirement. In particular, the information collection covers the following DFARS requirements:
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•
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Defense Acquisition Regulations System, Department of Defense (DoD).
Notice; request for comments.
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), DoD announces the proposed extension of a public information collection requirement and seeks public comment on the provisions thereof.
DoD will consider all comments received by January 27, 2012.
You may submit comments, identified by OMB Control Number 0704-0454, using any of the following methods:
•
•
•
Comments received generally will be posted without change to
Mr. Julian Thrash, at (703) 602-0310. The information collection requirements addressed in this notice are available electronically on the Internet at:
Under the U.S.-International Atomic Energy Agency (IAEA) Additional Protocol, the United States is required to declare a wide range of public and private nuclear-related activities to the IAEA and potentially provide access to IAEA inspectors for verification purposes. The U.S.-IAEA Additional Protocol permits the United States unilaterally to declare exclusions from inspection requirements for activities with direct national security significance.
The clause at 252.204-7010 is included in contracts for research and development or major defense acquisition programs involving fissionable materials (e.g., uranium, plutonium, neptunium, thorium, americium); other radiological source materials; or technologies directly related to nuclear power production, including nuclear or radiological waste materials.
The clause requires a contractor to provide written notification to the applicable DoD program manager and a copy of the notification to the contracting officer, if the contractor is required to report its activities under the U.S.-IAEA Additional Protocol. Upon such notification, DoD will determine if access may be granted to IAEA inspectors, or if a national security exclusion should be applied.
Department of Education (ED).
Notice of proposed information collection requests.
The Director, Information Collection Clearance Division, Privacy, Information and Records Management Services, Office of Management, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995.
An emergency review has been requested in accordance with the Act (44 U.S.C. Chapter 3507 (j)), since public harm is reasonably likely to result if normal clearance procedures are followed. Approval by the Office of Management and Budget (OMB) has been requested by December 9, 2011. A regular clearance process is also beginning. Interested persons are invited to submit comments on or before January 27, 2012.
Written comments should be addressed to the Office of Information and Regulatory Affairs, Attention: Education Desk Officer, Office of Management and Budget, 725 17th Street NW., Room 10222, New Executive Office Building, Washington, DC 20503, be faxed to (202) 395-5806 or emailed to
Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Director of OMB provide interested Federal agencies and the public an early opportunity to comment on information collection requests. The Office of Management and Budget (OMB) may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Director, Information Collection Clearance Division, Privacy, Information and Records Management Services, Office of Management, publishes this notice containing proposed information collection requests at the beginning of the Departmental review of the information collection. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested, e.g., new, revision, extension, existing or reinstatement; (2) Title; (3) Summary of the collection; (4) Description of the need for, and proposed use of, the information; (5) Respondents and frequency of collection; and (6) Reporting and/or Recordkeeping burden. ED invites public comment.
The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on respondents, including through the use of information technology.
The purpose of the special consolidation initiative is to encourage borrowers who have both commercially-held FFEL Program loans and other loans that are held by the Department (either Direct Loan Program loans or FFEL Program loans previously sold to the Department by a FFEL Program lender) to consolidate their commercially-held FFEL Program loans into the Direct Loan Program. Currently, these borrowers have at least two loan servicers and are required to make at least two separate monthly payments on
The Department is requesting emergency clearance of the Special Direct Consolidation Loan LVC because the regular clearance process would prevent the Department from making Special Direct Consolidation Loans by the announced implementation date. Further, because the statutory authority under which the Department is providing the incentives will end on June 30, 2012, the use of normal clearance procedures would significantly shorten the already limited period during which Special Direct Consolidation Loans can be offered, with the result that fewer borrowers would be able to benefit from the reduced interest rates offered as part of the special initiative.
Copies of the proposed information collection request may be accessed from
Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-(800) 877-8339.
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Additional comments may be submitted on or before December 28, 2011.
Submit your comments, referencing Docket ID No. EPA-HQ-OW-2004-0015, to: (1) EPA online using
Clifford Yee, Office of Wastewater Management, Mail Code: 4204M, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564-0598; fax number: (202) 501-2403; email address:
EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On July 11, 2011 (76 FR 40723), EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments during the comment period. Any additional comments on this ICR should be submitted to EPA and OMB within 30 days of this notice.
EPA has established a public docket for this ICR under Docket ID No. EPA-HQ-OW-2004-0015, which is available for online viewing at
Use EPA's electronic docket and comment system at
The 1987 Act declares that water pollution control revolving funds shall be administered by an instrumentality of the State subject to the requirements of the act. This means that each State has a general responsibility for administering its revolving fund and must take on certain specific responsibilities in carrying out its administrative duties. The information collection activities will occur primarily at the program level through the State IUP and Annual Report. The information is needed annually to implement section 606 of the Clean Water Act. The Act requires the information to ensure national accountability, adequate public comment and review, fiscal integrity and consistent management directed to achieve environmental benefits and results. The individual information collections are:
(1)
(2)
(3)
(4)
Environmental Protection Agency (EPA).
Notice of extension of public comment.
EPA is announcing an extension of the public comment period for the second external review draft of a document titled, “
The public comment period began on September 30, 2011, and ends December 30, 2011. Comments must be received by EPA by December 30, 2011.
The “
For technical information, contact Dr. James Brown, NCEA; telephone: (919) 541-0765; facsimile: (919) 541-1818; or email:
Comments may be submitted electronically via
For information on submitting comments to the docket, please contact the Office of Environmental Information Docket; telephone: (202) 566-1752; facsimile: (202) 566-1753; or email:
Environmental Protection Agency (EPA).
Notice.
The EPA Science Advisory Board (SAB) Staff Office announces a public teleconference of the Chartered SAB on December 21, 2011 to conduct a quality review of a draft SAB report, a draft
The public teleconference will be held on December 21, 2011 from 2:30 p.m. to 5 p.m. (Eastern Time).
The public teleconference will be conducted by telephone only.
Any member of the public wishing to obtain general information concerning the public teleconference may contact Dr. Angela Nugent, Designated Federal Officer (DFO). Dr. Nugent may be contacted at the EPA Science Advisory Board (1400R), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; or by telephone/voice mail at (202) 564-2218; fax at (202) 565-2098; or email at
The SAB was established pursuant to the Environmental Research, Development, and Demonstration Authorization Act (ERDAA), codified at 42 U.S.C. 4365, to provide independent scientific and technical advice to the EPA Administrator on the technical basis for Agency positions and regulations. The SAB is a Federal Advisory Committee chartered under the Federal Advisory Committee Act (FACA), 5 U.S.C., App. 2. Pursuant to FACA and EPA policy, notice is hereby given that the SAB will hold a public teleconference to conduct a quality review of a draft SAB report, a draft
EPA's Office of Air and Radiation (OAR) has requested SAB advice related to EPA's review of its regulatory standards in 40 CFR Part 192—Health and Environmental Protection Standards for Uranium and Thorium Mill Tailings in regard to underground In-Situ Leach Recovery (ISL/ISR) facilities.
EPA is authorized to develop standards for the protection of public health, safety, and the environment from radiological and non-radiological hazards associated with residual radioactive materials. The Agency is currently undertaking a review to determine if the existing standards, last revised by EPA in 1995, should be updated. The expectation is that ISL/ISR operations will be the most common type of new uranium extraction facility in the United States. These facilities can affect groundwater. Accordingly, EPA is seeking scientific advice and relevant technical criteria to establish standards and procedures, including the relevant period of monitoring for ISL/ISR facilities, once uranium extraction operations are completed, in order to provide reasonable assurances of aquifer stability and groundwater protection. Background information about this advisory activity can be found on the SAB Web site at
The agenda and other materials in support of the teleconference will be placed on the SAB Web site at
Public comment for consideration by EPA's federal advisory committees and panels has a different purpose from public comment provided to EPA program offices. Therefore, the process for submitting comments to a federal advisory committee is different from the process used to submit comments to an EPA program office.
Federal advisory committees and panels, including scientific advisory committees, provide independent advice to EPA. Members of the public can submit comments for a federal advisory committee to consider as it develops advice for EPA. Input from the public to the SAB will have the most impact if it provides specific scientific or technical information or analysis for the SAB to consider or if it relates to the clarity or accuracy of the technical information. Members of the public wishing to provide comment should contact the Designated Federal Officer directly.
In general, individuals or groups requesting an oral presentation at a teleconference will be limited to three minutes. Those interested in being placed on the public speakers list for the December 21, 2011 teleconference should contact Dr. Nugent at the contact information provided above no later than December 14, 2011.
Written statements should be supplied to the DFO via email at the contact information noted above by December 14, 2011 for the teleconference so that the information may be made available to the Panel members for their consideration. Written statements should be supplied in one of the following electronic formats: Adobe Acrobat PDF, MS Word, MS PowerPoint, or Rich Text files in IBM-PC/Windows 98/2000/XP format. It is the SAB Staff Office general policy to post written comments on the web page for the advisory meeting or teleconference. Submitters are requested to provide an unsigned version of each document because the SAB Staff Office does not publish documents with signatures on its Web sites. Members of
Copyrighted material will not be posted without explicit permission of the copyright holder.
For information on access or services for individuals with disabilities, please contact Dr. Nugent (202) 564-2218 or
Environmental Protection Agency.
Notice; request for public comment.
In accordance with Section 122(i) of the Comprehensive Environmental Response, Compensation, and Liability Act, as amended (“CERCLA”), 42 U.S.C. 9622(i), notice is hereby given of a proposed administrative settlement for recovery of past and projected future response costs concerning the ICG Castings, Inc., Dowagiac site in Dowagiac, Michigan with the following settling party: The City Of Dowagiac Brownfield Redevelopment Authority. The settlement requires the settling party to pay $25,000 to the Hazardous Substance Superfund and requires the performance of specified response activities for the site. The settlement includes a covenant not to sue the settling party pursuant to Sections 106 and 107(a) of CERCLA, 42 U.S.C. 9606 and 9607(a). For 30 days following the date of publication of this notice, the United States will receive written comments relating to the settlement. The United States will consider all comments received and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper or inadequate. The United States response to any comments received will be available for public inspection at the Dowagiac District Library, 211 Commercial Street, Dowagiac, Michigan 49047, Attn: Katherine Johnson and 77 West Jackson Boulevard, 7th floor Superfund File Room, Chicago, Illinois.
Comments must be submitted on or before December 28, 2011.
The proposed settlement is available for public inspection at 77 West Jackson Boulevard, 7th floor Superfund File Room, Chicago, Illinois. A copy of the proposed settlement may be obtained from Stuart P. Hersh, Associate Regional Counsel, C-14J, 77 West Jackson Boulevard, Chicago, Illinois 60604, telephone: (312) 886-6235. Comments should reference the ICG Castings, Inc., Dowagiac site in Dowagiac, Michigan and EPA Docket No. V-W-11-C-978 and should be addressed to Stuart P. Hersh, Associate Regional Counsel, C-14J, 77 West Jackson Boulevard, Chicago, Illinois 60604.
Stuart P. Hersh, Associate Regional Counsel, C-14J, 77 West Jackson Boulevard, Chicago, Illinois 60604, telephone (312) 886-6235
The Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended, 42 U.S.C. 9601,
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burden and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s). Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and (e) ways to further reduce the information burden for small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid OMB control number.
Written Paperwork Reduction Act (PRA) comments should be submitted on or before January 27, 2012. If you anticipate that you will be submitting PRA comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the FCC contact listed below as soon as possible.
Submit your PRA comments to Nicholas A. Fraser, Office of Management and Budget, via fax at (202) 395-5167 or via Internet at
Judith B. Herman, Office of Managing Director, (202) 418-0214.
Section 74.605 requires that licensees of TV pickup stations in the 6875-7125 MHz and 12700-13200 MHz bands shall register their stationary receive sites using the Commission's Universal Licensing System. TV Pickup licensees record their receive-only sites in the Universal Licensing System (ULS) database, including all fixed service locations. The TV Pickup stations, licensed under Part 74 of the Commission's rules, make it possible for television and radio stations and networks to transmit program material from the sites of breaking news stories or other live events to television studios for inclusion in broadcast programs, to transmit programming material from studios to broadcasting transmitters for delivery to consumers' televisions and radios, and to transmit programs between broadcast stations. Registering the receive sites will allow analysis to determine whether Fixed Service links will cause interference to TV Pickup stations.
Federal Communications Commission.
Notice of public meeting.
In accordance with the Federal Advisory Committee Act, this notice advises interested persons that the Federal Communications Commission's (FCC) third Communications Security, Reliability, and Interoperability Council (CSRIC III) will hold a meeting on December 16, 2011, from 9 a.m. to 1 p.m. in the Commission Meeting Room of the Federal Communications Commission, Room TW-C305, 445 12th Street SW., Washington, DC 20554.
December 16, 2011.
Federal Communications Commission, Room TW-C305 (Commission Meeting Room), 445 12th Street SW., Washington, DC 20554.
Jeffery Goldthorp, CSRIC Designated Federal Officer, (202) 418-1096 (voice) or
The CSRIC is a Federal Advisory Committee that will provide recommendations to the FCC regarding best practices and actions the FCC can take to ensure the security, reliability, and interoperability of communications systems. On March 19, 2011, the FCC, pursuant to the Federal Advisory Committee Act, renewed the charter for the CSRIC for a period of two years through March 18, 2013.
Working Group 1 on Next Generation 9-1-1, will present a final report for vote at this meeting. Each of the remaining Working Groups from CSRIC III will present an update. Topics will include alerting systems, 9-1-1 location accuracy, and network security. The FCC will attempt to accommodate as many attendees as possible; however, admittance will be limited to seating availability. The Commission will provide audio and/or video coverage of the meeting over the Internet from the FCC's Web page at
Federal Election Commission.
Thursday, December 1, 2011 at 10 a.m.
999 E Street NW., Washington, DC (Ninth Floor).
This meeting will be open to the public.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and the Board's Regulation LL (12 CFR part 238) to acquire shares of a savings and loan holding company. The factors that are considered in acting on the notices are
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than December 12, 2011.
1.
This notice corrects a notice (FR Doc. 11-30105) published on page 72206 of the issue for Tuesday, November 22, 2011.
Under the Federal Reserve Bank of San Francisco heading, the entry for American Start-Up Financial Institutions Investments, I, L.P., and CKH Capital, Inc., both in Monterey Park, California, is revised to read as follows:
A.
1.
In connection with this application, Applicants also have applied to retain 5.9 percent interest of the voting shares of First PacTrust Bancorp, Inc., and thereby indirectly retain Pacific Trust Bank, both in Chula Vista, California, and engage in operating as savings and loan association, pursuant to section 225.28(b)(4)(ii) of Regulation Y.
Federal Trade Commission.
Proposed consent agreement.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.
Comments must be received on or before December 22, 2011.
Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the
Linda Holleran (202) 326-2267, FTC, Bureau of Competition, 600 Pennsylvania Avenue NW., Washington, DC 20580.
Pursuant to section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and § 2.34 of the Commission's Rules of Practice, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for November 21, 2011), on the World Wide Web, at
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before December 22, 2011. Write “PoolCorp, File No. 101 0115” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at
Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which is obtained from any person and which is privileged or confidential,” as provided in Section
If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “PoolCorp, File No. 101 0115” on your comment and on the envelope, and mail or deliver it to the following address: Federal Trade Commission, Office of the Secretary, Room H-113 (Annex D), 600 Pennsylvania Avenue NW., Washington, DC 20580. If possible, submit your paper comment to the Commission by courier or overnight service.
Visit the Commission Web site at
The Federal Trade Commission has accepted for public comment an Agreement Containing Consent Order to Cease and Desist (“Agreement”) with Pool Corporation (“PoolCorp”). PoolCorp is the world's largest distributor of products used in the construction, renovation, repair, service, and maintenance of residential and commercial swimming pools. The Agreement resolves charges that PoolCorp used exclusionary acts and practices to maintain its monopoly power in the pool product distribution market in violation of Section 5 of the Federal Trade Commission Act, 15 U.S.C. 45.
The administrative complaint that accompanies the Agreement (“Complaint”) alleges that PoolCorp used its monopoly power in local geographic markets to prevent manufacturers from supplying pool products to new entrants since at least 2003. As a result, PoolCorp foreclosed rival distributors from obtaining pool products—a necessary input to compete—and significantly raised its rivals' costs, thereby lowering output, increasing prices, and diminishing consumer choice.
The Commission anticipates that the competitive issues described in the Complaint will be resolved by accepting the proposed Order, subject to final approval, contained in the Agreement. The Agreement has been placed on the public record for 30 days for receipt of comments from interested members of the public. Comments received during this period will become part of the public record. After 30 days, the Commission will again review the Agreement and comments received, and will decide whether it should withdraw from the Agreement or make final the Order contained in the Agreement.
The purpose of this Analysis to Aid Public Comment is to invite and facilitate public comment concerning the proposed Order. It is not intended to constitute an official interpretation of the Agreement and proposed Order or in any way to modify their terms.
The Agreement is for settlement purposes only and does not constitute an admission by PoolCorp that the law has been violated as alleged in the Complaint or that the facts alleged in the Complaint, other than jurisdictional facts, are true.
The Complaint makes the following allegations.
This case involves wholesale distribution in the swimming pool industry. There are over nine million residential pools in the United States, and over 250,000 commercial pools operated by hotels, country clubs, apartment buildings, municipalities, and others. In 2010, the distribution of pool products was an estimated $3 billion industry in the United States. Manufacturers use distributors to sell the products used to build, repair, service, and maintain residential and commercial swimming pools (“pool products”). Pool products include, among others, pumps, filters, heaters, covers, cleaners, diving boards, steps, rails, pool liners, pool walls, and the parts necessary to maintain pool equipment. Distributors purchase pool products from manufacturers, warehouse them, and then resell the products to pool retail stores, pool service companies and pool builders (collectively, “pool dealers” or “dealers”). Dealers, in turn, sell the pool products to the ultimate consumer: owners of residential and commercial swimming pools. The swimming pool industry is very fragmented and wholesale distributors make it more efficient for manufacturers and dealers to sell their products. Distributors purchase most, if not all, brands of pool products that are produced by manufacturers so that they can provide convenient one-stop shopping for their dealer customers. Distributors also extend credit and provide quick delivery of pool products to thousands of dealers. The vast majority of dealers are mom-and-pop operations that are too small to buy directly from manufacturers; for these dealers, distributors are their only source of pool products. Distributors also allow manufacturers to operate their factories year-round by purchasing large quantities of pool products throughout the year, even though the pool industry is seasonal.
In general, manufacturers are willing to sell their products to any credit-worthy distributor that has a physical warehouse and personnel with knowledge of the pool industry. Manufacturers typically prefer to have two or more distributors selling their products in a local geographic market in order to ensure that the distributors compete and give competitive service and prices to their dealer customers.
To compete effectively as a distributor, a firm must be able to buy pool products directly from manufacturers. There are no cost-effective alternatives. While there are
The relevant market is no broader than the wholesale distribution of pool products in the United States and numerous local geographic markets. With the exception of large national retail chains that purchase pool products for their retail centers located throughout the United States, competition among distributors for sales to dealers occurs locally. PoolCorp has monopoly power in numerous local markets, as evidenced by a persistently high market share of 80 percent or more for the past five years. PoolCorp's conduct of foreclosing new distributor entrants from obtaining pool products directly from manufacturers represents a significant barrier to entry.
Beginning in 2003 and continuing to today, PoolCorp has implemented an exclusionary policy that effectively impeded entry by new distributors by preventing them from being able to purchase pool products directly from manufacturers. Specifically, when a new distributor attempted to enter a local geographic market, PoolCorp threatened manufacturers that it would not deal with them if they also supplied the new entrant. PoolCorp threatened to terminate the purchase and sale of the manufacturer's pool products for all 200+ PoolCorp distribution centers located throughout the United States. PoolCorp's policy did not exclude existing rivals from obtaining pool products from manufacturers.
PoolCorp's threat was significant. The loss of sales to PoolCorp could be “catastrophic” to the financial viability of even major manufacturers. No other distributor could replace the large volume of potential lost sales to PoolCorp, particularly in markets where PoolCorp is the only distributor. New entrants could not offer any economic incentive to manufacturers that would offset the risks imposed by PoolCorp's threats.
After receiving these threats, manufacturers, including the three “must-have” manufacturers, refused to sell pool products to the new distributors and canceled any pre-existing orders. PoolCorp thus effectively foreclosed new distributors from obtaining pool products from manufacturers that represented more than 70 percent of all pool product sales.
In some cases, the new distributors were able to purchase pool products from other distributors. This counterstrategy, however, did not mitigate the effects of PoolCorp's conduct. As a general rule, distributors do not sell pool products to other distributors. Even when possible, this alternative is not a viable long-term strategy because it substantially increases the entrant's costs and lessens its quality of service. For example, buying pool products from a distributor forces the new distributor entrant to pay transportation costs from the distributor's location rather than receiving free shipping under manufacturer programs. The purchases are also at a marked-up price and do not qualify for key manufacturer year-end rebates.
By effectively increasing its rivals' costs, PoolCorp's exclusionary policy prevented the new distributor entrants from being able to compete aggressively on price. Additionally, without full control of their inventory, the entrants' ability to provide quality service to their dealer customers was diminished. PoolCorp specifically targeted new entrants, rather than established rivals, because the new distributors represented a significant competitive threat due to their likelihood to compete aggressively on price in order to earn new business. PoolCorp's conduct, therefore, had the purpose and effect of maintaining and enhancing PoolCorp's monopoly power in numerous local markets where its dominance would otherwise be threatened by new entrants. PoolCorp's exclusionary policy, therefore, has likely resulted in higher prices and reduced output. There are no procompetitive efficiencies that justify PoolCorp's conduct.
The offense of monopolization under § 2 of the Sherman Act has two elements: (1) the possession of monopoly power in the relevant market; and (2) the willful acquisition, enhancement or maintenance of that power through exclusionary conduct.
The factual allegations in the complaint regarding market structure support a finding of monopoly power and competitive harm. PoolCorp's “all or nothing” threats acted as a powerful deterrent to manufacturers against dealing with new distributor entrants by jeopardizing a large and irreplaceable percentage of the manufacturer's sales. PoolCorp's conduct effectively foreclosed new entrants from manufacturers representing more than 70 percent of pool product sales. New entrants were unable to provide any economic incentive to manufacturers that could offset the risk posed by PoolCorp's threats. Raising rivals' costs by restraining their supply of inputs can be a “particularly effective method of anticompetitive exclusion.”
Additionally, the work-around strategy employed by some new entrants of purchasing pool products from other distributors significantly raised their costs and reduced their ability to provide quality service. PoolCorp's exclusionary policy therefore prevented these firms from providing a meaningful
Notably, PoolCorp's conduct targeted new entry and did not exclude existing rivals. The test for exclusionary conduct, however, is not total foreclosure, but “whether the challenged practices bar a substantial number of rivals or severely restrict the market's ambit.”
A monopolist may rebut a
There are no procompetitive efficiencies that justify PoolCorp's conduct. In some cases, for example, exclusive arrangements with suppliers could be necessary to prevent free-riding or to secure adequate supply. Here, however, PoolCorp did not offer any services upon which a new entrant could free-ride. Further, the pool industry is not subject to product shortfalls that could justify exclusive arrangements with suppliers. In short, PoolCorp's practice of foreclosing new entrants from supply did not help PoolCorp compete on the merits by improving its efficiency, quality or prices.
The proposed Consent Order remedies PoolCorp's anticompetitive conduct. Paragraph II of the Order addresses the core of PoolCorp's conduct. Specifically, Paragraph II of the proposed Consent Order prohibits PoolCorp from:
• Conditioning the sale or purchase of pool products, or membership in PoolCorp's preferred vendor programs, on the intended or actual sale of pool products by a manufacturer to any distributor other than PoolCorp;
• Pressuring, urging or otherwise coercing manufacturers to refrain from selling, or to limit their sales, to any distributors other than PoolCorp; and
• Discriminating or retaliating against a manufacturer for selling, or intending to sell, pool products to any distributor other than PoolCorp.
The definition of “distributor” includes any entity that buys pool products directly from manufacturers and resells those products to dealers or others. The Order explicitly allows PoolCorp to enter into exclusive agreements with manufacturers to purchase private-label pool products.
Paragraph III of the Proposed Order requires PoolCorp to implement an antitrust compliance program. Paragraph IV-VI impose reporting and other compliance requirements. The Order will expire in 20 years.
By direction of the Commission, Commissioner Rosch dissenting.
The Commission is today issuing for public comment a Complaint and Order that would resolve allegations that Pool Corporation (“PoolCorp”) used anticompetitive acts and practices to exclude rivals from, and to maintain its monopoly power in, several local pool product distribution markets, in violation of Section 5 of the Federal Trade Commission Act, 15 U.S.C. 45.
On the basis of staff's investigation and as outlined in the Complaint, we have reason to believe that a violation of the antitrust laws has occurred—and that Commission action is in the public interest. 15 U.S.C. 45(b). Specifically, the Complaint alleges that PoolCorp, which possesses monopoly power in many local distribution markets, threatened its suppliers (
As alleged in the Complaint, PoolCorp's actions foreclosed new entrants from obtaining pool products from manufacturers representing more than 70 percent of sales. Significantly, there is no efficiency justification for PoolCorp's conduct. That is, without any legitimate justification, PoolCorp dictated whether new competitors could access the full range of merchandise needed to compete effectively in the market.
Although we recognize that PoolCorp's alleged conduct did not target incumbent distributors, we nevertheless have reason to believe that the conduct harmed competition and consumers. Separate from PoolCorp,
Because we have reason to believe that PoolCorp's conduct had the purpose and effect of maintaining PoolCorp's monopoly power in numerous local markets where its dominance was threatened by new distributor entrants, we support the attached Complaint and Order.
This case presents the novel situation of a company willing to enter into a consent decree notwithstanding a lack of evidence indicating that a violation has occurred. The FTC Act requires that the Commission find a “reason to believe” that a violation has occurred and determine that Commission action would be in the public interest any time it issues a complaint. 15 U.S.C. 45(b). In my view, the same standard applies regardless of whether the Commission is seeking a litigated decree or a consent decree for the charged violation. Accordingly, I would reject the proposed consent decree and close the investigation.
After a year and a half of investigation, we have not been able to identify any harm to consumers or competition as a result of actions by Pool Corporation, Inc. (“PoolCorp”), and further investigation appears unlikely to uncover such effects. As an initial matter, it is important to note that, even accepting the allegations in the complaint, PoolCorp did not engage in a general pattern of exclusionary conduct. Rather, the complaint alleges that PoolCorp threatened manufacturers not to supply an entering distributor in various local markets. There is no allegation that PoolCorp sought to restrict supply to (1) incumbents in any of these local markets, (2) established distributors seeking to expand into markets dominated by PoolCorp, or (3) established distributors in any of the dozens of other local markets across the country.
The limited scope of PoolCorp's alleged exclusionary conduct is, of course, no defense. PoolCorp's alleged threats to manufacturers, had they been successful, may well have violated the antitrust laws. But that is not what happened. The investigation revealed that PoolCorp's demands were not honored by manufacturers. Instead, the evidence showed that manufacturers made unilateral decisions not to supply the de novo entrants in the various local markets.
There were legitimate reasons for pool equipment manufacturers not to sell to these entrants. A manufacturer will typically accept a new distributor only if the distributor will add to the value of the distribution network by, for example, improving growth opportunities or increasing promotional activities. Manufacturers often require a de novo entrant to have adequate facilities, a history of successful operations, and a favorable credit history before supporting it. In this case, many of the allegedly excluded de novo entrants did not satisfy these requirements. The lack of evidence establishing causation between PoolCorp's requests and action by the manufacturers, combined with plausible justifications for the manufacturers' actions, should be fatal to this case.
Another problem with this case is that no entrants were actually excluded.
A third problem with this case is that there was no consumer injury. The investigation did not uncover price increases, service degradation, or other anticompetitive effects in any local markets.
The lack of consumer injury is also corroborated by the very low entry barriers in this industry. Opening a pool supply distributorship requires access to one or more of the major equipment suppliers, a few trucks, a medium-sized warehouse, access to credit, and no more than ten employees. There are hundreds of profitable pool supply distributors, and entry and expansion are frequent events. Thus, any effort to exclude a competitor would become a game of whack-a-mole: As soon as one competitor is driven from the market, another would pop up.
Accordingly, I cannot find that there is a “reason to believe” that a violation occurred or that accepting the proposed consent decree would be in the public
National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS).
Notice.
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from Vitro Manufacturing in Canonsburg, Pennsylvania, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 18, 2011, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
All Atomic Weapons Employees who worked at Vitro Manufacturing in Canonsburg, Pennsylvania, from January 1, 1960 through September 30, 1965, for a number of work days aggregating at least 250 work days, occurring either solely under this employment or in combination with work days within the parameters established for one or more other classes of employees in the Special Exposure Cohort.
This designation became effective on November 17, 2011, as provided for under 42 U.S.C. 7384l(14)(C). Hence, beginning on November 17, 2011, members of this class of employees, defined as reported in this notice, became members of the Special Exposure Cohort.
Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway, MS C-46, Cincinnati, OH 45226, Telephone (877) 222-7570. Information requests can also be submitted by email to
National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS).
Notice.
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from W.R. Grace and Company in Curtis Bay, Maryland, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 18, 2011, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
All Atomic Weapons Employees who worked at any building or area at the facility owned by W.R. Grace and Company in Curtis Bay, Maryland, for the operational period from May 1, 1956 through January 31, 1958, for a number of work days aggregating at least 250 work days, occurring either solely under this employment or in combination with work days within the parameters established for one or more other classes of employees included in the Special Exposure Cohort.
This designation became effective on November 17, 2011, as provided for under 42 U.S.C. 7384l(14)(C). Hence, beginning on November 17, 2011, members of this class of employees, defined as reported in this notice, became members of the Special Exposure Cohort.
Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway, MS C-46, Cincinnati, OH 45226, Telephone (877) 222-7570. Information requests can also be submitted by email to
National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS).
Notice.
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Y-12 facility in Oak Ridge, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 18, 2011, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
All employees of the Department of Energy, its predecessor agencies, and their contractors and subcontractors who worked at the Y-12 facility in Oak Ridge, Tennessee, during the period from January 1, 1948 through December 31, 1957, for a number of work days aggregating at least 250 work days, occurring either solely under this employment or in combination with work days within the parameters established for one or more other classes of employees in the Special Exposure Cohort.
This designation became effective on November 17, 2011, as provided for under 42 U.S.C. 7384l(14)(C). Hence, beginning on November 17, 2011, members of this class of employees, defined as reported in this notice, became members of the Special Exposure Cohort.
Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway, MS C-46, Cincinnati, OH 45226, Telephone (877) 222-7570. Information requests can also be submitted by email to DCAS@CDC.GOV.
National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS).
Notice.
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Ames Laboratory at Iowa State University, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 18, 2011, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
All Department of Energy (DOE) employees, its predecessor agencies, and its contractors and subcontractors who worked in any area of the Ames Laboratory at Iowa State University during the period from August 13, 1942 through December 31, 1970, for a number of work days aggregating at least 250 work days, occurring either solely under this employment or in combination with work days within the parameters established for one or more classes of employees included in the Special Exposure Cohort.
This designation became effective on November 17, 2011, as provided for under 42 U.S.C. 7384l(14)(C). Hence, beginning on November 17, 2011, members of this class of employees, defined as reported in this notice, became members of the Special Exposure Cohort.
Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway, MS C-46, Cincinnati, OH 45226, Telephone (877) 222-7570. Information requests can also be submitted by email to
National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS).
Notice.
HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from Titanium Alloys Manufacturing in Niagara Falls, New York, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows:
Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway, MS C-46, Cincinnati, OH 45226, Telephone (877) 222-7570. Information requests can also be submitted by email to
Agency for Healthcare Research and Quality, HHS.
Notice.
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: “Medical Office Survey on Patient Safety Culture Comparative Database.” In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Comments on this notice must be received by January 27, 2012.
Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at
Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer.
Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at
Medical Office Survey on Patient Safety Culture Comparative Database.
The Agency for Healthcare Research and Quality (AHRQ) requests that the Office of Management and Budget (OMB) approve, under the Paperwork Reduction Act of 1995, AHRQ's collection of information for the AHRQ Medical Office Survey on Patient Safety Culture (Medical Office SOPS) Comparative Database. The Medical Office SOPS Comparative Database consists of data from the AHRQ Medical Office Survey on Patient Safety Culture. Medical offices in the U.S. are asked to voluntarily submit data from the survey to AHRQ, through its contractor, Westat. The Medical Office SOPS Database is modeled after the Hospital SOPS Database [OMB NO. 0935-0162; approved 05/04/2010] that was originally developed by AHRQ in 2006 in response to requests from hospitals interested in knowing how their patient safety culture survey results compare to those of other hospitals.
In 1999, the Institute of Medicine called for health care organizations to develop a “culture of safety” such that their workforce and processes focus on improving the reliability and safety of care for patients (IOM, 1999; To Err is Human: Building a Safer Health System). To respond to the need for tools to assess patient safety culture in outpatient ambulatory health care, AHRQ developed and pilot tested the Medical Office Survey on Patient Safety Culture with OMB approval (OMB NO.0935-0131; Approved July 5, 2007).
The survey is designed to enable medical offices to assess provider and staff opinions about patient safety issues, medical error, and error reporting and includes 52 items that measure 12 dimensions of patient safety culture. AHRQ released the survey to the public along with a Survey User's Guide and other toolkit materials in December 2008 on the AHRQ Web site (located at
The Medical Office SOPS and the Comparative Database are supported by AHRQ to meet its goals of promoting improvements in the quality and safety of health care in medical office settings. The survey, toolkit materials, and preliminary comparative database results are all made available to the public along with technical assistance provided by AHRQ through its contractor at no charge to medical offices, to facilitate the use of these materials for medical office patient safety and quality improvement.
The goal of this project is to create the Medical Office SOPS Comparative Database. This database will (1) Allow medical offices to compare their patient safety culture survey results with those of other medical offices; (2) provide data to medical offices to facilitate internal assessment and learning in the patient safety improvement process; and (3) provide supplemental information to help medical offices identify their strengths and areas with potential for improvement in patient safety culture. De-identified data files will also be available to researchers conducting patient safety data analysis. The database will include 52 items that measure 12 areas, or composites, of patient safety culture.
This study is being conducted by AHRQ through its contractor, Westat, pursuant to AHRQ's statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to: The quality, effectiveness, efficiency, appropriateness and value of healthcare services; quality measurement and improvement; and database development. 42 U.S.C. 299a(a)(1), (2), and (a)(8).
To achieve the goal of this project the following activities and data collections will be implemented:
(1) Eligibility Form—The purpose of this form is to determine the eligibility status and initiate the registration process for medical offices seeking to voluntarily submit their MO SOPS data to the MO SOPS Comparative Database. The medical office point of contact (POC) will complete the form. The POC is either an office manager, nurse manager, or a survey vendor who contracts with a medical office to collect their data. The POC may submit data on behalf of multiple medical offices because many medical offices are part of a larger practice with multiple sites or part of a larger health system that includes many medical office sites.
(2) Data Use Agreement—The purpose of this form is to obtain authorization from medical offices to use their voluntarily submitted MO SOPS data for analysis and reporting according to the terms specified in the Data Use Agreement (DUA). The medical office POC will complete the form.
(3) Medical Office Information Form—The purpose of this form is to obtain basic information about the characteristics of the medical offices submitting their MO SOPS data to the MO SOPS Comparative Database (e.g., number of providers and staff, ownership, and type of specialty). The medical office POC will complete the form.
(4) Data Submission—After the medical office POC has completed the Medical Office Eligibility Form, the Data Use Agreement and the Medical Office Information Form, they will submit their data from the MO SOPS to the MO SOPS Comparative Database.
Data from the AHRQ Medical Office Survey on Patient Safety Culture are used to produce three types of products: 1) A Medical Office SOPS Comparative Database Report that is produced periodically and made available to the public on the AHRQ Web site (see
Medical offices are asked to voluntarily submit their Medical Office SOPS data to the comparative database. The data are then edited to detect and correct errors and aggregated and used to produce a Comparative Database Report that displays averages, standard deviations, and percentile scores on the survey's 52 items and 12 patient safety culture dimensions, as well as displaying these results by medical office characteristics (size of office, specialty, geographic region, etc.) and staff characteristics (staff position).
Exhibit 1 shows the estimated annualized burden hours for the medical office to participate in the Medical Office SOPS Comparative Database. The POC completes a number of data submission steps and forms, beginning with completion of the online Medical Office SOPS Database Eligibility Form and Data Use Agreement, which will be completed for 150 medical offices annually. The Medical Office Information Form will be completed for each medical office; since each POC represents an average of 10 medical offices, a total of 1,500 Information Forms will be completed annually, each requiring about 5 minutes to complete. The POC will submit data for all of the medical offices they represent which will take about 4 and
Medical offices administer the AHRQ Medical Office Survey on Patient Safety Culture on a periodic basis. Hospitals submitting to the Hospital SOPS Comparative Database administer the survey every 16 months on average. Similarly, the number of medical office submissions to the database is likely to vary each year because medical offices do not administer the survey and submit data every year. The 150 respondents/POCs shown in Exhibit 1 are based on an estimate.
Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to submit their data. The cost burden is estimated to be $34,779 annually.
The estimated annualized cost to the government for developing, maintaining, and managing the database and analyzing the data and producing reports is shown below. The cost is estimated to be $310,000 annually for 3 years. The total cost is estimated to be $930,000.
In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ healthcare research and healthcare information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.
Agency for Healthcare Research and Quality, HHS.
Notice.
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project:
Comments on this notice must be received by January 27, 2012.
Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at
Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer.
Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at
The Agency for Healthcare Research and Quality (AHRQ) requests that the Office of Management and Budget (OMB) approve, under the Paperwork Reduction Act of 1995, AHRQ's collection of information for the AHRQ Consumer Assessment of Healthcare Providers and Systems (CAHPS) Database for Clinicians and Groups. The CAHPS Clinician and Group Database (CAHPS CG Database) consists of data from the AHRQ CAHPS Clinician and Group Survey (CAHPS CG Survey). Health systems administrators, medical groups and medical practitioners in the U.S. are asked to voluntarily submit data from the CAHPS CG Survey to AHRQ through its contractor.
Dating back to the first phase of the CAHPS program (1996-2000), the CAHPS Consortium recognized the need for a standardized, evidence-based instrument that would gather data on patients' experiences with physicians and staff in outpatient medical practices, enabling clinicians and administrators to assess and improve patients' experiences with medical care. In 1999, the Consortium began work on a survey that would assess patients' experiences with medical groups and clinicians. Working in collaboration with the Pacific Business Group on Health, whose Consumer Assessment Survey established a precedent for this type of instrument; the CAHPS Consortium developed a preliminary instrument known as the CAHPS Group Practices Survey (G-CAHPS).
In August 2004, AHRQ issued a notice in the
The current CAHPS Consortium includes AHRQ, the Centers for Medicare & Medicaid Services (CMS), RAND, Yale School of Public Health, and Westat.
AHRQ has developed the database for CAHPS CG Survey data following the CAHPS Health Plan Database as a model. The CAHPS Health Plan Database was developed in 1998 in response to requests from health plans, purchasers, and CMS for comparative data to support public reporting of health plan ratings, health plan accreditation and quality improvement (OMB Control Number 0935-0165, Expiration Date 7/31/2013). Demand for comparative results from the CG Survey has grown as well, and therefore AHRQ has developed a dedicated CG Database to support benchmarking, quality improvement, and research.
The CAHPS CG Database contains data from AHRQ's standardized CAHPS CG Survey, which provides comparative measures of quality to health care purchasers, consumers, regulators, and policy makers. The Database also provides data for AHRQ's annual National Healthcare Quality and National Healthcare Disparities Reports.
Health systems, medical groups and practices that administer the CAHPS CG Survey according to CAHPS specifications can participate in this project. A health system is a complex of facilities, organizations, and providers of health care in a specified geographic area. A medical group is defined as a medical group, Accountable Care Organization (ACO), state organization or some other grouping of practices. A practice is an outpatient facility in a specific location whose physicians and other providers share administrative and clinical support staff Each practice located in a building containing multiple medical offices is considered a separate practice.
The goal of this project is to continue to update the CAHPS CG Database, with the latest results of the CAHPS CG Survey. These results consist of 37 items that measure 5 areas or composites of patients' experiences with physicians and staff in outpatient medical practices. This database will 1) allow participating organizations to compare their survey results with those of other outpatient medical groups; 2) facilitate internal assessment and learning in the quality improvement process; and 3) provide information to help identify strengths and areas with potential for improvement in patient care. The five composite measures are:
This study is being conducted by AHRQ through its contractor, Westat, pursuant to AHRQ's statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to: The quality, effectiveness, efficiency, appropriateness and value of healthcare services; quality measurement and improvement; and health surveys and database development. 42 U.S.C. 299a(a)(1), (2), and (8).
To achieve the goal of this project, the following activities and data collections will be implemented:
(1) Registration Form—The purpose of this form is to determine the eligibility status and initiate the registration process for participating organizations seeking to voluntarily submit their CAHPS CG Survey data to the CAHPS CG Comparative Database. The point of contact (POC) at the participating organization (or parent organization) will complete the form. The POC is either a corporate-level health care manager or a survey vendor who contracts with a participating organization to collect the CAHPS CG Survey data.
(2) Data Use Agreement—The purpose of this form is to obtain authorization from participating organizations to use
(3) Data Submission—After the POC has completed the Registration Form and the Data Use Agreement, they will submit their patient-level data from the CAHPS CG Survey to the CAHPS CG Comparative Database. Data on the organizational characteristics such as ownership, number of patient visits per year and medical specialty, and information related to survey administration such as mode and dates of survey administration, sample size, and response rate, which are collected as part of CAHPS CG Survey operations, are also submitted. Each submission will consist of 3 data files: (1) A Group File that contains information about the group ownership and size of group, (2) a Practice File containing type of practice, the practice ownership and affiliation (
Survey data from the CAHPS CG Database is used to produce three types of products: (1) An online reporting of results available to the public on the CAHPS User Network web site; (2) comparative reports that are confidential and customized for each participating organization (
Information for the CAHPS CG Database is collected by AHRQ through its contractor Westat. Participating organizations are asked to voluntarily submit their data to the CARPS Database. The data is cleaned with standardized programs, then aggregated and used to produce comparative results. In addition, reports are produced that compare the participating organizations' results to the database in a password-protected section of the CAHPS Database online reporting system. Trend data will be available to participants when enough data is collected across consecutive years.
Exhibit 1 shows the estimated annualized burden hours for participating organizations. The burden hours and costs below are based on an estimated number of participants. It is estimated that about 30 health systems, medical groups and practices will participate in the CAHPS CG Database. The number of data submissions per participating organization will vary because some participants may submit data for multiple practices, while others may only submit data for one.
The total burden for completing the registration, DUA and data submission process is estimated to be 246 hours. The 30 participating organizations that complete the registration form and submit information to the CAHPS CG Database are a combination of an estimated 20 health systems, medical groups and practices and 10 estimated vendors. Information about survey administration and the survey data files are submitted together for each participating organization.
Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to complete the submission process. The cost burden is estimated to be $10,485 annually.
Exhibit 3 shows the estimated annualized cost to the government for developing, maintaining and managing the CAHPS CG Database, analyzing the data and reporting results. The cost is estimated to be $220,000 annually. Annualized costs for collecting and processing the CAHPS CG Database are based upon 10 years of historical CAHPS Health Plan Database project costs. AHRQ wishes to continue this data collection indefinitely and requests OMB approval for 3 years.
In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ healthcare research and healthcare information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.
The Office of Grants Management (OGM), in the Administration for Children and Families (ACF) is proposing the collection of program performance data for ACF's discretionary grantees. To collect this data OGM has developed a form from the basic template of the OMB-approved reporting format of the Program Performance Report. OGM will use this data to determine if grantees are proceeding in a satisfactory manner in meeting the approved goals and objectives of the project, and if funding should be continued for another budget period.
Estimated Total Annual Burden Hours: 6,000.
In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email address:
The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.
The purpose of this Program Instruction is to streamline and simplify the application and reporting processes by consolidating the PIs into one single PI and requiring one single, consolidated application (App) package and program assessment report (PAR) per State court annually. These revisions will satisfy statutory programmatic requirements and reduce both the number of required responses and associated total burden hours for State courts.
This new PI also describes programmatic and fiscal provisions and reporting requirements for the grants, specifies the application submittal and approval procedures for the grants for fiscal years 2012 through 2015, and identifies technical resources for use by State courts during the course of the grants. The agency uses the information received to ensure compliance with the statute and provide training and technical assistance to the grantees.
Estimated Total Annual Burden Hours: 9,256.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an amendment to the Emergency Use Authorization (EUA) (the Authorization) for doxycycline hyclate tablet emergency kits for eligible United States Postal Service (USPS) participants in the Cities Readiness Initiative (CRI) and their household members issued on October 3, 2008, as amended on February 25, 2009, and on August 23, 2010, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS). Following issuance of FDA's August 23, 2010, amended Authorization letter, on April 8, 2011, BARDA submitted a request on behalf of ASPR to further amend the Authorization to reflect certain programmatic changes, including by replacing references to the CRI with the National Postal Model (NPM). In response to BARDA's request, FDA amended the Authorization letter and reissued the Authorization in its entirety on October 14, 2011. The Authorization, as amended and reissued, includes explanations for its reissuance and is reprinted in this document.
The amended Authorization is effective as of October 14, 2011.
Submit written requests for single copies of the EUA to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4121, Silver Spring, MD 20993. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the Authorization may be sent. See the
Luciana Borio, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4280, Silver Spring, MD 20993-0002, (301) 796-4637.
In 2004, the Secretary of the Department of Homeland Security (DHS) issued a material threat determination indicating that
On October 1, 2008, BARDA requested and on October 3, 2008, FDA issued an EUA for doxycycline hyclate tablet emergency kits for eligible USPS participants in the CRI and their household members, subject to the terms and conditions of the Authorization. As required under section 564(h)(1) of the FD&C Act, in the
An electronic version of this document and the full text of the Authorization are available on the Internet at
Having concluded that the criteria for issuance of the Authorization under section 564(c) of the FD&C Act were met, on October 3, 2008, FDA authorized the emergency use of doxycycline hyclate tablet emergency kits for eligible USPS participants in the CRI and their household members subject to the terms and conditions of the Authorization. The letter of Authorization in its entirety (not including the amended authorized versions of the fact sheets and other written materials), as amended on February 25, 2009, on August 23, 2010, and on October 14, 2011, follows and provides an explanation of the reasons for its amendment.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) has determined that TAXOTERE (docetaxel) Injection, 40 milligrams/milliliter (mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for docetaxel injection, 40 mg/mL, if all other legal and regulatory requirements are met.
Nam Kim, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6320, Silver Spring, MD 20993-0002, (301) 796-3472.
In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug.
The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.
TAXOTERE (docetaxel) Injection, 40 mg/mL is the subject of NDA 20-449, held by Sanofi-aventis U.S., and initially approved on May 14, 1996. TAXOTERE is indicated for breast cancer, non-small cell lung cancer, hormone refractory prostate cancer, gastric adenocarcinoma, and squamous cell carcinoma of the head and neck cancer as described in detail on the drug product's labeling.
TAXOTERE (docetaxel) Injection, 40 mg/mL, is currently listed in the “Discontinued Drug Product List” section of the Orange Book.
Sandoz, Inc. (Sandoz), submitted a citizen petition dated June 21, 2011 (Docket No. FDA-2011-P-0488), under 21 CFR 10.30, requesting that the Agency determine whether TAXOTERE (docetaxel) Injection, 40 mg/mL, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that TAXOTERE (docetaxel) Injection, 40 mg/mL was not withdrawn for reasons of safety or effectiveness. The petitioner Sandoz has identified no data or other information suggesting that TAXOTERE (docetaxel) Injection, 40 mg/mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of TAXOTERE (docetaxel) Injection, 40 mg/mL, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this product was withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list TAXOTERE (docetaxel) Injection, 40 mg/mL, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to TAXOTERE (docetaxel) Injection, 40 mg/mL, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled “Guidance for Industry: Use of Nucleic Acid Tests (NAT) on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Recovered Plasma, Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of Hepatitis B Virus (HBV), and Requalification of Donors Who Test HBV NAT Positive,” dated November 2011. The draft guidance document provides recommendations on the use of FDA-licensed nucleic acid tests (NAT) to screen blood donors for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and recommendations for product testing and disposition, donor management, methods for donor requalification, and product labeling. In addition, the draft guidance provides notification that FDA considers the use of an FDA-licensed HBV NAT to be necessary to reduce adequately and appropriately the risk of transmission of HBV. The guidance is intended for blood establishments that
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 27, 2012.
Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1-(800) 835-4709 or (301) 827-1800. See the
Submit electronic comments on the draft guidance to
Paul Levine, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, (301) 827-6210.
FDA is announcing the availability of a draft document entitled “Guidance for Industry: Use of Nucleic Acid Tests (NAT) on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Recovered Plasma, Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of Hepatitis B Virus (HBV), and Requalification of Donors Who Test HBV NAT Positive,” dated November 2011. FDA is providing blood establishments that collect Whole Blood and blood components for transfusion or for further manufacture, including recovered plasma, Source Plasma and Source Leukocytes; with recommendations concerning the use of FDA-licensed NAT to screen blood donors for HBV DNA. FDA is also providing these blood establishments with recommendations for product testing and disposition, donor management, methods for donor requalification, and product labeling.
In addition, FDA is notifying those blood establishments that FDA considers the use of an FDA-licensed HBV NAT to be necessary to reduce adequately and appropriately the risk of transmission of HBV. FDA-licensed HBV NAT can detect evidence of infection at an earlier stage than is possible using previously approved HBsAg and anti-HBc tests. Therefore, FDA is recommending the use of an FDA-licensed HBV NAT, in accordance with the requirements under 610.40(a) and (b) (21 CFR 610.40(a) and (b)).
The draft guidance, when finalized, is intended to supplement previous memoranda and guidance from FDA to blood establishments concerning the testing of donations for HBsAg and anti-HBc, and the management of donors and units mentioned in those documents. Note that testing Whole Blood and blood components for transfusion and Source Leukocytes for further manufacture for HBsAg and anti-HBc, and Source Plasma for HBsAg should continue when a blood establishment implements HBV NAT. FDA may consider advancements in technology for testing blood donations, as well as data obtained following the implementation of HBV NAT, to make future recommendations on adequate and appropriate testing for HBV.
The draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirement of the applicable statutes and regulations.
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 606.121, 610.40 and 640.70 have been approved under OMB Control Numbers 0910-0537, 0910-0116, and 0910-0338, respectively.
The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management (see
Persons with access to the Internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses.” This guidance document provides industry and Agency staff with recommendations for studies to establish the performance characteristics of in vitro diagnostic devices (IVDs) intended for the
Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.
Submit written requests for single copies of the guidance document entitled “Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses” to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to (301) 847-8149. See the
Submit electronic comments on the guidance to
Kate Simon, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5552, Silver Spring, MD 20993-0002, (301) 796-6210.
FDA is issuing this guidance to provide industry and Agency staff with recommendations for studies to establish the performance characteristics of IVDs intended for the detection, or detection and differentiation, of human papillomaviruses. These devices are used in conjunction with cervical cytology to aid in screening for cervical cancer. They include devices that detect a group of human papillomavirus (HPV) genotypes, particularly high risk human papillomaviruses, as well as devices that detect more than one genotype of HPV and further differentiate among them to indicate which genotype(s) of HPV is (are) present.
In the
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of human papillomaviruses. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
Persons interested in obtaining a copy of the guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at
This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 814 have been approved under OMB control number. 0910-0231; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 801 and 21 CFR 809.10 have been approved under OMB control number 0910-0485.
Interested persons may submit to the Division of Dockets Management (see
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals.” The purpose of this guidance is to provide recommendations to industry for designing nonclinical toxicity studies to determine potential late radiation effects (radiation-induced injuries occurring after a latency period of several months to years) of therapeutic radiopharmaceuticals administered systemically. The purpose of such studies is to help minimize the risk of late-occurring irreversible radiation toxicities in clinical trials of therapeutic radiopharmaceuticals. This guidance finalizes the draft guidance of the same name issued in June 2005.
Submit either electronic or written comments on Agency guidances at any time.
Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Submit electronic comments on the guidance to
Adebayo Laniyonu, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 2350, Silver Spring, MD 20993-0002, (301) 796-2050; or Siham Biade, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 2311, Silver Spring, MD 20993-0002, (301) 796-2050.
FDA is announcing the availability of a guidance for industry entitled “Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals.” The objective of this guidance is to provide recommendations to industry for designing nonclinical toxicity studies to determine potential late radiation effects of therapeutic radiopharmaceutical agents. This guidance is not intended to address late radiation toxicity of radiobiologicals (e.g., radiolabeled monoclonal antibodies) or to apply to diagnostic radiopharmaceuticals whose low doses are not expected to elicit late radiation toxic effects.
This guidance focuses solely on late radiation safety concerns that are unique to therapeutic radiopharmaceuticals and provides recommendations for late radiation toxicity nonclinical study designs including issues regarding good laboratory practices, species selection, dose selection, timing of study, and study parameters.
Late radiation toxicity differs from early or acute radiation toxicity. Acute radiation toxicity (
Therapeutic radiopharmaceuticals are typically administered systemically to treat cancer. The radiation absorbed doses delivered by therapeutic radiopharmaceuticals may be comparable to those delivered with external beam radiotherapy (XRT). At therapeutic doses of radiation, the late radiation toxicities commonly associated with XRT (
Therefore, there is a need to gain additional knowledge in this area to support the safe administration of therapeutic radiopharmaceuticals to humans. Because studies in humans would be unethical, the best means to gain insight into this issue is by conducting nonclinical late radiation toxicity studies. These studies will aid in identifying organs at risk and establish a margin of safety for late radiation toxicity. As a result, these studies will help to minimize the risk of late-occurring radiation toxicities in clinical trials of therapeutic radiopharmaceuticals.
This guidance finalizes the draft guidance of the same name issued in June 2005 and includes edits based on public comments to improve clarity.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on nonclinical evaluation of late radiation toxicity of therapeutic radiopharmaceuticals. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
Interested persons may submit to the Division of Dockets Management (see
Persons with access to the Internet may obtain the document at either
Food and Drug Administration, HHS.
Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
For those unable to attend in person, the meeting will also be webcast. The link for the webcast is available at
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Ms. Martha Monser, at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Science Board to the FDA (the Science Board).
FDA has special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.
Nominations received on or before December 28, 2011, will be given first consideration for membership on the Science Board. Nominations received after December 28, 2011, will be considered for nomination to the Science Board should nominees still be needed.
All nominations for membership should be sent electronically to
Regarding all nomination questions for membership, the primary contact is: Martha Monser, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4286, Silver Spring, MD 20993-0002, (301) 796-4627,
FDA is requesting nominations for voting members on the Science Board.
The Science Board shall provide advice primarily to the Commissioner of Food and Drugs (the Commissioner) and other appropriate officials on both general and specific scientific and technical issues as well as emerging issues within the scientific community. Additionally, the Science Board will
Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of food safety, nutrition, chemistry, pharmacology, toxicology, clinical research, and other scientific disciplines. Members shall represent academia and industry. The Science Board may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is either recommended by either a consortium of consumer oriented organizations or other interested persons. The Science Board may also include technically qualified federal members. FDA is currently specifically seeking persons knowledgeable in the fields of pharmacology, translational and clinical medicine, toxicology, clinical research and related biostatistics, public health and epidemiology, international public health and regulation, product safety, product manufacturing sciences and quality or other scientific areas relevant to FDA regulated products such as systems biology, advanced scientific informatics, nanotechnology, food sciences, medical devices and combination products.
Any interested person may nominate one or more qualified persons for membership on the Science Board. Self nominations are also accepted. Nominations shall include the name of the committee, complete curriculum vitae of each nominee, and their current business address and telephone number and email address if available. Nominations must specify the advisory committee for which the nominee is recommended. Nominations must also acknowledge that the nominee is aware of the nomination, unless self nominated. FDA will ask potential candidates to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts.
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14 relating to advisory committees.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for MYLOTARG (gemtuzumab ozogamicin) for Injection, held by Wyeth Pharmaceuticals, Inc. (Wyeth), 500 Arcola Rd., Collegeville, PA 19426. Wyeth, now a part of Pfizer, Inc., has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.
Effective November 28, 2011.
David Joy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6254, Silver Spring, MD 20993-0002, (301) 796-3601.
FDA approved MYLOTARG (gemtuzumab ozogamicin) for Injection on May 17, 2000, under the Agency's accelerated approval regulations, 21 CFR part 314, subpart H. MYLOTARG was indicated for the treatment of patients with CD33-positive acute myeloid leukemia in first relapse who were 60 years of age or older and who were not considered candidates for other cytotoxic chemotherapy. On May 21, 2010, FDA requested that Wyeth voluntarily withdraw MYLOTARG from the market, after results of a required postapproval clinical trial failed to verify clinical benefit to patients and raised new concerns about the drug's safety. In a letter dated October 25, 2010, Wyeth requested that FDA withdraw approval of NDA 21-174, MYLOTARG (gemtuzumab ozogamicin) for Injection, under § 314.150(d) (21 CFR 314.150(d)). In that letter, Wyeth also waived its opportunity for a hearing, provided under 21 CFR 314.150 and 314.530. In FDA's acknowledgment letter of November 2, 2010, the Agency stated that a large prospective trial that tested the addition of MYLOTARG to first-line chemotherapy for patients with newly diagnosed acute myelogenous leukemia failed to verify clinical benefit of MYLOTARG and raised safety concerns. FDA also acknowledged that Wyeth waived its opportunity for a hearing.
Therefore, under sections 505(e) and 506(b)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e) and 356(b)(3)) and § 314.150(d), and under authority delegated by the Commissioner to the Director, Center for Drug Evaluation and Research, approval of NDA 21-174, and all amendments and supplements thereto, is withdrawn (see
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Department of Bioethics, the Clinical Center, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Marion Danis at Department of Clinical Bioethics, National Institutes of Health, Building 10, Room 1C118, Bethesda, MD 20892-1156, Telephone: (301) 435-8727, Facsimile: (301) 496-0760, or email your request, including your address to:
Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the functioning of the National Cancer Institute, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Attention: NIH Desk Officer, Office of Management and Budget, at
Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Notice is hereby given of the “4th Annual Trauma Spectrum Conference: Bridging the Gap Between Research and Clinical Practice of Psychological Health and Traumatic Brain Injury: Prevention, Diagnosis, Treatment and Recovery for the Iraq and Afghanistan Cohort” to be held December 8-9, 2011, at the National Institutes of Health (NIH), Bethesda, Maryland.
This year's event focuses on bridging the gap between research and clinical practices for psychological health and traumatic brain injury (TBI) health concerns for returning service members
Presented annually by three Federal partners—the Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury (part of the Department of Defense), the National Institutes of Health, and the Department of Veterans Affairs—the conference highlights research findings, resources, and best practices for Post-Traumatic Stress Disorder and TBI recovery. Additional topics include cognitive rehabilitation, sleep disorders, pain management, depression, implementation science, comparative effectiveness research, co-occurring disorders, and integrative telehealth/mobile technologies. Attendees are expected to include a wide array of researchers, clinicians, advocates, military service members, veterans, and their families.
The conference will be held on Thursday, December 8, and Friday, December 9, in the Natcher Conference Center on the NIH main campus, from 8:30 a.m. to 4:30 p.m. each day. The conference is free, but pre-registration is required. Registration is now open.
To view the agenda, information about continuing education units, and general conference information, visit the Trauma Spectrum Conference Web site at
Information on traveling to NIH and a visitor's map can be found at
For attendees who take Metrorail, the nearest station is Medical Center (on the Red Line). Pay parking is available at the NIH Gateway parking garage. Sign language interpreters will be available.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Coast Guard, DHS.
Thirty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding Information Collection Requests (ICRs), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval of revisions to the following collections of information: 1625-0067, Claims under the Oil Pollution Act of 1990; and 1625-0068, State Access to the Oil Spill Liability Trust Fund for Removal costs under the Oil Pollution Act of 1990. Our ICRs describe the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.
Comments must reach the Coast Guard and OIRA on or before December 28, 2011.
You may submit comments identified by Coast Guard docket number [USCG-2011-0869] to the Docket Management Facility (DMF) at the U.S. Department of Transportation (DOT) and/or to OIRA. To avoid duplicate submissions, please use only one of the following means:
(1)
(2)
(3)
(4)
The DMF maintains the public docket for this Notice. Comments and material received from the public, as well as documents mentioned in this Notice as being available in the docket, will become part of the docket and will be available for inspection or copying at room W12-140 on the West Building Ground Floor, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also find the docket on the Internet at
Copies of the ICRs are available through the docket on the Internet at
Ms. Kenlinishia Tyler, Office of Information Management, telephone (202) 475-3652 or fax (202) 475-3929, for questions on these documents. Contact Ms. Renee V. Wright, Program Manager, Docket Operations, (202) 366-9826, for questions on the docket.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collections. There is one ICR for each Collection.
The Coast Guard invites comments on whether these ICRs should be granted based on the Collections being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collections; (2) the accuracy of the estimated burden of the Collections; (3) ways to enhance the quality, utility, and clarity of information subject to the Collections; and (4) ways to minimize the burden of the Collections on respondents, including the use of automated collection techniques or other forms of information technology. These comments will help OIRA determine whether to approve the ICRs referred to in this Notice.
We encourage you to respond to this request by submitting comments and
If you submit a comment, please include the docket number [USCG-2011-0869], indicate the specific section of the document to which each comment applies, providing a reason for each comment. If you submit a comment online via
You may submit comments and material by electronic means, mail, fax, or delivery to the DMF at the address under
To view comments, as well as documents mentioned in this Notice as being available in the docket, go to
OIRA posts its decisions on ICRs online at
Anyone can search the electronic form of comments received in dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act statement regarding Coast Guard public dockets in the January 17, 2008, issue of the
This request provides a 30-day comment period required by OIRA. The Coast Guard published the 60-day notice (76 FR 58529, September 21, 2011) required by 44 U.S.C. 3506(c)(2). That Notice elicited no comments.
1.
2.
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of an emergency for the State of New Hampshire (FEMA-3344-EM), dated November 1, 2011, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
Notice is hereby given that, in a letter dated November 1, 2011, the President issued an emergency declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:
I have determined that the emergency conditions in certain areas of the State of New Hampshire resulting from a severe storm during the period of October 29-30, 2011, are of sufficient severity and magnitude to warrant an emergency declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
You are authorized to provide appropriate assistance for required emergency measures, authorized under Title V of the Stafford Act, to save lives and to protect property and public health and safety, and to lessen or avert the threat of a catastrophe in the designated areas. Specifically, you are authorized to provide assistance for emergency protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program. This assistance excludes regular time costs for subgrantees' regular employees.
Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Public Assistance will be limited to 75 percent of the total eligible costs. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal emergency assistance and administrative expenses.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, Department of Homeland Security, under Executive Order 12148, as amended, Albert Lewis, of FEMA is appointed to act as the Federal Coordinating Officer for this declared emergency.
The following areas of the State of New Hampshire have been designated as adversely affected by this declared emergency:
All 10 counties in the State of New Hampshire for emergency practice measures (Category B) limited to direct Federal assistance, under the Public Assistance program.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of an emergency for the Commonwealth of Massachusetts (FEMA-3343-EM), dated November 1, 2011, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
Notice is hereby given that, in a letter dated November 1, 2011, the President issued an emergency declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:
I have determined that the emergency conditions in certain areas of the Commonwealth of Massachusetts resulting from a severe storm during the period of October 29-30, 2011, are of sufficient severity and magnitude to warrant an emergency declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
You are authorized to provide appropriate assistance for required emergency measures, authorized under Title V of the Stafford Act, to save lives and to protect property and public health and safety, and to lessen or avert the threat of a catastrophe in the designated areas. Specifically, you are authorized to provide assistance for emergency protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program. This assistance excludes regular time costs for subgrantees' regular employees.
Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Public Assistance will be limited to 75 percent of the total eligible costs. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal emergency assistance and administrative expenses.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, Department of Homeland Security, under Executive Order 12148, as amended, Mark H. Landry, of FEMA is appointed to act as the Federal Coordinating Officer for this declared emergency.
The following areas of the Commonwealth of Massachusetts have been designated as adversely affected by this declared emergency:
The counties of Berkshire, Essex, Franklin, Hampden, Hampshire, Middlesex, Norfolk, and Worcester for emergency protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
Pursuant to the Flood Disaster Protection Act of 1973, the Federal Emergency Management Agency (FEMA), via the Federal Insurance Administrator, must publish flood
The changes in procedure announced in this notice are effective December 1, 2011. The new procedure applies to all proposed flood hazard determinations including proposed flood elevation determinations published in the
The docket for this notice is available at
Lora Eskandary, Program Specialist, FEMA, 1800 South Bell Street, Mail Stop 3030, Arlington, VA 20598, at
The Federal Insurance Administrator must propose flood elevation determinations by publication of the proposed flood elevation determination for comment in the
Currently FEMA publishes base flood elevation (BFE) determinations for Flood Insurance Studies pursuant to 44 CFR 67.4 and 67.11 as proposed and final rules. However, there is no legal requirement to publish them as rules, and FEMA now plans to publish them as notices, which are administratively less burdensome. The background and legal authority for this change in procedure is explained below.
Sections 67.4 and 67.11 of Title 44 of the Code of Regulations (CFR) were initially promulgated in 1974, pursuant to section 110 of the Flood Disaster Protection Act of 1973, Public Law 93-234, which amended the National Flood Insurance Act of 1968. Section 110 states “In establishing projected flood elevations * * * [the agency] shall first propose such determinations by publication for comment in the
Sections 1917.4 and 1971.11 were finalized as proposed on July 24, 1974. The preamble to the final rule noted that one commenter had requested that the notification by newspaper could be more effective by increasing the number of days of publication. HUD did not alter the proposed regulatory text, however, because the publication standard had been set by the Flood Disaster Protection Act and could not be altered by regulation. Other commenters requested that communities who entered the flood insurance program prior to the passage of the Flood Disaster Protection Act of 1973 be allowed to appeal past flood elevation determinations. Again HUD declined to alter the proposed regulatory text because the Act did not apply retroactively. Further, HUD noted “an attempt to include such regular flood insurance program communities in this [sic] new appeals procedures could curtail the right of judicial review available to them under the National Flood Insurance Act of 1968 and Title 5 of the United States Code.”
The text of sections 1917.4 and 1917.11 has not changed since they were finalized in 1974.
The Federal Insurance Administrator shall propose flood elevation determinations in the following manner:
(a) Publication of the proposed flood elevation determination for comment in the
(b) Notification by certified mail, return receipt requested, of the proposed flood elevation determination to the CEO; and
(c) Publication of the proposed flood elevation determination in a prominent local newspaper at least twice during the ten day period immediately following the notification of the CEO.
The Federal Insurance Administrator's notice of the final flood elevation determination for a community shall be in written form and published in the
Since the applicable regulations were promulgated in 1974, base flood elevation determinations listed in feet or meters for specific localities have been published in the
Nowhere is it mentioned that the flood elevation determinations were to be published as rules. The extensive Congressional hearings from October 1973 regarding the proposed legislation focus on
The evidence indicates that publication in the
FEMA concludes that the statute does not require that the determinations must take the form of a regulation; rather, the requirement of publication in the
The information provided in the BFE notices will be less detailed than the information FEMA currently provides in the BFE rules. FEMA will no longer list in the
This new procedure will
This new procedure will also apply to certain Letters of Map Revision (LOMRs). A LOMR is a type of determination that FEMA issues under the authority of 44 CFR part 65. It may include changes to the technical content (
In addition to BFE determinations, FEMA also issues other types of flood hazard determinations including new and modified Special Flood Hazard Areas (SFHAs) and new and modified regulatory floodways. SFHAs are areas subject to inundation by the base flood and include the following flood insurance risk zone designations: A, AO, AH, A1-30, AE, A99, AR, AR/A1-30, AR/AE, AR/AO, AR/AH, AR/A, VO, V1-30, VE, and V. The various flood insurance risk zones represent different levels of risk and the type of flood hazard (
Under current practice, new or modified SFHAs or regulatory floodways not specifically related to changes in BFE determinations are not appealable under 44 CFR 67.8. For that reason, FEMA has not published notification of new and modified SFHAs and regulatory floodways in the
As of the effective date of this notice (December 1, 2011), FEMA will publish notification of new or modified SFHAs
As with appeals of BFE determinations, appeals of SFHA and regulatory floodway determinations must include supporting scientific and technical data certified by a registered professional engineer or licensed land surveyor pursuant to 44 CFR 67.6.
42 U.S.C. 4104; 44 CFR parts 65 and 67.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the State of Vermont (FEMA-4043-DR), dated November 8, 2011, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
Notice is hereby given that, in a letter dated November 8, 2011, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
I have determined that the damage in certain areas of the State of Vermont resulting from severe storms and flooding on May 20, 2011, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Public Assistance in the designated areas and Hazard Mitigation throughout the State. Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Public Assistance and Hazard Mitigation will be limited to 75 percent of the total eligible costs.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, James N. Russo, of FEMA, is appointed to act as the Federal Coordinating Officer for this major disaster.
The following areas of the State of Vermont have been designated as adversely affected by this major disaster:
Franklin, Washington, and Windham Counties for Public Assistance.
All counties within the State of Vermont are eligible to apply for assistance under the Hazard Mitigation Grant Program.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the Commonwealth of Virginia (FEMA-4042-DR), dated November 4, 2011, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
Notice is hereby given that, in a letter dated November 4, 2011, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
I have determined that the damage in certain areas of the Commonwealth of Virginia resulting from an earthquake during the period of August 23 to October 25, 2011, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Individual Assistance in the designated areas and Hazard Mitigation throughout the Commonwealth. Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation and Other Needs Assistance will be limited to 75 percent of the total eligible costs.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The time period prescribed for the implementation of section 310(a), Priority to Certain Applications for Public Facility and Public Housing Assistance, 42 U.S.C. 5153, shall be for
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Donald L. Keldsen, of FEMA, is appointed to act as the Federal Coordinating Officer for this major disaster.
The following areas of the Commonwealth of Virginia have been designated as adversely affected by this major disaster:
Louisa County for Individual Assistance.
All counties and independent cities in the Commonwealth of Virginia are eligible to apply for assistance under the Hazard Mitigation Grant Program.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the District of Columbia (FEMA-4044-DR), dated November 8, 2011, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
Notice is hereby given that, in a letter dated November 8, 2011, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
I have determined that the damage in certain areas of the District of Columbia resulting from an earthquake during the period of August 23-28, 2011, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Public Assistance in the designated areas and Hazard Mitigation in the District of Columbia. Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Public Assistance and Hazard Mitigation will be limited to 75 percent of the total eligible costs.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Kim R. Kadesch, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.
The following areas of the District of Columbia have been designated as adversely affected by this major disaster:
The District of Columbia for Public Assistance.
The District of Columbia is eligible to apply for assistance under the Hazard Mitigation Grant Program.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the Commonwealth of Pennsylvania (FEMA-4030-DR), dated September 12, 2011, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
The notice of a major disaster declaration for the Commonwealth of Pennsylvania is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of September 12, 2011.
Adams, Chester, and Northampton Counties for Public Assistance (already designated for Individual Assistance).
Lackawanna and Mifflin Counties for Public Assistance.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households in Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the Commonwealth of Virginia (FEMA-4042-DR), dated November 4, 2011, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
The notice of a major disaster declaration for the Commonwealth of Virginia is hereby amended to include the Public Assistance program for the following area among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of November 4, 2011.
Louisa County for Public Assistance (already designated for Individual Assistance).
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for State of Missouri (FEMA-4012-DR), dated August 12, 2011, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Stephen R. Thompson, of FEMA is appointed to act as the Federal Coordinating Officer for this disaster.
This action terminates the appointment of Michael L. Karl as Federal Coordinating Officer for this disaster.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for State of Missouri (FEMA-1980-DR), dated May 9, 2011, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Stephen R. Thompson, of FEMA is appointed to act as the Federal Coordinating Officer for this disaster.
This action terminates the appointment of Michael L. Karl as Federal Coordinating Officer for this disaster.
Transportation Security Administration, DHS.
Committee Management; Notice of Federal Advisory Committee Meeting.
The Transportation Security Administration (TSA) will hold a meeting of the Aviation Security Advisory Committee (ASAC) via telephone conference on December 15, 2011, to establish working groups and set the agenda for future activity. This meeting will be open to the public.
The Committee will meet on Thursday, December 15, 2011, from 1-3:30 p.m. Eastern Standard Time (EST). This meeting may end early if all business is completed.
The Committee will meet via telephone conference, on December 15, 2011. There will be 100 teleconference lines to accommodate committee members, staff and public participation. To participate via telephone conference, please contact the person listed in the
Dean Walter, ASAC Designated Federal Officer, Transportation Security Administration (TSA-28), 601 12th St. South, Arlington, VA 20598-4028,
Notice of this meeting is given under section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (Pub. L. 92-463). ASAC operates under the authority of 46 U.S.C. 70112 and provides advice, consults with, and makes recommendations to the Secretary of Homeland Security, via the Administrator of TSA on matters affecting civil aviation security.
This meeting is open to the public, but participation is limited to 100 telephone lines to accommodate all participants. Members of the public must make advance arrangements to present oral statements at the meeting. The public comment period will be held during the meeting on December 15, 2011, from approximately 3 to 3:30 p.m. EST, depending on the meeting progress. Speakers are requested to limit their comments to two minutes. Please note that the public comment period will end following the last call for comments. Written statements may also be presented to the Committee. Contact the person listed in the
The agenda for the meeting is as follows:
30-Day Notice of Information Collection Under Review; Form I-602, Application by Refugee for Waiver of Grounds of Excludability; OMB Control No. 1615-0069.
The Department of Homeland Security, U.S. Citizenship and Immigration Services (USCIS) will be submitted the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the
The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until December 28, 2011. This process is conducted in accordance with 5 CFR 1320.10.
Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Department of Homeland Security (DHS), and to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), USCIS Desk Officer. Comments may be submitted to: Sunday Aigbe, Chief, Regulatory Products Division, Office of the Executive Secretariat, USCIS, 20 Massachusetts Avenue NW., Washington, DC 20529-2020. Comments may also be submitted to DHS via facsimile to (202) 272-8352 or via email at
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(1)
(2)
(3)
(4)
(5)
(6)
If you need a copy of the information collection instrument, please visit the Web site at:
If additional information is required contact: USCIS, Regulatory Products Division, Office of the Executive Secretariat, 20 Massachusetts Avenue NW., Washington, DC 20529-2020, telephone (202) 272-8377.
Office of the Secretary, Interior.
Notice.
The Secretary of the Interior is publishing this notice as required by section 10(a) of the Soboba Band of Luiseño Indians Settlement Act of 2008, Public Law 110-297, 122 Stat. 2975, 2983 (Settlement Act). The publication of this notice causes certain waivers and releases of claims to become effective as required by the Settlement Act.
Address all comments and requests for additional information to Robert Laidlaw, Senior Policy Analyst, United States Department of the Interior, 1849 C Street NW., Room 3517, Washington, DC 20240.
The Settlement Act approves, ratifies, and confirms the Settlement Agreement entered into by the settlement parties, including the United States on behalf of the Tribe, the Tribe, the Metropolitan Water District of Southern California, Eastern Municipal Water District, and Lake Hemet Municipal Water District. The Settlement Act, which Congress enacted on July 31, 2008, determines the Tribe's water rights; resolves the Tribe's claims for interference with the water resources of, and damages to, the Tribe's Reservation; provides for construction of certain water projects to facilitate exercise of the Tribe's water rights secured by the Settlement Act; and resolves outstanding litigation.
Section 10(b) of the Settlement Act and article 3.3 of the Settlement Agreement provide that the Settlement Act and the Settlement Agreement shall be null and void if certain conditions are not fulfilled on or before March 1, 2012. The publication of this notice and the Statement of Findings below confirm that the conditions required by section 10(a) of the Settlement Act and article 3 of the Settlement Agreement have been fulfilled. Accordingly, the waivers and releases executed pursuant to section 8(a) of the Settlement Act and article 5 of the Settlement Agreement are effective as of November 28, 2011.
In accordance with section 10(a) of the Settlement Act and article 3.1 of the Settlement Agreement, I find as follows:
1. The Settlement Act was enacted on July 31, 2008.
2. To the extent that the Settlement Agreement conflicted with the Act, the Settlement Agreement has been revised to conform to the Act.
3. The Settlement Agreement, revised as necessary, and the waivers and releases described in article 5 of the Settlement Agreement and section 8(a) of the Settlement Act have been executed by the parties and by the Secretary.
4. Warranty deeds for the property to be conveyed to the Tribe described in article 4.6 of the Settlement Agreement have been placed in escrow and, in accordance with the Settlement Agreement, shall be delivered to the Tribe on the first business day following the Effective Date (
5. The Tribe and the Secretary have approved the Water Management Plan developed pursuant to article 4.8.A of the Settlement Agreement.
6. A judgment and decree substantially the same as Exhibit H to the Settlement Agreement has been approved by the United States District Court, Eastern Division of the Central District of California, and that judgment and decree has become final and non-appealable.
Fish and Wildlife Service, Interior.
Notice of issuance of permits.
We, the U.S. Fish and Wildlife Service (Service), have issued the following permits to conduct certain activities with endangered species, marine mammals, or both. We issue these permits under the Endangered Species Act (ESA) and Marine Mammal Protection Act (MMPA).
Brenda Tapia, Division of Management Authority, U.S. Fish and Wildlife Service, 4401 North Fairfax Drive, Room 212, Arlington, VA 22203; fax (703) 358-2280; or Email
Brenda Tapia, (703) 358-2104 (telephone); (703) 358-2280 (fax);
On the dates below, as authorized by the provisions of the ESA (16 U.S.C. 1531
Documents and other information submitted with these applications are available for review, subject to the requirements of the Privacy Act and Freedom of Information Act, by any party who submits a written request for a copy of such documents.
Bureau of Indian Affairs, Interior.
Notice of Reservation Proclamation.
This notice informs the public that the Assistant Secretary—Indian Affairs proclaimed approximately 30.00 acres, more or less, as the Fort Sill Apache Indian Reservation for the Fort Sill Apache Tribe of Indians.
Ben Burshia, Bureau of Indian Affairs, Division of Real Estate Services, Mail Stop-4639-MIB, 1849 C Street NW., Washington, DC 20240, telephone (202) 208-7737.
This notice is published in the exercise of authority delegated by the Secretary of the Interior to the Assistant Secretary—Indian Affairs by part 209 of the Departmental Manual.
A proclamation was issued according to the Act of June 18, 1934 (48 Stat. 986; 25 U.S.C. 467), for the land described below. The land was proclaimed to be an addition to and part of the reservation of the Fort Sill Apache Indian Reservation for the exclusive use of Indians entitled by enrollment or by tribal membership to residence at such reservation.
That part of the North half (N1/2) of Section Eleven (11), lying north of the Interstate 10 right-of-way, Township Twenty-four (24) south, Range Six (6) west, N.M.P.M., Luna County, New Mexico, being described as follows:
BEGINNING at a spike in the center of an abandoned asphalt roadway at the Northeast corner of said Section 11 and Northeast corner of this tract:
Thence S. 0°21′53″ W., along the east line of Section 11, a distance of 500.76 feet to a No. 5 steel rod at the Southeast corner of this tract and on the North boundary of the Interstate 10 right-of-way;
Thence adjoining the North boundary of said I-10 right-of-way through the following courses and distances; along a curve to the left from a tangent which bears N. 89°56′18″ W., having a radius of 789.30 feet, a delta angle of 32°47′40″, a chord which bears S. 73°39′52″ W., 445.63 feet through an arc length of 451.77 feet to I-10 P.C. marker 10+30.62;
Thence S. 57°12′44″ W., a distance of 231.01 feet to I-10 P.T. marker 8+00;
Thence along a curve to the right from a tangent which bears S. 57°16′8″ W., having a radius of 1096.00 feet, a delta angle of 39°58′50″, a chord which bears S. 77°15′43″ W., 749.36 feet, through an arc length of 764.78 feet to I-10 P.C. marker 45+11.53;
Thence N. 82°45′27″ W., a distance of 340.58 feet to a No. 5 steel rod at the Southwest corner of this tract;
Thence N. 0°21′53″ E., along a line parallel with the east line of Section 11, a distance of 871.49 feet to a No. 5 steel rod at the Northwest corner of this tract;
Thence N. 89°55′55″ E., along the North line of Section 11, a distance of 1688.27 feet to the point of beginning.
The above-described lands contain a total of 30.00 acres, more or less, which is subject to all valid rights, reservations, rights-of-way, and easements of record.
This proclamation does not affect title to the land described above, nor does it affect any valid existing easements for public roads and highways, public utilities and for railroads and pipelines and any other rights-of-way or reservations of record.
Bureau of Land Management, Interior.
Notice.
The purpose of this notice is to request public nominations to fill one position on the Utah Resource Advisory Council (RAC) in category three (representatives of state, county, or local elected office; employees of a state agency responsible for management of natural resources; representatives of Indian tribes within or adjacent to the area for which the council is organized; representatives of academia who are employed in natural sciences; or the public-at-large).
All nominations must be received no later than December 28, 2011.
Nominations should be sent to Sherry Foot, Special Programs Coordinator, Utah State Office, Bureau of Land Management, 440 West 200 South, Suite 500, Salt Lake City, UT 84101.
Sherry Foot, Special Programs Coordinator, Utah State Office, 440 West 200 South, Suite 500, Salt Lake City, UT 84101; phone (801) 539-4195; or email
Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-(800) 877-8339 to contact the above individual during normal business hours. The FIRS is available 24 hours a day, seven days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.
The Federal Land Policy and Management Act (FLPMA) directs the Secretary of the Interior to involve the public in planning and issues related to management of lands administered by the Bureau of Land Management (BLM). Section 309 of FLPMA directs the Secretary to establish 10- to 15-member citizen-based advisory councils that conform to the requirements of the Federal Advisory Committee Act (FACA). RAC membership must be balanced and representative of the various interests concerned with the land use planning and/or management of the public lands.
The BLM's Utah RAC is hosting a call for nominations for a position in category three (description addressed in the
Simultaneous with this notice, the BLM Utah State Office will issue a press release providing additional information for submitting nominations.
Bureau of Land Management, Interior.
Notice.
The plats of survey and supplemental plats of lands described below are scheduled to be officially filed in the Bureau of Land Management California State Office, Sacramento, California, thirty (30) calendar days from the date of this publication.
A copy of the plats may be obtained from the California State Office, Bureau of Land Management, 2800 Cottage Way, Sacramento, California 95825, upon required payment.
Chief, Branch of Geographic Services, Bureau of Land Management, California State Office, 2800 Cottage Way, Room W-1623, Sacramento, California 95825, (916) 978-4310.
These surveys and supplemental plats were executed to meet the administrative needs of various federal agencies; the Bureau of Land Management, Bureau of Indian Affairs, General Services Administration or U.S. Forest Service. The lands surveyed are:
43 U.S.C., Chapter 3.
Bureau of Land Management, Interior.
Notice of filing of plats of survey.
The Bureau of Land Management (BLM) will file the plat of survey of the lands described below in the BLM Montana State Office, Billings, Montana, on December 28, 2011.
Protests of the survey must be filed before December 28, 2011 to be considered.
Protests of the survey should be sent to the Branch of Cadastral Survey, Bureau of Land Management, 5001 Southgate Drive, Billings, Montana 59101-4669.
Marvin Montoya, Cadastral Surveyor, Branch of Cadastral Survey, Bureau of Land Management, 5001 Southgate Drive, Billings, Montana 59101-4669, telephone (406) 896-5124 or (406) 896-5009,
This survey was executed at the request of the Forest Supervisor, U.S. Forest Service, Flathead National Forest, Kalispell, Montana, and was necessary to determine federal interest lands.
The lands we surveyed are:
The plat, in one sheet, representing the corrective dependent resurvey of a portion of the section line between sections 2 and 11 and a portion of the subdivision of section 11, the dependent resurvey of a portion of the subdivision of section 11, and the survey of a portion of a warranty deed in Township 36
We will place a copy of the plat, in one sheet, and related field notes we described in the open files. They will be available to the public as a matter of information. If the BLM receives a protest against this survey, as shown on this plat, in one sheet, prior to the date of the official filing, we will stay the filing pending our consideration of the protest. We will not officially file this plat, in one sheet, until the day after we have accepted or dismissed all protests and they have become final, including decisions or appeals.
43 U.S.C. Chap. 3.
Bureau of Land Management, Interior.
Notice of Intent.
Pursuant to applicable provisions of the Federal Lands Recreation Enhancement Act (REA), the Bureau of Land Management (BLM) La Jara Field Office is proposing to collect fees at the Zapata Falls Campground in Alamosa County, Colorado (Township 28S, Range 73W, Section 17). Under Section 2(2) of the REA, Zapata Falls Campground qualifies as a site wherein visitors can be charged an “Expanded Amenity Recreation Fee” authorized under section 3(g). In accordance with the REA, and the BLM's implementing regulations, the La Jara Field Office is proposing to charge $11 per night for individual sites and $20 per night for group-site fees for overnight camping within the developed campground.
This notice initiates the public comment period. Comments on issues may be submitted in writing by December 28, 2011. New fee implementation is contingent on a recommendation of the Colorado Front Range Resource Advisory Council (RAC) review. Per the REA, effective 6 months after the publication of this notice, and dependent on review and an affirmative recommendation by the Colorado Front Range RAC and modification approval from the BLM Colorado State Director. To meet the terms of a RAC recommendation, the La Jara Field Office will provide final public notice under REA and initiate fee collection at the Zapata Falls Campground.
You may submit comments related to the proposed fee collection at Zapata Falls Campground by any of the following methods:
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Sean Noonan, Outdoor Recreation Planner; telephone (719) 655-6136; see address above; email snoonan@blm.gov.
The Zapata Falls Campground was built in 2010 with American Recovery and Reinvestment Act funding. The campground has one camp host site, one group site, and 23 individual sites divided between a tent camping loop and an RV camping loop. The site includes water, restrooms, trails and signs. Pursuant to the REA and implementing regulations at 43 CFR subpart 2933, fees may be charged for overnight camping. Specific visitor fees will be identified and posted at the site and the La Jara Field Office. Fees must be paid at the self-service pay station located at the site. People holding the America The Beautiful—The National Parks and Federal Recreational Lands—Senior Pass (i.e., Interagency Senior Pass), a Golden Age Passport, the America the Beautiful—The National Parks and Federal Recreational Lands—Access Pass (i.e, Interagency Access Pass), or a Golden Access Passport will be entitled to a 50 percent reduction on all overnight camping fees. The BLM is committed to providing and receiving fair value for the use of developed recreation facilities and services in a manner that meets public-use demands, provides for quality experiences, and protects important resources. The BLM's policy is to collect fees at all specialized recreation sites, or where the BLM provides facilities, equipment or services, at Federal expense, in connection with outdoor use as authorized by the REA. Implementing a fee program for the campground will help ensure that funding is available to accomplish deferred maintenance, make future enhancements, maintain facilities and recreational opportunities, provide for law enforcement presence, develop additional services, and protect resources. Campground development is consistent with the 1991 San Luis Resource Area Resource Management Plan, the 2009 Zapata Falls Recreation Area Management Plan, and was analyzed in the Zapata Falls Campground Construction Project Environmental Assessment, CO-140-2009-017-EA. Proposed fees at the Zapata Falls Campground are consistent with other established fee sites in the area, including other BLM-administered sites and those managed by the United States Department of Agriculture Forest Service, United States Department of the Interior National Park Service, and Colorado Parks and Wildlife. The REA was signed into law in December 2004. The REA provides authority for the Secretaries of the Interior and Agriculture to establish, modify, charge and collect recreation fees for use of some Federal recreation lands and waters for 10 years, and contains specific provisions addressing public involvement in the establishment of recreation fees, including a requirement that Recreation Resource Advisory Committees or BLM RACs have the opportunity to make recommendations regarding establishment of such fees. The REA also directed the secretaries of the Interior and Agriculture to publish advance notice in the
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be advised that your entire comment—including your personal identifying information—may be made publicly available at any time.
16 U.S.C. 6803(b).
Bureau of Land Management, Interior.
Notice of Realty Action.
The Bureau of Land Management (BLM), Hollister Field Office, proposes to sell a parcel of public land totaling approximately 23.42 acres, more or less, in Santa Clara County, California. The public land would be sold for appraised fair market value. The appraised value of the public land is $135,000.
Comments regarding the proposed sale must be received by the BLM on or before January 12, 2012.
Written comments concerning the proposed sale should be sent to the Field Manager, BLM, Hollister Field Office, 20 Hamilton Court, Hollister, California 95023.
Christine Sloand, Realty Specialist, BLM, Hollister Field Office, 20 Hamilton Court, Hollister, California 95023, or phone (831) 630-5022.
The following public land is proposed for competitive sale in accordance with Sections 203 and 209 of the Federal Land Policy and Management Act of 1976 (FLPMA), as amended (43 U.S.C. 1713 and 1719).
The area described contains 23.42 acres, more or less, in Santa Clara County, California.
Appraised fair market value: $135,000.
The public land was first identified as suitable for disposal in the 1984 BLM Hollister Resource Management Plan (RMP) and remains available for sale under the 2007 Hollister RMP revision. The land is not needed for any other Federal purpose, and its disposal would be in the public interest. The land is difficult and uneconomic to manage as part of the public lands because it lacks legal access and is isolated from other public lands. The BLM has concluded the public interest would be best served by a competitive sale. The BLM has completed a mineral potential report which concluded there are no known mineral values in the land proposed for sale. The BLM proposes that conveyance of the Federal mineral interests would occur simultaneously with the sale of the land. The purchaser would be required to pay a $50 nonrefundable filing fee for the conveyance of the mineral interests.
On November 28, 2011, the above described land will be segregated from appropriation under the public land laws, including the mining laws, except for the sale provisions of FLPMA. Until completion of the sale, the BLM will no longer accept land use applications affecting the identified public land, except applications for the amendment of previously filed right-of-way applications or existing authorizations to increase the term of the grants in accordance with 43 CFR 2802.15 and 2886.15. The segregation will terminate upon issuance of a patent, publication in the
1. A reservation of a right-of-way to the United States for ditches and canals constructed by authority of the United States under the Act of August 30, 1890 (43 U.S.C 945);
2. A condition that the conveyance be subject to all valid existing rights of record;
3. An appropriate indemnification clause protecting the United States from claims arising out of the patentee's use, occupancy, or operations on the patented lands;
4. Additional terms and conditions that the authorized officer deems appropriate.
Public Comments regarding the proposed sale may be submitted in writing to the attention of the BLM Hollister Field Manager (see
43 CFR 2711.1-2(a) and (c)
Office of Surface Mining Reclamation and Enforcement, Interior.
Notice and request for comments.
In compliance with the Paperwork Reduction Act of 1995, the Office of Surface Mining Reclamation and Enforcement (OSM) is announcing its intention to request renewed approval for the collection of information for surface and underground mining permit applications—minimum requirements for information on environmental resources.
Comments on the proposed information collection must be received by January 27, 2012, to be assured of consideration.
Comments may be mailed to John Trelease, Office of Surface Mining Reclamation and Enforcement, 1951 Constitution Ave. NW., Room 203—SIB, Washington, DC 20240. Comments may also be submitted electronically to
To receive a copy of the information collection request contact John Trelease, at (202) 208-2783, or by email at
The Office of Management and Budget (OMB) regulations at 5 CFR part 1320, which implement provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13), require that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities [see 5 CFR 1320.8 (d)]. This notice identifies an information collection that OSM will be submitting to OMB for renewed approval. This collection is contained in 30 CFR parts 779 and 783—Surface and Underground Mining Permit Applications—Minimum Requirements for Information on Environmental Resources. OSM will request a 3-year term of approval for this information collection activity.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control number for parts 779 and 783 is 1029-0035. Responses are required to obtain a benefit for this collection.
OSM has revised burden estimates, where appropriate, to reflect current reporting levels or adjustments based on Creestimates of burden on respondents and costs.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
This notice provides the public with 60 days in which to comment on the following information collection activity:
Notice is hereby given that on November 21, 2011, a proposed Consent Decree (“proposed Decree”) in
On September 21, 2009, the United States and the West Virginia Department of Environmental Protection and West Virginia Department of Health and Human Resources (collectively, “Plaintiffs”) filed a complaint against the Town of Fort Gay, West Virginia (“Defendant” or “Fort Gay”) for permanent injunctive relief and civil penalties under the Clean Water Act, 33 U.S.C. 1251-387; the Safe Drinking Water Act, 42 U.S.C. 300f-300j-26; the West Virginia Water Pollution Control Act, W.Va Code § 22-11-22; and Chapter 16, Article I, Section 9a of the West Virginia Code.
The proposed Decree requires Defendant to comply with certain permit requirements, to prepare and submit certain reports, to make capital improvements to the Fort Gay waste water collection and treatment system and drinking water treatment system (collectively, the “Facilities”), and to improve staffing at the Facilities. The proposed Decree appoints the County Commission of Wayne County, West Virginia as Receiver of the Facilities.
The Department of Justice will receive for a period of thirty (30) days from the date of this publication comments relating to the proposed Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and either emailed to
During the public comment period, the proposed Decree may be examined on the following Department of Justice Web site:
Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on July 18, 2011, Aldrich Chemical Company Inc., DBA Isotec, 3858 Benner Road, Miamisburg, Ohio 45342-4304, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances:
The company plans to manufacture small quantities of the listed controlled substances to produce isotope labeled standards for drug testing and analysis.
In reference to drug code 7370 the company plans to bulk manufacture a synthetic Tetrahydrocannabinol. No other activity for this drug code is authorized for this registration.
Any other such applicant, and any person who is presently registered with DEA to manufacture such substances, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a).
Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than January 27, 2012.
Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on September 9, 2011, Johnson Matthey Inc., Custom Pharmaceuticals Department, 2003 Nolte Drive, West Deptford, New Jersey 08066-1742, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances:
The company plans to manufacture the listed controlled substances in bulk for sale to its customers.
Any other such applicant, and any person who is presently registered with DEA to manufacture such substances, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a).
Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than January 27, 2012.
Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on September 15, 2011, Johnson Matthey Pharmaceutical Materials Inc., Pharmaceutical Service, 25 Patton Road, Devens, Massachusetts 01434, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances:
The company plans to utilize this facility to manufacture small quantities of the listed controlled substances in bulk and to conduct analytical testing in support of the company's primary manufacturing facility in West Deptford, New Jersey. The controlled substances manufactured in bulk at this facility will be distributed to the company's customers.
Any other such applicant, and any person who is presently registered with DEA to manufacture such substances, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a).
Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than January 27, 2012.
Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on March 30, 2010, Mallinckrodt Inc., 675 McDonnell Blvd., Hazelwood, Missouri 63042, made application to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances:
The company plans to manufacture the listed controlled substances as bulk controlled substances intermediates for distribution to its customers.
Any other such applicant, and any person who is presently registered with DEA to manufacture such substances, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a).
Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than January 27, 2012.
By Notice dated June 1, 2011 and published in the
The company plans to manufacture high purity drug standards used for analytical applications only in clinical, toxicological, and forensic laboratories.
No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Alltech Associates, Inc. to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Alltech Associates Inc. to ensure that the company's registration is consistent with the public interest. The investigation has included inspection and testing of the company's physical security systems, verification of the company's compliance with state and local laws, and a review of the company's background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic classes of controlled substances listed.
By Notice dated June 14, 2011, and published in the
The company plans to manufacture the listed controlled substances in bulk for distribution and sale to its customers. Regarding (9640) the company plans to manufacture another controlled substance for sale to its customers.
No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Chattem Chemicals Inc. to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Chattem Chemicals Inc. to ensure that the company's registration is consistent with the public interest. The investigation has included inspection and testing of the company's physical security systems, verification of the company's compliance with state and local laws, and a review of the company's background and history. Therefore, pursuant to 21 U.S.C. 823, and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic classes of controlled substances listed.
By Notice dated June 13, 2011, and published in the
The company plans to manufacture the listed controlled substances in bulk for sale to its customers for formulation into finished pharmaceuticals.
No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Boehringer Ingelheim Chemicals, Inc., to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Boehringer Ingelheim Chemicals, Inc. to ensure that the company's registration is consistent with the public interest. The investigation has included inspection and testing of the company's physical security systems, verification of the company's compliance with state and local laws, and a review of the company's background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic classes of controlled substances listed.
By Notice dated June 22, 2011, and published in the
The company plans to manufacture the listed controlled substance for analytical research and clinical trials.
No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Pharmagra Labs, Inc. to manufacture the listed basic class of controlled substance is consistent with the public interest at this time. DEA has investigated Pharmagra Labs, Inc. to ensure that the
60-day notice of information collection under review.
The Department of Justice, Federal Bureau of Investigation, Criminal Justice Information Services Division (CJIS), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with established review procedures of the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted until January 27, 2012. This process is conducted in accordance with 5 CFR 1320.10.
All comments, suggestions, or questions regarding additional information, to include obtaining a copy of the proposed information collection instrument with instructions, should be directed to Mr. Gregory E. Scarbro, Unit Chief, Federal Bureau of Investigation, CJIS Division, Module E-3, 1000 Custer Hollow Road, Clarksburg, West Virginia 26306, or facsimile to (304) 625-3566.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Comments should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques of other forms of information technology,
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Veterans' Employment and Training Service, Labor.
Notice of open meeting.
This notice sets forth the schedule and proposed agenda of a forthcoming meeting of the Advisory Committee on Veterans' Employment, Training and Employer Outreach (ACVETEO). The ACVETEO will discuss Department of Labor's Veterans' Employment and Training Services' (VETS) core programs and new initiatives regarding efforts that assist veterans seeking employment and raise employer awareness as to the advantages of hiring veterans. There will be an opportunity for persons or organizations to address the committee. Any individual or organization that wishes to do so should contact Mr. Gregory Green (202) 693-4734. Time constraints may limit the number of outside participants/presentations. Individuals who will need accommodations for a disability in order to attend the meeting (i.e., interpreting services, assistive listening devices, and/or materials in alternative format) should notify the Advisory Committee no later than Wednesday, December 7, 2011 by contacting Mr. Gregory Green (202) 693-4734. Requests made after this date will be reviewed, but availability of the requested accommodations cannot be guaranteed. The meeting site is accessible to individuals with disabilities. This notice also describes the functions of the Advisory Committee. Notice of this meeting is required under Section 10(a)(2) of the Federal Advisory Committee Act. This document is intended to notify the general public.
Veterans of Foreign Wars of the United States, 200 Maryland Avenue NE., Washington, DC 20002. ID is required to enter the building.
Ms. Nancy L. Hogan, Designated Federal Official, Advisory Committee on Veterans' Employment, Training and Employer Outreach, (202) 693-4700, or Mr. Gregory Green (202) 693-4734.
ACVETEO is a Congressionally mandated advisory committee authorized under Title 38, U.S. Code, Section 4110 and subject to the Federal Advisory Committee Act (FACA), 5 U.S.C. App. 2, as amended. The ACVETEO is responsible for: Assessing employment and training needs of veterans; determining the extent to which the programs and activities of the U.S. Department of Labor meet these needs; assisting to conduct outreach to employers seeking to hire veterans; making recommendations to the Secretary, through the Assistant Secretary of Labor for Veterans' Employment and Training (VETS), with respect to outreach activities and employment and training needs of veterans; and carrying out such other activities necessary to make required reports and recommendations. The ACVETEO meets at least quarterly.
In accordance with Section 223 of the Trade Act of 1974, as amended (“Act”), 19 U.S.C. 2273, the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance on October 6, 2010, applicable to workers of Whirlpool Corporation, including on-site leased workers from Career Solutions TEC Staffing, Fort Smith, Arkansas. The workers are engaged in the production of refrigerators and trash compactors. The notice was published in the
At the request of a company official, the Department reviewed the certification for workers of the subject firm. The company reports that workers leased from IBM Corporation, TEK Systems, Penske Logistics, Eurest, and Canteen were employed on-site at the Fort Smith, Arkansas location of Whirlpool Corporation. The Department has determined that these workers were sufficiently under the control of Whirlpool Corporation to be considered leased workers.
Based on these findings, the Department is amending this certification to include workers leased from IBM Corporation, TEK Systems, Penske Logistics, Eurest, and Canteen working on-site at the Fort Smith, Arkansas location of Whirlpool Corporation.
The amended notice applicable to TA-W-74,593 is hereby issued as follows:
All workers of Whirlpool Corporation, including on-site leased workers from Career Solutions TEC Staffing, Andrews International, IBM Corporation, TEK Systems, Penske Logistics, Eurest, and Canteen, Fort Smith, Arkansas, who became totally or partially separated from employment on or after October 2, 2010, through October 6, 2012, and all workers in the group threatened with total or partial separation from employment on the date of certification through two years from the date of certification, are eligible to apply for adjustment assistance under Chapter 2 of Title II of the Trade Act of 1974, as amended.
In accordance with section 223 of the Trade Act of 1974, as amended (“Act”), 19 U.S.C. 2273, the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance on June 25, 2010, applicable to workers of Premier Trim, LLC and Spectrum Trim, LLC, d/b/a Spectrum Grant De Mexico, Manufacturing Division, including on-site leased workers from Express Employment Professionals and Select Staff, Brownsville, Texas. The workers are engaged in activities related to the production of wood steering wheels. The notice was published in the
At the request of the State agency, the Department reviewed the certification for workers of the subject firm.
Information shows that as of January 29, 2010, Premier Trim, LLC, Spectrum Trim, LLC and Grant Products International, Inc. have merged and are officially one company under the name of Spectrum Grant de Mexico. Some workers separated from employment at the Brownsville, Texas location of Premier Trim, LLC and Spectrum Trim, LLC and Grant Products International, Inc. d/b/a Spectrum Grant de Mexico had their wages reported under a separate unemployment insurance (UI) tax account under the name Grant Products International, Inc.
Accordingly, the Department is amending this certification to properly reflect this matter.
The intent of the Department's certification is to include all workers of the subject firm who were adversely affected by a shift in the production of wood steering wheels to Mexico.
The amended notice applicable to TA-W-73,681 is hereby issued as follows:
All workers of Premier Trim, LLC, Spectrum Trim, LLC and Grant Products
Petitions have been filed with the Secretary of Labor under Section 221(a) of the Trade Act of 1974 (“the Act”) and are identified in the Appendix to this notice. Upon receipt of these petitions, the Director of the Division of Trade Adjustment Assistance, Employment and Training Administration, has instituted investigations pursuant to Section 221(a) of the Act.
The purpose of each of the investigations is to determine whether the workers are eligible to apply for adjustment assistance under Title II, Chapter 2, of the Act. The investigations will further relate, as appropriate, to the determination of the date on which total or partial separations began or threatened to begin and the subdivision of the firm involved.
The petitioners or any other persons showing a substantial interest in the subject matter of the investigations may request a public hearing, provided such request is filed in writing with the Director, Office of Trade Adjustment Assistance, at the address shown below, not later than December 8, 2011.
Interested persons are invited to submit written comments regarding the subject matter of the investigations to the Director, Office of Trade Adjustment Assistance, at the address shown below, not later than December 8, 2011.
The petitions filed in this case are available for inspection at the Office of the Director, Office of Trade Adjustment Assistance, Employment and Training Administration, U.S. Department of Labor, Room N-5428, 200 Constitution Avenue NW., Washington, DC 20210.
Employment and Training Administration, Labor.
Notice.
The Employment and Training Administration is issuing this notice to announce the receipt of a “Certification of Non-Relocation and Market and Capacity Information Report” (Form 4279-2) for the following:
All interested parties may submit comments in writing no later than December 12, 2011. Copies of adverse comments received will be forwarded to the applicant noted above.
Address all comments concerning this notice to Anthony D. Dais, U.S. Department of Labor, Employment and Training Administration, 200 Constitution Avenue NW., Room S-4231, Washington, DC 20210; or email
Anthony D. Dais, at telephone number (202) 693-2784 (this is not a toll-free number).
Section 188 of the Consolidated Farm and Rural Development Act of 1972, as established under 29 CFR part 75, authorizes the United States Department of Agriculture to make or guarantee loans or grants to finance industrial and business activities in rural areas. The Secretary of Labor must review the application for financial assistance for the purpose of certifying to the Secretary of Agriculture that the assistance is not calculated, or likely, to result in: (a) A transfer of any employment or business activity from one area to another by the loan applicant's business operation; or, (b) An increase in the production of goods, materials, services, or facilities in an area where there is not sufficient demand to employ the efficient capacity of existing competitive enterprises unless the financial assistance will not have an adverse impact on existing competitive enterprises in the area. The Employment and Training Administration within the Department of Labor is responsible for the review and certification process. Comments should address the two bases for certification and, if possible, provide data to assist in the analysis of these issues.
Occupational Safety and Health Administration (OSHA), Labor.
Request for public comments.
OSHA solicits public comments concerning its request for an extension of the Office of Management and Budget's (OMB) approval of the information collection requirements associated with its regulations and program regarding State Plans for the development and enforcement of state occupational safety and health standards (29 CFR Parts 1902, 1952, 1953, 1954, 1955, 1956).
Comments must be submitted (postmarked, sent, or received) by January 27, 2012.
Laura Seeman, Directorate of Cooperative and State Programs, Office of State Programs, Occupational Safety and Health Administration, U.S. Department of Labor, Room N-3700, 200 Constitution Avenue NW, Washington, DC 20210; telephone: (202) 693-2244; email,
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent (i.e., the 27 States with OSHA-approved State Plans) burden, conducts a preclearance consultation program to provide the public with an opportunity to comment on proposed and continuing information collection requirements in accordance with the Paperwork Reduction Act of 1995 (PRA 95) (44 U.S.C. 3506(c)(2)(A)). This program ensures that information is in
• 29 CFR part 1902, State Plans for the Development and Enforcement of State Standards;
• 29 CFR part 1952, Approved State Plans for Enforcement of State Standards;
• 29 CFR part 1953, Changes to State Plans for the Development and Enforcement of State Standards;
• 29 CFR part 1954, Procedures for the Evaluation and Monitoring of Approved State Plans;
• 29 CFR part 1955, Procedures for Withdrawal of Approval of State Plans; and
• 29 CFR part 1956, State Plans for the Development and Enforcement of State Standards Applicable to State and Local Government Employees in States without Approved Private Employee Plans.
Section 18 of the Occupational Safety and Health Act (29 U.S.C. 667) offers an opportunity to the states to assume responsibility for the development and enforcement of state standards through the mechanism of an OSHA-approved State Plan. Absent an approved plan, states are precluded from enforcing occupational safety and health standards in the private sector with respect to any issue for which Federal OSHA has promulgated a standard. Once approved and operational, the state adopts standards and provides most occupational safety and health enforcement and compliance assistance in the state, under the authority of its plan, instead of Federal OSHA. States also must extend their jurisdiction to cover state and local government employees and may obtain approval of State Plans limited in scope to these workers. To obtain and maintain State Plan approval, a state must submit various documents to OSHA describing its program structure and operation, including any modifications thereto as they occur, in accordance with the identified regulations. OSHA funds 50 percent of the costs required to be incurred by an approved State Plan with the state at least matching and providing additional funding at its discretion.
OSHA has a particular interest in comments on the following issues:
• Whether the proposed information collection requirements are necessary for the proper performance of the Agency's functions, including whether the information is useful;
• The accuracy of OSHA's estimate of the burden (time and costs) of the information collection requirements, including the validity of the methodology and assumptions used;
• The quality, utility, and clarity of the information collected; and
• Ways to minimize the burden on participating states who must comply; for example, by using automated or other technological information collection and transmission techniques.
OSHA is requesting that OMB extend its approval of the collection of information requirements associated with its State Plan regulations. In doing so, the Agency is proposing to increase the burden hours from 10,652 to 11,196 hours. The increase is a result of the approval of the Illinois Public Employee Only State Plan, increasing the number of approved State Plan respondents from 26 to 27, and an increase in the projected number of required State Plan responses and modifications as a result of changes in federal procedures. The total number of respondents increased to 28, including the 27 approved State Plans and one state developing a plan to seek State Plan approval. The Agency will summarize the comments submitted in response to this notice and will include this summary in its request to OMB.
You may submit comments in response to this document as follows: (1) Electronically at
Because of security procedures, the use of regular mail may cause a significant delay in the receipt of comments. For information about security procedures concerning the delivery of materials by hand, express delivery, messenger, or courier service, please contact the OSHA Docket Office at (202) 693-2350, (TTY (877) 889-5627).
Comments and submissions are posted without change at
David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506
Copyright Office, Library of Congress.
Notice of objections and specialty station filings; correction.
Periodically, the Copyright Office (“Office”) seeks to update its list of specialty stations related to the use of the cable compulsory license. In response to the publication of an initial list of specialty stations for this purpose in April of this year, the Office received objections filed by the Motion Picture Association of America to the identification of certain stations as being entitled to specialty station status in accordance with the Federal Communications Commission's (“FCC”) definition of specialty station in effect on June 24, 1981. Corrections are being made to the specialty station list published on November 8, 2011.
Ben Golant, Assistant General Counsel, Copyright GC/I&R, P.O. Box 70400, Southwest Station, Washington, DC 20024.
The Office corrects the following errors in the Notice of Objections published in the
• On page 69289, WNYA-CA, Albany, NY was misidentified as WYNA-CA.
• On page 69289, W34DI, Port Jervis, NY was misidentified as W34d1.
• On page 69289, W46DQ, Port Jervis, NY was misidentified as W42DQ.
• On page 69289, W42CX, Port Jervis, NY was missing from the list as a station to which MPAA filed an objection (no evidence of construction or the type of programming broadcast should not be identified as specialty stations)
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation announces the following meeting.
If you plan to attend the meeting, please send an email with your name and affiliation to the individual listed above, by the day before the meeting, so that a visitor badge can be prepared.
Nuclear Regulatory Commission.
Notice of pending NRC action to submit an information collection request to the Office of Management and Budget (OMB) and solicitation of public comment.
The U.S. Nuclear Regulatory Commission (NRC) invites public comment about our intention to request the OMB's approval for renewal of an existing information collection that is summarized below. We are required to publish this notice in the
Information pertaining to the requirement to be submitted:
1.
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3.
4.
5.
6.
7.
Submit, by January 27, 2012, comments that address the following questions:
1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility?
2. Is the burden estimate accurate?
3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?
4. How can the burden of the information collection be minimized,
The public may examine and have copied for a fee publicly available documents, including the draft supporting statement, at the NRC's Public Document Room, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. OMB clearance requests are available at the NRC Web site:
Public comments and supporting materials related to this document can be found at
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Notice of pending NRC action to submit an information collection request to the Office of Management and Budget (OMB) and solicitation of public comment.
The U.S. Nuclear Regulatory Commission (NRC) invites public comment about our intention to request the OMB's approval for renewal of an existing information collection that is summarized below. We are required to publish this notice in the
Information pertaining to the requirement to be submitted:
1.
2.
3.
4.
5.
6.
7.
Submit, by January 27, 2012, comments that address the following questions:
1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility?
2. Is the burden estimate accurate?
3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?
4. How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information technology?
The public may examine and have copied for a fee publicly available documents, including the draft supporting statement, at the NRC's Public Document Room, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. OMB clearance requests are available at the NRC Web site:
The document will be available on the NRC home page site for 60 days after the signature date of this notice. Comments submitted in writing or in electronic form will be made available for public inspection. Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including any information in your submission that you do not want to be publicly disclosed. Comments submitted should reference Docket No. NRC-2011-0263.
Public comments and supporting materials related to this document can be found at
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Notice of pending NRC action to submit an information collection request to the Office of Management and Budget (OMB) and solicitation of public comment.
The U.S. Nuclear Regulatory Commission (NRC) invites public comment about our intention to request the OMB's approval for renewal of an existing information collection that is
Information pertaining to the requirement to be submitted:
1.
2.
3.
4.
5.
6.
7.
Submit, by January 27, 2012, comments that address the following questions:
1. Is the proposed collection of information necessary for the NRC to properly perform its functions?
2. Is the burden estimate accurate?
3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?
4. How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information technology?
The public may examine and have copied for a fee publicly available documents, including the draft supporting statement, at the NRC's Public Document Room, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. OMB clearance requests are available at the NRC Web site:
Public comments and supporting materials related to this document can be found at
Questions about the information collection requirements may be directed to the NRC Clearance Officer, Tremaine Donnell (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, by telephone at (301) 415-6258, or by e-mail to
The application for a license to export high-enriched Uranium has been revised as noted below. Notice of this application was previously published in the
Pursuant to 10 CFR 110.70 (b) “Public Notice of Receipt of an Application,” please take notice that the Nuclear Regulatory Commission (NRC) has received the following request for an export license. Copies of the request are available electronically through ADAMS and can be accessed through the Public Electronic Reading Room (PERR) link
A request for a hearing or petition for leave to intervene may be filed within thirty (30) days after publication of this notice in the
A request for a hearing or petition for leave to intervene may be filed with the NRC electronically in accordance with NRC's E-Filing rule promulgated in August 2007, 72 FR 49139 (Aug. 28, 2007). Information about filing electronically is available on the NRC's public Web site at
In addition to a request for hearing or petition for leave to intervene, written comments, in accordance with 10 CFR 110.81, should be submitted within thirty (30) days after publication of this notice in the
The information concerning this application for an export license follows.
For the Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
This document informs the public that an appeal of the closing of the Witten, South Dakota post office has been filed. It identifies preliminary steps and provides a procedural schedule. Publication of this document will allow the Postal Service, petitioners, and others to take appropriate action.
November 21, 2011: Administrative record due (from Postal Service); December 13, 2011, 4:30 p.m., Eastern Time: Deadline for notices to intervene.
Submit comments electronically by accessing the “Filing Online” link in the banner at the top of the Commission's Web site (
Stephen L. Sharfman, General Counsel, at (202) 789-6820 (case-related information) or
Notice is hereby given that, pursuant to 39 U.S.C. 404(d), the Commission received two petitions for review of the Postal Service's determination to close the Witten post office in Witten, South Dakota. The first petition for review received November 4, 2011, was filed by Mr. & Mrs. Calvin W. Adel. The second petition for review received November 10, 2011, was filed by Cary Long. The earliest postmark date is October 26, 2011. The Commission hereby institutes a proceeding under 39 U.S.C. 404(d)(5) and establishes Docket No. A2012-53 to consider Petitioners' appeal. If Petitioners would like to further explain their position with supplemental information or facts, Petitioners may either file a Participant Statement on PRC Form 61 or file a brief with the Commission no later than December 9, 2011.
After the Postal Service files the administrative record and the Commission reviews it, the Commission may find that there are more legal issues than those set forth above, or that the Postal Service's determination disposes of one or more of those issues. The deadline for the Postal Service to file the applicable administrative record with the Commission is November 21, 2011.
The appeal and all related documents are also available for public inspection in the Commission's docket section. Docket section hours are 8 a.m. to 4:30 p.m., Eastern Time, Monday through Friday, except on Federal government holidays. Docket section personnel may be contacted via electronic mail at
Commission reserves the right to redact personal information which may infringe on an individual's privacy rights from documents filed in this proceeding.
It is ordered:
1. The Postal Service shall file the applicable administrative record regarding this appeal no later than November 21, 2011.
2. Any responsive pleading by the Postal Service to this notice is due no later than November 21, 2011.
3. The procedural schedule listed below is hereby adopted.
4. Pursuant to 39 U.S.C. 505, Tracy Ferguson is designated officer of the Commission (Public Representative) to represent the interests of the general public.
5. The Secretary shall arrange for publication of this notice and order and Procedural Schedule in the
By the Commission.
Pursuant to Section 11A of the Securities Exchange Act of 1934 (“Act”)
The OPRA Plan provides for the collection and dissemination of last sale and quotation information on options that are traded on the participant exchanges. The nine participants to the OPRA Plan are BATS Exchange, Inc., Chicago Board Options Exchange, Incorporated, C2 Options Exchange, Incorporated, International Securities Exchange, LLC, NASDAQ OMX BX Inc., NASDAQ OMX PHLX, Inc., NASDAQ Stock Market LLC, NYSE Amex, Inc., and NYSE Arca, Inc.
The purpose of OPRA's Datafeed Policy is to summarize, in one document, OPRA's definition of the term “datafeed” and a summary of information of interest to any prospective Vendor or Professional Subscriber that will receive a datafeed. OPRA requires that Professional Subscribers that receive OPRA datafeeds pay one of two fees, and requires that certain Vendors that receive OPRA datafeeds also pay a fee. OPRA is not proposing to change the amount of these fees in this filing, but rather to clarify the terms that describe when each of them is payable.
As stated in the Policy, OPRA defines a “datafeed” or “bulk datafeed”
OPRA classifies a datafeed recipient as either a “Vendor” or a “Professional Subscriber.” In either case, the datafeed recipient must enter into a contract directly with OPRA. OPRA classifies a datafeed recipient as a “Vendor” if the datafeed recipient intends to further retransmit the datafeed on an “external” basis, that is, to persons not employed by the datafeed recipient. In this case, the datafeed recipient must sign a “Vendor Agreement” with OPRA. A Vendor that receives an uncontrolled retransmission from another OPRA Vendor is sometimes referred to as a “downstream Vendor,” since it is “downstream” in the dissemination of the OPRA market data from the “upstream” Vendor that is sending the data to it. A Vendor that receives a datafeed directly from OPRA's data processor Securities Industry Automation Corporation (“SIAC”) must pay a monthly “Direct Access Fee” to OPRA.
OPRA classifies a datafeed recipient as a “Professional Subscriber” if the
The Policy describes the steps in the process by which OPRA approves a datafeed and the documentation that OPRA requires for each type of datafeed. For a prospective Vendor, the documentation consists of the Vendor Agreement and OPRA's form “Exhibit A” to the Vendor Agreement that has been completed by the entity. For a prospective Professional Subscriber, the documentation consists of the Professional Subscriber Agreement, one of the Riders described above, and OPRA's form “Exhibit A” to the applicable Rider that has been completed by the entity.
The Policy also describes OPRA' s reporting requirements for datafeed distributors and datafeed recipients. Datafeed distributors are required to report any changes in the datafeeds that they distribute on a monthly basis, and datafeed recipients are required to report with respect to their further distribution and use of OPRA data on a monthly basis.
The text of the proposed amendment to the OPRA Plan is available at OPRA, the Commission's Public Reference Room, on OPRA's Web site at
OPRA designated this amendment as qualified to be put into effect upon filing with the Commission in accordance with clause (i) of paragraph (b)(3) of Rule 608 under the Act.
The Commission may summarily abrogate the amendment within sixty days of its filing and require refiling and approval of the amendment by Commission order pursuant to Rule 608(b)(2) under the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed OPRA Plan amendment is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to amend the NYSE Arca Options Fee Schedule (“Fee Schedule”) to more clearly describe the fees and rebates relating to executed Qualified Contingent Cross (“QCC”) orders. The text of the proposed rule change is available at the Exchange, the Commission's Public Reference Room, and
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend the Fee Schedule to more clearly describe the fees and rebates relating to executed QCC orders. Specifically, the Exchange proposes to memorialize the intent set forth in its rule filing adopting the fee for executed QCC orders, which states that the fees relating to executed QCC orders “will apply to each side of the transaction.”
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were solicited or received with respect to the proposed rule change.
The foregoing rule change is effective upon filing pursuant to Section 19(b)(3)(A)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
Pursuant to Section 11A of the Securities Exchange Act of 1934 (“Act”)
The OPRA Plan provides for the collection and dissemination of last sale and quotation information on options that are traded on the participant exchanges. The nine participants to the OPRA Plan are BATS Exchange, Inc., Chicago Board Options Exchange, Incorporated, C2 Options Exchange, Incorporated, International Securities Exchange, LLC, NASDAQ OMX BX, Inc., NASDAQ OMX PHLX, Inc., NASDAQ Stock Market LLC, NYSE Amex, Inc., and NYSE Arca, Inc.
OPRA's proposed “Policies with respect to Reporting and Usage-based Vendor Fees” (the “Policies”) are comprised of three sections. The first section describes OPRA policies relating to the reports that OPRA requires in order to determine the fees that are payable to OPRA by Vendors' and Professional Subscribers. The second and third sections describe OPRA policies pertaining to “Usage-based Vendor Fees.”
(1)
• The Professional Subscribers to which the Vendor is providing bulk data feeds of OPRA Data (enabling these Professional Subscribers to act as internal distributors).
• The Professional Subscribers that have entered into Professional Subscriber Agreements directly with OPRA and that have devices and/or User IDs entitled by the Vendors.
• The Professional Subscribers to which the Vendor distributes OPRA data and for whose access it pays OPRA usage-based fees (
• The Non-Professional Subscribers to whom the Vendor distributes OPRA data on a “Per Query” or “meter-based” basis and for whose access it pays OPRA usage-based fees.
• The Non-Professional Subscribers to whom the Vendor distributes OPRA data and for whose access it pays OPRA Nonprofessional Subscriber Fees.
• Any voice-synthesized market data service provided by the Vendor.
Also as described in Section 1, OPRA requires that a Professional Subscriber that is an internal distributor report to OPRA with respect to the devices and User IDs that have .been entitled by the Professional Subscriber to have access to OPRA data.
(2)
Paragraph 2(a) states OPRA's policy with respect to a Vendor that wishes to have access to OPRA data other than in connection with its activities as a Vendor—that is, to have access to OPRA
Paragraph 2(b) states OPRA's policy that a Vendor must report with respect to its dissemination of OPRA data to a Professional Subscriber entirely on either a “meter-based” basis (in which case, the Vendor is responsible for paying Usage-based Vendor Fees for its dissemination of OPRA data to the Professional Subscriber) or on a “device-based” basis (in which case, the Professional Subscriber is responsible for paying device-based fees with respect to the Vendor's dissemination of OPRA data to the Professional Subscriber).
The policy described in paragraph 2(c) states that, if a device or User ID is capable of receiving OPRA information from one Vendor for which a Professional Subscriber pays device-based fees and from a second Vendor for which the second Vendor pays usage-based fees, both types of fees must be paid by the respective payors. OPRA has had a longstanding policy—stated in OPRA's “Policies with respect to Device-Based Fees,”
(3)
• The quote meter must be able to recognize and count “quote packets” and/or “options chains”
○ If the Vendor is “capping” the fee payable by the Vendor for any Nonprofessional Subscriber at the monthly maximum amount stated in OPRA's Fee Schedule, the quote meter needs to be able to count usage only up to the maximum amount.
○ If the Vendor is “capping” the fee payable by the Vendor for any Professional Subscriber at the monthly maximum amount stated in OPRA's Fee Schedule, the quote meter needs to be able to count usage only up to the maximum amount.
• The quote meter must not count usage for any Nonprofessional Subscriber for which the Vendor is paying the Nonprofessional Subscriber Fee. (The service to these Nonprofessional Subscribers is not on a usage basis.)
• The quote meter must count usage separately for each option listed in a portfolio format or a market minder service. (For example, quote packets for a portfolio with five options series would constitute five quote packets.)
• The quote meter must count all “current” OPRA market data (
A Vendor's quote counting system must be able to comply with these requirements if the system is to be able to count quotes in a manner that results in an accurate determination of the Usage-based Vendor Fees that the Vendor owes to OPRA. Section 3 of the Policies provides a more accurate description of these requirements than OPRA's current policy entitled “Auditing” does.
The text of the proposed amendment to the OPRA Plan is available at OPRA, the Commission's Public Reference Room, on OPRA's Web site at
OPRA designated this amendment as qualified to be put into effect upon filing with the Commission in accordance with clause (i) of paragraph (b)(3) of Rule 608 under the Act.
The Commission may summarily abrogate the amendment within sixty days of its filing and require refiling and approval of the amendment by Commission order pursuant to Rule 608(b)(2) under the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed OPRA Plan amendment is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to adopt Rule 8.12A
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
On November 7, 2011, the Exchange filed to adopt a Quote Risk Monitor (QRM) rule.
C2 Rules require Market-Makers to maintain continuous electronic quotes.
A Market-Maker's risk in an options class is not limited to the risk in a single series of that class. Rather, a Market-Maker typically is active in quoting in multiple option classes, and each such option class can comprise dozens of individual option series. On C2, trades are automatically effected against a Market-Maker's then current quote. As a result, a Market-Maker faces exposure in all series of a class, requiring that the Market-Maker off-set or otherwise hedge its overall position in a class. The QRM functionality helps Market-Makers limit this overall exposure and risk. Specifically, the functionality permits a Market-Maker to establish parameters in the system to cancel its electronic quotes in all series of an option class until the Market-Maker refreshes those electronic quotes.
Under proposed Rule 8.12A, each Market-Maker that elects to use the functionality would be required to specify two parameters that the QRM Mechanism would use to determine when that Market-Maker's quotes should be cancelled. In particular, each Market-Maker is required to specify a maximum number of contracts for each option class (the “Contract Limit”) and a rolling time period in seconds during which such Contract Limit is to be measured (the “Measurement Interval”).
When the QRM Mechanism determines that the Market-Maker has traded more than the Contract Limit for any option class during any rolling Measurement Interval, the QRM Mechanism automatically cancels all of the Market-Maker's quotes in any series of that option class. By limiting its exposure across series, a Market-Maker is better able to quote aggressively in an option, knowing that the QRM
The Exchange notes that the proposed rule would not relieve a Market-Maker of its obligations to provide continuous electronic quotes under the Exchange rules
The basis under the Securities Exchange Act of 1934 (the “Act”) for this proposed rule change is the requirement under Section 6(b)(5)
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange neither solicited nor received comments on the proposal.
Because the proposed rule change: (i) Does not significantly affect the protection of investors or the public interest; (ii) does not impose any significant burden on competition; and (iii) does not become operative for 30 days after the date of the filing, or such shorter time as the Commission may designate if consistent with the protection of investors and the public interest, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act
The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest. Waiver of the operative delay will allow market makers to continue to use the QRM to manage risk associated with providing continuous quotes across a multitude of series and classes and thereby avoid a potentially adverse effect on the C2 market. For these reasons, the Commission designates that the proposed rule change become operative immediately upon filing.
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 11A of the Securities Exchange Act of 1934 (“Act”)
The OPRA Plan provides for the collection and dissemination of last sale and quotation information on options that are traded on the participant exchanges. The nine participants to the OPRA Plan are BATS Exchange, Inc., Chicago Board Options Exchange, Incorporated, C2 Options Exchange, Incorporated, International Securities Exchange, LLC, NASDAQ OMX BX, Inc., NASDAQ OMX PHLX, Inc., NASDAQ Stock Market LLC, NYSE Amex, Inc., and NYSE Arca, Inc.
The purpose of OPRA's Policy with respect to Disaster Recovery Facilities is to address the fees that are payable to OPRA for a disaster recovery facility (a “DR facility”) maintained by an OPRA Vendor or Professional Subscriber.
The Policy states that a Vendor or Professional Subscriber that operates a DR facility at which it needs to have access to OPRA data should be certain that its agreements with OPRA accommodate the DR facility. The Policy states that, if a Vendor or Professional Subscriber operates multiple sites that act as “hot” back-up sites for each other, OPRA will consider the sites not to be DR facilities.
The Policy states that, if a Vendor is operating a DR facility and uses OPRA data at the site for purposes solely associated with operating the DR facility in furtherance of the Vendor's activities as a Vendor, OPRA does not charge fees specifically for the DR facility, with one exception: If the Vendor has a live direct circuit connection to receive OPRA data from OPRA's processor at the DR facility, OPRA's Direct Access Fee is applicable.
With respect to a Professional Subscriber, the Policy states that OPRA's standard Device-Based Fees will be applicable if a Professional Subscriber is operating a DR facility and has devices that are enabled to receive current OPRA data at the facility even when the site is not in actual use, but that these fees will not be applicable if devices at the site are not enabled to receive current OPRA data when the site is inactive. The Policy states that OPRA would not consider a device to be subject to fees if the device is temporarily enabled for current OPRA data solely for testing purposes. The Policy states that, as is the case for a Vendor that has a live direct circuit connection at its DR facility, if a Professional Subscriber has a live direct circuit connection at its DR facility, OPRA's Direct Access Fee will be applicable. Finally, the Policy states that, if devices at a DR facility are enabled to receive current OPRA data during an emergency, those devices will become fee-liable, but that OPRA will provide offsetting credits for devices that are unable to receive current OPRA data at the affected primary site as reasonably demonstrated by the Professional Subscriber to be appropriate in the circumstances.
The text of the proposed amendment to the OPRA Plan is available at OPRA, the Commission's Public Reference Room, on OPRA's Web site at
OPRA designated this amendment as qualified to be put into effect upon filing with the Commission in accordance with clause (i) of paragraph (b)(3) of Rule 608 under the Act.
The Commission may summarily abrogate the amendment within sixty days of its filing and require refiling and approval of the amendment by Commission order pursuant to Rule 608(b)(2) under the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed OPRA Plan amendment is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Virginia (FEMA-4045-DR), dated 11/17/2011.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the President's major disaster declaration on 11/17/2011, Private Non-Profit organizations that provide essential services of governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 12934B and for economic injury is 12935B.
U.S. Small Business Administration.
Amendment 3.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Pennsylvania (FEMA—4030—DR), dated 10/07/2011.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of Pennsylvania, dated 10/07/2011, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
The Social Security Administration (SSA) publishes a list of information collection packages requiring clearance by the Office of Management and Budget (OMB) in compliance with Public Law (Pub. L.) 104-13, the Paperwork Reduction Act of 1995, effective October 1, 1995. This notice includes revisions of OMB-approved information collections and new information collections.
SSA is soliciting comments on the accuracy of the agency's burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; and ways to minimize burden on respondents, including the use of automated collection techniques or other forms of information technology. Mail, email, or fax your comments and recommendations on the information collection(s) to the OMB Desk Officer and SSA Reports Clearance Officer at the following addresses or fax numbers.
Office of Management and Budget,
Social Security Administration, DCRDP,
I. The information collection below is pending at SSA. SSA will submit it to OMB within 60 days from the date of this notice. To be sure we consider your comments, we must receive them no later than January 27, 2012. Individuals can obtain copies of the collection instrument by calling the SSA Reports Clearance Officer at (410) 965-8783 or by writing to the above email address.
II. SSA submitted the information collections below to OMB for clearance. Your comments regarding the information collections would be most useful if OMB and SSA receive them within 30 days from the date of this publication. To be sure we consider your comments, we must receive them no later than December 28, 2011. Individuals can obtain copies of the OMB clearance packages by calling the SSA Reports Clearance Officer at (410) 965-8783 or by writing to the above email address.
1.
Because SSA employees are Federal workers exempt from the requirements of the PRA, the burden below is only for SSA contractors.
2.
3.
Notice of request for public comments.
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. The purpose of this notice is to allow 60 days for public comment in the
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The Department will accept comments from the public up to 60 days from November 28, 2011.
You may submit comments identified by any of the following methods:
• Persons with access to the Internet may view and comment on this notice by going to the regulations.gov Web site at
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You must include the DS form number (if applicable), information collection title, and OMB control number in any correspondence.
Rick A. Ruth, Deputy Assistant Secretary, Acting, for Private Sector Exchange, U.S. Department of State, SA-5, Floor 5, 2200 C Street NW., Washington, DC 20522-0505; or email at
We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the effective administration of the Summer Work Travel category of the Exchange Visitor Program.
• Evaluate the accuracy of our estimate of the burden of the proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of technology.
This collection of information is needed by the Bureau of Educational and Cultural Affairs in administering the Exchange Visitor Program (J-Visa) under the provisions of the Mutual Educational and Cultural Exchange Act, as amended. Summer Work Travel Job Placement Verification Forms are to be completed by designated program sponsors. A Job Placement Verification Form is required for each Summer Work Travel participant. It will set forth the employer, address of employment site, duties required by the job, whether the Summer Work Travel participant will receive any remuneration for housing and living expenses (and if so, the amount), and estimates of the living expenses and other costs the participants are likely to incur while in the United States. The Form must be signed by the participant, the sponsor, and the third party employer, if a third party organization is used in the conduct of the Summer Work Travel program.
Upon request, Summer Work Travel applicants must present fully executed Job Placement Verification Forms (Form DS-7007) to any Consular Official interviewing them in connection with the issuance of J-1 visas.
The collection will be submitted to the Department by mail or fax as requested by the Department of State during the review of program sponsor files, re-designations, incidents, etc.
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).
Notice of RTCA Special Committee 223 Airport Surface Wireless Communications Eleventh Meeting.
The FAA is issuing this notice to advise the public of a meeting of
The meeting will be held December 6-7th, 2011, from 9 a.m.-5 p.m.
The meeting will be held at Booz Allen Hamilton, 1201 Maryland Avenue SW., Suite 5121B, Washington, DC 20024
The RTCA Secretariat, 1150 18th Street NW., Suite 910, Washington, DC, 20036, or by telephone at (202) 833-9339, fax at (202) 833-9434, or Web site at
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given for a Special Committee 223, Airport Surface Wireless Communications Meeting. The agenda will include the following:
Attendance is open to the interested public but limited to space availability. With the approval of the chairman, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Announcement of Railroad Safety Advisory Committee (RSAC) Working Group activities.
The FRA is updating its announcement of RSAC's Working Group activities to reflect its current status.
Larry Woolverton, RSAC Designated Federal Officer/Administrative Officer, FRA, 1200 New Jersey Avenue SE., Mailstop 25, Washington, DC 20590, (202) 493-6212; or Robert Lauby, Deputy Associate Administrator for Regulatory and Legislative Operations, FRA, 1200 New Jersey Avenue SE., Mailstop 25, Washington, DC 20590, (202) 493-6474.
This notice serves to update FRA's last announcement of working group activities and status reports of December 7, 2010 (75 FR 76070). The 44th full RSAC meeting was held May 20, 2011, and the 45th meeting is scheduled for December 8, 2011, at the National Association of Home Builders, National Housing Center, located at 1201 15th Street NW., Washington, DC 20005.
Since its first meeting in April of 1996, the RSAC has accepted 36 tasks. Status for each of the open tasks (neither completed nor terminated) is provided below:
Engineering Task Force. The Passenger Safety Working Group approved a request from FRA to establish an ETF under the Passenger Safety Working Group in August 2009. The mission of the task force is to produce a set of technical evaluation criteria and procedures for passenger rail equipment built to alternative designs. The technical evaluation criteria and procedures would provide a means of establishing whether an alternative design would result in performance at least equal to the structural design standards set forth in the Passenger Equipment Safety Standards (Title 49 Code of Federal Regulations (CFR) part 238). The initial focus of this effort will be on Tier I standards. When completed, the criteria and procedures would form a technical basis for making determinations concerning equivalent safety pursuant to 49 CFR Section 238.201, and provide a technical framework for presenting evidence to FRA in support of any request for waiver of the compressive (buff) strength requirement, as set forth in 49 CFR 238.203.
Engineering Task Force II. To build on the success of the ETF in developing a set of alternative technical criteria and procedures for evaluating the crashworthiness and occupant protection performance of passenger rail equipment in service at conventional operating speeds, the FRA requested that the Passenger Safety Working Group re-task the group to concentrate on developing crashworthiness and occupant protection safety recommendations for high-speed passenger trains. The Passenger Safety Working Group accepted the task on July 28, 2010, by electronic vote. Under the new task, the task force may address any safety features of the equipment, including but not limited to crashworthiness, interior occupant protection, glazing, emergency egress, and fire safety features. Any type of equipment may be addressed, including conventional locomotives, high-speed power cars, cab cars, multiple-unit (MU) locomotives, and coach cars. The equipment addressed may be used in any type of passenger service, from conventional-speed to high-speed. Recommendations may take the form of criteria and procedures, revisions to existing regulations, or adoption of new regulations, including rules of particular applicability. The work of the re-tasked ETF is intended to assist FRA in developing appropriate safety standards for the high-speed rail projects planned for California. The Engineering Task Force II held a kickoff meeting on October 21-22, 2010, to begin work on the new high-speed task, and had follow-on meetings on January 11-12, 2011, February 14-15 2011, March 30-31, 2011, and June 16-17, 2011. Consensus Tier III recommendations of the ETF have been developed and were accepted by vote during a scheduled meeting on October 6-7, 2011. The ETF II has formed two additional Task Groups to work in the areas of track worthiness and brakes. The Track worthiness Task Group is tasked to identify potential safety issues related to operation of high-speed train sets on conventional track and to make recommendations on how best to mitigate any consequences. The Task Group includes experts and key stakeholders such as international operators of high-speed equipment, car builders, wheel/rail interaction dynamics specialists, and other RSAC working group members involved in vehicle/track interaction. The Brakes Task Group is tasked to review braking system requirements and international braking system requirements verses existing U.S. requirements including inspection and maintenance and identify common features, determine basic parameters and consider use of service proven braking systems. The Task Group will also consider performance based provisions/requirements with consideration for operator's to develop maintenance, inspection, and service plans and make recommendations regarding brakes to the ETF II as related to Tier III. Contact: Robert Lauby, (202) 493-6474.
Emergency Preparedness Task Force. At the working group meeting on March 9-10, 2005, the working group received and approved the consensus report of the Emergency Preparedness Task Force related to emergency communication, emergency egress, and rescue access. These recommendations were presented to and approved by the full RSAC on May 18, 2005. The working group met on September 7-8, 2005, and additional, supplementary recommendations were presented to and accepted by the full RSAC on October 11, 2005. The Notice of Proposed Rulemaking (NPRM) was published on August 24, 2006 (71 FR 50275), and was open for comment until October 23, 2006. The working group agreed upon recommendations for the final rule, including resolution of final comments received, during the April 17-18, 2007, meeting. The recommendations were presented to and approved by the full RSAC on June 26, 2007. The Passenger Train Emergency Systems final rule, focusing on emergency communication, emergency egress, and rescue access, was published on February 1, 2008 (73 FR 6370). The task force met on October 17-18, 2007, and reached consensus on the draft rule text for a followup NPRM on Passenger Train Emergency Systems, focusing on low location emergency exit path marking, emergency lighting, and emergency signage. The task force presented the draft rule text to the Passenger Safety Working Group on December 11-12, 2007, and the consensus draft rule text was presented to, and approved by full RSAC vote during the February 20, 2008, meeting. During the May 13-14, 2008, meeting, the task force recommended clarifying the applicability of back-up emergency communication system requirements in the February 1, 2008, final rule, and FRA announced its intention to exercise limited enforcement discretion for a new provision amending instruction requirements for emergency window exit removal. The working group ratified these recommendations on June 19, 2008. The task force met again on March 31, 2009, to clarify issues related to the followup NPRM raised by members. The modified rule text was presented to and approved by the Passenger Safety Working Group on June 8, 2009. The working group requested that FRA draft
Mechanical Task Force—Completed. Initial recommendations on mechanical issues (revisions to 49 CFR Part 238) were approved by the full RSAC on January 26, 2005. At the working group meeting of September 7-8, 2005, the task force presented additional perfecting amendments and the full RSAC approved them on October 11, 2005. An NPRM was published in the
Crashworthiness Task Force—Completed. Among its efforts, the Crashworthiness Task Force provided consensus recommendations on static-end strength that were adopted by the working group on September 7-8, 2005. The full RSAC accepted the recommendations on October 11, 2005. The front-end strength of cab cars and MU locomotives NPRM was published in the
Vehicle/Track Interaction Task Force. The task force is developing proposed revisions to 49 CFR Parts 213 and 238, principally regarding high-speed passenger service. The task force met on October 9-11, 2007, and again on November 19-20, 2007, in Washington, DC, and presented the final task force report and final recommendations and proposed rule text for approval by the Passenger Safety Working Group at the December 11-12, 2007, meeting. The final report and the proposed rule text were approved by the working group and were presented to and approved by full RSAC vote during the February 20, 2008, meeting. The group met on February 27-28, 2008, and by teleconference on March 18, 2010, to address unresolved issues, and the NPRM was published on May 10, 2010 (75 FR 25928). The task force was called back into session on August 5-6, 2010, to review and consider NPRM comments. The final rule will amend the Track Safety Standards and Passenger Equipment Safety Standards for high-speed train operations and train operations at high cant deficiencies to promote the safe interaction of rail vehicles with the track over which they operate. It will revise both the safety limits for these operations and the process to qualify them. It accounts for a range of vehicle types that are currently used and may likely be used on future high-speed or high cant deficiency rail operations, and would provide safety assurance for train operations in all classes of track. It is based on the results of simulation studies designed to identify track geometry irregularities associated with unsafe wheel forces and acceleration, thorough reviews of vehicle qualification and revenue service test data, and consideration of international practices. The draft final rule was sent to the task force for final consensus on November 11, 2011. The target date set for the final rule is April 2012. Contact: John Mardente, (202) 493-1335.
General Passenger Safety Task Force. At the Passenger Safety Working Group meeting on April 17-18, 2007, the task force presented a progress report to the working group. The task force met on July 18-19, 2007, and afterwards it reported proposed reporting cause codes for injuries involving the platform gap, which were approved by the Working Group by mail ballot in September 2007. The full RSAC approved the recommendations for changes to 49 CFR Part 225 accident/incident cause codes on October 25, 2007. The General Passenger Safety Task Force presented draft guidance material for management of the gap that was considered and approved by the Working Group during the December 11-12, 2007, meeting and was presented to and approved by full RSAC vote during the February 20, 2008, meeting. The group met April 23-24, 2008, December 3-4, 2008, April 21-23, 2009, October 7-8, 2009, and July 30, 2010 by GoTo/Webinar teleconference. The task force continues work on passenger train door securement, “second train in station,” trespasser incidents, and System Safety-based solutions by developing a regulatory approach to System Safety. The task force has created two task groups to focus on these issues.
The Door Safety Task Group has reached consensus on 47 out of 48 safety issues and had five items that have been remanded to the task force for vote. The issues are addressed in the area of passenger train door mechanical and operational requirements and presented draft regulatory language to the Passenger Safety Working Group at the September 16, 2010, meeting. More work remains to ensure the 49 CFR Part 238 door rule consensus document and the proposed American Public Transit Association (APTA) door standard (APTA SS-M-18-10) use uniform language. The document was approved by the Passenger Safety Working Group by electronic vote on March 31, 2011, and approved by the RSAC on May 20, 2011. This rulemaking would amend the passenger equipment safety standards to enhance safety standards as they relate to passenger door securement while a passenger train is in service based on research and experiences of FRA safety inspectors. Specifically, FRA would incorporate by reference APTA standard: “APTA SS-M-18-10 Standard for Powered Exterior Side Door System Design for New Passenger Cars.” A draft NPRM is currently under development with a target publication date of May 2012. No additional Door Task Group meetings are currently scheduled. Contact: Brian Hontz, (610) 521-8220.
The System Safety Task Group has produced draft regulatory language for a System Safety Rule, but further work on this rulemaking is delayed until a study of legal protections for Risk Reduction Program (RRP) and System Safety Program (SSP) risk analysis data that is required by the RSIA is complete. The legal study is expected to be complete by December 2012. The System Safety rulemaking would improve passenger railroad safety through structured, proactive processes and procedures developed by passenger railroad operators. It would require passenger railroads to establish an SSP that would systematically evaluate and manage risks in order to reduce the number and rates of railroad accidents, incidents, injuries, and fatalities. The target date
Physicians Task Force. A Physicians Task Force was established by the working group in May 2007, and tasked to draft recommended medical qualification criteria and protocols for locomotive engineers and conductors. The Physicians Task Force has had meetings or conference calls on July 24, 2007; August 20, 2007; October 15, 2007; October 31, 2007; June 23-24, 2008; September 8-10, 2008; October 8, 2008; November 12-13, 2008; December 8-10, 2008; January 27-28, 2009; February 24-25, 2009; March 11-12, 2009; March 31-April 1, 2009; April 15, 2009; April 22, 2009; May 13, 2009; May 20, 2009; June 17, 2009; January 21-22, 2010; March 3, 2010; August 16-17, 2010; and October 25-26, 2010; December 17, 2010; January 11, 2011; March 3-4, 2011; May 16-17, 2011; August 18, 2011; August 25, 2011; August 31, 2011. On September 1, 2011, the task force notified working group members that it had made significant progress in completing its task and requested that the working group participate in clarifying a limited number of remaining operational issues relevant to the task that merited review by industry management, labor, and other stakeholders. No further meetings of the Physicians Task Force are currently scheduled. Contact: Dr. Bernard Arseneau, (202) 493-6002.
Critical Incident Task Force. The Medical Standards Working Group accepted RSAC Task 2009-02, Critical Incident Response, during the December 8-9, 2010, meeting. The working group has been tasked to provide advice regarding development of implementing regulations for critical incident stress plans as required by the RSIA. A Critical Incident Task Force was established by the working group during the May 24-26, 2010, Medical Standards Working Group meeting. The scheduled kickoff meeting for the Critical Incident Task Force scheduled for September 2, 2010, was postponed at the request of industry participants. In late March 2011, FRA leadership decided to request that the RSAC be asked to amend the Critical Incident task statement to remove reference to the Medical Standards Working Group and to allow the group to assume full working group status to expedite the work. The Committee approved the revised task statement with a target date for recommendations to the Committee of December 2011 and the task force transitioned to the Critical Incident Working Group. (See Critical Incident Working Group entry.) Contact: Dr. Bernard Arseneau, (202) 493-6002.
PTC Implementation Plan Task Force. A task force was formed to assist FRA in developing a model template for a successful PTC Implementation Plan (PTCIP), and in development of an example associated Risk Prioritization Methodology. PTCIPs are required to be submitted by April 16, 2010, under the mandate of the RSIA. FRA posted a final version of a PTCIP template and an example risk prioritization methodology model for prioritization of line segment implementation to the FRA public Web site on January 12, 2010, the same day the final rule was made available for public review. No further meetings of this task force are currently scheduled. Contact: Tom McFarlin, (202) 493-6203.
PTC Risk Evaluation Task Force. The creation of the PTC Risk Evaluation Task Force was approved by the PTC Working Group on April 1, 2010, to develop a computer model to estimate the risk of PTC-preventable accidents on a line segment basis. The group was formed by nominations from members of the PTC Working Group and the kickoff meeting was held via GoTo/Webinar on June 17, 2010. A followup meeting was held on August 3, 2010, and an additional followup GoTo/Webinar meeting was held on September 7, 2010. No additional meetings are scheduled at this time. Contact: Mark Hartong, (202) 493-1332.
Please refer to the notice published in the
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before December 28, 2011.
Comments should refer to docket number MARAD-2011-0152. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Joann Spittle, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W21-203, Washington, DC 20590. Telephone (202) 366-5979, Email
As described by the applicant the intended service of the vessel DAUNTLESS is:
The complete application is given in DOT docket MARAD-2011-0152 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
National Highway Traffic Safety Administration, DOT.
Notice of Petition Grant.
JCA Corporation (JCA)
Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing rule at 49 CFR part 556), JCA has petitioned for an exemption from the notification and remedy requirements of 49 U.S.C. Chapter 301 on the basis that this noncompliance is inconsequential to motor vehicle safety.
Notice of receipt of JCA's petition was published, with a 30-day public comment period, on November 9, 2010, in the
For further information on this decision, contact Mr. George Gillespie, Office of Vehicle Safety Compliance, the National Highway Traffic Safety Administration (NHTSA), telephone (202) 366-5299, facsimile (202) 366-7002.
JCA estimates that approximately 899,804 Trail America brand Special Trailer “ST” tires that were
JCA states that the noncompliance is that the maximum single load labeling and maximum inflation pressures on the sidewalls of the tires are in English units of “lb” and “psi” only; no Metric units are included as required by paragraph S6.5(d) of FMVSS No. 119.
JCA explained that no property damage or accidents have been reported to it or its customers as a result of the subject noncompliance.
JCA further explains that it has taken steps to correct the noncompliance in future production.
JCA also states that it believes the noncompliance is inconsequential to motor vehicle safety because the affected tires fulfill all other relevant requirements of FMVSS No. 119.
In summation, JCA believes that the described noncompliance is inconsequential to motor vehicle safety, and that its petition, to exempt it from providing recall notification of noncompliance as required by 49 U.S.C. 30118 and remedying the recall noncompliance as required by 49 U.S.C. 30120, should be granted.
While the correct tire inflation pressure is included on the subject tire sidewalls, it is not marked in both English and Metric unit systems on each sidewall as required by S6.5(d). However, because the tire inflation pressure is available and stated correctly on each tire in English units, it is unlikely that a consumer will not find or will misread pressure units due to the noncompliance. Therefore, the tires, as labeled, are likely to achieve the safety purpose of the standard. In the agency's judgment, the subject incorrect labeling of the tire inflation pressure information will have an inconsequential effect on motor vehicle safety.
NHTSA notes that the statutory provisions (49 U.S.C. 30118 (d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, this decision only applies to the 899,804
In consideration of the foregoing, NHTSA has decided that JCA has met its burden of persuasion that the subject FMVSS No. 119 labeling noncompliances are inconsequential to motor vehicle safety. Accordingly, JCA's petition is granted and the petitioner is exempted from the obligation of providing notification of, and a remedy for, the subject noncompliance under 49 U.S.C. 30118 and 30120.
(49 U.S.C. 30118, 30120: delegations of authority at CFR 1.50 and 501.8)
National Highway Traffic Safety Administration, DOT.
Notice of Petition Grant.
General Motors, LLC (GM),
Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing rule at 49 CFR part 556), GM has petitioned for an exemption from the notification and remedy requirements of 49 U.S.C. Chapter 301 on the basis that this noncompliance is inconsequential to motor vehicle safety.
Notice of receipt of GM's petition was published, with a 30-day public comment period, on October 21, 2010, in the
GM described the noncompliance as the absence of the required transmission shift position display for a certain ignition key cylinder position. GM explained that while the key is in the ignition there is a narrow ignition key cylinder position between the “ACC” and “OFF” positions within which the transmission shift lever can be moved and the indicator light that illuminates the transmission shift position display is inoperative. The Company added that this noncompliance only occurs when the engine is not running.
GM additionally stated that in all other ignition activation and operation positions, all of the subject vehicles comply with paragraph S3.1.4.1 of FMVSS No. 102.
GM argued its belief that the subject noncompliance is inconsequential to motor vehicle safety because:
As NHTSA recognized in proposing the standard (53 FR 32409-32411 (August 25, 1988)), the purpose of the display requirement for PRNDM information is to “provide the driver with transmission position information for the vehicle conditions where such information can reduce the likelihood of shifting errors.” Thus, in all but the rarest circumstances, the primary function of the PRNDM display is to inform the driver of gear selection and
With the exception of the absence of the required transmission shift position display for one narrow ignition key cylinder position, the system meets all other applicable requirements of FMVSS No. 102.
GM has no record of any incidents, injuries, owner complaints or field reports related to this noncompliance. GM added that if a customer reports this problem to them and requests a remedy, the Company will replace the ignition switch with a conforming component.
Since this noncompliance only occurs during an atypical operation, the noncompliance is not likely to occur under normal driving conditions. The only circumstance where the noncompliance would appear is if the ignition switch is in the intermediary position between the “OFF” and “ACC” detent positions prior to the interlock. In order for this condition to be present, a driver would have to first move the transmission control to “PARK.” In such a case, there are two possible scenarios for the driver: 1) leaving the vehicle with the key in the ignition or 2) remaining in the vehicle. GM provides the following analysis for both scenarios:
1. The driver exits the vehicle while leaving the key in the ignition:
If the driver attempted to remove the key before exiting the vehicle, the key would not be capable of removal. The doors may also still be locked if they are in the factory default setting to unlock in the “PARK” position.
As required by S5.1.3 of FMVSS No. 114, GM provides an audible warning to the driver that activates whenever the key has been left in the ignition locking system and the driver's door is opened.
The Owner's Manual supplied with the vehicle provides specific warnings and instructions on ensuring the vehicle is in “PARK” and the key is removed before exiting the vehicle.
2. The driver remains in the vehicle:
If the driver remains in the vehicle, he or she would likely either restart the vehicle's engine or attempt to remove the key to exit the vehicle.
If the driver attempts to restart the engine, paragraph S3.1.3 of FMVSS No. 102 requires that the starter be inoperative whenever the vehicle's transmission shift position is in a forward or reverse drive position. The driver rotating the ignition switch forward attempting to start the engine will definitely activate the PRNDM display. Therefore, the PRNDM information will be available to the driver who can see that the vehicle did not start because the transmission was not in “Park” or “Neutral.”
GM says that because both of these situations are addressed by FMVSS requirements, a lack of a transmission shift position display in either of these cases may constitute a minor inconvenience, but will have no consequence to safety. In addition, GM stated that NHTSA has previously granted similar petitions on 3 occasions.
Furthermore, GM also stated the following:
GM recognizes that there may be isolated non-driving situations in which a person may desire to know gear selection or the relative position of the gears with the engine off, such as when placing the vehicle in tow. However, these cases occur infrequently and do not occur during normal ignition activation and vehicle operation. If the subject condition [noncompliance] is present during these infrequent non-driving situations when PRNDM information may be desired, gear selection and relative positioning can easily be determined by rotating the ignition switch slightly clockwise past the accessory “ACC” detent to activate the shift indicator display without starting the vehicle's engine. Given the nature of these non-driving situations and since the information can be readily obtained with a slight key rotation, GM believes that the subject condition [noncompliance] will have no real or implied degradation of motor vehicle safety.
GM also indicated that it has corrected the problem that caused the subject noncompliance so that it cannot reoccur in future production.
In view of the above, GM believes that the described noncompliance is inconsequential and does not present a risk to motor vehicle safety. Thus, GM requests that its petition, to exempt it from providing recall notification of noncompliance as required by 49 U.S.C. 30118 and remedying the recall noncompliance as required by 49 U.S.C. 30120, should be granted.
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, this decision only applies to the 462,227
In consideration of the foregoing, NHTSA has decided that GM has met its burden of persuasion that the subject FMVSS No. 102 noncompliance is inconsequential to motor vehicle safety. Accordingly, GM's petition is granted and the petitioner is exempted from the obligation of providing notification of, and a remedy for, the subject noncompliance under 49 U.S.C. 30118 and 30120.
(49 U.S.C. 30118, 30120: delegations of authority at CFR 1.50 and 501.8)
National Highway Traffic Safety Administration, DOT.
Grant of Petition for Decision of Inconsequential Noncompliance.
Goodyear Tire and Rubber Company, (Goodyear),
Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing rule at 49 CFR part 556), Goodyear has petitioned for an exemption from the notification and remedy requirements of 49 U.S.C. Chapter 301 on the basis that this noncompliance is inconsequential to motor vehicle safety.
Notice of receipt of Goodyear's petition was published, with a 30-day public comment period, on June 25, 2010, in the
For further information on this decision, contact Mr. George Gillespie, Office of Vehicle Safety Compliance, the National Highway Traffic Safety Administration (NHTSA), telephone (202) 366-5299, facsimile (202) 366-7002.
Affected are approximately 14,826 sizes P195/55R15 84V and P225/60R16 97H Goodyear brand Arizonian Silver Edition Plus model passenger car tires manufactured between August of 2007 and May of 2009 at Goodyear's plant located in Otrokovice, Czech Republic.
Goodyear explains that the noncompliance is that, due to a mold labeling error, the sidewall marking on the reference side of the tires incorrectly describes the actual number of plies in the tread area of the tires as required by paragraph S5.5(f). Specifically, the tires in question were inadvertently manufactured with “Tread Plies: 2 Polyester + 2 steel.” The labeling should have been “Tread Plies: 2 Polyester + 1 polyamide + 2 steel.
Goodyear also explains that while the non-compliant tires are mislabeled “the tires meet or exceed all applicable Federal Motor Vehicle Safety Standards.”
Goodyear argues that this noncompliance is inconsequential to motor vehicle safety because the noncompliant sidewall marking does not create an unsafe condition and all other labeling requirements have been met.
Goodyear points out that NHTSA has previously granted similar petitions for noncompliances in sidewall marking.
Goodyear additionally states that it has corrected the affected tire molds and all future production will have the correct material shown on the sidewall.
In summation, Goodyear believes that the described noncompliance of its tires to meet the requirements of FMVSS No. 139 is inconsequential to motor vehicle safety, and that its petition, to exempt from providing recall notification of noncompliance as required by 49 U.S.C. 30118 and remedying the recall noncompliance as required by 49 U.S.C. 30120, and should be granted.
The agency also believes the noncompliance will have no measurable effect on the safety of the tire retread, repair, and recycling industries. The use of steel cord construction in the sidewall and tread is the primary safety concern of these industries. In this case, since the tire sidewalls do not contain steel plies, this potential safety concern does not exist.
NHTSA notes that the statutory provisions (49 U.S.C. 30118 (d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, this decision only applies to the 14,826
In consideration of the foregoing, NHTSA has decided that Goodyear has met its burden of persuasion that the subject FMVSS No. 139 labeling noncompliances are inconsequential to motor vehicle safety. Accordingly, Goodyear's petition is granted and the petitioner is exempted from the obligation of providing notification of, and a remedy for, the subject noncompliance under 49 U.S.C. 30118 and 30120.
(49 U.S.C. 30118, 30120: Delegations of authority at CFR 1.50 and 501.8).
National Highway Traffic Safety Administration (NHTSA), Department of Transportation.
Request for comments on technical report.
This notice announces NHTSA's publication of a technical report describing relationships between a vehicle's mass, footprint (size), and body type and its rate of involvement in fatal crashes. The report's title is:
Comments must be received no later than January 27, 2012.
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You may call Docket Management at (202) 366-9826.
Charles J. Kahane, Chief, Evaluation Division, NVS-431, National Center for Statistics and Analysis, National Highway Traffic Safety Administration, Room W53-312, 1200 New Jersey Avenue SE., Washington, DC 20590.
Mass reduction while holding a vehicle's footprint (size) constant is a potential strategy for meeting footprint-based CAFE and GHG standards. An important corollary issue is the possible effect of mass reduction that maintains footprint on fatal crashes. One way to estimate these effects is statistical analyses of societal fatality rates per VMT, by vehicles' mass and footprint, for the current on-road vehicle fleet. Societal fatality rates include occupants of all vehicles in the crash as well as pedestrians. The analyses comprised MY 2000-2007 cars and LTVs in CY 2002-2008 crashes. Fatality rates were derived from FARS data, 13 State crash files, and registration and mileage data from R.L. Polk. The table presents the estimated percent increase in societal fatality rates per 100-pound mass reduction while holding footprint constant for five classes of vehicles:
Only the 1.44 percent risk increase in the lighter cars is statistically significant. There are non-significant increases in the heavier cars and the lighter truck-based LTVs and non-significant societal benefits for mass reduction in CUVs, minivans, and the heavier truck-based LTVs. Based on these results, potential combinations of mass reductions that maintain footprint and are proportionately somewhat higher for the heavier vehicles may be safety-neutral or better as point estimates and, in any case, unlikely to significantly increase fatalities. The primarily non-significant results are not due to a paucity of data, but because the societal effect of mass reduction while maintaining footprint, if any, is small.
This preliminary report is currently undergoing peer review. Information about the review is available in Docket No. NHTSA-2010-0152, including the peer-review charge at NHTSA-2010-0152-0024 and the names of the reviewers at NHTSA-2010-0152-0025.
This report updates and supersedes earlier NHTSA reports on vehicle mass, size and fatality risk issued in 2010 (75 FR 25324, Docket No. NHTSA-2010-0152, report available at
NHTSA welcomes public review of the evaluation plan and invites the reviewers to comment about the selection, priority, and schedule of the regulations to be evaluated. The agency is interested in learning of any additional data that may be useful in the evaluations. NHTSA will submit to the Docket a response to the comments and, if appropriate, will supplement or revise the evaluation plan.
Your comments must be written and in English. To ensure that your comments are correctly filed in the Docket, please include the Docket number of this document (NHTSA-2010-0152) in your comments.
Your primary comments must not be more than 15 pages long (49 CFR 553.21). However, you may attach additional documents to your primary comments. There is no limit on the length of the attachments.
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
Please send two paper copies of your comments to Docket Management, fax
We also request, but do not require you to send a copy to Charles J. Kahane, Chief, Evaluation Division, NVS-431, National Highway Traffic Safety Administration, Room W53-312, 1200 New Jersey Avenue SE., Washington, DC 20590 (or email them to
If you wish Docket Management to notify you upon its receipt of your comments, enclose a self-addressed, stamped postcard in the envelope containing your comments. Upon receiving your comments, Docket Management will return the postcard by mail.
If you wish to submit any information under a claim of confidentiality, send three copies of your complete submission, including the information you claim to be confidential business information, to the Chief Counsel, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590. Include a cover letter supplying the information specified in our confidential business information regulation (49 CFR Part 512).
In addition, send two copies from which you have deleted the claimed confidential business information to U.S. Department of Transportation, Docket Management Facility, M-30, West Building, Ground Floor, Rm. W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, or submit them via the Federal eRulemaking Portal.
In our response, we will consider all comments that Docket Management receives before the close of business on the comment closing date indicated above under
Please note that even after the comment closing date, we will continue to file relevant information in the Docket as it becomes available. Further, some people may submit late comments. Accordingly, we recommend that you periodically check the Docket for new material.
You may read the materials placed in the docket for this document (e.g., the comments submitted in response to this document by other interested persons) at any time by going to
49 U.S.C. 30111, 30168; delegation of authority at 49 CFR 1.50 and 501.8.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation.
Request for comments on technical report.
This notice announces NHTSA's publication of a Technical Report reviewing and evaluating its existing Safety Standard 201,
Comments must be received no later than March 27, 2012.
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You may call Docket Management at (202) 366-9826.
Charles J. Kahane, Chief, Evaluation Division, NVS-431, National Center for Statistics and Analysis, National Highway Traffic Safety Administration, Room W53-312, 1200 New Jersey Avenue SE., Washington, DC 20590.
Federal Motor Vehicle Safety Standard (FMVSS) No. 201—Occupant Protection in Interior Impact—was upgraded in 1995, with a 1998-2003 phase-in, to reduce occupants' risk of head injury from contact with a vehicle's upper interior, including its pillars, roof headers and side rails, and the upper roof. Initially, energy-absorbing materials alone were used to meet the standard. NHTSA
NHTSA issued previous evaluation reports on FMVSS No. 201 in 2006 (72 FR 9074, Docket No. NHTSA-2007-27371, report available at
NHTSA welcomes public review of the technical report. NHTSA will submit to the Docket a response to the comments and, if appropriate, will supplement or revise the report.
Your comments must be written and in English. To ensure that your comments are correctly filed in the Docket, please include the Docket number of this document (NHTSA-2011-0168) in your comments.
Your primary comments must not be more than 15 pages long (49 CFR 553.21). However, you may attach additional documents to your primary comments. There is no limit on the length of the attachments.
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
Please send two paper copies of your comments to Docket Management, fax them, or use the Federal eRulemaking Portal. The mailing address is U.S. Department of Transportation, Docket Management Facility, M-30, West Building, Ground Floor, Rm. W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. The fax number is 1-(202) 493-2251. To use the Federal eRulemaking Portal, go to
We also request, but do not require you to send a copy to Charles J. Kahane, Chief, Evaluation Division, NVS-431, National Highway Traffic Safety Administration, Room W53-312, 1200 New Jersey Avenue SE., Washington, DC 20590 (or email them to
If you wish Docket Management to notify you upon its receipt of your comments, enclose a self-addressed, stamped postcard in the envelope containing your comments. Upon receiving your comments, Docket Management will return the postcard by mail.
If you wish to submit any information under a claim of confidentiality, send three copies of your complete submission, including the information you claim to be confidential business information, to the Chief Counsel, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590. Include a cover letter supplying the information specified in our confidential business information regulation (49 CFR Part 512).
In addition, send two copies from which you have deleted the claimed confidential business information to U.S. Department of Transportation, Docket Management Facility, M-30, West Building, Ground Floor, Rm. W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, or submit them via the Federal eRulemaking Portal.
In our response, we will consider all comments that Docket Management receives before the close of business on the comment closing date indicated above under
Please note that even after the comment closing date, we will continue to file relevant information in the Docket as it becomes available. Further, some people may submit late comments. Accordingly, we recommend that you periodically check the Docket for new material.
You may read the materials placed in the docket for this document (e.g., the comments submitted in response to this document by other interested persons) at any time by going to
49 U.S.C. 30111, 30168; delegation of authority at 49 CFR 1.50 and 501.8.
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Notice of actions on Special Permit Applications.
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations (49 CFR part 107, subpart B), notice is hereby given of the actions on special permits applications in (January to November 2011). The mode
Issued in Washington, DC, on November 17, 2011.
The Department of the Treasury will submit the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, Public Law 104-13, on or after the date of publication of this notice.
Comments should be received on or before December 28, 2011, to be assured of consideration.
Send comments regarding the burden estimate, or any other aspect of the information collection, including suggestion for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Treasury, New Executive Office Building, Room 10235, Washington, DC 20503, or e-mail at
Copies of the submission(s) may be obtained by calling (202) 927-5331, email at
Notice.
Pursuant to United States Code, Title 31, section 5135(b)(8)(C), the United States Mint announces the Citizens Coinage Advisory Committee (CCAC) public meeting scheduled for November 29, 2011.
Interested persons should call the CCAC HOTLINE at (202) 354-7502 for the latest update on meeting time and room location.
In accordance with 31 U.S.C. § 5135, the CCAC:
• Advises the Secretary of the Treasury on any theme or design proposals relating to circulating coinage, bullion coinage, Congressional Gold Medals, and national and other medals.
• Advises the Secretary of the Treasury with regard to the events, persons, or places to be commemorated by the issuance of commemorative coins in each of the five calendar years succeeding the year in which a commemorative coin designation is made.
• Makes recommendations with respect to the mintage level for any commemorative coin recommended.
Andy Fishburn, United States Mint Liaison to the CCAC; 801 9th Street NW., Washington, DC 20220; or call (202) 354-6700.
Any member of the public interested in submitting matters for the CCAC's consideration is invited to submit them by fax to the following number: (202) 756-6525.
31 U.S.C. 5135(b)(8)(C).
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before January 27, 2012.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Nancy J. Kessinger at (202) 461-9769 or FAX (202) 275-5947.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501—3521), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before January 27, 2012.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Nancy J. Kessinger at (202) 461-9769 or FAX (202) 275-5947.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-3521), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Comments must be submitted on or before December 28, 2011.
Submit written comments on the collection of information through
Denise McLamb, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420, (202) 461-7485, FAX (202) 461-0966 or email
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Comments must be submitted on or before December 28, 2011.
Submit written comments on the collection of information through
Denise McLamb, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461-7485, FAX (202) 461-0966 or email
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Comments must be submitted on or before December 28, 2011.
Submit written comments on the collection of information through
Denise McLamb, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-7485, FAX (202) 461-0966 or email
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Comments must be submitted on or before December 28, 2011.
Submit written comments on the collection of information through
Denise McLamb, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-7485, FAX (202) 461-0966 or email
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Comments must be submitted on or before December 28, 2011.
Submit written comments on the collection of information through
Denise McLamb, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420, (202) 461-7485, FAX (202) 461-0966 or email
An agency may not conduct or sponsor, and a person is not required to
By direction of the Secretary.
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule with comment period.
This final rule with comment period addresses changes to the physician fee schedule and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. It also addresses, implements or discusses certain statutory provisions including provisions of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act) and the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008. In addition, this final rule with comment period discusses payments for Part B drugs; Clinical Laboratory Fee Schedule: Signature on Requisition; Physician Quality Reporting System; the Electronic Prescribing (eRx) Incentive Program; the Physician Resource-Use Feedback Program and the value modifier; productivity adjustment for ambulatory surgical center payment system and the ambulance, clinical laboratory, and durable medical equipment prosthetics orthotics and supplies (DMEPOS) fee schedules; and other Part B related issues.
In commenting, please refer to file code CMS-1524-FC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
4.
a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201.
b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-1066 in advance to schedule your arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
Ryan Howe, (410) 786-3355 or Chava Sheffield, (410) 786-2298, for issues related to the physician fee schedule practice expense methodology and direct practice expense inputs.
Elizabeth Truong, (410) 786-6005, or Sara Vitolo, (410) 786-5714, for issues related to potentially misvalued services and interim final work RVUs.
Ken Marsalek, (410) 786-4502, for issues related the multiple procedure payment reduction and pathology services.
Sara Vitolo, (410) 786-5714, for issues related to malpractice RVUs.
Michael Moore, (410) 786-6830, for issues related to geographic practice cost indices.
Ryan Howe, (410) 786-3355, for issues related to telehealth services.
Elizabeth Truong, (410) 786-6005, for issues related to the sustainable growth rate, or the anesthesia or physician fee schedule conversion factors.
Bonny Dahm, (410) 786-4006, for issues related to payment for covered outpatient drugs and biologicals.
Glenn McGuirk, (410) 786-5723, for issues related to the Clinical Laboratory Fee Schedule (CLFS) signature on requisition policy.
Claudia Lamm, (410) 786-3421, for issues related to the chiropractic services demonstration budget neutrality issue.
Jamie Hermansen, (410) 786-2064, or Stephanie Frilling, (410) 786-4507 for issues related to the annual wellness visit.
Christine Estella, (410) 786-0485, for issues related to the Physician Quality Reporting System, incentives for Electronic Prescribing (eRx) and Physician Compare.
Gift Tee, (410) 786-9316, for issues related to the Physician Resource Use Feedback Program and physician value modifier.
Stephanie Frilling, (410) 786-4507 for issues related to the 3-day payment window.
Pam West, (410) 786-2302, for issues related to the technical corrections or the therapy cap.
Rebecca Cole or Erin Smith, (410) 786-4497, for issues related to physician payment not previously identified.
(1) The interim final work, practice expense, and malpractice RVUs (including the physician time, direct practice expense (PE) inputs, and the equipment utilization rate assumption) for new, revised, potentially misvalued, and certain other CY 2012 HCPCS codes. These codes and their CY 2012 interim final RVUs are listed in Addendum C to this final rule with comment period.
(2) The physician self-referral designated health services codes listed in Tables 83 and 84.
Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-(800) 743-3951.
To assist readers in referencing sections contained in this preamble, we are providing a table of contents. Some of the issues discussed in this preamble affect the payment policies, but do not require changes to the regulations in the Code of Federal Regulations (CFR). Information on the regulations' impact appears throughout the preamble and, therefore, is not discussed exclusively in section IX. of this final rule with comment period.
In addition, because of the many organizations and terms to which we refer by acronym in this final rule with comment period, we are listing these acronyms and their corresponding terms in alphabetical order as follows:
In the past, the Addenda referred to throughout the preamble of our annual PFS proposed and final rules with comment period were included in the printed
Throughout this final rule with comment period, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descriptions are copyright 2010 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association (AMA). Applicable Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply.
Since January 1, 1992, Medicare has paid for physicians' services under section 1848 of the Social Security Act (the Act), “Payment for Physicians' Services.” The Act requires that payments under the physician fee schedule (PFS) are based on national uniform relative value units (RVUs) based on the relative resources used in furnishing a service. Section 1848(c) of the Act requires that national RVUs be established for physician work, practice expense (PE), and malpractice expense. Before the establishment of the resource-based relative value system, Medicare payment for physicians' services was based on reasonable charges. We note that throughout this final rule with comment period, unless otherwise noted, the term “practitioner” is used to describe both physicians and nonphysician practitioners (such as physician assistants, nurse practitioners, clinical nurse specialists, certified nurse-midwives, psychologists, or clinical social workers) that are permitted to furnish and bill Medicare under the PFS for their services.
The concepts and methodology underlying the PFS were enacted as part of the Omnibus Budget Reconciliation Act (OBRA) of 1989 (Pub. L. 101-239), and OBRA 1990, (Pub. L. 101-508). The final rule, published on November 25, 1991 (56 FR 59502), set forth the fee schedule for payment for physicians' services beginning January 1, 1992. Initially, only the physician work RVUs were resource-based, and the PE and malpractice RVUs were based on average allowable charges.
The physician work RVUs established for the implementation of the fee schedule in January 1992 was developed with extensive input from the physician community. A research team at the Harvard School of Public Health developed the original physician work RVUs for most codes in a cooperative agreement with the Department of Health and Human Services (DHHS). In constructing the code-specific vignettes for the original physician work RVUs, Harvard worked with panels of experts, both inside and outside the Federal government, and obtained input from numerous physician specialty groups.
Section 1848(b)(2)(B) of the Act specifies that the RVUs for anesthesia services are based on RVUs from a uniform relative value guide, with appropriate adjustment of the conversion factor (CF), in a manner to assure that fee schedule amounts for anesthesia services are consistent with those for other services of comparable value. We established a separate CF for anesthesia services, and we continue to utilize time units as a factor in determining payment for these services. As a result, there is a separate payment methodology for anesthesia services.
We establish physician work RVUs for new and revised codes based, in part, on our review of recommendations received from the American Medical Association's (AMA's) Specialty Society Relative Value Update Committee (RUC).
Section 121 of the Social Security Act Amendments of 1994 (Pub. L. 103-432), enacted on October 31, 1994, amended section 1848(c)(2)(C)(ii) of the Act and required us to develop resource-based PE RVUs for each physicians service beginning in 1998. We were to consider general categories of expenses (such as office rent and wages of personnel, but excluding malpractice expenses) comprising PEs.
Section 4505(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33), amended section 1848(c)(2)(C)(ii) of the Act to delay implementation of the resource-based PE RVU system until January 1, 1999. In addition, section 4505(b) of the BBA provided for a 4-year transition period from charge-based PE RVUs to resource-based RVUs.
We established the resource-based PE RVUs for each physician's service in a final rule with comment period, published November 2, 1998 (63 FR 58814), effective for services furnished in 1999. Based on the requirement to transition to a resource-based system for PE over a 4-year period, resource-based PE RVUs did not become fully effective until 2002.
This resource-based system was based on two significant sources of actual PE data: the Clinical Practice Expert Panel (CPEP) data and the AMA's Socioeconomic Monitoring System (SMS) data. The CPEP data were collected from panels of physicians, practice administrators, and nonphysician health professionals (for example, registered nurses (RNs)) nominated by physician specialty societies and other groups. The CPEP panels identified the direct inputs required for each physician's service in both the office setting and out-of-office setting. We have since refined and revised these inputs based on recommendations from the AMA RUC. The AMA's SMS data provided aggregate specialty-specific information on hours worked and PEs.
Separate PE RVUs are established for procedures that can be performed in both a nonfacility setting, such as a physician's office, and a facility setting, such as a hospital outpatient department (HOPD). The difference between the facility and nonfacility RVUs reflects the fact that a facility typically receives separate payment from Medicare for its costs of providing the service, apart from payment under the PFS. The nonfacility RVUs reflect all
Section 212 of the Balanced Budget Refinement Act of 1999 (BBRA) (Pub. L. 106-113) directed the Secretary of Health and Human Services (the Secretary) to establish a process under which we accept and use, to the maximum extent practicable and consistent with sound data practices, data collected or developed by entities and organizations to supplement the data we normally collect in determining the PE component. On May 3, 2000, we published the interim final rule (65 FR 25664) that set forth the criteria for the submission of these supplemental PE survey data. The criteria were modified in response to comments received, and published in the
In the calendar year (CY) 2007 PFS final rule with comment period (71 FR 69624), we revised the methodology for calculating direct PE RVUs from the top-down to the bottom-up methodology beginning in CY 2007 and provided for a 4-year transition for the new PE RVUs under this new methodology. This transition ended in CY 2010 and direct PE RVUs are calculated in CY 2012 using this methodology, unless otherwise noted.
In the CY 2010 PFS final rule with comment period (74 FR 61749), we updated the PE/hour (PE/HR) data that are used in the calculation of PE RVUs for most specialties. For this update, we used the Physician Practice Information Survey (PPIS) conducted by the AMA. The PPIS is a multispecialty, nationally representative, PE survey of both physicians and nonphysician practitioners (NPPs) using a survey instrument and methods highly consistent with those of the SMS and the supplemental surveys used prior to CY 2010. We note that in CY 2010, for oncology, clinical laboratories, and independent diagnostic testing facilities (IDTFs), we continued to use the supplemental survey data to determine practice expense per hour (PE/HR) values (74 FR 61752). Beginning in CY 2010, we provided for a 4-year transition for the new PE RVUs using the updated PE/HR data. In CY 2012, the third year of the transition, PE RVUs are calculated based on a 75/25 blend of the new PE RVUs developed using the PPIS data and the previous PE RVUs based on the SMS and supplemental survey data.
Section 4505(f) of the BBA amended section 1848(c) of the Act to require that we implement resource-based malpractice RVUs for services furnished on or after CY 2000. The resource-based malpractice RVUs were implemented in the PFS final rule with comment period published November 2, 1999 (64 FR 59380). The MP RVUs were based on malpractice insurance premium data collected from commercial and physician-owned insurers from all the States, the District of Columbia, and Puerto Rico. In the CY 2010 PFS final rule with comment period (74 FR 61758), we implemented the Second Five-Year Review and update of the malpractice RVUs. In the CY 2011 PFS final rule with comment period, we described our approach for determining malpractice RVUs for new or revised codes that become effective before the next Five-Year Review and update (75 FR 73208). Accordingly, to develop the CY 2012 malpractice RVUs for new or revised codes we crosswalked the new or revised code to the malpractice RVUs of a similar source code and adjusted for differences in work (or, if greater, the clinical labor portion of the fully implemented PE RVUs) between the source code and the new or revised code.
Section 1848(c)(2)(B)(i) of the Act requires that we review all RVUs no less often than every 5-years. The First Five-Year Review of Work RVUs was published on November 22, 1996 (61 FR 59489) and was effective in 1997. The Second Five-Year Review of Work RVUs was published in the CY 2002 PFS final rule with comment period (66 FR 55246) and was effective in 2002. The Third Five-Year Review of Work RVUs was published in the CY 2007 PFS final rule with comment period (71 FR 69624) and was effective on January 1, 2007. The Fourth Five-Year Review of Work RVUs was initiated in the CY 2010 PFS final rule with comment period where we solicited candidate codes from the public for this review (74 FR 61941). Proposed revisions to work RVUs and corresponding changes to PE and malpractice RVUs affecting payment for physicians' services for the Fourth Five-Year Review of Work RVUs were published in a separate
In 1999, the AMA RUC established the Practice Expense Advisory Committee (PEAC) for the purpose of refining the direct PE inputs. Through March 2004, the PEAC provided recommendations to CMS for over 7,600 codes (all but a few hundred of the codes currently listed in the AMA's Current Procedural Terminology (CPT) codes). As part of the CY 2007 PFS final rule with comment period (71 FR 69624), we implemented a new bottom-up methodology for determining resource-based PE RVUs and transitioned the new methodology over a 4-year period. A comprehensive review of PE was undertaken prior to the 4-year transition period for the new PE methodology from the top-down to the bottom-up methodology, and this transition was completed in CY 2010. In CY 2010, we also incorporated the new PPIS data to update the specialty-specific PE/HR data used to develop PE RVUs, adopting a 4-year transition to PE RVUs developed using the PPIS data.
In the CY 2005 PFS final rule with comment period (69 FR 66236), we implemented the First Five-Year Review of the malpractice RVUs (69 FR 66263). Minor modifications to the methodology were addressed in the CY 2006 PFS final rule with comment period (70 FR 70153). The Second Five-Year Review and update of resource-based malpractice RVUs was published in the CY 2010 PFS final rule with comment period (74 FR 61758) and was effective in CY 2010.
In addition to the Five-Year Reviews, beginning for CY 2009, CMS and the AMA RUC have identified and reviewed a number of potentially misvalued codes on an annual basis based on various identification screens. This annual review of work and PE RVUs for potentially misvalued codes was supplemented by section 3134 of the Affordable Care Act, which requires the agency to periodically identify, review and adjust values for potentially misvalued codes with an emphasis on the following categories: (1) Codes and families of codes for which there has been the fastest growth; (2) codes or families of codes that have experienced substantial changes in practice expenses; (3) codes that are recently established for new technologies or services; (4) multiple codes that are frequently billed in conjunction with furnishing a single service; (5) codes with low relative values, particularly those that are often billed multiple times for a single treatment; (6) codes which have not been subject to review
Budget neutrality typically requires that expenditures not increase or decrease as a result of changes or revisions to policy. However, section 1848(c)(2)(B)(ii)(II) of the Act requires adjustment only if the change in expenditures resulting from the annual revisions to the PFS exceeds a threshold amount. Specifically, adjustments in RVUs for a year may not cause total PFS payments to differ by more than $20 million from what they would have been if the adjustments were not made. In accordance with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions to the RVUs cause expenditures to change by more than $20 million, we make adjustments to ensure that expenditures do not increase or decrease by more than $20 million.
To calculate the payment for every physician's service, the components of the fee schedule (physician work, PE, and malpractice RVUs) are adjusted by geographic practice cost indices (GPCIs). The GPCIs reflect the relative costs of physician work, PE, and malpractice in an area compared to the national average costs for each component.
RVUs are converted to dollar amounts through the application of a CF, which is calculated by CMS' Office of the Actuary (OACT).
The formula for calculating the Medicare fee schedule payment amount for a given service and fee schedule area can be expressed as:
The CY 2011 PFS final rule with comment period (75 FR 73170) implemented changes to the PFS and other Medicare Part B payment policies. It also finalized many of the CY 2010 interim RVUs and implemented interim RVUs for new and revised codes for CY 2011 to ensure that our payment systems are updated to reflect changes in medical practice and the relative values of services. The CY 2011 PFS final rule with comment period also addressed other policies, as well as certain provisions of the Affordable Care Act and the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA).
In the CY 2011 PFS final rule with comment period, we announced the following for CY 2011: the total PFS update of −10.1 percent; the initial estimate for the sustainable growth rate of −13.4 percent; and the conversion factor (CF) of $25.5217. These figures were calculated based on the statutory provisions in effect on November 2, 2010, when the CY 2011 PFS final rule with comment period was issued.
On December 30, 2010, we published a correction notice (76 FR 1670) to correct several technical and typographical errors that occurred in the CY 2011 PFS final rule with comment period. This correction notice announced a revised CF for CY 2011 of $25.4999, which was in accordance with the statutory provisions in effect as of November 2, 2010, the date the CY 2011 PFS final rule with comment period was issued.
On November 30, 2010, the Physician Payment and Therapy Relief Act of 2010 (PPATRA) (Pub. L. 111-286) was signed into law. Section 3 of Pub. L. 111-286 modified the policy finalized in the CY 2011 PFS final rule with comment period (75 FR 73241), effective January 1, 2011, regarding the payment reduction applied to multiple therapy services provided to the same patient on the same day in the office setting by one provider and paid for under the PFS (hereinafter, the therapy multiple procedure payment reduction (MPPR)). The PPATRA provision changed the therapy MPPR percentage from 25 to 20 percent of the PE component of payment for the second and subsequent “always” therapy services furnished in the office setting on the same day to the same patient by one provider, and excepted the payment reductions associated with the therapy MPPR from budget neutrality under the PFS.
On December 15, 2010, the Medicare and Medicaid Extenders Act of 2010 (MMEA) (Pub. L. 111-309) was signed into law. Section 101 of the MMEA provided for a 1-year zero percent update for the CY 2011 PFS. As a result of the MMEA, the CY 2011 PFS conversion factor was revised to $33.9764.
Practice expense (PE) is the portion of the resources used in furnishing the service that reflects the general categories of physician and practitioner expenses, such as office rent and personnel wages but excluding malpractice expenses, as specified in section 1848(c)(1)(B) of the Act. Section 121 of the Social Security Amendments of 1994 (Pub. L. 103-432), enacted on October 31, 1994, required us to develop a methodology for a resource-based system for determining PE RVUs for each physician's service. We develop PE RVUs by looking at the direct and indirect physician practice resources involved in furnishing each service. Direct expense categories include clinical labor, medical supplies, and medical equipment. Indirect expenses include administrative labor, office expense, and all other expenses. The sections that follow provide more detailed information about the methodology for translating the resources involved in furnishing each service into service-specific PE RVUs. In addition, we note that section 1848(c)(2)(B)(ii)(II) of the Act provides that adjustments in RVUs for a year may not cause total PFS payments to differ by more than $20 million from what they would have been if the adjustments were not made. Therefore, if revisions to the RVUs cause expenditures to change by more than $20 million, we make adjustments to ensure that expenditures do not increase or decrease by more than $20 million. We refer readers to the CY 2010 PFS final rule with comment period (74 FR 61743 through 61748) for a more detailed history of the PE methodology.
We use a bottom-up approach to determine the direct PE by adding the costs of the resources (that is, the clinical staff, equipment, and supplies) typically required to provide each service. The costs of the resources are calculated using the refined direct PE inputs assigned to each CPT code in our PE database, which are based on our review of recommendations received from the AMA RUC. For a detailed explanation of the bottom-up direct PE methodology, including examples, we refer readers to the Five-Year Review of Work Relative Value Units Under the PFS and Proposed Changes to the Practice Expense Methodology proposed notice (71 FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 69629).
We use survey data on indirect practice expenses incurred per hour worked in developing the indirect
The PPIS is a multispecialty, nationally representative, PE survey of both physicians and NPPs using a consistent survey instrument and methods highly consistent with those used for the SMS and the supplemental surveys. The PPIS gathered information from 3,656 respondents across 51 physician specialty and healthcare professional groups. We believe the PPIS is the most comprehensive source of PE survey information available to date. Therefore, we used the PPIS data to update the PE/HR data for almost all of the Medicare-recognized specialties that participated in the survey for the CY 2010 PFS.
When we changed over to the PPIS data beginning in CY 2010, we did not change the PE RVU methodology itself or the manner in which the PE/HR data are used in that methodology. We only updated the PE/HR data based on the new survey. Furthermore, as we explained in the CY 2010 PFS final rule with comment period (74 FR 61751), because of the magnitude of payment reductions for some specialties resulting from the use of the PPIS data, we finalized a 4-year transition (75 percent old/25 percent new for CY 2010, 50 percent old/50 percent new for CY 2011, 25 percent old/75 percent new for CY 2012, and 100 percent new for CY 2013) from the previous PE RVUs to the PE RVUs developed using the new PPIS data.
Section 303 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) added section 1848(c)(2)(H)(i) of the Act, which requires us to use the medical oncology supplemental survey data submitted in 2003 for oncology drug administration services. Therefore, the PE/HR for medical oncology, hematology, and hematology/oncology reflects the continued use of these supplemental survey data.
We do not use the PPIS data for reproductive endocrinology, sleep medicine, and spine surgery since these specialties are not separately recognized by Medicare, nor do we have a method to blend these data with Medicare-recognized specialty data.
Supplemental survey data on independent labs, from the College of American Pathologists, were implemented for payments in CY 2005. Supplemental survey data from the National Coalition of Quality Diagnostic Imaging Services (NCQDIS), representing independent diagnostic testing facilities (IDTFs), were blended with supplementary survey data from the American College of Radiology (ACR) and implemented for payments in CY 2007. Neither IDTFs nor independent labs participated in the PPIS. Therefore, we continue to use the PE/HR that was developed from their supplemental survey data.
Consistent with our past practice, the previous indirect PE/HR values from the supplemental surveys for medical oncology, independent laboratories, and IDTFs were updated to CY 2006 using the MEI to put them on a comparable basis with the PPIS data.
Previously, we have established PE/HR values for various specialties without SMS or supplemental survey data by crosswalking them to other similar specialties to estimate a proxy PE/HR. For specialties that were part of the PPIS for which we previously used a crosswalked PE/HR, we instead use the PPIS-based PE/HR. We continue previous crosswalks for specialties that did not participate in the PPIS. However, beginning in CY 2010 we changed the PE/HR crosswalk for portable x-ray suppliers from radiology to IDTF, a more appropriate crosswalk because these specialties are more similar to each other with respect to physician time.
For registered dietician services, the resource-based PE RVUs have been calculated in accordance with the final policy that crosswalks the specialty to the “All Physicians” PE/HR data, as adopted in the CY 2010 PFS final rule with comment period (74 FR 61752) and discussed in more detail in the CY 2011 PFS final rule with comment period (75 FR 73183).
There are four specialties whose utilization data will be newly incorporated into ratesetting for CY 2012. We proposed to use proxy PE/HR values for these specialties by crosswalking values from other, similar specialties as follows: Speech Language Pathology from Physical Therapy; Hospice and Palliative Care from All Physicians; Geriatric Psychiatry from Psychiatry; and Intensive Cardiac Rehabilitation from Cardiology. Additionally, since section 1833(a)(1)(K) of the Act (as amended by section 3114 of the Affordable Care Act) requires that payment for services provided by a certified nurse midwife be paid at 100 percent of the PFS amount, this specialty will no longer be excluded from the ratesetting calculation. We proposed to crosswalk the PE\HR data from Obstetrics/gynecology to Certified Nurse Midwife. These proposed changes were reflected in the “PE HR” file available on the CMS Web site under the supporting data files for the CY 2012 PFS proposed rule at
After consideration of the public comments we received, we are finalizing our CY 2012 proposals to update the PE/HR data as reflected in the “PE HR” file available on the CMS Web site under the supporting data files for the CY 2012 PFS final rule with comment period at
As provided in the CY 2010 PFS final rule with comment period (74 FR 61751), CY 2012 is the third year of the 4-year transition to the PE RVUs calculated using the PPIS data.
To establish PE RVUs for specific services, it is necessary to establish the direct and indirect PE associated with each service.
The relative relationship between the direct cost portions of the PE RVUs for any two services is determined by the relative relationship between the sum of the direct cost resources (that is, the clinical staff, equipment, and supplies) typically required to provide the services. The costs of these resources are calculated from the refined direct PE inputs in our PE database. For example, if one service has a direct cost sum of $400 from our PE database and another service has a direct cost sum of $200, the direct portion of the PE RVUs of the first service would be twice as much as the direct portion of the PE RVUs for the second service.
Section II.A.2.b. of this final rule with comment period describes the current data sources for specialty-specific indirect costs used in our PE calculations. We allocate the indirect costs to the code level on the basis of the direct costs specifically associated with a code and the greater of either the clinical labor costs or the physician work RVUs. We also incorporate the survey data described earlier in the PE/HR discussion. The general approach to developing the indirect portion of the PE RVUs is described as follows:
• For a given service, we use the direct portion of the PE RVUs calculated as previously described and the average percentage that direct costs represent of total costs (based on survey data) across the specialties that perform the service to determine an initial indirect allocator. For example, if the direct portion of the PE RVUs for a given service were 2.00 and direct costs, on average, represented 25 percent of total costs for the specialties that performed the service, the initial indirect allocator would be 6.00 since 2.00 is 25 percent of 8.00 and 6.00 is 75 percent of 8.00.
• We then add the greater of the work RVUs or clinical labor portion of the direct portion of the PE RVUs to this initial indirect allocator. In our example, if this service had work RVUs of 4.00 and the clinical labor portion of the direct PE RVUs was 1.50, we would add 6.00 plus 4.00 (since the 4.00 work RVUs are greater than the 1.50 clinical labor portion) to get an indirect allocator of 10.00. In the absence of any further use of the survey data, the relative relationship between the indirect cost portions of the PE RVUs for any two services would be determined by the relative relationship between these indirect cost allocators. For example, if one service had an indirect cost allocator of 10.00 and another service had an indirect cost allocator of 5.00, the indirect portion of the PE RVUs of the first service would be twice as great as the indirect portion of the PE RVUs for the second service.
• We next incorporate the specialty-specific indirect PE/HR data into the calculation. As a relatively extreme example for the sake of simplicity, assume in our previous example that, based on the survey data, the average indirect cost of the specialties performing the first service with an allocator of 10.00 was half of the average indirect cost of the specialties performing the second service with an indirect allocator of 5.00. In this case, the indirect portion of the PE RVUs of the first service would be equal to that of the second service.
For procedures that can be furnished in a physician's office, as well as in a hospital or facility setting, we establish two PE RVUs: facility and nonfacility. The methodology for calculating PE RVUs is the same for both the facility and nonfacility RVUs, but is applied independently to yield two separate PE RVUs. Because Medicare makes a separate payment to the facility for its costs of furnishing a service, the facility PE RVUs are generally lower than the nonfacility PE RVUs.
Diagnostic services are generally comprised of two components: a professional component (PC) and a technical component (TC), each of which may be performed independently or by different providers, or they may be performed together as a “global” service. When services have PC and TC components that can be billed separately, the payment for the global component equals the sum of the payment for the TC and PC. This is a result of using a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global components, TCs, and PCs; that is, we apply the same weighted average indirect percentage factor to allocate indirect expenses to the global components, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global under the bottom-up methodology.)
For a more detailed description of the PE RVU methodology, we refer readers to the CY 2010 PFS final rule with comment period (74 FR 61745 through 61746).
First, we create a setup file for the PE methodology. The setup file contains the direct cost inputs, the utilization for each procedure code at the specialty and facility/nonfacility place of service level, and the specialty-specific PE/HR data from the surveys.
Sum the costs of each direct input.
Apply a scaling adjustment to the direct inputs.
Create indirect allocators.
There are two situations where this formula is modified:
• If the service is a global service (that is, a service with global, professional, and technical components), then the indirect allocator is: indirect percentage (direct PE RVUs/direct percentage) + clinical PE RVUs + work RVUs.
• If the clinical labor PE RVUs exceed the work RVUs (and the service is not a global service), then the indirect allocator is: Indirect percentage (direct PE RVUs/direct percentage) + clinical PE RVUs.
For presentation purposes in the examples in Table 2, the formulas were divided into two parts for each service.
• The first part does not vary by service and is the indirect percentage (direct PE RVUs/direct percentage).
• The second part is either the work RVUs, clinical PE RVUs, or both depending on whether the service is a global service and whether the clinical PE RVUs exceed the work RVUs (as described earlier in this step).
Apply a scaling adjustment to the indirect allocators.
Calculate the indirect practice cost index.
The final PE BN adjustment is calculated by comparing the results of Step 18 to the current pool of PE RVUs. This final BN adjustment is required primarily because certain specialties are excluded from the PE RVU calculation for ratesetting purposes, but all specialties are included for purposes of calculating the final BN adjustment. (See “Specialties excluded from ratesetting calculation” later in this section.)
• Specialties excluded from ratesetting calculation: For the purposes of calculating the PE RVUs, we exclude certain specialties, such as certain nonphysician practitioners paid at a percentage of the PFS and low-volume specialties, from the calculation. These specialties are included for the purposes of calculating the BN adjustment. They are displayed in Table 1. We note that since specialty code 97 (physician assistant) is paid at a percentage of the PFS and therefore excluded from the ratesetting calculation, this specialty has been added to the table for CY 2012.
• Crosswalk certain low volume physician specialties: Crosswalk the utilization of certain specialties with relatively low PFS utilization to the associated specialties.
• Physical therapy utilization: Crosswalk the utilization associated with all physical therapy services to the specialty of physical therapy.
• Identify professional and technical services not identified under the usual TC and 26 modifiers: Flag the services that are PC and TC services, but do not use TC and 26 modifiers (for example, electrocardiograms). This flag associates the PC and TC with the associated global code for use in creating the indirect PE RVUs. For example, the professional service, CPT code 93010 (Electrocardiogram, routine ECG with at least 12 leads; interpretation and report only), is associated with the global service, CPT code 93000 (Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report).
• Payment modifiers: Payment modifiers are accounted for in the creation of the file. For example, services billed with the assistant at surgery modifier are paid 16 percent of the PFS amount for that service; therefore, the utilization file is modified to only account for 16 percent of any service that contains the assistant at surgery modifier.
• Work RVUs: The setup file contains the work RVUs from this final rule with comment period.
The equipment cost per minute is calculated as:
In addition to examining the interest rate assumption, the RUC requested that CMS review the assumptions regarding useful life of equipment and yearly maintenance costs associated with maintaining high cost equipment and allow for comment on the methodologies used in developing these assumptions.
In this section, we discuss other specific CY 2012 proposals and changes related to direct PE inputs. The changes we proposed and are finalizing are included in the proposed CY 2012 direct PE database, which is available on the CMS Web site under the supporting data files for the CY 2012 PFS final rule with comment period at
It came to our attention that the minutes allocated for two particular equipment items have been inverted. This inversion affected three codes: 37232 (Revascularization, endovascular, open or percutaneous, tibial/peroneal artery, unilateral, each additional vessel; with transluminal angioplasty (List separately in addition to code for primary procedure)), 37233 (Revascularization, endovascular, open or percutaneous, tibial/peroneal artery, unilateral, each additional vessel; with atherectomy, includes angioplasty within the same vessel, when performed (List separately in addition to code for primary procedure)), and 37234 (Revascularization, endovascular, open or percutaneous, tibial/peroneal artery, unilateral, each additional vessel; with transluminal stent placement(s), includes angioplasty within the same vessel, when performed (List separately in addition to code for primary procedure)). In each case, the number of minutes allocated to the “printer, dye sublimation (photo, color)” (ED031) should have been appropriately allocated to the “stretcher” (EF018). The number of minutes allocated to the stretcher should have been appropriately allocated to the printer. Therefore, we proposed input corrections to the times associated with the two equipment items in the three codes.
After consideration of the public comments we received, we are finalizing our CY 2012 proposal to modify the direct PE database by correcting the input errors associated with the two equipment items in the three codes. The CY 2012 direct PE database reflects these changes and is available on the CMS Web site under the supporting data files for the CY 2012 PFS final rule with comment period at
We recently identified a number of CPT codes with inadvertently duplicated labor and supply inputs in the PE database. We proposed to remove the duplicate labor and supply inputs in the CY 2012 database as detailed in Table 3.
After consideration of the public comments we received, we are finalizing our CY 2012 proposal to remove the duplicate labor and supply inputs in the CY 2012 database as detailed in Table 3. The CY 2012 direct PE database reflects these changes and is available on the CMS Web site under the supporting data files for the CY 2012 PFS final rule with comment period at
For services described by certain codes, the direct PE database includes nonfacility inputs that reflect the assumption that moderate sedation is inherent in the procedure. These codes
• Clinical Labor Inputs: Registered Nurse (L051A) time that includes two minutes of time to initiate sedation, the number of minutes associated with the physician intra-service work time, and 15 minutes for every hour of patient recovery time for post-service patient monitoring. Supply Inputs: “Pack, conscious sedation” (SA044) that includes: an angiocatheter 14g-24g, bandage, strip 0.75in × 3in, catheter, suction, dressing, 4in × 4.75in (Tegaderm), electrode, ECG (single), electrode, ground, gas, oxygen, gauze, sterile 4in × 4in, gloves, sterile, gown, surgical, sterile, iv infusion set, kit, iv starter, oxygen mask (1) and tubing (7ft), pulse oximeter sensor probe wrap, stop cock, 3-way, swab-pad, alcohol, syringe 1ml, syringe-needle 3ml 22-26g, tape, surgical paper 1in (Micropore), tourniquet, and non-latex 1in × 18in.
• Equipment Inputs: “Table, instrument, mobile” (EF027), “ECG, 3-channel (with SpO2, NIBP, temp, resp)” (EQ011), “IV infusion pump” (EQ032), “pulse oxymetry recording software (prolonged monitoring)” (EQ212), and “blood pressure monitor, ambulatory, w-battery charger” (EQ269).
We have reviewed this recommendation and generally agree with these inputs. However, we note that the equipment item “ECG, 3-channel (with SpO2, NIBP, temp, resp)” (EQ011) incorporates the functionality of the equipment items “pulse oxymetry recording software (prolonged monitoring)” (EQ212), and “blood pressure monitor, ambulatory, w-battery charger” (EQ269). Therefore, we did not include these two items as standard nonfacility inputs for moderate sedation in our proposal to accept the AMA RUC recommendation with the refinement as stated.
After consideration of the public comments we received, we are finalizing our CY 2012 proposal to accept the AMA RUC recommendation with the refinement as stated. The CY 2012 direct PE database reflects these changes and is available on the CMS Web site under the supporting data files for the CY 2012 PFS final rule with comment period at
In the CY 2011 PFS final rule with comment period (75 FR 73205), we finalized a process to act on public requests to update equipment and supply price and equipment useful life inputs through annual rulemaking beginning with the CY 2012 PFS final rule with comment period.
During 2010, we received a request to update the price of “tray, bone marrow biopsy-aspiration” (SA062) from $24.27 to $34.47. The request included multiple invoices that documented updated prices for the supply item. We also received a request to update the useful life of “holter monitor” (EQ127) from 7 years to 5 years, based on its entry in the AHA's publication, ”Estimated Useful Lives of Depreciable Hospital Assets,” which we use as a standard reference. In each of these cases, we proposed to accept the updated inputs, as requested. The CY 2012 direct PE database reflects these proposed changes and is available on the CMS Web site under the supporting data files for the CY 2012 PFS final rule with comment period at
After consideration of the public comments we received, we are finalizing our CY 2012 proposal to accept the updated inputs, as requested. The CY 2012 direct PE database reflects these changes and is available on the CMS Web site under the supporting data files for the CY 2012 PFS final rule with comment period at
When creating G codes, we often develop work, PE, and malpractice RVUs by crosswalking the RVUs from similar (reference) codes. In most of these cases, the PE RVUs are directly crosswalked pending the availability of utilization data. Once that data is available, we crosswalk the direct PE inputs and develop PE RVUs using the regular practice expense methodology, including allocators that are derived from utilization data. For CY 2012, we are using this process to develop PE RVUs for the following services: G0245 (Initial physician evaluation and management of a diabetic patient with diabetic sensory neuropathy resulting in a loss of protective sensation (LOPS) which must include: (1) The diagnosis of LOPS, (2) a patient history, (3) a physical examination that consists of at least the following elements: (a) Visual inspection of the forefoot, hindfoot and toe web spaces, (b) evaluation of a protective sensation, (c) evaluation of foot structure and biomechanics, (d) evaluation of vascular status and skin integrity, and (e) evaluation and recommendation of footwear and (4) patient education); G0246 (Follow-up physician evaluation and management of a diabetic patient with diabetic sensory neuropathy resulting in a loss of protective sensation (LOPS) to include at least the following: (1) A patient history, (2) a physical examination that includes: (a) Visual inspection of the forefoot, hindfoot and toe web spaces, (b) evaluation of protective sensation, (c) evaluation of foot structure and biomechanics, (d) evaluation of vascular status and skin integrity, and (e) evaluation and recommendation of footwear, and (3) patient education); G0247 (Routine foot care by a physician of a diabetic patient with diabetic sensory neuropathy resulting in a loss of protective sensation (LOPS) to include, the local care of superficial wounds (for example, superficial to muscle and fascia) and at least the following if present: (1) Local care of superficial wounds, (2) debridement of corns and calluses, and (3) trimming and debridement of nails); G0341 (Percutaneous islet cell transplant, includes portal vein catheterization and infusion); G0342 (Laparoscopy for islet cell transplant, includes portal vein catheterization and infusion); G0343 (Laparotomy for islet cell transplant, includes portal vein catheterization and infusion); and G0365 (Vessel mapping of vessels for hemodialysis access (services for preoperative vessel mapping prior to creation of hemodialysis access using an autogenous hemodialysis conduit, including arterial inflow and venous outflow)). The values in Addendum B reflect the updated PE RVUs.
In addition, there is a series of G-codes describing surgical pathology services with PE RVUs historically valued outside of the regular PE methodology. These codes are: G0416 (Surgical pathology, gross and microscopic examination for prostate needle saturation biopsy sampling, 1-20 specimens); G0417 (Surgical pathology, gross and microscopic examination for prostate needle saturation biopsy
After consideration of the public comments we received, we are finalizing our CY 2012 proposal to develop PE RVUs through the methodologies explained in the proposal. The final CY 2012 RVUs for these codes are displayed in Addendum B to this final rule with comment period.
As we describe in section II.A.2.f. of this final rule with comment period, in creating the indirect practice cost index, we calculate specialty-specific aggregate pools of indirect PE for all PFS services for that specialty by adding the product of the indirect PE/HR for the specialty, the physician time for the service, and the specialty's utilization for the service across all services performed by the specialty.
During a review of the physician time data for the CY 2012 PFS rulemaking, we noted an anomaly regarding the physician time allotted to a series of group service codes that are listed in Table 5. We believe that the time associated with these codes reflects the typical amount of time spent by the practitioner in furnishing the group service. However, because the services are billed per patient receiving the service, the time for these codes should be divided by the typical number of patients per session. In reviewing the data used in the valuation of work RVUs for these services, we noted that in one vignette for these services, the typical group session consisted of 6 patients. Therefore we proposed adjusted times for these services based on 6 patients. However, we sought comment on the typical number of patients seen per session for each of these services.
We appreciate all of the comments regarding this proposal. In the following paragraphs, we address how we will use this submitted information in order to set final time values for these codes—
• 90849 (Multiple-family group psychotherapy);
• 90853 (Group psychotherapy (other than of a multiple-family group); and
• 90857 (Interactive group psychotherapy).
We believe that the typical group session may be similar for 90857 based on similar code descriptors, work RVUs, and clinical vignettes. Therefore, pending new recommendations from the AMA RUC, we believe it would be appropriate to establish physician time for this code as 3 pre-service minutes, 9 intra-service minutes, and 10 post-service minutes with the understanding that the total resulting minutes is the product of these and the number of patients in the group.
For 90849, we believe that it would be most appropriate to wait for the new recommendations prior to adjusting the physician time because the typical group size and typical patient size is different, and we received no information regarding the typical group size.
• 92508 (Treatment of speech, language, voice, communication, and/or auditory processing disorder; group, 2 or more individuals)
• 96153 (Health and behavior intervention, each 15 minutes, face-to-face; group (2 or more patients))
• 97150 (Therapeutic procedure(s), group (2 or more individuals))
• 97804 (Medical nutrition therapy; group (2 or more individual(s)), each 30 minutes)
• G0109 (Diabetes outpatient self-management training services, group session (2 or more), per 30 minutes)
• G0271 (Medical nutrition therapy, reassessment and subsequent intervention(s) following second referral in same year for change in diagnosis, medical condition, or treatment regimen (including additional hours needed for renal disease), group (2 or more individuals), each 30 minutes), and G0421 (Face-to-face educational services related to the care of chronic kidney disease; group, per session, per one hour)
We received no comments regarding the typical group time for these services. However, given the similarities of these services to CPT code 97804 (Medical nutrition therapy; group (2 or more individual(s)), each 30 minutes), we believe it would be appropriate to use the times for that code as a reasonable crosswalk and establish physician time for these codes as 2 pre-service minutes, 6 intra-service minutes, and 2 post-service minutes with the understanding that the total resulting minutes is the product of these and the number of patients in the group.
After consideration of the public comments and related information, we are finalizing our proposed updates to the physician time file, as amended for certain codes as explicitly addressed in this section. The final time values for these codes can be found in the final CY 2012 Physician Time file, which is available on the CMS Web site under the supporting data files for the CY 2012 PFS proposed rule at
As a result of our review, we also proposed to update our physician time file to reflect the physician time associated with certain G-codes that had previously been missing from the file.
We received no comments regarding our proposal to update the physician time file to reflect the physician time associated with the G-codes that were previously missing from the file. Therefore, we are finalizing our updates to the physician time file. The final time values can be found in the final CY 2012 Physician Time file, which is available on the CMS Web site under the supporting data files for the CY 2012 PFS proposed rule at
As discussed in section I. of this final rule with comment period, in order to value services under the PFS, section 1848(c) of the Act requires the Secretary to determine relative values for physicians' services based on three components: work, practice expense (PE), and malpractice. Section 1848(c)(1)(A) of the Act defines the work component to include “the portion of the resources used in furnishing the service that reflects physician time and intensity in furnishing the service.” Additionally, the statute provides that the work component shall include activities that occur before and after direct patient contact. Furthermore, the statute specifies that with respect to surgical procedures, the valuation of the work component for the code must reflect a “global” concept in which pre-operative and post-operative physicians' services related to the procedure are also included.
In addition, section 1848(c)(2)(C)(i) of the Act specifies that “the Secretary shall determine a number of work relative value units (RVUs) for the service based on the relative resources incorporating physician time and intensity required in furnishing the service.” As discussed in detail in sections I.A.2. and I.A.3. of this final rule with comment period, the statute also defines the PE and malpractice components and provides specific guidance in the calculation of the RVUs for each of these components. Section 1848(c)(1)(B) of the Act defines the PE component as “the portion of the resources used in furnishing the service that reflects the general categories of expenses (such as office rent and wages of personnel, but excluding malpractice expenses) comprising practice expenses.”
Section 1848(c)(2)(C)(ii) of the Act specifies that the “Secretary shall determine a number of practice expense relative value units for the services for years beginning with 1999 based on the relative practice expense resources involved in furnishing the service.” Furthermore, section 1848(c)(2)(B) of the Act directs the Secretary to conduct a periodic review, not less often than every 5 years, of the RVUs established under the PFS. On March 23, 2010, the Affordable Care Act was enacted, further requiring the Secretary to periodically identify and review potentially misvalued codes, and make appropriate adjustments to the relative values of those services identified as being potentially misvalued. Section 3134(a) of the Affordable Care Act added a new section 1848(c)(2)(K) to the Act which requires the Secretary to periodically identify potentially misvalued services using certain criteria, and to review and make appropriate adjustments to the relative values for those services. Section 3134(a) of the Affordable Care Act also added a new section 1848(c)(2)(L) to the Act which requires the Secretary to develop a process to validate the RVUs of certain potentially misvalued codes under the PFS, identified using the same criteria used to identify potentially misvalued codes, and to make appropriate adjustments.
As discussed in section I.A.1. of this final rule with comment period, we generally establish physician work RVUs for new and revised codes based on our review of recommendations received from the American Medical Association Specialty Society Relative Value Scale Update Committee (AMA RUC). We also receive recommendations from the AMA RUC regarding direct PE inputs for services, which we evaluate in order to develop the PE RVUs under the PFS. The AMA RUC also provides recommendations to us on the values for codes that have been identified as potentially misvalued. To respond to concerns expressed by MedPAC, the Congress, and other stakeholders regarding accurate valuation of services under the PFS, the AMA RUC created the Five-Year Review Identification Workgroup in 2006. In addition to providing recommendations to us for work RVUs and physician times, the AMA RUC's Practice Expense Subcommittee reviews direct PE inputs (clinical labor, medical supplies, and medical equipment) for individual services.
In accordance with section 1848(c) of the Act, we determine appropriate adjustments to the RVUs, taking into account the recommendations provided by the AMA RUC and MedPAC, explain the basis of these adjustments, and respond to public comments in the PFS proposed and final rules. We note that section 1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and other techniques to determine the RVUs for physicians' services for which specific data are not available, in addition to taking into account the results of consultations with organizations representing physicians.
In its March 2006 Report to the Congress, MedPAC noted that “misvalued services can distort the price signals for physicians' services as well as for other health care services that physicians order, such as hospital services.” In that same report MedPAC postulated that physicians' services under the PFS can become misvalued over time for a number of reasons: For example, MedPAC stated, “when a new service is added to the physician fee schedule, it may be assigned a relatively high value because of the time, technical skill, and psychological stress that are often required to furnish that service. Over time, the work required for certain services would be expected to decline as physicians become more familiar with the service and more efficient in furnishing it.” That is, the amount of physician work needed to furnish an existing service may decrease when new technologies are incorporated. Services can also become overvalued when practice expenses decline. This can happen when the costs of equipment and supplies fall, or when equipment is used more frequently, reducing its cost per use. Likewise, services can become undervalued when physician work increases or practice expenses rise. In the ensuing years since MedPAC's 2006 report, additional groups of potentially misvalued services have been identified by the Congress, CMS, MedPAC, the AMA RUC, and other stakeholders.
In recent years CMS and the AMA RUC have taken increasingly significant steps to address potentially misvalued codes. As MedPAC noted in its March 2009 Report to the Congress, in the intervening years since MedPAC made the initial recommendations, “CMS and the AMA RUC have taken several steps to improve the review process.” Most recently, section 1848(c)(2)(K)(ii) of the Act (as added by section 3134(a) of the Affordable Care Act) directed the Secretary to specifically examine, as determined appropriate, potentially misvalued services in seven categories as follows:
• Codes and families of codes for which there has been the fastest growth.
• Codes and families of codes that have experienced substantial changes in practice expenses.
• Codes that are recently established for new technologies or services.
• Multiple codes that are frequently billed in conjunction with furnishing a single service.
• Codes with low relative values, particularly those that are often billed multiple times for a single treatment.
• Codes which have not been subject to review since the implementation of the RBRVS (the so-called `Harvard-valued codes').
• Other codes determined to be appropriate by the Secretary.
Section 1848(c)(2)(K)(iii) of the Act also specifies that the Secretary may use existing processes to receive recommendations on the review and appropriate adjustment of potentially misvalued services. In addition, the Secretary may conduct surveys, other data collection activities, studies, or other analyses, as the Secretary determines to be appropriate, to facilitate the review and appropriate adjustment of potentially misvalued services. This section also authorizes the use of analytic contractors to identify and analyze potentially misvalued codes, conduct surveys or collect data, and make recommendations on the review and appropriate adjustment of potentially misvalued services. Additionally, this section provides that the Secretary may coordinate the review and adjustment of the RVUs with the periodic review described in section 1848(c)(2)(B) of the Act. Finally, section 1848(c)(2)(K)(iii)(V) of the Act specifies that the Secretary may make appropriate coding revisions (including using existing processes for consideration of coding changes) which may include consolidation of individual services into bundled codes for payment under the physician fee schedule.
Over the last several years, CMS, in conjunction with the AMA RUC, has identified and reviewed numerous potentially misvalued codes in all seven of the categories specified in section 1848(c)(2)(K)(ii) of the Act, and we plan to continue our work examining potentially misvalued codes in these areas over the upcoming years, consistent with the new legislative requirements on this issue. In the current process, we request the AMA RUC to review potentially misvalued codes that we identify and to make recommendations on revised work RVUs and/or direct PE inputs for those codes to us. The AMA RUC, through its own processes, also might identify and review potentially misvalued procedures. We then assess the recommended revised work RVUs and/or direct PE inputs and, in accordance with section 1848(c) of the Act, we determine if the recommendations constitute appropriate adjustments to the RVUs under the PFS.
Since CY 2009, as a part of the annual potentially misvalued code review, we have reviewed over 700 potentially misvalued codes to refine work RVUs and direct PE inputs in addition to continuing the comprehensive Five-Year Review process. We have adopted appropriate work RVUs and direct PE inputs for these services as a result of these reviews.
Our prior reviews of codes under the potentially misvalued codes initiative have included codes in all seven categories specified in section 1848(c)(2)(K)(ii) of the Act. That is, we have reviewed and assigned more appropriate values to certain—
• Codes and families of codes for which there has been the fastest growth;
• Codes and families of codes that have experienced substantial changes in practice expenses;
• Codes that were recently established for new technologies or services;
• Multiple codes that are frequently billed in conjunction with furnishing a single service;
• Codes with low relative values, particularly those that are often billed multiple times for a single treatment;
• Codes which had not been subject to review since the implementation of the RBRVS (`Harvard valued'); and
• Codes potentially misvalued as determined by the Secretary.
In this last category, we have previously proposed policies in CYs 2009, 2010, and 2011, and requested that the AMA RUC review codes for which there have been shifts in the site-of-service (that is, codes that were originally valued as being furnished in the inpatient setting, but that are now predominantly furnished on an outpatient basis), as well as codes that qualify as “23-hour stay” outpatient services (these services typically have lengthy hospital outpatient recovery periods). We note that a more detailed discussion of the extensive prior reviews of potentially misvalued codes is included in the CY 2011 PFS final rule with comment period (75 FR 73215 through 73216).
In CY 2011, we identified additional codes under section 1848(c)(2)(K)(ii) of the Act that we believe are ripe for review and referred them to the AMA RUC (75 FR 73215 through 73216). Specifically, we identified potentially misvalued codes in the category of “Other codes determined to be appropriate by the Secretary,” referring lists of codes that have low work RVUs but that are high volume based on claims data, as well as targeted key
Since the publication of the CY 2011 PFS final rule with comment period, we released the Fourth Five-Year Review of Work (76 FR 32410), which discussed the identification and review of an additional 173 potentially misvalued codes. We initiated the Fourth Five-Year Review of work RVUs by soliciting public comments on potentially misvalued codes for all services included in the CY 2010 PFS final rule with comment period that was published in the
In summary, since CY 2009, CMS and the AMA RUC have addressed a number of potentially misvalued codes. For CY 2009, the AMA RUC recommended revised work values and/or PE inputs for 204 misvalued services (73 FR 69883). For CY 2010, an additional 113 codes were identified as misvalued and the AMA RUC provided us new recommendations for revised work RVUs and/or PE inputs for these codes to us as discussed in the CY 2010 PFS final rule with comment period (74 FR 61778). For CY 2011, CMS reviewed and adopted more appropriate values for 209 codes under the annual review of potentially misvalued codes. For CY 2012, we recently released the Fourth Five-Year Review of Work, which discussed the review of 173 potentially misvalued codes and proposed appropriate adjustments to RVUs. In section II.B.5.of this final rule with comment period, we also provide a list of codes identified for future consideration as part of the potentially misvalued codes initiative, that is, in addition to the codes that are part of the Fourth Five-Year Review of Work, as discussed in that section, we are requesting the AMA RUC review these codes and submit recommendations to us.
In addition to identifying and reviewing potentially misvalued codes, section 3134(a) of the Affordable Care Act added a new section 1848(c)(2)(L) of the Act, which specifies that the Secretary shall establish a formal process to validate RVUs under the PFS. The validation process may include validation of work elements (such as time, mental effort and professional judgment, technical skill and physical effort, and stress due to risk) involved with furnishing a service and may include validation of the pre-, post-, and intra-service components of work. The Secretary is directed to validate a sampling of the work RVUs of codes identified through any of the seven categories of potentially misvalued codes specified by section 1848(c)(2)(K)(ii) of the Act. Furthermore, the Secretary may conduct the validation using methods similar to those used to review potentially misvalued codes, including conducting surveys, other data collection activities, studies, or other analyses as the Secretary determines to be appropriate to facilitate the validation of RVUs of services.
In the CY 2011 PFS proposed rule (75 FR 40068), we solicited public comments on possible approaches and methodologies that we should consider for a validation process. We received a number of comments regarding possible approaches and methodologies for a validation process. As discussed in the CY 2011 PFS final rule with comment period (75 FR 73217), some commenters were skeptical that there could be viable alternative methods to the existing AMA RUC code review process for validating physician time and intensity that would preserve the appropriate relativity of specific physician's services under the current payment system. These commenters generally urged us to rely solely on the AMA RUC to provide valuations for services under the PFS.
While a number of commenters strongly opposed our plans to develop a formal validation process, many other commenters expressed support for the development and establishment of a system-wide validation process of the work RVUs under the PFS. As noted in the CY 2011 PFS final rule with comment period (75 FR 73217 through 73218), these commenters commended us for seeking new approaches to validation, as well as being open to suggestions from the public on this process. A number of commenters submitted technical advice and offered their time and expertise as resources for us to draw upon in any examination of possible approaches to developing a formal validation process.
However, in response to our solicitation of comments regarding time and motion studies, a number of commenters opposed the approach of using time and motion studies to validate estimates of physician time and intensity, stating that properly conducted time and motion studies are extraordinarily expensive and, given the thousands of codes paid under the PFS, it would be unlikely that all codes could be studied. As we stated in the CY 2011 PFS final rule with comment period (75 FR 73218), we understand that these studies would require significant resources and we remain open to suggestions for other approaches to developing a formal validation process. We noted that MedPAC suggested in its comment letter that we should consider “collecting data on a recurring basis from a cohort of practices and other facilities where physicians and nonphysician clinical practitioners
While we received a modest number of comments specifically addressing technical and methodological aspects of developing a validation system, we believe it would be beneficial to provide an additional opportunity for stakeholders to submit comments on data sources and possible methodologies for developing a system-wide validation system. In the proposed rule, we solicited comments on data sources and studies which may be used to validate estimates of physician time and intensity that could be factored into the work RVUs, especially for services with rapid growth in Medicare expenditures, which is one of the Affordable Care Act categories that the statute specifically directs us to examine. We also solicited comments regarding MedPAC's suggestion of “collecting data on a recurring basis from a cohort of practices and other facilities where physicians and nonphysician clinical practitioners work.” We note that after our proposed rule was released, MedPAC further discussed its continuing concerns regarding accurate data. “In our June 2011 Report to the Congress, we expressed deep concern in particular about the accuracy of the fee schedule's time estimates--estimates of the time that physicians and other health professionals spend furnishing services. These estimates are an important factor in determining the RVUs for practitioner work. However, research for CMS and for the Assistant Secretary for Planning and Evaluation has shown that the time estimates are likely too high for some services. In addition, anecdotal evidence and the experience of clinicians on the Commission raises questions about the time estimates” (MedPAC Report to the Congress “Medicare and the Health Care Delivery System, June 2011”).
We plan to discuss the validation process in more detail in a future PFS rule once we have considered the matter further in conjunction with the public comments received on the CY 2011 rulemaking, as well as comments received on this final rule with comment period. We note that any proposals we would make on the formal validation process would be subject to public comment, and we would consider those comments before finalizing the policies.
As previously discussed, we are statutorily required under section 1848(c)(2)(B) of the Act to review the RVUs of services paid under the PFS no less often than every 5 years. In the past, we have satisfied this requirement by conducting separate periodic reviews of work, PE, and malpractice RVUs for established services every 5-years in what is commonly known as CMS' Five-Year Reviews of Work, PE, and Malpractice RVUs. On May 24, 2011, we released the proposed notice regarding the Fourth Five-Year Review of Work RVUs. The most recent comprehensive Five-Year Review of PE RVUs occurred for CY 2010; the same year we began using the Physician Practice Information Survey (PPIS) data to update the PE RVUs. The last Five-Year Review of Malpractice RVUs also occurred for CY 2010. These Five-Year Reviews have historically included codes identified and nominated by the public for review, as well as those identified by CMS and the AMA RUC.
In addition to the Five-Year Reviews, beginning for CY 2009, CMS and the AMA RUC have identified and reviewed a number of potentially misvalued codes on an annual basis using various identification screens, such as codes with high growth rates, codes that are frequently billed together in one encounter, and codes that are valued as inpatient services but that are now predominately furnished as outpatient services. These annual reviews have not included codes identified by the public as potentially misvalued since, historically, the public has the opportunity to submit potentially misvalued codes during the Five-Year Review process.
With the enactment of the Affordable Care Act in 2010, which endorsed our initiative to identify and review potentially misvalued codes and emphasized the importance of our ongoing work in this area to improve accuracy and appropriateness of payments under the PFS, we believe that continuing the annual identification and review of potentially misvalued codes is necessary. Given that we are engaging in extensive reviews of work RVUs and direct PE inputs of potentially misvalued codes on an annual basis, we believe that separate and “freestanding” Five-Year Reviews of Work and PE may have become redundant with our annual efforts. Therefore, for CY 2012 and forward, we proposed to consolidate the formal Five-Year Review of Work and PE with the annual review of potentially misvalued codes. That is, we would begin meeting the statutory requirement to review work and PE RVUs for potentially misvalued codes at least once every 5-years through an annual process, rather than once every 5-years. Furthermore, to allow for public input and to preserve the public's ability to identify and nominate potentially misvalued codes for review, we proposed a process by which the public could submit codes for our potential review, along with supporting documentation, on an annual basis. Our review of these codes would be incorporated into our potentially misvalued codes initiative. This proposed public process is further discussed in section II.B.4. of this final rule with comment period. In the CY 2012 proposed rule, we solicited comments on our proposal to consolidate the formal Five-Year Reviews of Work and PE with the annual review of potentially misvalued codes.
To alleviate concerns that the consolidation could result in requiring specialty societies to survey a large
Commenters also expressed concern that CMS is proposing to review potentially misvalued codes on the same time frame as the review of new and revised codes where CMS has historically issued interim final values for these codes in the final rule with comment period. The commenters asserted they need to have the opportunity to review CMS' response to AMA RUC recommendations, comment on CMS' proposed values, and receive a response from CMS to these comments prior to January 1 of the year the revised RVUs will be used to pay physician claims. A commenter noted “physicians should not be penalized by having to receive potentially incorrect reimbursement for a procedure for as much as 12 months because of the government's timing of its notice and comment processes.” Other commenters, while supportive of CMS' proposal to consolidate reviews, stressed that the process should not be condensed so much that there is not time for thoughtful comment and consideration. Consequently, commenters urged CMS to work with the AMA RUC so that all recommendations for a given year are received by an earlier deadline, allowing for publication in that year's proposed rule and for comments to be addressed by CMS in that year's final rule before changes that affect payment are implemented.
To respond to the commenters who were worried that codes identified through the potentially misvalued codes process may not be equitably or “fairly” distributed among specialty societies and have suggested that CMS review a comparable proportion of codes for each specialty each year, we note that, based on our previous experience, the objective screens we have used to identify potentially misvalued codes do not produce lists of codes that are evenly distributed among the specialties that furnish them. Rather, the screens have tended to identify certain types of services more frequently than others (for example, due to rapidly changing technology) and therefore yield disproportionate numbers of potentially misvalued codes to be reviewed by the various specialty societies. However, we have received similar comments in previous rules regarding distribution among specialty societies. Consequently, in the CY 2012 proposed rule, we explicitly identified a list of potentially misvalued high expenditure codes that spans most specialties discussed in II.B.5.a. of this final rule with comment period.
Finally, to respond to the comments regarding the code review cycle, we note that the timing of CMS' current review process is constrained by the CPT Editorial Panel's scheduled release of new and revised codes by October 1 and the receipt of the complete AMA RUC's recommendations later in the year, which are at odds with the PFS rulemaking cycle. As we have indicated for many years in our PFS final rules with comment period, most recently in the CY 2011 rule (75 FR 73170), before adopting interim RVUs for new and revised codes, we have the opportunity to review and consider AMA RUC recommendations which are based on input from the medical community. If we did not adopt RVUs for new and revised codes in the initial year on an interim final basis, we would either have to delay using the codes for a year or permit each Medicare contractor to establish their own payment rate for the codes. We believe it would be contrary to the public interest to delay adopting values for new and revised codes for the initial year, especially since we have an opportunity to receive significant input from the medical community before adopting the values, and the alternatives could produce undesirable levels of uncertainty and inconsistency in payment for a year. We understand the preference of some commenters for the review of potentially misvalued codes to be conducted within a single rulemaking year in order to avoid payment under interim values for the coming year. However, we continue to believe that it is important to consolidate the work and PE reviews for all codes (new, revised, and potentially misvalued) into one cycle. As we have explained in several previous PFS final rules with comment period, most recently in the CY 2011 PFS final rule with comment period (75 FR 73170), we believe it is in the public interest to adopt interim final revised RVUs for codes that have been identified as misvalued. Similar to the new and revised codes, before making any changes to RVUs for potentially misvalued codes, we have an opportunity to review input from the medical community in the form of the AMA RUC recommendations for the codes. We believe a delay in implementing revised values for codes that have been identified as misvalued would perpetuate payment for the services at a rate that does not appropriately reflect the relative resources involved in furnishing the service and would continue unwarranted distortion in the payment for other services across the PFS.
We note that it is often difficult to draw definitive lines between the codes that are being reviewed as new, revised, or potentially misvalued. For example, CMS may identify a code as potentially misvalued in a given year and refer the family of codes to the AMA RUC for review. Subsequently, the AMA RUC may send the family of codes to the CPT Editorial Panel for revision because upon an initial review, the AMA RUC may have concluded that the family of services has evolved to the point that the code descriptors are no longer appropriate. The CPT Editorial Panel may revise the code(s) descriptors or may create entirely new codes to better define the service. In this final rule with comment period, we reviewed several new codes initially referred to the AMA RUC for review through our potentially misvalued codes initiative, and we believe that this trend likely will increase in the near future. Additionally, since CMS reviews and assigns interim values to new and revised codes in the PFS final rule with comment period for the coming year, consolidating the review of potentially misvalued codes with the new and revised codes is a more efficient and transparent process, and reduces the burden on both specialty societies and other stakeholders who would otherwise be called upon to consider, review and comment on the same family of codes in multiple rules. Moreover, consolidation of our review of new, revised, and potentially misvalued codes in one cycle allows for codes in a family to be reviewed together, resulting in more consistent valuation within code families and a better opportunity to maintain appropriate relativity within code families which, as we discuss in this section of this final rule with comment period, is a high priority.
Therefore, given the considerable overall support commenters expressed, we are finalizing our proposal without modification to consolidate periodic reviews of work and PE RVUs under section 1848(c)(2)(B) of the Act and of potentially misvalued codes under section 1848(c)(2)(K) of the Act into one annual process.
We note that while we proposed to review the physician work RVUs and direct PE inputs of potentially misvalued codes on an annual basis, we did not propose at this time to review malpractice RVUs on an annual basis. As discussed in section II.C. of this final rule with comment period, in general, malpractice RVUs are based on malpractice insurance premium data on a specialty level. The last comprehensive review and update of the malpractice RVUs occurred for CY 2010 using data obtained from the PPIS data. Since it is not feasible to conduct such extensive physician surveys to obtain updated specialty level malpractice insurance premium data on an annual basis, we believe the comprehensive review of malpractice RVUs should continue to occur at 5-year intervals.
Furthermore, in identifying and reviewing potentially misvalued codes on an annual basis, we note that this new proposed process presents us with the opportunity to review simultaneously both the work RVUs and the direct PE inputs for each code. Heretofore, the work RVUs and direct PE inputs of potentially misvalued codes were commonly reviewed separately and at different times. For example, a code may have been identified as potentially misvalued based solely on its work RVUs so the AMA RUC would have reviewed the code and provided us with recommendations on the physician times and work RVUs. However, the direct PE inputs of the code would not necessarily have been reviewed concurrently and therefore, the AMA RUC would not necessarily have provided us with recommendations for any changes in the direct PE inputs of the code that would have been warranted to ensure that the PE RVUs of the code are determined more appropriately. Therefore, while this code may have been recently reviewed and revised under the potentially misvalued codes initiative for physician work, the PE component of the code could still be potentially misvalued. Going forward, we believe combining the reviews of both physician work and PE for each code under our potentially misvalued codes initiative will align the review of these codes and lead to more accurate and appropriate payments under the PFS.
Finally, it is important to note that the code-specific resource based relative value framework under the PFS system is one in which services are ranked relative to each other. That is, the work RVUs assigned to a code are based on the physician time and intensity expended on that particular service as compared to the physician time and intensity of the other services paid under the PFS. This concept of relativity to other services also applies to the PE RVUs, particularly when it comes to reviewing and assigning correct direct PE inputs that are relative to other similar services. Consequently, we are emphasizing the need to review both the work and PE components of codes that are identified as part of the potentially misvalued initiative to ensure that appropriate relativity is constructed and maintained in several key relationships:
• The work and PE RVUs of codes are ranked appropriately within the code family. That is, the RVUs of services within a family should be ranked progressively so that less intensive services and/or services that require less physician time and/or require fewer or less expensive direct PE inputs should be assigned lower work or PE RVUs relative to other codes within the family. For example, if a code for treatment of elbow fracture is under review under the potentially misvalued codes initiative, we would expect the work and PE RVUs for all the codes in the family also be reviewed in order to ensure that relativity is appropriately constructed and maintained within this family. Furthermore, as we noted in the CY 2010 PFS final rule with comment period (74 FR 61941), when we submit codes to the AMA RUC and request its review, in order to maintain relativity, we emphasized the importance of reviewing the base code of a family. The base code is the most important code to review because it is the basis for the valuation of other codes within the family and allows for all related codes to be reviewed at the same time (74 FR 61941).
• The work and PE RVUs of codes are appropriately relative based on a comparison of physician time and/or intensity and/or direct inputs to other services furnished by physicians in the same specialty. To continue the example discussed previously, if a code for treatment of elbow fracture is under review, we would expect this code to be compared to other codes, such as codes for treatment of humerus fracture, or other codes furnished by physicians in the same specialty, in order to ensure that the work and PE RVUs are appropriately relative within the specialty.
• The work and PE RVUs of codes are appropriately relative when compared to services across specialties. While it may be challenging to compare codes that describe completely unrelated services, since the entire PFS is a budget neutral system where payment differentials are dependent on the relative differences between services, it is essential that services across specialties are appropriately valued relative to each other. To illustrate the point, if a service furnished primarily by dermatology is analogous in physician time and intensity to another service furnished primarily by allergy/immunology, then we would expect the work RVUs for the two services to be
Under the previous Five-Year Reviews, the public was provided with the opportunity to nominate potentially misvalued codes for review. To allow for public input and to preserve the public's ability to identify and nominate potentially misvalued codes for review under our annual potentially misvalued codes initiative, we proposed a process by which on an annual basis the public could submit codes, along with documentation supporting the need for review. We proposed that stakeholders may nominate potentially misvalued codes by submitting the code with supporting documentation during the 60-day public comment period following the release of the annual PFS final rule with comment period. We would evaluate the supporting documentation and decide whether the nominated code should be reviewed as potentially misvalued during the following year. If we were to receive an overwhelming number of nominated codes that qualified as potentially misvalued in any given year, we would prioritize the codes for review and could decide to hold our review of some of the potentially misvalued codes for a future year. We noted that we may identify additional potentially misvalued codes for review by the AMA RUC based on the seven statutory categories under section 1848(c)(2)(K)(ii) of the Act.
We encouraged stakeholders who believe they have identified a potentially misvalued code, supported by documentation, to nominate codes through the public process. We emphasized that in order to ensure that a nominated code will be fully considered to qualify as a potentially misvalued code to be reviewed under our annual process, accompanying documentation must be provided to show evidence of the code's inappropriate valuation, either in terms of inappropriate physician times, work RVUs, and/or direct PE inputs. The AMA RUC developed certain “Guidelines for Compelling Evidence” for the Third Five-Year Review which we believe could be applicable for members of the public as they gather supporting documentation for codes they wish to nominate for the annual review of potentially misvalued codes. The specific documentation that we would seek under this proposal includes the following:
• Documentation in the peer reviewed medical literature or other reliable data that there have been changes in physician work due to one or more of the following:
++ Technique.
++ Knowledge and technology.
++ Patient population.
++ Site-of-service.
++ Length of hospital stay.
++ Physician time.
• An anomalous relationship between the code being proposed for review and other codes. For example, if code “A” describes a service that requires more work than codes “B,” “C,” and “D,” but is nevertheless valued lower. The commenter would need to assemble evidence on service time, technical skill, patient severity, complexity, length of stay and other factors for the code being considered and the codes to which it is compared. These reference services may be both inter- and intra-specialty.
• Evidence that technology has changed physician work, that is, diffusion of technology.
• Analysis of other data on time and effort measures, such as operating room logs or national and other representative databases.
• Evidence that incorrect assumptions were made in the previous valuation of the service, such as a misleading vignette, survey, or flawed crosswalk assumptions in a previous evaluation;
• Prices for certain high cost supplies or other direct PE inputs that are used to determine PE RVUs are inaccurate and do not reflect current information.
• Analyses of physician time, work RVU, or direct PE inputs using other data sources (for example, Department of Veteran Affairs (VA) National Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS), and the Physician Quality Reporting System (PQRS) databases).
• National surveys of physician time and intensity from professional and management societies and organizations, such as hospital associations.
We noted that when a code is nominated, and supporting documentation is provided, we would expect to receive a description of the reasons for the code's misvaluation with the submitted materials. That is, we would require a description and summary of the evidence is required that shows how the service may have changed since the original valuation or may have been inappropriately valued due to an incorrect assumption. We would also appreciate specific
As proposed in the CY 2012 proposed rule, after we receive the nominated codes during the 60-day comment period following the release of the annual PFS final rule with comment period, we would review the supporting documentation and assess whether they appear to be potentially misvalued codes appropriate for review under the annual process. We proposed that, in the following PFS proposed rule, we would publish a list of the codes received under the public nomination process during the previous year and indicate whether the codes would be included in the current review of potentially misvalued codes. We would also indicate the publicly nominated codes that we would not be including in the current review (whether due to insufficient documentation or for other reasons). Under this proposed process, the first opportunity for the public to nominate codes would be during the public comment period for this CY 2012 PFS final rule with comment period. We would publish in the CY 2013 PFS proposed rule, the list of nominated codes, and indicate whether they will be reviewed as potentially misvalued codes. We would request that the AMA RUC review these potentially misvalued codes along with any other codes identified by CMS as potentially misvalued, and provide to us recommendations for appropriate physician times, work RVUs, and direct PE inputs. We requested public comments on this proposed code nomination process and indicated that we would consider any suggestions to modify and improve the proposed process.
A number of commenters stated that they believe the supporting documentation criteria would ensure that all requests are considered fairly and urged CMS to conduct a rigorous review of public comments and supporting documentation when determining whether a publicly nominated code should be reviewed as a potentially misvalued code, especially when a code is nominated by only a few commenters or even a single commenter. Other commenters thought CMS should provide “guidelines” to justify bringing a code(s) forward for review in order to prevent a member of the public from asking that every single code paid under the Medicare PFS be reviewed. Some commenters noted that “professional associations participating on the RUC frequently struggle with the concept and documentation of ‘Compelling Evidence.' ” Consequently, the commenters believed that the public will likewise struggle with the concept of submitting evidence to substantiate potentially misvalued codes. Other commenters noted that the public nomination process proposed by CMS requires that commenters nominating codes include supportive evidence to show that the resource use related to the delivery of a service has changed in a way to suggest a code's RVUs may be misvalued, whereas CMS is not obligated to follow this same standard. The commenters suggested that CMS should be required to adhere to the supporting documentation that the public would need to provide when nominating a potentially misvalued code for review through the proposed public nomination process.
Several commenters believed that CMS should not restrict which codes could be nominated or referred. A number of commenters objected to CMS' proposal to consider only nominations of active codes that are covered by Medicare at the time of the nomination. The commenters believed this proposal was unfair to those specialties that do not serve a predominantly Medicare-aged population but who must also rely on the the resource based relative value scale. The commenters asserted that CMS has historically published the relative value recommendations from the AMA RUC for preventive services and other non-covered services. Commenters recommended that all valid CPT codes should remain open to comment and review. Commenters also believed as long as a stakeholder could provide adequate supporting documentation to support the nomination of the code, CMS should allow for the review of any code, including any codes that went through refinement in the past.
Commenters also expressed appreciation that CMS proposed to disclose in the PFS proposed rule the list of codes identified as potentially misvalued (including those that originated from the public nomination process) for future review because publishing the misvalued codes list provides some notice to affected parties who may wish to provide input during the review process. Some commenters suggested that following the nomination process, specialty societies should have another opportunity to review and comment on any relevant nominations before CMS decides to include the codes on the list of potentially misvalued codes in the proposed rule.
However, to respond to the commenters who suggested we should be required to follow the same process as the public for nominating potentially misvalued codes, we note that we have longstanding statutory authority to identify and review the RVUs of services no less often than every 5-years and that we frequently have exercised our discretion to prioritize codes for review.
We understand commenters' concerns about the burden that reviewing codes entails. We believe that by ranking codes in order of interest to CMS for review over a reasonable timeframe, we can help to reduce some of that burden. For this year, we have prioritized the review of codes to those that have some degree of significant financial impact on the PFS. Specifically, we have proposed a list of high expenditure codes for review in CY 2012. We also are limiting the review of RVUs to codes that are active, covered by Medicare, and for which the RVUs are used for payment purposes under the PFS so that resources are not expended on the review of codes with RVUs that have no financial impact on the PFS. We note that while we have published the AMA RUC relative value recommendations for non-covered services as a courtesy, these codes historically have not been reviewed by CMS and the RVUs are not valid for Medicare payment purposes. Therefore, while we will continue our historical practice of publishing the AMA RUC relative value recommendations for non-covered services, we will not be accepting for review either inactive or non-covered codes (for which the RVUs will have no financial impact on the PFS) through the public nomination process. We will consider any other active and Medicare covered services that are nominated by the public and supported by documentation of the nature described previously in this section.
Finally, we note that all timely comments received on the final rule with comment period can be accessed and reviewed by the public through
While we anticipate receiving nominations from the public for potentially misvalued codes in conjunction with rulemaking, we believe it is imperative that we continue
In the CY 2011 PFS proposed rule (75 FR 40068 through 40069), we identified and referred to the AMA RUC a list of potentially misvalued codes in three areas:
• Codes on the AMA RUC's multi-specialty points of comparison (MPC) list (used as reference codes in the valuation of other codes),
• Services with low work RVUs that are billed in multiples (a statutory category); and
• Codes that have low work RVUs for which CMS claims data show high volume (that is, high utilization of these codes represents a significant dollar impact in the payment system).
Our understanding is that the AMA RUC is currently working towards reviewing these codes at our request. We intend to provide an update and discuss any RVU adjustments to codes that have been identified as potentially misvalued in the CY 2012 PFS final rule, as they move through the review process.
Meanwhile, for CY 2012, we are continuing with our work to identify and review additional services under the potentially misvalued codes initiative. Stakeholders have noted that many of the services previously identified under the potentially misvalued codes initiative were concentrated in certain specialties. To develop a robust and representative list of codes for review under the potentially misvalued codes initiative, we examined the highest PFS expenditure services by specialty (based on our most recently available claims data and using the specialty categories listed in the PFS specialty impact table, see Table 84 in section IX.B. of this final rule with comment period) and identified those that have not been reviewed since CY 2006 (which was the year we completed the Third Five-Year Review of Work and before we began our potentially misvalued codes initiative).
In our examination of the highest PFS expenditure codes for each specialty (we used the specialty categories listed in the PFS specialty impact table, see Table 84 in section IX.B. of this final rule with comment period), we noted that Evaluation and Management (E/M) services consistently appeared in the top 20 high PFS expenditure services. We noted as well that most of the E/M services have not been reviewed since the comprehensive review of services for the Third Five-Year Review of Work in CY 2006. Therefore, after an examination of the highest PFS expenditure codes for each specialty, we have developed two code lists of potentially misvalued codes which we proposed to refer to the AMA RUC for review.
First, we proposed to request that the AMA RUC conduct a comprehensive review of all E/M codes, including the codes listed in Table 6. As shown previously, E/M services are commonly among the highest PFS expenditure services. Additionally in recent years, there has been significant interest in delivery system reforms, such as patient-centered medical homes and making the primary care physician the focus of managing the patient's chronic conditions. The chronic conditions challenging the Medicare population include heart disease, diabetes, respiratory disease, breast cancer, allergy, Alzheimer's disease, and factors associated with obesity. Thus, as the focus of primary care has evolved from an episodic treatment-based orientation to a focus on comprehensive patient-centered care management in order to meet the challenges of preventing and managing chronic disease, we believed a more current review of E/M codes was warranted. We note that although physicians in primary care specialties bill a high percentage of their services using the E/M codes, physicians in non-primary care specialties also bill these codes for many of their services.
Since we believe the focus of primary care is evolving to meet the challenges of preventing and managing chronic disease, we noted in the proposed rule that we would like the AMA RUC to prioritize review of the E/M codes and provide us with recommendations on the physician times, work RVUs, and direct PE inputs of at least half of the E/M codes listed in Table 6 by July 2012 in order for us to include any revised valuations for these codes in the CY 2013 PFS final rule with comment period. We also noted that we would expect the AMA RUC to review the remaining E/M codes listed in Table 6 by July 2013 in order for us to complete the comprehensive re-evaluation of E/M services and include the revised valuations for these codes in the CY 2014 PFS final rule with comment period.
The majority of commenters requested that CMS withdraw its proposal to review all E/M codes because the current E/M codes, as written, do not fully encompass the work associated with patient-centered care management. The commenters noted that there are many codes that have been reviewed and valued by the AMA RUC for such services, including medical team conference, comprehensive preventive evaluation, physician supervision of a hospice patient, international normalized ratio management, smoking and alcohol counseling, case management, monthly medical home management, anticoagulation management, and phone or electronic evaluation. Some commenters noted that the AMA RUC has previously provided recommendations to value telephone and electronic evaluation services that complement coordinated care. While Medicare either does not pay separately for or does not cover many of these services, the commenters believed these services are part of a patient centered care management model and are necessary services for managing patients with chronic conditions. The commenters urged CMS to provide explicit payment for these coordination services rather than attempt to address the primary care issue through the comprehensive review of current E/M code values. For example, commenters suggested CMS “work with the medical community to develop and implement the patient-centered medical home, reward prevention and wellness, eliminate fragmentation and duplication, and produce a cohesive system of care that prevents unnecessary complications from acute or chronic illness, hospitalizations, and other avoidable expenses.”
Some commenters asserted that the current E/M codes have code descriptors and documentation requirements that do not capture the work necessary for chronic disease management. Commenters noted that the current E/M codes were developed 20 years ago and describe care of patients with acute problems. In addition, the commenters believed the current E/M codes do not describe care to treat chronic medical problems of patients in skilled nursing facilities which were treated in the hospital a few years ago. Commenters asserted that physicians are now caring for an increasingly complex elderly population with multiple chronic problems who require services such as extensive care coordination that was not part of standard medical practice when many of the E/M codes were created. Thus, while the commenters agreed that care coordination would help better manage chronic diseases in the elderly, they believed this care would be better described by new codes, and not the current E/M codes. Accordingly, the commenters recommended that CMS undertake a comprehensive review of the existing E/M service codes in collaboration with the AMA RUC and the CPT Editorial Panel. That is, the commenters envisioned and supported an extensive review that considers revisions to these codes that will better recognize the work of primary care physicians and cognitive specialists who provide care for patients with acute and chronic conditions before focusing on the valuation of the codes.
Many commenters, representing different medical specialties, noted that CMS' focus on primary care as the locus for care coordination and chronic disease management is misplaced. Commenters asserted that patient care coordination, prevention, performance measurement and the adoption of health information technology affects the entire medical community. These commenters argued that that these trends and initiatives will pose challenges for specialty medicine as well. Specifically, a commenter stated, “We believe that high quality provision of such services is not defined by the specialty of the provider and thus we cannot support policy options that focus on provider specialty rather than on the content and the quality of the service being provided.”
Other commenters noted that the E/M codes are used by many surgeons and other specialists because nearly every procedural CPT code involves one or more E/M service within the code's global period. Commenters suggested that CMS unbundle E/M services from surgical codes in order to ensure that surgical patients received the appropriate follow-up care and management of post-procedure activity to achieve desired outcomes. That is, CMS should apply zero-day global periods to surgical codes, such that post-operative hospital and office visits must meet the medical necessity and documentation requirements for evaluation and management coding in order to be paid separately.
Finally, some commenters noted that the previous comprehensive review of the evaluation and management codes in 2006 did not improve the emphasis on chronic care management, stating that “the third 5-Year Review failed to achieve the goals of properly compensating primary physicians for chronic care management, so there is no expectation that another review within the existing system will result in a different outcome.” A few commenters supported the proposal to review the E/M codes and they “consider the review and re-evaluation of E&M codes as a critical immediate step to ensure patient access to care and to maintaining the viability of the [their] workforce.”
We would like to assure the commenters that we, as well as the HHS' Assistant Secretary for Planning and Evaluation (ASPE), are actively researching our current coding and payment systems to appropriately value these services. As detailed in the proposed rule (75 FR 42917), we are considering several approaches to improve coordinated care and health care transitions to reduce readmissions or subsequent illnesses, improve beneficiary outcomes, and avoid additional financial burden on the health care system. We are committed to achieving better care for individuals, better health for populations, and reduced expenditure growth. Reforms such as Accountable Care Organizations and Medical Homes and reforms of our current fee-for-service payment system are designed to achieve these goals.
As an example, we recently launched the Partnership for Patients (in April 2011), a national public-private patient safety initiative for which more than 6,000 organizations—including physician and nurses' organizations, consumer groups, employers and over 3,000 hospitals—have pledged to help achieve the Partnership's goals of reducing hospital complications and improving care transitions. The Partnership for Patients includes the Community-Based Care Transitions Program, which provides funding to community-based organizations partnering with eligible hospitals to coordinate a continuum of post-acute care in order to test models for improving care transitions for high risk Medicare beneficiaries. Achieving the goals of the Partnership for Patients will take the combined effort of many key stakeholders across the health care system—physicians, nurses, hospitals, health plans, employers and unions, patients and their advocates, as well as the Federal and State governments. Many important stakeholders have already pledged to join this Partnership in a shared effort to save thousands of lives, stop millions of injuries and take important steps toward a more dependable and affordable health care system. We are currently working with these stakeholders to improve care processes and systems, enhance communication and coordination to reduce complication for patients, raise public awareness and develop information, tools and resources to help patients and families effectively engage with their providers to avoid preventable complications, and provide the incentives and support that will enable clinicians and hospitals to deliver high-quality health care to their patients, with minimal burdens. (For more information regarding the Partnership for Patients Initiative, we refer readers to
Additionally, the Center for Medicare and Medicaid Innovation (Innovation Center) of CMS has undertaken several demonstrations to support care coordination and primary care. Most recently, on September 28, 2011, we released a request for applications for the Comprehensive Primary Care Initiative, a CMS-led multipayer initiative to provide enhanced support for comprehensive primary care. A primary care practice is a key point of contact for patients' health care needs. In recent years, new ways have emerged to strengthen primary care by improving care coordination, making it easier to work together, and helping clinicians spend more time with their patients. Under the Comprehensive Primary Care Initiative, we intend to pay primary care providers a monthly care management fee on behalf of Medicare fee-for-service beneficiaries and, in participating states, Medicaid fee-for-service beneficiaries for improved and comprehensive care management. Specifically, participating primary care practices will be given support to better coordinate primary care for their Medicare patients, including creating personalized care plans for patients with serious or chronic diseases follow personalized care plans, give patients 24-hour access to care and health information, more preventive care, and more patient centered care management. The work of the Comprehensive Primary Care Initiative could inform and help further develop innovative revisions to the PFS. (For more information regarding the Comprehensive Primary Care Initiative, we refer readers to
Further, HHS' ASPE has convened a Technical Expert Panel (TEP) to conduct studies that could inform efforts to accurately align physician payments in Medicare, which may help expand the supply of primary care physicians and improve the value of care for beneficiaries. One of the major tasks being undertaken by this TEP is to develop new approaches to defining visits and paying for primary care services under the physician fee schedule. There are a number of services that are increasingly viewed as key to high-quality primary care but that do not require a face-to-face encounter with the patient. While the valuations of current E/M services include care coordination, communication and other management, this project will consider how visits are defined and will examine whether we need to adjust payments to appropriately pay for primary care activities. It makes sense to reassess how visits are defined because it is becoming increasingly more common for primary care physicians to be engaged in the management of multiple established chronic conditions rather than evaluation and treatment of acute, new problems. The complexity and time for the physician is more often associated with decision-making than with the history-taking and physicals. Further, the chronic care model involves much greater attention to teaching patient self-management skills, doing more proactive care coordination, and anticipation of health care needs. We believe the TEP findings could provide us with improved information for the valuation of primary care services, including care coordination, which may be more effective than simply reviewing the work RVUs and direct PE inputs of current E/M services. In addition to ASPE's efforts that are focused directly on physician payment, they also have a second project underway to research effective methods for increasing the supply of primary care providers and services. This project will analyze what is known about the relative effectiveness of various strategies to increase the supply of primary care providers and services in order to meet these future health system needs.
Accordingly, given the significant concern expressed by the majority of commenters over the possible inadequacies of the current E/M coding and documentation structure to address evolving chronic care management and support primary care and our ongoing research on how to best provide payment for primary care and patient-centered care management, we are not finalizing the proposal to review the list of 91 E/M codes at this time. Instead, we believe allowing time for consideration of the findings of the Comprehensive Primary Care Initiative, the ASPE research on balancing physician incentives and evaluating payment for primary care services, demonstrations that we have undertaken on care coordination, as well as other initiatives assessing how to value and encourage primary care will provide improved information for the valuation of chronic care management, primary care, and care transitions. We also will continue to consider the numerous policy alternatives that commenters offered, such as separate E/M codes for established visits for patients with chronic disease versus a post-surgical follow-up office visits. We intend to continue to work with stakeholders on how to value and pay for primary care and patient-centered care management, and we continue to welcome ideas from the medical community for how to improve care management through the provision of primary care services. Second, we also proposed providing a select list of high PFS expenditure procedural codes representing services furnished by an array of specialties, as listed in Table 7. These procedural codes have not been reviewed since CY 2006 (before we began our potentially misvalued codes initiatives in CY 2008) and, based on the most recently available data, have CY 2010 allowed charges of greater than $10 million at the specialty level (based on the
Some commenters agreed that high expenditure codes should be reviewed on a periodic basis; however, the commenters suggested that the periodic basis should be a reasonably long length of time and 5 (or 6) years is not a sufficiently long period of time absent other evidence of potential changes in the service under review. The commenters suggested that CMS could automatically review high expenditure procedures every 10 or 15 years. MedPAC, commenting on the CY 2012 PFS proposed rule, agreed that accurate payments for high expenditure services “can improve the balance of payments between primary care and services such as imaging tests, and other procedures.”
Finally, we received a number of comments on specific codes where commenters provided arguments as to why CMS should remove these codes from the high expenditure code list. The commenters noted that specific codes had been considered by the AMA RUC in the past five years or that certain codes are currently scheduled to be considered by either the CPT Editorial Panel for new coding or the AMA RUC for revised valuations (for work RVUs and/or PE inputs) at an upcoming meeting.
Because of the concerns expressed by commenters about the burden associated with code reviews, we believe that it is appropriate to prioritize review of codes to a manageable subset that also have a high impact on the PFS and work with the specialty society to spread review of the remaining codes identified as potentially misvalued over a reasonable timeframe. In this spirit, we do not believe it would be appropriate to remove codes from the high expenditure list unless we find, as some commenters indicated, that we have reviewed both the work RVUs and direct PE inputs for the code during the
Finally, in reviewing the code specific comments, we noticed that in many cases, the commenters believed that the code should be removed from this code list because the work RVU had been reviewed within 6-years, or the code was recently considered at an AMA RUC meeting. We note that while a number of codes have been considered at an AMA RUC meeting, until we receive recommendations and review the codes for both work and direct PE inputs, we will continue to include these codes on the high expenditure list. We think some of the commenters may have believed that since a code was discussed at an AMA RUC meeting and sent to the CPT editorial panel or the code is being surveyed and prepared for a presentation at the AMA RUC, the code should be removed from the potentially misvalued high expenditure code list. We are clarifying that even if a code is about to be reviewed by the specialty society or AMA RUC, or referred to the CPT Editorial Panel, we would continue to include the code on our list of codes for review under the potentially misvalued codes initiative. Similarly, if a code is being reviewed by the CPT editorial panel, we would consider any replacement codes to address the potential misvaluation associated with the previous codes.
Accordingly, we are finalizing the proposed high expenditure/high volume list without modification.
On an ongoing basis, public stakeholders (including physician specialty societies, beneficiaries, and other members of the public) bring concerns to us regarding direct PE inputs and physician work. In the past, we would consider these concerns and address them through proposals in annual rulemaking, technical corrections, or by requesting that the AMA RUC consider the issue.
Since last year's rulemaking, the public has brought a series of issues to our attention that relate directly to direct PE inputs and physician work. We believe that some of these issues will serve as examples of codes that might be brought forward by the public as potentially misvalued in the proposed nomination process as discussed previously in section II.B.4. of this final rule with comment period.
As stated in the CY 2011 PFS final rule with comment period (75 FR 73350), we accepted the AMA RUC- recommended direct PE inputs for these codes, with refinements to the equipment minutes to assure that the time associated with the equipment items reflected the time during the intra-service period when a clinician is using the piece of equipment, plus any additional time the piece of equipment is not available for use for another patient due to its use during the designated procedure. We believe that the direct PE inputs of the new codes reflect the typical resources required to furnish the services in question.
However, stakeholders have alerted us that the resulting PE RVUs for the new codes reflect an anomalous rank order in comparison to the previously existing stand-alone codes. Specifically, the PE RVUs for the codes that describe CT scans without contrast for either body region are greater than the PE RVUs for 74176, which describes a CT scan of both body regions. We believe that the anomalous rank order of the PE RVUs for this series of codes may be the result of outdated direct PE inputs for the previously existing stand-alone codes. The physician work for those codes was last reviewed by the AMA RUC during the Third Five-Year Review of Work for CY 2007. However, the direct PE inputs for the codes have not been reviewed since 2003. Therefore, we are requesting that the AMA RUC review both the direct PE inputs and work values of the following codes in accordance with the consolidated approach to reviewing potentially misvalued codes as outlined in section II.B.2.c. of this final rule with comment period:
• 72192 Computed tomography, pelvis; without contrast material.
• 72193 Computed tomography, pelvis; with contrast material(s).
• 72194 Computed tomography, pelvis; without contrast material, followed by contrast material(s) and further sections.
• 74150 Computed tomography, abdomen; without contrast material.
• 74160 Computed tomography, abdomen; with contrast material(s).
• 74170 Computed tomography, abdomen; without contrast material, followed by contrast material(s) and further sections.
While we acknowledge the occasional irregularities that result from the application of broad-based payment transitions, our longstanding policy in a PFS transition payment year is that if the CPT Editorial Panel creates a new code for that year, the new code would be paid at its fully implemented PFS amount and not at a transition rate for that year.
While the commenters suggested that the RUC reviewed the direct PE inputs of the component codes recently, we have received no recent recommendation from the RUC regarding the direct PE inputs for these codes. Had the RUC reviewed the direct PE inputs for the component codes and made recommendations either to maintain or amend the current direct PE inputs, we would have responded to those recommendations. After considering these comments and noting the technical refinements to the direct PE inputs of the combined codes, we continue to believe that the direct PE inputs of the component codes should be reviewed. Therefore, we are maintaining our request that the RUC review the component codes.
We acknowledge the RUC's concern that the commenter may have been comparing his perception of direct practice expense costs with broader practice expense payments for this code. We acknowledge the practice expense portion of PFS payment is developed in consideration of both direct and indirect practice expense costs. We also concur with the RUC that interested stakeholders can review the publicly available direct PE inputs associated with each code. Those inputs are available in the direct PE database on the CMS Web site under the downloads section for the “CY 2012 PFS final rule with comment period” at:
However, we note that the stakeholder's assessment of the direct costs associated with the typical service reported using CPT code 88305 is significantly lower than the summed direct practice expense inputs currently associated with the code. Additionally, as we stated in the CY 2012 PFS proposed rule, we are asking the RUC to review the direct PE inputs of the code because they have not been reviewed since 1999. We also point out that if the stakeholder had not brought the concern to us, this code would have appeared on our list of PFS high expenditure procedural codes that had not been reviewed since CY 2006. After consideration of these comments, we are maintaining our request that the RUC review CPT code 88305, but in the case of this code, we are only asking for a review of direct PE inputs.
For CY 2011, the AMA's CPT Editorial Panel created two new cytopathology codes that describe in situ hybridization testing using urine samples: CPT code 88120 (Cytopathology, in situ hybridization (
Because the descriptors indicate that the new codes account for approximately four probes, whereas 88367 and 88368 describe each probe, there are more PE RVUs associated with the new codes than with the previously existing codes that are currently still used for any specimen except for urine. However, because the previously existing codes are billed per probe, the payment for a test using a different specimen type could vary depending upon the number of probes. For example, a practitioner furnishing a test involving a blood specimen and using three probes would bill CPT code 88368 (total RVUs: 6.28) three times with the result of 18.84 RVUs. A practitioner furnishing the same test but using a urine sample instead of a blood sample would receive payment based on the 13.47 RVUs associated with CPT code 88120.
We accepted the RUC-recommended work values and direct PE inputs, without refinement, for the two new cytopathology codes that describe in situ hybridization testing using urine samples. We reviewed the direct PE recommendations made by the AMA RUC and considered the inputs to be appropriate. However, we shared LUGPA's concerns regarding the potential payment discrepancies between the codes that describe the same test using different specimen media. Therefore, in the CY 2012 PFS proposed rule, we asked the AMA RUC to review the both the direct PE inputs and work values of the following codes
However, we continue to share the commenter's concerns regarding the potential payment discrepancies between the codes that describe the same test using different specimen media. If the direct resources required for conducting the test using urine specimens are different from the direct resources required for conducting the test using other specimen media, we do not believe it would be appropriate to assume the typical direct practice expense inputs for the non-specific specimen media codes that were previously valued based upon all the specimen media including urine are still accurate now that services using urine will be reported using different codes.
Therefore, we maintain our request as stated in the in the CY 2012 PFS proposed rule (76 FR 42795 and 42796) that the AMA RUC review both the direct PE inputs and work values of the existing codes that describe the test using specimen media other than urine.
After consideration of these comments, and in anticipation of forthcoming review of codes 88365, 88367, and 88368, we are maintaining for CY 2012 the current direct PE inputs for CPT codes 88120 and 88121 on an interim basis subject to public comment.
In the past, the AMA RUC has provided us with valuable recommendations regarding particular categories of equipment and supply items that are used as direct PE inputs for a range of codes. For example, in the 2011 PFS final rule (75 FR 73204), we made changes to a series of codes following the RUC's review of services that include the radiographic fluoroscopic room (CMS Equipment Code EL014) as a direct PE input. The RUC review revealed the use of the item to no longer be typical for certain services in which it had been specified within the direct cost inputs. These recommendations have often prompted our proposals that have served to maintain appropriate relativity within the PFS, and we hope that the RUC will continue to address issues relating to equipment and supply inputs that affect many codes. Furthermore, we believe that in these kinds of cases, it may be appropriate to make changes to the related direct PE inputs for a series of codes without reevaluating the physician work or other direct PE inputs for the individual codes. In other words, while we generally believe that both the work and the direct practice expense inputs should be reviewed whenever the RUC makes recommendations regarding either component of a code's value, we recognize the value of discrete RUC reviews of direct PE items that serve as inputs for a series of service codes.
• 22523 (Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device, 1 vertebral body, unilateral or bilateral cannulation (
• 22524 (Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device, 1 vertebral body, unilateral or bilateral cannulation (
• 22525 (Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device, 1 vertebral body, unilateral or bilateral cannulation (
In the case of these codes, we are asking the RUC to make recommendations regarding the appropriateness of creating nonfacility direct PE inputs. If the RUC were to make direct PE recommendations, we would review those recommendations as part of the annual process.
We thank the public for bringing these issues to our attention and kindly request that the public continue to do so.
Medicare has a longstanding policy to reduce payment by 50 percent for the second and subsequent surgical procedures furnished to the same patient by the same physician on the same day, largely based on the presence of efficiencies in the practice expense (PE) and pre- and post-surgical physician work. Effective January 1, 1995, the MPPR policy, with the same percentage reduction, was extended to nuclear medicine diagnostic procedures (CPT codes 78306, 78320, 78802, 78803, 78806, and 78807). In the CY 1995 PFS final rule with comment period (59 FR 63410), we indicated that we would consider applying the policy to other diagnostic tests in the future.
Consistent with recommendations of MedPAC in its March 2005 Report to the Congress on Medicare Payment Policy, under the CY 2006 PFS, the MPPR policy was extended to the technical component (TC) of certain diagnostic imaging procedures performed on contiguous areas of the body in a single session (70 FR 70261). The reduction recognizes that, for the second and subsequent imaging procedures, there are some efficiencies in clinical labor, supplies, and equipment time. In particular, certain clinical labor activities and supplies are not duplicated for subsequent procedures and, because equipment time and indirect costs are allocated based on clinical labor time, those would also be reduced accordingly.
The imaging MPPR policy originally applied to computed tomography (CT) and computed tomographic angiography (CTA), magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA), and ultrasound services within 11 families of codes based on imaging modality and body region. When we adopted the policy in CY 2007, we stated that we believed efficiencies were most likely to occur when imaging procedures are performed on contiguous body areas because the patient and equipment have already been prepared for the second and subsequent procedures, potentially yielding resource savings in areas such as clerical time, technical preparation, and supplies (70 FR 45850). The MPPR policy originally applied only to procedures furnished in a single session involving contiguous body areas within a family of codes, not across families. Additionally, while the MPPR policy applies to TC-only services and to the TC of global services, it does not apply to professional component (PC) services.
Under the current imaging MPPR policy, full payment is made for the TC of the highest paid procedure, and payment is reduced by 50 percent of the TC for each additional procedure when an MPPR scenario applies. We originally planned to phase in the imaging MPPR policy over a 2-year period, with a 25 percent reduction in CY 2006 and a 50 percent reduction in
In the July 2009 GAO report entitled, “Medicare Physician Payments: Fees Could Better Reflect Efficiencies Achieved when Services are Provided Together,” the GAO recommended that we take further steps to ensure that fees for services paid under the PFS reflect efficiencies that occur when services are furnished by the same physician to the same beneficiary on the same day. The GAO recommended the following: (1) expanding the existing imaging MPPR policy for certain services to the PC to reflect efficiencies in physician work for certain imaging services; and (2) expanding the MPPR to reflect PE efficiencies that occur when certain nonsurgical, nonimaging services are furnished together. The GAO report also encouraged us to focus on service pairs that have the most impact on Medicare spending.
In its March 2010 report, MedPAC noted its concerns about mispricing of services under the PFS. MedPAC indicated that it would explore whether expanding the unit of payment through packaging or bundling would improve payment accuracy and encourage more efficient use of services.
In the CYs 2009 and 2010 PFS proposed rules (73 FR 38586 and 74 FR 33554, respectively), we stated that we planned to analyze nonsurgical services commonly furnished together (for example, 60 to 75 percent of the time) to assess whether an expansion of the MPPR policy could be warranted. MedPAC encouraged us to consider duplicative physician work, as well as PE, in any expansion of the MPPR policy.
Section 1848(c)(2)(K) of the Act (as added by section 3134(a) of the Affordable Care Act) specifies that the Secretary shall identify potentially misvalued codes by examining multiple codes that are frequently billed in conjunction with furnishing a single service, and review and make appropriate adjustments to their relative values. As a first step in applying this provision, in the CY 2010 final rule with comment period, we implemented a limited expansion of the imaging MPPR policy to additional combinations of imaging services.
Effective January 1, 2011 the imaging MPPR applies regardless of code family; that is, the policy applies to multiple imaging services furnished within the same family of codes or across families. This policy is consistent with the standard PFS MPPR policy for surgical procedures that does not group procedures by body region. The current imaging MPPR policy applies to CT and CTA, MRI and MRA, and ultrasound procedure services furnished to the same patient in the same session, regardless of the imaging modality, and is not limited to contiguous body areas.
We note that section 1848(c)(2)(B)(v)(VI) of the Act (as added by section 3135(b) of the Affordable Care Act) specifies that reduced expenditures attributable to the increase in the imaging MPPR from 25 to 50 percent (effective for fee schedules established beginning with 2010 and for services furnished on or after July 1, 2010) are excluded from the PFS budget neutrality adjustment. That is, the reduced payments for code combinations within a family of codes (contiguous body areas) are excluded from budget neutrality. However, this exclusion only applies to reduced expenditures attributable to the increase in the MPPR percentage from 25 to 50 percent, and not to reduced expenditures attributable to our policy change regarding additional code combinations across code families (non-continguous body areas) that are subject to budget neutrality under the PFS
The complete list of codes subject to the CY 2012 MPPR policy for diagnostic imaging services is included in Addendum F.
As a further step in applying the provisions of section 3134(a) of the Affordable Care Act, effective January 1, 2011, we implemented an MPPR for therapy services. The MPPR applies to separately payable “always therapy” services, that is, services that are only paid by Medicare when furnished under a therapy plan of care. Contractor-priced codes, bundled codes, and add-on codes are excluded because an MPPR would not be applicable for “always therapy” services furnished in combination with these codes. The complete list of codes subject to the MPPR policy for therapy services is included in Addendum H.
In the CY 2011 proposed rule (75 FR 44075), we proposed to apply a 50 percent payment reduction to the PE component of the second and subsequent therapy services for multiple “always therapy” services furnished to a single patient in a single day. However, in response to public comments, in the CY 2011 PFS final rule with comment period (75 FR 73232), we adopted a 25 percent payment reduction to the PE component of the second and subsequent therapy services for multiple “always therapy” services furnished to a single patient in a single day.
Subsequent to publication of the CY 2011 PFS final rule with comment period, section 3 of the Physician Payment and Therapy Relief Act of 2010 (Pub. L. 111-286) revised the payment reduction percentage from 25 percent to 20 percent for therapy services furnished in office settings. The payment reduction percentage remains at 25 percent for services furnished in institutional settings. Section 4 of the Physician Payment and Therapy Relief Act of 2010 exempted the reduced expenditures attributable to the therapy MPPR policy from the PFS budget neutrality provision. Under our current policy as amended by the Physician Payment and Therapy Relief Act, for institutional services, full payment is made for the service or unit with the highest PE and payment for the PE component for the second and subsequent procedures or additional units of the same service is reduced by 25 percent. For non-institutional services, full payment is made for the service or unit with the highest PE and payment for the PE component for the second and subsequent procedures or additional units of the same service is reduced by 20 percent.
The MPPR policy applies to multiple units of the same therapy service, as well as to multiple different services, when furnished to the same patient on the same day. It applies to services furnished by an individual or group practice or “incident to” a physician's service. The MPPR applies when multiple therapy services are billed on the same date of service for one patient by the same practitioner or facility under the same National Provider Identifier (NPI), regardless of whether the services are furnished in one therapy discipline or multiple
The MPPR policy applies in all settings where outpatient therapy services are paid under Part B. This includes both services paid under the PFS that are furnished in the office setting, as well as to institutional services paid at the PFS rates that are furnished by outpatient hospitals, home health agencies, comprehensive outpatient rehabilitation facilities (CORFs), and other entities that are paid under Medicare Part B for outpatient therapy services.
In its June 2011 Report to the Congress, MedPAC further discussed its concern about the significant growth in ancillary services, specifically services for which physicians can self-refer under the in office ancillary exceptions list for the Ethics in Patient Referrals Act (also known as the Stark Law) including imaging, other diagnostic tests, and therapeutic services such as physical therapy and radiation therapy. MedPAC argues, in its June 2011 Report, that inaccurate pricing has played a role in this growth, and that there are additional efficiencies to be achieved in pricing imaging services notwithstanding a series of payment adjustments for imaging services over the past several years. MedPAC specifically recommended a multiple procedure payment reduction to the professional component of diagnostic imaging services provided by the same practitioner in the same session.
Over the past few years, as part of the potentially misvalued service initiative, the AMA RUC has examined several services that are billed together 75 percent or more of the time as part of the potentially misvalued service initiative. In several cases, the AMA RUC-recommended work values for new codes that describe the combined services, and those recommended values reflected the expected efficiencies. For example, for CY 2011, the AMA RUC valued the work for a series of new codes that describe CT of the abdomen and pelvis, specifically CPT codes:
• 74176 (Computed tomography, abdomen and pelvis; without contrast material).
• 74177 (Computed tomography, abdomen and pelvis; with contrast material).
• 74178 (Computed tomography, abdomen and pelvis; without contrast material in one or both body regions, followed by with contrast material(s) and further sections in one or both body regions).
We accepted the work values recommended by the AMA RUC for these codes in the CY 2011 PFS final rule with comment period (75 FR 73229). The recommended work values reflected an expected efficiency for the typical combined service that paralleled the reductions that would typically result from a MPPR adjustment. For example, in support of the recommended work value of 1.74 RVUs for 74176, the AMA RUC explained that the full value of 74150 (Computed tomography, abdomen; without contrast material) (Work RVU = 1.19) plus half the value of 72192 (Computed tomography, pelvis; without contrast material) (
We continue to believe that there may be additional imaging and other diagnostic services for which there are efficiencies in work when furnished together, resulting in potentially excessive payment for these services under current policy. MedPAC also made this same observation in their recent June 2011 Report to the Congress.
As noted, Medicare has a longstanding policy to reduce payment by 50 percent for the second and subsequent surgical procedures and nuclear medicine diagnostic procedures furnished to the same patient by the same physician on the same day.
In continuing to apply the provisions of section 3134(a) of the Affordable Care Act, for CY 2012 we proposed to expand the MPPR to the PC of Advanced Imaging Services (CT, MRI, and Ultrasound), that is, the same list of codes to which the MPPR on the TC of advanced imaging already applies (see Addendum F). Thus, the MPPR would apply to the PC and the TC of the codes. Specifically, we proposed to expand the 50 percent payment reduction currently applied to the TC to apply also to the PC of the second and subsequent advanced imaging services furnished in the same session. Full payment would be made for the PC and TC of the highest paid procedure, and payment would be reduced by 50 percent for the PC and TC for each additional procedure furnished to the same patient in the same session. This proposal was based on the expected efficiencies in furnishing multiple services in the same session due to duplication of physician work—primarily in the pre- and post-service periods, with smaller efficiencies in the intra-service period.
The proposal is consistent with the statutory requirement for the Secretary to identify, review, and adjust the relative values of potentially misvalued services under the PFS as specified by section 3134(a) of the Affordable Care Act. The proposal is also consistent both with our longstanding policy on surgical and nuclear medicine diagnostic procedures, which apply a 50 percent reduction to second and subsequent procedures. Furthermore, it is responsive to continued concerns about significant growth in imaging spending, and to MedPAC (March 2010, June 2011) and GAO (July 2009) recommendations regarding the expansion of MPPR policies under the PFS to account for additional efficiencies.
Finally, as noted, the proposal is consistent with the AMA RUC's recent methodology and rationale in valuing the work for a combined CT of the pelvis (CPT codes 72192, 72193 and 72194), and abdomen (CPT codes 74150, 74160 and 74170) where the AMA RUC assumed the work efficiency for the second service was 50 percent. Savings resulting from this proposal would be redistributed to other PFS services as required by the general statutory PFS budget neutrality provision.
In contrast, a few commenters, including MedPAC, supported the proposal. MedPAC indicated that the proposal is consistent with the recommendation from its June 2011
Commenters opposed to our proposal raised several issues about the basis for CMS' proposed 50 percent reduction to the professional component for second and subsequent imaging services Many commenters cited a recent article entitled, “Professional Component Payment Reductions for Diagnostic Imaging Examinations When More Than One Service Is Rendered by the Same Provider in the Same Session: An Analysis of Relevant Payment Policy,” published June 29, 2011, in the Journal of the American College of Radiology”
Commenters point out that neither GAO nor MedPAC supported a specific percentage reduction, but recommended that CMS conduct a review and analysis to determine the extent of efficiencies associated with the PC of multiple imaging services, and suggested that such efficiencies may vary by modality. Commenters highlighted several perceived deficiencies in the GAO's technical methodology, including a failure to distinguish between pre- post- and intra- physician work intensity, failure to recognize the wide variability in pre- and post- service time allocation among varied imaging services which makes a blanket policy more imprecise, and failure to consider clinical practice. Commenters argued that CMS provided no analysis to support the proposed MPPR level of 50 percent and did not identify potential areas of duplication in the pre-, post- and intra-service periods.
Commenters expressed views regarding our reference to the AMA RUC valuation of the work for bundled codes for CT of the pelvis and abdomen. Many commenters did not believe it was appropriate to propose a 50 percent MPPR to the PC for all advanced imaging services based on the AMA RUC's 50 percent reduction in work RVUs when valuing the combined pelvis and abdomen CT codes. Commenters indicated that the bundled code pair is not representative of most code pairs in that it is a focused contiguous body area using the same modality with significant overlap in the regions evaluated. Commenters noted that the AMA RUC has not consistently found a 50 percent reduction in physician work when imaging services are performed together.
The AMA RUC also objected to CMS using its recommended work values for the CT of Abdomen/Pelvis to substantiate our proposal. The AMA RUC asserted that it developed the recommended physician work values by estimating the magnitude of the physician work of the surveyed codes relative to physician work values of MRI, MRA, and evaluation and management services. When valuing the code for CT of Abdomen/Pelvis, the AMA RUC did not believe that the recommended physician work RVUs should be lower than the total RVUs resulting from applying a 50 percent MPPR to the professional component of the second and subsequent imaging service in the CT Abdomen/Pelvis code pair. The AMA RUC pointed out that the committee arrived at the recommended values using magnitude estimation and did not sum values for the component codes as suggested by CMS in the proposed rule.
Some commenters acknowledged that there are some efficiencies in the combined CT of the abdomen and pelvis, noting that overlapping images on a CT of the abdomen and pelvis may require less scrutiny. Commenters also noted that the physician has to review the patient history and provide dictation only once for multiple scans. Other commenters rejected the idea that there are efficiencies in the CT of the abdomen and pelvis. Commenters indicated that the service included only about 75 images 5 years ago. Today, it includes approximately 375 images, with the addition of thinner slice images and multiplanar reformatting.
Many commenters maintained that the proposed 50 percent MPPR for the PC of advanced imaging services is based on erroneous assumptions and a misunderstanding of the practice of medicine. These commenters argued that, generally, patients who are having multiple imaging studies on the same day tend to be patients who are seriously ill or injured patients, including cancer, trauma and stroke patients who invariably have significantly more complex pathology, requiring more time, rather than less. In some cases, the image using an initial modality may be inconclusive, requiring use of another imaging modality. Commenters argued that there are no efficiencies in physician work for interpretation of multiple advanced imaging scans for trauma and cancer patients, where images are less likely to be of contiguous anatomic areas.
Commenters maintained that, on average, studies with comparisons take longer than those that do not have comparison studies. The radiologists must look at more films and, when abnormalities are present, must compare each finding to the previous exam. The more studies there are, the more time it takes to interpret each one. Commenters asserted that radiologists are morally and professionally obligated to spend an equal amount of time, effort, and skill on interpreting images, irrespective of whether previous examinations have been performed on the same patient on the same day.
Finally, several commenters argued that technological advances in imaging have increased the intra-service work requiring radiologists to review many more images and more complex images than when the services were originally valued. They argue that contrary to the CMS proposal, clinical practice has become more time consuming because of the need to review hundreds of images per study compared to earlier imaging methods which took far fewer images. In addition to axial images, there frequently are coronal, sagittal, and oblique sequences as well as maximal intensity 3D images with each study. Images of non-contiguous body areas, for example, a CT of the brain and abdomen, are unrelated and are often read by different specialists, each separately requiring dedicated time for interpretation. Further, the search patterns used to identify possible issues in the images are different; technical aspects of viewing non-contiguous images are different; and the mental process used to formulate differential diagnoses are often unrelated. In some cases, such as when it is necessary to re-review prior images, commenters stated
Our claims analysis revealed that the majority of multiple imaging studies were for contiguous anatomic areas including thorax and abdomen/pelvis, and head/brain and neck/spine, and utilized the same modality. This suggests that multiple studies are typically performed to view a single underlying pathology that spans either multiple regions or lies in the region of overlap where a single study might be suboptimal. If the reasons for the studies were relatively unrelated, the observed association between contiguous areas and same modality would not exist. Conversely, the observation of this firm association between multiple studies on the same day implies that there are some efficiencies in interpreting history; predicting pathology; selecting protocols; reviewing scout and technique scans; focusing on particular tissue types and imaging windows; reviewing overlapping fields; reporting preliminary if not final results; and follow-up discussions with patients, staff and physicians. In contrast to the analysis published by the ACR, we found—
• Significant duplication in the pre-service work, which consists of reviewing patient history and any prior imaging studies, and determining the protocol and communicating that protocol with technologists;
• Significant duplication in the post-service work, which almost always consists of reviewing and signing a final report and discussing findings with the referring physician; and
• Moderate efficiencies in intra-service work. Specifically, supervising contrast (where appropriate), interpreting the examination and comparing it to other studies, and dictating the report for the medical record.
In conclusion, our analysis showed that, after applying a reduction percentage to each vignette component for the second and subsequent scans, identified as the code(s) in the code pair with the lower professional component RVU, and adjusting for intensity differences between pre-service and post-service work and intra-service work, the total RVU reduction ranges from 27.3 to 43.1 percent for second and subsequent procedures in the 12 code pairs.
Based on our further analysis and in response to comments, we believe that a 25 percent reduction would more appropriately capture the range of physician work efficiencies for second and subsequent imaging services furnished by the same physician (including physicians in the same group practice) to the same patient in the same session on the same day.
Commenters expressed concerns that there is wide variation in the potential efficiencies among different code pairs that such variability precludes broad application of a single percentage reduction, and that establishing new combined codes is the only mechanism for capturing accurate payment, for multiple imaging services. In general, we believe that MPPR policies capture efficiencies when several services are furnished in the same session and that it is appropriate to apply a single percentage reduction to second and subsequent procedures to capture those efficiencies. Because of the myriad potential combinations of advanced imaging scans, establishing new combined codes for each combination of advanced imaging scans is unwieldy and impractical. An MPPR policy is not precise, but reflects efficiencies in the aggregate, such as common patient history, interpretation of multiple images involving the same patient and same anatomical structures, and, typically, same modality. Our analysis of the specific activities included in furnishing advanced imaging scans together supports a reduction between 27.3 and 43.1 percent. The implementation of a 25 percent reduction in the PC for second and subsequent imaging services furnished by the same physician in the same session is less than range of reductions we observed for second and subsequent scans in our analysis. Therefore, while we acknowledge that efficiencies may vary across code pairs, we believe that a 25 percent reduction in the PC is reasonable and supported by our analysis. We note that, as with many of our policies, we will continue to review this MPPR policy and refine it as needed in future years to ensure that we continue to provide accurate payments under the PFS.
We disagree with commenters' assertions that there are no efficiencies in physician work for the interpretation of multiple advanced imaging scans for trauma and cancer patients. As noted previously, our analysis indicates that the typical multiple imaging case involves contiguous body areas, and only a very small percentage involve more than one modality. We note that this analysis included all claims data, including trauma and cancer patient imaging studies. In addition, we used conservative estimates of the reduction percentages for the observed efficiencies for second and subsequent procedures in our analysis. Finally, we believe there are efficiencies in work for all multiple imaging studies, including the review of medical history and prior imaging studies; contrast administration; review of the final report; and discussion of findings with the referring physician, regardless of the type of injury or patient's diagnosis.
Concerning comparison studies, we note that when interpreting previous studies, the radiologist would interpret not just the prior image itself, but also the patient history or, at a minimum, the portfolio of similar available studies. While we understand that time spent reviewing prior studies adds work by requiring the radiologist to review such studies, we believe that the availability of prior studies may also reduce work by creating a baseline against which new images can be quickly compared.
Commenters were also concerned with technological advances that may exponentially multiply the number of images that are produced in a single imaging session. While we agree with commenters that technology has multiplied the number of images produced, we note that that same technology has vastly improved viewability. The use of shuttles to scan through a series of images along imaged axis, 3-D rendering to allow visualization, rotation and zoom, and modeling to enhance suspect findings and increase the utility of pattern recognition all exist to improve the efficiency of data extraction that at one time had to be visualized entirely in the mind of the radiologist from a series of side-by-side flat images. Therefore, we believe that, in the aggregate, technological advances in imaging have not significantly increased the work of interpretation. Efficiencies resulting from technological advances are even more evident in cases of multiple contiguous images, where rendering allows joystick maneuvering through a single continuous image that may be billed independently, but which may be acquired as a single activity. Finally, we note that other commenters, and the study cited by the American College of Radiology, have acknowledged some efficiencies do exist and are not currently recognized in the coding and payment structure of these codes.
As explained previously, section 1848(c)(2)(K)(i) of the Act requires the Secretary to identify services within several specific categories as being potentially misvalued, and to make appropriate adjustments to their relative values. One of the specific categories listed under section 1834(c)(2)(K)(ii) of the Act is “multiple codes that are frequently billed in conjunction with furnishing a single service.”
Therefore, we do not agree with the commenters that the MPPR policy undermines the goals of the Affordable Care Act. It appears the commenter may have misunderstood the point of the quoted statement from the proposed rule that, “[b]ecause of the different pieces of equipment used for CT/CTA, MRI/MRA, and ultrasound procedures, it would be highly unlikely that a single practitioner would furnish more than one imaging procedure involving two different modalities to one patient in a single session where the proposed MPPR would apply.” The commenter is correct that we conceded, in the circumstance where two different modalities are used, it is unlikely that two advanced imaging codes would be billed by a single physician for a single patient in a single session. However, the point of this statement was to indicate that the proposed MPPR would not apply in the vast majority of these situations. Although there remains the remote possibility that the MPPR would apply in a scenario where the codes for multiple advanced imaging services are not “frequently billed in conjunction with furnishing a single service,” we believe this would be exceedingly rare. Moreover, we would expect there to be some level of efficiencies in work even in these cases. As we indicated in the CY 2011 PFS final rule with comment period (75 FR 73231), application of a general MPPR policy to numerous imaging service combinations may result in an overestimate of efficiencies in some cases and an underestimate in others. But this can be true for any service paid under the PFS, and we believe it is important to establish a general policy to pay appropriately for the typical service or services furnished. Given that, based on our review of CY 2010 claims data, 97 percent of second and subsequent advanced imaging services furnished to the same patient on the same day involved the use of the same imaging modality, and that some of the cases that did involve different modalities might have been furnished by different physicians in different group practices (in which case the MPPR would not apply), we do not believe it is necessary to adjust our MPPR policy to address an uncommon scenario. Therefore, we believe the MPPR policy is fully consistent with section 1848(c)(2)(K) of the statute, as added by section 3134(a) of the Affordable Care Act, and that the policy fulfills several of our key statutory obligations by more appropriately valuing combinations of imaging services furnished to patients and paid under the PFS.
Commenters noted that imaging tests utilizing different modalities are rarely performed in the same session. For example, a patient may undergo an ultrasound, which would be interpreted by the physician to determine whether the patient requires a CT for further diagnostic evaluation. The physician supervises and/or performs and interprets each test separately, at different times, and speaks to the patient about the results of each test on separate occasions during the patient's visit. Also, separate written reports are required for each test.
Commenters further noted that in multiple trauma cases, the same radiologist would not interpret the entire series of exams. In addition, there are cases when a radiologist determines upon review that X-rays were insufficient to determine the problem and, therefore, recommends another type of imaging study be performed. The same radiologist may review the results of this second imaging test for the same
• A physician does not read both scans together, for example, in emergency situations even though both scans were performed in the same session;
• Two physicians with different specialties each read a separate scan of a patient, though both scans were taken during the same session; and
• Physicians are in the same group practice.
We believe the term “advanced imaging” has confused commenters because this term has been used to define different sets of imaging services for different Medicare initiatives. We have not revised the definition of advanced imaging services that we have used for the imaging MPPR policy regarding the TC of the second and subsequent imaging services Since 2006, for payment under the PFS, the imaging MPPR for the TC has included CT, MRI and ultrasound. While ultrasound services are included in both the existing imaging MPPR for the TC and in the MPPR policy we are finalizing for the PC beginning in CY 2012, we do not consider ultrasound services to be advanced imaging procedures for purposes of accreditation. Section 135(a) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275) required the Secretary to designate organizations to accredit suppliers, including but not limited to physicians, non-physician practitioners and Independent Diagnostic Testing Facilities that furnish the technical component (TC) of advanced diagnostic imaging services, which include MRI, CT, and nuclear medicine imaging such as positron emission tomography (PET). The MIPPA provision expressly excludes ultrasound, X-ray, and fluoroscopy from this requirement.
With respect to the ordering and scheduling of imaging services for Medicare beneficiaries, we require that Medicare-covered services be appropriate to patient needs. We would not expect the adoption of an MPPR for the PC of imaging services to result in imaging services being furnished on separate days by one provider merely so that the practitioner or provider may garner increased payment. We agree with the commenters who noted that such an unprofessional response on the part of practitioners would be inefficient and inappropriate. We will continue to monitor access to care and patterns of delivery for imaging services, with particular attention focused on identifying any changes in the delivery of same day imaging services that may be clinically inappropriate.
In summary, after consideration of the public comments received, we are adopting our CY 2012 proposal to apply an MPPR to the PC of advanced imaging services, with a modification to apply a 25 percent reduction for CY 2012 rather than the 50 percent reduction we had proposed. We continue to believe that efficiencies exist in the PC of multiple imaging services, and we will continue to monitor code combinations for possible future adjustments to the reduction percentage applied through this MPPR policy.
Specifically, beginning in CY 2012 we are adopting an MPPR that applies a 25 percent reduction to the PC of second and subsequent advanced imaging services furnished by the same physician to the same patient, in the same session, on the same day. We are proposing to add CPT 74174 (Computed tomographic angiography, abdomen and pelvis; with contrast material(s), including noncontrast images, if performed, and image postprocessing), which is a new code for CY 2012, to the imaging MPPR list. This code is being added on an interim final basis and is open to public comment on this final rule with comment period. We note that the MPPR will apply when the combined new procedure is furnished in conjunction with another procedure(s). The complete list of services subject to the MPPR for the PC of imaging services is the same as for the MPPR currently applied to the TC of imaging services, and is shown in Addendum F. The PFS budget neutrality provision is applicable to the new MPPR for the PC of advanced imaging services. Therefore, the estimated reduced expenditures for imaging services have been redistributed to increase payment for other PFS services. We refer readers to section IX.C. of this final rule with comment period for further discussion of the impact of this policy.
Currently, the MPPR policies focus only on a select number of codes. We will be aggressively looking for efficiencies in other sets of codes during the coming years and will consider implementing more expansive multiple procedure payment reduction policies in CY 2013 and beyond. In the proposed rule, we invited public comment on the following MPPR policies which are under consideration. Any proposals would be presented in future rulemaking and subject to further public comment:
• Apply the MPPR to the TC of All Imaging Services. This approach would apply a payment reduction to the TC of the second and subsequent imaging services performed in the same session. Such an approach could define imaging consistent with our existing definition of imaging for purposes of the statutory cap on payment at the OPPS rate (including X-ray, ultrasound (including echocardiography), nuclear medicine (including positron emission tomography), magnetic resonance imaging, computed tomography, and fluoroscopy, but excluding diagnostic and screening mammography). Add-on codes that are always furnished with another service and have been valued accordingly could be excluded.
Such an approach would be based on the expected efficiencies due to duplication of clinical labor activities, supplies, and equipment time. This approach would apply to approximately 530 HCPCS codes, including the 119 codes to which the current imaging MPPR applies. Savings would be redistributed to other PFS services as required by the statutory PFS budget neutrality provision.
• Apply the MPPR to the PC of All Imaging Services. This approach would apply a payment reduction to the PC of the second or subsequent imaging services furnished in the same encounter. Such an approach could define imaging consistent with our existing definition of imaging for the cap on payment at the OPPS rate. Add-on codes that are always furnished with another service and have been valued accordingly could be excluded.
This approach would be based on efficiencies due to duplication of physician work primarily in the pre- and post-service periods, with smaller efficiencies in the intra-service period. This approach would apply to approximately 530 HCPCS codes, including the 119 codes to which the current imaging MPPR applies. Savings would be redistributed to other PFS services as required by the statutory PFS budget neutrality provision.
• Apply the MPPR to the TC of All Diagnostic Tests. This approach would apply a payment reduction to the TC of the second and subsequent diagnostic tests (such as radiology, cardiology, audiology, etc.) furnished in the same encounter. Add-on codes that are always furnished with another service and have been valued accordingly could be excluded.
The approach would be based on the expected efficiencies due to duplication of clinical labor activities, supplies, and equipment time. The approach would apply to approximately 700 HCPCS codes, including the approximately 560 HCPCS codes subject to the OPPS cap. The savings would be redistributed to other PFS services as required by the statutory PFS budget neutrality provision.
We received several comments concerning the future expansion of the MPPR. We will take the comments under consideration as we develop future proposals. Any proposals would be presented in future rulemaking and subject to further public comment.
We are proposing to add the new codes in Table 9 to the list of procedures subject to the OPPS cap, effective January 1, 2012. These procedures meet the definition of imaging under section 5102(b) of the DRA. These codes are being added on an interim final basis and are open to public comment in this final rule with comment period.
Section 1848(c) of the Act requires that each service paid under the PFS be comprised of three components: work, PE, and malpractice. From 1992 to 1999, malpractice RVUs were charge-based, using weighted specialty-specific malpractice expense percentages and 1991 average allowed charges. Malpractice RVUs for new codes after 1991 were extrapolated from similar existing codes or as a percentage of the corresponding work RVU. Section 4505(f) of the BBA amended section 1848(c) of the Act which required us to implement resource-based malpractice RVUs for services furnished beginning in 2000. Therefore, initial implementation of resource-based malpractice RVUs occurred in 2000.
The statute also requires that we review, and if necessary adjust, RVUs no less often than every 5-years. The first review and update of resource-based malpractice RVUs was addressed in the CY 2005 PFS final rule with comment period (69 FR 66263). Minor modifications to the methodology were addressed in the CY 2006 PFS final rule with comment period (70 FR 70153). In the CY 2010 PFS final rule with comment period, we implemented the second review and update of malpractice RVUs. For a discussion of the second review and update of malpractice RVUs, see the CY 2010 PFS proposed rule (74 FR 33537) and final rule with comment period (74 FR 61758).
As explained in the CY 2011 PFS final rule with comment period, malpractice RVUs for new and revised codes effective before the next Five-Year Review of Malpractice (for example, effective CY 2011 through CY 2014, assuming that the next review of malpractice RVUs occurs for CY 2015) are determined either by a direct crosswalk to a similar source code or by a modified crosswalk to account for differences in work RVUs between the new/revised code and the source code (75 FR 73208). For the modified crosswalk approach, we adjust (or “scale”) the malpractice RVU for the new/revised code to reflect the difference in work RVU between the source code and the new/revised work value (or, if greater, the clinical labor portion of the fully implemented PE RVU) for the new code. For example, if the proposed work RVU for a revised code is 10 percent higher than the work RVU for its source code, the malpractice RVU for the revised code would be increased by 10 percent over the source code RVU. This approach presumes the same risk factor for the new/revised code and source code but uses the work RVU for the new/revised code to adjust for risk-of-service.
Section 1848(e)(1)(A) of the Social Security Act requires us to develop separate Geographic Practice Cost Indices (GPCIs) to measure resource cost differences among localities compared to the national average for each of the three fee schedule components (that is, physician work, practice expense (PE), and malpractice). While requiring that the PE and malpractice GPCIs reflect the full relative cost differences, section 1848(e)(1)(A)(iii) of the Act requires that the physician work GPCIs reflect only one-quarter of the relative cost differences compared to the national average. In addition, section 1848(e)(1)(G) of the Act sets a permanent 1.5 work GPCI floor for services furnished in Alaska beginning January 1, 2009, and section 1848(e)(1)(I) of the Act sets a permanent 1.0 PE GPCI floor for services furnished in frontier States beginning January 1, 2011.
Section 1848(e)(1)(E) of the Act provides for a 1.0 floor for the work GPCIs which was set to expire at the end of 2009 until it was extended through December 31, 2010 by section 3102(a) of the Affordable Care Act. Because the work GPCI floor was set to expire at the end of 2010, the GPCIs published in Addendum E of the CY 2011 PFS final rule with comment period did not reflect the 1.0 physician work floor. However, section 1848(e)(1)(E) of the Act was amended on December 15, 2010, by section 103 of the Medicare and Medicaid Extenders Act (MMEA) of 2010 (P.L. 111-309) to extend the 1.0 work GPCI floor through December 31, 2011. Appropriate changes to the CY 2011 GPCIs were made to reflect the 1.0 physician work floor required by section 103 of the MMEA. Since the work GPCI floor provided in section 1848(e)(1)(E) of the Act is set to expire prior to the implementation of the CY 2012 PFS, the CY 2012 physician work GPCIs, and summarized geographic adjustment factors (GAFs), presented in this final rule with comment period do not reflect the 1.0 work GPCI floor. As required by section 1848(e)(1)(G) and section 1848(e)(1)(I) of the Act, the 1.5 work GPCI floor for Alaska and the 1.0 PE GPCI floor for frontier States will be applicable in CY 2012. Moreover, the limited recognition of cost differences in employee compensation and office rent for the PE GPCIs, and the related hold harmless provision, required under section 1848(e)(1)(H) of the Act was only applicable for CY 2010 and CY 2011 (75 FR 73253) and, therefore, is no longer effective beginning in CY 2012.
Section 1848(e)(1)(C) of the Act requires us to review and, if necessary, adjust the GPCIs not less often than every 3 years. This section also specifies that if more than 1 year has elapsed since the last GPCI revision, we must phase in the adjustment over 2 years, applying only one-half of any adjustment in the first year.
As noted in the CY 2011 PFS final rule with comment period (75 FR 73252 through 73262), for the sixth GPCI update, we updated the data used to
Since more than 1-year had elapsed since the fifth GPCI update, as required by law, the sixth GPCI update changes are being phased in over a 2-year period. The current CY 2011 GPCIs reflect the first year of the transition. The final CY 2012 GPCIs reflect the full implementation with modifications reflecting the revisions contained in this final rule with comment period.
The Affordable Care Act requires that we analyze the current methodology and data sources used to calculate the PE GPCI component. Specifically, section 1848(e)(1)(H)(iv) of the Act (as added by section 3102(b) of the Affordable Care Act) requires the Secretary to “analyze current methods of establishing practice expense adjustments under subparagraph (A)(i) and evaluate data that fairly and reliably establishes distinctions in the cost of operating a medical practice in different fee schedule areas.” Section 1848(e)(1)(H)(iv) of the Act also requires that such analysis shall include an evaluation of the following:
• The feasibility of using actual data or reliable survey data developed by medical organizations on the costs of operating a medical practice, including office rents and non-physician staff wages, in different fee schedule areas.
• The office expense portion of the practice expense geographic adjustment; including the extent to which types of office expenses are determined in local markets instead of national markets.
• The weights assigned to each area of the categories within the practice expense geographic adjustment.
In addition, the weights for different categories of practice expense in the GPCIs have historically matched the weights developed by the CMS Office of the Actuary (OACT) for use in the Medicare Economic Index (MEI), the measure of inflation used as part of the basis for the annual update to the physician fee schedule payment rates. In response to comments received on the CY 2011 Physician Fee Schedule proposed rule, however, we delayed moving to the new MEI weights developed by OACT for CY 2011 pending further analysis.
Lastly, we asked the Institute of Medicine (IOM) to evaluate the accuracy of the geographic adjustment factors used for Medicare physician payment. IOM will prepare two reports for the Congress and the Secretary of the Department of Health and Human Services. The revised first report (Phase I), which includes supplemental recommendations to the initial IOM release of June1, 2011, was released on September 28, 2011, and includes an evaluation of the accuracy of geographic adjustment factors for the hospital wage index and the GPCIs, and the methodology and data used to calculate them. The second report, expected in spring 2012, will evaluate the effects of the adjustment factors on the distribution of the health care workforce, quality of care, population health, and the ability to provide efficient, high value care. Given the timing of the release of IOM's revised report, we are unable to address the full scope of the IOM recommendations in this final rule with comment period. These reports can be accessed on the IOM's Web site at:
The recommendations that relate to or would have an effect on the GPCIs included in IOM's revised Phase I report are summarized as follows:
• Recommendation 2-1: The same labor market definition should be used for both the hospital wage index and the physician geographic adjustment factor. Metropolitan statistical areas and Statewide non-metropolitan statistical areas should serve as the basis for defining these labor markets.
• Recommendation 2-2: The data used to construct the hospital wage index and the physician geographic adjustment factor should come from all health care employers.
• Recommendation 5-1: The GPCI cost share weights for adjusting fee-for-service payments to practitioners should continue to be national, including the three GPCIs (work, practice expense, and liability insurance) and the categories within the practice expense (office rent and personnel).
• Recommendation 5-2: Proxies should continue to be used to measure geographic variation in the physician work adjustment, but CMS should determine whether the seven proxies currently in use should be modified.
• Recommendation 5-3: CMS should consider an alternative method for setting the percentage of the work adjustment based on a systematic empirical process.
• Recommendation 5-4: The practice expense GPCI should be contructed with the full range of occupations employed in physicians' offices, each with a fixed national weight based on the hours of each occupation employed in physicians' offices nationwide.
• Recommendation 5-5: CMS and the Bureau of Labor Statistics should develop an agreement allowing the Bureau of Labor Statistics to analyze confidential data for the Centers for Medicare and Medicaid Services.
• Recommendation 5-6: A new source of information should be developed to determine the variation in the price of commercial office rent per square foot.
• Recommendation 5-7: Nonclinical labor-related expenses currently included under practice expense office expenses should be geographically adjusted as part of the wage component of the practice expense.
The revised GPCI values we proposed were developed by a CMS contractor. As mentioned previously, there are three GPCI components (physician work, PE, and malpractice), and all GPCIs are developed through comparison to a national average for each component. Additionally, each of the three GPCIs relies on its own data source(s) and methodology for calculating its value. As discussed in more detail later in this section, we proposed to revise the PE GPCIs for CY 2012, as well as the cost share weights which correspond to all three GPCIs.
The physician work GPCIs are designed to capture the relative cost of physician labor by Medicare PFS locality. Previously, the physician work GPCIs were developed using the median hourly earnings from the 2000 Census of workers in seven professional specialty occupation categories which we used as a proxy for physicians' wages. Physicians' wages are not included in the occupation categories because Medicare payments are a key determinant of physicians' earnings. That is, including physicians' wages in the physician work GPCIs would, in effect, have made the indices dependent upon Medicare payments. As required by law, the physician work GPCI reflects one quarter of the relative wage differences for each locality compared to the national average.
The physician work GPCI updates in CYs 2001, 2003, 2005, and 2008 were based on professional earnings data from the 2000 Census. For the sixth GPCI update in CY 2011, we used the 2006 through 2008 Bureau of Labor Statistics (BLS) Occupational Employment Statistics (OES) data as a replacement for the 2000 Census data. We did not propose to revise the physician work GPCI data source for CY 2012. However, we note that the work GPCIs will be revised to account for the expiration of the statutory work floor. The 1.5 work floor for Alaska is permanent and will be applicable in CY 2012. In addition, we proposed to revise the physician work cost share weight from 52.466 to 48.266 in line with the 2011 MEI weights, which are based on 2006 data (referred to hereinafter as the 2006-based MEI).
(1) Affordable Care Act Analysis and Revisions for PE GPCIs
(A) General Analysis for the CY 2012 PE GPCIs
As previously mentioned, section 1848(e)(1)(H)(iv) of the Act (as added by section 3102(b) of the Affordable Care Act) requires the Secretary to “analyze current methods of practice expense adjustments under subparagraph (A)(i) and evaluate data that fairly and reliably establishes distinctions in the cost of operating a medical practice in the different fee schedule areas.”
Moreover, section 1848 (e)(1)(H)(v) of the Act requires the Secretary to make appropriate adjustments to the PE GPCIs as a result of the required analysis, no later than January 1, 2012. We proposed to make four revisions to the PE data sources and cost share weights discussed herein effective January 1, 2012. Specifically, we proposed to: (1) Revise the occupations used to calculate the employee wage component of PE using BLS wage data specific to the office of physicians' industry; (2) utilize two bedroom rental data from the 2006-2008 American Community Survey as the proxy for physician office rent; (3) create a purchased service index that accounts for regional variation in labor input costs for contracted services from industries comprising the “all other services” category within the MEI office expense and the stand alone “other professional expenses” category of the MEI; and (4) use the 2006-based MEI (most recent MEI weights finalized in the CY 2011 final rule with comment period) to determine the GPCI cost share weights. These proposals were based on analyses we conducted to address commenter concerns in the CY 2011 final rule with comment period and a continuation of our PE evaluation as required by the Affordable Care Act. The main comments were related to: (1) the occupational groups used to calculate the employee wage component of PE, and (2) concerns by commenters stating that regional variation in purchased services such as legal and accounting were not sufficiently included in the GPCI methodology.
We began analyzing the current methods and data sources used in the establishment of the PE GPCIs during the CY 2011 rulemaking process (75 FR 40084). With respect to our CY 2011 analysis, we began with a review of the Government Accountability Office's (GAO) March 2005 Report entitled, “Medicare Physician Fees: Geographic Adjustment Indices Are Valid in Design, but Data and Methods Need Refinement” (GAO-05-119). While we have raised concerns in the past about some of the GAO's GPCI recommendations, we noted that with respect to the PE GPCIs, the GAO did not indicate any significant issues with the methods underlying the PE GPCIs. Rather, the report focused on some of the data sources used in the method. For example, the GAO stated that the wage data used for the PE GPCIs are not current. Similarly, commenters on previous PE GPCI updates predominantly focused on either the data sources used in the method or raised issues such as incentivizing the provision of care in different geographic areas. However, the latter issue (incentivizing the provision of care) is outside the scope of the statutory requirement that the PE GPCIs reflect the relative costs of the mix of goods and services comprising practice expenses in the different fee schedule areas relative to the national average.
To further analyze the PE office expense in accordance with section 1848(e)(1)(H)(iv) of the Act, we examined the following issues: the appropriateness of expanding the number of occupations included in the employee wage index; the appropriateness of replacing rental data from the Department of Housing and Urban Development (HUD) with data from the 2006-2008 American Community Survey (ACS) two bedroom rental data as a proxy for the office rent subcomponent of PE; and the appropriateness of adjusting the “all other services” and “other professional expenses” MEI categories for geographic variation in labor-related costs. We also examined available ACS occupational group data for potential use in determining geographic variation in the employee wage component of PE.
An additional component of the analysis under section 1848(e)(1)(H)(iv) of the Act is to evaluate the weights assigned to each of the categories within the practice expense geographic adjustment. As discussed in the CY 2011 final rule with comment period (75 FR 73256), in response to concerns raised by commenters and to allow us time to conduct additional analysis, we did not revise the GPCI cost share weights to reflect the weights used in the revised and rebased 2006 MEI that we adopted beginning in CY 2011. In response to those commenters who raised many points regarding the appropriateness of assigning labor-related costs in the medical equipment and supplies and miscellaneous component which do not reflect locality cost differentials, we agreed to address the GPCI cost share weights again in the CY 2012 PFS proposal. These issues are discussed in greater detail in section II.D.2.b.(1).(E). of this final rule with comment period that discusses our determination of the cost share weights.
We also stated in the CY 2011 final rule with comment period that we would review the findings of the Secretary's Medicare Geographic Payment Summit and the MEI technical advisory panel during future rulemaking (75 FR 73256). The Secretary convened the National Summit on Health Care Quality and Value on October 4, 2010. This Summit was attended by a number of policy experts that engaged in detailed discussions regarding geographic adjustment factors and geographic variation in payment and the promotion of high quality care. This National Summit was useful by informing us on issues that we are studying further through two Institute of Medicine studies. In accordance with section 3102(b) of the Affordable Care Act, we are also continuing to consider these issues in the course of this notice and comment rulemaking for the CY 2012 PFS, which includes revisions to the GPCI, and through preparation of a report to the Congress that we will be submitting later this year in accordance with section 3137(b) of the Affordable Care Act on a plan for reforming the hospital wage index. In addition, we announced the establishment of the MEI Technical Advisory Panel and request for nominations of members on October 7, 2011 (76 FR 62415 through 62416). We note that the panel will conclude by September 28, 2012 and we look forward to examining the recommendations of this panel once it has issued its report.
In the CY 2011 final rule with comment period, we finalized our policy to use the 2010 Fair Market Rent (FMR) data produced by HUD at the 50th percentile as the proxy for relative cost differences in physician office rents. However, as part of our analysis required by section 1848(e)(1)(H)(iv) of the Act, we have now examined the suitability of utilizing 3-year (2006-2008) ACS rental data to serve as a proxy for physician office rents. We believe that the ACS rental data provide a sufficient degree of reliability and are an appropriate source on which to base our PE GPCI office rent proxy. We also believe that the ACS data provide a higher degree of accuracy than the HUD data since the ACS data are updated annually and not based on data collected by the 2000 Census long form. Moreover, it is our understanding that the Census “long form,” which is utilized to collect the necessary base year rents for the HUD Fair Market Rent (FMR) data, will no longer be available in future years. Therefore, we proposed to use the available 2006 through 2008 ACS rental data for two bedroom residential units as the proxy for physician office rent. We also sought comment regarding the potential use of 5-year ACS rental data as a proxy for physician office rent in future rulemaking.
We believe the ACS data will more accurately reflect geographic variation in the office rent component. As in past GPCI updates, we proposed to apply a nationally uniform weight to the office rent component. We proposed to use the 2006-based MEI weight for fixed capital and utilities as the weight for the office rent category in the PE GPCI, and to use the ACS residential rent data to develop the practice expense GPCI value.
Accurately evaluating the relative price that physicians pay for labor inputs requires both a mechanism for selecting the occupations to include in the employee wage index and identifying an accurate measure of the wages for each occupation. We received comments during the CY 2011 rulemaking cycle noting that the current employee wage methodology may omit key occupational categories for which cost varies significantly across regions. Commenters suggested including occupations such as accounting, legal, and information technology in the employee wage component of the PE GPCI. To address these concerns, we proposed to revise the employee wage index framework within the practice expense (PE) GPCI. Under this new methodology, we would only select occupational categories relevant to a physician's practice. We would use a comprehensive set of wage data from the Bureau of Labor Statistics Occupational Employment Statistics (BLS OES) specific to the offices of physicians industry. Utilizing wage and national cost share weight data from the BLS OES would not only provide a more systematic approach to determining which occupations should be included in the non-physician employee wage category of the PE GPCI, but would also enable us to determine how much weight each occupation should receive within the index.
Due to its reliability, public availability, level of detail, and national scope, we proposed to use BLS OES data to estimate both occupation cost shares and hourly wages for purposes of determining the non-physician employee wage component of the PE GPCI. The OES panel data are collected from approximately 200,000 establishments, and provide employment and wage estimates for about 800 occupations. At the national level, OES provides estimates for over 450 industry classifications (using the 3, 4, and 5 digit North American Industry Classification System (NAICS)), including the Offices of Physicians industry (NAICS 621100). As described in the census, the Offices of Physicians industry comprises establishments of health practitioners having the degree of M.D. (Doctor of Medicine) or D.O. (Doctor of Osteopathy) primarily engaged in the independent practice of general or specialized medicine (except psychiatry or psychoanalysis) or surgery. These practitioners operate private or group practices in their own offices (such as centers, clinics) or in the facilities of others (such as hospitals or Health Maintenance Organization (HMO) medical centers). The OES data provide significant detail on occupational categories and offer national level cost share estimates for the offices of physicians industry.
In the BLS OES data methodology, we weighted each occupation based on its share of total labor cost within the offices of physician industry. Specifically, each occupation's weight is proportional to the product of its occupation's employment share and average hourly wage. In this calculation, we used each occupation's employment level rather than hours worked, because the BLS OES does not contain industry-specific information describing the number of hours worked in each occupation (see:
We also evaluated available ACS occupational data as a potential data source for the non-physician employee wage PE GPCI subcomponent. Based on the occupations currently used to calculate employee wages, the BLS OES captures occupations with greater relevancy to physician office practices and is a more appropriate data source than the currently available ACS data. In addition, since our publication of the CY 2012 proposed rule, we have conducted an analysis of ACS wage data including an expanded mix of occupations. A review of this analysis can be found in our contractors “Revisions to the Sixth Update of the Geographic Practice Cost Index: Final Report” located on the physician fee schedule CY 2012 final rule with comment period Web site at:
For CY 2012, we proposed to geographically adjust the labor-related industries within the “all other services” and “other professional expenses” categories of the MEI. In response to commenters who stated that these purchased services were labor-related and should be adjusted geographically, we agreed to examine this issue further in the CY 2011 final rule with comment period and refrained from making any changes. Based on our subsequent examination of this issue, we believe it would be appropriate to geographically adjust for the labor-related component of purchased services within the “All Other Services” and “Other Professional Expenses” categories using BLS wage data. In total, there are 63 industries, or cost categories, accounted for within the “all other services” and “other professional services” categories of the 2006-based MEI. For purposes of the hospital wage index at 74 FR 43845, we defined a cost category as labor-related if the cost category is defined as being both labor intensive and its costs vary with, or are influenced by the local labor market.
In order to calculate the labor-related and non labor- related shares, we would use a similar methodology that is employed in estimating the labor-related share of various CMS market baskets. A more detailed explanation of this methodology can be found under the supporting documents section of the CY 2012 PFS final rule with comment period Web page at
We believe our analysis, during 2010 and this year, of the current methods of establishing PE GPCIs and our evaluation of data that fairly and reliably establish distinctions in the cost of operating a medical practice in the different fee schedule areas meet the statutory requirements of section 1848(e)(1)(H)(iv) of the Act. A more detailed discussion of our analysis of current methods of establishing PE GPCIs and evaluation of data sources is included in our contractor's draft report entitled, “Proposed Revisions to the Sixth Update of the Geographic Practice Cost Index.” Our contractor's final report and associated analysis of the GPCI revisions, including the PE GPCIs, will be made publicly available on the CMS Web site. The final report may be accessed from the PFS Web site at:
Additionally, see section IX.F. of this final rule with comment period for Table 86, which reflects the GAF impacts resulting from these proposals. As the table demonstrates, the primary driver of the CY 2012 impact is the expiration of the work GPCI floor which had produced non budget-neutral increases to the CY 2011 GPCIs for lower cost areas as authorized under the Affordable Care Act the Medicare and Medicaid Extenders Act (MMEA).
To determine the cost share weights for the CY 2012 GPCIs, we proposed to use the weights established in the 2006-based MEI. The MEI was rebased and revised in the CY 2011 final rule with comment period to reflect the weighted-average annual price change for various inputs needed to provide physicians' services. As discussed in detail in that section (75 FR 73262 through 73277), the proposed expense categories in the MEI, along with their respective weights, were primarily derived from data collected in the 2006 AMA PPIS for self-employed physicians and selected self-employed non-medical doctor specialties. Since we have historically updated the GPCI cost share weights consistent with the most recent update to the MEI, and because we have addressed commenter concerns regarding the inclusion of the weight assigned to utilities with office rent and geographically adjusted for the labor intensive industries within the “all other services” and “other professional expenses” MEI categories, we believe it is appropriate to adopt the 2006-based MEI cost share weights.
For the cost share weight for the CY 2012 PE GPCIs, we used the 2006-based MEI weight for the PE category of 51.734 percent minus the professional liability insurance category weight of 4.295 percent. Therefore, we proposed a cost share weight for the PE GPCIs of 47.439 percent.
For the employee compensation portion of the PE GPCIs, we proposed to use the non-physician employee compensation category weight of 19.153 percent reflected in the 2006-based MEI.
We proposed that the weight for the office rent component be revised from 12.209 percent to 10.223 percent. The 12.209 percent office rent GPCI weight was set equal to the 2000-based MEI cost weight for office expenses, which was calculated using the American Medical Association's (AMA) Socioeconomic Monitoring Survey (SMS). The 12.209 percent reflected the expenses for rent, depreciation on medical buildings, mortgage interest, telephone, and utilities. We proposed to set the GPCI office rent equal to 10.223 percent reflecting the 2006-based MEI cost weights (75 FR 73263) for fixed capital (reflecting the expenses for rent, depreciation on medical buildings and mortgage interest) and utilities. We are no longer including telephone costs in the GPCI office rent cost weight because we believe these expenses do not vary by geographic area.
Consistent with the revised and rebased 2006-based MEI which was adopted in the CY 2011 final rule with comment period (75 FR 73263), we disaggregated the broader office expenses component for the PE GPCI into 10 new cost categories. In this disaggregation, the fixed capital component is the office expense category applicable to the office rent component of the PE GPCI. As discussed in the section dealing with office rent, we proposed to use 2006-2008 ACS rental data as the proxy for physician office rent. These data represent a gross rent amount and includes data on utilities expenditures. Since it is not possible to separate the utilities component of rent for all ACS survey respondents, it was necessary to combine these two components to calculate office rent and by extension, we proposed combining those two cost categories when assigning a weight to the office rent component.
As discussed in the previous paragraphs, a new purchased services index was created to geographically adjust the labor-related components of the “All Other Services” and “Other Professional Expenses” categories of the 2006-based MEI office market basket. In order to calculate the purchased services index, we proposed to merge the corresponding weights of these two categories to form a combined purchased services weight of 8.095 percent. However, we proposed to only adjust for locality cost differences of the labor-related share of the industries comprising the “All Other Services” and “Other Professional Expenses” categories. We have determined that only 5.011 percentage points of the 8.095 percentage points would be adjusted for locality cost differences (5.011 adjusted purchased service + 3.084 non-adjusted purchased services = 8.095 total cost share weight).
To calculate the proposed medical equipment, supplies, and other miscellaneous expenses component, we removed professional liability (4.295 percentage points), non-physician employee compensation (19.153 percentage points), fixed capital/utilities (10.223 percentage points), and
Furthermore, we proposed to use the physician compensation cost category weight of 48.266 percent as the work GPCI cost share weight; and we proposed to use the professional liability insurance weight of 4.295 percent for the malpractice GPCI cost share weight. We believe our analysis and evaluation of the weights assigned to each of the categories within the PE GPCIs satisfies the statutory requirements of section 1848(e)(1)(H)(iv) of the Act.
The cost share weights for the CY 2012 GPCIs are displayed in Table 10. For a detailed discussion regarding the GPCI cost share weights and how the weights account for local and national adjustments, see our contractor's “Proposed Revisions to the Sixth Update of the Geographic Practice Cost Index” draft report at (
Section 10324(c) of the Affordable Care Act added a new subparagraph (I) under section 1848(e)(1) of the Act to establish a 1.0 PE GPCI floor for physicians' services furnished in frontier States effective January 1, 2011. In accordance with section 1848(e)(1)(I) of the Act, beginning in CY 2011, we applied a 1.0 PE GPCI floor for physicians' services furnished in States determined to be frontier States. There are no changes to those States identified as “Frontier States” for the CY 2012 final rule with comment period. The qualifying States are reflected in Table 11. In accordance with statute, we will apply a 1.0 GPCI floor for these States in CY 2012.
The PE GPCIs include four components: employee compensation, office rent, purchased services, and medical equipment, supplies and miscellaneous expenses. Our proposals relating to each of these components are as follows:
• Employee Compensation: We proposed to geographically adjust the employee compensation using the 2006 through 2008 BLS OES data specific to the offices of physicians industry along with nationwide wage data to determine the employee compensation component of the PE GPCIs. The employee compensation component accounts for 19.153 percent of total practice costs or 40.4 percent of the total PE GPCIs.
• Office Rents: We proposed to geographically adjust office rent using the 2006 through 2008 ACS residential rental data for two bedroom units as a proxy for the relative cost differences in physician office rents. In addition, we proposed to consolidate the utilities into the office rent weight to account for the utility data present in ACS gross rent data. The office rent component accounts for 10.223 percent of total practice cost or 21.5 percent of the PE GPCIs.
• Purchased Services: We proposed to geographically adjust the labor-related component of purchased services within the “All Other Services” and “Other Professional Expenses “categories using BLS wage data. The methodology employed to estimate purchased services expenses is based on the same data used to estimate the employee wage index. Specifically, the purchased services framework relies on BLS OES wage data to estimate the price of labor in industries that physician offices frequently rely upon for contracted services. As previously mentioned, the labor-related share adjustment for each industry was derived using a similar methodology as is employed for estimating the labor-related shares of CMS market baskets. Furthermore, the weight assigned to each industry within the purchased services index was based on the 2006-based MEI. A more detailed discussion regarding CMS market baskets, as well as the corresponding definitions of a “labor-related share” and a “non-labor-related share” can be viewed at (74 FR 43845). The total purchased services component accounts for 8.095 percent of total practice cost or 17.1 percent of the PE GPCI. However, the proportion of purchased services that is geographically adjusted for locality cost difference is 5.011 percentage points of the 8.095 percentage points or 10.6 percent of the PE GPCI.
• Medical Equipment, Supplies, and other Miscellaneous Expenses: We continue to believe that items such as medical equipment and supplies have a national market and that input prices do not vary appreciably among geographic areas. As discussed in previous GPCI updates in the CY 2008 and CY 2011 PFS proposed rules, specifically the fifth GPCI update (72 FR 38138) and sixth GPCI update (75 FR 73256), respectively, some price differences may exist, but we believe these differences are more likely to be based on volume discounts rather than on geographic market differences. For example, large physicians' practices may utilize more medical equipment and supplies and therefore may or may not receive volume discounts on some of these items. To the extent that such discounting may exist, it is a function of purchasing volume and not geographic location. The medical equipment, supplies, and miscellaneous expenses component was factored into the PE GPCIs with a component index of 1.000. The medical equipment, supplies, and other miscellaneous expense component account for 9.968 percent of total practice cost or 21.0 percent of the PE GPCI.
The malpractice GPCIs are calculated based on insurer rate filings of premium data for $1 million to $3 million mature “claims-made” policies (policies for claims made rather than services furnished during the policy term). We chose claims-made policies because they are the most commonly used malpractice insurance policies in the United States. We used claims-made policy rates rather than occurrence policies because a claims-made policy covers physicians for the policy amount in effect when the claim is made, regardless of the date of event in question; whereas an occurrence policy covers a physician for the policy amount in effect at the time of the event in question, even if the policy is expired. Based on the data we analyzed, we proposed to revise the cost share weight for the malpractice GPCI from 3.865 percent to 4.295 percent.
We received many public comments regarding the CY 2012 proposed GPCIs. Summaries of the comments and our responses follow.
We also agree with commenters who stated that the updated occupations better reflect the occupations found in physician practices and those who indicated we should expand the occupations to include the full range of
We disagree with commenters who provide radiation oncology services and suggested that we should include medical physicists wage data from the American Association of Physicists in Medicine or the American Academy of Pain Medicine. The use of a consistent and contemporaneous source for the employment and wage data included in the calculation is preferable to a mix of supplemental data sources. Also, while BLS does not collect employment and wage data for medical physicists or health physicists specifically, it does collect employment and wage data for physicists as a whole (SOC code 19-2012 specifically includes physicists, see
With respect to the commenters who indicated the occupational weights utilized by CMS are not representative of their actual practices or the MGMA data, we understand that national occupational weights may not match individual practices or subsets of practices. However, we agree with IOM's preference for “a consistent set of national weights applied to wage data from the full range of health sector occupations so that hourly wage comparisons can be made” (pp. 5-34).
With regards to surveying physicians directly to gather data to compute office rent, we note that development and implementation of a survey could take several years. Moreover, we have historically not sought direct survey data from physicians related to the GPCI to avoid issues of circularity and self-reporting bias. Also, in the CY 2011 final rule with comment period (75 FR 73259) we asked for specific public comments regarding the benefits of utilizing physician cost reports to potentially achieve greater precision in measuring the relative cost difference among Medicare localities. We also asked for comments related to the administrative burden of requiring physicians to routinely complete these cost reports and whether this should be mandatory for physicians practices. We did not receive any feedback specifically related to this comment solicitation during the open public comment period for the CY 2011 final rule with comment period.
With regard to comments requesting that CMS use data from the MGMA survey to develop the office rent index, as we stated in the CY 2011 final rule with comment period (75 FR 73257), we have concerns with both the sample size and representativeness of the MGMA data. For example, the responses represent only about 2,250 (or approximately 1 percent of physician practices nationwide) and have disproportionate sample sizes for each State, suggesting very uneven response rates geographically. In addition, we also have concerns that the MGMA data have the potential for response bias. The MGMA's substantial reliance on its membership base suggests a nonrandom selection into the respondent group. Some evidence for such issues in the MGMA data arises from the very different sample sizes by State. For example, in the MGMA data, 10 States have fewer than 10 observations each, and California, New York, and New Jersey have fewer than 10 observations per locality. Therefore, we continue to believe the MGMA survey data would not be a sufficient rental data source for all PFS localities.
With regards to comments that rents in Santa Clara increased 7 percent yet remained unchanged in the surrounding counties (San Francisco, San Mateo and Santa Cruz), we contacted the Census Bureau and verified that the data were correct. We also checked with the Census Bureau regarding commenter observations that the rent index value
With regards to comments on rents in Polk County, Iowa, compared to San Francisco County, California, Polk County has the second highest office rent index of any county in Iowa (at 0.848). In order to accurately compare the specific relationship between these two counties office rent indices, the Polk County specific office rent index of (.848) should be applied. However, the commenters applied the Iowa “Statewide” locality level index of (.696) to Polk County in their calculations. Because Iowa is a Statewide locality, the higher office rent index for Polk County is reduced when combined with lower cost counties in our GPCI methodology.
As we have stated previously, we did not receive a special tabulation from Census in time to analyze 5-year ACS rental data as a potential data source for physician office rent for the CY 2012 rulemaking cycle. We have now received the 5-year ACS special tabulation from Census and will examine its suitability as a potential proxy for physician office rent. We will also continue our evaluation of ACS rental data during the upcoming year, and may propose further modifications to our office rent methodology in the CY 2013 PFS proposed rule.
We also note that HUD has proposed a new FMR methodology for 2012 that abandons the use of Census long-form data, which are no longer being collected, and instead relies exclusively on ACS data. We will be examining this new proposed methodology to potentially inform future rulemaking.
We disagree with commenters who think there is insufficient statutory basis for a purchased services index. The incorporation of a purchased services index improves the accuracy of the GPCI consistent with the statute. It will allow for the GPCI to account for geographic variation in the price of a wider range of inputs.
We also disagree with commenters who asserted that the proposed methodology does not adequately capture geographic variation in purchased services, including the cost of capital, and asserted that our data sources were inadequate. To adjust for regional variation in the labor inputs of purchased services requires four key elements. These elements include: Wage data by occupation, industry employment levels, labor-related classifications by industry, and the share of physician practice expense. We are using a combination of BLS OES data and MEI weight data for these elements. The BLS OES data is the best currently available data source for this purpose and is used in many aspects of the GPCI calculation. The MEI weights represent our actuaries' best estimate for the weights for these categories. For a fuller discussion of the derivation of the MEI weights, see the CY 2011 final rule with comment period (75 FR 73262). With respect to capital, it is important to note that the proposed purchased services index does not assume that the cost of capital for physician practices is constant across the nation; instead, it assumes that the cost of capital for contracted firms is constant across the nation. Within the purchased services index, we assume a constant cost of capital for the purchased service firm primarily because we do not believe a reliable data source to measure capital costs for each purchased service industry currently exists.
With respect to commenters who recommended that we consult with physician organizations and others to test our categorizations, methodologies, and assumptions, we have been and will continue to be transparent with respect to our calculation of the purchased services index. We solicited comments on our proposed approach and have given consideration to all comments received.
We disagree with commenters who indicated that the cost share weights
Moreover, section 1848(e)(1)(H)(v) of the Act requires the Secretary to make appropriate adjustments to the PE GPCIs as a result of the required analysis no later than January 1, 2012. As a result of our analysis, we proposed the four changes to the PE GPCI calculation as discussed previously in this section. While we fully intend to continue our review of the recently released revised IOM Phase I report on the Medicare GPCIs, it is important and consistent with the statute to proceed with appropriate improvements to the GPCI methodology in conjunction with our review of IOM's reports and IOM's continuing work in this area. We may propose further improvements and modifications to the GPCIs methodology in future rulemaking once we have had an opportunity to assess IOM's recommendations in their entirety.
We received other public comments on matters that were not related to our proposed CY 2012 changes to the GPCIs. We thank the commenters for sharing their views and suggestions. Because we did not make proposals regarding these matters, we do not generally summarize or respond to such comments in this final rule with comment period. For example, we received numerous comments related to the physician work GPCI and the aforementioned expiration of the 1.000 work floor. Since we only proposed to update the cost share weights attributed to physician work, and noted that the statutorily required 1.0 physician work floor would be expiring at the end of CY 2011 in the CY 2012 proposed rule, we will not be responding to comments related to our methodologies or calculations of physician work in this final rule with comment period. For an in-depth discussion of our most recent physician work GPCI update, see the CY 2011 final rule with comment period (75 FR 73252 and 75 FR 73256 through 73260). We look forward to reviewing and evaluating the IOM's recommendations related to physician work included in its revised Phase I report. After we have reviewed the IOM's recommendations in their entirety, we may propose modifications to the physician work GPCI in future rulemaking.
We also received several comments regarding the calculations and methodology used to calculate the MEI, although we did not propose any changes in the methodology used to calculate the MEI. Many commenters reiterated concerns regarding the assignment of MEI weights to the 10 office expense subcategories as outlined in the 2011 Medicare physician payment schedule final rule with comment period. According to some commenters, it is not clear that the AMA PPIS survey expense categories match up with the industry-level data from the Bureau of Economic Analysis in a way that makes this assignment of subcategory weights possible. These commenters further state that the MEI technical advisory panel should revisit this issue, and consider whether other sources of data are available to split office rent from other types of office expenses, and to validate the office rent share as a percent of total expense.
While this issue is outside the scope of this final rule with comment, we note that the costs reported in the 2006 AMA PPIS survey questions for office expenses were crosswalked as closely as possible to the 2002 BEA I/O benchmark categories. The weights for Office Expenses found in the MEI were appropriately based on information reported by self-employed physicians and selected self-employed non-medical doctor specialties found in the 2006 American Medical Association Physician Practice Information Survey (PPIS). The PPIS was developed by medical associations and captures the costs of operating a medical practice, including office rents and non-physician wages. The survey results were further disaggregated using data from the Bureau of Economic Analysis' Benchmark Input/Output tables for Offices of Physicians, Dentists, and
After consideration of the public comments received on the GPCIs, we are finalizing the revisions to the 6th GPCI update using the most current data, with modifications. We are also finalizing the proposal to change the GPCI cost share weights for CY 2012. As a result, the cost share weight for the physician work GPCI (as a percentage of the total) will be 48.266 percent, and the cost share weight for the PE GPCI will be 47.439 percent with a change in the employee compensation component from 18.654 to 19.153 percentage points. The cost share weight for the office rent component of the PE GPCI will be 10.223 percentage points (fixed capital with utilities), and the medical equipment, supplies, and other miscellaneous expenses component will be 9.968 percentage points. Moreover, the cost share weight for the malpractice GPCI will be 4.295 percent. In addition, we are finalizing the weight for purchased services at 8.095 percentage points (5.011 percentage points will be adjusted for geographic cost differences). Additionally, we will review the complete findings and recommendations from the Institute of Medicine's studies on geographic adjustment factors for physician payment and the MEI technical advisory panel once that information becomes fully available to CMS. We will once again consider the GPCIs for CY 2013 rulemaking in the context of our annual PFS rulemaking beginning in CY 2012 based on the information available at that time. We are finalizing the use of 2006 through 2008 ACS two bedroom rental data as a proxy for the relative cost difference in physicians' offices. Moreover, we will examine 5-year ACS rental data to determine its appropriateness as a potential data source for physician office rent. We will also examine HUDs CY 2012 proposed methodology, which utilizes ACS data exclusively, for potential use in future rulemaking. We are also finalizing our proposal to create a purchased services index to account for labor-related services with the “all other services” and “other professional expenses” MEI components. In response to public commenters who recommended we utilize BLS data to capture the “full range” of occupations included in the offices of physician industry to calculate employee wage, we are modifying our original proposal and expanding the number of occupations utilized in our calculation of non-physician employee wages to reflect 100 percent of the total wage share of non-physician occupations in the offices of physicians' industry.
As we indicated previously in this section, section 103 of the Medicare and Medicaid Extenders Act (MMEA) of 2010 (Pub. L. 111-309) extended the 1.0 work GPCI floor only through December 31, 2011. Therefore, the CY 2012 physician work GPCIs and summarized GAFs do not reflect the 1.0 work floor. Moreover, the limited recognition of cost differences in employee compensation and office rent for the PE GPCIs, and the related hold harmless provision, required under section 1848 (e)(1)(H) of the Act was only applicable for CY 2010 and CY 2011 (75 FR 73253) and, therefore under current law, is no longer effective beginning in CY 2012. However, the permanent 1.5 work GPCI floor for Alaska (as established by section 134(b) of the MIPPA) will remain in effect for CY 2012. We are finalizing the CY 2012 GPCIs shown in Addendum E. The GPCIs have been budget neutralized to ensure that nationwide, total RVUs are not impacted by changes in locality GPCIs. The 1.0 PE GPCI floor for frontier States was applied to the budget neutralized GPCIs. The frontier States are the following: Montana; Wyoming; North Dakota; Nevada; and South Dakota. The CY 2012 updated GAFs and GPCIs may be found in Addenda D and E of this final rule with comment period.
The current PFS locality structure was developed and implemented in 1997. There are currently 89 total PFS localities; 34 localities are Statewide areas (that is, only one locality for the entire State). There are 52 localities in the other 16 States, with 10 States having 2 localities, 2 States having 3 localities, 1 State having 4 localities, and 3 States having 5 or more localities. The District of Columbia, Maryland, Virginia suburbs, Puerto Rico, and the Virgin Islands are additional localities that make up the remaining 3 of the total of 89 localities. The development of the current locality structure is described in detail in the CY 1997 PFS proposed rule (61 FR 34615) and the subsequent final rule with comment period (61 FR 59494).
As we have previously noted in the CYs 2008 and 2009 proposed rules (72 FR 38139 and 73 FR 38513), any changes to the locality configuration must be made in a budget neutral manner within a State and can lead to significant redistributions in payments. For many years, we have not considered making changes to localities without the support of a State medical association in order to demonstrate consensus for the change among the professionals whose payments would be affected (since such changes would be redistributive, with some increasing and some decreasing). However, we have recognized that, over time, changes in demographics or local economic conditions may lead us to conduct a more comprehensive examination of existing payment localities.
For the past several years, we have been involved in discussions with physician groups and their representatives about recent shifts in relative demographics and economic conditions. We explained in the CY 2008 PFS final rule with comment period that we intended to conduct a thorough analysis of potential approaches to reconfiguring localities and would address this issue again in future rulemaking. For more information, we refer readers to the CY 2008 PFS proposed rule (72 FR 38139) and subsequent final rule with comment period (72 FR 66245).
As a follow-up to the CY 2008 PFS final rule with comment period, we acquired a contractor to conduct a preliminary study of several options for revising the payment localities on a nationwide basis. The final report entitled, “Review of Alternative GPCI Payment Locality Structures—Final Report,” is accessible from the CMS PFS Web page
We did not make any proposals regarding the PFS locality configurations for CY 2012. However, we did receive some comments regarding IOM's recommendation to modify Medicare PFS localities to reflect metropolitan statistical areas (MSA)-based definitions. We will
At our request, the Institute of Medicine is conducting a study of the geographic adjustment factors in Medicare payment. It is a comprehensive empirical study of the geographic adjustment factors established under sections 1848(e) (GPCI) and 1886(d)(3)(E) of the Act (hospital wage index). These adjustments are designed to ensure Medicare payment fees and rates reflect differences in input costs across geographic areas. The factors IOM is evaluating include the—
• Accuracy of the adjustment factors;
• Methodology used to determine the adjustment factors, and
• Sources of data and the degree to which such data are representative.
Within the context of the U.S. health care marketplace, the IOM is also evaluating and considering the—
• Effect of the adjustment factors on the level and distribution of the health care workforce and resources, including—
++ Recruitment and retention taking into account mobility between urban and rural areas;
++ Ability of hospitals and other facilities to maintain an adequate and skilled workforce; and
++ Patient access to providers and needed medical technologies;
• Effect of adjustment factors on population health and quality of care; and
• Effect of the adjustment factors on the ability of providers to furnish efficient, high value care.
The revised first report “Geographic Adjustment in Medicare Payment, Phase I: Improving Accuracy” that was released September 28, 2011 and is available on the IOM Web site
The recommendations included in IOM's revised Phase I report that relate to or would have an effect on the GPCIs are summarized as follows:
• Recommendation 2-1: The same labor market definition should be used for both the hospital wage index and the physician geographic adjustment factor. Metropolitan statistical areas and Statewide non-metropolitan statistical areas should serve as the basis for defining these labor markets.
• Recommendation 2-2: The data used to construct the hospital wage index and the physician geographic adjustment factor should come from all health care employers.
• Recommendation 5-1: The GPCI cost share weights for adjusting fee-for-service payments to practitioners should continue to be national, including the three GPCIs (work, practice expense, and liability insurance) and the categories within the practice expense (office rent and personnel).
• Recommendation 5-2: Proxies should continue to be used to measure geographic variation in the physician work adjustment, but CMS should determine whether the seven proxies currently in use should be modified.
• Recommendation 5-3: CMS should consider an alternative method for setting the percentage of the work adjustment based on a systematic empirical process.
• Recommendation 5-4: The practice expense GPCI should be constructed with the full range of occupations employed in physicians' offices, each with a fixed national weight based on the hours of each occupation employed in physicians' offices nationwide.
• Recommendation 5-5: CMS and the Bureau of Labor Statistics should develop an agreement allowing the Bureau of Labor Statistics to analyze confidential data for the Centers for Medicare and Medicaid Services.
• Recommendation 5-6: A new source of information should be developed to determine the variation in the price of commercial office rent per square foot.
• Recommendation 5-7: Nonclinical labor-related expenses currently included under practice expense office expenses should be geographically adjusted as part of the wage component of the practice expense.
We note that the GPCI revisions we are finalizing in this final rule with comment period address three of the IOM recommendations referenced above. Specifically, our final GPCIs utilize the full range of non-physician occupations in the non-physician employee wage calculation consistent with IOM recommendation 5-4. Additionally, we created a new purchased service index to account for non-clinical labor-related expenses similar to IOM recommendation 5-7. Lastly, we have consistently used national cost share weights (MEI) to determine the appropriate weight attributed to each GPCI component, which is supported by recommendation 5-1. We may propose further improvements to the GPCI methodology in future rulemaking to address the remaining IOM recommendations once we have had an opportunity to assess IOM's recommendations in their entirety.
Prior to January 1, 1999, Medicare coverage for services delivered via a telecommunications system was limited to services that did not require a face-to-face encounter under the traditional model of medical care. Examples of these services included interpretation of an x-ray, or electrocardiogram, or electroencephalogram tracing, and cardiac pacemaker analysis.
Section 4206 of the BBA provided for coverage of, and payment for, consultation services delivered via a telecommunications system to Medicare beneficiaries residing in rural health professional shortage areas (HPSAs) as defined by the Public Health Service Act. Additionally, the BBA required that a Medicare practitioner (telepresenter) be with the patient at the time of a teleconsultation. Further, the BBA specified that payment for a teleconsultation had to be shared between the consulting practitioner and the referring practitioner and could not exceed the fee schedule payment which would have been made to the consultant for the service provided. The BBA prohibited payment for any telephone line charges or facility fees associated with the teleconsultation. We implemented this provision in the CY 1999 PFS final rule with comment period (63 FR 58814).
Effective October 1, 2001, section 223 of the Medicare, Medicaid and SCHIP Benefits Improvement Protection Act of 2000 (Pub. L. 106-554) (BIPA) added a new section, 1834(m), to the Act which significantly expanded Medicare telehealth services. Section 1834(m)(4)(F)(i) of the Act defines
As specified in regulations at § 410.78(b), we generally require that a telehealth service be furnished via an interactive telecommunications system. Under § 410.78(a)(3), an interactive telecommunications system is defined as multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real time interactive communication between the patient and the practitioner at the distant site. Telephones, facsimile machines, and electronic mail systems do not meet the definition of an interactive telecommunications system. An interactive telecommunications system is generally required as a condition of payment; however, section 1834(m)(1) of the Act does allow the use of asynchronous “store-and-forward” technology in delivering these services when the originating site is a Federal telemedicine demonstration program in Alaska or Hawaii. As specified in regulations at § 410.78(a)(1), store and forward means the asynchronous transmission of medical information from an originating site to be reviewed at a later time by the practitioner at the distant site.
Medicare telehealth services may be provided to an eligible telehealth individual notwithstanding the fact that the individual practitioner providing the telehealth service is not at the same location as the beneficiary. An eligible telehealth individual means an individual enrolled under Part B who receives a telehealth service furnished at an originating site. As specified in BIPA, originating sites are limited under section 1834(m)(3)(C) of the Act to specified medical facilities located in specific geographic areas. The initial list of telehealth originating sites included the office of a practitioner, a critical access hospital (CAH), a rural health clinic (RHC), a Federally qualified health center (FQHC) and a hospital (as defined in Section 1861(e) of the Act). More recently, section 149 of the Medicare Improvements for Patients and Providers Act of 2008 (Pub. L. 110-275) (MIPPA) expanded the list of telehealth originating sites to include hospital-based renal dialysis centers, skilled nursing facilities (SNFs), and community mental health centers (CMHCs). In order to serve as a telehealth originating site, these sites must be located in an area designated as a rural health professional shortage area (HPSA), in a county that is not in a metropolitan statistical area (MSA), or must be an entity that participates in a Federal telemedicine demonstration project that has been approved by (or receives funding from) the Secretary of Health and Human Services as of December 31, 2000. Finally, section 1834(m) of the Act does not require the eligible telehealth individual to be presented by a practitioner at the originating site.
As noted previously, Medicare telehealth services can only be furnished to an eligible telehealth beneficiary in an originating site. An originating site is defined as one of the specified sites where an eligible telehealth individual is located at the time the service is being furnished via a telecommunications system. In general, originating sites must be located in a rural HPSA or in a county outside of an MSA. The originating sites authorized by the statute are as follows:
• Offices of a physician or practitioner.
• Hospitals.
• CAHs.
• RHCs.
• FQHCs.
• Hospital-Based Or Critical Access Hospital-Based Renal Dialysis Centers (including Satellites).
• SNFs.
• CMHCs.
Currently approved Medicare telehealth services include the following:
• Initial inpatient consultations.
• Follow-up inpatient consultations.
• Office or other outpatient visits.
• Individual psychotherapy.
• Pharmacologic management.
• Psychiatric diagnostic interview examination.
• End-stage renal disease (ESRD) related services.
• Individual and group medical nutrition therapy (MNT).
• Neurobehavioral status exam.
• Individual and group health and behavior assessment and intervention (HBAI).
• Subsequent hospital care.
• Subsequent nursing facility care.
• Individual and group kidney disease education (KDE).
• Individual and group diabetes self-management training services (DSMT).
In general, the practitioner at the distant site may be any of the following, provided that the practitioner is licensed under State law to furnish the service being furnished via a telecommunications system:
• Physician.
• Physician assistant (PA).
• Nurse practitioner (NP).
• Clinical nurse specialist (CNS);
• Nurse-midwife.
• Clinical psychologist.
• Clinical social worker.
• Registered dietitian or nutrition professional.
Practitioners furnishing Medicare telehealth services are located at a distant site, and they submit claims for telehealth services to the Medicare contractors that process claims for the service area where their distant site is located. Section 1834(m)(2)(A) of the Act requires that a practitioner who furnishes a telehealth service to an eligible telehealth individual be paid an amount equal to the amount that the practitioner would have been paid if the service had been furnished without the use of a telecommunications system. Distant site practitioners must submit the appropriate HCPCS procedure code for a covered professional telehealth service, appended with the -GT (Via interactive audio and video telecommunications system) or -GQ (Via asynchronous telecommunications system) modifier. By reporting the -GT or -GQ modifier with a covered telehealth procedure code, the distant site practitioner certifies that the beneficiary was present at a telehealth originating site when the telehealth service was furnished. The usual Medicare deductible and coinsurance policies apply to the telehealth services reported by distant site practitioners.
Section 1834(m)(2)(B) of the Act provides for payment of a facility fee to the originating site. To be paid the originating site facility fee, the provider or supplier where the eligible telehealth individual is located must submit a claim with HCPCS code Q3014 (Telehealth originating site facility fee), and the provider or supplier is paid according to the applicable payment methodology for that facility or location. The usual Medicare deductible and coinsurance policies apply to HCPCS code Q3014. By submitting HCPCS code Q3014, the originating site certifies that it is located in either a rural HPSA or non-MSA county or is an entity that participates in a Federal telemedicine demonstration project that has been approved by (or receives funding from) the Secretary of Health and Human Services as of December 31, 2000 as specified in section 1834(m)(4)(C)(i)(III) of the Act.
As previously described, certain professional services that are commonly
As noted previously, in the December 31, 2002
• Category 1: Services that are similar to professional consultations, office visits, and office psychiatry services that are currently on the list of telehealth services. In reviewing these requests, we look for similarities between the requested and existing telehealth services for the roles of, and interactions among, the beneficiary, the physician (or other practitioner) at the distant site and, if necessary, the telepresenter. We also look for similarities in the telecommunications system used to deliver the proposed service, for example, the use of interactive audio and video equipment.
• Category 2: Services that are not similar to the current list of telehealth services. Our review of these requests includes an assessment of whether the use of a telecommunications system to deliver the service produces similar diagnostic findings or therapeutic interventions as compared with the in-person delivery of the same service. Requestors should submit evidence showing that the use of a telecommunications system does not affect the diagnosis or treatment plan as compared to in-person delivery of the requested service.
Since establishing the process to add or remove services from the list of approved telehealth services, we have added the following to the list of Medicare telehealth services: individual and group HBAI services; psychiatric diagnostic interview examination; ESRD services with 2 to 3 visits per month and 4 or more visits per month (although we require at least 1 visit a month to be furnished in-person by a physician, CNS, NP, or PA in order to examine the vascular access site); individual and group MNT; neurobehavioral status exam; initial and follow-up inpatient telehealth consultations for beneficiaries in hospitals and skilled nursing facilities (SNFs); subsequent hospital care (with the limitation of one telehealth visit every 3 days); subsequent nursing facility care (with the limitation of one telehealth visit every 30 days); individual and group KDE; and individual and group DSMT services (with a minimum of 1 hour of in-person instruction to ensure effective injection training).
Requests to add services to the list of Medicare telehealth services must be submitted and received no later than December 31 of each calendar year to be considered for the next rulemaking cycle. For example, requests submitted before the end of CY 2011 will be considered for the CY 2013 proposed rule. Each request for adding a service to the list of Medicare telehealth services must include any supporting documentation the requester wishes us to consider as we review the request. Because we use the annual PFS rulemaking process as a vehicle for making changes to the list of Medicare telehealth services, requestors should be advised that any information submitted is subject to public disclosure for this purpose. For more information on submitting a request for an addition to the list of Medicare telehealth services, including where to mail these requests, we refer readers to the CMS Web site at
We received requests in CY 2010 to add the following services as Medicare telehealth services effective for CY 2012: (1) Smoking cessation services; (2) critical care services; (3) domiciliary or rest home evaluation and management services; (4) genetic counseling services; (5) online evaluation and management services; (6) data collection services; and (7) audiology services. The following presents a discussion of these requests, including our proposals for additions to the CY 2012 telehealth list.
The American Telemedicine Association and the Marshfield Clinic submitted requests to add smoking cessation services, reported by CPT codes 99406 (Smoking and tobacco use cessation counseling visit; intermediate, greater than 3 minutes up to 10 minutes) and 99407 (Smoking and tobacco use cessation counseling visit; intensive, greater than 10 minutes) to the list of approved telehealth services for CY 2012 on a category 1 basis.
Smoking Cessation services are defined as face-to-face behavior change interventions. We believe the interaction between a practitioner and a beneficiary receiving smoking cessation services is similar to the education, assessment, and counseling elements of individual KDE reported by HCPCS code G0420 (Face-to-face educational services related to the care of chronic kidney disease; individual, per session, per 1 hour), and individual MNT services, reported by HCPCS code G0270 (Medical nutrition therapy; reassessment and subsequent intervention(s) following second referral in the same year for change in diagnosis, medical condition or treatment regimen (including additional hours needed for renal disease), individual, face-to-face with the patient, each 15 minutes); CPT code 97802 (Medical nutrition therapy; initial assessment and intervention, individual, face-to-face with the patient, each 15 minutes); and CPT code 97803 (Medical nutrition therapy; re-assessment and intervention, individual, face-to-face with the patient, each 15 minutes), all services that are currently on the telehealth list.
Therefore, we proposed to add CPT codes 99406 and 99407 to the list of telehealth services for CY 2012 on a category 1 basis. Additionally, we proposed to add HCPCS codes G0436 (Smoking and tobacco cessation
Consistent with this proposal, we also proposed to revise our regulations at § 410.78(b) and § 414.65(a)(1) to include these smoking cessation services as Medicare telehealth services.
After consideration of the public comments we received, we are finalizing our CY 2012 proposal to add CPT codes 99406 and 99407 to the list of telehealth services for CY 2012 on a category 1 basis. Additionally, we are finalizing our proposal to add HCPCS codes G0436 (Smoking and tobacco cessation counseling visit for the asymptomatic patient; intermediate, greater than 3 minutes, up to 10 minutes) and G0437 (Smoking and tobacco cessation counseling visit for the asymptomatic patient; intensive, greater than 10 minutes) to the list of telehealth services for CY 2012 and to revise our regulations at § 410.78(b) and § 414.65(a)(1) to include smoking cessation services as Medicare telehealth services.
The American Telemedicine Association and the Marshfield Clinic submitted requests to add critical care service CPT codes 99291 (Critical care, evaluation and management of the critically ill or critically injured patient; first 30-74 minutes) and 99292 (Critical care, evaluation and management of the critically ill or critically injured patient; each additional 30 minutes) to the list of approved telehealth services. We previously received this request for the CY 2009 and CY 2010 PFS rulemaking cycles (73 FR 38517, 73 FR 69744 and 69745, 74 FR 33548, and 74 FR 61764) and did not add the codes on a category 1 basis due to the acute nature of the typical patient. We continue to believe that patients requiring critical care services are more acutely ill than those patients typically receiving any service currently on the list of telehealth services. Therefore, we cannot consider critical care services on a category 1 basis.
In the CY 2009 PFS proposed rule (73 FR 38517), we explained that we had no evidence suggesting that the use of telehealth could be a reasonable surrogate for the in-person delivery of critical care services; therefore, we would not add the services on a category 2 basis. Requestors submitted new studies for CY 2012, but none demonstrated that comparable outcomes to a face-to-face encounter can be achieved using telehealth to deliver these services. The studies we received primarily addressed other issues relating to telehealth services. Some studies addressed the cost benefits and cost savings of telehealth services. Others focused on the positive outcomes of telehealth treatment when compared with no treatment at all. One submitted study addressed the equivalency of patient outcomes for telehealth services delivered to patients in emergency rooms, but the study's authors specifically restricted their population to patients whose complaints were not considered to be genuine emergencies. Given that limitation, it seems unlikely that any of these patients would have required critical care services as defined by CPT codes 99291 and 99292.
We note that consultations are included on the list of Medicare telehealth services and may be billed by practitioners furnishing services to critically ill patients These services are described by the following HCPCS codes: G0425 (Initial inpatient telehealth consultation, typically 30 minutes communicating with the patient via telehealth), G0426 (Initial inpatient telehealth consultation, typically 50 minutes communicating with the patient via telehealth), G0427 (Initial inpatient telehealth consultation, typically 70 minutes or more communicating with the patient via telehealth), G0406 (Follow-up inpatient telehealth consultation, limited, physicians typically spend 15 minutes communicating with the patient via telehealth), G0407 (Follow-up inpatient telehealth consultation, intermediate, physicians typically spend 25 minutes communicating with the patient via telehealth), and G0408 (Follow-up inpatient telehealth consultation, complex, physicians typically spend 35 minutes or more communicating with the patient via telehealth). Critical care services, as reported by the applicable CPT codes and described in the introductory language in the CPT book, consist of direct delivery by a physician of medical care for a critically ill or injured patient, including high complexity decision-making to assess, manipulate, and support vital system functions. Critical care requires interpretation of multiple physiologic parameters and/or application of advanced technologies, including temporary pacing, ventilation management, and vascular access services. The payment rates under the PFS reflect this full scope of physician work. To add the critical services to the telehealth list would require the physician to be able to deliver this full scope of services via telehealth. Based on the code descriptions, we have previously believed that it is not possible to deliver the full range of critical care services without a physical physician presence with the patient.
We note that there are existing Category III CPT codes (temporary codes for emerging services that allow data collection) for remote real-time interactive video-conferenced critical care services that, consistent with our treatment of other Category III CPT codes, are not nationally priced under the PFS. The fact that the CPT Editorial Panel created these additional Category III CPT codes suggests to us that these video-conferenced critical care services are not the same as the in-person critical care services requested for addition to the telehealth list.
Because we did not find evidence that use of a telecommunications system to deliver critical care services produces similar diagnostic or therapeutic outcomes as compared with the face-to-face deliver of the services, we did not propose to add critical care services (as described by CPT codes 99291 and 99292) to the list of approved telehealth services. We reiterated that our decision not to propose to add critical care services to the list of approved telehealth services does not preclude physicians from furnishing telehealth consultations to critically ill patients using the consultation codes that are on the list of Medicare telehealth services.
After consideration of the public comments we received, we are finalizing our decision not to add critical care services to the list of Medicare telehealth services for CY 2012.
The American Telemedicine Association and the Marshfield Clinic submitted requests to add the following domiciliary or rest home evaluation and management CPT codes to the telehealth list for CY 2012:
• 99334 (Domiciliary or rest home visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components: A problem focused interval history; a problem focused examination; or straightforward medical decision making. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are self-limited or minor. Physicians typically spend 15 minutes with the patient and/or family or caregiver).
• 99335 (Domiciliary or rest home visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components: An expanded problem focused interval history; An expanded problem focused examination; Medical decision making of low complexity. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of low to moderate severity. Physicians typically spend 25 minutes with the patient and/or family or caregiver).
• 99336 (Domiciliary or rest home visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components: A detailed interval history; a detailed examination; medical decision making of moderate complexity. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of moderate to high severity. Physicians typically spend 40 minutes with the patient and/or family or caregiver).
• 99337 (Domiciliary or rest home visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components: A comprehensive interval history; a comprehensive examination; medical decision making of moderate to high complexity. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of moderate to high severity. The patient may be unstable or may have developed a significant new problem requiring immediate physician attention. Physicians typically spend 60 minutes with the patient and/or family or caregiver).
A domiciliary or rest home is not permitted under current statute to serve as an originating site for Medicare telehealth services. Therefore, we did not propose to add domiciliary or rest home evaluation and management services to the list of Medicare telehealth services for CY 2012.
After consideration of the public comments we received, we are finalizing our decision not to add domiciliary or rest home evaluation and management services to the list of Medicare telehealth services for CY2012.
The American Telemedicine Association and the Marshfield Clinic submitted requests to add CPT code 96040 (Medical genetics and genetic counseling services, each 30 minutes face-to-face with patient/family) to the telehealth list for CY 2012. We note that CPT guidance regarding reporting genetic counseling and education furnished by a physician to an individual directs physicians to evaluation and management (E/M) CPT codes and that services described by CPT code 96040 are provided by trained genetic counselors. Physicians and nonphysician practitioners who may independently bill Medicare for their service and who are counseling individuals would generally report office or other outpatient evaluation and management (E/M) CPT codes for office visits that involve significant counseling, including genetic counseling, and these office visit CPT codes are already on the list of telehealth services. CPT code 96040 would only be reported by genetic counselors for genetic counseling services. These practitioners cannot bill Medicare directly for their professional services and they are also not on the list of practitioners who can furnish telehealth services (specified in section 1834(m)(4)(E) of the Act). As such, we do not believe that it would be necessary or appropriate to add CPT code 96040 to the list of Medicare
After consideration of the public comments we received, we are finalizing our decision not to add genetic counseling services to the list of Medicare telehealth services for CY 2012.
The American Telemedicine Association and the Marshfield Clinic submitted requests to add CPT code 99444 (Online evaluation and management service provided by a physician to an established patient, guardian, or health care provider not originating from a related E/M service provided within the previous 7 days, using the Internet or similar electronic communications network) to the list of Medicare telehealth services.
As we explained in the CY 2008 PFS final rule with comment period (72 FR 66371), we assigned a status indicator of “N” (Non-covered service) to these services because: (1) These services are non-face-to-face; and (2) the code descriptor includes language that recognizes the provision of services to parties other than the beneficiary and for whom Medicare does not provide coverage (for example, a guardian).
According to section 1834(m)(2)(A) of the Act, Medicare is required to pay for telehealth services at an amount equal to the amount that a practitioner would have been paid had such service been furnished without the use of a telecommunications system. As such, we do not believe it would be appropriate to make payment for services furnished via telehealth when those services would not otherwise be covered under Medicare. Because CPT code 99444 is currently noncovered, we did not propose to add online evaluation and management services to the list of Medicare Telehealth Services for CY 2012.
After consideration of the public comments we received, we are finalizing our decision not to add online evaluation and management services to the list of Medicare telehealth services for CY 2012.
The American Telemedicine Association and the Marshfield Clinic submitted requests to add CPT codes 99090 (Analysis of clinical data stored in computers (
As we explained in the in CY 2002 PFS final rule with comment period (66 FR 55309), we assigned a status indicator of “B” (Payment always bundled into payment for other services not specified) to these services because the associated work is considered part of the pre- and post-service work of an E/M service. We note that many E/M codes are on the list of Medicare telehealth services.
According to section 1834(m)(2)(A) of the Act, Medicare is required to pay for telehealth services an amount equal to the amount that a practitioner would have been paid had such service been furnished without the use of a telecommunications system. Similar to the point noted previously for online E/M services, we do not believe it would be appropriate to make separate payment for services furnished via telehealth when Medicare would not otherwise make separate payment for the services. Moreover, we believe the payment for these data collection services should be bundled into the payment for E/M services, many of which are already on the Medicare telehealth list. Because CPT codes 99090 and 99091 are currently bundled, we did not propose to add data collection services to the list of Medicare telehealth services for CY 2012.
After consideration of the public comments we received, we are finalizing our decision not to add data collection services to the list of Medicare telehealth services for CY 2012.
The American Academy of Audiology submitted a request that CMS add services that audiologists provide for balance disorders and hearing loss to the list of Medicare telehealth services. The request did not include specific HCPCS codes. Nevertheless, it is not within our administrative authority to pay audiologists for services furnished via telehealth. The statute authorizes the Secretary to pay for telehealth services only when furnished by a physician or a practitioner as physician or practitioner are defined in sections 1834(m)(4)(D) and (E) of the Act. Therefore, we did not propose to add services that are primarily provided by audiologists to the list of Medicare telehealth services for CY 2012.
After consideration of the public comments we received, we are finalizing our decision not to add audiology services to the list of Medicare telehealth services for CY 2012.
Along with its submission of codes for consideration as additions to the Medicare telehealth list for CY 2012, the American Telemedicine Association (ATA) also requested that CMS consider revising the annual process for adding to or deleting services from the list of telehealth services. The existing process, adopted in the CY 2003 PFS rulemaking cycle (67 FR 43862 through 43863 and 67 FR 79988 through 79989), is described in section II.E.1. of this final rule with comment period. The following discussion includes a summary of recent requests by the ATA and other stakeholders for changes to the established process for adding services to the telehealth list, an assessment of our historical experience with the current process including the request review criteria, and our proposed refinement to the process for adding services to the telehealth list that would be used in our evaluation of candidate telehealth services beginning for CY 2013.
The ATA asked CMS to consider two specific changes to the process, including—
• Broadening the factors for consideration to include shortages of health professionals to provide in-person services, speed of access to in-person services, and other barriers to care for beneficiaries; and
• Equalizing the standard for adding telehealth services with the standard for deleting telehealth services by adopting a standard that allows services that are safe, effective or medically beneficial when furnished via telehealth to be added to the list of Medicare telehealth services. Similarly, we have received recommendations that CMS place all codes payable under the PFS on the telehealth list and allow physicians and practitioners to make a clinical determination in each case about whether a medically reasonable and necessary service could be appropriately furnished to a beneficiary through telehealth. Under this scenario, stakeholders have argued that CMS would only remove services from the telehealth list under its existing policy for service removal; specifically, that a decision to remove a service from the list of telehealth services would be made using evidence-based, peer-reviewed data which indicate that a specific service is not safe, effective, or medically beneficial when furnished via telehealth (67 FR 79988).
While we share the interests of stakeholders in reducing barriers to health care access faced by some beneficiaries, given that section 1834(m)(2)(F)(ii) of the Act requires the Secretary to establish a process that provides, on an annual basis, for the addition or deletion of telehealth services (and HCPCS codes), as appropriate, we do not believe it would be appropriate to add all services for which payment is made under the PFS to the telehealth list without explicit consideration as to whether the candidate service could be effectively furnished through telehealth. For example, addition of all codes to the telehealth list could result in a number of services on the list that could never be furnished by a physician or nonphysician practitioner who was not physically present with the beneficiary, such as major surgical procedures and interventional radiology services. Furthermore, we do not believe it would be appropriate to add services to the telehealth list without explicit consideration as to whether or not the nature of the service described by a candidate code allows the service to be furnished effectively through telehealth. Section 1834(m)(2)(A) of the Act requires that the distant site physician or practitioner furnishing the telehealth service must be paid an amount equal to the amount the physician or practitioner would have been paid under the PFS has such service been furnished without the use of a telecommunications system. Therefore, we believe that candidate telehealth services must also be covered when furnished in-person; and that any service that would only be furnished through a telecommunications system would be a new service and, therefore, not a candidate for addition to the telehealth list. In view of these considerations, we will continue to consider candidate additions to the telehealth list on a HCPCS code-specific basis based on requests from the public and our own considerations.
We also believe it continues to be most appropriate to consider candidate services for the telehealth list based on the two mutually exclusive established categories into which all services fall—specifically, services that are similar to services currently on the telehealth list (category 1) and services that are not similar to current telehealth services (category 2). Under our existing policy, we add services to the telehealth list on a category 1 basis when we determine that they are similar to services on the existing telehealth list with respect to the roles of, and interactions among, the beneficiary, physician (or other practitioner) at the distant site and, if necessary, the telepresenter (67 FR 43862). Since CY 2003, we have added 35 services to the telehealth list on a category 1 basis based on public requests and our own identification of such services. We believe it is efficient and valuable to maintain the existing policy that allows us to consider requests for additions to the telehealth list on a category 1 basis and proposed to add them to the telehealth list if the existing criteria are met. This procedure expedites our ability to identify codes for the telehealth list that resemble those services already on this list, streamlining our review process and the public request and information-submission process for services that fall into this category. Therefore, we believe that any changes to the process for adding codes to the telehealth list should be considered with respect to category 2 additions, rather than category 1 additions.
Our existing criteria for consideration of codes that would be category 2 additions, specifically those candidate telehealth services that are not similar to any current telehealth services, include an assessment of whether the use of a telecommunications system to deliver the services produces similar diagnostic findings or therapeutic interventions as compared with a face-to-face in-person delivery of the same service (67 FR 43682). In other words, the discrete outcome of the interaction between the clinician and patient facilitated by a telecommunications system should correlate well with the discrete outcome of the clinician-patient interaction when performed face-to-face. In the CY 2003 PFS proposed rule (67 FR 43862), we explained that requestors for category 2 additions to the telehealth list should submit evidence that the use of a telecommunications systems does not affect the diagnosis or treatment plan as compared to in-person delivery of the service. We indicated that if evidence shows that the candidate telehealth service is equivalent when furnished in person or through telehealth, we would add it to the list of telehealth services. We refer to this standard in further discussion in this final rule with comment period as the “comparability standard.” We stated in the CY 2003 PFS proposed rule (67 FR 43862) that if we determine that the use of a telecommunications system changes the nature or outcome of the service, for
We believe it is most appropriate to address the ATA and other stakeholder requests to broaden the current factors we consider when deciding whether to add candidate services to the telehealth list—to include factors such as the effects of barriers to in-person care and the safety, effectiveness, or medical benefit of the service furnished through telehealth, as potential refinements to our category 2 criteria. We initially established these category 2 criteria in the interest of ensuring that the candidate services were safe, effective, medically beneficial, and still accurately described by the corresponding codes when delivered via telehealth, while also ensuring that beneficiaries furnished telehealth services receive high quality care that is comparable to in-person care. We believed that the demonstration of comparable clinical outcomes (diagnostic findings and/or therapeutic interventions) from telehealth and in-person services would prove to be the best indicator that all of these conditions were met. While we continue to believe that safety, effectiveness, and medical benefit, as well as accurate description of the candidate telehealth services by the CPT or HCPCS codes, are necessary conditions for adding codes to the list of Medicare telehealth services, our recent experience in reviewing public requests for telehealth list additions and our discussions with stakeholders regarding contemporary medical practice and potential barriers to care, have led us to conclude that the comparability standard for category 2 requests should be modified.
In our annual evaluation of category 2 requests since we adopted the process for evaluating additions to the telehealth list almost 10 years ago, we have consistently observed that requestors have difficulty demonstrating that clinical outcomes of a service delivered via telehealth are comparable to the outcomes of the in-person service. The medical literature frequently does not include studies of the outcomes of many types of in-person services that allow for comparison to the outcomes demonstrated for candidate telehealth services. Furthermore, we know that in some cases the alternative to a telehealth service may be no service rather than an in-person service. The comparability standard may not sufficiently allow for the opportunity to add candidate services to the telehealth list that may be safe, effective, and medically beneficial when delivered via telehealth, especially to beneficiaries who experience significant barriers to in-person care. While we continue to believe that beneficiaries receiving services through telehealth are deserving of high quality health care and that in-person care may be very important and potentially preferable for some services when in-person care is possible, we are concerned that we have not added any services to the telehealth list on a category 2 basis as a result of our reviews. While some candidate services appear to have the potential for clinical benefit when furnished through telehealth, the requests have not met the comparability standard.
Therefore, we proposed to refine our category 2 review criteria for adding codes to the list of Medicare telehealth services beginning in CY 2013 by modifying the current requirement to demonstrate similar diagnostic findings or therapeutic interventions with respect to a candidate service delivered through telehealth compared to in-person delivery of the service (the comparability standard). We proposed to establish a revised standard of demonstrated clinical benefit when the service is furnished via telehealth. We refer to this proposed standard in further discussion in this final rule with comment period as the “clinical benefit standard.” To support our review using this revised standard, we would ask requestors to specify in their request how the candidate telehealth service is still accurately described by the corresponding HCPCS or CPT code when delivered via telehealth as opposed to in-person.
We proposed that our refined criteria for category 2 additions would be as follows:
• Category 2: Services that are not similar to the current list of telehealth services. Our review of these requests would include an assessment of whether the service is accurately described by the corresponding code when delivered via telehealth and whether the use of a telecommunications system to deliver the service produces demonstrated clinical benefit to the patient. Requestors should submit evidence indicating that the use of a telecommunications system in delivering the candidate telehealth service produces clinical benefit to the patient.
The evidence submitted should include both a description of relevant clinical studies that demonstrate the service furnished by telehealth to a Medicare beneficiary improves the diagnosis or treatment of an illness or injury or improves the functioning of a malformed body part, including dates and findings and a list and copies of published peer-reviewed articles relevant to the service when furnished via telehealth. Some examples of clinical benefit include the following:
• Ability to diagnose a medical condition in a patient population without access to clinically appropriate in-person diagnostic services.
• Treatment option for a patient population without access to clinically appropriate in-person treatment options.
• Reduced rate of complications.
• Decreased rate of subsequent diagnostic or therapeutic interventions (for example, due to reduced rate of recurrence of the disease process).
• Decreased number of future hospitalizations or physician visits.
• More rapid beneficial resolution of the disease process treatment.
• Decreased pain, bleeding, or other quantifiable symptom.
• Reduced recovery time.
We believe the adoption of this clinical benefit standard for our review of candidate telehealth services on a category 2 basis is responsive to the requests of stakeholders that we broaden the factors taken into consideration to include barriers to care for beneficiaries. It allows us to consider the demonstrated clinical benefit of telehealth services for beneficiaries who might otherwise have no access to certain diagnostic or treatment services. Furthermore, we believe the focus on demonstrated clinical benefit in our review of category 2 requests for addition to the telehealth lists is equivalent to our standard for deleting services from the telehealth list that rests upon evidence that a service is not safe, not effective, or not medically beneficial. Finally, we believe the proposed clinical benefit standard for our review of candidate telehealth services on a category 2 basis is fully consistent with our responsibility to ensure that telehealth services are safe, effective, medically beneficial, and still accurately described by the corresponding codes that would be used for the services when delivered in-person.
We solicited public comments on the proposed refinement to our established process for adding codes to the telehealth list, including the information that requestors should furnish to facilitate our full review of requests in preparation for the CY 2013 PFS rulemaking cycle during which we will use the category 2 review criteria finalized in this final rule with comment period.
We continue to believe safety, effectiveness, and medical benefit, as well as accurate description of the candidate telehealth services by the CPT or HCPCS codes, are necessary conditions for adding codes to the list of Medicare telehealth services. While we believe that in many cases, the existing standard has led to appropriate category 2 determinations not to add services to the telehealth benefit, we also believe that the current standard has prevented consideration of some services that could be clinically beneficial because there are no studies that compare patient outcomes when services are delivered via telehealth versus in person. This does not support our interests in identifying beneficial services for the telehealth benefit. Specifically, we observe that the medical literature frequently does not include studies of the outcomes of many types of in-person services that allow for comparison to the outcomes demonstrated for candidate telehealth services. We believe that the proposed revision to the existing criteria will allow thorough consideration of a greater number of requests for addition to the list. We would also remind commenters that the annual process will continue to provide stakeholders who support or oppose adding particular services to the list the opportunity to contribute to our evaluations of particular requests through public comment.
Additionally, we note that the established process for deleting services from the list would allow Medicare to consider any available evidence suggesting that the addition of particular services to the list of Medicare telehealth services had detrimentally changed the quality of medical care for Medicare beneficiaries in remote areas. Such evidence could be considered in the context of either a public request or internally generated proposal to delete services from the list of Medicare telehealth services during annual PFS rulemaking. This process was
Finally, we agree with the commenter that argued that we should not add services to the telehealth list based on demonstrated evidence of minor benefit. We would like to clarify that our evidentiary standard of clinical benefit would not include minor or incidental benefits.
We believe that establishing more rigid evaluation criteria (for example, criteria that rely on measurement of a series of demonstrated clinical outcomes specified by CMS) might present as many problems as has the current category 2 criteria, because under such a process requestors would be required to submit medical literature that passes a series of hurdles established by us prior to receiving a particular request. We would not be able to assess the benefit of the requested service within the context of the submitted evidence and the specific services. We also believe that such a process might lead to greater administrative burden for requestors and might require constant revision through annual rulemaking to adapt any specific criteria to changes in medical and communication technology as well as developments in medical literature.
Additionally, we note that the application of the proposed criteria to each request will remain subject to public notice and comment. Since we implemented the process to add or delete services, including the existing category 2 criteria, we have used the PFS notice and comment rulemaking process to propose, accept public comments, and ultimately explain how the established evaluation criteria apply to each service we evaluate for addition to the list of Medicare telehealth services. We are not proposing a change to that aspect of the process with this proposed change in category 2 criteria.
With regard to the request to add critical care services to the list of Medicare telehealth services, the application of the proposed category 2 criteria to that request is contingent on both the finalization of the proposed criteria and our receipt of a new request to add the services. However, as we noted in the CY 2012 PFS proposed rule with comment period (76 FR 42824), the fact that the CPT Editorial Panel created the Category III CPT codes suggests to us that these video-conferenced critical care services are not the same as the in-person critical care services requested for addition to the telehealth list.
After consideration of the public comments we received, we are
Our revised criteria for category 2 additions are as follows:
• Category 2: Services that are not similar to the current list of telehealth services. Our review of these requests will include an assessment of whether the service is accurately described by the corresponding code when delivered via telehealth and whether the use of a telecommunications system to deliver the service produces demonstrated clinical benefit to the patient. Requestors should submit evidence indicating that the use of a telecommunications system in delivering the candidate telehealth service produces clinical benefit to the patient.
The evidence submitted should include both a description of relevant clinical studies that demonstrate the service furnished by telehealth to a Medicare beneficiary improves the diagnosis or treatment of an illness or injury or improves the functioning of a malformed body part, including dates and findings and a list and copies of published peer reviewed articles relevant to the service when furnished via telehealth. Our evidentiary standard of clinical benefit will not include minor or incidental benefits. Some examples of clinical benefit include the following:
• Ability to diagnose a medical condition in a patient population without access to clinically appropriate in person diagnostic services.
• Treatment option for a patient population without access to clinically appropriate in-person treatment options.
• Reduced rate of complications.
• Decreased rate of subsequent diagnostic or therapeutic interventions (for example, due to reduced rate of recurrence of the disease process).
• Decreased number of future hospitalizations or physician visits.
• More rapid beneficial resolution of the disease process treatment.
• Decreased pain, bleeding, or other quantifiable symptom.
• Reduced recovery time.
We have recently been asked to clarify instructions regarding appropriate reporting of telehealth services that, prior to our policy change regarding consultation codes, would have been reported as consultations furnished to patients in an emergency department. When we eliminated the use of consultation codes under the PFS beginning in CY 2010, we instructed practitioners, when furnishing a service that would have been reported as a consultation service, to report the E/M code that is most appropriate to the particular service for all office/outpatient or inpatient visits. Since section 1834(m) of the Act includes “professional consultations” (including the initial inpatient consultation codes “as subsequently modified by the Secretary”) in the definition of telehealth services, we established several HCPCS codes to describe the telehealth delivery of initial inpatient consultations. For inpatient hospital and skilled nursing facility care telehealth services, we instructed practitioners to use the inpatient telehealth consultation G-codes listed in Table 12 to report those telehealth services (74 FR 61763, 61774). However, we neglected to account for the fact that E/M emergency department visit codes (99281-99285) are not on the telehealth list. As a result, there has not been a clear means for practitioners to bill a telehealth consultation furnished in an emergency department. In order to address this issue, we proposed to change the code descriptors for the inpatient telehealth consultation G-codes to include emergency department telehealth consultations effective January 1, 2012. However, we requested public comment regarding other options, including creating G-codes specific to these services when furnished to patients in the emergency department.
However, the comments regarding site of service coding distinctions have prompted us to reconsider the need to provide a mechanism for follow-up consultations in the emergency department. While follow-up consultative services are furnished to hospital and SNF inpatients, we do not believe these services are furnished to patients in emergency departments since patients do not spend enough time in the emergency department to warrant a second consultative service by the same practitioner. Therefore, we are amending our proposal to pertain only to the G-codes that describe initial telehealth consultations.
After consideration of the public comments we received, we are finalizing our proposal to change the code descriptors for initial inpatient telehealth consultation G-codes to reflect telehealth consultations furnished to emergency department patients in addition to inpatient telehealth consultations effective January 1, 2012. The descriptors for these codes for CY 2012 appear in table 13. After consideration of the public comments we received, we are not finalizing our proposal to change the code descriptors for follow-up inpatient telehealth consultations, since we do not believe follow-up consultations are furnished to emergency department patients.
Section 1834(m)(2)(B) of the Act establishes the payment amount for the Medicare telehealth originating site facility fee for telehealth services provided from October 1, 2001, through December 31, 2002, at $20. For telehealth services provided on or after January 1 of each subsequent calendar year, the telehealth originating site facility fee is increased by the percentage increase in the MEI as defined in section 1842(i)(3) of the Act. The MEI increase for 2012 is 0.6 percent. Therefore, for CY 2012, the payment amount for HCPCS code Q3014 (Telehealth originating site facility fee) is 80 percent of the lesser of the actual charge or $24.24. The Medicare telehealth originating site facility fee and MEI increase by the applicable time period is shown in Table 14.
Under section 1848(c)(2)(B) of the Act, we review and make adjustments to RVUs for physicians' services at least once every 5 years. Under section 1848(c)(2)(K) of the Act (as added by section 3134 of the Affordable Care Act), we are required to identify and revise RVUs for services identified as potentially misvalued. Section 1848(c)(2)(K)(iii) specifies that the Secretary may use existing processes to receive recommendations on the review and appropriate adjustment of potentially misvalued services. In accordance with section 1848(c)(2)(K)(iii) of the Act, we develop and propose appropriate adjustments to the RVUs, taking into account the recommendations provided by the AMA RUC, the Medicare Payment Advisory Commission (MedPAC), and others. To respond to concerns expressed by MedPAC, the Congress, and other stakeholders regarding the accuracy of values for services under the PFS, the AMA RUC has used an annual process to systematically identify, review, and provide CMS with recommendations for revised work values for many existing potentially misvalued services.
For many years, the AMA RUC has provided CMS with recommendations on the appropriate relative values for PFS services. In recent years CMS and the AMA RUC have taken increasingly significant steps to address potentially misvalued codes. In addition to the Five-Year Reviews of Work, over the past several years CMS and the AMA RUC have identified and reviewed a number of potentially misvalued codes on an annual basis based on various identification screens for codes at risk for being misvalued, such as codes with high growth rates, codes that are frequently billed together in one encounter, and codes that are valued as inpatient services but that are now predominantly performed as outpatient services. This annual review of work RVUs and direct PE inputs for potentially misvalued codes was further bolstered by the Affordable Care Act mandate to examine potentially misvalued codes, with an emphasis on the following categories specified in section 1848(c)(2)(K)(ii) (as added by section 3134 of the Affordable Care Act):
• Codes and families of codes for which there has been the fastest growth.
• Codes or families of codes that have experienced substantial changes in practice expenses.
• Codes that are recently established for new technologies or services.
• Multiple codes that are frequently billed in conjunction with furnishing a single service.
• Codes with low relative values, particularly those that are often billed multiple times for a single treatment.
• Codes which have not been subject to review since the implementation of the RBRVS (the “Harvard-valued” codes).
• Other codes determined to be appropriate by the Secretary. (For example, codes for which there have been shifts in the site-of-service (site-of-service anomalies).)
In addition to providing recommendations to CMS for work RVUs, the AMA RUC's Practice Expense Subcommittee reviews, and then the AMA RUC recommends, direct PE inputs (clinical labor, medical supplies, and medical equipment) for individual services. To guide the establishment of malpractice RVUs for new and revised codes before each Five-Year Review of Malpractice, the AMA RUC also provides crosswalk recommendations, that is, “source” codes with a similar specialty mix of practitioners furnishing the source code and the new/revised code.
CMS reviews the AMA RUC recommendations on a code-by-code basis. For AMA RUC recommendations regarding physician work RVUs, we determine whether we agree with the recommended work RVUs for a service (that is, whether we agree the valuation is accurate). If we disagree, we determine an alternative value that
If we receive public comments on the interim final work RVUs for a specific code indicating that refinement of the interim final work value is warranted based on sufficient information from the commenters concerning the clinical aspects of the physician work associated with the service (57 FR 55917), we refer the service to a refinement panel, as discussed in further detail in section III.B.1.a. of this final rule with comment period.
In the interval between closure of the comment period and the subsequent year's PFS final rule with comment period, we consider all of the public comments on the interim final work, PE, and malpractice RVUs for the new, revised, and potentially misvalued codes and the results of the refinement panel, if applicable. Finally, we address the interim final RVUs (including the interim final direct PE inputs) by providing a summary of the public comments and our responses to those comments, including a discussion of any changes to the interim final work or malpractice RVUs or direct PE inputs, in the following year's PFS final rule with comment period. We then typically finalize the direct PE inputs and the work, PE, and malpractice RVUs for the service in that year's PFS final rule with comment period, unless we determine it would be more appropriate to continue their interim final status for another year and solicit further public comment.
We conducted a clinical review of each code identified in this section and reviewed the AMA RUC recommendations for work RVUs, time to perform the “pre-,” “intra-,” and “post-” service activities, as well as other components of the service which contribute to the value. Our clinical review generally includes, but is not limited to, a review of information provided by the AMA RUC, medical literature, public comments, and comparative databases, as well as a comparison with other codes within the Medicare PFS, consultation with other physicians and healthcare care professionals within CMS and the Federal Government, and the views based on clinical experience of the physicians on the clinical team. We also assessed the AMA RUC's methodology and data used to develop the recommendations and the rationale for the recommendations. As we noted in the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), the AMA RUC uses a variety of methodologies and approaches to assign work RVUs, including building block, survey data, crosswalk to key reference or similar codes, and magnitude estimation. The building block methodology is used to construct, or deconstruct, the work RVU for a CPT code based on component pieces of the code. Components may include pre-, intra-, or post-service time and post-procedure visits, or, when referring to a bundled CPT code, the components could be considered to be the CPT codes that make up the bundled code. Magnitude estimation refers to a methodology for valuing physician work that determines the appropriate work RVU for a service by gauging the total amount of physician work for that service relative to the physician work for similar service across the physician fee schedule without explicitly valuing the components of that work. The resource-based relative value system (RBRVS) has incorporated into it cross-specialty and cross-organ system relativity. This RBRVS requires assessment of relative value and takes into account the clinical intensity and time required to perform a service. In selecting which methodological approach will best determine the appropriate value for a service we consider the current physician work and time values, AMA RUC-recommended physician work and time values, and specialty society physician work and time values, as well as the intensity of the service, all relative to other services. During our clinical review to assess the appropriate values for the codes we developed systematic approaches to address particular areas of concern. Specifically, the application of work budget neutrality within clinical categories of CPT codes, CPT codes with site-of-service anomalies, and CPT codes for services typically furnished on the same day as an evaluation and management visit. A description of those methodologies follows.
We apply work budget neutrality to hold the aggregate work RVUs constant within a set of clinically related CPT codes, while maintaining the relativity of values for the individual codes within that set. In some cases, when the CPT coding framework for a clinically related set of CPT codes is revised by the creation of new CPT codes or existing CPT codes are revalued, the aggregate work RVUs recommended by the AMA RUC within that clinical category of CPT codes may change, although the actual physician work associated with the services has not changed. When this occurs, we may apply work budget neutrality to adjust the work RVUs of each clinically related code so that the sum of the new/revised code work RVUs (weighted by projected utilization) for a set of CPT codes would be the same as the sum of the current work RVUs (weighted by projected utilization) for that set of codes.
When the AMA RUC recommends work RVUs for new or revised CPT codes, we review the work RVUs and adjust or accept the recommended values as appropriate, making note of whether any estimated changes in aggregate work RVUs would result from true change in physician work, or from structural coding changes. We then determine whether the application of budget neutrality within sets of codes is appropriate. If the aggregate work RVUs would increase without a corresponding true increase in physician work, we generally view this as an indication that an adjustment to ensure work budget neutrality within the set of CPT codes is warranted. Ensuring work budget neutrality is an important principle so that structural coding changes are not unjustifiably redistributive among PFS services.
In the CY 2011 PFS final rule with comment period, there were four sets of clinically related CPT codes where we believed that the application of work budget neutrality was appropriate. These codes were in the areas of paraesophageal hernia procedures, esophageal motility and high resolution esophageal pressure topography, skin excision and debridement, and obstetrical care. The CY 2011 interim final values and CY 2012 final values for these services are discussed in section
Since CY 2009, CMS and the AMA RUC have reviewed a number of CPT codes that have experienced a change in the typical site-of-service since the original valuation of the codes. Specifically, these codes were originally furnished in the inpatient setting, but Medicare claims data show that the typical case has shifted to being furnished in the outpatient setting. As we discussed in the CY 2011 PFS final rule with comment period (75 FR 73221) and the CY 2012 PFS proposed rule (76 FR 42797), when the typical case for a service has shifted from the inpatient setting to an outpatient or physician's office setting, we do not believe the inclusion of inpatient hospital visits in the post-operative period is appropriate. Additionally, we believe that it is reasonable to expect that there have been changes in medical practice for these services, and that such changes would represent a decrease in physician time or intensity or both.
For CY 2009 and CY 2010, the AMA RUC reviewed and recommended—RVUs for 40 CPT codes we identified as being potentially misvalued under the Secretary's discretion to identify other categories of potentially misvalued codes (see section II.B. of this final rule) because a site-of-service anomaly exists. In the CYs 2009 and 2010 PFS final rule with comment period (73 FR 69883 and 74 FR 61776 through 61778, respectively), we indicated that although we would accept the AMA RUC valuations for these CPT codes on an interim basis, we had ongoing concerns about the methodology used by the AMA RUC to value these services, and in the CY 2010 PFS final rule with comment period (74 FR 61777) we encouraged the AMA RUC to utilize the building block methodology when revaluing services with site-of-service anomalies. In the CY 2011 final rule with comment period (75 FR 73221), we requested that the AMA RUC re-examine the site-of-service anomaly codes and adjust the work RVU, times, and post-service visits to reflect those typical of a service furnished in an outpatient or physician's office setting.
Following this request, the AMA RUC re-reviewed these site-of-service anomaly codes and recommended work RVUs to us for these services. Of the 40 CPT codes on the CY 2009 and CY 2010 site-of-service anomaly codes lists, 1 CPT code was not re-reviewed, as it was addressed in the CY 2011 PFS final rule with comment period. Ten of the remaining 39 site-of-service anomaly codes were addressed in the Fourth Five-Year Review of Work (76 FR 32410), and the remaining 29 CPT codes were addressed in the CY 2012 PFS proposed rule (76 FR 72798 through 42809). In addition, several other CPT codes were identified as having site-of-service anomalies and were addressed in the Fourth Five-Year Review of Work (76 FR 32410). In the CY 2012 PFS proposed rule (76 FR 42797), we stated that we would respond to public comments and adopt final work RVUs for these codes in the CY 2012 PFS final rule with comment period.
When Medicare claims data show that the typical setting for a CPT code has shifted from the inpatient setting to the outpatient setting, we believe that the work RVU, time, and post-service visits of the code should reflect a service furnished in the outpatient setting. For nearly all of the codes with site-of-service anomalies, the accompanying survey data suggest they are “23-hour stay” outpatient services. As we discussed in detail in the CY 2011 PFS final rule with comment period (75 FR 73226), the Fourth Five-Year Review of Work (76 FR 32410) and the CY 2012 PFS proposed rule (76 FR 42798), the “23-hour stay service” is a term of art describing services that typically have lengthy hospital outpatient recovery periods. For these 23-hour stay services, the typical patient is at the hospital for less than 24-hours, but often stays overnight at the hospital. Unless a treating physician has written an order to admit the patient as an inpatient, the patient is considered for Medicare purposes to be a hospital outpatient, not an inpatient, and our claims data support that the typical 23-hour stay service is billed as an outpatient service.
As we discussed in the Five-Year Review of Work (76 FR 32410), and CY 2012 PFS proposed rule (76 FR 42798) we believe that the values of the codes that fall into the 23-hour stay category should not reflect work that is typically associated with an inpatient service. However, as we stated in the CY 2011 PFS final rule with comment period (75 FR 73226 through 73227), while the patient receiving the outpatient 23-hour stay service remains a hospital outpatient, the patient would typically be cared for by a physician during that lengthy recovery period at the hospital. While we do not believe that post-procedure hospital visits would be at the inpatient level since the typical case is an outpatient who would be ready to be discharged from the hospital in 23-hours or less, we believe it is generally appropriate to include the intra-service time of the inpatient hospital visit in the immediate post-service time of the 23-hour stay code under review. In addition, we indicated that we believe it is appropriate to include a half day, rather than a full day, of a discharge day management service.
We finalized this policy in the CY 2011 PFS final rule with comment period (75 FR 73226 through 73227) and applied this methodology when valuing 23-hour stay codes in the Fourth Five-Year Review and CY 2012 PFS proposed rule in order to ensure the consistent and appropriate valuation of the physician work for these services. A full description of our methodology for revaluing the site-of-service anomaly codes can be found in the Fourth Five-Year Review of Work (76 FR 32410), and the CY 2012 PFS proposed rule (76 FR 72798 through 42809). In brief, where Medicare claims data suggested a site-of-service anomaly (more than 50 percent of the Medicare PFS utilization is outpatient) and the AMA RUC's recommended value continued to include inpatient visits in the post-operative period, we removed any post-procedure inpatient visits or subsequent observation care services included in the AMA RUC-recommended values for these codes and adjusted the physician times accordingly. We also consistently included the value of a half day of discharge management service.
There are many reasons that services move from the inpatient to outpatient setting that reduce the overall risk of adverse outcomes and intensity of physician work. Services frequently move to the outpatient setting when the technique matures; that is, the risk-benefit ratio of the service is better understood and the efficacy of the service is more clearly established. Services may move to the outpatient setting because technological advances decrease the need for intensive monitoring and allow the discharge of sicker patients. Patient-controlled analgesia, for example, reduces the iterative assessment and response work necessary to manage post-operative pain and allows earlier discharge. Technological advances in the procedures themselves also reduce the risk of adverse outcomes. Electronic imaging and robotic surgery both allow procedures to be performed with increasingly smaller incisions, decreasing post-operative morbidity. Accordingly, we believe that, generally, the valuation of the codes that fall into the 23-hour stay category should not reflect physician work that is typically associated with an inpatient service.
Since CY 2011, we have reviewed a number of CPT codes that are typically billed with an E/M service on the same day. In cases where a service is typically furnished with an E/M service on the same day, we believe that there may be overlap between the two services in some of the activities conducted during the pre- and post-service times of the procedure code. Accordingly, in cases where the most recently available Medicare PFS claims data show the code is typically billed with an E/M visit on the same day, and where we believe that the AMA RUC did not adequately account for overlapping activities in the recommended value for the code, we systematically adjusted the physician times for the code to account for the overlap. After clinical review of the pre- and post-service work, we believe that at least one-third of the physician time in both the pre-service evaluation and post-service period is duplicative of the E/M visit in this circumstance. Therefore, for a number of CPT codes discussed in the following paragraphs, we adjusted the pre-service evaluation portion of the pre-service time to two-thirds of the AMA RUC-recommended time. Similarly, we also adjusted the post-service time to two-thirds of the AMA RUC-recommended time.
In this section, we address the interim final values published in Appendix C of the CY 2011 PFS final rule with comment period (75 FR 73810 through 73815), as subsequently corrected in the January 11, 2011 (76 FR 1670) correction notice; the proposed values published in the Fourth Five-Year Review of Work (76 FR 32410 through 32813); and the proposed values published in the CY 2012 PFS proposed rule (76 FR 42772 through 42947). We discuss the results of the CY 2011 multi-specialty refinement panel, respond to public comments received on specific interim final and proposed values (including direct PE inputs), and address the other new, revised, or potentially misvalued codes with interim final or proposed values. In section II.B.3. of this final rule with comment period, we emphasized the importance of reviewing the full value for services (the work, PE, and malpractice components of codes) that are identified as part of the potentially misvalued code initiative in order to maintain appropriate relativity and key relationships within the components of codes. The final CY 2012 direct PE database that lists the direct PE inputs is available on the CMS Web site under the downloads for the CY 2012 PFS final rule with comment period at:
As discussed in the 1993 PFS final rule with comment period (57 FR 55938), we adopted a refinement panel process to assist us in reviewing the public comments on CPT codes with interim final work RVUs for a year and in developing final work values for the subsequent year. We decided that the panel would be comprised of a multispecialty group of physicians who would review and discuss the work involved in each procedure under review, and then each panel member would individually rate the work of the procedure. We believed that establishing the panel with a multispecialty group would balance the interests of the specialty societies who commented on the work RVUs with the budgetary and redistributive effects that could occur if we accepted extensive increases in work RVUs across a broad range of services.
Historically, the refinement panel's recommendation to change a work value or to retain the interim value had hinged solely on the outcome of a statistical test on the ratings (an F-test of panel ratings among the groups of participants). Depending on the number and range of codes that specialty societies request be subject to refinement through their public comments, we establish refinement panels with representatives from 4 groups of physicians: Clinicians representing the specialty most identified with the procedures in question; physicians with practices in related specialties; primary care physicians; and contractor medical directors (CMDs). Typically, the refinement panels meet in the summer prior to the promulgation of the PFS final rule with comment period that finalizes the RVUs for the codes. Typical panels have included 8 to 10 physicians across the 4 groups. Over time, we found that the statistical test
Recently, section 1848(c)(2)(K) of the Act (as added by section 3134 of the Affordable Care Act) authorized the Secretary to review potentially misvalued codes and make appropriate adjustments to the relative values. In addition, MedPAC has encouraged CMS to critically review the values assigned to the services under the PFS. As detailed in the CY 2011 PFS final rule with comment period (75 FR 73306), we believed the refinement panel process may provide an opportunity to review and discuss the proposed and interim final work RVUs with a clinically diverse group of experts, which then provides informed recommendations. Therefore, we indicated that we would like to continue the refinement process, including the established composition that includes representatives from the 4 groups of physicians, but with administrative modification and clarification. We eliminated the use of the statistical F-test and instead indicated that we would base revised RVUs on the median work value of the individual panel members' ratings. We believed this approach would simplify the refinement process administratively, while resulting in a final panel recommendation that reflects the summary opinion of the panel members based on a commonly used measure of central tendency that is not significantly affected by outlier values. We clarified that we have the final authority to set the RVUs, including making adjustments to the work RVUs resulting from refinement process if policy concerns warrant modification (75 FR 73307).
Due to the major increase in the number of codes reviewed by the CY 2011 multi-specialty refinement panels as compared to refinement panels in recent years, and public comments requesting more clarification about the refinement panels, we would like to remind readers that historically the refinement panels were not intended to review every code for which we did not propose to accept the AMA RUC-recommended RVUs. Furthermore, in the past, we have asked commenters requesting refinement panel review to submit sufficient information concerning the clinical aspects of the work assigned for a service to indicate that referral to the refinement panel is warranted (57 FR 55917). We note that the majority of the information that was presented during the CY 2011 refinement panel discussions was duplicative of the information provided to the AMA RUC during its development of recommendations. As detailed in section III.B. of this final rule with comment period, we consider information and recommendations from the AMA RUC when assigning proposed and interim final RVUs to services. To facilitate the selection of services for the refinement panels, we would like to remind specialty societies seeking reconsideration of proposed or interim final work RVUs, including consideration by a refinement panel, to specifically request refinement panel review in their public comment letters. Also, we request that commenters seeking refinement panel review of work RVUs submit supporting information that has not already been considered by the AMA RUC in creating recommended work RVUs or by CMS in assigning proposed and interim final work RVUs. In order to make the best use of the agency's limited resources and avoid inefficient duplicative consideration of information by the AMA RUC, CMS, and then a refinement panel, CMS will more critically evaluate the need to refer codes to refinement panels in future years, specifically considering any new information provided by commenters.
We referred to the CY 2011 refinement panel 143 CPT codes with proposed or interim final work values for which we received comments from least one major specialty society. For these 143 CPT codes, all commenters requested increased work RVUs. For ease of discussion, we will be referring to these services as “refinement codes.” Consistent with past practice (62 FR 59084), we convened a multi-specialty panel of physicians to assist us in the review of the comments. The panel was moderated by our physician advisors, and consisted of the following voting members:
• One to two clinicians representing the commenting organization;
• One to two primary care clinicians nominated by the American Academy of Family Physicians and the American College of Physicians;
• One to three contractor medical directors (CMDs); and
• One to two clinicians with practices in related specialties who were expected to have knowledge of the services under review.
The panel process was designed to capture each participant's independent judgment and his or her clinical experience which informed and drove the discussion of the refinement code during the refinement panel proceedings. Following the discussion, each voting participant rated the physician work of the refinement code. Ratings were obtained individually and confidentially, with no attempt to achieve consensus among the panel members.
As finalized in the CY 2011 PFS final rule with comment period (75 FR 73307), we reviewed the ratings from each panel member and determined the median value for each service that was reviewed by the refinement panels. Our decision to convene multi-specialty panels of physicians has historically been based on our need to balance the interests of those who commented on the interim final work values with the redistributive effects that would occur in other specialties if the work values were changed. We refer readers to section III.I. of the CY 2011 PFS final rule with comment period for a full discussion of the changes to the refinement process that we adopted for refinement panels beginning in CY 2011.
We note that individual codes, including those that were reviewed by the refinement panels, and their final work RVUs are discussed in section III.B.1.b. of this final rule with comment period. Also, see Table 15 for the refinement panel ratings and the final work RVUs for the codes that were reviewed by the CY 2011 multi-specialty refinement panels.
In this section we discuss all code families for which we received a comment on an interim final physician work value in CY 2011 PFS final rule with comment period, on a proposed value in the Fourth Five-Year Review of Work, or on a proposed value in the CY 2012 PFS proposed rule. Table 15 provides a comprehensive list of all final values.
(1) Integumentary System: Skin, Subcutaneous, and Accessory Structures (CPT codes 10140, 10160, 11010-11012, 11042-11047) and Active Wound Care Management (CPT codes 97597 and 97598)
For the Fourth Five-Year Review, we identified CPT codes 10140 and 10160
As detailed in the Fourth Five-Year Review, for CPT codes 10140 (Incision and drainage of hematoma, seroma or fluid collection) and 10160 (Puncture aspiration of abscess, hematoma, bulla, or cyst) we believed that the current (CY 2011) work RVUs continued to accurately reflect the work of these services. For CPT code 10140 we proposed a work RVU of 1.58, and for CPT code 10160 we proposed a work RVU of 1.25. The AMA RUC recommended maintaining the current work RVUs for these services as well. For CPT code 10160, the AMA RUC recommended a pre-service evaluation time of 7 minutes. As CPT codes 10160 and 10140 have the same description of pre-service work, we believed that they should have the same pre-service time. Therefore, we reduced the pre-service evaluation time for CPT code 10140 from 17 minutes to 7 minutes, to match the pre-service evaluation time of CPT code 10160 (76 FR 32431 through 32432).
CPT codes 11043 (Debridement; skin, subcutaneous tissue, and muscle) and 11044 (Debridement; skin, subcutaneous tissue, muscle, and bone) were identified by the AMA RUC's Five-Year Review Identification Workgroup through the “site-of-service anomalies” potentially misvalued codes screen in September 2007. The AMA RUC recommended that the entire family of services described by CPT codes 11040 through 11044, and 97597 and 97598 be referred to the CPT Editorial Panel because the current descriptors allowed reporting of the codes for a bimodal distribution of patients and also to better define the terms excision and debridement. The CPT Excision and Debridement Workgroup and the CPT Editorial Panel reviewed and revised the CPT code descriptors for CPT codes 11042 through 11047, along with the descriptors for other related CPT codes. Following the descriptor changes, the related specialty societies surveyed their members, gathering information for work RVU and time recommendations for these services, and the AMA RUC issued recommendations to us for CY 2011. We reviewed these CPT codes, and published the CY 2011 interim final work RVUs in the CY 2011 PFS final rule with comment period (75 FR 73329 through 73330). Based on comments received during the public comment period, we referred CPT codes 11042 through 11047 to the CY 2011 multi-specialty refinement panel for further review.
As detailed in the CY 2011 PFS final rule with comment period, for CPT code 11042 (Debridement, subcutaneous tissue (includes epidermis and dermis, if performed); first 20 sq cm or less) we assigned a work RVU of 0.80 on an interim final basis for CY 2011. After clinical review, we believed that the then current (2010) work RVU of 0.80 continued to accurately reflect the work of the service relative to similar services, including reference CPT code 16020 (Dressings and/or debridement of partial-thickness burns, initial or subsequent; small (less than 5 percent total body surface area)). We found no grounds to increase the work RVU for this service. The AMA RUC recommended a work RVU of 1.12 for CPT code 11042 for CY 2011 (75 FR 73329).
As detailed in the CY 2011 PFS final rule with comment period, for CPT code 11045 (Debridement, subcutaneous tissue (includes epidermis and dermis, if performed); each additional 20 sq cm, or part thereof (List separately in addition to code for primary procedure)) we assigned a work RVU of 0.33 on an interim final basis for CY 2011. CPT code 11045 is the add-on code to CPT code 11042. To obtain the appropriate RVU for this add-on service, we started with the CMS-assigned CY 2011 interim final RVU of 0.80 for the primary code (CPT code 11042), and removed the work RVUs corresponding to the pre- and post-service time (add-on codes generally do not have pre- and post-service time because that work is captured by the primary service). The AMA RUC recommended a work RVU of 0.69 for CPT code 11045 for CY 2011 (75 FR 73329 and 73330).
As detailed in the CY 2011 PFS final rule with comment period, for CPT code 11043 (Debridement, muscle and/or fascia (includes epidermis, dermis, and subcutaneous tissue, if performed); first 20 sq cm or less) we assigned a work RVU of 2.00 on an interim final basis for CY 2011. After clinical review, we believed that the work RVU of 2.00 (the survey low) appropriately reflected the AMA RUC-recommended decrease in clinical time and follow-up E/M visits attributed to the performance of this service (CY 2010 work RVU=3.14). The AMA RUC recommended a work RVU of 3.00 for CPT code 11043 for CY 2011. (75 FR 73330)
As detailed in the CY 2011 PFS final rule with comment period, for CPT code 11046 (Debridement, muscle and/or fascia (includes epidermis, dermis, and subcutaneous tissue, if performed); each additional 20 sq cm, or part thereof (List separately in addition to code for primary procedure)) we assigned a work RVU of 0.70 on an interim final basis for CY 2011. After clinical review, we believed that the work RVU of 0.70 (the survey low) appropriately placed this add-on service relative to its primary service, CPT code 11043. The AMA RUC recommended a work RVU of 1.29 for CPT code 11046 for CY 2011 (75 FR 73330).
As detailed in the CY 2011 PFS final rule with comment period, for CPT code 11044 (Debridement, bone (includes epidermis, dermis, subcutaneous tissue, muscle and/or fascia, if performed); first 20 sq cm or less) we assigned a work RVU of 3.60 on an interim final basis for CY 2011. After clinical review, we believed that the work RVU of 3.60 (the survey low) appropriately reflected the AMA RUC-recommended decrease in clinical time and follow-up E/M visits attributed to the performance of this service (CY 2010 work RVU = 4.26). The AMA RUC recommended a work RVU of 4.56 for CPT code 11044 for CY 2011 (75 FR 73330).
As detailed in the CY 2011 PFS final rule with comment period, for CPT code 11047 (Debridement, bone (includes epidermis, dermis, subcutaneous tissue, muscle and/or fascia, if performed); each additional 20 sq cm, or part thereof (List separately in addition to code for primary procedure)) we assigned a work RVU of 1.20 on an interim final basis for CY 2011. After clinical review, we believed that the work RVU of 1.20 (the survey low) appropriately placed this add-on service relative to its primary service, CPT code 11044. The AMA RUC recommended a work RVU of 2.00 for CPT code 11047 for CY 2011 (FR 75 73330).
As stated in the CY 2011 PFS final rule with comment period (75 FR 73338 and 73339), in the excision and debridement set of services, for CY 2011 two CPT codes were deleted and the services that would previously have been reported under those CPT codes are now reported under two revised codes, CPT code 97597 (Debridement (
As mentioned previously, and detailed in the CY 2011 PFS final rule with comment period, for CPT code 97598, we disagreed with the HCPAC-recommended work RVU of 0.40 and assigned alternate work RVU of 0.25 prior to the application of work budget neutrality (75 FR 73330). We believed that a work RVU of 0.25, which corresponded to the specialty society survey low value, was consistent with new CY 2011 add-on CPT code 11045 (Debridement, subcutaneous tissue (includes epidermis and dermis, if performed); each additional 20 sq cm, or part thereof (List separately in addition to code for primary procedure)), which we assigned a CY 2011 interim final work RVU of 0.33.
For CY 2012, we received no comments on the CY 2011 interim final work RVUs of 4.19 for CPT code 11010 (Debridement including removal of foreign material at the site of an open fracture and/or an open dislocation (
For the Fourth Five-Year Review, we identified CPT codes 11732 and 11765 as potentially misvalued through the Harvard-Valued—Utilization > 30,000 screen. The related specialty societies surveyed their members and the HCPAC issued recommendations to us for the Fourth Five-Year Review.
As detailed in the Fourth Five-Year Review, for CPT code 11732 (Avulsion of nail plate, partial or complete, simple; each additional nail plate (List separately in addition to code for primary procedure)) we proposed a work RVU of 0.44, with refinement to time. After clinical review, we believed that Multi-Specialty Points of Comparison (MPC) CPT code 92250 (Fundus photography with interpretation and report) (work RVU=0.44) provided an appropriate crosswalk work RVU for this service. We found the HCPAC-recommended decrease in work RVU (from 0.57 to 0.48) to be too small, given the recommended reduction in time (from 20 minutes total time in CY 2011, to a recommended 15 minutes total time for CY 2012). Additionally, we refined the post-service time for CPT code 11732 to 1 minute, as we believed the HCPAC-recommended 3 minutes of post-service time was excessive for this service (76 FR 32459).
As detailed in the Fourth Five-Year Review, for CPT code 11765 (Wedge excision of skin of nail fold (
In response to commenters' note that CPT code 11765 was billed with an E/M visit less than 50 percent of the time and therefore, should not be subject to the same day E/M adjustment, we looked back at the data for this and all other Five-Year Review CPT codes for which we proposed a same day E/M adjustment. When calculating the number of times a service was performed on the same day as an E/M visit, we likely over-counted multiple billings of a CPT code and depending on billing patterns may have identified an inappropriately higher percentage of same day E/M billing. We recalculated these figures using combined occurrence pairs, which we now believe is the more appropriate measure of same day E/M billings for this purpose. We note that for all codes reviewed for the CY 2012 PFS proposed and final rules we used figures calculated based on combined occurrence pairs. After recalculating the same day E/M percentages for the Five-Year Review CPT codes, CPT code 11765 was the only code that had originally appeared to be billed over 50 percent with an E/M visit, but under the revised calculation is billed less than 50 percent with an E/M visit. As such, we no longer believe it is appropriate to remove one-third of the pre-service evaluation time and one-third of the post service time to account for the E/M visit on the same date of service. For CY 2012 we are finalizing the HCPAC-recommended times of 17 minutes of pre-service evaluation time, 1 minute of pre-service positioning time, 5 minutes of pre-service dress, scrub and wait time, 5 minutes of intra-service time, 5 minutes of post-service time, and 1 CPT code 99212 office or outpatient visit for CPT code 11765.
In the Fourth Five-Year Review, we identified CPT codes 12031, 12051, 13101, and 15260 as potentially misvalued through the Harvard-Valued—Utilization > 30,000 screen. CPT codes 12032-12047, 12052-12057, and 13100 were added as part of the
As detailed in the Fourth Five-Year Review, in its review of this set of CPT codes, the AMA RUC determined that the original Harvard-valued work RVUs led to compression within these code families, which the AMA RUC recommended correcting by reducing the relative values for the smallest wound size repair codes and increasing the relative values for the larger wound size repair codes. Our proposed range of work RVUs for these CPT codes, while not as large as the range that would have resulted from our adoption of the AMA RUC recommendations, nevertheless is greater than the current range of work RVUs for the variety of wound sizes described by the repair codes (76 FR 32431 through 32432).
For CPT codes 12035 (Repair, intermediate, wounds of scalp, axillae, trunk and/or extremities (excluding hands and feet); 12.6 cm to 20.0 cm), 12036 (Repair, intermediate, wounds of scalp, axillae, trunk and/or extremities (excluding hands and feet); 20.1 cm to 30.0 cm), 12037 (Repair, intermediate, wounds of scalp, axillae, trunk and/or extremities (excluding hands and feet); over 30.0 cm), 12045 (Repair, intermediate, wounds of neck, hands, feet and/or external genitalia; 12.6 cm to 20.0 cm), 12046 (Repair, intermediate, wounds of neck, hands, feet and/or external genitalia; 20.1 cm to 30.0 cm), 12047 (Repair, intermediate, wounds of neck, hands, feet and/or external genitalia; over 30.0 cm), 12055 (Repair, intermediate, wounds of face, ears, eyelids, nose, lips and/or mucous membranes; 12.6 cm to 20.0 cm), 12056 (Repair, intermediate, wounds of face, ears, eyelids, nose, lips and/or mucous membranes; 20.1 cm to 30.0 cm), and 12057 (Repair, intermediate, wounds of face, ears, eyelids, nose, lips and/or mucous membranes; over 30.0 cm), we proposed specialty society survey 25th percentile work RVU. The specialty society surveys of physicians furnishing these services indicated that the work of performing these services has not changed in the past 5 years and that the complexity of patients requiring the services has also remained constant. The survey 25th percentile work RVUs were somewhat higher than the current work RVUs for CPT codes 12035-12037, 12045-12047, 12055 and 12056, and the survey 25th percentile work RVU for CPT code 12057 was the same as the current (CY 2011) work RVU. Given the survey responses indicating that the work and complexity of these services has remained constant, we believed that adopting the survey 25th percentile work RVUs both accurately valued the work associated with these services and addressed the compression-related relativity adjustments recommended by the AMA RUC. For CPT codes 12035-12037, 12045-12047, and 12055-12057 the AMA RUC recommended the survey median work RVU, which was higher than both the current (CY 2011) and survey 25th percentile work RVU. The CY 2011, CMS-proposed survey 25th percentile, and AMA RUC-recommended survey median work RVUs are listed in Table 15.
In addition to proposed changes to the AMA RUC-recommended work RVUs for these services, we also refined the time associated with several of these services. For CPT codes 12036, and 12055-12057, we found the survey median intra-service times to be more appropriate for these services than the higher AMA RUC-recommended times. After clinical review, we believed that these survey median times accurately reflected the work associated with performing these services. We also refined the times for CPT codes 12046 and 12047. Both CPT codes are typically performed on the same day as an E/M visit and we believed that some of the activities conducted during the pre- and post- service times of the procedure code and the E/M visit overlap. To account for this overlap, we reduced the pre-service evaluation and post-service time by one third.
Commenters also disagreed with the CMS-proposed reductions in time for CPT codes 12036, 12046-12047, and 12055-12057, and recommended that CMS accept the AMA RUC-recommended times. For CPT codes 12036, 12055, and 12057 commenters noted that a significant number of providers who do not typically perform the procedure responded to the survey, resulting in an artificially reduced median intra-service time. Commenters asserted that in this case it is more valid to utilize the results from the providers with experience performing this service. For CPT codes 12046 and 12047 commenters asserted that it was not appropriate for CMS to reduce the pre-evaluation and post service time to account for a same day E/M visit. Commenters noted that these services have very low utilization, and that the CMS data showing that these services are typically billed with an E/M may be incorrect. Commenters also noted that the recommended pre-service time for these two codes was already reduced from 19 minutes to 13 minutes so they believed that a further reduction was not justified.
In sum, we are holding as interim for CY 2012 the Fourth Five-Year Review proposed work RVUs and times for CPT codes 12035-12037, 12045-12047, and 12055-12057 (the larger of the intermediate wound repair services), so we can review these services alongside the complex wound repair codes before finalizing their values. For clarification, we do not expect that the AMA RUC would resurvey these codes. For CY 2012 the interim work RVUs are as follows: A work RVU of 3.50 for CPT code 12035, a work RVU of 4.23 for CPT code 12036, a work RVU of 5.00 for CPT code 12037, a work RVU of 3.75 for CPT code 12045, a work RVU of 4.30 for CPT code 12046, a work RVU of 4.95 for CPT code 12047, a work RVU of 4.50 for CPT code 12055, a work RVU of 5.30 for CPT code 12056, and a work RVU of 6.00 for CPT code 12057. A complete listing of the times associated with these, and all CPT codes, is available on the CMS web site at:
As detailed in the Fourth Five-Year Review, for CPT code 13100 (Repair, complex, trunk; 1.1 cm to 2.5 cm) and 13101 (Repair, complex, trunk; 2.6 cm to 7.5 cm) the AMA RUC reviewed the specialty society survey results and determined that the current (CY 2011) work RVUs maintain the appropriate relativity for these services. We noted that the AMA RUC reviewed only two CPT codes in the complex wound repair family. We agreed with the AMA RUC-recommended work RVUs for these two services, and requested that, in order to ensure consistency, the AMA RUC review the entire set of codes in the complex wound repair family and assess the appropriate gradation of the work RVUs in this family. We maintained the current (CY 2011) work RVUs and times for CPT codes 13100 and 13101 pending the AMA RUC review of the other CPT codes in this family (76 FR 32434 through 32435).
In the Fourth Five-Year Review (76 FR 32435), we identified CPT codes 15120 and 15732 as potentially misvalued through the site-of-service anomaly screen. CPT code 15121 was added as part of the family of services for AMA RUC review. In addition, we identified CPT code 15260 as potentially misvalued through the Harvard-Valued—Utilization > 30,000 screen. For CPT code 15120 (Split-thickness autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits; first 100 sq cm or less, or 1 percent of body area of infants and children (except 15050)), we proposed a work RVU of 10.15 for CY 2012, which was in agreement with the AMA RUC-recommended work RVU for this CPT code. Because the most recent Medicare PFS claims data showed that CPT code 15120 is a code with a site-of-service anomaly, we adjusted the times in accordance with the policy discussed in section III.A. of this final rule with comment period. Specifically, we removed the current (CY 2011) 0.5 subsequent hospital care day, added 5 minutes to the immediate post-operative period, and reduced the discharge day management service to one-half. These time changes were reflected in the Five-Year Review physician time file available on the CMS Web site at:
For CPT code 15732 (Muscle, myocutaneous, or fasciocutaneous flap; head and neck (
The AMA RUC asserted that claims data indicating that this service was furnished in an outpatient setting was the result of miscoding but, until the claims data indicate that this service typically was furnished in the inpatient setting (greater than 50 percent), we believed it was inappropriate for the service to be valued including inpatient E/M building blocks. We also stated that we will continue to monitor site-of-service utilization for this code and may consider reviewing the work RVU for this code again in the future if utilization patterns change (76 FR 32435).
For CY 2012, we received no comments on the CY 2011 interim final work RVUs for CPT codes 11900, 11901, 12001-12018, and 15823. Additionally, for CY 2012, we received no comments on the Fourth Five-Year Review proposed work RVUs for CPT codes 12041-12044, 12051-12054, 15120, 15121, and 15260. We believe these values continue to be appropriate and are finalizing them without modification (Table 15).
In the Fourth Five-Year Review (76 FR 32436), we identified CPT codes 17271, 17272 and 17280 as potentially misvalued through the Harvard-Valued—Utilization > 30,000 screen. The dominant specialty for this family—dermatology—identified several other codes in the family to be reviewed concurrently with these services and submitted to the AMA RUC recommendations for CPT codes 17260 through 17286. The AMA RUC concluded that, with the exception of one CPT code, 17284, the survey data validated the current values of the destruction of skin lesion services. We agreed with this assessment, with a few refinements to physician time.
As detailed in the Fourth Five-Year Review (76 FR 32436), we proposed work RVUs of 1.37 for CPT codes 17270 (Destruction, malignant lesion (
For CY 2012, we received no comments on the Fourth Five-Year Review proposed work RVUs for CPT codes 17250, 17260-17264, 17266, 17272, 17273, 17276, 17280-17284, and 17286. We believe these values continue to be appropriate and are finalizing them without modification (Table 15).
In the Fourth Five-Year Review (76 FR 32437), we identified CPT code 19302 as potentially misvalued through the site-of-service anomaly screen. For CPT code 19302 (Mastectomy, partial (
For CY 2012, we received no comments on the Fourth Five-Year Review proposed work RVU for CPT code 19357. We believe this value continue to be appropriate and are finalizing it without modification (Table 15).
In the Fourth Five-Year Review, we identified CPT code 22521 as potentially misvalued through the site-of-service anomaly screen. CMS also requested that the AMA RUC review other CPT codes in the family including
In the Fourth Five-Year Review, we proposed a work RVU of 8.01 for CPT code 22521 (Percutaneous vertebroplasty, 1 vertebral body, unilateral or bilateral injection; lumbar); a work RVU of 8.62 for CPT code 22523 (Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device, 1 vertebral body, unilateral or bilateral cannulation (
The AMA RUC identified CPT code 22554 (Arthrodesis, anterior interbody technique, including minimal discectomy to prepare interspace (other than for decompression); cervical below C2) through the “Codes Reported Together” potentially misvalued code screen. After review, the AMA RUC referred CPT code 22554 to the CPT Editorial Panel to create a new coding structure for this family of services. For CY 2011, the CPT Editorial Panel created 2 new CPT codes—22551 (Arthrodesis, anterior interbody, including disc space preparation, discectomy, osteophytectomy and decompression of spinal cord and/or nerve roots; cervical below C2) and 22552 (Arthrodesis, anterior interbody, including disc space preparation, discectomy, osteophytectomy and decompression of spinal cord and/or nerve roots; cervical below C2, each additional interspace (List separately in addition to code for separate procedure)—to describe fusion and discectomy of the anterior cervical spine.
In the CY 2011 PFS final rule with comment period (75 FR 73331), we assigned a work RVU of 25.00 to CPT code 22551 on an interim final basis for CY 2011. The AMA RUC recommended a work RVU of 24.50. The specialty society requested a work RVU of 25.00. Upon review of the AMA RUC-recommended value and the reference codes used, it was unclear why the AMA RUC decided not to accept the specialty society's recommended work RVU of 25.00. We agreed with the specialty society and believed a work RVU of 25.00 was appropriate for this service. We also requested that the specialty society, with the AMA RUC, re-review the pre-service times for codes in this family since concerns were noted in the AMA RUC recommendation about the pre-service time for this service.
We did not receive any public comments that disagreed with the interim final work values. Therefore, we are finalizing a work RVU of 25.00 for CPT code 22551. For CY 2012, we received no comments on the CY 2011 interim final work RVUs for CPT codes 22552, 22554, 22585, and 22851. We believe these values continue to be appropriate and are finalizing them without modification (Table 15).
In the Fourth Five-Year Review, we identified CPT codes 25600 (Closed treatment of distal radial fracture (
As detailed in the Fourth Five-Year Review of Work, for CPT code 25600, we proposed a work RVU of 2.64 for CY 2012. After clinical review, we believed that CPT code 25600 required more work than key reference CPT code 26600 (Closed treatment of metacarpal fracture, single; without manipulation, each bone), and found that CPT code 27767 (Closed treatment of posterior malleolus fracture; without manipulation) (work RVU = 2.64) is similar in complexity and intensity to CPT code 25600. In addition to the work RVU adjustment for CPT code 25600, we refined the time associated with this CPT code. We believed some of the activities conducted during the pre- and post-service times of the procedure code and the E/M visit overlap. Therefore, to account for this overlap, we refined the
With regard to the post-service time, though the procedure described by CPT code 25600 would occur after the E/M service, after a review of the post-service work associated with the E/M visit and the procedure, we continue to believe that there is overlap, and that this overlap was appropriately accounted for by removing one-third of the post-service minutes from CPT code 25600, thereby reducing the post-service time from 10 minutes to 7 minutes. In sum, for CY 2012 we are finalizing the refinement panel result median work RVUs of 2.78 and the following pre- and post-service times: 5 minutes pre-service evaluation time, 1 minute pre-service positioning time, and 7 minutes post-service time for CPT code 25600. CMS time refinements are listed in Table 16.
As detailed in the Fourth Five-Year Review of Work, for CPT code 25605, we proposed a work RVU of 6.00 for CY 2012. After clinical review, including comparison to CPT code 28113 (Ostectomy, complete excision; fifth metatarsal head), we believed that an RVU of 6.00 (the survey low) correctly reflected relativity across these services. The AMA RUC recommended a work RVU of 6.50 for CPT code 25605 for CY 2011 (76 FR 32438). In addition to the work RVU adjustment for CPT code 25605, we refined the time associated with this code. Recent Medicare PFS claims data show that this service is typically performed on the same day as an E/M visit. We believed that, in its time recommendation to us, the AMA RUC accounted for duplicate E/M work associated with the pre-service period, but not the post service period. To account for this post-service overlap, we proposed to reduced the post service time by one-third.
In the Fourth Five-Year Review, we identified CPT codes 27385 and 27530 as potentially misvalued through the site-of-service anomaly screen.
As detailed in the Fourth Five-Year Review of Work, for CPT code 27385 (Suture of quadriceps or hamstring muscle rupture; primary), we proposed a work RVU of 6.93 for CY 2012. Medicare PFS claims data indicated that CPT code 27385 is typically performed as an outpatient rather than inpatient service. In accordance with our methodology to address 23-hour stay and site-of-service anomalies described in section III.A. of this final rule with comment period, for CPT code 27385, we removed the hospital visit, reduced the discharge day management service by one-half, and increased the post-service time to 30 minutes. The AMA RUC recommended a work RVU of 8.11 for CPT code 27385 (76 FR 32438). The AMA RUC reviewed the survey results from physicians who frequently perform this service and decided that the work required to perform this service had not changed. The AMA RUC recommended that this service be valued as a service performed predominately in the inpatient setting, as the survey data indicated that half of patients have an overnight stay.
As detailed in the Fourth Five-Year Review of Work, for CPT code 27530 (Closed treatment of tibial fracture, proximal (plateau); without manipulation), we proposed a work RVU of 2.65 for CY 2012. Recent Medicare PFS claims data has shown that this service is typically performed on the same day as an E/M visit. We believed there was some overlap in the activities conducted during the pre- and post-service times between the procedure code and the E/M visit and, therefore, the time should not be counted twice in developing the procedure's work value. As described earlier in section III.A. of this final rule with comment period, to account for this overlap, we reduced the pre-service evaluation and post-service time by one-third. We believed that 5 minutes pre-service evaluation time and 7 minutes post-service time accurately reflected the time required to conduct the work associated with this service. We also removed the 2 minutes of pre-service positioning time, as it does not appear from the vignette that positioning is required for a non-manipulated extremity.
In order to determine the appropriate work RVU for this service given the time changes, we calculated the value of the extracted time and subtracted it from the AMA RUC-recommended work RVU. The AMA RUC recommended a work RVU of 2.81 for CPT code 27530 (76 FR 32438).
In the Fourth Five-Year Review, we identified CPT code 27792 (Open treatment of distal fibular fracture (lateral malleolus), includes internal fixation, when performed) as potentially
For the Fourth Five-Year Review, we identified CPT codes 28002, 28715, 28820 as potentially misvalued though the site-of-service anomaly screen. CPT code 28003 was added as a part of the family of services for review. We also identified CPT code 28285 as potentially misvalued through the Harvard-Valued—Utilization > 30,000 screen. The related specialty societies surveyed these codes and the AMA RUC issued recommendations to us for the Fourth Five-Year Review of Work.
CPT codes 28120 and 28122 were identified in 2007 by the AMA RUC Relativity Assessment Workgroup as potentially misvalued through the site-of-service anomaly screen. The related specialty societies surveyed these codes and the AMA RUC issued recommendations to us for CY 2010. As described in section III.A. of this final rule with comment period, we accepted these CY 2010 site-of-service anomaly code values on an interim basis but requested that the AMA RUC re-examine the site-of-service anomaly codes and adjust the work RVUs, times, and post-operative visits to reflect those typical of a service furnished in an outpatient or physician's office setting. The AMA RUC re-reviewed the survey data for these codes and issued recommendations to us for the Fourth Five-Year Review of Work.
We reviewed CPT codes 28002-28003, 28120-21822, 28285, 28715, 28820, and 28825, and published proposed work RVUs in the Fourth Five-Year Review of Work (76 FR 32440). Based on comments received during the public comment period, we referred CPT codes 28002, 28120-21822, 28285, 28715, 28820, and 28825 to the CY 2011 multi-specialty refinement panel for further review.
As detailed in the Fourth Five-Year Review of Work, for CPT code 28002 (Incision and drainage below fascia, with or without tendon sheath involvement, foot; single bursal space), we proposed a work RVU of 4.00 for CY 2012. After clinical review, including comparison to CPT code 58353 (Endometrial ablation, thermal, without hysteroscopic guidance) (work RVU=3.60), we believed that the survey low value work RVU of 4.00 accurately reflected the work associated with this service. The AMA RUC recommended a work RVU of 5.34 for CPT code 28002 for CY 2011 (76 FR 32440).
As detailed in the Fourth Five-Year Review of Work, for CPT code 28120 (Partial excision (craterization, saucerization, sequestrectomy, or diaphysectomy) bone (
As detailed in the Fourth Five-Year Review of Work, for CPT code 28122 (Partial excision (craterization, saucerization, sequestrectomy, or diaphysectomy) bone (
As detailed in the Fourth Five-Year Review of Work, for CPT code 28285 (correction, hammertoe (
As detailed in the Fourth Five-Year Review of Work, for CPT code 28715 (Arthrodesis; triple), we proposed a work RVU of 13.42 for CY 2012. Medicare PFS claims data indicated that CPT code 28715 is typically performed in an outpatient setting. However, the current and AMA RUC-recommended values for this code reflected work that is typically associated with an inpatient service. Therefore, in accordance with our methodology to address 23-hour stay and site-of-service anomalies described previously, for CPT code 28715, we removed the subsequent hospital care service, reduced the discharge day management service by one-half, and adjusted the physician times accordingly. The AMA RUC recommended maintaining the current work RVU of 14.60 for CPT code 28715 for CY 2012 (76 FR 32441).
As discussed in the CY 2012 MPFS proposed rule, for CPT code 28725 (Arthrodesis; subtalar) and 28730 (Arthrodesis, midtarsal or tarsometatarsal, multiple or transverse), we proposed work RVUs of 11.22 for CPT code 28725, and work RVUs of 10.70 for CPT code 28730 respectively. The most recently available Medicare claims data suggested that these site-of-service anomaly codes could be “23-hour stay” outpatient services. As detailed in the CY 2012 MPFS proposed rule, for CY 2010, CPT codes 28725 and 28730 were identified as potentially misvalued through the site-of-service anomaly screen and were reviewed by the AMA RUC. For both of these services, based on reference services and specialty survey data, the AMA RUC recommended maintaining the current (CY 2009) work RVU, which saw a slight increase based on the redistribution of RVUs that resulted from the CY 2010 policy to no longer recognize the CPT consultation codes (74 FR 61775). The AMA RUC re-reviewed CPT codes 28725 and 28730 for CY 2012 and, contrary to the 23-hour stay valuation policy we finalized in the CY 2011 PFS final rule with comment period (75 FR 73226 through 73227), recommended replacing the hospital inpatient post-operative visit in the current work values with a subsequent observation care service, specifically CPT code 99224 (Level 1 subsequent observation care, per day) and recommended maintaining the current interim value for the two CPT codes. Specifically, for CY 2012 the AMA RUC recommended a work RVU of 12.18 for CPT code 28725 and a work RVU of 12.42 for CPT code 28730 (76 FR 42798).
We disagreed with the AMA RUC-recommended values for CPT codes 28725 and 28730. We believed the appropriate methodology for valuing these codes entails accounting for the removal of the inpatient visits in the work value for the site-of-service anomaly codes since these services are no longer typically furnished in the inpatient setting. We did not believe it is appropriate to simply exchange the inpatient post-operative visits in the original value with subsequent observation care visits and maintain the current work RVUs.
As detailed in the Fourth Five-Year Review of Work, for CPT code 28820 (Amputation, toe; metatarsophalangeal joint), we proposed a work RVU of 5.82 for CY 2012. Medicare PFS claims data indicated that CPT code 28820 is typically performed in an outpatient setting. However, the current and AMA RUC-recommended values for this code reflected work that is typically associated with an inpatient service. Therefore, in accordance with our methodology described previously to address 23-hour stay and site-of-service anomalies, for CPT code 28820, we removed the subsequent hospital care service, reduced the discharge day management service to one-half, and adjusted the physician times accordingly. The AMA RUC recommended the survey median work RVU of 7.00 for CPT code 28820 for CY 2012 (76 FR 32441).
As detailed in the Fourth Five-Year Review of Work, for CPT code 28825 (Amputation, toe; interphalangeal joint), we proposed a work RVU of 5.37 for CY 2012. Medicare PFS claims data indicated that CPT code 28825 is typically performed in an outpatient setting. However, the current and AMA RUC recommended values for this code reflected work that is typically associated with an inpatient service. Therefore, in accordance with our methodology to address 23-hour stay and site-of-service anomalies described previously, for CPT code 28825, we reduced the discharge day management service to one-half, and adjusted the physician times accordingly. The AMA RUC recommended maintaining the current work RVU of 6.01 for CPT code 28825 for CY 2012 (76 FR 32441).
In the Fourth Five-Year Review, we identified CPT code 29125 (Application of short arm splint (forearm to hand); static), as potentially misvalued through the Harvard-Valued-Utilization > 30,000
As detailed in the Fourth Five-Year Review of Work, for CPT code 29125 (Application of short arm splint (forearm to hand); static), we proposed a work RVU of 0.50 for CY 2012. Medicare PFS claims data affirmed that this service is typically performed on the same day as an E/M visit. We believed some of the activities conducted during the pre- and post-service times of the procedure code and the E/M visit overlap and, therefore, should not be counted twice in developing the procedure's work value. As described earlier in section III.A. to account for this overlap, we reduced the pre-service evaluation and post-service time by one third. We believed that 5 minutes pre-service evaluation time and 3 minutes post-service time accurately reflect the time required to conduct the work associated with this service as described by the CPT code-associated specialties to the AMA RUC. The AMA RUC recommended maintaining the current work RVU of 0.59 for CPT code 29125 (76 FR 32441).
As detailed in the Fourth Five-Year Review of Work, for CPT code 29126 (Application of short arm splint (forearm to hand); dynamic), we proposed a work RVU of 0.68 for CY 2012. Medicare PFS claims data affirmed that this service is typically performed on the same day as an E/M visit. We believed some of the activities conducted during the pre- and post-service times of the procedure code and the E/M visit overlap and, therefore, should not be counted twice in developing the procedure's work value. As described earlier in section III.A. of this final rule with comment period, to account for this overlap, we reduced the pre-service evaluation and post-service time by one-third. The AMA RUC recommended maintaining the current work RVU of 0.77 for CPT code 29126 (76 FR 32442).
As detailed in the Fourth Five-Year Review, for CPT code 29515 (Application of short leg splint (calf to foot)) we believed that the current (CY 2011) work RVU continued to accurately reflect the work of this service. For CPT code 29515 we proposed the current (CY 2011) work RVU of 0.73. The AMA RUC recommended maintaining the current work RVUs for this service as well. For CPT code 29515, the AMA RUC recommended 7 minutes of pre-service evaluation time and 5 minutes of post-service time. We proposed to reduce the AMA RUC-recommended times to 5 minutes of pre-service evaluation time and 3 minutes of post-service time for CPT code 29515 (76 FR 32442).
As detailed in the CY 2011 final rule with comment period (75 FR 73331), for CPT code 29540, we assigned an interim final work RVU of 0.32. The HCPAC-recommended a work RVU of 0.39. The HCPAC compared the total time required for CPT code 29540 to CPT code 29580 (Strapping; Unna boot), 18 and 27 minutes, respectively, and noted that CPT code 29540 requires less time, mental effort/judgment, technical skill and psychological stress than CPT code 29580. The HCPAC determined that CPT code 29540 was approximately 30 percent less intense and complex than CPT code 29580, resulting in work RVUs of 0.39 for CPT code 29540 (75 FR 73331). We disagreed with the HCPAC-recommended work RVU for this service and believed work RVUs of 0.32 were appropriate. We believed CPT code 11720 (Debridement of nail(s) by any method(s); 1 to 5) (work RVUs = 0.32) was a more appropriate crosswalk (75 FR 73331).
As detailed in the CY 2011 final rule with comment period (75 FR 73331), for CPT code 29550 (Strapping; toes), we assigned an interim final work RVU of 0.15. The HCPAC recommended a work RVU of 0.25. The HCPAC compared this service to CPT code 97762 (Checkout for orthotic/prosthetic use, established patient, each 15 minutes) (work RVU = 0.25), which it believed requires the same intensity and complexity to perform as CPT code 29550. The HCPAC recommended crosswalking the work RVUs for 29550 to reference CPT code 97762. The HCPAC reviewed the survey time and determined that 7 minutes pre-service, 5 minutes intra-service, and 1 minute immediate post-service time were appropriate to perform this service. We disagreed with the HCPAC-recommended value for this service and believed a work RVU of 0.15, the survey low value, was appropriate, with 5 minutes of pre- and intra-service time and 1 minute of post-service time, as we believed the HCPAC-recommended pre-service time of 7 minutes was excessive (75 FR 73331).
We discussed CPT code 32851 (Lung transplant, single; without cardiopulmonary bypass) in the Fourth Five-Year Review of Work (76 FR 32444). As noted in the proposed notice, the AMA RUC reviewed the survey responses and concluded that the survey 25th percentile work RVU of 63.00 appropriately accounted for the physician work required to perform this service. We disagreed with the AMA RUC-recommended work RVU for CPT code 32851 and upon a clinical review where we compared this service to other services, we concluded that a work RVU of 59.64 was more appropriate for this service. Comparing CPT code 33255 (Operative tissue ablation and reconstruction of atria, extensive (
In addition, we stated that we believed this was the appropriate interval in physician work distinguishing CPT code 32852 (Lung transplant, single; with cardiopulmonary bypass), from CPT code 32851 (Lung transplant, single; without cardiopulmonary bypass). Since we proposed a work RVU of 65.05 for CPT code 32852 (see below), we believed a work RVU of 59.64 accurately reflects the work associated with CPT code 32851 and maintains appropriate relativity among similar services. Therefore, we proposed an alternative work RVU of 59.64 for CPT code 32851 for CY 2012.
For CPT code 32852 (Lung transplant, single; with cardiopulmonary bypass), the AMA RUC reviewed the survey responses and concluded that the survey 25th percentile work RVU was too low and the median work RVU was too high. Therefore, the AMA RUC recommended a work RVU of 74.37 for CPT code 32582. We disagreed with the AMA RUC-recommended work RVU for CPT code 32582 and believed that the survey 25th percentile value of a work RVU of 65.50 was more appropriate for
We discussed CPT code 32853 (Lung transplant, double (bilateral sequential or en bloc); without cardiopulmonary bypass) in the Fourth Five-Year Review of Work (76 FR 32444). As noted in the proposed notice the AMA RUC reviewed the survey responses and concluded that the survey median work RVU of 90.00 appropriately accounted for the physician work required to perform this service. We disagreed with the AMA RUC-recommended work RVU for CPT code 32853 and believed that the survey 25th percentile value of 84.48 was more appropriate for this service as a reflection of the time and intensity of the service in relation to other major surgical procedures. Therefore, we proposed an alternative work RVU of 84.48 for CPT code 32853 for CY 2012.
For CPT code 32854 (Lung transplant, double (bilateral sequential or en bloc); with cardiopulmonary bypass), the AMA RUC reviewed the survey responses and concluded that the survey median work RVU of 95.00 appropriately accounted for the physician work required to perform this service. We disagreed with the AMA RUC-recommended work RVU for CPT code 32854 and believed that the survey 25th percentile value of 90.00 was more appropriate for this service. We stated that a work RVU of 90.00 maintains the relativity between CPT code 32851 (Lung transplant, single; without cardiopulmonary bypass) and CPT code 32854, which describes a double lung transplant. We believed this work RVU reflects the increased intensity in total service for CPT code 32584 when compared to CPT code 32851. Therefore, we proposed an alternative work RVU of 90.00 for CPT code 32854 for CY 2012.
We note that CPT code 32405 (Biopsy, Lung or mediastinum) was also reviewed in this family for the Fourth Five-Year Review. We agreed with the AMA RUC's methodology and recommended value for this code. Accordingly, we are finalizing a work RVU of 1.93 for CPT code 32405. We note the CY 2012 final values for the codes in this family are summarized in Table 15.
We discussed CPT code 33030 (Pericardiectomy, subtotal or complete; without cardiopulmonary bypass) in the Fourth Five-Year Review of Work (76 FR 32444) where we noted the AMA RUC reviewed the survey responses and concluded that the survey median work RVUs of 39.50 for CPT code 33030 appropriately accounted for the work required to perform this service.
We disagreed with the AMA RUC-recommended work RVUs for CPT code 33030. Following comparison with similar codes, we believed that the survey 25th percentile value of 36.00 was more appropriate for this service. Therefore, we proposed an alternative work RVUs of 36.00 for CPT code 33030 for CY 2012.
We discussed CPT code 33120 (Excision of intracardiac tumor, resection with cardiopulmonary bypass) in the Fourth Five-Year Review of Work (76 FR 32444), where we noted the AMA RUC reviewed the survey responses and concluded that the 25th percentile work RVUs for CPT code 33120 appropriately accounted for the work required to furnish this service. The AMA RUC recommended work RVUs of 42.88 for CPT code 33120.
We disagreed with the AMA RUC-recommended work RVUs for CPT code 33120 and believed that work RVUs of 38.45 were more appropriate for this service. We compared CPT code 33120 with CPT code 33677 (Closure of multiple ventricular septal defects; with removal of pulmonary artery band, with or without gusset) (work RVUs = 38.45) and found the codes to be similar in complexity and intensity. We believed that work RVUs of 38.45 accurately reflect the work associated with CPT code 33677 and properly maintains the relativity of similar services. Therefore, we proposed an alternative work RVUs of 38.45 for CPT code 33120 for CY 2012.
We discussed CPT code 33412 (Replacement, aortic valve; with transventricular aortic annulus enlargement (Konno procedure)) in the Fourth Five-Year Review of Work (76 FR 32444) where we noted the AMA RUC reviewed the survey responses and concluded that the survey median work RVUs for CPT code 33412 appropriately accounted for the work required to furnish this service. The AMA RUC recommended work RVUs of 60.00 for CPT code 33412. We disagreed with the AMA RUC-recommended work RVUs for CPT code 33412 and believed that the survey 25th percentile value of 59.00 was more appropriate for this service. Therefore, we proposed alternative work RVUs of 59.00 for CPT code 33412 for CY 2012.
We discussed CPT code 33468 (Tricuspid valve repositioning and plication for Ebstein anomaly) in the Fourth Five-Year Review of Work (76 FR 32444) where we noted the AMA RUC reviewed the survey responses and concluded that the survey median work RVUs for CPT code 33468 appropriately accounted for the work required to furnish this service. The AMA RUC recommended work RVUs of 50.00 for CPT code 33468. We disagreed with the AMA RUC-recommended work RVUs for CPT code 33468 and believed that the survey 25th percentile value of 45.13 was more appropriate for this service. Therefore, we proposed alternative work RVUs of 45.13 for CPT code 33468 for CY 2012.
We discussed CPT code 33645 (Direct or patch closure, sinus venosus, with or without anomalous pulmonary venous drainage) in the Fourth Five-Year Review of Work (76 FR 32445) where we noted the AMA RUC reviewed survey responses and concluded that the survey median work RVUs for CPT code 33645 appropriately accounts for the work required to perform this service. The AMA RUC recommended work RVUs of 33.00 for CPT code 33645. We disagreed with the AMA RUC-recommended work RVUs for CPT code 33645 and believed that the survey 25th percentile value of 31.30 appropriately captures the total work for the service. Therefore, we proposed alternative work RVUs of 31.30 for CPT code 33645 for CY 2012.
We discussed CPT code 33647 (Repair of atrial septal defect and ventricular septal defect, with direct or patch closure) in the Fourth Five-Year Review of Work (76 FR 32445) where we noted the AMA RUC reviewed survey responses and concluded that the survey median work RVUs for CPT code 33467 appropriately account for the work required to furnish this service. The AMA RUC recommended work RVUs of 35.00 for CPT code 33647. We disagreed with the AMA RUC-recommended work RVUs for CPT code 33647 and believed that the survey 25th percentile value of 33.00 was more appropriate for this service. Therefore, we proposed alternative work RVUs of 33.00 for CPT code 33647 for CY 2012.
Fourth Five-Year Review of Work (76 FR 32445) where we noted the AMA RUC reviewed survey responses, and recommended the survey median work RVUs of 38.75 for CPT code 33692. We disagreed with the AMA RUC-recommended work RVUs for CPT code 33692 and believed that the survey 25th percentile value of 36.15 was more appropriate for this service. Therefore, we proposed alternative work RVUs of 36.15 for CPT code 33692 for CY 2012.
We recommended work RVUs of 43.00 for CPT code 33710, the survey median work RVUs. We disagreed with the AMA RUC-recommended work RVUs for CPT code 33710 and believed that the survey 25th percentile value of 37.50 was more appropriate for this service. We believed the physician time and intensity for CPT code 33710 reflected the appropriate incremental adjustment when compared to the key reference service, CPT code 33405 (Replacement, aortic valve, with cardiopulmonary bypass; with prosthetic valve other than homograft or stentless valve) (work RVUs = 41.32 and intra-service time = 198 minutes). Therefore, we proposed alternative work RVUs of 37.50 for CPT code 33710 for CY 2012.
Commenters disagreed with CMS' proposed value and stated that the AMA RUC workgroup closely reviewed this service and compared 33710 to key reference service CPT code 33405. The commenters asserted that 33710 is similarly intense and complex, and requires more physician work and time to furnish than the key reference service.
We discussed CPT code 33875 (Descending thoracic aorta graft, with or without bypass) in the Fourth Five-Year Review of Work (76 FR 32445) and noted that the AMA RUC reviewed survey responses and concluded that the 25th percentile work RVUs for code 33875 appropriately account for the work required to furnish this service. The AMA RUC recommended work RVUs of 56.83 for CPT code 33875. We disagreed with the AMA RUC-recommended work RVUs for CPT code 33875 and believed that work RVUs of 50.72 were more appropriate for this service. We compared CPT code 33875 with CPT code 33465 (Replacement, tricuspid valve, with cardiopulmonary bypass) (work RVUs = 50.72) and believed that CPT code 33875 was similar to CPT code 33465, with similar inpatient and outpatient work. We believed these work RVUs corresponded better to the value of the service than the survey 25th percentile work RVUs. Therefore, we proposed alternative work RVUs of 50.72 for CPT code 33875 for CY 2012.
We discussed CPT code 33910 (Pulmonary artery embolectomy; with cardiopulmonary bypass) in the Fourth Five-Year Review of Work (76 FR 32445) and noted that after reviewing the service, the AMA RUC recommended work RVUs of 52.33 for CPT code 33910. We disagreed with the AMA RUC-recommended work RVUs for CPT code 33910 and believed that work RVUs of 48.21 were more appropriate for this service. We compared CPT code 33910 with CPT code 33542 (Myocardial resection (
Fourth Five-Year Review of Work (76 FR 32445) and noted that the AMA RUC reviewed survey responses and recommended work RVUs of 100.00, the survey median work RVUs, for CPT code 33935. We disagreed with the AMA RUC-recommended work RVUs for CPT code 33935 and believed that the survey 25th percentile value of 91.78 was more appropriate for this service. We believed this service is more intense and complex than the reference CPT code 33945 (Heart transplant, with or without recipient cardiectomy) (work RVU = 89.50) and that the survey 25th percentile work RVUs accurately reflected the increased intensity and complexity when compared to the reference CPT code 33945. Therefore, we proposed alternative work RVUs of 91.78 for CPT code 33935 for CY 2012.
We discussed CPT code 33980 (Removal of ventricular assist device, implantable intracorporeal, single ventricle) in the Fourth Five-Year Review of Work (76 FR 32445). We noted the AMA RUC reviewed the survey results and recommended the survey median work RVUs of 40.00. Additionally, the AMA RUC recommended a global period change from 090 (Major surgery with a 1-day pre-operative period and a 90-day postoperative period included in the fee schedule amount) to XXX (the global concept does not apply to the code). We agreed with the AMA RUC-recommended global period change from 090 to XXX. However, we disagreed with the AMA RUC-recommended work RVUs for CPT code 33980. We believed the work RVUs of 33.50 were more appropriate, given the significant reduction in physician times and decrease in the number and level of post-operative visits that the AMA RUC included in the value of CPT code 33980. For CY 2012, we proposed alternative work RVUs of 33.50, the survey 25th percentile work RVUs.
We discussed CPT code 35188 (Repair, acquired or traumatic arteriovenous fistula; head and neck) in the Fourth Five-Year Review of Work (76 FR 32446) and noted the AMA RUC reviewed the survey results and recommended the survey median work RVUs of 18.50 for CPT code 35188. We disagreed with the AMA RUC-recommended work RVUs for CPT code 35188 and proposed alternative work RVUs of 18.00, which are the survey 25th percentile work RVUs. We believed the work RVUs of 18.00 are more appropriate, given the decrease in the number and level of post-operative visits that the AMA RUC included in the value of CPT code 35188.
We discussed CPT code 35612 (Bypass graft, with other than vein; subclavian) in the Fourth Five-Year Review of Work (76 FR 32446) and noted the AMA RUC reviewed the survey results and recommended work RVUs of 22.00 for CPT code 35612. We disagreed with the AMA RUC-recommended work RVUs for CPT code 35612 and proposed alternative work RVUs of 20.35, which were the survey 25th percentile work RVUs. We believed the work RVUs of 20.35 were more appropriate, given the decrease in the number and level of post-operative visits that the AMA RUC included in the value of CPT code 35612.
We discussed CPT code 35800 (Exploration for postoperative hemorrhage, thrombosis or infection; neck) in the Fourth Five-Year Review of Work (76 FR 32446) and noted the AMA RUC used magnitude estimation to recommend work RVUs for CPT code 35800 between the survey 25th percentile (12.00 RVUs) and median (15.00 RVUs) work value. Accordingly, the AMA RUC recommended work RVUs of 13.89 for CPT code 35800. We disagreed with the AMA RUC-recommended work RVUs for CPT code 35800 and proposed alternative work RVUs of 12.00, which were the survey 25th percentile work RVUs. We believed the work RVU of 12.00 were more appropriate, given that two of the key reference codes to which this service has been compared have identical intra-service time (60 minutes), but significantly lower work RVUs.
We discussed CPT code 35840 (Exploration for postoperative hemorrhage, thrombosis or infection; abdomen) in the Fourth Five-Year Review of Work (76 FR 32446) and noted the AMA RUC used magnitude estimation to recommend work RVUs for CPT code 35840 between the survey 25th percentile (19.25 RVU) and survey median (22.30 RVUs) work value. Accordingly, the AMA RUC recommended a work RVU of 21.19 for CPT code 35840. We disagreed with the AMA RUC-recommended work RVU for CPT code 35840 and proposed alternative work RVUs of 20.75, which were between the survey 25th percentile and survey median work RVUs. We believed the work RVUs of 20.75 were more appropriate given the comparison to the two reference codes.
We discussed CPT code 35860 (Exploration for postoperative hemorrhage, thrombosis or infection; extremity) in the Fourth Five-Year Review of Work (76 FR 32446-32447) and noted the AMA RUC used magnitude estimation to recommend work RVUs between the survey 25th percentile (15.25 RVUs) and median work value (18.00 RVUs). The AMA RUC recommended work RVUs of 16.89 for CPT code 35860. We disagreed with the AMA RUC-recommended work RVUs for CPT code 35860 and proposed alternative work RVUs of 15.25, which were the survey 25th percentile work RVUs. We believed these work RVU maintained appropriate relativity within the family of related services for the exploration of postoperative hemorrhage.
As detailed in the Fourth Five-Year Review, for CPT code 36600 (Arterial puncture, withdrawal of blood for diagnosis) we believed that the current (CY 2011) work RVUs continued to accurately reflect the work of these services and, therefore, proposed work RVUs of 0.32 for CPT code 36600. The AMA RUC also recommended maintaining the current (CY 2011) work RVUs for these services. For CPT code 36600, the AMA RUC recommended a pre-service evaluation time of 5 minutes and immediate post service time of 5 minutes. We proposed a pre-service evaluation time for CPT code 36600 of 3 minutes and a post service time of 3 minutes (76 FR 32447).
We discussed CPT code 36247 (Selective catheter placement, arterial system; initial third order or more selective abdominal, pelvic, or lower extremity artery branch, within a vascular family) in the Fourth Five-Year Review of Work (76 FR 32445) and proposed a CY 2012 work RVU of 6.29 and a global period change from 90-days (Major surgery with a 1-day pre-operative period and a 90-day postoperative period included in the fee schedule amount) to XXX (the global concept does not apply to the code). The AMA RUC recommended the survey median work RVU of 7.00 for this service. We disagreed with the RUC-recommended value noting that a reduced global period would support a reduction in the RVUs.
We discussed CPT code 36819 (Arteriovenous anastomosis, open; by upper arm basilic vein transposition) in the Fourth Five-Year Review of Work (76 FR 32447) where we noted this code was identified as a code with a site-of- service anomaly. Medicare PFS claims data indicated that this code is typically furnished in an outpatient setting. However, the current and AMA RUC-recommended values for this code reflected work that is typically associated with an inpatient service. As discussed in section III.A. of this final rule with comment period, our policy is to remove any post-procedure inpatient and subsequent observation care visits remaining in the values for these codes and adjust physician times accordingly. It is also our policy for codes with site-of-service anomalies to consistently include the value of half of a discharge day management service. While the AMA RUC recommended maintaining the current (CY 2011) work RVU of 14.47, utilizing our methodology, we proposed an alternative work RVU for CY 2012 of 13.29 with refinements in time for CPT code 36819.
We discussed CPT code 36825 (Creation of arteriovenous fistula by other than direct arteriovenous anastomosis (separate procedure); autogenous graft) in the Fourth Five-Year Review of Work (76 FR 32445 and 32446) where we noted this code was identified as a code with a site-of-service anomaly. Medicare PFS claims data indicated that this code is typically furnished in an outpatient setting. However, the current and AMA RUC-recommended values for this code reflected work that is typically associated with an inpatient service. As discussed in section III.A. of this final rule with comment period, consistent with that methodology, we removed the subsequent observation care service, reduced the discharge day management service by one-half, and adjusted times for CPT code 36825. While the AMA RUC recommended maintaining the current (CY 2011) work RVU of 15.13, utilizing our methodology for codes with site-of-service anomalies, we proposed an alternative work RVU of 14.17 with refinements to the time for CPT code 36825 for CY 2012.
For CY 2012, we received no comments on the Fourth Five-Year Review of Work proposed work RVUs for CPT codes 33916, 33975, 33976, 33977, 33978, 33979, 33981, 33982, 33983, 36200, 36246, 36470, 36471, 36600, 36821, 37140, 37145, 37160, 37180, and 37181. Additionally, we received no comments on the CY 2011 final rule with comment period work RVUs for CPT codes 33620, 33621, 33622, 33860, 33863, 33864, 34900, 35471, 36410, 37205, 37206, 37207, 37208, 37220, 37221, 37222, 37223, 37224, 37225, 37226, 37228, 37229, 27230, 37231, 37232, 37233, 37234, 37235, 37765, 37766. We believe these values continue to be appropriate and are finalizing them without modification (Table 15).
In the Fourth Five-Year Review, we identified CPT codes 42415 and 42420 as potentially misvalued through the site-of-service anomaly screen. The related specialty societies surveyed these codes and the AMA RUC issued recommendations to us for the Fourth Five-Year Review of Work.
As detailed in the Fourth Five-Year Review of Work (76 FR 32447), for CPT code 42415 (Excision of parotid tumor or parotid gland; lateral lobe, with dissection and preservation of facial nerve), we proposed a work RVU of 17.16 for CY 2012. Medicare PFS claims data indicated that CPT code 42415 is typically furnished in an outpatient setting. However, the current AMA RUC-recommended values for this code reflected work that is typically associated with an inpatient service. Therefore, in accordance with our methodology to address 23-hour stay and site-of-service anomalies described in section III.A. of this final rule with comment period, for CPT code 42415, we removed the observation care service, reduced the discharge day management service by one-half, and adjusted the physician times accordingly. The AMA RUC recommended maintaining the current work RVU of 18.12 for CPT code 42415.
Furthermore, as detailed in the Fourth Five-Year Review of Work (76 FR 32447), for CPT code 42420 (Excision of parotid tumor or parotid gland; total, with dissection and preservation of facial nerve) we proposed a work RVU of 19.53 for CY 2012. Medicare PFS claims data indicated that CPT code 42420 is typically furnished in an outpatient setting. However, the current AMA RUC-recommended values for this code reflected work that is typically associated with an inpatient service. Therefore, in accordance with our methodology to address 23-hour stay and site-of-service anomalies described in section III.A. of this final rule with comment period, for CPT code 42420, we removed the subsequent observation care service, reduced the discharge day management service by one-half, and adjusted the physician times accordingly. The AMA RUC recommended maintaining the current work RVU of 21.00 for CPT code 42420.
As detailed in the CY 2012 PFS proposed rule (76 FR 42799), for CPT code 42440 (Excision of submandibular (submaxillary) gland), we proposed a work RVU of 6.14 for CY 2012. As stated in section III.A. of this final rule with comment period, we believe the appropriate methodology for valuing site-of-service anomaly codes entails not just removing the inpatient visits, but also accounting for the removal of the inpatient visits in the work value of the CPT code. To appropriately revalue this CPT code to reflect an outpatient service we started with the original CY 2008 work RVU of 7.05 then, in accordance with the policy discussed in section III.A. of this final rule with comment period, we removed the value of the subsequent hospital care service and one-half discharge day management service, and added back the subsequent hospital care intra-service time to the immediate post-operative care service.
As detailed in the Fourth Five-Year Review (76 FR 32448), for CPT code 43262 (Endoscopic retrograde cholangiopancreatography (ERCP); with sphincterotomy/papillotomy), we believed that the current (CY 2011) work RVU of 7.38 continued to accurately reflect the work of this service. We proposed to maintain the current work RVU and physician times for CPT code 43262. The AMA RUC recommended maintaining the current work RVUs for these services as well. However, the AMA RUC recommended a pre-service evaluation time of 15 minutes and immediate post service time of 20 minutes. Additionally, the AMA RUC recommended a pre-service positioning time of 5 minutes; a pre-service dress/scrub time of 5 minutes; and an intra-service time of 45 minutes. We noted that based on a preliminary review of the intra-service times for these codes, we were concerned the codes in this family are potentially misvalued. We requested that the AMA RUC undertake a comprehensive review of the entire family of ERCP codes, including the base CPT code 43260, and provide us with work RVU recommendations.
For CY 2012, we did not receive any public comments on the Fourth Five-Year Review proposed work RVUs for CPT code 43262. We believe this value continues to be appropriate and are finalizing it without modification (Table 15).
For CY 2011 the CPT Editorial Panel deleted six existing CPT codes and created ten new CPT codes (CPT codes 43283, 43327-43328, 43332-43338) to better report current surgical techniques for paraesophageal hernia procedures. The specialty societies surveyed their members, and the AMA RUC issued recommendations to us for the CY 2011 PFS final rule with comment period.
As stated in the CY 2011 PFS final rule with comment period, after reviewing these new CPT codes, we believed that this coding change resulted in more codes that describe the same physician work with a greater degree of precision, and that the aggregate increase in work RVUs that would result from the adoption of the CMS-adjusted pre-budget neutrality RVUs would not represent a true increase in physician work. Therefore, we believed it was appropriate to apply work budget neutrality to this set of CPT codes. After reviewing the AMA RUC-recommended work RVUs, we adjusted the work RVUs for two CPT codes (CPT code 43333 and 43335), and then applied work budget neutrality to the set of clinically related CPT codes. The work budget neutrality factor for the 10 paraesophageal hernia procedure CPT codes was 0.7374. The AMA RUC-recommended work RVU, CMS-adjusted work RVU prior to the budget neutrality adjustment, and the CY 2011 interim final work RVU for these paraesophageal hernia procedure codes follow (CPT codes 43283, 43327-43328, 43332-43338) (75 FR 73338).
As mentioned previously, and detailed in the CY 2011 PFS final rule with comment period, for CPT codes 43333 (Repair, paraesophageal hiatal hernia (including fundoplication), via laparotomy, except neonatal; with implantation of mesh or other prosthesis) and 43335 (Repair, paraesophageal hiatal hernia (including fundoplication), via thoracotomy, except neonatal; with implantation of mesh or other prosthesis), we disagreed with the AMA RUC-recommended work RVUs and assigned alternate RVUs prior to the application of work budget neutrality (75 FR 73331). For CPT code 43333 we assigned a pre-budget neutrality work RVU of 29.10 and for CPT code 43335 we assigned a pre-budget neutrality work RVU of 32.50. We arrived at these values by starting with the AMA RUC-recommended values for the repair of papaesophageal hernia without mesh, CPT codes 43332 (Repair, paraesophageal hiatal hernia (including fundoplication), via laparotomy, except neonatal; without implantation of mesh or other prosthesis) and 43334 (Repair, paraesophageal hiatal hernia (including fundoplication), via thoracotomy, except neonatal; without implantation of mesh or other prosthesis) then adjusted them upward by a work RVU of 2.50 to account for the incremental difference associated with the implantation of mesh or other prosthesis. The AMA RUC recommended a work RVU of 30.00 for CPT code 43333 and a work RVU of 33.00 for CPT 43335 for CY 2011.
With regard to CPT codes 43333 and 43335, commenters disagreed with the CMS-assigned pre-budget neutrality work RVU of 29.10 for CPT code 43333 and 32.50 for CPT code 43335, and believe that the AMA RUC-recommended work RVUs of 30.00 for CPT code 43333 and 33.00 for CPT code 43335 are more appropriate for these services. Commenters noted that CMS adjusted the AMA RUC-recommended values for CPT codes 43333 and 43335 by 2.50 work RVUs, an increment established in the AMA RUC's valuation of CPT codes 43336 and 43337. In other words CMS added 2.50 work RVUs to the AMA RUC-recommended work RVUs of 26.60 for CPT code 43332, which resulted in a value of 29.10 for CPT code 43333. Also, CMS added 2.50 work RVUs to the AMA RUC-recommended work RVUs of 30.00 for CPT code 43334, which resulted in a value of 32.50 for CPT code 43335. Commenters disagreed with this method because CMS' interim values were not supported by the survey results or AMA RUC recommendations. Commenters note that the AMA RUC recommendations were based on magnitude estimation rather than the building block methodology, which considers the total work of the service rather than the work of the component parts of the service. Commenters did not agree with adding component parts on to values that were based through magnitude estimation. Commenters asserted that these,services should be valued through magnitude estimation, rather than incremental addition of work RVUs of 2.50 in order to account for both the work related to inserting mesh, as well as other patient factors that in turn make the insertion of mesh necessary. Based on these arguments, commenters stated that work budget neutrality should not be applied to these codes, and urged CMS to accept the AMA RUC-recommended values for these services.
Additionally, we received no public comments on the Fourth Five-Year Review proposed work RVUs for CPT code 43415. We believe these values continue to be appropriate and are finalizing them without modification (Table 15).
As detailed in the Fourth Five-Year Review, for CPT code 45331 (Sigmoidoscopy, flexible; with biopsy, single or multiple) we believed that the current (CY 2011) work RVUs continued to accurately reflect the work of these services and, therefore, proposed a work RVU of 1.15 for CPT code 45331. The AMA RUC recommended maintaining the current work RVUs for this service as well. For CPT code 45331, the AMA RUC recommended a pre-service time of 15 minutes, intra-service time of 15 minutes, and post-service time of 10 minutes. While the AMA RUC recommended pre-service times based on the 75th percentile of the survey results, we believed it was more appropriate to accept the median survey physician times. Accordingly, we proposed to refine the times to the following: 5 minutes for pre-evaluation; 5 minutes for pre-service other, 5 minutes for pre- dress, scrub, and wait; 10 minutes intra-service; and 10 minutes immediate post-service (76 FR 32448).
In the Fourth Five-Year Review, CMS identified CPT code 47563 as potentially misvalued through the Harvard Valued—Utilization > 30,000 screen and site-of-service anomaly screen. The AMA RUC reviewed CPT codes 47564 and 47563.
As detailed in the Fourth Five-Year Review (76 FR 32448), for CPT code 47563 (Laparoscopy, surgical; cholecystectomy with cholangiography), we proposed a work RVU of 11.47 with refinements in time for CPT code 47563 for CY 2012. The survey data show 95 percent (57 out of 60) of survey respondents stated they furnish the procedure “in the hospital.” However, of those respondents who stated that they typically furnish the procedure in the hospital, 30 percent (17 out of 57) stated that the patient is “discharged the same day”; 46 percent (26 out of 57) stated the patient is “kept overnight (less than 24 hours)”; and 25 percent (14 out of 57) stated the patient is “admitted (more than 24 hours).” These responses make no distinction between the patient's status as an inpatient or outpatient of the hospital for stays of longer than 24 hours. Based on the survey data, we valued this service based on our methodology to address 23-hour stay site-of-service anomaly services.
As we discussed in section III.A. of this final rule with comment period, for codes with site-of-service anomalies, our policy is to remove any post-procedure inpatient visits remaining in the values for these codes and adjust physician times accordingly. It is also our policy for codes with site-of-service anomalies to consistently include the value of half of a discharge day management service, adjusting physician times accordingly. The AMA RUC recommended that this service be valued as a service furnished predominately in the facility setting with a work RVU of 12.11 for CPT code 47563 (76 FR 32448).
As detailed in the Fourth Five-Year Review (76 FR 32449), for CPT code 47564 (Laparoscopy, surgical; cholecystectomy with exploration of common duct), we proposed a work RVU of 18.00, the survey low work RVU, for CY 2012. We accepted the AMA RUC-recommended median survey times and believed the work RVU of 18.00 for CPT code 35860 was more appropriate given the significant reduction in recommended physician times in comparison to the current times. The AMA RUC recommended a work RVU of 20.00, the 25th survey percentile, for CPT code 47564.
For CY 2012, we received no comments on the Fourth Five-Year Review proposed work RVUs for CPT codes 47480 and 47490. We believe these values continue to be appropriate and are finalizing them without modification (Table 15).
We discussed CPT codes 49507 (Repair initial inguinal hernia, age 5 years or over; incarcerated or strangulated), 49521 (Repair recurrent inguinal hernia, any age; incarcerated or strangulated), and 49587 (Repair umbilical hernia, age 5 years or over; incarcerated or strangulated) in the Fourth Five-Year Review (76 FR 32449) where we noted these codes were identified as codes with a site-of- service anomaly. Medicare PFS claims data indicated that these codes are typically furnished in an outpatient setting. However, the current and AMA RUC-recommended values for these codes reflected work that is typically associated with an inpatient service. As discussed in section III.A. of this final rule with comment period, our policy is to remove any post-procedure inpatient and subsequent observation care visits remaining in the values for these codes and adjust physician times accordingly. It is also our policy for codes with site-of- service anomalies to consistently include the value of half of a discharge day management service. While the AMA RUC recommended maintaining the current work RVUs, utilizing our methodology, we proposed an alternative work RVU of 9.09 for CPT code 49507, 11.48 for CPT code 49521, and 7.08 for CPT code 49587, with appropriate refinements to the time.
We discussed CPT code 49652 (Laparoscopy, surgical, repair, ventral, umbilical, spigelian or epigastric hernia (includes mesh insertion, when performed); reducible), CPT code 49653 (Laparoscopy, surgical, repair, ventral, umbilical, spigelian or epigastric hernia (includes mesh insertion, when performed); incarcerated or strangulated), CPT code 49654 (Laparoscopy, surgical, repair, incisional hernia (includes mesh insertion, when performed); reducible), and CPT code 49655 (Laparoscopy, surgical, repair, incisional hernia (includes mesh insertion, when performed)) in the Fourth Five-Year Review of Work (76 FR 32450-32452) where we noted these codes were identified as codes with a sites-of-services anomaly. Medicare PFS claims data indicated that these codes are typically furnished in an outpatient setting. However, the current and AMA RUC-recommended values for these codes reflected work that is typically associated with an inpatient service. As discussed in section III.A. of this final rule with comment period, our policy is to remove any post-procedure inpatient and subsequent observation care visits remaining in the values for these codes and adjust physician times accordingly. It is also our policy for codes with site-of-service anomalies to consistently include the value of half of a discharge day management service. While the AMA RUC recommended maintaining the current work RVUs, utilizing our methodology, we proposed an alternative work RVU of 11.92 with refinements to the time for CPT code 49652, 14.92 with refinements to the time for CPT code 49653, 13.76 with refinements to the time for CPT code 49654, and 16.84 with refinements to the time for CPT code 49655.
For CY 2012, we received no public comments on the CY 2011 interim final work RVUs for CPT codes 49324, 49327, 49412, 49418, 49419, 49421, and 49422. We believe these values continue to be appropriate and are finalizing them without modification (Table 15).
As detailed in the Fourth Five-Year Review, for CPT code 51710 (Change of cystostomy tube; complicated), we agreed with the AMA RUC-recommended work RVU, and proposed a work RVU of 1.35 for CY 2012. The AMA RUC noted that a request was sent to CMS to have the global service period changed from a 10-day global period (010) to a 0-day global period (000), which only includes RVUs for the same day pre- and post-operative period. The AMA RUC indicated that in the standards of care for this procedure, there is no hospital time and there are no follow up visits. The AMA RUC also noted that while the service was surveyed as a 10-day global, the respondents inadvertently included a hospital visit, CPT code 99231 (Subsequent hospital care), and removed the RVUs for that visit.
Consequently, the AMA RUC did not use the survey results to value the code. Rather, comparing the physician work within the family of services, the AMA RUC compared CPT code 51710 to CPT code 51705 (Change of cystostomy tube; simple) and recommended a work RVU of 1.35 for CPT code 51710.
We agreed to change the global period from a 10-day global to 0-day global. However, we noted that while we believed that changing a cystostomy tube in a complicated patient may be more time consuming than in a patient that requires a simple cystostomy tube change, we believed that the prepositioning time is unnecessarily high given the recommended pre-positioning time of 5 minutes for CPT
CPT codes 52281 (Cystourethroscopy, with calibration and/or dilation of urethral stricture or stenosis, with or without meatotomy, with or without injection procedure for cystography, male or female) and 52332 (Cystourethroscopy, with insertion of indwelling ureteral stent (
As detailed in the CY 2011 final rule with comment period (75 FR 73339), for CPT code 52281, we assigned an interim final work RVU of 2.60. The AMA RUC reviewed the survey results and determined that the physician time of 16 minutes pre-, 20 minutes intra-, and 10 minutes immediate post-service time and maintaining the current work RVUs of 2.80 appropriately accounted for the time and work required to furnish this procedure. We disagreed with the AMA RUC recommendation to maintain the current RVUs for this code because the physician time to furnish this service (a building block of the code) has changed since the original “Harvard values” were established, as indicated by the AMA RUC-recommended reduction in pre-service time. Accounting for the reduction in pre-service time, we calculated work RVUs that were close to the survey 25th percentile.
As detailed in the CY 2011 final rule with comment period (75 FR 73339), for CPT code 52332, we assigned an interim final work RVU of 2.60. We disagreed with the AMA RUC's CY 2011 work RVU recommendation to maintain the current value due significant reduction in pre-service time. Based on the same building block rationale we applied to CPT code 52281, the other code within this family, we believed 2.60, which is the survey 25th percentile and maintains rank order, was a more appropriate valuation for 52332.
Commenters also acknowledged that CPT code 52332 had significant reductions to the pre-service times. However, commenters stated that the work for this service had not changed. Commenters asserted that because this service was valued using magnitude estimation based on comparison reference codes, which considers the total work of the service rather than the work of the component parts of the service, it is not appropriate to remove RVUs based on time (a building block of the code). For CPT code, commenters requested that CMS accept the AMA RUC-recommended work RVU of 2.83.
In the Fourth Five-Year Review, we identified CPT codes 51705, 52005 and 52310 as potentially misvalued through the Harvard-Valued—Utilization > 30,000 screen. CPT codes 51710, 52007 and 52315 were added as part of the family of services for AMA RUC review. In addition, we identified CPT codes 52630, 52649, 53440 and 57288 as potentially misvalued through the site-of-service anomaly screen. The specialty agreed to add CPT codes 52640 and 57287 as part of the family of services for AMA RUC review.
As detailed in the Fourth Five-Year Review of Work (76 FR 32452), for CPT code 52630 (Transurethral resection; residual or regrowth of obstructive prostate tissue including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, and internalurethrotomy are included)), we proposed a work RVU of 6.55 for CY 2012. Medicare PFS claims data indicated that CPT code 52630 is typically furnished in an outpatient setting. However, the current AMA RUC-recommended values for this code reflected work that is typically associated with an inpatient service. Therefore, in accordance with our methodology to address 23-hour stay and site-of-service anomalies described
As detailed in the Fourth Five-Year Review of Work (76 FR 32453), for CPT code 52649 (Laser enucleation of the prostate with morcellation, including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, internal urethrotomy and transurethral resection of prostate are included if performed)), we proposed a work RVU of 14.56 for CY 2012. Medicare PFS claims data indicated that CPT code 52649 is typically furnished in an outpatient setting. However, the current AMA RUC-recommended values for this code reflected work that is typically associated with an inpatient service. Therefore, in accordance with our methodology to address 23-hour stay and site-of-service anomalies described in section III.A. of this final rule with comment period, CPT code 52649, we reduced the discharge day management service to one-half and adjusted the physician times accordingly. The AMA RUC recommended a work RVU of 15.20 for CPT code 52649.
As detailed in the Fourth Five-Year Review of Work (76 FR 32453), for CPT code 53440 (Sling operation for correction of male urinary incontinence (
For CY 2009, CPT code 53445 (Insertion of inflatable urethral/bladder neck sphincter, including placement of pump, reservoir, and cuff) was identified as potentially misvalued through the site-of-service anomaly screen. As detailed in the CY 2012 PFS proposed rule (76 FR 42799), we proposed a work RVU of 13.00 for CY 2012. Medicare PFS claims data indicated that CPT code 53445 is typically furnished in a hospital setting as an outpatient service. Upon clinical review of this service and the time and visits associated with it, we believe that the survey 25th percentile work RVU of 13.00 appropriately accounts for the work required to furnish this service (76 F42800).
For CY 2012, we received no public comments on the CY 2011 interim final work RVUs for CPT codes 50250, 50542, 51736, 51741, 53860, 55866, and 55876. Also, for CY 2012, we received no public comments on the CY 2012 proposed work RVUs for CPT codes 52341, 52342, 52343, 52344, 52345, 52346, 52400, 52500, 54410, and 54530. Finally, for CY 2012, we received no public comments on the Fourth Five-Year Review proposed work RVUs for CPT codes 51705, 52005, 52007, 52310, 52315, and 52640. We believe these values continue to be appropriate and are finalizing them without modification (Table 15).
We discussed CPT code 57155 (Insertion of uterine tandems and/or vaginal ovoids for clinical brachytherapy) in the CY 2011 PFS final rule with comment period (75 FR 73330). For CY 2011, the AMA RUC reviewed survey responses, concluded that the survey median work RVU appropriately accounts for the physician work required to furnish this service, and recommended a work RVU of 5.40 for CPT code 57155. We disagreed with the AMA RUC-recommended value for this service because the description of the AMA RUC's methodology was unclear to us. We believed the work RVU of 3.37 was more appropriate for this service, which is the same as the value assigned to CPT code 58823 (Drainage of pelvic abscess, transvaginal or transrectal approach, percutaneous (
We discussed CPT code 57156 (Insertion of a vaginal radiation afterloading apparatus for clinical brachytherapy) in the CY 2011 PFS final rule with comment period (75 FR 73330). For CY 2011, the AMA RUC reviewed survey responses, concluded that the survey 25th work RVU appropriately accounts for the physician work required to furnish this service, and recommended a work RVU of 2.69. We disagreed with the AMA RUC's valuation of the work associated with this service and determined it was more appropriate to crosswalk CPT code 57156 to CPT code 62319 (Injection, including catheter placement, continuous infusion or intermittent bolus, not including neurolytic substances, with or without contrast (for either localization or epidurography), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), epidural or subarachnoid; lumbar, sacral (caudal)) (work RVUs = 1.87), which has the same intra-service time (30 minutes) and overall lower total time than the comparison services referenced by the AMA RUC. We assigned an alternative value of 1.87 work RVUs to CPT code 57156 on an interim final basis for CY 2011.
Additionally, we note there were two other codes in the Female Genital System: Vagina family for which we agreed with the AMA RUC recommendations. We received no public comments on CPT codes 57287 (Revise/remove sling repair) and 57288 (Repair bladder defect). For CY 2012, we received no public comments on the Fourth Five-Year Review of Work proposed work RVUs for CPT codes 57287 and 57288. We believe these values continue to be appropriate and are finalizing them without modification (Table 15).
CPT codes 54900-59622 were identified as potentially misvalued codes “High IWPUT” screen. The specialty societies surveyed their members, and the AMA RUC issued recommendations to us for the CY 2011 PFS final rule with comment period.
As stated in the CY 2011 PFS final rule with comment period (75 FR 73338), for CY 2011 the AMA RUC reviewed 17 existing obstetrical care codes as part of the potentially misvalued code initiative. The AMA RUC recommended significant increases in the work RVUs for some of the comprehensive obstetrical care codes, largely to address the management of labor. While we generally agreed with the resulting AMA RUC-recommended rank order of services in this family, we believed that the aggregate increase in work RVUs for the obstetrical services that would result from the adoption of the CMS-adjusted pre-budget neutrality work RVUs was not indicative of a true increase in physician work for the services. Therefore, we believed that it would be appropriate to apply work budget neutrality to this set of CPT codes. After reviewing the AMA RUC-recommended work RVUs, we adjusted the work RVUs for several codes, then applied work budget neutrality to the set of clinically related CPT codes. The work budget neutrality factor for the 17 obstetrical care CPT codes was 0.8922. The AMA RUC-recommended work RVU, CMS-adjusted work RVU prior to the budget neutrality adjustment, and the CY 2011 interim final work RVU for obstetrical care codes (CPT codes 59400-59410, 59510-59515, and 59610-59622) follow.
As mentioned previously, and detailed in the CY 2011 PFS final rule with comment period, we disagreed with the AMA RUC-recommended work RVUs for a subset of the obstetrical care CPT codes, and assigned alternate RVUs prior to the application of work budget neutrality (75 FR 73340). For obstetrical care services that include postpartum care with delivery, the AMA RUC included one CPT code 99214 visit (Level 4 established patient office or other outpatient visit). We believed that one CPT code 99213 visit (Level 3 established patient office or other outpatient visit) more accurately reflected the services furnished at this postpartum care visit. Therefore, for the obstetrical care services that include postpartum care following delivery, we converted the CPT code 99214 visit to a 99213 visit and revised the work RVUs accordingly. This includes the following CPT codes: 59400 (Routine obstetric care including antepartum care, vaginal delivery (with or without episiotomy, and/or forceps) and postpartum care), 59410 (Vaginal delivery only (with or without episiotomy and/or forceps); including postpartum care), 59510 (Routine obstetric care including antepartum care, cesarean delivery, and postpartum care), 59515 (Cesarean delivery only; including postpartum care), 59610 (Routine obstetric care including antepartum care, vaginal delivery (with or without episiotomy, and/or forceps) and postpartum care, after previous cesarean delivery), 59614 (Vaginal delivery only, after previous cesarean delivery (with or without episiotomy and/or forceps); including postpartum care), 59618 (Routine obstetric care including antepartum care, cesarean delivery, and postpartum care, following attempted vaginal delivery after previous cesarean delivery), and 59622 (Cesarean delivery only, following attempted vaginal delivery after previous cesarean delivery; including postpartum care).
Additionally, commenters disagreed with the CMS decision to change the post-partum visit building block from a CPT code 99214 office visit to a CPT code 99213 office visit. Commenters noted that the post-partum visit includes not only a post-procedure physical exam, but also counseling and screening. They reiterated that they believe the CPT code 99214 office visit best reflects the amount of services provided by the physician at this visit. Therefore, commenters requested that CMS accept the AMA RUC-recommended values for all of the obstetrical care services.
In the Fourth Five-Year Review, we identified CPT codes 60220, 60240, and 60500 as potentially misvalued through the sites-of-service anomaly screen. The related specialty societies surveyed these codes and the AMA RUC issued recommendations to CMS for the Fourth Five-Year Review of Work.
As detailed in the Fourth Five-Year Review of Work (76 FR 32453), for CPT code 60220 (Total thyroid lobectomy, unilateral; with or without isthmusectomy), we proposed a work RVU of 11.19 for CY 2012. Medicare PFS claims data indicated that CPT code 60220 is typically furnished as an outpatient rather than inpatient service. However, the AMA RUC recommended that this service be valued as a service furnished predominately in the facility setting. The AMA RUC indicated that since the typical patient is kept overnight, the AMA RUC believes that one inpatient hospital visit as well as one discharge day management service should be maintained in the post operative visits for this service. Using magnitude estimation, the AMA RUC recommended the current work RVU of 12.37 for CPT code 60220. In accordance with our methodology to address 23-hour stay and site-of-service anomalies described in III.A. of this final rule with comment period, for CPT code 60220, we removed the hospital visit, reduced the discharge day management service by one-half, and adjusted times.
As detailed in the Fourth Five-Year Review of Work (76 FR 32454), for CPT code 60240 (Thyroidectomy, total or complete), we proposed a work RVU of 15.04 for CY 2012. Medicare PFS claims data indicated that CPT code 60240 is typically furnished as an outpatient rather than inpatient service. Using magnitude estimation, the AMA RUC believed the current work RVU of 16.22 for CPT code 60240 was appropriate. However, in accordance with our methodology to address 23-hour stay and site-of-service anomalies described in section III.A. of this final rule with comment period, for CPT code 60240, we removed the post-procedure inpatient visit and reduced the discharge day management service to one-half. The AMA RUC recommended maintaining the current work RVU of 16.22 for CPT code 60240.
As detailed in the Fourth Five-Year Review of Work (76 FR 32454), for CPT code 60500 (Parathyroidectomy or exploration of parathyroid(s)), we proposed a work RVU of 15.60 for CY 2012. Medicare PFS claims data indicated that CPT code 60500 is typically furnished as an outpatient rather than inpatient service. Using magnitude estimation, the AMA RUC believed the current work RVU of 16.78 for CPT code 60500 was appropriate. Therefore, in accordance with our methodology to address 23-hour stay and site-of-service anomalies described in section III.A. of this final rule with comment period, for CPT code 60500, we removed the hospital visit, reduced the discharge day management service by one-half, and adjusted times. The AMA RUC recommended maintaining the current work RVU of 16.78 for CPT code 60500.
We discussed CPT code 61885 (Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to a single electrode array) in the CY 2011 final rule with comment period (75 FR 73332) where we noted that this code was identified as a site-of-service anomaly code in September 2007. After reviewing the vagal nerve stimulator family of services, the specialty societies agreed that the family lacked clarity and the CPT Editorial Panel created three new codes to accurately describe revision of a vagal nerve stimulator lead, the placement of the pulse generator and replacement or revision of the vagus nerve electrode. For CY 2011, the AMA RUC recommended a work RVU of 6.44 for CPT code 61885. Although the AMA RUC compared this service to the key reference service, CPT code 63685 (Insertion or replacement of spinal neurostimulator pulse generator or receiver, direct or inductive coupling) (work RVUs = 6.05) and other relative services and noted the similarities in times, the AMA RUC elected not to recommend this value of 6.05 for CPT code 61885. We believed the AMA RUC-recommended work RVUs did not adequately account for the elimination of two inpatient visits and the reduction in outpatient visits for this service. We disagreed with the AMA RUC recommended value and believed 6.05 work RVUs, the survey 25th percentile, was appropriate for this service. Therefore, we assigned an alternative value of 6.05 work RVUs to CPT code 61885 on an interim final basis for CY 2011.
In the Fourth Five-Year Review (76 FR 32455), CMS identified CPT code 64405 as potentially misvalued through the Harvard-Valued—Utilization > 30,000 screen. As detailed in the Fourth Five-Year Review of Work, for CPT code 64405 ((Injection, anesthetic agent; greater occipital nerve), we proposed a work RVU of 0.94 for CY 2012. The AMA RUC reviewed the survey results and recommended the median survey work RVU of 1.00 for CPT code 64405. We disagreed with the AMA RUC-recommended work RVU for CPT code 64405. Upon clinical review and a consideration of physician time and intensity, we believed this code is comparable to the key reference CPT code 20526 (Injection, therapeutic (
For CPT code 64568 (Incision for implantation of cranial nerve (
In the CY 2011 PFS final rule with comment period (75 FR 73332), for CPT codes 64569 (Revision or replacement of cranial nerve (
For CY 2012, we received no public comments on the CY 2011 interim final work RVUs for CPT codes 61781, 61782, 61783, 64415, 64445, 64447, 64479, 64480, 64484, 64566, 64581, 64611, 64708, 64712, 64713, and 64714. We believe these values continue to be appropriate and are finalizing them without modification (Table 15).
Finally, we received no public comments on the CY 2012 proposed work RVUs for CPT codes 64831 and 64708. We believe these values continue to be appropriate and are finalizing them without modification (Table 15).
As we discussed in the CY 2012 PFS proposed rule (76 FR 42800), CPT code 62263 (Percutaneous lysis of epidural adhesions using solution injection (
Upon re-review for CY 2012, the AMA RUC reaffirmed its previous recommendation and recommended that the current work RVU of 6.54 for CPT code 62263 be maintained. In the CY 2012 PFS proposed rule (76 FR 42800), we indicated that we continue to disagreed with the AMA RUC recommended work RVU for this service because we believe the appropriate methodology for valuing site-of-service anomaly codes entails not just removing the inpatient visits, but also accounting for the removal of the inpatient visits in the work value of the CPT code. We noted also that the AMA RUC disregarded survey results that indicated the respondents believed this service should be valued lower. In fact, the median survey work RVU was 5.00. After CMS clinical review of this service where we considered this code in comparison to other codes in the PFS and accounted for the change in the site-of-service, we believed that the survey median work RVU of 5.00 appropriately accounted for the removal of the inpatient visits. Therefore, we proposed a work RVU of 5.00 for CPT code 62263 for CY 2012.
As we discussed in the CY 2012 PFS proposed rule (76 FR 42800), CPT code 62355 (Removal of previously implanted intrathecal or epidural catheter) was identified as potentially misvalued through the site-of-service anomaly screen for CY 2009. The AMA RUC reviewed this service and recommended a work RVU of 4.30, approximately midway between the survey median and 75th percentile. The AMA RUC also recommended removing the inpatient building blocks to reflect the outpatient site-of-service, removing all but 1 of the post-procedure office visits to reflect the shift in global period from 90 days to 10 days, and reducing the physician time associated with this service. While we accepted the AMA RUC-recommended work RVU for this
Upon re-review for CY 2012, the AMA RUC reaffirmed its previous recommendation and ultimately recommended that the current work RVU of 4.35 for CPT code 62355 be maintained. We disagreed with the AMA RUC-recommended work RVU for CPT code 62355. As stated previously, we believed the appropriate methodology for valuing site-of-service anomaly codes entails not just removing the inpatient visits, but also accounting for the removal of the inpatient visits in the work value of the CPT code. We did not believe that the reduction from the CY 2008 work RVU of 6.60 to the CY 2009 work RVU of 4.30 adequately accounted for the removal of 3 subsequent hospital care visits and half a discharge management day, which together represent a work RVU of 5.40. Also, the time required to furnish this service dropped significantly, even after considering the global period change. Upon clinical review, we believed that the survey median work RVU of 3.55 appropriately accounted for the removal of the inpatient visits and decreased time for this service. Therefore, proposed a work RVU of 3.55 for CPT code 62355 for CY 2012.
As we discussed in the CY 2012 PFS proposed rule (76 FR 42800), CPT code 62361 (Implantation or replacement of device for intrathecal or epidural drug infusion; nonprogrammable pump) was identified for CY 2009 as potentially misvalued through the site-of-service anomaly screen. The AMA RUC reviewed this code and recommended a work RVU of 5.60, approximately midway between the survey median and 75th percentile. The AMA RUC also recommended removing the inpatient visits to reflect the outpatient site-of-service, removing all but 1 of the post procedure office visits to reflect the shift in global period from 90 days to 10 days, and reducing the physician time associated with this service. While we accepted the AMA RUC's recommended work RVU for this code on an interim basis for CYs 2009 and 2010 (with a slight adjustment to 5.65 work RVUs in CY 2010 due to the consultation code policy (74 FR 61775)), we referred the code back to the AMA RUC to be reexamined because we did not believe the AMA RUC recommended work RVU fully accounted for the reduction in inpatient building blocks to reflect the shift to the outpatient setting.
Upon re-review for CY 2012, the AMA RUC reaffirmed its previous recommendation and ultimately recommended that the work RVU of 5.65 for CPT code 62361 be maintained. We disagreed with the AMA RUC-recommended work RVU for CPT code 62361. As stated previously, we believe the appropriate methodology for valuing site-of-service anomaly codes entails not just removing the inpatient visits, but also accounting for the removal of the inpatient visits in the work value of the CPT code. We did not believe that the reduction from the CY 2008 work RVU of 6.59 to the CY 2009 work RVU of 5.60 adequately accounted for the removal of 3 subsequent hospital care visits and half a discharge management day, which together represent a work RVU of 5.40. Also, the time required to furnish this service dropped significantly, even after considering the global period change. Upon clinical review, we believed that the survey 25th percentile work RVU of 5.00 appropriately accounted for the removal of the inpatient visits and decreased time for this service. Therefore, we proposed a work RVU of 5.00 for CPT code 62361 for CY 2012.
As we discussed in the CY 2012 PFS proposed rule (76 FR 42800), CPT code 62362 (Implantation or replacement of device for intrathecal or epidural drug
As we discussed in the CY 2012 PFS proposed rule (76 FR 42801), CPT code 62365 (Removal of subcutaneous reservoir or pump, previously implanted for intrathecal or epidural infusion) was identified for CY 2009 as potentially misvalued through the site-of-service anomaly screen. The AMA RUC reviewed this service and recommended a work RVU of 4.60, the survey median. Additionally, the AMA RUC recommended removing the inpatient visits to reflect the outpatient site-of-service, removing all but 1 of the post-procedure office visits to reflect the shift in global period from 90 days to 10 days, and reducing the physician time associated with this service. While we accepted the AMA RUC's recommended work RVU for this code on an interim basis for CYs 2009 and 2010 (with a slight adjustment to 4.65 work RVUs in CY 2010 due to the consultation code policy (74 FR 61775)), we referred the code back to the AMA RUC to be reexamined because we did not believe the AMA RUC-recommended work RVU fully accounted for the reduction in inpatient building blocks to reflect the shift to the outpatient setting.
Upon re-review for CY 2012, the AMA RUC reaffirmed its previous recommendation and ultimately recommended that the current work RVU of 4.65 for CPT code 62365 be maintained. We disagreed with the AMA RUC recommended work RVU for CPT code 62365. As stated previously, we believed the appropriate methodology for valuing site-of-service anomaly codes entails not just removing the inpatient visits, but also accounting for the removal of the inpatient visits in the work value of the CPT code. We did not believe that the reduction from the CY 2008 work RVU of 6.57 to the CY 2009 work RVU of 4.60 adequately accounted for the removal of 3 subsequent hospital care visits and half a discharge management day, which together represent a work RVU of 5.40. Also, the time required to furnish this service dropped significantly, even after considering the global period change. We believed that this service is similar in terms of time intensity to that of CPT code 33241 (Subcutaneous removal of single or dual chamber pacing cardioverter-defibrillator pulse generator) which has a work RVU of 3.29 but does not include a half day of discharge management service. Upon clinical review, we believed that a work RVU of 3.93, that is a work RVU of 3.29 plus a work RVU of 0.64 to account for the half day of discharge management service, appropriately accounted for the removal of the inpatient visits and decreased time for this service. Therefore, we proposed a work RVU of 3.93 for CPT code 62365 for CY 2012.
As we discussed in the CY 2012 PFS proposed rule (76 FR 42802), CPT code 63650 (Percutaneous implantation of neurostimulator electrode array, epidural) or mechanical means (such as, catheter) including radiologic localization (includes contrast when administered), multiple adhesiolysis sessions; 2 or more days, was identified for CY 2009 as potentially misvalued through the site-of-service anomaly screen. The AMA RUC reviewed this service and recommended the survey median work RVU of 7.15 as well as removing the inpatient subsequent hospital care visits to reflect the current outpatient place of service. While we accepted the AMA RUC's recommended work RVU for this code on an interim basis for CYs 2009 and 2010 (with a slight adjustment to 7.20 work RVUs in CY 2010 due to the consultation code policy (74 FR 61775)), we referred the code back to the AMA RUC to be reexamined because we did not believe the AMA RUC-recommended work RVU fully accounted for the reduction in inpatient building blocks to reflect the shift to the outpatient setting.
Upon re-review for CY 2012, the AMA RUC reaffirmed its previous recommendation and ultimately recommended that the current work RVU of 7.20 for CPT code 63650 be maintained. We disagreed with the AMA RUC-recommended work RVU of 7.20 for CPT code 63650. As stated previously, we believed the appropriate methodology for valuing site-of-service anomaly codes entails not just removing the inpatient visits, but also accounting for the removal of the inpatient visits in the work value of the CPT code. Upon clinical review, we believed that the survey median work RVU of 7.15 appropriately accounted for the removal of the inpatient visits, as well as the physician time and post-operative office visit changes. Therefore, we proposed a work RVU of 7.15 for CPT code 63650 for CY 2012.
As discussed in the Fourth Five-Year Review of Work (76 FR 32454), CMS identified CPT code 63655 (Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural) as potentially misvalued through the Site-of-Service Anomaly screen. The AMA RUC recommended maintaining the current work RVU of 11.56, as well as the current physician time components. We disagreed with the AMA RUC-recommended work RVU for CPT code 63655. We noted that according to the survey data provided by the AMA RUC, of the 90 percent of respondents that stated they furnish the procedure “in the hospital,” 18 percent stated that the patient is “discharged the same day” and 55 percent stated that the patient was “kept overnight (less than 24 hours).” Given that the most recently available Medicare PFS claims data continue to show the typical case is not an inpatient, and that the survey data for this code suggested the typical case is a 23-hour stay service, we believed it was appropriate to apply our established policy and reduce the discharge day management service to one-half. Accordingly, we proposed an alternative work RVU of 10.92 with refinements in time for CPT code 63655 for CY 2012.
As we discussed in the CY 2012 PFS proposed rule (76 FR 42802), CPT code 63685 (Insertion or replacement of spinal neurostimulator pulse generator or receiver, direct or inductive coupling) was identified for CY 2009 as potentially misvalued through the site-of-service anomaly screen. The AMA RUC reviewed this service and recommended the survey median work RVU of 6.00. The AMA RUC also recommended removing the inpatient subsequent hospital care visits to reflect the current outpatient place of service. While we accepted the AMA RUC's recommended work RVU for this code on an interim basis for CYs 2009 and 2010 (with a slight adjustment to the work RVUs in CY 2010 due to the consultation code policy (74 FR 61775)), we referred the code back to the AMA RUC to be reexamined because we did not believe the AMA RUC-recommended work RVU fully accounted for the reduction in inpatient building blocks to reflect the shift to the outpatient setting.
Upon re-review for CY 2012, the AMA RUC affirmed its previous recommendation and ultimately recommended that the current work RVU for CPT code 63685 be maintained. We disagreed with the AMA RUC-recommended work RVU of 6.05 for CPT code 63685. As stated previously, we believed the appropriate methodology for valuing site-of-service anomaly codes entails not just removing the inpatient visits, but also accounting for the removal of the inpatient visits in the work value of the CPT code. Upon clinical review, we believed that the survey 25th percentile work RVU of 5.19 appropriately accounted for the removal of the inpatient visits, as well as the physician time and post-operative office visit changes. Therefore, we proposed a work RVU of 5.19 for CPT code 63685 for CY 2012.
We received no public comments on the CY 2011 final rule with comment period interim work RVUs for CPT codes 63075 and 63076. We received no public comments on the Fourth Five-Year Review of Work proposed work RVUs for CPT code 62284. Finally, we also received no public comments on the CY 2012 PFS proposed rule proposed work RVUs for CPT codes 62360 and 62350. We believe these values continue to be appropriate and are finalizing them without modification (Table 15).
As detailed in the CY 2012 PFS proposed rule (76 FR 42802), we identified CPT code 65285 (Repair of laceration; cornea and/orsclera, perforating, with reposition or resection of uveal tissue) as a potentially misvalued code through the site-of-service anomaly screen in 2009. The AMA RUC recommended removing the CPT code from the site-of-service anomaly list and maintaining the CY 2008 work RVUs (14.43), physician times, and visits. In the CY 2010 PFS final rule with comment period, while we adopted the AMA RUC-recommended work value on an interim final basis and referred the service back to the AMA RUC to be reexamined, the work RVU for CPT code 65285 used under the PFS was increased to 14.71 based on the redistribution of RVUs that resulted from the our policy to no longer recognize the CPT consultation codes (74 FR 61775).
In the CY 2012 PFS proposed rule (76 FR 42802), we proposed to apply the 23-hour stay methodology described in section III.A. of this final rule with comment period. That is, we reduced the one day of discharge management service to one-half day, and adjusted physician work RVUs and times accordingly. As a result, we proposed a work RVU of 15.36 with refinements to
For CY 2012, we receive no public comments on the CY 2011 interim final work RVUs for CPT codes 65778 through 65780, 66174, 66175, and 66761. We believe these values continue to be appropriate and are finalizing them without modification (Table 15).
CPT code 67028 (Intravitreal injection of a pharmacologic agent (separate procedure) was identified for review by the Five-Year Identification Workgroup through the High Volume CMS Fastest Growing Screen. For CY 2011, the AMA RUC reviewed the survey results, compared the code to other services, and concluded that CPT code 67028 was similar in both physician time and intensity to another eye injection code, CPT code 67500 (retrobulbar injection: Medication). Accordingly, the AMA RUC recommended accepting the specialty society recommended time and directly crosswalking the work RVUs of CPT code 67500 of 1.44 to CPT code 67028. Upon clinical review, we agreed that these two services are similar and therefore assigned a CY 2011 interim final work RVU of 1.44 to CPT code 67028 (75 FR 73732).
As we discussed in the CY 2011 final rule with comment period (75 FR 73340), CPT Code 71250 (Computed tomography, thorax; without contrast material) was identified as a potentially misvalued code by the Five-Year Review Identification Workgroup under the “CMS Fastest Growing” potentially misvalued codes screen. While the AMA RUC recommended the survey results for physician times, the AMA RUC believed maintaining the code's current value of 1.16 work RVUs was more appropriate, noting that this recommended value is slightly lower than the survey 25th percentile of 1.20. We disagreed with the AMA RUC's CY 2011 work RVU recommendation to maintain the current value for CPT code 71250 and similar codes. As we noted in the CY 2011 final rule with comment period (75 FR 73340), we were increasingly concerned over the validity of accepting work valuations based upon surveys conducted on existing codes as we have noticed a pattern of predictable survey results. Increasingly, rather than recommending the median survey value that has historically been most commonly used, the AMA RUC has been choosing to recommend the 25th percentile value, potentially responding to the same concern we have identified. Therefore, based on our concern that CT codes would continue to be misvalued if we were to accept the AMA RUC recommendation to maintain the current value, we assigned an alternative value of 1.00 work RVUs (the survey low value) to CPT code 71250 on an interim final basis for CY 2011.
Also in the CY 2011 final rule with comment period (75 FR 73341), we noted CPT codes 72125 (Computed tomography, cervical spine; without contrast material), 72128 (Computed tomography, thoracic spine; without contrast material), and 72131 (Computed tomography, lumbar spine; without contrast material) were also identified as potentially misvalued codes by the Five-Year Review Workgroup under the “CMS Fastest Growing” screen for potentially misvalued codes. For CPT code 72125, the AMA RUC concurred with the specialty-recommended times but concluded that it was appropriate to maintain the current work RVUs of 1.16. Similarly, for CPT codes 72128 and 72131, the AMA RUC accepted the survey physician times, but also disregarded the median survey work RVU results in favor of recommending
As discussed in the CY 2011 final rule with comment period (75 FR 73341), CPT codes 73200 (Computed tomography, upper extremity; without contrast material) and 73700 (Computed tomography, lower extremity; without contrast material) were identified as potentially misvalued codes by the Five-Year Review Workgroup under the “CMS Fastest Growing” screen for potentially misvalued codes. Our clinical review of CPT codes 73200 and 73700, as with the other CT codes previously discussed, concluded that maintaining the current values would result in an overvaluing of this type of service. Similar to the other CT codes previously discussed, the AMA RUC reviewed the survey results and accepted the survey physician times but recommended maintaining the current work RVUs of 1.09 for both of these services. We remain concerned over the validity of the survey results. Therefore, based on our concern that CT codes would continue to be misvalued if we were to accept the AMA RUC recommendation to maintain the current values, we assigned alternative work RVUs of 1.00 (the survey low RVU value) to CPT codes 73200 and 73700 on an interim final basis for CY 2011.
Furthermore, for CY 2012, we received no public comments on the CY 2011 interim final work RVUs for CPT codes 73080, 73510, 73610, and 73630. We believe these values continue to be appropriate and are finalizing them without modification (Table 15).
As discussed in the CY 2011 final rule with comment period (75 FR 73332), in October 2008, CPT code 76880 (Ultrasound, extremity, nonvascular, real time with image documentation) was identified by the Five-Year Review Identification Workgroup through its “CMS Fastest Growing” screen for potentially misvalued codes. In February 2009, the CPT Editorial Panel deleted CPT code 76880 and created two new codes, CPT codes 76881 (Ultrasound, extremity, nonvascular, real-time with image documentation; complete) and 76882 (Ultrasound, extremity, nonvascular, real-time with image documentation; limited anatomic specific) to distinguish between the comprehensive diagnostic ultrasound and the focused anatomic-specific ultrasound. For CPT code 76881, the AMA RUC recommended work RVUs of 0.72. For CPT code 76882, the AMA RUC recommended 0.50 work RVUs. We noted the predecessor CPT code 76880 (Ultrasound, extremity, nonvascular, real time with image documentation) described a nonvascular ultrasound of the entire extremity and was assigned work RVUs of 0.59. In contrast, the new CPT codes describe a complete service, CPT code 76881, and a limited service, CPT code 76882 (defined as examination of a specific anatomic structure, such as a tendon or muscle). As such, for CPT code 76881, we did not believe an increase in work RVUs was justified given that this service will be reported for the evaluation of the extremity, as was CPT code 76800 which is being deleted for CY 2011. Therefore, we assigned a CY 2011 interim work RVU of 0.59 for this service, which is consistent with the value of the predecessor code. For CPT code 76882, we assigned a CY 2011 interim work RVU of 0.41 to maintain appropriate relativity with CPT code 76800.
Furthermore, for CY 2012, we received no public comments on the CY 2011 interim final work RVUs for CPT code 74962. We believe these values continue to be appropriate and are finalizing them without modification (Table 15).
CPT code 77427 (Radiation treatment management, 5 treatments) was identified as a potentially misvalued code by the Five-Year Identification Workgroup's “Site-of-Service Anomalies” screen for potentially misvalued codes in 2007.
As detailed in the CY 2011 PFS final rule with comment period (75 FR73341), we assigned a work RVU of 3.37 for CPT code 77427 on an interim final basis for CY 2011. We agreed with the AMA RUC's use of the building block approach to value the treatment visits associated with CPT code 77427. The AMA RUC averaged the number of weekly E/M visits, that is, 4 of CPT code 99214 (Level 4 established patient office or other outpatient visit) and 2 of CPT code 99213 (Level 3 established patient office or other outpatient visit) over 6 weeks to calculate an E/M building block of 1.32 RVUs. Similarly, to value the post-operative office visits associated with this code, the AMA RUC calculated a building block of 0.57 to account for the average over 6 weeks of “E/M visits after treatment planning.” The AMA RUC then crosswalked the physician times for CPT code 77427 to CPT code 77315 (Teletherapy, isodose plan (whether hand or computer calculated); complex (mantle or inverted Y, tangential ports, the use of wedges, compensators, complex blocking, rotational beam, or special beam considerations)) and used the value of CPT code 77315 as the remaining building block for CPT code 77427.
Upon clinical review, we modified one of the building blocks that the AMA RUC used to calculate the work RVUs associated with the treatment E/M office visits. We believed instead of the average based upon 4 units of CPT code 99214 and 2 units of CPT code 99213, a more appropriate estimation was an average of 3 units of CPT code 99214 and 3 units of CPT code 99213. Accordingly, we assigned a work RVU of 3.37 on an interim final basis for CY 2011 for CPT code 77427 (75 FR73341, corrected in 76 FR 1670). The AMA RUC recommended a work RVU of 3.45 for CPT code 77427 based on the use of 4 units of CPT code 99214 and 2 units of CPT code 99213 (75 FR 73341).
In the Fourth Five-Year Review (76 FR 32455), we identified CPT code 78264 as potentially misvalued through the Harvard-Valued—Utilization > 30,000 screen.
As detailed in the Fourth Five-Year Review, for CPT code 78264 (Gastric emptying study), we proposed a work RVU of 0.80 for CPT code 78264 for CY 2012. We believed the 25th percentile survey value was appropriate based on its similarity in physician work to other diagnostic tests. The AMA RUC reviewed the survey results and recommended the survey median work RVU of 0.95 for CPT code 78264 (76 FR 32455).
For CY 2011, the AMA's CPT Editorial Panel created two new cytopathology codes that describe in situ hybridization testing using urine samples: CPT code 88120 (Cytopathology, in situ hybridization (
In February 2010, the CPT Editorial Panel revised the descriptor for CPT code 88172 (Cytopathology, evaluation of fine needle aspirate; immediate cytohistologic study to determine adequacy of specimen(s)) and created a new code, CPT code 88177 (Cytopathology, evaluation of fine needle aspirate; immediate cytohistologic study to determine adequacy for diagnosis, each separate additional evaluation episode, same site), to report the first evaluation episode and each additional episode of cytopathology evaluation of fine needle aspirate. As detailed in the CY 2011 PFS final rule with comment period (75 FR 73333), we maintained the CY 2010
For CY 2012, we received no public comments on the CY 2011 interim final work RVUs for CPT codes 88173 and 88177. We believe these values continue to be appropriate and are finalizing them without modification (Table 15).
As detailed in the CY 2011 PFS final rule with comment period (75 FR 73333), the CPT Editorial Panel revised the reporting of immunization administration in the pediatric population in order to better align the service with the evolving best practice model of delivering combination vaccines. In addition, effective January 1, 2011, reporting and payment for these services is to be structured on a per toxoid basis rather than a per vaccine (combination of toxoids) basis as it was in prior years. We maintained the CY 2010 work RVUs for the related predecessor codes since these codes would be billed on a per toxoid basis in CY 2011. We assigned a work RVU of 0.17 for CPT code 90460 (Immunization administration through 18 years of age via any route of administration, with counseling by physician or other qualified health care profession; first vaccine/toxoid component) and a work RVU of 0.15 for CPT code 90461 (Immunization administration through 18 years of age via any route of administration, with counseling by physician or other qualified health profession; each additional vaccine/toxoid component (List separately in addition to code for primary procedure)) on an interim final basis for CY 2011. The AMA RUC recommended a work RVU of 0.20 for CPT code 90460 and 0.16 for CPT code 90461 (75 FR 73333).
For CY 2011 the CPT Editorial Panel restructured a set of CPT codes used to describe esophageal motility and high resolution esophageal pressure topography services. The specialty societies surveyed their members, and the AMA RUC issued recommendations to us for the CY 2011 PFS final rule with comment period.
As stated in the CY 2011 PFS final rule with comment period (75 FR 73338), in the esophageal motility and high resolution esophageal pressure topography set of services, for CY 2011 two CPT codes were deleted and the services are now reported under a revalued existing CPT code 91010 (Esophageal motility (manometric study of the esophagus and/or gastroesophageal junction) study with interpretation and report; 2-dimensional data) and a new add-on CPT code 91013 (Esophageal motility (manometric study of the esophagus and/or gastroesophageal junction) study with interpretation and report; with stimulation or perfusion during 2-dimensional data study (
We received no public comments on the CY 2011 final rule with comment period interim work RVUs for CPT codes 91038 and 91117. We believe these values continue to be appropriate and are finalizing them without modification (Table 15).
In February, 2010 the CPT Editorial Panel established two codes for reporting remote imaging for screening retinal disease and management of active retinal disease. As detailed in the CY 2011 PFS proposed rule (75 FR 73333), for CPT code 92228 (Remote imaging for monitoring and management of active retinal disease (
For CY 2012, we received no public comment on the CY 2011 interim final work RVUs for CPT codes 92132 through 92134 and 9222. We believe these values continue to be appropriate and are finalizing them without modification (Table 15).
Section 143 of the MIPPA specifies that speech-language pathologists may independently report services they provide to Medicare patients. Starting in July 2009, speech-language pathologists were able to bill Medicare as independent practitioners. As a result, the American Speech-Language-Hearing Association (ASHA) requested that CMS ask the AMA RUC to review the speech-language pathology codes to newly value the professionals' services in the work and not the practice expense. ASHA indicated that it would survey the 12 speech-language pathology codes over the course of the CPT 2010 and CPT 2011 cycles. Four of these services were reviewed by the HCPAC or the AMA RUC and were included in the CY 2010 PFS final rule with comment period (74 FR 61784 and 62146). For CY 2011, the HCPAC submitted work recommendations for the remaining eight codes.
As detailed in the CY 2011 PFS final rule with comment period (75 FR 7333), for CPT code 92508 (Treatment of speech, language, voice, communication, and/or auditory processing disorder; group, 2 or more individuals), we assigned a work RVU of 0.33 on an interim final basis for CY 2011. We derived the work RVU of 0.33 by dividing the value for CPT code 92507 (Treatment of speech, language, voice, communication, and/or auditory processing disorder; individual) (work RVU = 1.30) by 4 participants based on our understanding from practitioners that 4 accurately represented the typical number of participants in a group. Additionally, the work RVU of 0.33 was appropriate for this group treatment service relative to the work RVU of 0.27 for CPT code 97150 (Therapeutic procedure(s), group (2 or more individuals)), which is furnished to a similar patient population, namely patients who have had a stroke. The
As detailed in the Fourth Five-Year Review, for CPT code 92511 (Nasopharyngoscopy with endoscope (separate procedure)) we proposed a work RVU of 0.61 for CY 2012. The AMA RUC recommended a work RVU of 0.61 for this service as well. For CPT code 92511, the AMA RUC recommended the following times: pre-service evaluation time of 6 minutes; pre-service (dress, scrub, wait) of 5 minutes; an intra-service time of 5 minutes; and a post-service time of 5 minutes. We proposed a pre-service evaluation time for CPT code 92511 of 4 minutes, pre-service (dress, scrub, wait) of 5 minutes, an intra-service time of 5 minutes, and a post-service time of 3 minutes to account for the E/M service begin provided on the same day (76 FR 32455).
For CY 2012, we received no public comments on the CY 2011 interim final work RVUs for CPT Codes 92504, 92507, and 92508. We believe these values continue to be appropriate and are finalizing them without modification (Table 15).
(38) Special Otorhinolaryngologic Services: Evaluative and Therapeutic Services (CPT Codes 92605-92618)
As detailed in the CY 2011 PFS final rule with comment period (75 FR 7333), for CPT code 92606 (Therapeutic service(s) for the use of non-speech generating device, including programming and modification), we published the AMA RUC-recommended work RVU of 1.40 in Addendum B to the final rule with comment period in accordance with our usual practice for bundled services. This service is currently bundled under the PFS and we maintained the bundled status for CY 2011.
For CY 2012, we received no public comments on the CY 2011 interim final work RVUs for CPT codes 92607 through 92609. We believe these values continue to be appropriate and are finalizing them without modification (Table 15).
In the Fourth Five-Year Review, CMS identified CPT code 92950 (Cardiopulmonary resuscitation (
Sleep testing CPT codes were identified by the Five-Year Review Identification Workgroup as potentially misvalued codes through the “CMS Fastest Growing” potentially misvalued codes screen. The CPT Editorial Panel created separate Category I CPT codes to report for unattended sleep studies. The AMA RUC recommended concurrent review of the family of sleep codes.
As detailed in the CY 2011 PFS final rule with comment period (75 FR 73334), we assigned a work RVU of 1.25 for CPT codes 95806 (Sleep study, unattended, simultaneous recording of, heart rate, oxygen saturation, respiratory airflow, and respiratory effort (
For CY 2012, we received no public comments on the CY 2011 interim final work RVUs for CPT codes 95800, 95801, 95803, 95805, 95808, 95810, and 95811. We believe these values continue to be appropriate and are finalizing them without modification (Table 15).
In the Fourth Five-Year Review (76 FR 32456 through 32458), we identified CPT codes 98925, 98928 and 98929 as potentially misvalued through the Harvard-Valued—Utilization > 30,000 screen. Additionally, the American Osteopathic Association identified CPT codes 98926 and 98927 to be reviewed as part of this family since these were also identified to be reviewed by the AMA RUC Relativity Assessment Workgroup because these codes were identified through the Harvard-Valued—Utilization > 100,000 screen.
We reviewed CPT codes 98925 through 98929 and published proposed work RVUs in the Fourth Five-Year Review of Work (76 FR 32456 through 32458). Based on comments we received during the public comment period, we referred CPT codes 98925 through 98929 to the CY 2011 multi-specialty refinement panel for further review.
For CPT code 98925 (Osteopathic manipulative treatment (OMT); 1-2 body regions involved), we proposed a work RVU of 0.46 in the Fourth Five-Year Review (76 FR 32456). We also refined the time associated with CPT code 98925. Recent PFS claims data showed that this service is typically furnished on the same day as an E/M visit. While we understand that there are differences between these services, we believed some of the activities conducted during the pre- and post-service times of the osteopathic manipulative treatment code and the E/M visit overlapped and should not be counted in developing the work RVUs for this service. As described earlier in section III.A. of this final rule with comment period, we reduced the pre-service evaluation and post-service time by 1x3 to account for the overlap. We believed that 1 minute of pre-service evaluation time and 2 minutes post-service time accurately reflected the time required to conduct the work associated with this service.
As detailed in the Fourth Five-Year Review (76 FR 32456), we calculated the value of the extracted time and subtracted it from the AMA RUC-recommended work RVU of 0.50. For CPT code 98925, we removed a total of 2 minutes from the AMA RUC-recommended pre- and post-service times, which amounts to the removal of .04 of a work RVU, resulting in a work RVU of 0.46. We noted that 70 percent of the survey respondents indicated that the work of furnishing this service has not changed in the past 5 years (current RVU = 0.45). We proposed a work RVU of 0.46, with refinement in time for CPT code 98925 for CY 2012. CMS time refinements can be found in Table 16. The AMA RUC recommended a work RVU of 0.50 for CPT code 98925.
For CPT code 98926 (Osteopathic manipulative treatment (OMT); 3-4 body regions involved), we proposed a work RVU of 0.71 in the Fourth Five-Year Review (76 FR 32456). We also refined the time associated with CPT code 98926. Recent PFS claims data showed that this service is typically furnished on the same day as an E/M visit. While we understand that there are differences between these services, we believed some of the activities conducted during the pre- and post-service times of the osteopathic manipulative treatment code and the E/M visit overlapped and should not be counted in developing the work RVUs for this service. As described earlier in section III.A. of this final rule with comment period, we reduced the pre-service evaluation and post-service time by one-third to account for the overlap. We believed that 1 minute of pre-service evaluation time and 2 minutes post-service time accurately reflected the time required to conduct the work associated with this service.
As detailed in the Fourth Five-Year Review (76 FR 32456), we calculated the value of the extracted time and subtracted it from the AMA RUC-recommended work RVU of 0.75. For CPT code 98926, we removed a total of 2 minutes from the AMA RUC-recommended pre- and post-service times, which amounts to the removal of .04 of a work RVU, resulting in a work RVU of 0.71. We noted that 81 percent of the survey respondents indicated that the work of furnishing this service has not changed in the past 5 years (current RVU = 0.65). We proposed an alternative work RVU of 0.71, with refinement in time for CPT code 98926 for CY 2012. CMS time refinements can be found in Table 16. The AMA RUC recommended a work RVU of 0.75 for CPT code 98926.
For CPT code 98927 (Osteopathic manipulative treatment (OMT); 5-6 body regions involved), we proposed a work RVU of 0.96 in the Fourth Five-Year Review (76 FR 32457). We also refined the time associated with CPT code 98927. Recent PFS claims data showed that this service is typically furnished on the same day as an E/M visit. While we understand that there are differences between these services, we believed some of the activities conducted during the pre- and post-service times of the osteopathic manipulative treatment code and the E/M visit overlapped and should not be counted in developing the work RVUs
As detailed in the Fourth Five-Year Review (76 FR 32457), we calculated the value of the extracted time and subtracted it from the AMA RUC-recommended work RVU of 1.00. For CPT code 98927, we removed a total of 2 minutes from the AMA RUC-recommended pre- and post-service times, which amounts to the removal of 0.04 of a work RVU, resulting in a work RVU of 0.96. We noted that 77 percent of the survey respondents indicated that the work of furnishing this service has not changed in the past 5 years (current RVU = 0.87). We proposed a work RVU of 0.96, with refinement in time for CPT code 98927 for CY 2012. CMS time refinements can be found in Table 16. The AMA RUC recommended a work RVU of 1.00 for CPT code 98927.
For CPT code 98928 (Osteopathic manipulative treatment (OMT); 7-8 body regions involved), we proposed a work RVU of 1.21 in the Fourth Five-Year Review (76 FR 32457). We also refined the time associated with CPT code 98928. Recent PFS claims data showed that this service is typically furnished on the same day as an E/M visit. While we understand that there are differences between these services, we believed some of the activities conducted during the pre- and post-service times of the osteopathic manipulative treatment code and the E/M visit overlapped and should not be counted in developing the work RVUs for this service. As described earlier in section III.A. of this final rule with comment period, we reduced the pre-service evaluation and post-service time by one-third to account for the overlap. We believed that 1 minute of pre-service evaluation time and 2 minutes post-service time accurately reflected the time required to conduct the work associated with this service.
As detailed in the Fourth Five-Year Review (76 FR 32457), we calculated the value of the extracted time and subtracted it from the AMA RUC-recommended work RVU of 1.25. For CPT code 98928, we removed a total of 2 minutes from the AMA RUC-recommended pre- and post-service times, which amounts to the removal of 0.04 of a work RVU, resulting in a work RVU of 1.21. We noted that 67 percent of the survey respondents indicated that the work of furnishing this service has not changed in the past 5 years (current RVU = 1.03). We proposed a work RVU of 1.21, with refinement in time for CPT code 98928 for CY 2012. CMS time refinements can be found in Table 16. The AMA RUC recommended a work RVU of 1.25 for CPT code 98928.
For CPT code 98929 (Osteopathic manipulative treatment (OMT); 9-10 body regions involved), we proposed a work RVU of 1.46 in the Fourth Five-Year Review (76 FR 32457). We also refined the time associated with CPT code 98929. Recent PFS claims data showed that this service is typically furnished on the same day as an E/M visit. While we understand that there are differences between these services, we believed some of the activities conducted during the pre- and post-service times of the osteopathic manipulative treatment code and the E/M visit overlapped and should not be counted in developing the work RVUs for this service. As described earlier in section III.A. of this final rule with comment period, we reduced the pre-service evaluation and post-service time by 1x3 to account for the overlap. We believed that 1 minute of pre-service evaluation time and 2 minutes post-service time accurately reflected the time required to conduct the work associated with this service.
As detailed in the Fourth Five-Year Review (76 FR 32457), we calculated the value of the extracted time and subtracted it from the AMA RUC-recommended work RVU of 1.50. For CPT code 98929, we removed a total of 2 minutes from the AMA RUC-recommended pre- and post-service times, which amounts to the removal of .04 of a work RVU, resulting in a work RVU of 1.46. We noted that 63 percent of the survey respondents indicated that the work of furnishing this service has not changed in the past 5 years (current RVU = 1.19). We proposed a work RVU of 1.46, with refinement in time for CPT code 98928 for CY 2012. CMS time refinements can be found in Table 16. The AMA RUC recommended a work RVU of 1.50 for CPT code 98929.
Commenters also found that the survey responses indicating that the work of furnishing these services had not changed in the past 5 years were irrelevant to valuing these services because there was compelling evidence that the methodology was flawed in the original valuation of these codes. Commenters requested that CMS accept the AMA RUC-recommended work RVUs and physician time.
In the Fourth Five-Year Review (76 FR 32458), we identified CPT codes 99218 through 99220 as potentially misvalued through the Harvard-Valued—Utilization > 30,000 screen. The American College of Emergency Physicians (ACEP) submitted a public comment identifying CPT codes 99218 through 99220 to be reviewed in the Fourth Five-Year Review. ACEP also identified CPT codes 99234 through 99236 as part of the family of services for AMA RUC review. For CPT codes 99218 (Level 1 initial observation care, per day), 99219 (Level 2 initial observation care, per day), and 99220 (Level 3 initial observation care, per day), we stated that we believed there were differences in physician work in the outpatient and inpatient settings, and proposed work RVUs of 1.28 for CPT code 99218, 2.14 for CPT code 99219, and 2.99 for CPT code 99220.
We agreed with the AMA RUC that appropriate relativity must be maintained within and between the families of similar codes. However, we believed that while the work RVUs of the initial observation care codes (99218, 99219, and 99220) should be greater than those of the subsequent observation care codes (99224, 99225, and 99226), we did not believe the work RVUs of the initial observation care codes (99218, 99219, and 99220) should be equivalent (or close) to the initial hospital care codes (99221, 99222, and 99223). We noted that we believed the acuity level of the typical patient receiving outpatient observation services would generally be lower than that of the inpatient level. We believed the work RVUs of the initial observation care codes should reflect the modest differences in patient acuity between the outpatient and inpatient settings. We compared the CY 2011 work RVUs of the initial observation care codes to the CY 2011 interim final work RVUs of the subsequent observation care codes and found that the relativity existing between these codes was acceptable. We also believed that the CY 2011 work RVUs of the initial observation care codes maintained the proper rank order with the initial hospital care services. Therefore, we proposed to maintain the CY 2011 work RVUs for CPT codes 99218, 99219, and 99220. We accepted the survey median physician times for these codes, as recommended by the AMA RUC. CMS time refinements can be found in Table 16. The AMA RUC asserted that a rank order anomaly existed within this family of codes as the observation care codes have an analogous relationship to the initial hospital care codes (99221 through 99223), and recommended work RVUs of 1.92 for CPT code 99218, 2.60 for CPT code 99219, and 3.56 for CPT code 99220.
At the June 2009 CPT Editorial Panel meeting, three new codes were approved to report subsequent observation services in a facility setting. These codes are CPT code 99224 (Level 1 subsequent observation care, per day); CPT code 99225 (Level 2 subsequent observation care, per day); and CPT code 99226 (Level 3 subsequent observation care, per day). Observation services are outpatient services ordered by a patient's treating practitioner. In the CY 2011 PFS final rule with comment period (75 FR 73334), we assigned interim final work RVUs of 0.54 to CPT code 99224, 0.96 to CPT code 99225, and 1.44 to CPT code 99226 for CY 2011. As detailed in the CY 2011 PFS final rule with comment period, we stated that there are generally differences in patient acuity between the inpatient and outpatient settings. To account for these differences, we removed the pre- and post-services times from the AMA RUC-recommended values for subsequent observation care, reducing the values to approximately 75 percent of the values for the subsequent hospital care codes. The AMA RUC recommended work RVUs of 0.76 for CPT code 99224, 1.39 for CPT code 99225, and 2.00 for CPT 99226.
In the Fourth Five-Year Review (76 FR 32458), for CPT codes 99234 (Level 1, observation or inpatient hospital care, for the evaluation and management of a patient including admission and discharge on the same date); 99235 (Level 2, observation or inpatient hospital care, for the evaluation and management of a patient including admission and discharge on the same
As noted previously, for all CY 2011 new, revised, or potentially misvalued codes with CY 2011 interim final work RVUs that are not specifically discussed in this final rule with comment period, we are finalizing, without modification, the interim final direct PE inputs that we initially adopted for CY 2011. Table 15 provides a comprehensive list of all final values.
In this section, we address interim final direct PE inputs as presented in the CY 2011 PFS final rule with comment period and displayed in the final CY 2011 direct PE database (as subsequently corrected on December 30, 2010) available on the CMS Web site under the downloads for the “Payment Policies under Physician Fee Schedule and other Revisions to Part B for CY 2011; Corrections” at:
On an annual basis, the AMA RUC provides CMS with recommendations regarding direct PE inputs, including clinical labor, supplies, and equipment, for new, revised, and potentially misvalued codes. We review the AMA RUC-recommended direct PE inputs on a code-by-code basis, including the recommended facility PE inputs and/or nonfacility PE inputs, as clinically appropriate for the code. We determine whether we agree with the AMA RUC's recommended direct PE inputs for a service or, if we disagree, we refine the PE inputs to represent inputs that better reflect our estimate of the PE resources required for the service in the facility and/or nonfacility settings. We also confirm that CPT codes should have facility and/or nonfacility direct PE inputs and make changes based on our clinical judgment and any PFS payment policies that would apply to the code.
In the CY 2011 PFS final rule with comment period (75 FR 73350), we addressed the general nature of some common refinements to the AMA RUC-recommended direct PE inputs as well as the reasons for refinements to particular inputs. In the following subsections, we respond to comments we received regarding common refinements and the direct PE inputs specific to particular codes.
As we stated in the CY 2011 PFS final rule with comment period (75 FR 73350), many of the refinements to the AMA RUC direct PE recommendations were made in the interest of promoting a transparent and consistent approach to equipment time inputs. In the past, the AMA RUC had not always provided us with recommendations regarding equipment time inputs. In CY 2010, we requested that the AMA RUC provide equipment times along with the other direct PE recommendations, and we provided the AMA RUC with general guidelines regarding appropriate equipment time inputs. We appreciate the AMA RUC's willingness to provide us with these additional inputs as part of their direct PE recommendations.
In general, the equipment time inputs correspond to the intra-service portion of the clinical labor times. We have clarified that assumption to consider equipment time as the sum of the times within the intra-service period when a clinician is using the piece of equipment, plus any additional time the piece of equipment is not available for use for another patient due to its use during the designated procedure. In addition, when a piece of equipment is typically used during additional visits included in a service's global period, the equipment time should also reflect that use.
Certain highly technical pieces of equipment and equipment rooms are less likely to be used by a clinician over the full course of a procedure and are typically available for other patients during time that may still be in the intra-service portion of the service. We adjust those equipment times accordingly. For example, CPT code 74178 (Computed tomography, abdomen and pelvis; without contrast material in more than one body region) includes 3 minutes of intra-service clinical labor time associated with obtaining the patient's consent for the procedure. Since it would be atypical for this activity to occur within the CT room, we believe these 3 minutes should not be attributed to the CT room as equipment time. We refined the CY 2011 AMA RUC direct PE recommendations to conform to these equipment time policies.
Another commenter expressed similar concerns regarding CMS' refinements of equipment minutes allocated to a CT room for a series of new codes that describe combined CTs of the abdomen and pelvis. This commenter argued that equipment minutes should be allocated based on the full number of minutes in the clinical labor intraservice time since, for example, even when a CT technologist greets a patient in a different room, the CT room cannot be used for another patient. This commenter argued that current CMS allocation of room minutes is inconsistent with the historically accepted premise that if the technologists are involved with a patient, the room cannot be used for a different patient until after it has been cleaned and therefore 100 percent of the clinical labor time should be attributed to “Room Time.” Both commenters argued that CMS should accept the direct PE input recommendations of the AMA RUC, without refining the equipment room minutes that were allocated for greeting/gowning, obtaining vital signs or providing pre-service education or obtaining consent.
In the case of services that require the use of certain highly technical pieces of equipment and equipment rooms, however, we believe it is inappropriate to assume that all of the same intra-service clinical labor activities typically make these equipment items unavailable for use in furnishing services to other patients. For example, we do not believe it is typical to occupy a CT room while gowning a patient, providing pre-service education, or
While recent RUC recommendations have often reflected an agreement with that principle, some of the recommendations have required CMS refinements to make sure the equipment time minutes adhere to these principles. We note that we have only recently asked the RUC to provide CMS with recommendations regarding equipment time, and both CMS and the RUC considered the CY 2011 refinements to be technical modifications to the direct PE input recommendations instead of disagreements. Therefore, we do not agree with the commenters' premise that these refinements to equipment time are necessarily in conflict with the clinical judgment of the RUC.
We understand commenters' concerns regarding the importance of accurate and consistent allocation of equipment minutes as direct PE inputs. We agree that equipment minutes have not always been allocated with optimal precision, and we believe that imprecise allocation of equipment minutes may be a factor in certain potentially misvalued codes. We point the reader to section II.B.5.b.1. of this final rule with comment period for an example of this issue.
We believe that our CY 2011 refinements of equipment minutes for new and revised, and potentially misvalued codes most accurately reflect typical use of resources required to furnish PFS services to Medicare beneficiaries. We will continue to work to improve the accuracy of the equipment minutes and will address any further improvements in future rulemaking.
When clinically appropriate, the AMA RUC generally recommends the use of supply and equipment items that already exist in the direct PE database as inputs for new, revised, and potentially misvalued codes. Some recommendations include supply or equipment items that are not currently in the direct PE database. In these cases, the AMA RUC has historically recommended a new item be created and has facilitated CMS' pricing of that item by working with the specialty societies to provide sales invoices to us. We appreciate the contributions of the AMA RUC in that process.
Despite the assistance of the AMA RUC for CY 2011, we did not receive adequate information for pricing the following new supply items included in the AMA RUC's CY 2011 direct PE recommendations: SC098 (Catheter, angiographic, Berman); SD251 (Sheath Shuttle (Cook); SD255 (Reentry Device (Frontier, Outback, Pioneer); SD257 (Tunneler); and SD258 (Vacuum Bottle). Therefore, for CY 2011, these supply items had no price inputs associated with them in the direct PE database. In the CY 2011 PFS final rule (75 FR 73351), we noted that we would consider any newly submitted information for these items as part of our annual supply and equipment price update process.
We remind stakeholders that we established a process that allows the public to submit requests for updates to supply price inputs or equipment price or useful life inputs in the CY 2011 PFS final rule with comment period (75 FR 73205 through 73207). As part of this established process, we ask that requests be submitted as comments to the PFS final rule with comment period each year, subject to the deadline for public comments applicable to that rule. Alternatively, stakeholders may submit requests to CMS on an ongoing basis throughout a given calendar year to
For CY 2011, AMA CPT created a series of new codes that describe combined CTs of the abdomen and pelvis. Prior to 2011, these services would have been billed using multiple stand-alone codes for each body region. The new codes are: 74176 (Computed tomography, abdomen and pelvis; without contrast material); 74177 (Computed tomography, abdomen and pelvis; with contrast material); and 74178 (Computed tomography, abdomen and pelvis; without contrast material in one or both body regions, followed by with contrast material(s) and further sections in one or both body regions.)
After consideration of these comments, for CY 2012, we are finalizing the direct PE inputs, with the labor category refinement, for CPT codes 74176, 74177, and 74178.
In the CY 2011 PFS final rule with comment period (75 FR 73351), we explained our refinements of the supply input recommendations from the AMA RUC for CPT codes describing certain endovascular revascularization services. The recommendations included two or three high-cost stents for each of the following six CPT codes: 37226 (Revascularization, femoral/popliteal artery(s), unilateral; with transluminal stent placement(s); 37227 (Revascularization, femoral/popliteal artery(s), unilateral; with transluminal stent placement(s) and atherectomy); 37230 (Revascularization, tibial/peroneal artery, unilateral, initial vessel; with transluminal stent placement(s)); 37231 (Revascularization, tibial/peroneal artery, unilateral, initial vessel; with transluminal stent placement(s) and atherectomy); 37234 (Revascularization, tibial/peroneal artery, unilateral, each additional vessel; with transluminal stent placement(s) (List separately in addition to code for primary procedure)); and 37235 (Revascularization, tibial/peroneal artery, unilateral, each additional vessel; with transluminal stent placement(s) and atherectomy (List separately in addition to code for primary procedure)).
Given the complex clinical nature of these services, their new pricing in the nonfacility setting under the PFS, and the high cost of each stent, we were concerned that inclusion of two or three stents could overestimate the number of stents used in the typical office procedure that would be reported under one of the CPT codes. Therefore, we examined CY 2009 hospital OPPS claims data for the combinations of predecessor codes that would have historically been reported for each case reported in under CY 2011 under a single comprehensive code. Because of the OPPS device-to-procedure claims processing edits, all prior cases would have included a HCPCS C-code for at least one stent on the claim for the case. Based on our analysis of these data, we determined that for each new CY 2011 comprehensive code, the predecessor code combinations would have used only one stent in 65 percent or more of the cases. We had no reason to believe that when these new CPT codes were reported for procedures performed in the nonfacility setting, the typical patient would receive more than the one stent typically used in the hospital outpatient setting. Therefore, we refined the CY 2011 AMA RUC recommendations to include one stent in the direct PE inputs for each of the six endovascular revascularization stent insertion codes, including the add-on codes. These refinements were reflected in the final CY 2011 PFS direct PE database.
After consideration of all comments received, we are finalizing the direct PE inputs, as amended in section II.A.3.a. of this final rule with comment period, for these codes for CY 2012.
The CY 2011 AMA RUC recommendation for direct PE inputs for CPT code 31295 (Nasal/sinus endoscopy, surgical; with dilation of maxillary sinus ostium (
Upon receipt of these recommendations, we requested that the AMA RUC clarify the initial recommendation by determining which of these supply items would be used in the typical case. The AMA RUC recommended that the supply item “kit, sinus surgery, balloon (maxillary, frontal, or sphenoid)” be included in the inputs for the code. We considered that recommendation, but we believed the item “kit, sinus surgery, balloon (maxillary)” to be more clinically appropriate based on the description of CPT code 32195.
The AMA RUC recommendation for equipment inputs for the same code (CPT code 31295) included a parallel irregularity by distributing half of the equipment minutes to each of two similar pieces of equipment, one existing and one new: “endoscope, rigid, sinoscopy” (ES013) and “fiberscope, flexible, sinoscopy” (ES035 and new for CY 2011). We believed that this recommendation was intended to reflect an assumption that each of these distinct pieces of equipment is used in approximately half of the cases in which the service is furnished. Again, we noted that, in general, the direct PE inputs should reflect the items used when the service is furnished in the typical case. Therefore, the equipment time inputs associated with a code should reflect the number of minutes an equipment item is used in the typical case, and not be distributed among a set of equipment items to reflect an estimate of the proportion of cases in which a particular equipment item might be used. Upon review of these items, we believed the new piece of equipment, “fiberscope, flexible, sinoscopy” to be more clinically appropriate based on the description of CPT code 32195. We refined the CY 2011 AMA RUC direct PE recommendations to conform to these determinations.
As part of their CY 2012 recommendations, the AMA RUC provided a new recommendation regarding the disposable sinus surgery kits included as direct PE supply inputs for each of these three codes. When developing direct PE input recommendations for these new codes, the AMA RUC believed that the codes would be typically billed in one unit per patient encounter. Following implementation of these codes for Medicare purposes at the start of CY 2011, the RUC received reports that multiple units of services were being reported in the same patient encounter and that corresponding number of kits was not utilized. The RUC reported this information to CMS in conjunction with a request for preliminary claims data. The RUC then examined partial year sample claims data that overwhelmingly demonstrated each of the codes was typically billed with another code in the family and more often billed in multiples of three than singularly. Using this information to corroborate the reports the RUC had previously received, the RUC submitted a refined recommendation for CMS to consider for CY 2012. The new recommendation requests that CMS remove the disposable sinus surgery kits from each of the codes for CY 2012 and implement separately billable alpha-numeric HCPCS codes when possible to allow practitioners to be paid the cost of the disposable kits per patient encounter instead of per CPT code.
We appreciate and agree with the RUC's concern that the CY 2011 recommendations reflect an incorrect assumption about the number of services furnished per disposable sinus surgery kit used. We have considered the RUC's recommendation to remove the sinus surgery kits from the codes immediately and establish separately payable alpha-numeric HCPCS codes to use to report using the kits in furnishing the services described by these codes, and we agree that it provides one potential long-term solution to the problem with the high-cost disposable supply inputs for these particular codes. However, the RUC's solution presents a series of potential problems that we have addressed previously in the context of the broader challenges regarding our ability to price high cost disposable supply items. For the most recent discussion of this issue, we direct the reader to our discussion in the CY 2011 PFS final rule with comment period (75 FR 73251). However, we will consider the recommendation of the RUC regarding these and similar supply items during preparation for future rulemaking.
For CY 2012, we do not believe it would be appropriate to remove these items as supply inputs for these codes without providing an alternative means for paying practitioners for the resources associated with furnishing the related services. At the same time, however, we do not believe that it would be appropriate to maintain supply inputs that are based on an incorrect assumption about the relationship between how a service is furnished and how it is reported. Given the recent recommendation from the RUC, as well as our concurring interpretation of preliminary claims data for these codes, we believe that modifying the supply inputs for these codes is the most appropriate means for achieving accurate payment for CY 2012. Recognizing that these codes are typically billed in units of two, we believe that reducing the sinus surgery kit supply quantity to one-half for each of the codes will best reflect the number of kits used when the services are typically furnished. As part of our initial refinements, we only included the sinus surgery kit specific to the maxillary sinus in CPT code 32195. Since we now understand that the non-specific kits can be used when
After consideration of both the public comments and the recommendations of the AMA RUC, we are altering the direct PE inputs for these codes as follows. The “kit, sinus surgery, balloon (maxillary, frontal, or sphenoid)” (SA106) will be included in the direct PE database at the quantity of one-half for each of the three CPT codes: 31295, 31296, and 31297. The “kit, sinus surgery, balloon (maxillary)” (SA107) will be removed as an input for 31295 in the direct PE database. We are not allocating equipment for an additional scope or an additional light source for any of the codes. However, we are not finalizing the direct PE inputs for 31295, 31296, or 31297 for CY 2012. Instead, we will keep these direct PE inputs as interim final for CY 2012. We seek additional public comments regarding the appropriate direct PE inputs for these codes and we will continue to consider the AMA RUC's solution for future rulemaking.
For CY 2011, CPT created a new code to describe percutaneous procedures: 49418 (Insertion of tunneled intraperitoneal catheter (
In addition to the public comments, we have reviewed the inputs for this code and are concerned with one of the disposable supplies included in the recommendation. We accepted an item called “Y-set connection tubing” (SD260). The invoice submitted with the recommendation describes an item that is used to replace a plastic catheter connecter included with a disposable flex-neck catheter. We are asking for public comment regarding the accuracy of this item.
We are maintaining the direct PE inputs for CPT code 49418 for CY 2012, but since we are seeking public comment regarding a particular supply item, we are keeping the direct PE inputs as interim for CY 2012.
We note that we also received comments on the interim final direct PE inputs for CPT codes 88120 (Cytopathology, in situ hybridization (
In the CY 2011 PFS final rule with comment period, after consideration of the public comments we received, we established a national price for CPT code 93229 (Wearable mobile cardiovascular telemetry with electrocardiographic recording, concurrent computerized real time data analysis and greater than 24 hours of accessible ECG data storage (retrievable with query) with ECG-triggered and patient selected events transmitted to a remote attended surveillance center for up to 30 days; technical support for connection and patient instructions for use, attended surveillance, analysis and physician prescribed transmission of daily and emergent data reports) instead of maintaining the code as contractor-priced as we had proposed for CY 2011. We adopted the AMA RUC's recommendations for the clinical labor and supply inputs, and utilized price, utilization, and useful life information provided by commenters as equipment inputs for the cardiac telemetry monitoring device worn by the patient. In developing PE RVUS for this service, we classified the costs associated with the centralized monitoring equipment, including the hardware and software, workstation, webserver, and call recording system, as indirect costs.
a. Finalizing CY 2011 Interim Final Malpractice RVUs
Consistent with our malpractice methodology described in section II.C.1. of this final rule with comment period, for the CY 2011 PFS final rule, we developed malpractice RVUs for new codes and adjusted malpractice RVUs for revised codes by scaling the malpractice RVUs of the CY 2011 new/revised codes for differences in work RVUs between a source code and the new/revised codes. For CY 2011 we adopted the AMA RUC-recommended source code crosswalks for all new and revised codes on an interim final basis.
We did not receive any comments to the CY 2011 PFS final rule with comment period disagreeing with the malpractice crosswalk for any of the CY 2011 new and revised codes. However, we note that we did receive a comment to the CY 2012 PFS proposed rule for CPT codes 88120 (Cytopathology, in situ hybridization (
Additionally, we received a comment to the CY 2011 PFS final rule requesting that we reevaluate the malpractice risk factor for a number of largely pediatric cardiothoracic surgery CPT codes. These CPT codes were not open for comment for CY 2011, however we addressed this malpractice comment in the CY 2012 PFS proposed rule (76 FR 42814), and it is discussed in greater detail in section II.A.3.d. of this final rule with comment period.
As described in the Five Year Review (76 FR 32469) for CPT codes with work RVU changes included in the Fourth Five-Year Review, the malpractice source code for nearly all reviewed codes was the code itself (a 1 to 1 crosswalk). For these CPT codes, we calculated the revised malpractice RVUs by scaling the current (CY 2011) malpractice RVU by the percent difference in work RVU between the current (CY 2011) work RVU and the proposed work RVU. However, there were three CPT codes included in the Five Year Review that were previously contractor priced and did not have current (CY 2011) work RVUs—CPT codes 33981 (Replacement of extracorporeal ventricular assist device, single or biventricular, pump(s), single or each pump), 33982 (Replacement of ventricular assist device pump(s); implantable intracorporeal, single ventricle, without cardiopulmonary bypass), and 33983 (Replacement of ventricular assist device pump(s); implantable intracorporeal, single ventricle, with cardiopulmonary bypass). For all three CPT codes, we applied the AMA RUC-recommended malpractice crosswalks to obtain the appropriate malpractice RVUs. The crosswalk source code for CPT code 33981 was CPT code 33976 (Insertion of ventricular assist device; extracorporeal, biventricular), and the crosswalk source for CPT codes 33982 and 33983 was CPT code 33979 (Insertion of ventricular assist device, implantable intracorporeal, single ventricle). Consistent with the malpractice methodology, the malpractice RVUs for these three newly-valued CPT codes were developed by adjusting the malpractice RVU of the source codes for the difference in work RVU between the source code and the newly-valued codes.
We received no comments on the malpractice crosswalks included in the Five-Year Review. We are finalizing the Five-Year Review malpractice crosswalks without modification for CY 2012.
In the CY 2012 PFS proposed rule there were a number of codes for which we reviewed the physician work and practice expense. Like the Five-Year Review, for these CPT codes the source code for each code was the code itself (a 1-to-1 crosswalk). Therefore, we calculated the revised malpractice RVUs for these codes by scaling the current (CY 2011) malpractice RVU by the percent difference in work RVU between the current (CY 2011) work RVU and the proposed work RVU (76 FR 42813).
In addition to the scaling of malpractice RVUs to account for the proportionate difference between current and proposed work RVUs, there were 19 cardiothoracic surgery codes for which we proposed to scale the malpractice RVUs to account for the proportionate difference between the current and proposed revised specialty risk factor (76 FR 42813). These codes and their short descriptors are listed in Table 17. We assign malpractice RVUs to each service based upon a weighted average of the malpractice risk factors of all specialties that furnish the service. For the CY 2010 review of malpractice RVUs, we used CY 2008 Medicare claims data on allowed services to establish the frequency of a service by specialty. For a number of cardiothoracic surgery CPT codes representing major open heart procedures performed primarily on neonates and infants, CY 2008 Medicare claims data showed zero allowed services. Therefore, our contractor set the number of services to 1, and assigned a risk factor according to the average risk factor for all services that do not explicitly have a separate technical or professional component (average risk factor = 1.95). In the CY 2010 PFS final rule with comment period, we published interim final malpractice RVUs for these codes calculated using the average physician risk factor, and finalized them in the CY
We also proposed to scale the malpractice RVUs to reflect a change in risk factor for CPT code 32442 (Removal of lung, total pneumonectomy; with resection of segment of trachea followed by broncho-tracheal anastomosis (sleeve pneumonectomy)). In the CY 2010 review of malpractice RVUs we assigned CPT code 32442 the pulmonary disease risk factor (2.09) and published the interim final malpractice RVU calculated from this risk factor in the CY 2010 PFS final rule with comment period. This value was finalized in the CY 2011 PFS final rule with comment period. Since finalizing this value, stakeholders have suggested that a blended risk factor of thoracic surgery (6.49) and general surgery (5.91) would be more appropriate for this service. As described in the CY 2010 PFS final rule with comment period (74 FR 61760), we do not use a blended risk factor for services with Medicare utilization under 100; instead, we use the malpractice risk factor of the specialty that performs the given service the most (the dominant specialty). As CPT code 32442 has Medicare utilization well below the 100 occurrences threshold, and current Medicare claims data show that the dominant specialty for CPT code 32442 is thoracic surgery, we believed that the thoracic surgery risk factor is the appropriate risk factor for this service. Adjusting the malpractice RVU to reflect the thoracic surgery risk factor rather than the pulmonary disease risk factor resulted in a malpractice RVU of 13.21 for CPT code 32442. Therefore, we proposed a malpractice RVU of 13.21 for CPT code 32442 for CY 2012.
Section 1848(b)(6) of the Act (as amended by section 3111(a) of the Affordable Care Act) changed the payment calculation for dual-energy x-ray absorptiometry (DXA) services described by two specified DXA CPT codes for CY s 2010 and 2011. This provision required payment for these services at 70 percent of the product of the CY 2006 RVUs for these DXA codes, the CY 2006 CF, and the geographic adjustment for the relevant payment year.
Effective January 1, 2007, the CPT codes for DXA services were revised. The former DXA CPT codes 76075 (Dual energy X-ray absorptiometry (DXA), bone density study, one or more sites; axial skeleton (
As mentioned previously, section 1848(b) of the Act revised the payment for CPT codes 77080 and 77082 during CY 2010 and CY 2011. We provided for payment in CY s 2010 and 2011 under the PFS for CPT codes 77080 and 77082 at the specified rates (70 percent of the product of the CY 2006 RVUs for these DXA codes, the CY 2006 CF, and the geographic adjustment for the relevant payment year). Because the statute specifies a payment calculation for these services for CY s 2010 and 2011 as described previously, for those years we implemented the payment provision by imputing RVUs for these services that would provide the specified payment amount for these services when multiplied by the current year's conversion factor.
As discussed in the CY 2012 PFS proposed rule (76 FR 42809 and 42810), for CY 2012, the payment rate for CPT codes 77080 and 77082 will be based upon resource-based, rather than imputed, RVUs, and the current year's conversion factor. The CY 2012 work, PE, and malpractice RVUs for these codes are shown in Table 18, CY 2012 RVUs for DXA CPT Codes 77080 and 77082, as well as in Addendum B of this final rule with comment period.
In addition to temporarily changing the payment rate for the two DXA CPT codes, section 3111(b) of the Affordable Care Act also authorizes the Secretary to enter into agreement with the Institute of Medicine of the National Academies to conduct a study on the ramifications of Medicare payment reductions for dual-energy x-ray absorptiometry (as described in section 1848(b)(6) of the Act) during years 2007, 2008, and 2009 on beneficiary access to bone mass density tests. This study has not yet been conducted. In the absence of this study, we have requested that the AMA RUC review CPT codes 77080 and 77082 during CY 2012.
For all other new, revised, or potentially misvalued codes with CY 2011 interim final RVUs or CY 2012 proposed RVUs that are not specifically discussed in this final rule with comment period, we are finalizing for CY 2012, without modification, the interim final or proposed work and malpractice RVUs and direct PE inputs. Unless otherwise indicated, we agreed with the time values recommended by the AMA RUC or HCPAC for all codes addressed in this section. The time values for all codes appear on the CMS Web site at:
As previously discussed in section III.A of this final rule with comment period, on an annual basis, the AMA RUC and HCPAC provide CMS with recommendations regarding physician work values for new and revised CPT codes. This section discusses the families of clinically related CPT codes where CMS disagreed with the AMA RUC or HCPAC recommended physician work RVU or time values for a service for a CY 2012 new or revised CPT code. The interim or interim final physician work RVUs for all new and revised codes, including those where CMS agreed with the recommended work RVU appear in Table 19 at the end of this section. Unless otherwise indicated, we agreed with the time values recommended by the AMA RUC or HCPAC for all codes addressed in this section. The time values for all codes appear on the CMS Web site at:
We note that the AMA RUC also reviewed over 100 CPT codes describing molecular pathology services. These CPT codes are new for CY 2012, however they will not be valid for Medicare purposes for CY 2012—For CY 2012 Medicare will continue to use the current “stacking” codes for the reporting and payment for these services. These molecular pathology codes appear in Addendum B to this final rule with the procedure status indicator of I (Not valid for Medicare purposes. Medicare uses another code for the reporting and payment for these services).
CPT code 10061 was identified by the AMA RUC Relativity Assessment Workgroup through the Harvard-Valued—Utilization > 100,000 screen. CPT code 10060 was identified as part of this family to be reviewed. We identified CPT code 11056 as part of the MPC List screen.
After clinical review of CPT codes 10060 (Incision and drainage of abscess (
For the Third Five-Year Review for CY 2007, the HCPAC recommended increasing the work RVU for CPT code 10060 from 1.17 to 1.50 because the HCPAC believed the survey methodology used for this code in the original Harvard valuation was flawed. In reviewing this code for the Third Five-Year Review we compared the specialty society survey times with the Harvard-based times and found them comparable (71 FR 37236). As such, we found no grounds for increase, and ultimately maintained the work RVU of 1.17 for this service (71 FR 69733). For the CY 2010 PFS, the work RVU for CPT code 10060 was increased to 1.22 based on the redistribution of RVUs resulting from the CMS policy to no longer recognize the CPT consultation codes.
For CY 2012, the AMA RUC reviewed the survey results from physicians who perform this service. Citing the HCPAC rationale and recommendation in the Third Five-Year Review, the AMA RUC recommended the survey median work RVU of 1.50 for CPT code 10060 for CY 2012. We continue to believe that the original valuation of the service was appropriate, and since the work associated with the procedure has not changed, we believe that the current work RVU of 1.22 should be maintained. Therefore, we are assigning a work RVU of 1.22 to CPT code 10060 on an interim final basis for CY 2012.
We reviewed CPT code 11056 (Paring or cutting of benign hyperkeratotic lesion (
For the CY 2012 new, revised, and potentially misvalued CPT codes reviewed in this family of services and not specifically discussed here, we agree with the AMA RUC/HCPAC-recommended work RVUs and are setting as interim final the work RVUs listed in Table 19.
We identified CPT code 11721 as part of the MPC List screen. The AMA RUC recommended that CPT codes 11721, along with CPT code 11719 and 11720 be surveyed for CY 2012.
After reviewing the survey data, the specialty society concluded that the survey data for CPT code 11719 (Trimming of nondystrophic nails, any number) was not reflective of the service, and is resurveying CPT code 11719 for CY 2013. We will review CPT code 11719 at that time, along with G0127 (Trimming of dystrophic nails, any number) which is crosswalked to CPT code 11719.
After clinical review of CPT code 11720 (Debridement of nail(s) by any method(s); 1 to 5.), and 11721 (Debridement of nail(s) by any method(s); 6 or more.), we believe that the current (CY 2011) work RVUs of 0.32 and 0.54 (respectively) continue to accurately account for the work of these services. The HCPAC also recommended maintaining the current (CY 2011) work RVUs for these services. Therefore, we are assigning a work RVU of 0.32 for CPT code 11720 and a work RVU of 0.54 for CPT code 11721 on an interim final basis for CY 2012.
For CY 2012, the CPT Editorial Panel deleted 24 skin substitute codes and established a 2-tier structure with 8 new codes (CPT codes 15271 through 15278) to report the application of skin substitute grafts, which are distinguished according to the anatomic location and surface area rather than by product description. Additionally, the CPT Editorial Panel created a new add-on code (CPT code 15777) to report implantation of a biological implant for soft ties reinforcement. For CY 2012, the AMA RUC Relativity Assessment Workgroup identified CPT codes 16020 and 16025 through its Different Performing Specialty from Survey screen.
For CY 2011, we created 2 HCPCS codes, G0440 (Application of tissue cultured allogeneic skin substitute or dermal substitute; for use on lower limb, includes the site preparation and debridement if performed; first 25 sq cm or less) and G0441 (Application of tissue cultured allogeneic skin substitute or dermal substitute; for use on lower limb, includes the site preparation and debridement if performed; each additional 25 sq cm), that are recognized for payment under the PFS for the application of products described by the codes to the lower limb. These codes will be deleted for CY 2012. Providers reporting the application of tissue cultured allogeneic skin substitute or dermal substitutes to the lower limb for payment under the PFS in CY 2012 should report under the appropriate new CPT code(s).
After clinical review of CPT code 15272 (Application of skin substitute graft
However, we believe this value overstates the work of this procedure when compared to the base CPT code 15271 (Application of skin substitute graft
After clinical review of CPT code 15276 (Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure)), we believe that a work RVU of 0.50 accurately reflects the work associated with this service. The AMA RUC reviewed the survey results for CPT code 15276 and recommended a work RVU of 0.59 which corresponds to the the AMA RUC's recommended work RVU for CPT code 15272. As discussed previously, we are assigning an interim final work RVU of 0.33 to CPT code 15272. We believe that the work associated with CPT code 15276, which describes work on the face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple
CPT codes 16020 (Dressings and/or debridement of partial-thickness burns, initial or subsequent; small (less than 5 percent total body surface area)) and 16025 (Dressings and/or debridement of partial-thickness burns, initial or subsequent; medium (
In order to determine the appropriate work RVUs for these services given the time changes, we calculated the value of the extracted time and subtracted it from the AMA RUC-recommended work RVUs. For CPT code 16020, we removed a total of 4 minutes at an intensity of 0.0224 per minute, which amounts to the removal of 0.09 of a work RVU. The AMA RUC recommended a work RVU of 0.80, the current (CY 2011) work RVU. We are assigning an interim final work RVU of 0.71, with refinement to time, to CPT code 16020 for CY 2012. For CPT code 16025, we removed a total of 5 minutes at an intensity of 0.0224 per minute, which amounts to the removal of 0.11 of a work RVU. The AMA RUC recommended a work RVU of 1.85, the current (CY 2011) work RVU. We are assigning an interim final work RVU of 1.74, with refinement to time, to CPT code 16025 for CY 2012.
For the CY 2012 new, revised, and potentially misvalued CPT codes reviewed in this family of services and not specifically discussed here, we agree with the AMA RUC/HCPAC-recommended work RVUs and are setting as interim final the work RVUs listed in Table 19.
For CY 2012, the CPT Editorial Panel created CPT codes 26341 and 20517 to describe a new technique for treating Dupuytren's contracture by injecting an enzyme into the Dupuytren's cord for full finger extension and manipulation.
After clinical review of CPT code 26341 (Manipulation, palmar fascial cord (ie, Dupuytren's cord), post enzyme injection (
For CY 2012 the CPT Editorial Panel revised the descriptor for CPT code 29581, and also created CPT codes 29582, 29583, and 29584 to describe the application of multi-layer compression to the upper and lower extremities. The CPT Editorial Panel and AMA RUC concluded that the revisions to the descriptor for CPT code 29581 were
After clinical review, we believe that CPT codes 29581 (Application of multi-layer compression system; leg (below knee), including ankle and foot), 29582 (Application of multi-layer compression system; thigh and leg, including ankle and foot, when performed), 29583 (Application of multi-layer compression system; upper arm and forearm) and 29584 (Application of multi-layer compression system; upper arm, forearm, hand, and fingers) all describe similar services from a resource perspective and should be valued similarly. We believe CPT code 29581 (work RVU = 0.60) is valued inappropriately high in relation to newly created, surveyed, and HCPAC-reviewed CPT codes 29582, 29583, and 29584. We believe that the HCPAC recommended work RVUs of 0.35 for CPT code 29682, 0.25 for CPT code 29583, and 0.35 for CPT code 29584 accurately reflect the work associated with these services. Additionally, we believe that the clinical conditions treated by CPT codes 29581 and 29583 are essentially the same, namely the treatment of venus ulcers and lymphedema. We recognize that there will be mild differences and variation in the application of a multi-layer compression system to the upper extremity versus the lower extremity, which is accounted for in the intra-service times of the codes. As such, we believe a work RVU of 0.25 appropriately accounts for the work associated with CPT code 29581. We believe that a survey that addresses all 4 CPT codes together as a family and gathers responses from all clinicians who furnish the services described by CPT codes 29581 through 29584 would help assure the appropriate gradation in valuation of these 4 services. In sum, on an interim basis for CY 2012 we are assigning a work RVU of 0.25 to CPT code 29581, a work RVU of 0.35 to CPT code 29582, a work RVU of 0.25 to 29593, and a work RVU of 0.35 to CPT code 29584.
CPT code 29826 was identified by the AMA RUC Relativity Assessment Workgroup through the Codes Reported Together 75 percent or More screen. This service is commonly performed with CPT codes 29824, 29827 and 29828. In addition, as part of the Fourth Five-Year Review, CMS identified 29826 through the Harvard-Valued—Utilization > 30,000 screen.
Given that CPT code 29826 (Arthroscopy, shoulder, surgical; decompression of subacromial space with partial acromioplasty, with coraco-acromial ligament (ie, arch) release, when performed) is rarely performed as a stand-alone procedure (less than 1 percent of the time), the American Academy of Orthopaedic Surgeons (AAOS) sent us a request to change the global period from 090 to ZZZ. A global surgical period of 090 is reflects a major surgery with a 1-day preoperative period and a 90-day postoperative period included in the fee schedule payment amount. A global surgical period of ZZZ reflects a service that is related to another service and is always included in the global period of the other service. These are often referred to as “add-on” codes or services. We agreed to change the global surgical period for CPT code 29826, and CPT code 29826 was surveyed and presented as an add-on service with a ZZZ global period.
After clinical review of CPT code 29826, we believe that the AMA RUC-recommended work RVU of 3.00, the survey 25th percentile value, accurately values the work associated with this service. We are assigning a work RVU of 3.00 to CPT code 29826 on an interim final basis for CY 2012.
For the CY 2012 new, revised, and potentially misvalued CPT codes reviewed in this family of services and not specifically discussed here, we agree with the AMA RUC/HCPAC-recommended work RVUs and are setting as interim final the work RVUs listed in Table 19.
The CPT Editorial Panel reviewed the lung resection family of codes for CY 2012 and deleted 8 codes, revised 5 codes and created 18 new codes to describe new thoracoscopic procedures and to clarify coding confusion between lung biopsy and lung resection procedures. For the wedge resection procedures, the revisions were based on three tiers; first, the approach, thoracotomy or thoracoscopy; second, the target to remove nodules or infiltrates; and lastly the intent, diagnostic or therapeutic (for nodules only, all infiltrates will be removed for diagnostic purposes).
After clinical review of CPT code 32096 (Thoracotomy, with diagnostic biopsy(ies) of lung infiltrate(s) (
After clinical review of CPT code 32097 (Thoracotomy, with diagnostic biopsy(ies) of lung nodule(s) or mass(es) (
After clinical review of CPT code 32098 (Thoracotomy, with biopsy(ies) of pleura), we believe a work RVU of 12.91 accurately reflects the work associated with this service compared to other related services. The AMA RUC reviewed the survey results, compared the code to other services, and recommended the survey 25th percentile work RVU of 14.99. We determined that the work associated with CPT code 32098 was similar in terms of physician time and intensity to CPT code 47100 (Biopsy of liver, wedge). We believe crosswalking to the work RVU of CPT code 47100 appropriately accounts for the work associated with CPT code 32098. Therefore, we are assigning a work RVU of 12.91 to CPT code 32098 on an interim final basis for CY 2012.
After clinical review of CPT code 32100 (Thoracotomy; with exploration), we believe a work RVU of 13.75 accurately reflects the work associated with this service compared to other related services. The AMA RUC reviewed the survey results, compared the code to other services, and recommended a work RVU of 17.00. The AMA RUC concluded that CPT code 32100 is similar to new CPT code 32096, for which the AMA RUC recommended a work RVU of 17.00. We recognize the specialty society and AMA RUC assertion that CPT code 32100 should be valued the same as CPT codes 32096 and 32097 based on the assessment that the work is similar between these three services. We note that we assigned a work RVU of 13.75 to CPT codes 32096 and 32097. Accordingly, we are assigning a work RVU of 13.75 for CPT code 32100 on an interim final basis for CY 2012.
After clinical review of CPT code 32505 (Thoracotomy; with therapeutic wedge resection (
After clinical review of CPT code 32507 (Thoracotomy; with diagnostic wedge resection followed by anatomic lung resection (List separately in addition to code for primary procedure)), we believe a work RVU of 3.00 accurately reflects the work associated with this service compared to other related services. The AMA RUC reviewed the survey results, compared the code to other services, and recommended the survey 25th percentile work RVU of 3.78. We believe that the work associated with this service is similar to the work of CPT code 32506 and should be valued the same. Accordingly, we are assigning a work RVU of 3.00 to CPT code 32507 on an interim final basis for CY 2012.
For CPT code 32663 (Thoracoscopy, surgical; with lobectomy (single lobe)), the AMA RUC recommended a work RVU of 24.64. Upon clinical review, we have determined that it is most appropriate to accept the AMA RUC recommended work RVU of 24.64 on a provisional basis, pending review of the open heart surgery analogs, in this case, CPT code 32480. We are requesting the AMA RUC look at the incremental difference in RVUs and times between the open and laparoscopic surgeries and recommend a consistent valuation of RVUs and time for CPT code 32663 and other services within this family with this same issue. Accordingly, we are assigning a work RVU of 24.64 for CPT code 32663 on an interim basis for CY 2012.
After clinical review of CPT code 32668 (Thoracoscopy, surgical; with diagnostic wedge resection followed by anatomic lung resection (List separately in addition to code for primary procedure)), we believe a work RVU of 3.00 accurately reflects the work associated with this service compared to other related services. The AMA RUC reviewed the survey results, compared the code to other services, and recommended the survey 25th percentile work RVU of 4.00. We believe that the work associated with this service is similar to the work of CPT code 32506, which we have valued at a work RVU of 3.00. Accordingly, we are assigning a work RVU of 3.00 to CPT code 32668 on an interim basis for CY 2012.
For CPT code 32669 (Thoracoscopy, surgical; with removal of a single lung segment (segmentectomy)), the AMA RUC recommended a work RVU of 23.53. Upon clinical review, we have determined that it is most appropriate to accept the AMA RUC recommended work RVU of 23.53 on a provisional basis, pending review of the open heart surgery analogs, in this case CPT code 32480. We are requesting the AMA RUC look at the incremental difference in RVUs and times between the open and laparoscopic surgeries and recommend a consistent valuation for CPT 32669 and other services within this family with this same issue. Accordingly, we are assigning a work RVU of 23.53 to CPT code 32669 on an interim basis for CY 2012.
For CPT code 32670 (Thoracoscopy, surgical; with removal of two lobes (bilobectomy)) the AMA RUC recommended a work RVU of 28.52. Upon clinical review, we have determined that it is most appropriate to accept the AMA RUC recommended work RVU of 28.52 on a provisional basis, pending review of the open heart surgery analogs, in this case CPT code 32482. We are requesting the AMA RUC look at the incremental difference in RVUs and times between the open and laparoscopic surgeries and recommend a consistent valuation for CPT 32670 and other services within this family with this same issue. Accordingly, we are assigning a work RVU of 28.52 to CPT code 32670 on an interim basis for CY 2012.
For CPT code 32671 (Thoracoscopy, surgical; with removal of lung (pneumonectomy)), the AMA RUC recommended a work RVU of 31.92. Upon clinical review, we have determined that it is most appropriate to accept the AMA RUC recommended work RVU of 31.92 on a provisional basis, pending review of the open heart surgery analogs, in this case CPT code 32440. We are requesting the AMA RUC look at the incremental difference in RVUs and times between the open and laparoscopic surgeries and recommend a consistent valuation for CPT 32671 and other services within this family with this same issue. Accordingly, we are assigning a work RVU of 31.92 to CPT code 32671 on an interim basis for CY 2012.
For CPT code 32672 (Thoracoscopy, surgical; with resection-plication for emphysematous lung (bullous or non-bullous) for lung volume reduction (LVRS), unilateral includes any pleural procedure, when performed), the AMA RUC recommended a work RVU of 27.00. Upon clinical review, we have determined that it is most appropriate to accept the AMA RUC recommended work RVU of 27.00 on a provisional basis, pending review of the open heart surgery analogs, in this case CPT code 32491. We are requesting the AMA RUC look at the incremental difference in RVUs and times between the open and laparoscopic surgeries and recommend a consistent valuation for CPT 32672 and other services within this family with this same issue. Accordingly, we are assigning a work RVU of 27.00 to CPT code 32672 on an interim basis for CY 2012.
For CPT code 32673 (Thoracoscopy, surgical; with resection of thymus, unilateral or bilateral), the AMA RUC recommended a work RVU of 21.13. Upon clinical review, we have determined that it is most appropriate to accept the AMA RUC recommended work RVU of 21.13 on a provisional basis, pending review of related CPT codes 60520 (Thymectomy, partial or total; transcervical approach (separate procedure)), 60521 (Thymectomy, partial or total; sternal split or transthoracic approach, without radical mediastinal dissection (separate procedure)), and 60522 (Thymectomy, partial or total; sternal split or transthoracic approach, with radical mediastinal dissection (separate procedure)). At this time, we have concerns about appropriate relativity between the times and RVUs of these services. We are assigning a work RVU of 21.13 to CPT code 32673 on an interim basis for CY 2012.
For the CY 2012 new, revised, and potentially misvalued CPT codes reviewed in this family of services and not specifically discussed here, we agree with the AMA RUC/HCPAC-recommended work RVUs and are setting as interim final the work RVUs listed in Table 19.
The AMA RUC recommended that CMS consider a bundled status for CPT code 36000, (Introduction of needle or intracatheter, vein) because the AMA RUC and many specialty societies believe CPT code 36000 always is a component of other services. We agree with the AMA RUC recommendation and for CY 2012, CPT code 36000 will have a status code of B (bundled). We are publishing the RVUs for CPT code 36000 in the CY 2012 PFS, but Medicare will no longer make separate payment for this service.
CPT codes 75722 and 75724 were identified through the Codes Reported Together 75 percent or More screen. These supervision and interpretation codes were commonly billed with the catheter placement code 36245. For CY 2012, the specialties submitted a code change proposal to the CPT Editorial Panel to bundle the services commonly reported together. The panel deleted CPT codes 75722 and 75724 and created 4 bundled services (CPT codes 36251, 36252, 36253, and 36254) for CY 2012.
After clinical review of CPT code 36251 (Selective catheter placement (first-order), main renal artery and any accessory renal artery(s) for renal angiography, including arterial puncture and catheter placement(s), fluoroscopy, contrast injection(s), image postprocessing, permanent recording of images, and radiologic supervision and interpretation, including pressure gradient measurements when performed, and flush aortogram when performed; unilateral), we believe a work RVU of 5.35 accurately reflects the work associated with this service. The AMA RUC reviewed the survey results, compared the code to other services, and concluded that the work value for CPT code 36251 should be directly crosswalked to CPT code 31267 (Nasal/sinus endoscopy, surgical, with maxillary antrostomy; with removal of tissue from maxillary sinus) (work RVU = 5.45). The AMA RUC recommended a work RVU of 5.45 for CPT code 36251. We determined that the work associated with CPT code 36251 is closely aligned in terms of physician time and intensity with CPT code 52341 (Cystourethroscopy; with treatment of ureteral stricture (
After clinical review of CPT code 36252 (Selective catheter placement (first-order), main renal artery and any accessory renal artery(s) for renal angiography, including arterial puncture and catheter placement(s), fluoroscopy, contrast injection(s), image postprocessing, permanent recording of images, and radiologic supervision and interpretation, including pressure gradient measurements when performed, and flush aortogram when performed; bilateral), we believe a work RVU of 6.99 accurately reflects the work associated with this service. The AMA RUC reviewed the survey results, compared the code to other services, and concluded that the work value for CPT code 36252 should be directly crosswalked to CPT code 43272 (Endoscopic retrograde cholangiopancreatography (ERCP); with ablation of tumor(s), polyp(s), or other lesion(s) not amenable to removal by hot biopsy forceps, bipolar cautery or snare technique) (work RVU = 7.38). While the AMA RUC recommended a work RVU of 7.38 for CPT code 36252. We believe the intensity of this service is akin to CPT code 58560 (Hysteroscopy, surgical; with division or resection of intrauterine septum (any method)) (work RVU = 6.99). Accordingly, we are assigning a work RVU of 6.99 to CPT code 36252 on an interim final basis for CY 2012.
For the CY 2012 new, revised, and potentially misvalued CPT codes reviewed in this family of services and not specifically discussed here, we agree
After clinical review of CPT code 37192 (Repositioning of intravascular vena cava filter, endovascular approach inclusive of vascular access, vessel selection, and all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance (ultrasound and fluoroscopy)), we believe a work RVU of 7.35 accurately reflects the work associated with this service. The AMA RUC reviewed the survey results, compared the code to other services, and concluded that the survey 75th percentile intra-service time of 60 minutes and the 25th percentile of work RVU of 8.00 accurately describes the physician work involved in the service. We determined that the work associated with CPT code 37192 is similar to CPT code 93460 (Catheter placement in coronary artery(s) for coronary angiography, including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation; with right and left heart catheterization including intraprocedural injection(s) for left ventriculography, when performed), which has a work RVU of 7.35 and has the following times: 48 minutes pre-service, 50 minutes intra-service, and 30 minutes post-service. As such, we believe that the survey median intra-service time of 45 minutes appropriately accounts for the time required to furnish the intra-service work of this procedure. Therefore, we are assigning a work RVU of 7.35 to CPT code 37192, with a refinement to 45 minutes of intra-service time, on an interim final basis for CY 2012. A complete listing of the times associated with this code is available on the CMS Web site at:
After clinical review of CPT code 37193 (Retrieval (removal) of intravascular vena cava filter, endovascular approach inclusive of vascular access, vessel selection, and all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance (ultrasound and fluoroscopy)), we believe a work RVU of 7.35 accurately reflects the work associated with this service. The AMA RUC reviewed the survey results, compared the code to other services, and concluded that the survey 75th percentile intra-service time of 60 minutes and the 25th percentile of work RVU of 8.00 accurately describes the physician work involved in the service. We believe that the work associated with CPT code 37193 is similiar to CPT code 93460 (Catheter placement in coronary artery(s) for coronary angiography, including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation; with right and left heart catheterization including intraprocedural injection(s) for left ventriculography, when performed), which has a work RVU of 7.35 and the following times: 48 minutes pre-service, 50 minutes intra-service, and 30 minutes post-service. As such, we believe that the survey median intra-service time of 45 minutes appropriately accounts for the time required to furnish the intra-service work associated with this procedure. Therefore, we are assigning a work RVU of 7.35 to CPT code 37193, with a refinement to 45 minutes of intra-service time, on an interim final basis for CY 2012. A complete listing of the times associated with this code is available on the CMS Web site at:
After clinical review of CPT code 37619 (Ligation of inferior vena cava), we believe a work RVU of 30.00 accurately reflects the work associated with this service. The AMA RUC reviewed the survey results, compared the code to other services, and concluded that the survey respondents underestimated the total physician work for this rarely performed service, by underestimating the significant post-operative work. The AMA RUC recommended a work RVU of 37.60 for CPT code 37619. We determined that the work associated with this service is more aligned with reference CPT code 37617 (Ligation, major artery (
For the CY 2012 new, revised, and potentially misvalued CPT codes reviewed in this family of services and not specifically discussed here, we agree with the AMA RUC/HCPAC-recommended work RVUs and are setting as interim final the work RVUs listed in Table 19.
For CY 2012, the CPT Editorial Panel split CPT code 38230 into two separate codes: 38230 (Bone marrow harvesting for transplantation; allogeneic), and 38232 (Bone marrow harvesting for transplantation; autologous) to more accurately reflect current practice. For CY 2012, we changed the global period from 010 to 000 for CPT code 38230, and also assigned a global period of 000 to CPT code 38232, as these services rarely require overnight hospitalization and physician follow-up in the days following the procedure.
After clinical review of CPT codes 38230 and 38232, we believe that a work RVU of 3.09 appropriately accounts for the work associated with these services. The AMA RUC reviewed the specialty society survey results and, after comparison to similar CPT codes, the AMA RUC recommended the survey median work RVU of 4.00 for CPT code 38230, and the survey median work RVU of 3.50 for CPT code 38232. We believe that the work for these services is very similar and should be valued the same. CPT code 38230 currently (CY 2011) has a work RVU of 4.85 with a ten-day global period that includes 1 CPT code 99213 level 3 office or outpatient visit, and 1 CPT code 99238 discharge day management service. To
We identified CPT code 47000 (Biopsy of liver, needle; percutaneous) as potentially misvalued through the Harvard-Valued—Utilization > 30,000 screen.
After clinical review of CPT code 47000, we believe that the current (CY 2011) work RVU of 1.90 be maintained. The AMA RUC reviewed the specialty society survey data, and also concluded that a work RVU of 1.90 be maintained. We request that the AMA RUC and CPT Editorial Panel consider reviewing all the percutaneous biopsy CPT codes to incorporate imaging guidance into the RVU and descriptor where appropriate. We are assigning a work RVU of 1.90 to CPT code 47000 on an interim final basis for CY 2012.
The AMA RUC identified CPT codes 49080 and 49081 through the Harvard-Valued—Utilization > 100,000 screen. The related specialty societies noted that the services have evolved since the codes were initially established and need separate codes that distinguish paracentesis performed without imaging guidance and paracentesis performed with imaging guidance. For CY 2012, the CPT Editorial Panel deleted CPT codes 49080 and 49081 and created 3 new CPT codes, 49082, 49083, and 49084, to more accurately describe the current medical practice.
After clinical review of CPT code 49082 (Abdominal paracentesis (diagnostic or therapeutic); without imaging guidance), we believe that a work RVU of 1.24 accurately accounts for the work associated with this service. The AMA RUC recommended a work RVU of 1.35 for CPT code 49082, which corresponds to the current (CY 2011) work RVU for CPT code 49080 (CY 2011 descriptor: Peritoneocentesis, abdominal paracentesis, or peritoneal lavage (diagnostic or therapeutic); initial). For CPT code 49082 we believe that the survey response rate (9 of 517) is too low to produce a reliable estimate. We believe that CPT code 49082 is similar in time and intensity to CPT code 32562 (Instillation(s), via chest tube/catheter, agent for fibrinolysis (
After clinical review of CPT codes 49083 (Abdominal paracentesis (diagnostic or therapeutic); with imaging guidance) and 49084 (Peritoneal lavage, including imaging guidance, when performed), we believe that a work RVU of 2.00 accurately accounts for the work associated with these services. After comparison to similar CPT codes, the AMA RUC recommended a work RVU of 2.00 for CPT code 49083 and a work RVU of 2.50 for CPT code 49084. We agree with the AMA RUC-recommended work RVU of 2.00 for CPT code 49083, and believe that CPT code 49084 requires similar work and should be valued the same. Therefore, we are assigning a work RVU of 2.00 to CPT codes 49083 and 49084 on an interim final basis for CY 2012.
For CY 2012 the AMA RUC Relativity Assessment Workgroup identified CPT codes 62367, 62368, 95990, and 95991 as part of the Codes Reported Together 75 percent or More screen. For CY 2012, the CPT Editorial Panel created 2 new CPT codes, 62369 and 62370, to report electronic analysis of programmable implanted pump for intrathecal or epidural drug infusion with reprogramming and refill requiring and not requiring physician's skill and editorially revised 3 existing CPT codes, CPT code 62367 to report without reprogramming or refill and CPT codes 95990 and 95991 to report refilling and maintenance of implantable pump or reservoir for drug delivery requiring and not requiring physician skill. The changes to CPT code 95990 and 95991 were editorial only and did not require a review of the physician work or practice expense.
After clinical review of CPT code 62370 (Electronic analysis of programmable, implanted pump for intrathecal or epidural drug infusion (includes evaluation of reservoir status, alarm status, drug prescription status); with reprogramming and refill (requiring physician's skill)), we believe that a work RVU of 0.90 accurately accounts for the work associated with this service. After a comparison to similar services, the AMA RUC recommended a work RVU of 1.10 for CPT code 62370 based on a crosswalk to CPT code 56605 (Biopsy of vulva or perineum (separate procedure); 1 lesion). We believe that a work RVU of 1.10 for CPT code 62370 is too high compared to similar services in this family. We find CPT code 62370 to be similar in intensity and complexity to CPT code 93281 (Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with physician analysis, review and report; multiple lead pacemaker system) (work RVU = 0.90). We believe that a work RVU of 0.90, which is between the specialty society survey 25th percentile and median work RVU, appropriately reflects the work of CPT code 62370. Therefore, we are assigning a work RVU of 0.90 to CPT code 62370 on an interim final basis for CY 2012.
For the CY 2012 new, revised, and potentially misvalued CPT codes reviewed in this family of services and not specifically discussed here, we agree with the AMA RUC/HCPAC-recommended work RVUs and are setting as interim final the work RVUs listed in Table 19.
CPT code 64626 was identified by the AMA RUC's Five-Year Review Identification Workgroup as potentially misvalued through the Site-of-Service Anomaly screen. The specialty society requested and the AMA RUC agreed that CPT codes 64622, 64623, 64626, 64627 be referred to CPT to clarify that imaging is required. For CY 2012, the CPT Editorial Panel deleted four CPT codes (64622-64623, and 64626-64627) and created four new CPT codes (64633-64636) to describe neurolysis reported per joint (2 nerves per each joint) instead of per nerve, under image guidance.
After clinical review of CPT codes 64633 (Destruction by neurolytic agent, paravertebral facet joint nerve(s); cervical or thoracic, with image guidance (fluoroscopy or CT), single facet joint), 64634 (Destruction by neurolytic agent, paravertebral facet joint nerve(s); cervical or thoracic, with image guidance (fluoroscopy or CT), each additional facet joint (List separately in addition to code for primary procedure)), 64635 (Destruction by neurolytic agent, paravertebral facet joint nerve(s); lumbar or sacral, with image guidance (fluoroscopy or CT), single facet joint), and 64636 (Destruction by neurolytic agent, paravertebral facet joint nerve(s); lumbar or sacral, with image guidance (fluoroscopy or CT), each additional facet joint (List separately in addition to code for primary procedure)), we believe that the specialty society survey 25th percentile work RVUs of 3.84, 1.32, 3.78, and 1.16 (respectively) accurately reflect the work associated with these services. These are also the AMA RUC-recommended work RVUs for these services. For CPT codes 64635 and 64636, we believe that the survey median intra-service times of 28 minutes and 15 minutes (respectively) appropriately allow for the intra-service work associated with furnishing these services. The AMA RUC recommended an intra-service time of 30 minutes for CPT code 64635, and an intra-service time of 20 minutes for CPT code 64636.
CPT codes 74175 and 72191 were identified by the AMA RUC Relativity Assessment Workgroup's Codes Reported Together 75 percent or More screen, with both services reported over 95 percent of the time together. For CY 2012, the CPT Editorial Panel created CPT code 74174 which bundles the work of CPT codes 74175 and 72191 when reported together on the same date of service.
We reviewed CPT code 74174 (Computed tomographic angiography, abdomen and pelvis; with contrast material(s), including noncontrast images, if performed, and image postprocessing), and are accepting the AMA RUC-recommended work RVUs and times on an interim basis for CY 2012. We request that the AMA RUC review the component CPT codes: 74175 (Computed tomographic angiography, abdomen, with contrast material(s), including noncontrast images, if performed, and image postprocessing) and 72191 (Computed tomographic angiography, pelvis, with contrast material(s), including noncontrast images, if performed, and image postprocessing). On an interim basis for CY 2012 we are assigning a work RVU of 2.20 to CPT code 74174.
CPT code 88104 was identified through the AMA RUC Relativity Assessment Workgroup by the Harvard-Valued—Utilization > 100,000. Additionally, CPT codes 88106-88108 were identified as part of the Cytopathology family for AMA RUC review.
After clinical review of CPT code 88104 (Cytopathology, fluids, washings or brushings, except cervical or vaginal; smears with interpretation), we believe that the current (CY 2011) work RVU of 0.56 accurately reflects the work associated with this service. We also believe that 24 minutes of intra-service time, the survey median, and no pre- or post-service time is appropriate for this service. That AMA RUC also recommended a work RVU of 0.56 for CPT code 88104 and 24 minutes of intra-service time with no pre- or post-service time. Therefore, we are maintaining the current work RVU of 0.56 and 24 minutes of intra service time for CPT code 88104 on an interim final basis for CY 2012.
After clinical review of CPT code 88106 (Cytopathology, fluids, washings or brushings, except cervical or vaginal; simple filter method with interpretation) we believe that a work RVU of 0.37 accurately reflects the work associated with this service. The AMA RUC reviewed the survey results for CPT code 88106 and recommended a work RVU of 0.56. However, we believe that this value overstates the work of this service when compared to the CPT code 88104. We believe that CPT code 88106 is similar in intensity to CPT code 88104, and that the primary factor distinguishing the work of the two services is the intra-service time. As previously, CPT code 88104 has a work RVU of 0.56, and 24 minutes of intra-service time. For CPT code 88106, we believe 16 minutes of intra-service time, the survey median, is appropriate for this service. Therefore, we believe that the work RVU for CPT code 88106 should be reduced proportionately to reflect the lower intra-service time in order to maintain relativity with the CPT code 88104.
In calculating the RVU for CPT code 88106, we determined the RVU per minute (0.56/24 = 0.023) for the CPT code 88104. Then we multiplied the RVU per minute (0.023) of CPT code 88104 by the intra-service minutes for CPT code 88106 (0.023*16 = 0.37). We believe a work RVU of 0.37 appropriately maintains relativity with CPT code 88104. Therefore, we are assigning a work RVU of 0.37 for CPT code 88106 and an intra-service time of 16 minutes on an interim final basis for CY 2012. The times assigned to this CPT code are available on the CMS Web site at:
After clinical review of CPT code 88108 (Cytopathology, concentration technique, smears and interpretation
In calculating the RVU for CPT code 88108, we determined the RVU per minute (0.56/24 = 0.023) for the CPT code 88104. Then we multiplied the RVU per minute (0.023) of CPT code 88104 by the intra-service minutes for CPT code 88108 (0.023*19 = 0.44). We believe a work RVU of 0.44 appropriately maintains relativity with CPT code 88104. Therefore we are assigning a work RVU of 0.44 and an intra-service time of 19 minutes to CPT code 88108 on an interim final basis for CY 2012. The times assigned to this CPT code are available on the CMS Web site at:
After clinical review of CPT code 90845 (Psychoanalysis), including a review of the information provided by the specialty societies and the AMA RUC, we believe that the current (2011) work RVU of 1.79 and the current times should be maintained for this code until the other codes in the family are revised by CPT and reviewed by the AMA RUC. The AMA RUC recommended a work RVU of 2.10 for CPT code 90845. We would like to refrain from establishing a new interim final value for CPT code 90845 until we can view this CPT code relative to the revised codes in the family, which we anticipate reviewing for CY 2013. Therefore, we are maintaining the current work RVU of 1.79 and current times for CPT code 90845 on an interim basis for CY 2012. A complete listing of the times associated with CPT code 90845 is available on the CMS Web site at:
For CY 2011 the CPT Editorial Panel converted Category III codes 0160T and 0161T to Category I status CPT codes 90867 and 90868, which were contractor priced on the Physician Fee Schedule. For CY 2012, the CPT Editorial Panel modified CPT codes 90867 and 90868, and created CPT code 90869. These three CPT codes are priced on the Physician Fee Schedule for CY 2012.
After clinical review of CPT code 90867 (Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; initial, including cortical mapping, motor threshold determination, delivery and management), we believe that the AMA RUC-recommended survey median work RVU of 3.52 appropriately reflects the work associated with this service. However, we believe that the survey 75th percentile intra-service time of 60 minutes appropriately accounts for the time required to furnish the intra-service work of this procedure. The AMA RUC recommended 65 minutes of intra-service time for CPT code 90867. We are assigning a work RVU of 3.52, with refinement to 60 minutes of intra-service time, to CPT code 90867 on an interim final basis for CY 2012. A complete listing of the times associated with CPT code 90867 is available on the CMS Web site at:
After clinical review of CPT code 90869 (Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; subsequent motor threshold re-determination with delivery and management), we believe that a work RVU of 3.00 appropriately accounts for the work associated with this service. The original specialty society recommendation to the AMA RUC for CPT code 90869 was for a work RVU of 3.00, and the AMA RUC recommended to us a work RVU of 3.20, the survey median. We believe that CPT code 90869 is similar in time and intensity to CPT code 95974 (Electronic analysis of implanted neurostimulator pulse generator system (
For the CY 2012 new, revised, and potentially misvalued CPT codes reviewed in this family of services and
For the Fourth Five-Year Review, we identified CPT code 92070 through the Harvard-Valued—Utilization > 30,000 screen. Upon review of this service, the specialty societies agreed that there are two distinct uses for CPT code 92070 that have substantially different levels of work. For CY 2012, the CPT Editorial Panel agreed and deleted CPT code 92070 and created two new CPT codes (92071 and 92072) to distinguish reporting of fitting of contact lens for treatment of ocular surface disease and fitting of contact lens for management of keratoconus.
CPT code 92070 (Fitting of contact lens for treatment of disease, including supply of lens) is being deleted for CY 2012 and the utilization from CPT code 92070 is expected to be captured by new CPT code 92071(Fitting of contact lens for treatment of ocular surface disease). As CPT code 92070 was typically billed with an E/M service on the same day, we believe that CPT code 92071 will also be billed typically with an E/m service on the same day. We believe some of the activities conducted during the pre- and post-service times of the procedure code and the E/M visit overlap and, therefore, should not be counted twice in developing the procedure's work value. As described earlier in section III.A. of this final rule with comment period, to account for this overlap, we reduced the pre-service evaluation and post-service time by one-third. For CPT code 92071 we reduced the pre-service evaluation time and the post service time from 5 minutes to 3 minutes.
In order to determine the appropriate work RVU for CPT code 92071, given the time change, we calculated the value of the extracted time and subtracted it from the AMA RUC-recommended work RVU. For CPT code 92071, we removed a total of 4 minutes at an intensity of 0.0224 per minute, which amounts to the removal of 0.09 of a work RVU. The AMA RUC recommended a work RVU of 0.70, the current (CY 2011) work RVU for CPT code 92070. Therefore, we are assigning an interim final work RVU of 0.61, with refinement to time, to CPT code 92071 for CY 2012. A complete listing of the times assigned to CPT code 92071 is available on the CMS Web site at:
For the CY 2012 new, revised, and potentially misvalued CPT codes reviewed in this family of services and not specifically discussed here, we agree with the AMA RUC/HCPAC-recommended work RVUs and are setting as interim final the work RVUs listed in Table 19.
We identified CPT code 92587 through the CMS Fastest Growing screen. For CY 2011, the specialty society surveyed this service, however, after reviewing the survey data, they concluded that more than one service is being represented under this code and requested the service be referred back to the CPT Editorial Panel for further clarification. For CY 2012, the CPT Editorial Panel created CPT code 92558 to describe evoked otoacoustic emissions screening and revised CPT codes 92587 and 92588 clarify the otoaucoustic emissions evaluations.
New CPT code 92558 (Evoked otoacoustic emissions; screening (qualitative measurement of distortion product or transient evoked otoacoustic emissions), automated analysis) describes a screening service that does not fall within the statutory definition of a physicians' service, per section 1848 of the Act. As such, CPT code 92558 will have procedure status of X on the PFS for CY 2012, which indicates that this service is not within the statutory definition of “physicians' service” for PFS payment purposes. We will not pay for CPT code 92558 under the PFS. We note that the HCPAC recommended a work RVU of 0.17, with 5 minutes of intra-service time and 2 minutes of immediate post-service time, for CPT code 92558.
After clinical review of CPT code 92587 (Distortion product evoked otoacoustic emissions; limited evaluation (to confirm the presence or absence of hearing disorder, 3-6 frequencies) or transient evoked otoacoustic emissions, with interpretation and report), we believe that the survey 25th percentile work RVU of 0.35 accurately describes the work associated with this service. The HCPAC reviewed the survey results, and
After clinical review of CPT code 92588 (Distortion product evoked otoacoustic emissions; comprehensive diagnostic evaluation (quantitative analysis of outer hair cell function by cochlear mapping, minimum of 12 frequencies), with interpretation and report), we believe that the survey 25th percentile work RVU of 0.55 accurately describes the work associated with this service. The HCPAC reviewed the survey results, and after a comparison to similar CPT codes, recommended the survey median work RVU of 0.62 for CPT code 92588. We believe that CPT code 92588 is similar in work to CPT code 92570 (Acoustic immittance testing, includes tympanometry (impedance testing), acoustic reflex threshold testing, and acoustic reflex decay testing) (work RVU = 0.55), and that the survey 25th percentile work RVU of 0.55 appropriately reflects the relativity of this service. Therefore, we are assigning a work RVU of 0.55 to CPT code 92588 on an interim final basis for CY 2012.
As a result of the Medicare Improvements for Patients and Providers Act of 2008, starting in July 2009, speech-language pathologists were able to bill Medicare independently as private practitioners. The American Speech-Language-Hearing Association (ASHA) requested that we, in light of the legislation, base speech-language pathology services on professional work values and not through the practice expense component. As a result, we requested that the AMA RUC review the speech-language pathology codes for professional work as requested by ASHA. After reviewing the survey data for CPT code 92605, the specialty society indicated and the HCPAC agreed that CPT code 92605 would be better captured as a “per hour” code. For CY 2012, the CPT Editorial Panel revised CPT code 92605 to indicate “first hour” and created a new add-on code (CPT code 92618) to capture each additional 30 minutes.
Revised CPT code 92605 (CY 2012 long descriptor: Evaluation for prescription of non-speech-generating augmentative and alternative communication device, face-to-face with the patient; first hour) currently (CY 2011) has a procedure status indicator of B on the PFS, which indicates that payment for the service is always bundled into payment for other services not specified. We continue to believe that payment for this service is included in other services and, therefore, that CPT code 92605 should maintain the procedure status indicator of B on the PFS. As new CPT code 92618 (Evaluation for prescription of non-speech-generating augmentative and alternative communication device, face-to-face with the patient; each additional 30 minutes (List separately in addition to code for primary procedure)) is the add-on procedure code to CPT code 92605, we believe that payment for that service should also be considered bundled into payment for other services, and therefore, should also have a procedure status indicator of B on the PFS. For CPT code 92605 the HCPAC recommended the survey 25th percentile work RVU of 1.75. For CPT code 92618 the HCPAC recommended the survey 25th percentile work RVU of 0.65. We are publishing these RVUs in the CY 2012 PFS, however, as stated previously, both codes will have a procedure status indicator of B and will not be separately payable on the PFS.
In the CY 2012 final rule with comment period (75 FR 73334 through 73337), we discussed generally the concept of bundling services and specifically, new CY 2011 CPT codes that describe the bundling of two or more existing component services performed together 95 percent or more of the time. As we noted in that rule, we expect this bundling of component services to continue over the next several years as the work efficiencies for services commonly furnished together are recognized. Stakeholders should expect that increased bundling of services into fewer codes will result in reduced PFS payment for a comprehensive service. Specifically, the decrease in RVUs assigned to the comprehensive service, as compared to the total RVUs of the sum of the individual component services, reflects the efficiencies in work and/or PE that occur when component services are furnished together.
For CY 2011, the AMA RUC provided CMS with recommendations for several categories of new comprehensive services that historically have been reported under multiple component codes. These services fell into the three major clinical categories of: Endovascular revascularization, computed tomography (CT), and diagnostic cardiac catheterization. In the CY 2011 final rule with comment period, we acknowledged that while each category of services is unique, since bundling of component services is likely to occur more often in the coming years, we believe a consistent approach is especially important when valuing bundled services to ensure that RVUs reflect work efficiencies.
As discussed in the CY 2011 final rule with comment period, the AMA RUC used a variety of methodologies in developing RVUs for comprehensive codes in these three categories of bundled services. To develop the RVUs for the comprehensive endovascular revascularization services, the AMA RUC generally recommended the median work RVUs from the physician survey performed by the specialty society. The recommended values for the comprehensive services are an average of 27 percent lower than the summed RVUs of the component services (taking into consideration any MPPR that would currently apply) included in the bundle. To develop the RVUs for comprehensive CT services, the AMA RUC recommended taking the sum of 100 percent of the current work RVUs for the code with the highest RVUs and 50 percent for the second code. Under this methodology, the recommended work RVUs for the comprehensive CT codes are consistently approximately 25 percent lower than the sum of the RVUs for the component services (75 FR 7335 through 7336). We agreed in the CY 2011 final rule with comment period that the decreased work RVUs that the AMA RUC recommended for comprehensive services in these two categories reflected a reasonable estimation of the work efficiencies created by the bundling of the component services. Therefore, for CY 2011, we accepted as interim final work RVUs the AMA RUC-recommended values for endovascular revascularization and CT services, and we are finalizing our interim final work RVUs without modification for CY 2012 (Table 15) see section III.B.1. of this final rule with comment period.
In contrast to the endovascular revascularization and CT codes, the AMA RUC recommended values for the comprehensive diagnostic cardiac catheterization codes did not appear to reflect the efficiencies in work and/or PE that occur when component services are furnished together. To develop the RVUs for comprehensive diagnostic cardiac catheterization services, the AMA RUC generally recommended the lower of either the sum of the current RVUs for the component services or the physician survey 25th percentile value. In most cases, the AMA RUC's recommendation for the comprehensive service was actually the sum of the current work RVUs for the component services, and we stated in the CY 2011 final rule with comment period that we were unsure how this approach is resource-based with respect to physician work. We also were concerned that the results of the physician survey overstated the work for these well-established procedures because the 25th percentile work RVU value was usually higher than the sum of the current RVUs for the component services. Finally, we noted that, in
In contrast to the result of combining the component codes into comprehensive endovascular revascularization and CT bundles where efficiencies were reflected through significant reductions in the RVUs (average of 27 percent and 25 percent respectively), the AMA RUC-recommended RVUs for the comprehensive codes for diagnostic cardiac catheterization were an average of only one percent lower. We noted that if we were to accept the AMA RUC's recommended values for these cardiac catheterization codes, we essentially would be agreeing with the presumption that there are negligible work efficiencies gained in the bundling of these services. On the contrary, we believed that the AMA RUC did not fully consider or account for the efficiency gains when the component services are furnished together, which was also supported by the significant reduction in reported service time on the survey. Therefore, in the CY 2011 final rule with comment period, we requested that the AMA RUC reexamine the cardiac catheterization codes as quickly as possible, given the significant PFS utilization and spending for these services, and put forward an alternative approach to valuing these services that would produce relative values that are resource-based and account for efficiencies inherent in bundling.
For CY 2011, we also stated that we believed the new comprehensive diagnostic cardiac catheterization codes would be overvalued under the AMA RUC's CY 2011 recommendations. To address this potential overvaluation, we employed an interim methodology to approximate the efficiencies garnered through the bundling of the component codes to determine alternative CY 2011 interim values for the cardiac catheterization codes based on the information that we had at the time. Given that the AMA RUC recommendations for the bundling of endovascular revascularization and CT codes resulted in average reductions in the RVUs of 27 percent and 25 percent respectively, we believed an approximation of work efficiencies garnered through the bundling of the component codes could be up to 27 percent. Since we were referring the cardiac catheterization codes back to the AMA RUC, requesting that the AMA RUC provide CMS with a better estimate of the work efficiencies, we believed at the time that applying a conservative estimate of the work efficiencies was appropriate as an interim measure. Accordingly, to account for efficiencies inherent in bundling, we set the work RVUs for all of the bundled CY 2011 cardiac catheterization codes for which we received AMA RUC recommendations to 10 percent less than the sum of the current work RVUs for the component codes, taking into consideration any MPPR that would apply under current PFS policy.
At our request, the AMA RUC reviewed these codes again for CY 2012 and reiterated its previous recommendations, maintaining that there are negligible work efficiencies gained in the bundling of these services. The AMA RUC noted that over the 20 years that cardiac catheterization services have been available to patients, several of the codes being bundled have been bundled and unbundled a number of times in the past and that in each instance, the CMS has retained the RVUs of component codes. In response to CMS' observation that the recently surveyed physician times of the new CY 2011 comprehensive codes were significantly reduced, the AMA RUC stated that the new times were correct and that the previous times were grossly overstated. That is, the previous times originating from the Harvard valuation process rather than the survey process were inaccurate. The AMA RUC explained that the specialty societies have not previously addressed inaccurate physician times in any of the previous bundling/unbundling opportunities, because the societies deemed physician time unimportant and stakeholders focused on the work RVUs of the services instead. Stakeholders also strongly argued that no one had previously validated the physician time for the services in place for 20 years, although they continued to urge CMS to accept that the RVUs developed through the same process remain unchanged.
In lieu of a more specific estimate from the AMA RUC, and using the best information available to us at this time, we believe it is appropriate to assign as interim final for CY 2012 our CY 2011 interim values with a 10 percent reduction in work efficiencies. Specifically, for CY 2012, we are assigning the following interim final work RVUs for the following CPT codes: 2.72 for CPT code 93451 (Right heart catheterization including measurement(s) of oxygen saturation and cardiac output, when performed), 4.75 for CPT code 93452 (Left heart catheterization including intraprocedural injection(s) for left ventriculography, imaging supervision and interpretation, when performed), 6.24 for CPT code 93453 (Combined right and left heart catheterization including intraprocedural injection(s) for left ventriculography, imaging supervision and interpretation, when performed), 4.79 for CPT code 93454 (Catheter placement in coronary artery(s) including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation),
For the CY 2012 new, revised, and potentially misvalued CPT codes reviewed in this family of services and not specifically discussed here, we agree with the AMA RUC/HCPAC-recommended work RVUs and are setting as interim final the work RVUs listed in Table 19.
We identified CPT code 94060 through the MPC List screen. The AMA RUC Relativity Assessment Workgroup identified CPT codes 94240, 94260, 94350, 94360, 94370, and 94725 through the Codes Reported Together 75 percent or More screen. These codes are commonly billed together with CPT code 94720, 94360, 94240, and 94350. For CY 2012, the specialty society submitted a codes change proposal to the CPT Editorial Panel to bundle the services commonly reported together. As a result, CPT created CPT codes 94726, 94727, 94728, and 94729. For CY 2012, CPT also created CPT codes 94780 and 94781 to report car seat testing administered to the patient in the private physician's office.
After clinical review, we determined that CPT codes 94060 (Bronchodilation responsiveness, spirometry as in 94010, pre- and post-bronchodilator
After clinical review of CPT code 94729 (Diffusing capacity (
For the CY 2012 new, revised, and potentially misvalued CPT codes reviewed in this family of services and not specifically discussed here, we agree with the AMA RUC/HCPAC-recommended work RVUs and are setting as interim final the work RVUs listed in Table 19.
CPT codes 95860, 95861, 95863 and 95864 were identified by the AMA RUC Relativity Assessment Workgroup through the Codes Reported Together 75 percent or More screen. These codes are billed commonly with CPT code 95904. The specialty societies submitted a code change proposal to the CPT Editorial Panel to bundle the services commonly reported together. For CY 2012, the CPT Editorial Panel created 3 new add-on procedure codes: CPT codes 95885, 95886, and 95887. The CPT Editorial Panel noted, and the AMA RUC agreed, that these 3 new codes were approved with the intent that the specialties will take additional time and bring forward a more comprehensive coding solution which bundles services commonly performed together for CY 2013.
We reviewed CPT codes 95885 (Needle electromyography, each extremity, with related paraspinal areas, when performed, done with nerve conduction, amplitude and latency/velocity study; limited), 95886 (Needle electromyography, each extremity with related paraspinal areas when performed, done with nerve conduction, amplitude and latency/velocity study; complete, five or more muscles studied, innervated by three or more nerves or four or more spinal levels), 95887 (Needle electromyography, non-extremity (cranial nerve supplied or axial) muscle(s) done with nerve conduction, amplitude and latency/velocity study), and are accepting the AMA RUC-recommended work RVUs and times on an interim basis, pending review of the other electromyography services for CY 2012. On an interim basis for CY 2012 we are assigning a work RVU of 0.35 to CPT code 95885, a work RVU of 0.92 to CPT code 95886, and a work RVU of 0.73 to CPT code 95887.
CPT code pairs 95925/95926 and 95928/95929 were identified by the AMA RUC Relativity Assessment Workgroup Codes Reported Together 75 percent or More screen. For CY 2012, the CPT Editorial Panel created CPT code 95938 to capture the reporting of CPT codes 95925 and 95926 together, and CPT codes 95939 to capture the reporting CPT codes 95928 and 95929 together. The specialty society had obtained valid survey results for CPT code 95938 but not for 95939, as only 31 percent of the respondents indicated the vignette was typical. The AMA RUC and specialty societies agreed that a new survey should be conducted for CY 2013.
We reviewed CPT codes 95938 (Short-latency somatosensory evoked potential study, stimulation of any/all peripheral nerves or skin sites, recording from the central nervous system; in upper and lower limbs) and 95939 (Motor evoked potential study; in upper and lower limbs), and are accepting the AMA RUC-recommended work RVUs and times on an interim basis, pending resurvey of CPT code 95939. We also request that the AMA RUC review the component CPT codes 95925, 95926, 95928, and 95929. On an interim basis for CY 2012 we are assigning a work RVU of 0.86 to CPT code 95938, and a work RVU of 2.25 to CPT code 95939.
For all other CY 2012 new, revised, and potentially misvalued CPT codes not specifically discussed previously, we agree with the AMA RUC/HCPAC recommended work RVUs and are setting as interim final the work RVUs listed in Table 19.
The AMA RUC provides CMS with recommendations regarding direct PE inputs, including clinical labor, supplies, and equipment, for new, revised, and potentially misvalued codes. We review the AMA RUC-recommended direct PE inputs on a code-by-code basis, including the recommended facility PE inputs and/or nonfacility PE inputs, as clinically appropriate for the code. We determine whether we agree with the AMA RUC's recommended direct PE inputs for a service or, if we disagree, we refine the PE inputs to represent inputs that better reflect our estimate of the PE resources required for the service in the facility and/or nonfacility settings. We also confirm that CPT codes should have facility and/or nonfacility direct PE inputs and make changes based on our clinical judgment and any PFS payment policies that would apply to the code.
We have accepted for CY 2012, as interim final and without refinement, the direct PE inputs based on the recommendations submitted by the AMA RUC for the codes listed in Table 20. For the remainder of the AMA RUC's direct PE recommendations, we have accepted the PE recommendations submitted by the AMA RUC as interim final, but with refinements. These codes and the refinements to their direct PE inputs are listed in Table 21.
Generally, we only establish interim final direct PE inputs for services when the RUC has provided a new recommendation. For CY 2012, we are establishing interim final direct PE inputs for several codes for which the RUC did not provide direct PE recommendations. In the case of these codes, we believe it is necessary to establish new interim final direct PE inputs for codes not recently reviewed by the RUC for the same reasons we explain in greater detail in section II.B (“Potentially Misvalued Services Under the Physician Fee Schedule”) of this final rule with comment period: In order to maintain appropriate relativity among those codes and other related codes or between the PE and work components of PFS payment. There are two situations that have prompted us to establish interim final direct PE inputs for particular codes without a corresponding direct PE recommendation from the RUC.
The first situation occurs when the direct PE inputs of new, combined codes are developed without parallel review of the direct PE inputs of the component codes that describe the same services. For CY 2012, this situation applies to three sets of codes. CPT has created a new code, 74174, to describe CTA of the abdomen and pelvis. Prior to CY 2012, practitioners would have reported the combined service using two separate codes (74175 to describe CTA of the abdomen and 72191 to describe CTA of the pelvis). CPT similarly created a new combined code to describe short latency somatosensory evoked potential studies of the upper and lower limbs (95938). This combined service would have been previously reported using CPT codes 95925 (short latency somatosensory evoked potential studies of the upper limbs) and 95926 (short latency somatosensory evoked potential studies of the lower limbs). Finally, CPT created 95939 to describe central motor evoked potential study of the upper and lower limbs. This combined service would have been previously reported using component CPT codes 95928 (central motor evoked potential study of the upper limbs) and 95929 (central motor evoked potential study of the lower limbs).
Since each of these sets of component and combined codes is used to report the same service, we believe that it is important to maintain relativity among the associated practice expense values. We received direct PE recommendations from the RUC for the new codes describing combined services, but we did not receive corresponding recommendations regarding the existing codes describing the component services. The new direct PE inputs for the combined services are not fully congruent with the current direct PE inputs for the component codes. Therefore, maintaining the direct PE inputs for the existing component codes until we receive a RUC recommendation would result in at least one year of incongruent practice expense values. Therefore, we believe that it would be inappropriate to develop PE values for these sets of codes based on these inputs. Since we do not have corresponding recommendations regarding the existing component codes, we cannot maintain appropriate relativity among the codes without either refining the direct PE inputs of the new combined codes to conform to the existing component codes or refining the direct PE inputs of the existing component codes to conform to the direct PE inputs of the new combined codes. The direct PE inputs for each of the existing component codes were developed over 5 years ago. Since the direct PE inputs for the new combined codes were developed more recently, we believe that they better reflect current typical practice. Therefore, in order to maintain appropriate relativity among these sets of codes that describe the same services and in order to use the most accurate information available, we used the direct PE inputs for the new, combined codes in order to develop appropriate refinements to the direct PE inputs for the existing, component codes. The refinements to the current PE inputs for these codes are included in Table 21 and they will be considered interim final for CY 2012. In conjunction with our request for comprehensive review of code families as described in section II.B. of this final rule with comment period, we encourage the RUC to review component codes when developing recommendations regarding combined codes.
The second situation arises when the physician work values of particular codes are reviewed as part of the potentially misvalued code initiative without parallel review of the
While Table 21 details the CY 2012 refinements of the AMA RUC's direct PE recommendations at the code-specific level, we discuss the general nature of some common refinements and the reasons for particular refinements in the following section.
Some direct PE inputs are directly affected by revisions in physician time described in section III.B.1 of this final rule with comment period. Specifically, changes in the intra-service portions of the physician time and changes in the number or level of postoperative visits associated with the global periods result in corresponding changes to direct PE inputs.
For equipment associated with the intra-service period in the nonfacility setting, we generally allocate time based on the typical number of minutes a piece of equipment is being used and, therefore, not available for use with another patient during that period. In general, we allocate these minutes based on the description of typical clinical labor activities. To the extent that we are making changes in the clinical labor times associated with the intra-service portion of procedures, we have adjusted the corresponding equipment minutes associated with the codes.
These refinements are reflected in the final CY 2011 PFS direct PE database and detailed in Table 21.
In general, the equipment time inputs correspond to the intra-service portion of the clinical labor times. Certain highly technical pieces of equipment and equipment rooms are less likely to be used by a clinician over the full course of a procedure and are typically available for other patients during time that may still be in the intra-service portion of the service. We adjust those equipment times accordingly. We refer interested stakeholders to our extensive discussion of these policies in the context of our CY 2011 interim final direct PE inputs in section III.B.2 of this final rule with comment period. We are refining the CY 2012 AMA RUC direct PE recommendations to conform to these equipment time policies. These refinements are reflected in the final CY 2011 PFS direct PE database and detailed in Table 21.
In section II.A.3 of this final rule with commenter period, we finalized a standard package of direct PE inputs for services where moderate sedation is considered inherent in the procedure. We refer interested parties to our extensive discussion of these policies as proposed and finalized in section III.A.3 of this final rule with comment period. We are refining the CY 2012 AMA RUC direct PE recommendations to conform to these policies. These refinements are reflected in the final CY 2012 PFS direct PE database and detailed in Table 21.
In general, the minutes associated with certain clinical labor tasks are standardized depending on the type of procedure, its typical setting, its global period, and the other procedures with which it is typically reported. In the case of some services, the RUC has recommended a numbers of minutes either greater or lesser than time typically allotted for certain tasks. In those cases, CMS clinical staff has reviewed the deviations from the standards to determine their clinical appropriateness. Where the recommended exceptions have not been accepted, we have refined the interim final direct PE inputs to match the standard times for those tasks and each of those refinements appears in Table 21.
When clinically appropriate, the AMA RUC generally recommends the use of supply and equipment items that already exist in the direct PE database for new, revised, and potentially misvalued codes. Some recommendations include supply or equipment items that are not currently in the direct PE database. In these cases, the AMA RUC has historically
We received invoices for several new supply and equipment items for CY 2012. We have accepted each of these items and added them to the direct PE database. In general, the prices listed on the submitted invoices match the items listed in the RUC direct PE recommendations. However, in some cases, the relationship between submitted invoices and the items listed on the direct PE recommendations is not clear. For example, some submitted invoices only list total charges that include all of the line items on the invoice, including charges for costs other than the price of the equipment listed on the recommendation. When the price for all of those line items is apparent, we subtract that amount from the total charges to determine the appropriate price of the equipment. For example, equipment item invoices often include line items reflecting a limited quantity of disposable supplies for use during procedures. When these supplies are built into the overall price of the equipment and they also appear as direct PE inputs, we subtract the price of the supplies from the overall price of the equipment since we have an empirical basis for determining the price of the excluded line item and the price of those supplies is built into the payment rate for the service. When we have no way of determining how much of the total price listed on the invoice includes amounts attributed to excluded line items, we cannot accept the invoice as acceptable information to establish or update a price input. In terms of the CY 2012 direct PE recommendations, we point out that while we have accepted the RUC's recommendation for direct PE inputs for SBRT treatment delivery, we could not accept the accompanying invoices to update the price of the “SRS system, SBRT, six systems, average” equipment (ER083). Each of these invoices included line items that we would not accept as part of the cost of the equipment, such as costs for training technologists to use the equipment, and the price for these items were not separately identifiable. Therefore, we did not update the equipment price for ER083 in establishing interim final direct PE inputs for CY 2012.
The RUC recommended establishing a new supply input for CPT codes 29582 (Application of multi-layer venous wound compression system, below knee; thigh and leg, including ankle and foot, when performed), 29583 (Application of multi-layer venous wound compression system, below knee; upper arm and forearm), and 29584 (Application of multi-layer venous wound compression system, below knee; upper arm, forearm, hand, and fingers). Accompanying the RUC recommendations, we received an invoice that reflected a price of $16.39 per system when purchased as part of case of eight. In response to this recommendation, we have created a supply item called “multi-layer compression system bandages” (SG096) with a price input of $16.39. As discussed in section III.B.1.b. of this final rule for comment period, for CY 2012 the CPT Editorial Panel revised the descriptor for CPT code 29581 (Application of multi-layer compression system; leg (below knee), including ankle and foot), and also created CPT codes 29582, 29583, and 29584 to describe the application of multi-layer compression to the upper and lower extremities. The CPT Editorial Panel and AMA RUC concluded that the revisions to the descriptor for CPT code 29581 were editorial only, and the specialty society believed that resurveying CPT code 29581 was not necessary. As such, the AMA RUC did not review the direct PE inputs for CPT code 29581. After clinical review, we believe that CPT codes 29581, 29582, 29583, and 29584 all describe similar services from a resource perspective. In line with this determination, we are treating all four codes as physical therapy services and replacing the supply input called “dressing, multi layer system, venous ulcer” (SG093) in 29581 with the new supply item “multi-layer compression system bandages” (SG096) on an interim basis for CY 2012.In section III.B.1.b (Establishing Interim final RVUs for CY 2012) of this CY 2012 PFS final rule, we believe that a survey that addresses all 4 CPT codes together as a family and gathers responses from all clinicians who furnish the services described by CPT codes 29581 through 29584 would help assure the appropriate gradation in valuation of these 4 services Therefore, for CY 2012 we are holding the work, practice expense, and malpractice values interim.
The RUC submitted direct PE inputs for CPT codes CPT codes 47000 (Biopsy of liver, needle; percutaneous) and 32405 (Biopsy, lung or mediastinum, percutaneous needle) including minutes allocated to a CT room. As reflected in Table 21, we refined both recommendations to exclude the CT room. For 47000, CPT instructs practitioners to report separate codes when image guidance is used to furnish the service. Therefore, it would be inappropriate to include the equipment used for image guidance as a direct PE input for 47000. For 32405, we note that the recommendations for the new nonfacility direct PE inputs for the code were developed using the direct PE inputs for recently CPT code 49083 (Abdominal paracentesis (diagnostic or therapeutic); with imaging guidance) and that code does not include use of a CT room as a typically used resource. These refinements are reflected in the final CY 2012 PFS direct PE database.
For CY 2012, CPT created CPT Editorial Panel deleted four codes and created four new codes to describe neurolysis reported per joint (2 nerves per each joint) instead of per nerve under image guidance. The new codes are: 64633 (Destruction by neurolytic agent, paravertebral facet joint nerve(s); cervical or thoracic, with image guidance (fluoroscopy or CT), single facet joint); 64634 (Destruction by neurolytic agent, paravertebral facet joint nerve(s); cervical or thoracic, with image guidance (fluoroscopy or CT), each additional facet joint (List separately in addition to code for primary procedure)); 64635 (Destruction by neurolytic agent, paravertebral facet joint nerve(s); lumbar or sacral, with image guidance (fluoroscopy or CT), single facet joint); and 64636 (Destruction by neurolytic agent, paravertebral facet joint nerve(s); lumbar or sacral, with image guidance (fluoroscopy or CT), each additional facet joint (List separately in addition to code for primary procedure)).
The RUC submitted direct practice expense inputs for these new codes that describe existing services. For codes 64633 and 64635, in addition to the cannula (SD011), the radiofrequency generator (EQ214), and other inputs, the direct PE input recommendation included a very expensive supply item called “kit, probe, radiofrequency, XIi-enhanced RF probe” (SA100). The recommendation did not provide a rationale as to why this highly priced kit should be included as a direct PE input for these existing services when the four predecessor codes that described the services prior to CY 2012 included neither this item nor any similarly priced disposable supply. Therefore, we are refining the RUC recommendation by removing the supply item SA100
According to our malpractice methodology discussed in section II.C.1. of this final rule with comment period, we have assigned malpractice RVUs for CY 2012 new and revised codes by utilizing a crosswalk to a source code with a similar malpractice risk-of-service. We have reviewed the AMA RUC-recommended malpractice source code crosswalks for CY 2012 new and revised codes, and we are accepting nearly all of them on an interim final basis for CY 2012. For four CPT codes describing multi-layer compression systems, we are assigning a source code crosswalk different from the source code crosswalks recommended by the AMA RUC and HCPAC.
For CPT codes 29582 (Application of multi-layer venous wound compression system, below knee; thigh and leg, including ankle and foot, when performed), 29583 (Application of multi-layer venous wound compression system, below knee; upper arm and forearm), and 29584 (Application of multi-layer venous wound compression system, below knee; upper arm, forearm, hand, and fingers), the AMA RUC recommended a malpractice source code crosswalk to CPT code 29540 (Strapping; ankle and/or foot). For CPT codes 29582 and 29584 the HCPAC recommended a malpractice source code crosswalk to CPT code 97124 (Therapeutic procedure, 1 or more areas, each 15 minutes; massage, including effleurage, petrissage and/or tapotement (stroking, compression, percussion)), and for CPT code 29583 the HCPAC recommended a malpractice source code crosswalk to CPT code 97762 (Checkout for orthotic/prosthetic use, established patient, each 15 minutes).
In addition to providing recommendations on malpractice source code crosswalks, the AMA RUC also provides recommendations to us on utilization crosswalks, which are largely used to estimate utilization shifts for budget neutrality. CPT codes 29582, 29583, and 29584 are new for CY 2012. The AMA RUC recommended, and we agreed, that the estimated utilization for CPT codes 29582, 29583, and 29584 would have previously been reported using CPT code 97140 (Manual therapy techniques (
As discussed in section III.B.1.b. of this final rule with comment period, for CY 2012 the CPT Editorial Panel revised the descriptor for CPT code 29581 (Application of multi-layer compression system; leg (below knee), including ankle and foot), and also created CPT codes 29582, 29583, and 29584 to describe the application of multi-layer compression to the upper and lower extremities. The CPT Editorial Panel and AMA RUC concluded that the revisions to the descriptor for CPT code 29581 were editorial only, and the specialty society believed that resurveying CPT code 29581 was not necessary. As such, the AMA RUC issued a recommendation of “No Change” to us for CPT code 29581. After clinical review, we believe that CPT codes 29581, 29582, 29583, and 29584 all describe similar services from a resource perspective. In line with this determination, we assigned CPT code 29581 the same interim work RVU as CPT code 29583. Because we find these services to be so similar, to we also believe that it is appropriate for CPT codes 29581 and 29583 to have the same malpractice source code crosswalk. Therefore, we are assigning CPT code 97140 as the malpractice source code crosswalk for CPT code 29581 on an interim basis for CY 2012. In section III.B.1.b. of this final rule with comment period, we requested that the layer compression systems family of services be surveyed together and that the AMA RUC and HCPAC review their recommendations to us for these services. For CY 2012 we are holding the work, practice expense, and malpractice values interim pending resurvey and review.
In addition to changes to the AMA RUC-recommended malpractice crosswalk mentioned previously, we also added HCPCS code G0451 to the malpractice crosswalk. As discussed in section III.B.1.b. of this final rule with comment period, for CY 2012 we created HCPCS code G0451 (Development testing, with interpretation and report, per standardized instrument form) to replace CPT code 96110 (Developmental screening, with interpretation and report, per standardized instrument form), as CPT code 96110 will be excluded from payment on the physician fee schedule effective January 1, 2012. We assigned CPT code 96110 as the malpractice source code crosswalk for HCPCS code G0451.
In accordance with our malpractice methodology, we have adjusted the malpractice RVUs of the CY 2012 new/revised codes for difference in work RVUs (or, if greater, the clinical labor portion of the fully implemented PE RVUs) between the source code and the new/revised code to reflect the specific risk-of-service for the new/revised codes. Table 22 lists the CY 2012 new/revised CPT codes and their respective source codes used to set the interim final CY 2012 malpractice RVUs. Revised CPT codes that are crosswalked to themselves (that is, CPT code 27096 to 27096) are not listed.
The SGR is an annual growth rate that applies to physicians' services paid by Medicare. The use of the SGR is intended to control growth in aggregate Medicare expenditures for physicians' services. Payments for services are not withheld if the percentage increase in actual expenditures exceeds the SGR. Rather, the PFS update, as specified in section 1848(d)(4) of the Act, is adjusted based on a comparison of allowed expenditures (determined using the SGR) and actual expenditures. If actual expenditures exceed allowed expenditures, the update is reduced. If actual expenditures are less than allowed expenditures, the update is increased.
Section 1848(f)(2) of the Act specifies that the SGR for a year (beginning with CY 2001) is equal to the product of the following four factors:
(1) The estimated change in fees for physicians' services;
(2) The estimated change in the average number of Medicare fee-for-service beneficiaries;
(3) The estimated projected growth in real GDP per capita; and
(4) The estimated change in expenditures due to changes in statute or regulations.
In general, section 1848(f)(3) of the Act requires us to publish SGRs for 3 different time periods, no later than November 1 of each year, using the best data available as of September 1 of each year. Under section 1848(f)(3)(C)(i) of the Act, the SGR is estimated and subsequently revised twice (beginning with the FY and CY 2000 SGRs) based on later data. (The Act also provides for adjustments to be made to the SGRs for FY 1998 and FY 1999. See the February 28, 2003
Section 1848(f)(4)(A) of the Act defines the scope of physicians' services covered by the SGR. The statute indicates that “the term physicians' services includes other items and services (such as clinical diagnostic laboratory tests and radiology services), specified by the Secretary, that are commonly performed or furnished by a physician or in a physician's office, but does not include services furnished to a Medicare+Choice plan enrollee.”
We published a definition of physicians' services for use in the SGR in the November 1, 2001
As discussed in the CY 2010 PFS final rule with comment period (74 FR 61961), the statute provides the Secretary with clear discretion to decide whether physician-administered drugs should be included or excluded from the definition of “physicians' services.” Accordingly, we removed physician-administered drugs from the definition of “physicians' services” in section 1848(f)(4)(A) of the Act for purposes of computing the SGR and the levels of allowed expenditures and actual expenditures beginning with CY 2010, and for all subsequent years. Furthermore, in order to effectuate fully the Secretary's policy decision to remove drugs from the definition of “physicians' services,” we removed physician-administered drugs from the calculation of allowed and actual expenditures for all prior years.
Thus, for purposes of determining allowed expenditures, actual expenditures for all years, and SGRs beginning with CY 2010 and for all subsequent years, we are specifying that physicians' services include the following medical and other health services if bills for the items and services are processed and paid by Medicare carriers (and those paid through intermediaries where specified) or the equivalent services processed by
• Physicians' services.
• Services and supplies furnished incident to physicians' services, except for the expenditures for drugs and biologicals which are not usually self-administered by the patient.
• Outpatient physical therapy services and outpatient occupational therapy services.
• Services of PAs, certified registered nurse anesthetists, certified nurse midwives, clinical psychologists, clinical social workers, nurse practitioners, and certified nurse specialists.
• Screening tests for prostate cancer, colorectal cancer, and glaucoma.
• Screening mammography, screening pap smears, and screening pelvic exams.
• Diabetes outpatient self-management training (DSMT) services.
• MNT services.
• Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests (including outpatient diagnostic laboratory tests paid through intermediaries).
• X-ray, radium, and radioactive isotope therapy.
• Surgical dressings, splints, casts, and other devices used for the reduction of fractures and dislocations.
• Bone mass measurements.
• An initial preventive physical exam.
• Cardiovascular screening blood tests.
• Diabetes screening tests.
• Telehealth services.
• Physician work and resources to establish and document the need for a power mobility device.
• Additional preventive services.
• Pulmonary rehabilitation.
• Cardiac rehabilitation.
• Intensive cardiac rehabilitation.
• Kidney disease education services.
• Personalized prevention plan services.
Our preliminary estimate of the CY 2012 SGR is −16.9 percent. We first estimated the CY 2012 SGR in March 2011, and we made the estimate available to the MedPAC and on our Web site. Table 23 shows the March 2011 estimate and our current estimates of the factors included in the CY 2012 SGR. The majority of the difference between the March estimate and our current estimate of the CY 2012 SGR is explained by net adjustments that reflect higher physician fees and fee-for-service enrollment after our March estimate was prepared. Estimates of 2012 real per capita GDP are also lower than were included in our March, 2011 estimate of the SGR.
Our current estimate of the CY 2011 SGR is 6.0 percent. Table 24 shows our preliminary estimate of the CY 2011 SGR that was published in the CY 2011 PFS final rule with comment period (75 FR 73278) and our current estimate. The majority of the difference between the preliminary estimate and our current estimate of the CY 2011 SGR is explained by adjustments to reflect two intervening legislative changes that have occurred since publication of the CY 2011 final rule with comment period.
The SGR for CY 2010 is 8.9 percent. Table 25 shows our preliminary estimate of the CY 2010 SGR from the CY 2010 PFS final rule with comment period (74 FR 61965), our revised estimate from the CY 2011 PFS final rule with comment period (75 FR 73278), and the final figures determined using the best available data as of September 1, 2011.
All of the figures used to determine the CY 2012 SGR are estimates that will be revised based on subsequent data. Any differences between these estimates and the actual measurement of these figures will be included in future revisions of the SGR and allowed expenditures and incorporated into subsequent PFS updates.
This factor is calculated as a weighted average of the CY 2012 changes in fees for the different types of services included in the definition of physicians' services for the SGR. Medical and other health services paid using the PFS are estimated to account for approximately 89.4 percent of total allowed charges included in the SGR in CY 2012 and are updated using the percent change in the Medicare Economic Index (MEI). As discussed in section IV.C. of this final rule with comment period, the percent change in the MEI for CY 2012 is 0.6 percent. Diagnostic laboratory tests are estimated to represent approximately 10.6 percent of Medicare allowed charges included in the SGR for CY 2012. Medicare payments for these tests are updated by the Consumer Price Index for Urban Areas (CPI-U), which is 3.6 percent for CY 2012. Section 3401(l) of the Affordable Care Act requires the Secretary to reduce the CPI-U update applied to clinical laboratory tests under the clinical laboratory fee schedule be reduced by a multi-factor productivity adjustment (MFP adjustment) and, for each of years 2011 through 2015, by 1.75 percentage points (percentage adjustment). The MFP adjustment will not apply in a year where the CPI-U is zero or a percentage decrease for a year. Further, the application of the MFP adjustment shall not result in an adjustment to the fee schedule of less than zero for a year. However, the application of the percentage adjustment may result in an adjustment to the fee schedule being less than zero for a year and may result in payment rates for a year being less than such payment rates for the preceding year. The applicable productivity adjustment for CY 2012 is 1.2 percent. Adjusting the CPI-U update by the productivity adjustment results in a 2.4 percent (3.6 percent (CPI-U)- 1.2 percent (MFP adjustment) update for CY 2012. However, the percentage reduction of 1.75 percent is applied for CYs 2011 through 2015, as discussed previously. Therefore, for CY 2012, diagnostic laboratory tests will receive an update of 0.7 percent (rounded). Table 26 shows the weighted average of the MEI and laboratory price changes for CY 2012.
We estimate that the weighted average increase in fees for physicians' services in CY 2012 under the SGR will be 0.6 percent.
This factor is our estimate of the percent change in the average number of fee-for-service enrollees from CY 2011 to CY 2012. Services provided to Medicare Advantage (MA) plan enrollees are outside the scope of the SGR and are excluded from this estimate. We estimate that the average number of Medicare Part B fee-for-service enrollees will increase by 3.5 percent from CY 2011 to CY 2012. Table 27 illustrates how this figure was determined.
An important factor affecting fee-for-service enrollment is beneficiary enrollment in MA plans. Because it is difficult to estimate the size of the MA enrollee population before the start of a CY, at this time we do not know how actual enrollment in MA plans will compare to current estimates. For this reason, the estimate may change substantially as actual Medicare fee-for-service enrollment for CY 2012 becomes known.
We estimate that the growth in real GDP per capita from CY 2011 to CY 2012 will be 0.6 percent (based on the annual growth in the 10 year moving average of real GDP per capita (2003 through 2012)). Our past experience indicates that there have also been changes in estimates of real GDP per capita growth made before the year begins and the actual change in real GDP per capita growth computed after the year is complete. Thus, it is possible that this figure will change as actual information on economic performance becomes available to us in CY 2012.
The statutory and regulatory provisions that will affect expenditures in CY 2012 relative to CY 2011 are estimated to have an impact on expenditures of −20.7 percent. The impact is primarily due to the expiration of the physician fee schedule update included in the Medicare and Medicaid Extenders Act (MMEA) which specified a physician fee schedule update for CY 2011 only. Additionally, section 3102 of the Affordable Care Act revised the methodology for calculating the PE GPCIs for CY 2010 and CY 2011 so that the employee compensation and rent components of the PE GPCIs reflect only one-half of the relative cost differences for each locality compared to the national average. This provision included a hold harmless so that no area's GPCI could decline and was not budget neutral. In addition, section 103 of the MMEA extended the floor of 1.0 on the work GPCI through the end of CY 2011. This provision was also not budget neutral. The expiration of the methodological changes to the PE GPCIs and the floor of the work GPCI in CY 2012 will cause a reduction in spending in CY 2012 compared to CY 2011.
A more detailed discussion of our revised estimates of the four elements of the CY 2011 SGR follows.
This factor was calculated as a weighted-average of the CY 2011 changes in fees that apply for the different types of services included in the definition of physicians' services for the SGR in CY 2011.
We estimate that services paid using the PFS account for approximately 92.1 percent of total allowed charges included in the SGR in CY 2011. These services were updated using the CY 2011 percent change in the MEI of 0.4 percent. We estimate that diagnostic laboratory tests represent approximately 7.9 percent of total allowed charges included in the SGR in CY 2011. Medicare payments for these tests are updated by the CPI-U, which was 1.1 percent for CY 2011. However, section 3401(l)(2)(iv)(subclause I) of the Affordable Care Act requires the Secretary to reduce the CPI-U update applied to clinical laboratory tests by a productivity adjustment, but does not allow the productivity adjustment to result in a negative CLFS update. The result is that the CLFS update for CY 2011 was 0.0 percent. Additionally, section 3401(1)(2)(iv)(II) of the Affordable Care Act reduces the update applied to clinical laboratory tests by 1.75 percent for CYs 2011 through 2015. Therefore, for CY 2011, diagnostic laboratory tests received an update of −1.75 percent.
Table 28 shows the weighted-average of the MEI and laboratory price changes for CY 2011.
After considering the elements described in Table 28, we estimate that the weighted-average increase in fees for physicians' services in CY 2011 under the SGR was 0.2 percent. Our estimate of this factor in the CY 2011 PFS final rule with comment period was 0.2 percent (75 FR 73279).
We estimate that the average number of Medicare Part B fee-for-service enrollees (excluding beneficiaries enrolled in Medicare Advantage plans) increased by 1.8 percent in CY 2011. Table 29 illustrates how we determined this figure.
Our estimate of the 1.8 percent change in the number of fee-for-service enrollees, net of Medicare Advantage enrollment for CY 2011 compared to CY 2010, is different than our original estimate of an increase of 2.4 percent in the CY 2011 PFS final rule with comment period (75 FR 73279). While our current projection based on data from 8 months of CY 2011 differs from our original estimate of 2.4 percent when we had no actual data, it is still possible that our final estimate of this figure will be different once we have complete information on CY 2011 fee-for-service enrollment.
We estimate that the growth in real GDP per capita will be 0.6 percent for CY 2011 (based on the annual growth in the 10-year moving average of real GDP per capita (2002 through 2011)). Our past experience indicates that there have also been differences between our estimates of real per capita GDP growth made prior to the year's end and the actual change in this factor. Thus, it is possible that this figure will change further as complete actual information on CY 2011 economic performance becomes available to us in CY 2012.
The statutory and regulatory provisions that affected expenditures in CY 2011 relative to CY 2010 are estimated to have an impact on expenditures of 3.3 percent. These include the Department of Defense Appropriations Act (DODAA), the Temporary Extension Act (TEA), and the Preservation of Access to Care for Medicare Beneficiaries and Pension Relief Act (PACMBPRA) which provided for physician fee schedule updates. Furthermore, the Affordable Care Act contained provisions regarding the policy on equipment utilization for imaging services, the multiple procedure payment reduction policy for imaging services, and the annual wellness visit providing personalized prevention plan services.
A more detailed discussion of our final revised estimates of the four elements of the CY 2010 SGR follows.
This factor was calculated as a weighted-average of the CY 2010 changes in fees that apply for the different types of services included in the definition of physicians' services for the SGR in CY 2010.
We estimate that services paid under the PFS account for approximately 91.3 percent of total allowed charges included in the SGR in CY 2010. These services were updated using the CY 2010 percent change in the MEI of 1.2 percent. We estimate that diagnostic laboratory tests represent approximately 8.7 percent of total allowed charges included in the SGR in CY 2010. Medicare payments for these tests are updated by the CPI-U, which was −1.4 percent for CY 2010. However, section 145 of the Medicare Improvements for Patients and Providers Act (MIPPA), reduced the update applied to clinical laboratory tests by 0.5 percent for CY 2009 and CY 2010. Therefore, for CY 2010, diagnostic laboratory tests received an update of −1.9 percent. Since we removed physician-administered drugs from the definition of “physicians' services” for purposes of computing the SGR and the levels of allowed expenditures and actual
Table 30 shows the weighted-average of the MEI and laboratory price changes for CY 2010.
After considering the elements described in Table 30, we estimate that the weighted-average increase in fees for physicians' services in CY 2010 under the SGR was 0.9 percent. This figure is a final one based on complete data for CY 2010.
We estimate the change in the number of fee-for-service enrollees (excluding beneficiaries enrolled in MA plans) from CY 2009 to CY 2010 was 1.1 percent. Our calculation of this factor is based on complete data from CY 2010. Table 31 illustrates the calculation of this factor.
We estimate that the growth in real per capita GDP was 0.6 percent in CY 2010 (based on the annual growth in the 10-year moving average of real GDP per capita (CYs 2001 through 2010)). This figure is a final one based on complete data for CY 2010.
Our final estimate for the net impact on expenditures from the statutory and regulatory provisions that affect expenditures in CY 2010 relative to CY 2009 is 6.1 percent. The statutory and regulatory provisions that affected expenditures in CY 2010 relative to CY 2009 include the DODAA, the TEA, and the Preservation of Access to Care for Medicare Beneficiaries and Pension Relief Act (PACMBPRA) which provided for physician fee schedule updates. Also included are the MIPPA provisions regarding the physician fee schedule update, PQRI and E-prescribing incentives, the work GPCIs, and payment provisions related to certain pathology services. Additionally, the Affordable Care Act contained provisions regarding the work GPCIs, the policy on equipment utilization for imaging services, coverage of preventive services, and a physician enrollment requirement.
Section 1848(d) of the Act provides that the PFS update is equal to the product of the the UAF and the MEI. The UAF is applied to make actual and target expenditures (referred to in the statute as “allowed expenditures”) equal. As discussed previously, allowed expenditures are equal to actual expenditures in a base period updated each year by the SGR. The SGR sets the annual rate of growth in allowed expenditures and is determined by a formula specified in section 1848(f) of the Act.
Under section 1848(d)(4)(B) of the Act, the UAF for a year beginning with CY 2001 is equal to the sum of the following—
•
++ Computing the difference (which may be positive or negative) between the amount of the allowed expenditures for physicians' services for the prior year (the year prior to the year for which the update is being determined) and the amount of the actual expenditures for those services for that year;
++ Dividing that difference by the amount of the actual expenditures for those services for that year; and
++ Multiplying that quotient by 0.75.
•
++ Computing the difference (which may be positive or negative) between the amount of the allowed expenditures for physicians' services from April 1, 1996, through the end of the prior year and the amount of the actual expenditures for those services during that period;
++ Dividing that difference by actual expenditures for those services for the prior year as increased by the SGR for the year for which the UAF is to be determined; and
++ Multiplying that quotient by 0.33.
Section 1848(d)(4)(E) of the Act requires the Secretary to recalculate allowed expenditures consistent with section 1848(f)(3) of the Act. As discussed previously, section 1848(f)(3) specifies that the SGR (and, in turn, allowed expenditures) for the upcoming CY (CY 2012 in this case), the current CY (that is, CY 2011) and the preceding CY (that is, CY 2010) are to be determined on the basis of the best data available as of September 1 of the current year. Allowed expenditures for a year generally are estimated initially and subsequently revised twice. The second revision occurs after the CY has ended (that is, we are making the second revision to CY 2010 allowed expenditures in this final rule with comment).
Table 32 shows the historical SGRs corresponding to each period through CY 2012.
Consistent with section 1848(d)(4)(E) of the Act, Table 32 includes our second revision of allowed expenditures for CY 2010, a recalculation of allowed expenditures for CY 2011, and our initial estimate of allowed expenditures for CY 2012. To determine the UAF for CY 2012, the statute requires that we use allowed and actual expenditures from April 1, 1996 through December 31, 2011 and the CY 2012 SGR. Consistent with section 1848(d)(4)(E) of the Act, we will be making revisions to the CY 2011 and CY 2012 SGRs and CY 2011 and CY 2012 allowed expenditures. Because we have incomplete actual expenditure data for CY 2011, we are using an estimate for this period. Any difference between current estimates and final figures will be taken into account in determining the UAF for future years.
We are using figures from Table 32 in the following statutory formula:
UAF
Target
Actual
Target
Actual
SGR
Section 1848(d)(4)(D) of the Act indicates that the UAF determined under section 1848(d)(4)(B) of the Act for a year may not be less than −0.07 or greater than 0.03. Since −0.04 (−4 percent) is between −0.07 and 0.03, the UAF for CY 2012 will be −0.04.
Section 1848(d)(4)(A)(ii) of the Act indicates that 1.0 should be added to the UAF determined under section 1848(d)(4)(B) of the Act. Thus, adding 1.0 to −0.04 makes the UAF equal to 0.96.
The MEI is authorized by section 1842(b)(3) of the Act, which states that prevailing charge levels beginning after June 30, 1973 may not exceed the level from the previous year except to the extent that the Secretary finds, on the basis of appropriate economic index data, that the higher level is justified by year-to-year economic changes. The current form of the MEI was detailed in the CY 2011 PFS final rule with comment period (75 FR 73262) which updated the cost structure of the index from a base year of 2000 to 2006.
The MEI measures the weighted-average annual price change for various inputs needed to produce physicians' services. The MEI is a fixed-weight input price index, with an adjustment for the change in economy-wide multifactor productivity. This index, which has CY 2006 base year weights, is comprised of two broad categories: (1) Physician's own time; and (2) physician's practice expense (PE).
The physician's compensation (own time) component represents the net income portion of business receipts and primarily reflects the input of the physician's own time into the production of physicians' services in physicians' offices. This category consists of two subcomponents: (1) Wages and salaries; and (2) fringe benefits.
The physician's practice expense (PE) category represents nonphysician inputs used in the production of services in physicians' offices. This category consists of wages and salaries and fringe benefits for nonphysician staff and other nonlabor inputs. The physician's PE component also includes the following categories of nonlabor inputs: Office expenses; medical materials and supplies; professional liability insurance; medical equipment; medical materials and supplies; and other professional expenses.
Table 33 presents a listing of the MEI cost categories with associated weights and percent changes for price proxies for the 2012 update. The CY 2012 final MEI update is 1.8 percent and reflects a 2.3 percent increase in physician's own time and a 1.4 percent increase in physician's PE. Within the physician's PE, the largest increase occurred in chemicals, which increased 10.2 percent, and rubber and plastic products, which increased 5.2 percent.
For CY 2012, the increase in the productivity adjusted MEI is 0.6 percent, which reflects an increase in the MEI of 1.8 percent and a productivity adjustment of 1.2 percent based on the 10-year moving average of economy-wide private nonfarm business multifactor productivity. The Bureau of Labor Statistics (BLS) is the agency that publishes the official measure of private non-farm business MFP. Please see
The CY 2012 PFS CF is $24.6712. The CY 2012 national average anesthesia CF is $15.5264.
The formula for calculating the PFS update is set forth in section 1848(d)(4)(A) of the Act. In general, the PFS update is determined by multiplying the CF for the previous year by the percentage increase in the MEI times the UAF, which is calculated as specified under section 1848(d)(4)(B) of the Act.
Generally, the PFS CF for a year is calculated in accordance with section 1848(d)(1)(A) of the Act by multiplying the previous year's CF by the PFS update.
We note section 101 of the Medicare Improvements and Extension Act, Division B of the Tax Relief and Health Care Act of 2006 (MIEA-TRHCA) provided a 1-year increase in the CY 2007 CF and specified that the CF for CY 2008 must be computed as if the 1-year increase had never applied. Section 101 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA) provided a 6-month increase in the CY 2008 CF, from January 1, 2008, through June 30, 2008, and specified that the CF for the remaining portion of CY 2008 and the CFs for CY 2009 and subsequent years must be computed as if the 6-month increase had never applied. Section 131 of the MIPPA extended the increase in the CY 2008 CF that applied during the first half of the year to the entire year, provided for a 1.1 percent increase to the CY 2009 CF, and specified that the CFs for CY 2010 and subsequent years must be computed as if the increases for CYs 2007, 2008, and 2009 had never applied. Section 1011(a) of the DODAA and section 5 of the TEA specified a zero percent update for CY 2010, effective January 1, 2010 through March 31, 2010. Section 4 of the Continuing Extension Act of 2010 (CEA) extended the zero percent update for CY 2010 through May 31, 2010. Subsequently, section 101(a)(2) of the PACMBPRA provided for a 2.2 percent update to the CF, effective from June 1, 2010 to November 30, 2010. Section 2 of the Physician Payment and Therapy Relief Act of 2010 (Pub. L. 111-286) extended the 2.2 percent through the end of CY 2010. Finally, section 101 of the MMEA provided a zero percent update for CY 2011, effective January 1, 2011 through December 31, 2011, and specified that the CFs for CY 2012 and subsequent years must be computed as if the increases in previous years had never applied. Therefore, under current law, the CF that would be in effect in CY 2011 had the prior increases specified above not applied is $25.4999.
In addition, when calculating the PFS CF for a year, section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or decreases in RVUs may not cause the amount of expenditures for the year to differ more than $20 million from what it would have been in the absence of these changes. If this threshold is exceeded, we must make adjustments to preserve budget neutrality. We estimate that CY 2012 RVU changes would result in a decrease in Medicare physician expenditures of more than $20 million. Accordingly, we are increasing the CF by 1.0018 to offset this estimated decrease in Medicare physician expenditures due to the CY 2012 RVU changes. We calculate the CY 2012 PFS CF to be $24.6712. This final rule with comment period announces a reduction to payment rates for physicians' services in CY 2012 under the SGR formula. These payment rates are currently scheduled to be reduced under the SGR system on January 1, 2012. The total reduction in MPFS rates between CY 2011 and CY 2012 under the SGR system will be 27.4 percent. By law, we are required to make these reductions in accordance with section 1848(d) and (f) of the Act, and these reductions can only be averted by an Act of Congress. While Congress has provided temporary relief from these reductions every year since 2003, a long-term solution is critical. We will continue to work with Congress to fix this untenable situation so doctors and beneficiaries no longer have to worry about the stability and adequacy of their payments from Medicare under the Physician Fee Schedule.
We illustrate the calculation of the CY 2012 PFS CF in Table 34.
We note payment for services under the PFS will be calculated as follows:
We calculate the anesthesia CF as indicated in Table 35. Anesthesia services do not have RVUs like other PFS services. Therefore, we account for any necessary RVU adjustments through an adjustment to the anesthesia CF to simulate changes to RVUs. More specifically, if there is an adjustment to the work, PE, or malpractice RVUs, these adjustments are applied to the respective shares of the anesthesia CF as these shares are proxies for the work, PE, and malpractice RVUs for anesthesia services. Information regarding the anesthesia work, PE, and malpractice shares can be found at the following:
The anesthesia CF in effect in CY 2011 is $21.0515. As explained previously, in order to calculate the CY 2012 PFS CF, the statute requires us to calculate the CFs for all previous years
Section 542(c) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554), as amended by section 732 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173), section 104 of division B of the Tax Relief and Health Care Act of 2006 (MIEA-TRHCA) (Pub. L. 109-432), section 104 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA) (Pub. L. 110-173), section 136 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275) and section 3104 of the Affordable Care Act (Pub. L. 111-148), as amended by section 105 of the Medicare and Medicaid Extenders Act of 2010 (MMEA) (Pub. L. 111-309), continued payment to independent laboratories for the technical component (TC) of physician pathology services for fee-for-service Medicare beneficiaries who are inpatients or outpatients of a covered hospital through CY 2011. The TC of physician pathology services refers to the preparation of the slide involving tissue or cells that a pathologist interprets. The professional component (PC) of physician pathology services refers to the pathologist's interpretation of the slide.
When the hospital pathologist furnishes the PC service for a hospital patient, the PC service is separately billable by the pathologist. When an independent laboratory's pathologist furnishes the PC service, the PC service is usually billed with the TC service as a combined service.
Historically, any independent laboratory could bill the Medicare contractor under the PFS for the TC of physician pathology services for hospital patients even though the payment for the costs of furnishing the pathology service (but not its interpretation) was already included in the bundled inpatient stay payment to the hospital. In the CY 2000 PFS final rule with comment period (64 FR 59408 and 59409), we stated that this policy has contributed to the Medicare program paying twice for the TC service: (1) To the hospital, through the inpatient prospective payment rate, when the patient is an inpatient; and (2) to the independent laboratory that bills the Medicare contractor, instead of the hospital, for the TC service. While the policy also permits the independent laboratory to bill for the TC of physician pathology services for hospital outpatients, in this case, there generally would not be duplicate payment because we would expect the hospital to not also bill for the pathology service, which would be paid separately to the hospital only if the hospital were to specifically bill for it. We further indicated that we would implement a policy to pay only the hospital for the TC of physician pathology services furnished to its inpatients.
Therefore, in the CY 2000 PFS final rule with comment period, we revised § 415.130(c) to state that for physician pathology services furnished on or after January 1, 2001 by an independent laboratory, payment is made only to the hospital for the TC of physician pathology services furnished to a hospital inpatient. Ordinarily, the provisions in the PFS final rule with comment period are implemented in the following year. However, the change to § 415.130 was delayed 1-year (until January 1, 2001), at the request of the industry, to allow independent laboratories and hospitals sufficient time to negotiate arrangements.
Full implementation of § 415.130 was further delayed by section 542 of BIPA and section 732 of the MMA, which directed us to continue payment to independent laboratories for the TC of physician pathology services for hospital patients for a 2-year period beginning on January 1, 2001 and for CYs 2005 and 2006, respectively. In the CY 2007 PFS final rule with comment period (71 FR 69788), we amended § 415.130 to provide that, for services furnished after December 31, 2006, an independent laboratory may not bill the carrier for the TC of physician pathology services furnished to a hospital inpatient or outpatient. However, section 104 of the MIEA-TRHCA continued payment to independent laboratories for the TC of physician pathology services for hospital patients through CY 2007, and section 104 of the MMSEA further extended such payment through the first 6 months of CY 2008.
Section 136 of the MIPPA extended the payment through CY 2009. Section 3104 of the Affordable Care Act amended the prior legislation to extend the payment through CY 2010. Subsequent to publication of the CY 2011 PFS final rule with comment period, section 105 of the MMEA extended the payment through CY 2011.
Consistent with this statutory change, we proposed to revise § 415.130(d) to specify that for services furnished after December 31, 2011, an independent laboratory may not bill the Medicare contractor for the TC of physician pathology services furnished to a hospital inpatient or outpatient. We would implement this provision effective for TC services furnished on or after January 1, 2012.
We received the following comments.
After consideration of all public comments, we are finalizing our proposal without modification. Absent additional legislation, for services furnished after December 31, 2011, an independent laboratory may not bill a Medicare contractor for the TC of physician pathology services for fee-for service Medicare beneficiaries who are inpatients or outpatients of a covered hospital. Accordingly, we are finalizing the proposed revisions to § 415.130(d)(1) and (2) to reflect this change.
On June 25, 2010, the Preservation of Access to Care for Medicare Beneficiaries and Pension Relief Act of 2010 (PACMBPRA) (Pub. L. 111-192) was enacted. Section 102 of this Act entitled, “Clarification of 3-Day Payment Window,” clarified when certain services furnished to Medicare beneficiaries in the 3-days (or, in the case of a hospital that is not a subsection (d) hospital, during the 1-day) preceding an inpatient admission should be considered “operating costs of inpatient hospital services” and therefore included in the hospital's payment under the Hospital Inpatient Prospective Payment System (IPPS). This policy is generally known as the “3-day payment window.” Under the 3-day payment window, a hospital (or an entity that is wholly owned or wholly operated by the hospital) must include on the claim for a Medicare beneficiary's inpatient stay, the technical portion of any outpatient diagnostic services and nondiagnostic services related to the admission provided during the payment window. The new law makes the policy pertaining to admission-related nondiagnostic services more consistent with common hospital billing practices. Section 102 of the PACMBPRA is effective for services furnished on or after June 25, 2010.
We discussed changes to the 3-day payment window policy in the interim final rule with comment period that was issued as part of last year's IPPS final rule (75 FR 50346). The PACMBPRA made no changes to the billing of “diagnostic services” furnished during the 3-day payment window, which are included in the “operating costs of inpatient hospital services” pursuant to section 1886(a)(4) of the Act. All diagnostic services furnished to a Medicare beneficiary by a hospital (or an entity wholly owned or wholly operated by the hospital), on the date of a beneficiary's admission or during the 3-days (1-day for a non-subsection (d) hospital) immediately preceding the date of a beneficiary's inpatient hospital admission, continue to be included on the Part A bill for the beneficiary's inpatient stay at the hospital. In accordance with section 102(a)(1) of the PACMBPRA, for outpatient services
Prior to the enactment of the 3-day payment window clarification under section 102 of the PACMBPRA, the term “related to the admission” was defined in section 40.3, Chapter 3, Inpatient Hospital Billing, of the Medicare Claims Processing Manual (Pub. 100-04) to mean an exact match between the principal ICD-9 CM diagnosis codes for the outpatient encounter and the inpatient admission. On November 5, 1990, section 4003(a) of the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508) amended the statutory definition of “operating cost of inpatient hospital services” in section 1886(a)(4) of the Act to include the costs of certain services furnished prior to admission. Section 4003(a) also required that these preadmission services be included on the Medicare Part A bill for the subsequent inpatient stay. With this amendment, section 1886(a)(4) of the Act defines the operating costs of inpatient hospital services to include diagnostic services (including clinical diagnostic laboratory tests) or other services related to the admission (as defined by the Secretary) that are furnished by the hospital (or by an entity that is wholly owned or wholly operated by the hospital) to the patient during the 3-days prior to the date of the patient's admission to the hospital.
Section 1886(a)(4) of the Act was further amended by section 110 of the Social Security Amendments of 1994 (Pub. L. 103-432) enacted on October 31, 1994. This provision revised the payment window for hospitals that are excluded from the IPPS to include only those services furnished by the hospital or an entity wholly owned or wholly operated by the hospital during the 1-day (instead of the previous 3-days) prior to the patient's hospital inpatient admission. The hospital and hospital units excluded from the IPPS and affected by this policy are psychiatric hospitals and units, inpatient rehabilitation hospitals and units, long-term care hospitals, children's hospitals, and cancer hospitals. In the FY 1996 IPPS final rule (60 FR 45840), we noted that the term “day,” as referenced in the 3-day or 1-day payment window policy refers to the entire calendar day immediately preceding the date of admission and not the 24-hour time period that immediately precedes the hour of admission.
On February 11, 1998, we published a final rule (63 FR 6864), that responded to public comments received on a prior interim final rule on this policy. In that final rule, we confirmed that ambulance services and chronic maintenance of renal dialysis services are excluded from the 3-day payment window. This final rule with comment period also clarified that the payment window applies to outpatient services that are otherwise billable under Part B and does not apply to nonhospital services that are generally covered under Part A (such as home health, skilled nursing facility, and hospice). In addition the rule clarified the terms “wholly owned or operated” and “admission-related” for nondiagnostic services.
The 1998 final rule (63 FR 6866) defined an entity as wholly owned or wholly operated if a hospital has direct ownership or control over another entity's operations. Specifically, 42 CFR 412.2(c)(5)(i) states, “An entity is wholly owned by the hospital if the hospital is the sole owner of the entity. An entity is wholly operated by a hospital if the hospital has exclusive responsibility for conducting and overseeing the entity's routine operations, regardless of whether the hospital also has policymaking authority over the entity.” The 1998 final rule also stated “that we have defined services as being related to the admission only when there is an exact match between the ICD-9-CM diagnosis code assigned for both the preadmission services and the inpatient stay” and that “[a]” hospital-owned or hospital-operated physician clinic or practice is subject to the payment window provision.” Therefore, related preadmission nondiagnostic services provided by a wholly owned or wholly operated physician clinic or practice are also included in the 3-day (or 1-day) payment window policy, and services were considered related when there was an exact match between ICD-9 CM diagnosis codes for the outpatient encounter and the inpatient admission.
Prior to the June 25, 2010 enactment of section 102(a)(1) of PACMBPRA (Pub. L. 111-192), the payment window policy for preadmission nondiagnostic services was rarely applied in the wholly owned or operated physician's office or clinic because, as we previously noted, the policy required an exact match between the principal ICD-9 CM diagnosis codes for the outpatient services and the inpatient admission. Because of the exact match policy, very few services furnished in a physician's office or clinic that is wholly owned or operated by the hospital would be subject to the policy. Because the policy applied only in such narrow circumstances, until the recent statutory change, we have not provided further guidance to wholly owned or wholly operated physician offices on how nondiagnostic services are to be included on hospital bills when the 3-day payment window applied. However, the statutory change to the payment window policy made by Pub. L. 111-192 significantly broadened the definition of nondiagnostic services that are subject to the payment window to include any nondiagnostic service that is clinically related to the reason for a patient's inpatient admission, regardless of whether the inpatient and outpatient diagnoses are the same.
The FY 2012 IPPS proposed (76 FR 25960) and final rules (76 FR 51705) further discuss the application of the 3-day payment window for both preadmission diagnostic and related nondiagnostic services furnished to a patient at wholly owned or wholly operated physician practices after June 25, 2010. We do not know how many physician offices are wholly owned or wholly operated. Our expectation is that most hospital-owned entities providing outpatient services would be considered part of the hospital, likely as an outpatient department, and not as separate physician clinics or practices or other entities such as clinical laboratories. However, we believe there may be at least some hospital clinics that meet the definition of a wholly owned or wholly operated physician practice. When a physician furnishes a service in a hospital, including an outpatient department of a hospital, Medicare pays the physician under the physician fee schedule, generally at a facility-based payment rate that is lower than the “nonfacility” payment rate in order to avoid duplication of payment for supplies, equipment, and staff that are paid directly to the hospital by Medicare.
In circumstances where the 3-day payment window applies to nondiagnostic services related to an inpatient admission furnished in a wholly owned or wholly operated physician practice, we proposed that Medicare would make payment under the physician fee schedule for the physicians' services that are subject to the 3-day payment window at the facility rate. As explained more fully later in this section, the services that are subject to the 3-day payment window would be billed to Medicare in a similar manner to services that are furnished in a hospital, including an outpatient department of a hospital. We proposed that, effective on or after January 1, 2012, when a physician furnishes services to a beneficiary in a hospital's wholly owned or wholly operated physician practice and the beneficiary is admitted as an inpatient within 3 days (or, in the case of non-IPPS hospitals, 1 day), the payment window will apply to all diagnostic services furnished and to any nondiagnostic services that are clinically related to the reason for the patient's inpatient admission regardless of whether the reported inpatient and outpatient diagnosis codes are the same.
The principal focus of our CY 2012 proposed rule and our discussion in the IPPS FY 2012 final rule with comment period was on physician offices and clinics. We are concerned that hospitals may not realize that some of the services provided by wholly owned or wholly operated entities that might furnish preadmission services, other than physician practices and clinics, such as ambulatory surgical centers, are subject to the payment window. The purpose of this discussion in the CY 2012 PFS proposed rule was to address how a wholly owned or wholly operated physician practice would bill for professional and technical services when provided within the 3-day payment window. We believe that physician practices are the majority of wholly hospital owned or wholly operated Part B entities providing nondiagnostic services that are related to an inpatient admission. We previously addressed applicability of the payment window policy to wholly owned or wholly operated entities in our 1998 final rule, and at that time emphasized that diagnostic services are always included in the 3-day payment window (75 FR 6866). In this final rule with comment period, we are addressing the policy's application to entities that are wholly owned or wholly operated physician practices and clinics, and we note that wholly owned or wholly operated entities providing diagnostic services always have been subject to the payment window. We encourage hospitals to bring any other wholly owned or wholly operated Part B entities into compliance with the 3-day payment window policy as discussed in this final rule. If needed, we will address specifics related to other Part B entities in future rulemaking.
Although rural health clinics (RHCs) and Federally qualified health centers (FQHCs) would be considered “entities,” we are not applying the 3-day payment window policy to these entities. Medicare pays RHCs and FQHCs for their services through an all-inclusive rate that incorporates payment for all covered items and services provided to a beneficiary on a single day by an RHC/FQHC physician, physician assistant, nurse practitioner, clinical nurse midwife, clinical psychologist, clinical social worker, or visiting nurse; and related services and supplies (Publication 100-04 (Medicare Claims Processing Manual), chapter 19, section 20.1). RHCs and FQHCs can only bill and be paid for services included in their all-inclusive rate. Although the majority of those services are professional services, it is impossible to distinguish within the all-inclusive rate the amount of the payment for any particular patient that represents the professional versus the technical portion. As previously discussed, the 3-day payment window policy requires a hospital to include in its bill for an inpatient admission the technical portion of any outpatient diagnostic services and admission-related nondiagnostic services provided during the preadmission payment window. Professional services are not considered to be operating costs of inpatient hospital services and, accordingly, are not subject to the 3-day payment window policy. Given that the 3-day payment window policy does not include professional services, and that RHCs and FQHCs are paid an all-inclusive rate within which the professional and technical portions are indeterminate, we do not consider RHC or FQHC services to be subject to the 3-day payment window policy. However, if in the future RHCs or FQHCs are no longer paid an all-inclusive rate, but rather, under a prospective or other payment system that allows distinction between the PC and TC for services, the 3-day payment policy would apply in these settings In addition the list of covered services paid through the RHC and FQHC benefits is relatively small. Practitioners who furnish additional services in RHCs or FQHCs bill Medicare Part B for any additional
In the proposed rule, we indicated that we would establish a new Medicare HCPCS modifier that will signal claims processing systems to provide payment to wholly owned or wholly operated entities at the facility rate. We proposed to pay only the Professional Component (PC) for CPT/HCPCS codes with a Technical Component (TC)/PC split that are provided in the 3-day (or, in the case of non-IPPS hospitals, 1-day) payment window in a hospital's wholly owned or wholly operated physician practice. We proposed to pay at the facility rate for codes without a TC/PC split to avoid duplicate payment for the technical resources required to provide the preadmission services as those costs will be included on the hospital's inpatient claim for the related inpatient admission. The facility rate includes physician work, malpractice, and the facility practice expense, which is a payment to support services provided by the physician office when a physician treats patients at another facility. We proposed to modify our regulation at § 414.22(b)(5)(i), which defines the sites of service that result in a facility practice expense RVU for payment, to add an entity that is wholly
We indicated in the proposed rule that we would establish a new HCPCS modifier through sub-regulatory guidance. We said that we would require that this modifier be appended to the physician preadmission diagnostic and admission-related nondiagnostic services, reported with HCPCS codes, which are subject to the 3-day payment window policy. We stated that each wholly owned or wholly operated physician's practice would need to manage its billing processes to ensure that it billed for its physician services appropriately when a related inpatient admission has occurred.
We stated that the hospital will be responsible for notifying the practice of related inpatient admissions for a patient who received services in a wholly owned or wholly operated physician practice within the 3-day (or, when appropriate, 1-day) payment window prior to the inpatient stay. We proposed to make the new modifier effective for claims with dates of service on or after January 1, 2012, and we proposed that wholly owned or wholly operated physician practices would receive payment at the facility rate for related nondiagnostic services and receive payment for only the professional component for diagnostic services effective for services furnished on or after January 1, 2012.
We expect that the cost of diagnostic and related nondiagnostic services that are provided in wholly owned or wholly operated entities during the 3-day payment window will be included in the data used to determine future IPPS relative payment weights. This cycle of having costs and charges reflected in the payment rates for future years is part of the longstanding methodology behind setting hospital prospective payment rates. Hospitals should already be including the costs of diagnostic services furnished by wholly owned or wholly operated entities on their cost report because the 3-day payment window policy for diagnostic services is longstanding. Furthermore, we note that the inclusion of charges for diagnostic and related nondiagnostic services that are provided in wholly hospital owned or wholly operated entities during the 3-day payment window on an inpatient claim could increase the probability that the claim for the inpatient admission would garner outlier payments.
Beginning on January 1, 2012, CMS payment modifier PD (Diagnostic or related nondiagnostic item or service provided in a wholly owned or wholly operated entity to a patient who is admitted as an inpatient within 3 days, or 1 day) will be available, and wholly owned or wholly operated entities should begin to append the modifier to claims subject to the 3-day payment window at that time. We expect that hospitals and their wholly owned or wholly operated entities will continue working toward establishing internal processes to ensure compliance with section 102 of PACMBPRA as quickly as possible to achieve coordinated billing for services subject to the 3-day payment window policy. We will require hospitals and their wholly owned or wholly operated entities to fully coordinate their billing and to properly bill for diagnostic and related nondiagnostic services subject to the
With regard to the comment that the hospital should not need to notify its wholly owned or wholly operated entities, we note that the 3-day payment policy implemented on October 1, 1991, is an existing statutory requirement located in the statutory definition of hospital operating costs, and that the purpose of this final rule is to clarify the implementation of the policy when a entity that is wholly owned or wholly operated by a hospital furnishes preadmission diagnostic and related nondiagnostic services to a patient who is later admitted as an inpatient within the payment window. In the FY 2012 IPPS final rule we responded to a comment on this topic, stating that because the hospital owns the facility, it is our expectation that the hospital will be able to coordinate and track the patient activity of the facilities it owns. The full adoption of electronic medical record should help facilitate coordination and tracking of patients within and among hospital systems (76 FR 51709).
We realize that the time frames associated with the global surgical package for many surgical services could overlap with the 3-day (or 1-day) payment window policy. Global surgical payment rules apply to major and minor surgeries, and endoscopies. Section 40.1 of the Claims Processing Manual (100-04 chapter 12 Physician/Nonphysician Practitioners) defines the global surgical package. Procedures can have a global surgical period of 0, 10, or 90-days. Generally, the global period for major surgeries is 1 day prior to the surgical procedure and 90 days immediately following the procedure. For minor surgeries, the global period is the day of the procedure and 10 days immediately following the procedure.
Medicare payment for the global surgical package is based on the typical case for a procedure, and includes preoperative visits, intra-operative services, and complications following surgery, postoperative visits, postsurgical pain management, supplies, and miscellaneous other services such as dressing changes and removal of sutures or staples. Medicare makes a single payment to the treating physician (or group practice) for the surgical procedure and any of the pre- and post-operative services typically associated with the surgical procedure provided within the global surgical period (10 or 90-days). The same section of the Claims Processing Manual (100-04 chapter 12 Physician/Nonphysician Practitioners) also discusses the services that are not included in payment for the global surgical period. In general, these services are unrelated to the surgery, are diagnostic or are part of the decision to pursue surgery, or are related to the surgery but are so significant they warrant an additional payment. Some examples of services not included in payment for the global surgical period include the initial evaluation of the problem by the surgeon to determine the need for major surgery; services of another physician; visits unrelated to the diagnosis for the surgical procedure unless the visits occur due to surgical complications; treatment that is not part of the normal recovery from surgery; diagnostic tests; distinct surgical procedures that are not re-operations; treatment for postoperative complications that require a return trip to the operating room; critical care unrelated to the surgery where a seriously injured or burned patient is critically ill and requires the constant attention of the physician; and immunosuppressive therapy for organ transplants.
The time frames for application of the 3-day payment window and the global surgical package could overlap. In some cases, the application of the 3-day payment window is straightforward. For example, a patient could have minor surgery in a wholly owned or wholly operated physician's office and, due to complications, need to be admitted within 3-days to an acute care hospital paid under the IPPS for follow-up surgery. Under the 3-day payment window policy, the practice expense portion of the initial surgery and any pre- and post-operative visits associated with the surgery (both those subject to the global surgery rules and separate diagnostic procedures) should be included on the hospital's Part A claim for the inpatient admission. The wholly owned or wholly operated physician practice would bill for the surgery performed for the inpatient as well as for the initial surgical procedure performed in the physician practice that
However, the situation could arise where a global surgical period overlaps with the 3-day payment window, but the actual surgical procedure with the global surgical package occurred before the 3-day payment window. In this case, several post-operative services, such as follow-up visits, would occur during the global period, but the surgeon would not bill separately for those services. We proposed that services with a global surgical package would be subject to the 3-day payment window policy when wholly owned or wholly operated physician practices furnish preadmission diagnostic and nondiagnostic services that are clinically related to an inpatient admission when the date of the actual surgical procedure falls within the 3-day payment window policy. However, when the actual surgical procedure for a service that has a global surgical package is furnished on a date that falls outside the 3-day payment window, the 3-day window policy would not apply. We do not believe it would be appropriate to require the wholly owned or wholly operated physician practice to unbundle the post operative services associated with the global surgical procedure so that the practice expense portion of those services could be paid under the PFS at the facility rate and the costs included on the hospital's inpatient claim. However, any service that a wholly owned or wholly operated physician practice would bill separately from the global surgical package, such as a separate initial evaluation of a problem by the surgeon to determine the need for surgery or separate diagnostic tests, would continue to be subject to the 3-day payment window policy.
We did not receive any comments on our proposal to include diagnostic and related nondiagnostic services with a global surgical package in the 3-day payment window when the date of the surgical procedure falls within the 3 day payment window, and we are finalizing our policy without modification.
The 1998 final rule (63 FR 6864) defined wholly owned or wholly operated as a hospital's direct ownership or control over another entity's operations. In that rule, we added the regulation at 42 CFR 412.2(c)(5)(i) which states, “An entity is wholly owned by the hospital if the hospital is the sole owner of the entity. An entity is wholly operated by a hospital if the hospital has exclusive responsibility for conducting and overseeing the entity's routine operations, regardless of whether the hospital also has policymaking authority over the entity.”
Physician practices self-designate whether they are owned or operated by a hospital during the Medicare enrollment process. Currently, a physician practice enrolls in Medicare with CMS form “855B.” This enrollment form reports pertinent practice information such as ownership, organizational structure, and operational duties. Likewise, hospitals enroll in Medicare using CMS form “855A” also reporting pertinent hospital information such as ownership, organizational structure and operational duties. Medicare Administrative Contractors update files of physician practices that are owned and operated by hospitals, and the files of hospitals that own those physician practices, in their claims processing systems and use that data to confirm an ownership relationship for identified physician practices. We will investigate the feasibility of establishing national system edits within the Common Working File to fully identify whether a physician practice is wholly owned or wholly operated by a hospital and to associate such practice with its affiliated hospital.
The 3-day payment window policy has been applicable for all preadmission diagnostic and related nondiagnostic services provided by wholly owned or wholly operated entities for over a decade. In 1998, we clarified the definition of “wholly owned” and “wholly operated,” and we responded to comments on specific owner and operator relationships (63 FR 6866). In this rule, we discussed several different illustrative examples of ownership and operational interests and how the 3-day payment window will apply in each circumstance. These examples provide guidelines to help each entity determine whether they believe they are wholly owned or wholly operated by a hospital. For ease of reference, we are reprinting those responses here:
• Arrangement: A hospital owns a physician clinic or a physician practice that performs preadmission testing for the hospital. Policy: A hospital-owned or hospital operated physician clinic or practice is subject to the payment window provision. The technical portion of preadmission diagnostic services performed by the physician clinic or practice must be included in the inpatient bill and may not be billed separately. A physician's professional service is not subject to the window.
• Arrangement: Hospital A owns Hospital B, which in turn owns Hospital C. Does the payment window apply if preadmission services are performed at Hospital C and the patient is admitted to Hospital A? Policy: Yes. We would consider that Hospital A owns both
• Arrangement: Corporation Z owns Hospitals A and B. If Hospital A performs preadmission services and the patient is subsequently admitted as an inpatient to Hospital B, are the services subject to the payment window? Policy: No. The payment window does not apply to situations in which both the admitting hospital and the entity that furnishes the preadmission services are owned by a third entity. The payment window includes only those situations in which the entity furnishing the preadmission services is wholly owned or operated by the admitting hospital itself.
• Arrangement: A hospital refers its patient to an independent laboratory for preadmission testing services. The laboratory does not perform testing by arrangement with the admitting hospital. Are the laboratory services subject to the payment window provisions? Policy: No. The payment window does not apply to situations in which the admitting hospital is not the sole owner operator of the entity performing the preadmission testing.
• Arrangement: Hospital A is owned by Corporations Y and Z in a joint venture. Corporation Z is the sole owner of Hospital B. Does the payment window apply when one of these hospitals furnishes preadmission services and the patient is admitted to the other hospital? Policy: No. As noted previously, the payment window provision does not apply to situations in which both the admitting hospital and the entity that furnishes the preadmission services are owned or operated by a third entity.
• Arrangement: A clinic is solely owned by Corporation Z and is jointly operated by Corporation Z and Hospital A. Does the payment window apply if preadmission services are furnished by the clinic and the patient is subsequently admitted to Hospital A? Policy: No. The payment window does not apply because Hospital A is neither the sole owner nor operator of the clinic.
After consideration of the public comments we received, we are finalizing our proposal with clarification of the term “entity” and a modification of the implementation date from January 1, 2012 to July 1, 2012. The 3-day payment window policy applies to nondiagnostic services that are clinically related to an inpatient admission when preadmission services are furnished in a wholly owned or wholly operated entity and the patient is later admitted as an inpatient within the payment window. In such cases, Medicare will make payment for the preadmission services under the physician fee schedule at the facility rate. Specifically, a new Medicare HCPCS modifier PD will be available to wholly owned or wholly operated entities beginning January 1, 2012 and may be appended to Part B claims lines to identify preadmission services that are subject to the 3-day window policy. However, we will not formally implement the PD modifier for use by wholly hospital owned or wholly operated entities until July 1, 2012 in order to provide wholly owned or operated entities sufficient time to coordinate their billing practices for clinically related nondiagnostic preadmission services. The PD modifier will signal claims processing systems to provide payment only for the PC for CPT/HCPCS codes with a TC/PC split and to pay services without a PC/TC split at the facility rate when they are provided in the 3-day (or, in the case of non-IPPS hospitals, 1-day) payment window. The facility rate will be paid for codes without a TC/PC split to avoid duplicate payment for the technical resources required to provide the services. We agree with commenters that the statutory term “entity” is broader than physician practices or clinics. Accordingly, we are modifying our proposal to revise our regulatory definition of facility practice expense RVUs at section 42 CFR 414.22 by revising paragraph (b)(5)(i)(A) to include a wholly owned or wholly operated entity. In addition, the technical costs of diagnostic and related nondiagnostic services of the wholly owned or wholly operated entity subject to the 3-day payment window shall be included on the hospital's inpatient claim for the related inpatient admission and reflected appropriately on the hospital cost report. The definitions of “wholly owned” and “wholly operated” continue to be those set forth in the 1998 IPPS final rule (63 FR 6864), and this policy makes no change to the requirement that all diagnostic services furnished during the 3-day payment window must be included on the hospital claim for the inpatient admission.
Section 1833(g) of the Act (as amended by section 4541 of the Balanced Budget Act of 1997) applies an annual, per beneficiary combined cap on expenses incurred for outpatient physical therapy and speech-language pathology services under Medicare Part B. A separate but identical cap also applies for outpatient occupational therapy services under Medicare Part B. The caps apply to expenses incurred for therapy services furnished in outpatient settings, other than in an outpatient hospital setting which is described under section 1833(a)(8)(B) of the Act. The caps were in effect during 1999, from September 1, 2003 through December 7, 2003, and continuously beginning January 1, 2006. The caps are a permanent provision, that is, there is no end date specified in the statute for therapy caps.
Beginning January 1, 2006, the DRA provided for exceptions to the therapy caps until December 31, 2006. Provisions for the exceptions process for therapy caps was further extended through December 31, 2010 pursuant to four subsequent amendments (in MEIA-TRHCA, MMSEA, MIPPA, and Affordable Care Act). Section 1833(g)(5) of the Act (as amended by section 104 of the MMEA) extended the exceptions process for therapy caps through December 31, 2011.
The therapy cap amounts are required to be updated each year based on the MEI. The updated cap amount for CY 2012 is computed by multiplying the cap amount for CY 2011, which is $1,870, by the MEI for CY 2012, and rounding to the nearest $10. This amount is added to the CY 2011 cap to obtain the CY 2012 cap. Since the MEI for CY 2012 is 0.6 percent, the therapy cap amount for CY 2012 is $1,880.
Our authority to provide for exceptions to therapy caps (independent of the statutory exclusion for outpatient hospital therapy services) will expire on December 31, 2011, unless the Congress acts to extend it. If the current exceptions process expires, the caps will be applicable in accordance with
Section 1847A of the Act requires use of the average sales price (ASP) payment methodology for payment for drugs and biologicals described in section 1842(o)(1)(C) of the Act furnished on or after January 1, 2005. The ASP methodology applies to most drugs furnished incident to a physician's service, drugs furnished under the DME benefit, certain oral anti-cancer drugs, and oral immunosuppressive drugs.
Section 1847A(d)(1) of the Act states that “The Inspector General of HHS shall conduct studies, which may include surveys, to determine the widely available market prices (WAMP) of drugs and biologicals to which this section applies, as the Inspector General, in consultation with the Secretary, determines to be appropriate.” Section 1847A (d)(2) of the Act states, “Based upon such studies and other data for drugs and biologicals, the Inspector General shall compare the ASP under this section for drugs and biologicals with—
• The widely available market price (WAMP) for these drugs and biologicals, (if any); and
• The average manufacturer price (AMP) (as determined under section 1927(k) (1) of the Act) for such drugs and biologicals.”
Section 1847A(d)(3)(A) of the Act states that, “The Secretary may disregard the ASP for a drug or biological that exceeds the WAMP or the AMP for such drug or biological by the applicable threshold percentage (as defined in subparagraph (B)).” Section 1847A(d)(3)(C) of the Act states that if the Inspector General (OIG) finds that the ASP for a drug or biological is found to have exceeded the WAMP or AMP by this threshold percentage, the OIG “shall inform the Secretary (at such times as the Secretary may specify to carry out this subparagraph) and the Secretary shall, effective as of the next quarter, substitute for the amount of payment otherwise determined under this section for such drug or biological, the lesser of—
• The widely available market price for the drug or biological (if any); or
• 103 percent of the average manufacturer price as determined under section 1927(k)(1) of the Act for the drug or biological.”
The applicable threshold percentage is specified in section 1847A(d)(3)(B)(i) of the Act as 5 percent for CY 2005. For CY 2006 and subsequent years, section 1847A(d)(3)(B)(ii) of the Act establishes that the applicable threshold percentage is “the percentage applied under this subparagraph subject to such adjustment as the Secretary may specify for the WAMP or the AMP, or both.” In the CY 2006 (70 FR 70222), CY 2007 (71 FR69680), CY 2008 (72 FR 66258), CY 2009 (73 FR 69752), and CY 2010 (74 FR 61904) PFS final rules with comment period, we specified an applicable threshold percentage of 5 percent for both the WAMP and AMP. We based this decision on the fact that data was too limited to support an adjustment to the current applicable threshold percentage.
For CY 2011, we proposed to specify two separate adjustments to the applicable threshold percentages. When making comparisons to the WAMP, we proposed the applicable threshold percentage to remain at 5 percent. The applicable threshold percentage that we proposed for the AMP is addressed later in this section of the preamble. The latest WAMP comparison was published in 2008, and the OIG is continuing to perform studies comparing ASP to WAMP. Based on available OIG reports that have been published comparing WAMP to ASP, we did not have sufficient information at the time to determine that the 5 percent threshold percentage is inappropriate and should be changed. As a result, we believed that continuing the 5 percent applicable threshold percentage for the WAMP was appropriate for CY 2011. Therefore, we proposed to revise § 414.904(d)(3) to specify the 5 percent WAMP threshold for CY 2011. After soliciting and reviewing comments, we finalized our proposal to continue the 5 percent WAMP threshold for CY 2011 (75 FR 73469).
For CY 2012, we again proposed to specify a separate adjustment to the applicable threshold percentage for WAMP comparisons. When making comparisons to the WAMP, we proposed the applicable threshold percentage to remain at 5 percent. We still do not have sufficient information to determine that the 5 percent threshold percentage is inappropriate and, as a result, we believe that continuing the 5 percent applicable threshold percentage for the WAMP is appropriate for CY 2012. As we noted in the CY 2011 PFS final rule with comment period (75 FR 73470), we understand that there are complicated operational issues associated with the WAMP-based substitution policy. We continue to proceed cautiously in this area. We remain committed to providing stakeholders, including providers and manufacturers of drugs impacted by potential price substitutions with adequate notice of our intentions regarding such, including the opportunity to provide input with regard to the processes for substituting the WAMP for the ASP.
After reviewing the comments, we will continue to maintain separate price substitution policies for comparisons based on WAMP and AMP. We are finalizing our proposal to continue the 5 percent WAMP threshold for CY2012
As mentioned previously in section V.A.1. of this final rule with comment period, when making comparisons of ASP to AMP, the applicable threshold percentage for CY 2005 was specified in statute as 5 percent. Section 1847A(d)(3) of the Act allows the Secretary to specify adjustments to this threshold percentage for years subsequent to 2005. For CY 2006 (70 FR 70222), CY 2007 (71 FR 69680), CY 2008 (72 FR 66258), CY 2009 (73 FR 69752), and CY 2010 (74 FR 61904), the Secretary made no adjustments to the threshold percentage; it remained at 5 percent.
For CY 2011, we proposed, with respect to AMP substitution, to apply the applicable percentage subject to certain adjustments such that substitution of AMP for ASP will only be made when the ASP exceeds the AMP by 5 percent in two consecutive quarters immediately prior to the current pricing quarter, or three of the previous four quarters immediately prior to the current quarter. We further proposed to apply the applicable AMP threshold percentage only for those situations where AMP and ASP comparisons are based on the same set of National Drug Codes (NDCs) for a billing code (that is, “complete” AMP data).
Furthermore, we proposed a price substitution policy to substitute 103 percent of AMP for 106 percent of ASP for both multiple and single source drugs and biologicals as defined respectively at section 1847(A)(c)(6)(C) and (D) of the Act. Specifically, we proposed that this substitution—
• Would occur when the applicable threshold percentage has been met for two consecutive quarters immediately prior to the current pricing quarter, or three of the previous four quarters immediately prior to the current quarter;
• Would permit for a final comparison between the OIG's volume-weighted 103 percent of AMP for a billing code (calculated from the prior quarter's data) and the billing code's volume weighted 106 percent ASP (as calculated by CMS for the current quarter) to avoid a situation in which the AMP-based price substitution would exceed that quarter's ASP; and
• That the duration of the price substitution would last for only one quarter.
We also sought comment on other issues related to the comparison between ASP and AMP, such as the following—
• Any effect of definitional differences between AMP and ASP, particularly in light of the definition of AMP as revised by section 2503 of the Affordable Care Act;
• The impact of any differences in AMP and ASP reporting by manufacturers on price substitution comparisons; and
• Whether and/or how general differences and similarities between AMP and manufacturer's ASP would affect comparisons between these two.
In the CY 2011 PFS final rule with comment, we did not finalize our proposed adjustments to the 5 percent AMP threshold or our price substitution policy because of legislative changes, regulatory changes, and litigation that affected this issue. Specifically—
• A preliminary injunction issued by the United States District Court for the District of Columbia in National Association of Chain Drug Stores et al v. Health and Human Services, Civil Action No. 1:07-cv-02017 (RCL) was still in effect;
• We were continuing to expect to develop regulations to implement section 2503 of the Affordable Care Act, which amended the definition of AMP, and section 202 of the Federal Aviation Administration Air Transportation Modernization and Safety Improvement Act (Pub. L. 111-226) as enacted on August 10, 2010, which further amended section 1927(k) of the Act; and
• We proposed to withdraw certain provisions of the AMP final rule published on July 17, 2007 (75 FR 54073).
As a result, we finalized the portion of our proposal that sets the AMP threshold at 5 percent for CY 2011 and revised the regulation text accordingly (75 FR 73471).
The preliminary injunction was vacated by the United States District Court for the District of Columbia on December 15, 2010. Currently, we continue to expect that regulations to implement section 2503 of the Affordable Care Act and section 202 of the Federal Aviation Administration Air Transportation Modernization and Safety Improvement Act will be developed. However, these statutory amendments became effective on October 1, 2010 without regard to whether or not final regulations to carry out such amendments have been promulgated by such date. Moreover, our Medicaid final rule published on November 15, 2010 finalized regulations requiring manufacturers to calculate AMP in accordance with section 1927(k)(1) of the Act (75 FR 69591). Since statutory and regulatory provisions exist and are currently utilized by manufacturers for the calculation and submission of AMP data, we revisited the AMP threshold and price substitution issues.
Section 1847A(d)(3) of the Act allows the Secretary to specify adjustments to the AMP threshold percentage for years subsequent to 2005, and to specify the timing for any price substitution. Therefore, for CY 2012, with respect to AMP substitution, we proposed (76 FR 42829) to apply the applicable percentage subject to certain adjustments. Specifically, a price substitution of AMP for ASP will be made only when the ASP exceeds the AMP by 5 percent in two consecutive quarters immediately prior to the current pricing quarter, or three of the previous four quarters immediately prior to the current quarter.
In general, the ASP methodology reflects average market prices for Part B drugs for a quarter. The ASP is based on the average sales price to all purchasers for a calendar quarter. The AMP, in turn, primarily represents the average price paid by wholesalers for drugs distributed to retail community pharmacies and by retail community pharmacies that purchase drugs directly from the manufacturers, and also includes a subset of drugs sold to other purchasers. Accordingly, while the ASP payment amount for a billing code may exceed its AMP for that billing code for any given quarter, this may reflect only a temporary fluctuation in market prices that would be corrected in a subsequent quarter. We believe this is demonstrated by how few billing codes exceed the applicable threshold percentage over multiple quarters. For example, in the Inspector General's report “Comparison of Average Sales Prices and Average Manufacturer Prices: An Overview of 2009,” only 11 of 493 examined billing codes exceeded the applicable threshold percentage over multiple quarters (OEI-03-10-00380). We are concerned that substitutions based on a single quarter's ASP to AMP comparison will not appropriately or accurately account for temporary fluctuations. We believe that applying this threshold percentage adjusted to reflect data from multiple quarters will account for continuing differences between ASP and AMP, and allow us to more accurately identify those drugs that consistently trigger the substitution threshold and thus warrant price substitution.
We further proposed to apply the applicable AMP threshold percentage only for those situations where AMP and ASP comparisons are based on the same set of NDCs for a billing code (that
Because the OIG's partial AMP data comparison did not reflect all of the NDCs used in our volume-weighted ASP calculations, we discussed our concern about using the volume-weighted AMP in the CY 2011 PFS proposed rule. We believed that such AMP data may not adequately account for market-related drug price changes and may lead to the substitution of incomplete and inaccurate volume-weighted prices. Payment amount reductions that result from potentially inaccurate substitutions may impact physician and beneficiary access to drugs. Therefore, consistent with our authority as set forth in section 1847A(d)(1) and (3) of the Act, we proposed in the CY 2011 PFS proposed rule that the substitution of 103 percent of AMP for 106 percent of ASP should be limited to only those drugs with ASP and AMP comparisons based on the same set of NDCs.
In response to our CY 2011 proposed rule, the OIG changed its methodology for “partial” AMP data comparisons beginning with its report titled “Comparison of First-Quarter 2010 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for Third Quarter 2010.” Specifically, in addition to calculating a volume-weighted AMP based on “partial” data and identifying billing codes that exceeded the price substitution threshold, the OIG began to replace each missing NDC-level AMP with corresponding NDC-level ASP data. The OIG then calculated a volume-weighted AMP for the billing code. If the volume-weighted AMP continued to exceed the price substitution threshold, the report attributed this to an actual difference between ASPs and AMPs in the marketplace (OEI-03-10-00440).
We appreciate that the Inspector General has acknowledged the importance of protecting beneficiary and physician access in its methodology change. However, section 1847(A)(d)(2)(B) of the Act specifically indicates that the comparison be made to AMP as determined under section 1927(k)(1) of the Act. Moreover, we continue to be concerned that comparisons based on partial AMP data may not adequately account for market-related drug price changes and may lead to the substitution of incomplete and inaccurate volume-weighted prices. Therefore, for CY 2012, we proposed to apply the applicable AMP threshold percentage only for those situations where AMP and ASP comparisons are based on the same set of NDCs for a billing code (that is, “complete” AMP data). Furthermore, we proposed to revise § 414.904(d)(3) to reflect corresponding regulatory text changes.
After reviewing the public comments, we are finalizing the 5 percent threshold for AMP comparisons for CY 2012 and the corresponding regulation text at 42 CFR 414.904(d)(3)(iii) as proposed, except that we are correcting one typographical error in which we referred to ASP instead of AMP. We are also finalizing the proposal that specifies that the AMP for a billing code is calculated using the same set of NDCs used to calculate the ASP for the billing code and corresponding regulation text at 42 CFR 414.904(d)(3)(iii)(B).
Section 1847A(d) of the Act requires the Inspector General to conduct studies of the widely available market price for drugs and biologicals to which section 1847A of the Act applies. However, it does not specify the frequency of when such studies should be conducted. The Inspector General has conducted studies comparing AMP to ASP for essentially each quarter since the ASP system has been implemented. Since 2005, the OIG has published 25 reports pertaining to the price substitution issue (see Table 36), of which 23 have identified billing codes with volume-weighted ASPs that have exceeded their volume-weighted AMPs by the applicable threshold percentage.
In the quarterly report comparing AMP to ASP, titled “Comparison of Third-Quarter 2010 Average Sales Price and Average Manufacturer Prices: Impact on Medicare Reimbursement for First Quarter 2011” (OEI-03-11-00160), the Inspector General found that of 365 billing codes with “complete” AMP data in the third quarter of 2010, only 14 met the 5 percent threshold; that is, ASP exceeded AMP by at least 5 percent. Eight of these 14 billing codes also exceeded the AMP by at least 5 percent in one or more of the previous four quarters; only two drugs had ASPs that exceeded the 5 percent threshold in all four quarters under review. This Inspector General report further indicates that, “If reimbursement amounts for all 14 codes with complete AMP data had been based on 103 percent of the AMPs during the first quarter of 2011, we estimate that Medicare expenditures would have been reduced $10.3 million in that quarter alone.” The savings found by the Inspector General constitute potential savings for the Medicare program and beneficiaries. Since the publication of the proposed rule, the OIG has released two additional AMP comparison studies (OEI-03-11-00540, and OEI-03-11-00360)., Report OEI-03-11-00360, entitled “Comparison of Fourth Quarter 2010 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for Second Quarter 2011,” has findings that indicate the potential for cost savings through the implementation of price substitution, and it states that “of the 338 drug codes with complete AMP data, 15 exceeded the 5 percent threshold. If reimbursement amounts for all 15 codes had been based on 103 percent of the AMPS in the second quarter of 2011, Medicare would have saved an estimated $1.3 million. Under CMS proposed price substitution policy, reimbursement amounts for 5 of the 15 drugs would have been reduced, saving an estimated $554,000.” The more recent report describes more modest cost savings than the report cited in the proposed rule.
As discussed previously, section 1847A(d)(3) of the Act provides authority for us to determine the applicable percentage subject to “such adjustment as the Secretary may specify for the widely available market price or the average manufacturer price, or both.” We also have authority to specify the timing of any ASP substitution. Consistent with this authority, we proposed a policy to substitute 103 percent of AMP for 106 percent of ASP where the applicable percentage threshold has been satisfied for the two consecutive quarters immediately prior to the current pricing quarter, or for three of the previous four quarters immediately prior to the current pricing quarter. This policy would apply to single source drugs and biologicals, multiple source drugs, and biosimilar biological products as defined at section 1847A(c)(6)(C), (D), and (H) of the Act.
After reviewing the public comments, we are finalizing our proposal that implements the substitution of 103 percent of AMP for 106 percent of ASP where the applicable percentage threshold has been satisfied for the two consecutive quarters immediately prior to the current pricing quarter, or for three of the previous four quarters immediately prior to the current pricing quarter and corresponding regulation text at 42 CFR 414.904(d)(3)(iii)(A). This policy will apply to single source drugs and biologicals, multiple source drugs, and biosimilar biological products as defined at section 1847A(c)(6)(C), (D), and (H) of the Act.
As stated in § 414.804(a)(5), a manufacturer's average sales price must be submitted to CMS within 30 days of the close of the quarter. We then calculate an ASP for each billing code in accordance with the process outlined at § 414.904. Then, as described in our CY 2005 PFS final rule (69 FR 66300), we implement these new prices through program instructions or otherwise at the first opportunity after we receive the data, which is the calendar quarter after receipt.
Section 1847A(d)(3)(C) of the Act indicates that a price substitution would be implemented “effective as of the next quarter” after the OIG has informed us that the ASP for a drug or biological exceeds its AMP by the applicable percentage threshold. The OIG does not receive new ASPs for a given quarter until after we have finalized our calculations for the quarter. Also, the results of the OIG's pricing comparisons are not available until after the ASPs for a given quarter have gone into effect. Therefore, we anticipate that there will be a three-quarter lag for substituted prices from the quarter in which manufacturer sales occurred, though this will depend in great part upon the timeframe in which we obtain comparison data from the OIG. Table 37 provides an example of this timeframe.
Given this lag in time, the ASP for a billing code may have decreased since the OIG's comparison. Therefore, consistent with our authorities in section 1847A(d)(3) of the Act and our desire to provide accurate payments consistent with these provisions, we believe that the timing of any substitution policy should permit a final comparison between the OIG's volume-weighted 103 percent AMP for a billing code (calculated from the data from sales three quarters prior) and the billing code's volume-weighted 106 percent ASP (as calculated by CMS for the upcoming quarter). In Table 37 for example, this comparison would be done between the HCPCS payment limits calculated for Q1-12, and the OIG's volume-weighted AMPs from their examination of Q4-11 payment limits. This final comparison would assure the Secretary that the 106 percent ASP payment limit for the current pricing quarter continues to exceed 103 percent of the OIG's calculated AMP in order to avoid a situation in which the Secretary would inadvertently raise the Medicare payment limit through this price substitution policy. We specifically requested comments on this proposal.
We would like to clarify that our approach utilizes the OIG's calculation of AMP and does not incorporate the use of restated AMPs. We are not persuaded to incorporate restated AMPs into the calculation because, as discussed earlier in the rule and noted by commenters, AMP can fluctuate from quarter to quarter. The use of a restated AMP would require additional calculations and the incorporation of additional analysis similar to the safeguards finalized in this rule that confirm that the AMP to ASP comparison is not just a one quarter fluctuation that may not represent the actual state of the marketplace. The use of restated AMPs may also lead to comparisons that are beyond the 3 quarter lag and changes the comparison from one based on a single quarter to being based on potentially changing data; the ASP methodology generally relies on data from a single time period. We believe that additional pricing variations, which could result from the use of restated AMPs over multiple quarters could further increase providers' uncertainty about payment rates. The final comparison between the OIG's volume-weighted 103 percent AMP for a billing code (calculated from the data from sales three quarters prior) and the billing code's volume-weighted 106 percent ASP (as calculated by CMS for the upcoming quarter) is intended to minimize the effect of the three quarter lag and further minimize the effect of AMP fluctuation on our substitution policy, and we believe that this final check, as well as the additional safeguards described in this rule, are sufficient. An additional check based on restated AMP is not necessary at this time.
After reviewing the public comments, we are finalizing our proposal regarding the final comparison between AMP and ASP and the related regulation text at 42 CFR 414.904(d)(3)(ii)(B).
ASP payment limits are calculated on a quarterly basis as per section 1847A(c)(5)(A) of the Act, and we are particularly mindful that the ASP-based payment allowance for a billing code may change from quarter to quarter. As such, we proposed that any price substitution based on the comparison that triggered its application would last for one quarter.
We are finalizing the one quarter duration for AMP-based price substitutions and the related regulation text at § 414.904(d)(3)(i). We note that in a subsequent quarter, the OIG may identify that a volume-weighted ASP continues to exceed the volume-weighted AMP for a billing code that previously triggered a price substitution. In this scenario, if the criteria for the price substitution policy are met, we would substitute 103 percent of the OIG's updated volume-weighted AMP for that billing code.
In the preceding section, we have discussed various details, limitations, and safeguards regarding the AMP-based price substitutions. In general, comments regarding these items supported our proposals regarding those items, and agreed that we were being consistent with the cautious approach described in the proposal and previous rules. In this section, we will discuss whether the AMP based price substitutions should be implemented in CY 2012.
In general, we believe that our proposal to substitute 103 percent of AMP for 106 percent of ASP provides us with a viable mechanism for generating savings for the Medicare program and its beneficiaries because it will allow Medicare to pay based on lower market prices for those drugs and biologicals that consistently exceed the applicable threshold percentage. Moreover, it will enable us to address a programmatic vulnerability identified by the OIG.
In the CY 2010 proposed rule, we sought comment on other issues related to the comparison between ASP and AMP, and in the CY 2012 proposed rule we sought comments on the following issues again—
• The effect of definitional differences between AMP and ASP, particularly in light of the definition of AMP as revised by section 2503 of the Affordable Care Act;
• The impact of any differences in AMP and ASP reporting by manufacturers on price substitution comparisons; and
• Whether and/or how general differences and similarities between AMP and manufacturer's ASP would affect comparisons between these two.
Although most commenters agree with specific details of our proposals that we described and finalized, nearly all of the commenters were concerned about the impact of recent changes to the definition of AMP and how they would affect the relationship of AMP to ASP.
• A lack of experience with the new definitions of AMP and an incomplete understanding of the relationship between ASP and the new definitions of AMP by the industry and CMS, particularly for AMP reporting of drugs with payment limits that are determined under the ASP methodology. Commenters indicated that the definition of AMP in the Affordable Care Act that describes drugs sold to retail community pharmacies is expected to increase AMP, but commenters expressed uncertainty about how the updated definition in the FAA Air Transportation Modernization and Safety Improvement Act would affect the AMP/ASP relationship.
• A lack of guidance in recent rulemaking and statutory provisions about assumptions that manufacturers should use in order to uniformly calculate AMP. In particular, commenters were concerned about how the phrase “not generally dispensed through a retail community pharmacy,” which was added in the updated definition of AMP in the FAA Air Transportation Modernization and Safety Improvement Act, might be defined in rulemaking;
• Uncertainty about how future rulemaking regarding the AMP would affect the ASP/AMP relationship;
• Inconsistency in how AMP and ASP incorporate prompt pay discounts; and
• Concern about any further reductions in payments to providers, particularly small practices and the potential effect on access to care.
Commenters also stated that implementation of a price substitution policy in 2012 was not consistent with the “slow and cautious” approach that we have described in previous rulemaking. They recommended delaying the implementation of a price substitution policy until additional guidance about AMP has been finalized and more experience has been gained.
First, we disagree that implementation of the policy in CY 2012 is inconsistent with a slow and cautious approach regarding price substitution. While additional guidance and experience with the new definitions of AMP would be helpful, our 6-years' experience in monitoring AMP and ASP have shown that very few ASP payment limits exceed the existing AMP threshold (even absent the safeguards that we are finalizing in this rule). Moreover, most of the drugs that exceed the threshold in previous reports are infrequently used. We understand that the updated definition of AMP encompasses sales of injected, infused, instilled, inhaled, and implanted drugs that are not generally dispensed through a retail community pharmacy, including a wider range of customers and discounted sales to non-pharmacy entities, and commenters' concerns that implementation of the most recent definition could decrease AMP for certain drugs. However, we do not have any specific information from commenters that persuades us to believe that the AMP-based price substitution policy will be applied frequently or to high cost/high volume items, despite the changes to the definition of AMP. Therefore, we believe that proceeding with implementation in 2012 is consistent with a slow and cautious approach toward this policy.
Second, we have worked closely with the OIG and have reviewed 25 price substitution reports from the OIG over the past 6 years. The drugs and biologicals identified as candidates for price substitution were typically uncommonly used and many were inexpensive items. Based on this experience, we do not believe that this policy will substantially affect providers' financial situation, access to care for beneficiaries, the payment rate for highly utilized and expensive drugs and biologicals, or the manufacturers of these items. Further, we are finalizing in this rule additional safeguards to prevent the triggering of the price substitutions for drugs that do not consistently exceed the AMP threshold. We believe these safeguards are both consistent with a cautious approach and provide assurance that the price substitution policy will be applied only when appropriate.
Finally, while the Affordable Care Act did change the definition of AMP, and AMP data captures sales differently than ASP, the Congress did not modify its mandate that the OIG compare AMP to ASP for purposes of section 1847A(d)(3), nor did it change how prompt pay discounts are treated under ASP. Thus, in our view, the statute requires the Secretary to use AMP, as modified by the Affordable Care Act and updated by the FAA Air Transportation Modernization and Safety Improvement Act, as the basis for a comparison value and an alternative payment limit for ASP, and we will not make further revisions to the proposed implementation of this policy at this time. We appreciate the comments that we have received regarding this proposal and we look forward to continuing to work with the OIG and stakeholders on this matter.
In summary we are finalizing the implementation of an AMP based substitution policy to substitute 103 percent of AMP for 106 percent of ASP beginning in CY 2012 and proposed regulation text at 42 CFR 414.904(d)(3), as described in the ASP section of this rule. We note that although this policy will become effective on January 1, 2012, because of the three quarter lag, the earliest that price substitutions could occur is April 1, 2012.
For purposes of this part, unless otherwise specified, the term “drugs” will hereafter refer to both drugs and biologicals. Sections 1847A and 1927(b) of the Act specify quarterly ASP data reporting requirements for manufacturers. Specific ASP reporting requirements are set forth in section 1927(b)(3) of the Act. For the purposes of reporting under section 1847A of the Act, the term “manufacturer” is defined in section 1927(k)(5) of the Act and means any entity engaged in the following: Production; preparation, propagation, compounding, conversion or processing of prescription drug products; either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis; or packaging, repackaging, labeling, relabeling, or distribution of prescription drug products. The term manufacturer does not include a wholesale distributor of drugs or a retail pharmacy licensed under State law. However, manufacturers that also engage in certain wholesaler activities are required to report ASP data for those drugs that they manufacture. Note that the definition of manufacturers for the purposes of ASP data reporting includes repackagers.
Section 1927(b)(3)(A)(iii) of the Act specifies that manufacturers must report their average sales price and the number of units by NDC. As established by 42 CFR part 414 subpart J, manufacturers are required to report data at the NDC level, which includes the following elements: (1) The manufacturer ASP; (2) the Wholesale Acquisition Cost (WAC) in effect on the last day of the reporting period; (3) the number of units sold; and (4) the NDC. The reported ASP data are used to establish the Medicare payment amounts.
Section 1927(b)(3)(A)(iii)(II) of the Act specifies that the manufacturer must report the WAC if it is required for payment to be made under section 1847A of the Act. In the 2004 IFC that
In order to facilitate more accurate and consistent ASP data reporting from manufacturers, we have proposed additional revisions to the Addendum A template. Specifically, we have proposed to revise existing reporting fields and add new fields to the Addendum A template as follows—
• To split the current NDC column into three separate reporting fields, corresponding to the three segments of an NDC;
• To add a new field to collect an Alternate ID for products without an NDC; and
• To expand the current FDA approval number column to account for multiple entries and supplemental numbers.
We have also added a macro to the Addendum A template that will allow manufacturers to validate the format of their data prior to submission. This will help verify that data are complete and submitted to CMS in the correct format, thereby minimizing time and resources spent on identifying mistakes or errors. We note that the use of this macro does not preclude or supersede manufacturers' responsibility to provide accurate and timely ASP data in accordance with the reporting obligation under section 1927(b)(3) of the Act. We also note that manufacturers who misrepresent or fail to report manufacturer ASP data will remain subject to civil monetary penalties, as applicable and described in sections 1847A and 1927(b) of the Act and codified in regulations at § 414.806.
In summary we are finalizing our proposal to amend the Addendum A template, including the use of a data validation macro and with the expansion of the “Alternate ID” field. The companion Users' Guide and other documents will be available on our ASP Web site:
As required by 42 CFR part 414 subpart J, manufacturers report ASP price and volume data at the NDC level. This is appropriate for most drug and biological products because an NDC is usually associated with a consistent amount of product that is being sold. Our experience with manufacturer reporting of ASPs has revealed that a limited number of drug products, as defined by an NDC, might contain a variable amount of active ingredient. This situation is common for plasma derived clotting factors; for example, we are aware of one product where a vial described as nominally containing 250 international units (IUs) of clotting factor activity might actually contain between 220 and 400 IUs. Although the exact factor activity is specified on the label, the amount of IUs contained in an NDC might vary between manufacturing lots. For these types of products, it is possible that vials with the same NDC but different amounts of clotting factor activity (as measured in IUs) might be sold during the same ASP reporting period. For drugs paid under Medicare Part B, such variability in the amount of drug product within an NDC appears to apply mostly to clotting factors that are prepared from plasma sources; it also applies to a few other products, including a plasma protein product used to treat antitrypsin deficiency.
As stated in the section 1847A(b)(2) of the Act, for years after 2004, the Secretary has the authority to “establish the unit for a manufacturer to report and methods for counting units as the Secretary determines appropriate to implement.” There are limited situations when ASP price and volume reporting by product NDC may affect the accuracy of subsequent pricing calculations done by us (for example, when an NDC is associated with a variable amount of drug product as described in the paragraph previously). We believe that in such cases it is appropriate to amend the definition of the ASP unit associated with the NDC that is reported to us by manufacturers for the purposes of calculating ASP. Under the authority in the section
In conjunction with the proposals in the preceding paragraph and the expectation that nearly all ASP price and sales volume reporting will continue to be at the NDC level (that is, the reported ASP sales and volume will be associated with a non-variable amount that is represented by the NDC), we proposed a clarification to existing regulation text at § 414.802. Current regulation text states that “Unit means the product represented by the 11-digit National Drug Code.” We proposed to update the definition to account for situations when an alternative unit of reporting must be used; the definition of the term unit will continue to be based on reporting of ASP data per NDC unless otherwise specified by CMS to account for situations where the amount of drug product represented by an NDC varies.
The instructions for reporting products with variable amounts of drug product, along with general instructions on completing the revised ASP Data Form (Addendum A), will be delineated in a User Guide that will be available on the ASP Web site. In the User Guide, we will also be revising our instructions for the reporting of dermal grafting products as follows—
• If an NDC is not associated with a dermal grafting product, manufacturers should enter the UPC or other unique identifier (such as an internal product number) in the alternate ID column; and
• Manufacturers should report ASP prices and sales volumes for dermal grafting products in units of area by square centimeter.
The User Guide will be available on the CMS ASP Web site at:
We would also like to remind manufacturers that additional information about reporting ASP data to us is available (for examples, see the following: (69 FR 17936), (69 FR 66299), (70 FR 70215), (71 FR 69665), (72 FR 66256), (73 FR 69751), and (74 FR 61904)). Also, a link to the ASP Frequently Asked Questions (FAQs) is posted in the “Related Links Inside CMS” section of the ASP Overview Web page. We welcome comments on the ASP reporting proposals that are described in this section.
We received comments pertaining to: (1) Coding and pricing for new molecular diagnostic codes; (2) the continued use of G0440 and G0441 in 2012 as well as general comments on the coding and payment of skin substitute products; (3) updating supplying and dispensing fees for Part B drugs; (4) low reimbursement rates in a HCPCS-based claims systems for pharmacies and other community based practices; (5) the exclusion of prompt pay discounts from ASP calculations; and, (6) a request to pay all Part B drugs under the Part D benefit.
These comments are outside the scope of this rule, and therefore are not addressed in this final rule with comment period.
Section 651 of MMA requires the Secretary to conduct a demonstration for up to 2 years to evaluate the feasibility and advisability of expanding coverage for chiropractic services under Medicare. Current Medicare coverage
In the CY 2006, 2007, and 2008 PFS final rules with comment period (70 FR 70266, 71 FR 69707, 72 FR 66325, respectively), we included a discussion of the strategy that would be used to assess budget neutrality (BN) and the method for adjusting chiropractor fees in the event the demonstration resulted in costs higher than those that would occur in the absence of the demonstration. We stated that BN would be assessed by determining the change in costs based on a pre-post comparison of total Medicare costs for beneficiaries in the demonstration and their counterparts in the control groups and the rate of change for specific diagnoses that are treated by chiropractors and physicians in the demonstration sites and control sites. We also stated that our analysis would not be limited to only review of chiropractor claims because the costs of the expanded chiropractor services may have an impact on other Medicare costs for other services.
In the CY 2010 PFS final rule with comment period (74 FR 61926), we discussed the evaluation of this demonstration conducted by Brandeis University and the two sets of analyses used to evaluate budget neutrality. In the “All Neuromusculoskeletal Analysis,” which compared the total Medicare costs of all beneficiaries who received services for a neuromusculoskeletal condition in the demonstration areas with those of beneficiaries with similar characteristics from similar geographic areas that did not participate in the demonstration, the total effect of the demonstration on Medicare spending was $114 million higher costs for beneficiaries in areas that participated in the demonstration. In the “Chiropractic User Analysis,” which compared the Medicare costs of beneficiaries who used expanded chiropractic services to treat a neuromusculoskeletal condition in the demonstration areas, with those of beneficiaries with similar characteristics who used chiropractic services as was currently covered by Medicare to treat a neuromusculoskeletal condition from similar geographic areas that did not participate in the demonstration, the total effect of the demonstration on Medicare spending was a $50 million increase in costs.
As explained in the CY 2010 PFS final rule, we based the BN estimate on the “Chiropractic User Analysis” because of its focus on users of chiropractic services rather than all Medicare beneficiaries with neuromusculoskeletal conditions, as the latter included those who did not use chiropractic services and who may not have become users of chiropractic services even with expanded coverage for them (74 FR 61926 through 61927). Users of chiropractic services are most likely to have been affected by the expanded coverage provided by this demonstration. Cost increases and offsets, such as reductions in hospitalizations or other types of ambulatory care, are more likely to be observed in this group.
As explained in the CY 2010 PFS final rule (74 FR 61927), because the costs of this demonstration were higher than expected and we did not anticipate a reduction to the PFS of greater than 2 percent per year, we finalized a policy to recoup $50 million in expenditures from this demonstration over a 5-year period, from CYs 2010 through 2014 (74 FR 61927). Specifically, we are recouping $10 million for each such year through adjustments to the chiropractic CPT codes. Payment under the PFS for these codes will be reduced by approximately 2 percent. We believe that spreading this adjustment over a longer period of time will minimize its potential negative impact on chiropractic practices.
We are continuing the implementation of the required budget neutrality adjustment by recouping $10 million in CY 2012. Our Office of the Actuary estimates chiropractic expenditures in CY 2012 will be approximately $470 million based on actual Medicare spending for chiropractic services for the most recent available year. To recoup $10 million in CY 2012, the payment amount under the PFS for the chiropractic CPT codes (CPT codes 98940, 98941, and 98942) will be reduced by approximately 2 percent. We are reflecting this reduction only in the payment files used by the Medicare contractors to process Medicare claims rather than through adjusting the RVUs. Avoiding an adjustment to the RVUs would preserve the integrity of the PFS, particularly since many private payers also base payment on the RVUs.
The following is the summary of the public comments we received and our responses.
With respect to the commenter that requested more information, we note that the final evaluation report, which describes, among other things, our methodology for calculating budget neutrality for this demonstration, is located on our Web site at the following URL:
Regardless of the differences in the costs associated with the demonstration areas, the evaluation conducted by Brandeis University found that expanding coverage for chiropractic services under the demonstration resulted in increased Medicare expenditures, and the Secretary must recoup these costs in order to meet the budget neutrality requirement of the law.
In response to the comment suggesting that the data from this demonstration should not be used to estimate the cost of a national rollout of the expansion of chiropractic services, we note the data from the demonstration is the only information CMS had at the time of the Report to the Congress for estimating the costs of a national rollout.
After consideration of the public comments received, we are continuing the implementation of the required budget neutrality adjustment by recouping $10 million in CY 2012 by reducing the payment amount under the PFS for chiropractic codes (that is, CPT codes 98940, 98941, and 98942) by approximately 2 percent.
Section 3401 of the Affordable Care Act requires that the update factor under certain payment systems be annually adjusted by changes in economy-wide productivity. The year that the productivity adjustment is effective varies by payment system. Specifically, section 3401 of the Affordable Care Act requires that in CY 2011 (and in subsequent years) update factors under the ambulatory surgical center (ASC) payment system, the ambulance fee schedule (AFS), the clinical laboratory fee schedule (CLFS) and the DMEPOS fee schedule be adjusted by changes in economy wide productivity. Section 3401(a) of the Affordable Care Act amends section 1886(b)(3)(B) of the Act to add clause (xi)(II) which sets forth the definition of this productivity adjustment. The statute defines the productivity adjustment to be equal to the 10-year moving average of changes in annual economy-wide private nonfarm business multifactor productivity (MFP) (as projected by the Secretary for the 10-year period ending with the applicable fiscal year, year, cost reporting period, or other annual period). Historical published data on the measure of MFP is available on the Bureau of Labor Statistics' (BLS) Web site at
As stated in the CY 2012 PFS proposed rule (76 FR 42834 and 35), the projection of MFP is currently produced by IHS Global Insight, Inc. (IGI). The methodology for calculating MFP for the ASC payment system, and the AFS, CLFS, and DMEPOS fee schedules was finalized in the CY 2011 PFS final rule with comment period (75 FR 73394 through 73399). As described in the CY 2011 PFS final rule with comment period (75 FR 73394), IGI replicates the MFP measure calculated by the BLS using a series of proxy variables derived from the IGI US macro-economic models. For CY 2012, we proposed to revise the IGI series used to proxy the labor index used in the MFP forecast calculation from man-hours in private nonfarm establishments (billions of hours—annual rate) to hours of all persons in private nonfarm establishments, (2005 = 100.00), adjusted for labor composition effects. We proposed this revision after further analysis showed that the proposed series is a more suitable proxy for the BLS private nonfarm business sector labor input series since it accounts for the changes in skill-mix of the workforce over time (referred to above as labor composition effects). The BLS labor input series includes labor composition effects. We did not propose any additional changes to the IGI MFP forecast methodology or its application to the CPI-U update factors for the ASC payment system, and the AFS, CLFS, and DMEPOS fee schedules.
We received one comment on our proposal to revise the labor proxy used to forecast MFP.
Therefore, we are finalizing our proposal to use hours of all persons in private nonfarm establishments, (2005 = 100.00), adjusted for labor composition effects as the proxy for labor index used in the MFP forecast calculation.
In the March 10, 2000
In the November 23, 2001
On March 5, 2002, we issued a program memorandum (Transmittal AB-02-030, Change Request 1998) implementing the administrative policies set forth in the November 23, 2001 final rule, including the following instruction:
Medicare does not require the signature of the ordering physician on a laboratory service requisition. While the signature of a physician on a requisition is one way of documenting that the treating physician ordered the service, it is not the only permissible way of documenting that the service has been ordered. For example, the physician may document the ordering of specific services in the patient's medical record.
On January 24, 2003, we issued a program transmittal (Transmittal 1787, Change Request 2410) to manualize the March 5, 2002 program memorandum. The transmittal page, entitled “Section 15021, Ordering Diagnostic Tests, manualizes Transmittal AB-02-030, dated March 5, 2002”, stated: “In accordance with negotiated rulemaking for outpatient clinical diagnostic laboratory services, no signature is required for the ordering of such services or for physician pathology services.” In the manual instructions in that transmittal (that is, Transmittal 1787), we stated in a note: “No signature is required on orders for clinical diagnostic tests paid on the basis of the physician fee schedule or for physician pathology services.” The manual instructions inadvertently omitted the reference to clinical diagnostic laboratory tests. Thus, the transmittal seemed to extend the policy set forth in the November 23, 2001 final rule (that no signature is required on requisitions for clinical diagnostic laboratory tests paid under the CLFS) to also apply to clinical diagnostic tests paid on the basis of the PFS and physician pathology services. In addition, the manual instructions used the term “order” instead of “requisition,” which we understand caused some confusion. In addition, when we transitioned from paper manuals to the current electronic Internet Only Manual (IOM) system, these manual instructions were inadvertently omitted from the new Benefit Policy Manual (BPM).
On August 28, 2008, we issued a program transmittal (Transmittal 94, Change Request 6100) to update the BPM to incorporate language that was previously contained in section 15021 of the Medicare Carriers Manual. The reissued language stated, “No signature is required on orders for clinical diagnostic tests paid on the basis of the clinical laboratory fee schedule, the physician fee schedule, or for physician pathology services.” After the publication of the August 2008 Program Transmittal (Transmittal 94), we received numerous inquiries from laboratories, diagnostic testing facilities, and hospital representatives who had questions about whether the provision applied to all diagnostic services, including x-rays, magnetic resonance imaging (MRIs), and other nonclinical laboratory fee schedule diagnostic services.
To resolve any confusion surrounding the implementation of the CLFS policy in 2001 and subsequent transmittals, we restated and solicited public comments on our policy in the July 13, 2009 proposed rule (74 FR 33641 and 33642), entitled “Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2010” (CY 2010 PFS proposed rule). At that time, our policy was that the signature of a physician or NPP was not required on a requisition for clinical diagnostic laboratory tests paid on the basis of the CLFS. However, we were clear that we would still require that it must be evident, in accordance with our regulations at § 410.31(d)(2) and (3), that the physician or NPP had ordered the services .
We clarified that this policy regarding requisitions for clinical diagnostic laboratory tests would not supersede other applicable Medicare requirements (such as those related to hospital conditions of participation (CoPs)), which require the medical record to include an order signed by the physician or NPP who is treating the beneficiary. In addition, we stated that we did not believe that our policy regarding signatures on requisitions for clinical diagnostic laboratory tests supersedes other requirements mandated by professional standards of practice or obligations regarding orders and medical records promulgated by
In the CY 2010 PFS proposed rule (74 FR 33641 and 33642), we also restated and solicited public comment on our longstanding policy, consistent with the principle in § 410.32(a), that a written order for diagnostic tests including those paid under the CLFS and those that are not paid under the CLFS (for example, that are paid under the PFS or under the OPPS), such as X-rays, MRIs, and the technical component (TC) of physician pathology services, must be signed by the ordering physician or NPP. We were clear that the policy that signatures are not required on requisitions for clinical diagnostic laboratory tests paid under the CLFS applied only to requisitions (as opposed to written orders).
Additionally, in the CY 2010 PFS proposed rule (74 FR 33642) we solicited public comments about the distinction between an order and a requisition. We noted that an “order” as defined in our IOM, 100-02, Chapter 15, Section 80.6.1, is a communication from the treating physician or NPP requesting that a diagnostic test be performed for a beneficiary. The order may conditionally request an additional diagnostic test for a particular beneficiary if the result of the initial diagnostic test ordered yields a certain value determined by the treating physician or NPP (for example, if test X is negative, then perform test Y). We further clarified in the CY 2010 PFS final rule with comment period (74 FR 61930) that an order may be delivered via any of the following forms of communication:
• A written document signed by the treating physician or NPP, which is hand-delivered, mailed, or faxed to the testing facility.
• A telephone call by the treating physician or NPP or his or her office to the testing facility.
• An electronic mail, or other electronic means, by the treating physician or NPP or his or her office to the testing facility.
If the order is communicated via telephone, both the treating physician or NPP, or his or her office, and the testing facility must document the telephone call in their respective copies of the beneficiary's medical records.
In contrast, in the CY 2010 PFS proposed rule (74 FR 33642), we defined a “requisition” as the actual paperwork, such as a form, which is furnished to a clinical diagnostic laboratory that identifies the test or tests to be performed for a patient. The requisition may contain patient information, ordering physician information, referring institution information, information on where to send reports, billing information, specimen information, shipping addresses for specimens or tissue samples, and checkboxes for test selection. We believed the requisition was ministerial in nature, assisting laboratories with the billing and handling of results, and serves as an administrative convenience to providers and patients. We believed that a written order, which may be part of the medical record, and the requisition, were two different documents, although a requisition that is signed may serve as an order.
During the public comment period for the CY 2010 PFS proposed rule, we received numerous comments on these issues. Subsequently, in the CY 2010 PFS final rule with comment period (74 FR 61931), we stated that we would continue to carefully consider the issue of physician signatures on requisitions and orders and that we planned to revisit these issues in the future.
In the CY 2011 PFS proposed rule (75 FR 40162 through 40163), we proposed to require a physician's or NPP's signature on requisitions for clinical diagnostic laboratory tests paid on the basis of the CLFS. We stated that we believed this policy would result in a less confusing process because a physician's signature would be required for all requisitions and orders, eliminating the uncertainty over whether the documentation is a requisition or an order, whether the type of test being ordered requires a signature, or which payment system does or does not require a physician's or NPP's signature. We also stated that we believed the requirement would not increase the burden on physicians and it would be easier for the reference laboratory technicians to know whether a test was appropriately requested, which would minimize potential compliance problems for laboratories during the course of a subsequent Medicare audit because a signature would be consistently required. We solicited public comments on the CY 2011 PFS proposed rule.
After careful consideration of all the comments received, we finalized our proposed policy without modification to require a physician's or NPP's signature on requisitions for clinical diagnostic laboratory tests paid under the CLFS in the CY 2011 PFS final rule with comment period (75 FR 73483), which became effective on January 1, 2011. This policy did not affect physicians or NPPs who chose not to use requisitions to request clinical diagnostic laboratory tests paid under the CLFS. Such physicians or NPPs could continue to request such tests by other means, such as by using the annotated medical records, documented telephonic requests, or electronic requests.
In the June 30, 2011
While we did not solicit further comments on the signature on requisition issue in the CY 2011 PFS final rule with comment period, we did receive additional feedback from industry stakeholders on the issue after its publication in the
Even in cases where the physician or NPP sees the patient in his or her offices for an appointment and recommends that clinical diagnostic laboratory testing be performed, we now better understand that, typically, the information is transcribed from the medical record onto a paper requisition by office staff after the physician or NPP and the patient have concluded their interaction. In practice, we can see how requiring the physician or NPP to sign the paper requisition could, in some cases, be very inconvenient and disruptive to the physician, NPP, the beneficiary, and other patients. The physician or NPP may need to take time either during appointments with subsequent patients or between patient appointments to make sure that the requisition is signed for a particular patient prior to his or her departure from the office. In addition, a beneficiary might have to wait for a physician or NPP to complete the requisition signature process before the beneficiary could depart from the office.
Another situation identified by industry stakeholders that we did not previously consider concerns physicians or NPPs who maintain several practice locations. A patient may see his or her physician or NPP only at one particular practice location. If that patient presents to the practice location with a medical issue that the physician or NPP believes warrants immediate laboratory testing, but the physician or NPP is physically at a different location that day, the physician or NPP may be able to direct his or her nursing staff to prepare a requisition for the laboratory test. But, if the physician or NPP must sign the requisition, there could be a delay of several days or longer before the physician or NPP is able to do so, which means the patient would have to wait to have the laboratory test performed.
The aforementioned scenarios have detrimental implications for expeditious patient care that were not evident to us until the new policy was effectuated and we started hearing from stakeholders in the industry that would be negatively impacted by the policy. In response to a comment suggesting that physicians be educated about this new requirement to alleviate problems of non-compliance, we stated, in the CY 2011 PFS final rule with comment period (75 FR 73482), that we would update our manuals and direct the Medicare contractors to educate physicians and NPPs on this policy. After publication of the CY 2011 PFS final rule with comment period, it became even clearer to us that some physicians, NPPs, and clinical diagnostic laboratories were not aware of, or did not understand, the policy. Therefore, in the first calendar quarter of 2011, we focused on developing educational and outreach materials to educate those affected by this policy. Further, we issued a statement that, once the educational campaign conducted in the first quarter of 2011 was fully underway, we would expect requisitions to be signed. While developing educational and outreach materials, we realized how difficult and burdensome the actual implementation of this policy was for physicians and NPPs and that, in some cases, the implementation of this policy could have a negative impact on patient care. At that point, we decided that the better course of action was to re-examine the policy.
We re-examined our policy and our reasons for adopting this policy in light of industry stakeholders' comments received after publication of the CY 2011 PFS final rule with comment period and comments received on the CY 2011 PFS proposed rule. We reviewed our beliefs and assumptions regarding the effect of our policy on access to care and with respect to administrative burden on physicians and NPPs, the effect on innovation, and the impact on laboratories. We originally believed that the policy would not have a negative impact on beneficiary access to care. However, we now believe that we underestimated the potential impact on beneficiary health and safety. As discussed previously, care may be delayed under this policy in situations where the physician or NPP orders the test but is not available onsite to sign the requisition. For example, we understand there are concerns that certain populations of patients, such as nursing home patients and patients confined to their homes, may have laboratory tests ordered urgently by a distant physician or NPP to obtain information that is imminently needed in order to assess a need for immediate referral to a hospital, emergency department or other facility. If the ordering physician or NPP is not onsite, it is unlikely that he or she would be able to receive, sign, and return a requisition in the timeframe needed to respond to the patient's urgent clinical status. We had not anticipated this impact on care when we finalized our policy.
We also believed that the administrative burden on physicians and NPPs would be minimal and would result in a less confusing process. Physicians and NPPs must document their orders, in some form, in one or more of the medical records of the patient. We still believe that signing a laboratory requisition at the time of the order, if the requisition is ready for signature, imposes little burden on the physician or NPP, while significantly increasing our ability to minimize improper payments due to fraud and abuse. However, we believe we may have underestimated the number of occasions in which the physician or NPP cannot perform both steps concurrently. We now understand that it is not always the case that a physician or NPP can perform both steps concurrently. For instance, a physician may sign an order at the time of delivering care, but the requisition may not be available for signature until sometime later. In that situation, the physician may need to interrupt a subsequent examination in order to sign a completed requisition so that the patient may leave with the requisition. Given recently released estimates of physician shortfalls in primary care (for example, as referenced in remarks by the Health Resources and Services Administration (HRSA) Administrator to the Bureau of Health Professions Advisory Committee on April 21, 2009), the cost of lost physician time must also be revalued upwards. Alternatively, the beneficiary may have to wait for the physician or NPP to conclude his or her subsequent appointment, which could be as long as 30 minutes or more. Neither of these situations—interrupting the physician or NPP in a subsequent appointment or making the beneficiary wait for an inconvenient period of time—is acceptable. Further, we believed that the policy resulted in a less confusing process because a physician or NPP signature would be required for all requisitions and orders, eliminating uncertainty over whether the documentation is a requisition or an order, whether the type of test being ordered requires a signature, or which payment system does or does not require a physician or NPP signature. However, based on industry stakeholder comments subsequent to the publication of the CY 2011 PFS final rule with comment period, we now believe this process may not be less confusing. Further, industry stakeholders assured us that they had not been confused about the former physician/NPP signature policy and that they never intended for us to interpret their call for consistency in the signature process to mean that they should be burdened with an additional requirement when they were already signing the medical record.
In addition, we believed that many stakeholders either had converted or were in the process of converting to an electronic health records process that would negate the need for a requisition. Electronic health records and electronic transmission of health information are key pieces of this Administration's economic recovery plan and, moreover, are key elements of our plan to improve healthcare quality and efficiency. From the additional stakeholder concerns subsequent to our CY 2011 PFS final rule with comment period, we are sensitive to the increasing migration of information transfer away from paper forms, such as requisitions, to the direct electronic submission of requests for services. After we adopted the new policy, stakeholders expressed their concerns that the requirement for a signature would increase paperwork, in direct opposition to our promotion of time-saving electronic communications. We believe that the requirement for a signature on the requisition does not impact stakeholders who utilize an electronic process for ordering clinical diagnostic laboratory tests because the policy only applies to requisitions, which are paper forms. Our intent was not to suggest that a requisition was necessary in those cases. However, we recognize that members of the provider and supplier community still believe this regulation could inhibit their use of innovative technology and investment in healthcare IT resources. Therefore, we recognize that we underestimated the potential for paperwork burden.
Finally, we believed that the policy would make it easier for a reference laboratory to know whether a test is appropriately requested and to minimize potential compliance problems. Specifically, we believed that the policy would improve a laboratory's ability to authenticate requisitions. However, based on industry stakeholder concerns received after the CY 2011 PFS final rule with comment period and comments submitted on the CY 2011 PFS proposed rule (75 FR 40161 through 40163), we now believe this aspect of the policy is less financially beneficial than we had estimated, because the percentage of laboratory requests covered by the policy may be smaller than we predicted and may continue to shrink as new technology is adopted. We also believed the policy provided a mechanism for laboratories to fulfill their responsibility to ensure that they only provide and bill for services on the direct order of a physician or NPP because the signature on the requisition would provide documentation and evidence that the physician or NPP had ordered the service. However, industry stakeholders expanded on comments to the CY 2011 PFS proposed rule and informed us that there was a cost to adopting a rigid mechanism of establishing authenticity. Laboratories believe it is more efficient for them to use internal procedures and controls to ensure that they do not provide and bill for services without a physician authorization rather than through a Federal policy. Thus, we believe the expected benefits of the policy may be less than we originally estimated.
In summary, there were many situations that we did not recognize as problematic until we finalized the requisition signature policy and stakeholders began to implement it. Upon review of the concerns that industry stakeholders raised after we finalized our policy in the CY 2011 PFS final rule with comment period, and in reconsideration of comments to the CY 2011 PFS proposed rule, we proposed to retract the policy that was finalized in the CY 2011 PFS final rule with comment period, which required a physician's or NPP's signature on a requisition for clinical diagnostic laboratory tests paid under the CLFS (75 FR 73483). We proposed to reinstate our prior policy that the signature of the physician or NPP is not required on a requisition for a clinical diagnostic laboratory test paid under the CLFS for Medicare purposes.
We remain concerned about the costs and impact of fraud and abuse on the Medicare program. The requirement that the treating physician or NPP must document the ordering of the test remains, as does our longstanding policy that requires orders, including those for clinical diagnostic laboratory tests, to be signed by the ordering physician or NPP. We believe that all parties share in the responsibility of ensuring that Medicare services are provided only in accordance with all applicable statutes and regulations, such as the requirement for a physician or NPP order. In many instances, such as in the case of orders originating in hospitals, we believe that retaining all the other requirements previously discussed, especially requiring the physician or NPP who orders the service to maintain documentation of medical necessity in the beneficiary's medical record according to § 410.32(d)(2)(i), as well as the hospital CoPs on medical record services at § 482.24, are sufficient. However, we note that hospital CoPs do not apply to other settings, such as private offices.
We believe it is the responsibility of the clinical diagnostic laboratory, as it is for the provider of any service, to have sufficient processes and safeguards in place to ensure that all services are delivered only when ordered by a physician or NPP. This proposed rule does not preclude an individual laboratory from requiring a physician's or NPP's signature on the requisition. The laboratory may develop its own compliance procedures to ensure that it only furnishes services in response to a physician or NPP order. Such procedures could include internal audits, agreements with ordering physicians or NPPs to provide medical record evidence of the order in the event of an internal or external audit, steps to confirm the existence of an order under certain circumstances, or any other measures including the acceptance of risk by the clinical laboratory. We believe this financial and compliance responsibility was implicit in the 2001 final rule (66 FR 58788), was reiterated in the March 5, 2002 transmittal (Change Request 2410, Transmittal AB-02-030), and has remained a consistent element of the subsequent instructions.
After consideration of the public comments received, we are finalizing our proposal to retract the policy that was finalized in the CY 2011 PFS final rule with comment period, which required a physician's or NPP's signature on a requisition for clinical diagnostic laboratory tests paid under the CLFS (75 FR 73483) and to reinstate our prior policy that the signature of the physician or NPP is not required on a requisition for a clinical diagnostic laboratory test paid under the CLFS for Medicare purposes.
Preventive care and beneficiary wellness are important to the Medicare program and have become an increasing priority. In section 4103 of the Affordable Care Act, the Congress expanded Medicare Part B benefits to include an annual wellness visit providing personalized prevention plan services (hereinafter referred to as an annual wellness visit). The annual wellness visit is described more fully in section 1861(hhh) of the Act, and coverage was effective for services furnished on or after January 1, 2011. Regulations for Medicare coverage of the annual wellness visit are established at 42 CFR 410.15. The annual wellness visit may be performed by a physician, nonphysician practitioner (physician assistant, nurse practitioner, or clinical nurse specialist), or a medical professional (including a health educator, a registered dietitian, or a nutrition professional, or other licensed practitioner) or a team of such medical professionals, working under the direct supervision of a physician. In summary, for CY 2011, the first annual wellness visit includes—
• Establishment of an individual's medical and family history;
• Establishment of a list of current medical providers and suppliers involved in providing medical care to the individual;
• Measurement of an individual's height, weight, body mass index (or waist circumference, if appropriate), blood pressure, and other routine measurements as deemed appropriate, based on the beneficiary's medical and family history;
• Detection of any cognitive impairment that the individual may have;
• Review of the individual's potential (risk factors) for depression;
• Review of the individual's functional ability and level of safety;
• Establishment of a written screening schedule for the individual such as a checklist for the next 5 to 10 years, as appropriate, based on recommendations of the United States Preventive Services Task Force, the Advisory Committee on Immunization Practices, and the individual's health status, screening history, and age-appropriate preventive services covered by Medicare;
• Establishment of a list of risk factors for which primary, secondary or tertiary interventions are recommended or underway for the individual, including any mental health conditions or any such risk factors or conditions that have been identified through an initial preventive physical examination (IPPE), and a list of treatment options and their associated risks and benefits;
• Furnishing of personalized health advice to the individual and referrals, as appropriate, to health education or preventive counseling services or programs aimed at reducing identified risk factors and improving self-management; and
• Any other element determined appropriate through the national coverage determination process (NCD).
In summary, for CY 2011, subsequent annual wellness visits include—
• An update of the individual's medical and family history;
• An update of the list of current providers and suppliers that are regularly involved in providing medical care to the individual;
• Measurement of an individual's weight (or waist circumference), blood pressure and other routine measurements as deemed appropriate, based on the individual's medical and family history;
• Detection of any cognitive impairment that the individual may have;
• An update to the written screening schedule for the individual;
• An update to the list of risk factors and conditions for which primary, secondary, or tertiary interventions are recommended or are underway for the individual;
• Furnishing of personalized health advice to the individual and referrals, as appropriate, to health education or preventive counseling services;
• Any other element determined appropriate through the NCD process.
The annual wellness visit is specifically designed as a wellness visit that focuses on identification of certain risk factors, personalized health advice, and referral for additional preventive services and lifestyle interventions (which may or may not be covered by Medicare). The elements included in the annual wellness visit differ from comprehensive physical examination protocols with which some providers may be familiar since the annual wellness visit is a visit that is specifically designed to provide personalized prevention plan services as defined in the Act.
Section 1861(hhh)(1)(A) of the Act specifies that a personalized prevention plan for an individual includes a health risk assessment (HRA) that meets the guidelines established by the Secretary. In general, an HRA is an evaluation tool designed to provide a systematic approach to obtaining accurate information about the patient's health status, injury risks, modifiable risk factors, and urgent health needs. This evaluation tool is completed prior to, or as part of, an annual wellness visit. The information from the HRA is reflected in the personalized prevention plan that is created for the individual.
Although the annual wellness visit was effective on January 1, 2011, section 4103 of the Affordable Care Act provided the Secretary additional time to establish guidelines for HRAs after consulting with relevant groups and entities (see section 1861(hhh)(4)(A) of the Act). A technology assessment from the Agency for Healthcare Research and Quality (AHRQ) was commissioned to describe key features of HRAs, to examine which features were associated with successful HRAs, and to discuss the applicability of HRAs to the Medicare population. The finalized technology assessment was posted on July 6, 2011 and is publicly available on the CMS Web site at
We collaborated with the Centers for Disease Control and Prevention (CDC), due to their in-depth knowledge of HRAs, and because the CDC was directed by section 4004(f) of the Affordable Care Act to develop guidelines for a personalized prevention plan tool. In the November 16, 2010
The CDC convened a public meeting in Atlanta, Georgia in February 2011 to facilitate the development of guidance for HRAs. (See the December 30, 2010
Consistent with section 1861(hhh) of the Act and the initial CDC guidance document, we proposed to amend 42 CFR 410.15 by: (1) Adding the term “health risk assessment” and its definition; (2) revising the definitions of “first annual wellness visit providing personalized prevention plan services” and “subsequent annual wellness visit providing personalized prevention plan services;” and (3) incorporating the use and results of an HRA into the provision of personalized prevention plan services during the annual wellness visit.
The following is a summary of the provisions of the proposed rule and the comments received. We received 59 public comments from national and State professional associations, national medical advisory and patient advocacy groups, health insurance associations, health care systems, manufacturers, a government agency, and other national healthcare organizations. Thirty-two (32) comments supported incorporation of an HRA into the annual wellness visit and 5 were opposed. The remaining 22 comments provided feedback about the impact of the annual wellness visit as a whole requested modifications or additional elements to the annual wellness visit, and coverage for additional preventive services and vaccines.
Most supporters generally agreed with the proposed major HRA components. One commenter indicated that the inclusion of the HRA would help make care more preventive and proactive, and help avoid long-term maladies associated with aging and chronic diseases. Some commenters expressed concern that the proposal was too prescriptive and did not allow for sufficient flexibility. Other commenters were concerned that the HRA components were not sufficiently targeted to specific diseases. One commenter was of the opinion that there was a lack of evidence for the usefulness of an HRA, and believed the best evidence on the efficacy of comprehensive health risk assessment for the elderly comes from highly specialized geriatric assessment clinics capable of targeting individuals at high risk and providing longitudinal follow-up. This commenter believed that it would be impossible to replicate similar interventions without follow-up visits, and indicated that additional research is needed to determine how an HRA can be effectively translated into primary care practice.
Regarding flexibility of the HRA, some commenters supported a more flexible approach to HRA development and use, while others requested that a standardized tool be developed and certified by either CMS or an outside accrediting organization. A few commenters believed the HRA would be difficult for health professionals to implement since the CDC guidance had not been published and work had not been completed on establishing standards for interactive web-based programs to furnish HRAs, referencing other components of section 4103 of the Affordable Care Act.
In the proposed rule, we requested public comment on the overall impact and burden of the annual wellness visit on health professional practices, including the impact that incorporation and use of an HRA would have on health professionals and their practices. Two commenters believed that the incorporation of an HRA supports a systematic approach to patient wellness, providing a foundation for development of a personalized prevention plan and they supported the inclusion of a minimum set of topics as part of the HRA. Four commenters indicated that the use of an HRA would have a significant impact on health professional practices. One commenter stated that inclusion of an HRA would be somewhat or very difficult. Another was concerned that health professionals would be penalized if an individual refuses to complete an HRA or follow the personalized prevention plan recommendations. Another commenter was concerned with the lack of a publicly available HRA.
Of those commenters that provided feedback on the potential burden of the HRA as part of both first and subsequent AWVs on health professional practices, the comments ranged from requesting that HRAs be optional and used at the discretion of a health professional, to requesting that the CDC develop a standardized HRA tool for use with the Medicare aged population. One commenter opined that a quality HRA will provide health professionals information that shows patient progress over time without adding additional effort on the practitioner. This same commenter also believed that HRAs could have a positive impact on health professional practices by helping patients understand their health care needs. Three commenters indicated that development and implementation of an HRA that meets CDC guidelines could be a significant burden. One commenter recommended that the HRA implementation date be extended to July 1, 2012. Three comments expressed concern with what they believed to be a rigid approach that would require questions for all Medicare beneficiaries in conjunction with prevention plan services that they believed would not be applicable for every beneficiary on an annual basis.
We proposed to revise § 410.15 by adding the term “health risk assessment” and defining such term as an evaluation tool that meets the following requirements:
• Collects self-reported information about the beneficiary.
• Can be administered independently by the beneficiary or administered by a health professional prior to or as part of the AWV encounter.
• Is appropriately tailored to and takes into account the communication
• Takes no more than 20 minutes to complete.
• Addresses, at a minimum, the following topics:
++ Demographic data, including but not limited to age, gender, race, and ethnicity.
++ Self assessment of health status, frailty, and physical functioning.
++ Psychosocial risks, including but not limited to depression/life satisfaction, stress, anger, loneliness/social isolation, pain, or fatigue.
++ Behavioral risks, including but not limited to tobacco use, physical activity, nutrition and oral health, alcohol consumption, sexual practices, motor vehicle safety (seat belt use), and home safety.
++ Activities of daily living (ADLs), including but not limited to dressing, feeding, toileting, grooming, physical ambulation (including balance/risk of falls), and bathing.
++ Instrumental activities of daily living (IADLs), including but not limited to shopping, food preparation, using the telephone, housekeeping, laundry, mode of transportation, responsibility for own medications, and ability to handle finances.
The standards outlined in the definition of the term health risk assessment represent a minimum set of topics that need to be addressed as part of an HRA, while allowing the health professional the flexibility to evaluate additional topics, as appropriate, to provide a foundation for development of a personalized prevention plan.
In § 410.15(a), we defined first and subsequent annual wellness visits to include provisions for the furnishing of personalized health advice and referrals, as appropriate, to health education or preventive counseling services, including among other things, tobacco use cessation. We note that Medicare covers counseling to prevent tobacco use as an “additional preventive service” under Medicare Part B (additional information available in Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Section 210.4.1). We believe that the health professionals who are furnishing the annual wellness visits, whether they are first or subsequent annual wellness visits, will establish or update an appropriate list of referrals for education services and preventive counseling services for each individual.
We also note that an evidence-based, standardized screening tool for dementia is not currently available for assessment of cognitive impairments. The USPSTF noted: “[M]ost screening tests have been evaluated in studies with small sample sizes, and the populations of patients on whom screening instruments have been tested have varied greatly, making it difficult to determine the overall performance of screening tests for dementia” (
We appreciate the interest in the identification and development of an appropriate cognitive screening instrument. We are collaborating with the National Institute on Aging, the Department of Veterans Affairs, CDC, AHRQ, and other relevant stakeholders to assess the current methods for detecting cognitive impairment to develop recommendations for health professionals with respect to appropriate responses to both positive and negative cognitive impairment assessment results. We will continue to monitor advancements in screening, collaborate with the USPSTF, and will consider revising this element if the evidence is sufficient and a standardized screening test becomes available. Thus, at this time, we are not adopting the suggestion to include additional mandatory components related to memory or cognitive assessment within the HRA.
In § 410.15, we adopted the components of the annual wellness visit, consistent with the statutory elements described in section 1861(hhh)(2) of the Act. The first and subsequent annual wellness visits, as defined in § 410.15(a), are meant to represent a beneficiary visit focused on prevention. Among other things, the annual wellness visit encourages beneficiaries to obtain the preventive services covered by Medicare that are appropriate for them. First and subsequent annual wellness visits also include elements that focus on the furnishing of personalized health advice and referral, as appropriate, to health education, preventive counseling services, programs aimed at improving
We proposed to revise the definitions for first and subsequent annual wellness visits to incorporate the use and results of an HRA in the provision of personalized prevention plan services during the annual wellness visit. The HRA is integral to the provision of personalized prevention plan services, consistent with section 1861(hhh) of the Act. We proposed to incorporate the HRA by revising the definitions for first and subsequent annual wellness visits as follows—
• Specify that the annual wellness visit take into account the results of an HRA;
• Add the review (and administration, if needed) of an HRA as an element of both first and subsequent annual wellness visits; and
• Specify that the establishment of a written screening schedule for the individual, such as a checklist, includes and takes into account the HRA.
The HRA facilitates a systematic method for identifying health behaviors and risk factors known to the patient (for example: tobacco use, physical activity, and nutritional habits) for which the medical provider can discuss and provide tailored feedback aimed at reducing risk factors as well as reducing the potential for developing the diseases to which they are related.
During the annual wellness visit encounter, the HRA information is utilized by the health professional in a thought process intended to develop a personalized prevention plan for the patient to improve health status and delay the onset of disease. For instance, if the information provided by the HRA indicated that the beneficiary had a current or past history of tobacco use, the health professional may deem it appropriate to perform those commonly used aspects of a clinical evaluation (for instance, listening to (auscultation) the heart and lungs) in order to provide the appropriate personalized health advice and referrals for additional preventive services such as tobacco use cessation counseling.
We believe that the incorporation of the HRA will increase the efficiency of the health professional's effort during the annual wellness visit. For instance, during the annual wellness visit encounter, the health professional furnishing the annual wellness visit would review the information reported in the HRA, which would serve as the basis for a personalized prevention plan provided during the annual wellness visit encounter. The beneficiary would leave the visit with personalized health advice, appropriate referrals, and a written individualized screening schedule, such as a check list. We would not expect that the health professional would provide only general recommendations during the annual wellness visit encounter and then mail a personalized prevention plan that incorporates an HRA to the beneficiary outside of the annual wellness visit encounter. While the annual wellness visit is a wellness visit that focuses on wellness and disease prevention, a follow-up visit to treat an identified illness may be needed to address an urgent health issue. For example, if a beneficiary is determined to have high blood pressure, a follow- up visit for further review of symptoms and evaluation and management, along with determining whether additional interventions are necessary, may be performed after the completion of the annual wellness visit as a separate service.
We also proposed changes to the definition of the term “subsequent annual wellness visit providing personalized prevention plan services” to clarify that the health professional should furnish personalized prevention plan services and updated information if there have been changes since the beneficiary's last annual wellness visit, whether that was a first annual wellness visit or a subsequent annual wellness visit. In the CY 2011 PFS final rule, we stated in the definition for subsequent annual wellness visits that certain elements should be updated based on information developed during the first annual wellness visit (for example, lists of risk factors and screening schedules). Since all annual wellness visits that follow the first annual wellness visit are considered subsequent annual wellness visits, the health professional should update elements that were developed during the previous annual wellness visit if there have been changes. We received one comment regarding the proposed changes to update elements of the annual wellness visit developed during the previous annual wellness visit. The commenter agreed with the proposed changes. The proposed changes to the definition for subsequent annual wellness visits, which we are finalizing in this final rule with comment period are as follows:
• Newly redesignated paragraph (iii) states “an update of the list of current providers and suppliers that are regularly involved in providing medical care to the individual as that list was developed for the first annual wellness visit providing personalized prevention plan services or the previous subsequent annual wellness visit providing personalized prevention plan services”.
• Newly redesignated paragraph (vi)(B), states “the list of risk factors and conditions for which primary, secondary or tertiary interventions are recommended or are underway for the individual as that list was developed at the first annual wellness visit providing personalized prevention plan services or the previous subsequent annual wellness visit providing personalized prevention plan services”.
In the proposed rule, we included language that specified that first and subsequent annual wellness visits providing personalized prevention plan
One commenter suggested a hierarchy of preferred administration methods, starting with internet-based systems, kiosk-style systems, automated telephone response systems, and paper-based mail-in systems. However, the same commenter, along with several others, opined that the paper-based system may be the most appropriate for Medicare beneficiaries. Commenters believed that beneficiaries may not be comfortable with or use the internet for health information.
While we appreciate the commenters' concerns, we are not assigning particular tasks or restrictions for specific members of the team in this final rule. We believe it is better for the supervising physician to assign specific tasks to qualified team members (as long as they are licensed in the State and working within their State scope of practice). This approach gives the physician and the team the flexibility needed to address the beneficiary's particular needs on a particular day.
As we discussed in the proposed rule, the CDC plans to publish “A Framework for Patient-Centered Health Assessments, a Morbidity and Mortality Weekly Report (MMWR).” The MMWR will include additional information applicable for the successful implementation of the HRA, such as the CDC interim guidance document, as well as information related to implementation, feedback, and follow-up that evidence suggests is critical for improving health outcomes using this process.
As we discussed in the proposed rule, the CDC plans to publish “A Framework for Patient-Centered Health Assessments, a Morbidity and Mortality Weekly Report (MMWR).” The MMWR will include additional information applicable for the successful implementation of the HRA, such as the CDC interim guidance document, as well as information related to implementation, feedback, and follow-up that evidence suggests is critical for improving health outcomes using this process. While we are not including requirements for accreditation or certification of HRA instruments in this final rule, we may consider a certification process in the future.
We requested comments on the impact of the elements included in the definitions of first and subsequent annual wellness visits and requested comments on the modification of those annual wellness visit elements for which the Secretary has the authority to determine appropriateness.
Some commenters requested that CMS include a comprehensive physical exam as part the annual wellness visit. Other commenters requested that additional biometric assessments and routine blood work also be included as part of the AWV. One indicated that furnishing and coding for a separate physical exam may be confusing for physicians and deter the provision of the annual wellness visit. One commenter said that the physical exam is necessary to develop an accurate and appropriate list of risk factors and conditions for which primary, secondary, and tertiary interventions are recommended or are underway. Other commenters requested that laboratory tests and blood work should also be included in the annual wellness visit since the commenter considers blood work and laboratory tests standards in physician practice.
Regarding requests that routine blood work be included in the annual wellness visit, we note that Medicare Part B already covers the following screenings that include blood work—
• Cardiovascular disease screenings once every 5 years (lipid panel, cholesterol, lipoprotein, and triglycerides); and
• Diabetes screening tests for beneficiaries that meet certain conditions (2 screening tests per year for beneficiaries diagnosed with pre-diabetes; 1 screening per year if previously tested, but not diagnosed with pre-diabetes, or if never tested). Given that these are separate Part B benefits, we are not adding routine blood work as a component of the annual wellness visit.
We believe that the health professional who is furnishing an annual wellness visit will determine an appropriate list of referrals for education services and preventive counseling services for each individual as part of the provision of personalized prevention plan services. We believe that the definitions for first and subsequent annual wellness visits address commenters' concerns regarding referrals for community-based services, mental health issues, and medical nutrition therapy. Therefore, we are not making the requested changes.
We also acknowledge that assessment of functional ability and level of safety are important, and we agree that for certain individuals, functional status and safety assessments (for example, fall prevention) may be important to consider on a more routine basis. The annual wellness visit does allow for an individualized approach with a personalized prevention plan. For certain individuals where these areas are determined to be priorities, specific evaluations may be voluntary parts of subsequent visits. We also note that the HRA (which is updated during subsequent annual wellness visits) includes components related to functional ability and level of safety such as self assessment of health status, frailty, physical functioning, and behavioral risks, such as seat belt use and home safety. Therefore, we are not making the suggested changes.
In summary, as a result of the comments received, we are finalizing the provisions of the proposed rule, with the following modifications, in this final rule:
• We are modifying sub-paragraph (v)(C) of the definition of the term “health risk assessment” to read, “Psychosocial risks, including but not limited to, depression/life satisfaction, stress, anger, loneliness/social isolation, pain, and fatigue” to correct a typographical error in the proposed rule.
• We are modifying paragraph (v)(D) of the definition of the term “health risk assessment” to read, “Behavioral risks, including but not limited to, tobacco use, physical activity, nutrition and oral health, alcohol consumption, sexual health, motor vehicle safety (seat belt use), and home safety.”
• We are modifying the introductory text of the definition of the term “subsequent annual wellness visit providing personalized prevention plan services” to read as follows: “subsequent annual wellness visit providing personalized prevention plan services means the following services furnished to an eligible beneficiary by a health professional that include, and take into account the results of an updated health risk assessment, as those terms are defined:”
• We are modifying newly designated paragraph (i) of the definition of “subsequent annual wellness visit providing personalized prevention plan services” to read as follows: “(i) Review (and administration, if needed) of an updated health risk assessment (as defined in this section).”
In the CY 2011 PFS final rule with comment period (75 FR 73411), we stated “that when the HRA is incorporated in the AWV, we will reevaluate the values for HCPCS codes G0438 and G0439”. As discussed in the CY 2011 PFS final rule with comment period, the services described by CPT codes 99204 and 99214 already include “preventive assessment” forms. For CY 2012, we believe that the current payment crosswalk for HCPCS codes G0438 and G0439 continue to be most accurately equivalent to a level 4 E/M new or established patient visit; and therefore, we proposed to continue to crosswalk HCPCS codes G0438 and G0439 to CPT codes 99204 and 99214, respectively.
Most commenters agreed that CPT codes 99204 and 99214 include “preventive assessment,” but continued to believe the payment is insufficient for the complexity of the HRA elements created by CDC and that the administration of the HRA will place a burden on practitioners and, even more so on their office staff, for which they would not be compensated under the equivalent of a level 4 E/M office visit payment. We wish to clarify that not only does the physician work in 99204 and 99214 include “preventive assessment” but that we finalized in our 2011 PFS final rule with comment period (75 FR 73409) the addition of preventive assessment forms as a direct PE input to HCPCS codes G0438 and G0439 as we had for HCPCS code G0402 (Initial preventive physical examination; face-to-face visit, services limited to new beneficiary during the first 12 months of Medicare enrollment) in addition to the PE inputs for CPT Codes 99204 and 99214.
Many commenters did not identify a specific adjustment to account for the additional complexity introduced by the HRA, but indicated that they should be compensated for the additional time that their staff will have to dedicate to helping Medicare beneficiaries complete the HRA over the phone or in person at their AWV. A few commenters provided a specific recommendation for reflecting staff resources needed to support the HRA and suggested that CMS add the RVUs for CPT code 99420 (Administration and interpretation of a Health Risk Assessment Instrument), which is currently not covered, to the current practice expense RVUs for the AWV. Some commenters requested that CMS add additional physician work RVUs to the AWV without specifying how much to add. One commenter suggested adding CPT code 99406 (smoking and tobacco use cessation visit, intermediate, greater than 3 minutes up to 10 minutes) to the level 4 payment to reflect the additional physician work associated with adding the HRA element to the AWV visit.
We disagree with the commenters that believe review of the HRA during the AWV requires additional physician work. The level 4 E/M code RVUs that are used to establish payment for the initial and subsequent AWV already include physician review of preventive assessment forms. While we agree that greater staff time will be required to help Medicare beneficiaries to complete the HRA, we do not believe that review of the HRA during the visit constitutes more physician work than is already contemplated by a level 4 E/M visit.
In consideration of public comments, we are finalizing our CY 2012 proposal for the first and subsequent AWV services with modification. Beginning January 1, 2012, we will crosswalk G0438 and G0439 to CPT codes 99204 and 99214, with the addition of direct PE inputs for preventive assessment forms as finalized in CY 2011 final rule with comment period (75 FR 73409) and, for CY 2012, an increase the direct PE inputs for clinical labor time to recognize an additional 10 and 5 minutes, respectively. We agree with commenters that furnishing a meaningful HRA to Medicare beneficiaries will require accommodation and that those beneficiaries may need assistance from physician office staff when completing the HRA. The following Table 39, shows the final total RVUs adjusted for the inclusion of additional clinical labor time to support beneficiary completion of the required HRA element during the first and subsequent AWV services furnished on or after January 1, 2012.
The Physician Quality Reporting System is a quality reporting program that provides incentive payments and payment adjustments to identified eligible professionals who satisfactorily report data on quality measures for covered professional services furnished during a specified reporting period. The Physician Quality Reporting System was initially implemented in 2007 as a result of section 101 of Division B of the Tax Relief and Health Care Act of 2006. The Physician Quality Reporting System was extended and further enhanced as a result of the Medicare, Medicaid, and SCHIP Extension Act of 2008 (MMSEA), the Medicare Improvements for Patients and Providers Act of 2009 (MIPPA), which was enacted on July 15, 2008, and the Affordable Care Act, which was enacted on March 23, 2010.
Changes to the Physician Quality Reporting System as a result of these laws, as well as information about the Physician Quality Reporting System in 2007, 2008, 2009, 2010, and 2011 are discussed in detail in the CY 2008 PFS proposed and final rules (72 FR 38196 through 38204 and 72 FR 66336 through 66353, respectively), CY 2009 PFS proposed and final rules (73 FR 38558 through 38575 and 73 FR 69817 through 69847, respectively), CY 2010 PFS proposed and final rules (74 FR 33559 through 33600 and 74 FR 61788 through 61861, respectively), and CY 2011 PFS proposed and final rules (75 FR 73487 through 73552). Further detailed information, about the Physician Quality Reporting System, related laws, and help desk resources, is available on the CMS Web site at
We received numerous comments that were not related to our specific proposals for the 2012 Physician Quality Reporting System. While we appreciate the commenters' feedback, these comments are outside the scope of the issues addressed in this final rule with comment period.
There are two ways an eligible professional may participate in the Physician Quality Reporting System: (1) as an individual eligible professional or (2) as part of a group practice under the Physician Quality Reporting System group practice reporting option (GPRO). The details of each method of participation are described in this section.
As defined at 42 CFR 414.90(b) the term “eligible professional” means any of the following: (1) a physician; (2) a practitioner described in section 1842(b)(18)(C) of the Act; (3) a physical or occupational therapist or a qualified speech-language pathologist; or (4) a qualified audiologist. For more information on which professionals are eligible to participate in the Physician Quality Reporting System, we refer readers to the “List of Eligible Professionals” download located in the “How to Get Started section of the Physician Quality Reporting CMS Web site at:
As required by section 1848(m)(3)(C)(i) of the Act, we established and have had in place since January 1, 2010, a process under which eligible professionals in a group practice are treated as satisfactorily submitting data on quality measures under the Physician Quality Reporting System if, in lieu of reporting measures under the Physician Quality Reporting System, the group practice reports measures determined appropriate by the Secretary, for example measures that target high-cost chronic conditions and preventive care, in a form and manner, and at a time specified by the Secretary. Section 1848(m)(3)(C)(ii) of the Act requires that this process provide for the use of a statistical sampling model to submit data on measures, for example the model used under the Medicare Physician Group Practice (PGP) demonstration project under section 1866A of the Act. We established a GPRO for the Physician Quality Reporting System under 42 CFR 414.90(g).
Under 42 CFR 414.90(b), a “group practice” means “a single Tax Identification Number (TIN) with two or more eligible professionals, as identified by their individual National Provider Identifier (NPI), who have reassigned their Medicare billing rights to the TIN”. We proposed (76 FR 42840) to change the definition of “group practice” under 42 CFR 414.90(b). Specifically, we proposed that under the Physician Quality Reporting System, a “group practice” would consist of a physician group practice, as defined by a TIN, with 25 or more individual eligible professionals (or, as identified by NPIs) who have reassigned their billing rights to the TIN.
For the 2010 Physician Quality Reporting System, our definition of “group practice” was limited to practices with 200 or more eligible professionals because our intent was to model the Physician Quality Reporting System GPRO after a quality reporting program that group practices may already be familiar with—the PGP demonstration. Since participation in the PGP demonstration was limited to large group practices, we wanted to initially limit participation in the Physician Quality Reporting System GPRO to similar large group practices. In 2011, we expanded this definition to include practices with 2-199 eligible professionals because we developed a second reporting option (GPRO II) specifically for smaller group practices that was based largely on the Physician Quality Reporting System reporting options for individual eligible professionals. We have since observed that many of these smaller group practices that self-nominated to participate in GPRO II for 2011 subsequently elected to opt out of participation in the GPRO II for 2011 so that members of the group practices can participate in the Physician Quality Reporting System individually instead. Out of 107 total groups that self-nominated for GPRO II, only 25 group practices comprised of 2-10 eligible professionals and 15 group practices comprised of 11-25 eligible professionals are still participating in GPRO II for 2011 at this time.
Since the GPRO II seems to be a less attractive reporting option than GPRO I, we proposed (76 FR 42840) to consolidate GPRO I and II into a single GPRO. Since our experience with using the GPRO submission web interface under the Physician Quality Reporting System has been limited to larger practices or practices participating in demonstration projects, we hesitated to expand what we referred to as GPRO I to all group practices until we gain some experience with smaller practices on a larger scale. For example, we believe that participation under the Physician Quality Reporting System GPRO is a more effective method of participation for larger as opposed to smaller group practices. As described in section VI.F.1.e.6 of this final rule with comment period, a group practice must take extra steps to participate in the Physician Quality Reporting System GPRO, for example reporting on more measures overall than is required for individual eligible professionals. In contrast, members of a group practice who choose to participate in the
We recognize that a group's size can fluctuate throughout the year as professionals move from practice to practice. We allow for fluctuation of the group practice's size throughout the reporting period. However, we proposed (76 FR 42840) that the group practice's size after the group practice's participation is approved by CMS must continue to meet the definition of a group practice as proposed in 42 CFR 414.90(b) for the entire reporting period.
We also proposed (76 FR 42840) that under 42 CFR 414.90(g)(1), a group practice of any size (including solo practitioners) or comprised of multiple TINs participating in a Medicare approved demonstration project of other programs would also be deemed to be participating in the Physician Quality Reporting System GPRO. For example, the PGP demonstration, as well as the Medicare Shared Savings Program (governing accountable care organizations (ACOs)), and Pioneer ACO have incorporated or proposed to incorporate aspects of the Physician Quality Reporting System reporting requirements and incentives under those respective programs.
Our intention to recognize (deem) group practices participating in such other programs or demonstration projects as having participated in the Physician Quality Reporting System was to ensure that such groups would not be barred from participating in the group practice reporting option under the eRx Incentive program, since we previously required and have proposed to continue to require that group practices interested in participating in the eRx Incentive Program GPRO also participate in the Physician Quality Reporting System GPRO. We are not changing the eligibility for group practices, including those participating in the programs mentioned previously, to participate in the eRx Incentive program. As discussed in the changes to the eRx Incentive Program in section VI.F.1.e.2. later in this final rule with comment period, however, a group practice must self-nominate to participate under the eRx Incentive Program's group practice reporting option. We invited comments on the proposed change to the definition of “group practice” under 42 CFR 414.90(b) under the Physician Quality Reporting System and also, whether we should retain the existing definition under the regulation despite our proposal to retain only the GPRO I for 2012. Following is a summary of the comments received that were related to this proposal.
Based on the comments received and for the reasons stated above, we are finalizing our proposal to change the definition of “group practice” at 42 CFR 414.90(b) to recognize groups with 25 or more eligible professionals. In addition, as we did not receive comments to make a technical change to 42 CFR 414.90(g)(1) to eliminate the reference to group practices in demonstrations that are deemed to have participated in the Physician Quality Reporting System, we are finalizing that change to the regulation. We believe that this language is unnecessary given the regulation at 42 CFR 414.92(b). In addition, we believe
In order to participate in the Physician Quality Reporting System GPRO for 2012 and subsequent years, we proposed to require group practices to complete a self-nomination process and to meet certain technical and other requirements described in the proposed rule (76 FR 42841 and 42842). As in prior years, we proposed to require these self-nomination and additional process requirements so that we may identify which group practices are interested in participating in the Physician Quality Reporting System as a GPRO as well as to ensure that group practices participating in the GPRO understand the process for satisfactorily reporting Physician Quality Reporting System quality measures under the GPRO method of reporting.
We proposed that the self-nomination statement would be submitted by the group practice wishing to participate in the GPRO for the first time via a web-based tool. However, we also stated that if it is not operationally feasible for us to collect self-nomination statements via a web-based tool for 2012, we would require group practices interested in participating in the Physician Quality Reporting System GPRO to submit a self-nomination statement via a letter accompanied by an electronic file submitted in a format specified by us (such as a Microsoft Excel file). At this time, it is not technically feasible to collect self-nomination statements via a web-based tool. Therefore, until the web-based tool is fully capable of accepting self-nomination statements, we are finalizing our proposal that group practices submit the self-nomination statement via a letter accompanied by an electronic file submitted in a format specified by us (such as a Microsoft Excel file) that includes the group practice's TIN(s) and name of the group practice, the name and email address of a single point of contact for handling administrative issues as well as the name and email address of a single point of contact for technical support purposes. However, once the web-based tool is capable of accepting self-nomination statements, which we anticipate will occur by the 2013 Physician Quality Reporting System, the web-based tool is the method for a group practice to submit a self-nomination statement for the respective program year.
A group practice that submits an incomplete self-nomination statement (such as, a valid email address is not provided), would not be considered for inclusion in the 2012 Physician Quality Reporting System GPRO, though as we noted in the proposed rule, we would notify a group practice should we receive an incomplete self-nomination statement.
We proposed that the Physician Quality Reporting System GPRO self-nomination statement must also indicate the group practice's compliance with the following requirements:
• Agree to attend and participate in all mandatory GPRO training sessions.
• Is an established Medicare provider that has billed Medicare Part B on or after January 1 and prior to October 29 of the year prior to the reporting period for the respective year. For example, for purposes of participating in the 2012 Physician Quality Reporting System GPRO, the group practice must have billed Medicare Part B on or after January 1, 2011 and prior to October 29, 2011.
• Agree to have the results on the performance of their Physician Quality Reporting System measures publicly posted on the Physician Compare Web site.
• Obtain and/or have access to the identity management system specified by CMS (such as, but not limited to, the Individuals Authorized Access to CMS Computer Systems, or IACS) to submit Medicare clinical quality data to a CMS clinical data warehouse.
• Provide CMS access (upon request for health oversight purposes like validation) to review the Medicare beneficiary data on which Physician Quality Reporting System GPRO submissions are founded or provide to CMS a copy of the actual data (upon request for health oversight purposes like validation).
To ensure that accurate data is being reported, we reserve the right to validate the data submitted by GPROs.
For 2012 and future years, we proposed that a group practice that wishes to participate in both the Physician Quality Reporting System and eRx GPRO (see the eRx Incentive Program's section VI.F.2.(b).(2).(B) of this final rule with comment period) must indicate its desire to participate in both programs in its self-nomination statement.
In addition, in the proposed rule (76 FR 42841 and 42842), we stated that we were interested in testing the extraction of EHR data submitted by group practices through the GPRO web interface in 2012. Group practices wishing to participate in this test must state their interest to participate in the group practice's self-nomination letter.
We further proposed (76 FR 42842) that group practices that wish to self-nominate must do so by January 31 of the calendar year in which the group practice wishes to participate in the Physician Quality Reporting System GPRO. For example, in order to participate in the GPRO for the 2012 Physician Quality Reporting System, the group practice will need to self-nominate by January 31, 2012. Upon receipt of the self-nomination statements, we would assess whether the participation requirements for the respective reporting period were met by each group practice using Medicare claims data from the year prior to the respective reporting period. We would not preclude a group practice from participating in the GPRO if we discover, from analysis of the Medicare claims data, that there are some eligible professionals (identified by NPIs) that are not established Medicare providers (that is, have not billed Medicare Part B on or after January 1 and prior to or on October 29 of the year prior to the respective reporting period) as long as the group has at least the minimum proposed number (that is, 25) of established Medicare providers required to participate in the Physician Quality Reporting System as a group practice. Eligible professionals, as classified by their NPIs, who do not submit Medicare Part B claims for PFS covered professional services during the reporting period, however, will not be included in our payment calculations.
Furthermore, we proposed (76 FR 42842) that group practices who have previously participated in the Physician Quality Reporting System GPRO would automatically be qualified to participate in the GPRO in 2012 and future program years. For example, group practices that were selected to participate in the 2011
We indicated that we recognized that, for various reasons, there potentially could be a discrepancy between the number of eligible professionals (that is, NPIs) submitted by the practice during the self-nomination process and the number of eligible professionals billing Medicare under the practice's TIN as people move in and out of practices. Therefore, if we find more NPIs in the Medicare claims than the number of NPIs submitted by the practice during the self-nomination process and this will result in the practice being subject to different criteria for satisfactory reporting, we will notify the practice of this finding as part of the self-nomination process. At this point, the practice will have the option of either agreeing to be subject to the different criteria for satisfactory reporting or opting out of participation in the Physician Quality Reporting System GPRO to enable the members of their practice to participate in the Physician Quality Reporting System as individual eligible professionals.
We invited public comment regarding our proposed process for group practices to participate in the Physician Quality Reporting System GPRO. We received the following comment regarding this proposal.
Based on the comments received and for the reasons stated previously, we are finalizing the self-nomination and participation processes for group practices under the Physician Quality Reporting System GPRO. As we noted previously, it was not technically feasible to develop a web-based tool by the time of this final rule, and therefore, for 2012, self-nomination statements must be submitted via a letter accompanied by and electronic file described previously.
Since the implementation of the Physician Quality Reporting System in 2007, depending on an eligible professional's chosen reporting mechanism, we have offered up to two different reporting periods for satisfactorily reporting Physician Quality Reporting System quality measures: a 12-month reporting period (from January 1 through December 31of the respective program year) and a 6-month reporting period (from July 1 through December 31of the respective program year). Section 1848(m)(5)(F) of the Act requires CMS to provide alternative reporting periods and criteria for measures groups and registry reporting. To comply with this provision, for 2012 and subsequent years, we proposed (76 FR 42842) to retain the 6-month reporting period option for the reporting of Physician Quality Reporting System measures groups via registry. We invited but received no comments on our proposal to retain the 6-month reporting period for measures groups via registry. For the reasons described previously, we are finalizing our proposal to retain the 6-month reporting period for 2012 and beyond. We are therefore modifying 42 CFR 414.90(f)(1)(ii)(B) to reflect this finalized proposal.
Additionally, we proposed (76 FR 42842) to modify 42 CFR § 414.90(g)(1) to specify a 12-month reporting period (that is, January 1through December 31of the respective program year) for the Physician Quality Reporting System GPRO. We received no comments regarding our proposal to modify 42 CFR § 414.90(g)(1) to specify a 12-month reporting period (that is, January 1 through December 31of the respective program year) for the Physician Quality Reporting System GPRO for 2012 and beyond, and are therefore, finalizing this proposal. As such, we are making technical changes to modify the clause numbers under 42 CFR 414.90(g) to reflect our finalized proposal to indicate a 12-month reporting period for the GPRO under 42 CFR 414.90.
Furthermore, for 2012 and subsequent years, we proposed (76 FR 42842) to modify 42 CFR 414.90(f)(1) to specify a 12-month reporting period (that is, January 1 through December 31of the respective program year), consistent with section 1848(m)(6)(C)(i)(II) of the Act, for the satisfactory reporting of Physician Quality Reporting System quality measures for claims, registry, and EHR-based reporting. In proposing these modifications to 42 CFR 414.90, we proposed to eliminate the 6-month reporting period for claims and registry previously available under the Physician Quality Reporting System (with the exception of reporting measures groups via registry). Although we did not propose a 6-month reporting period for claims and registry reporting, we note that the 12-month reporting period aligns with other CMS quality reporting programs. In addition, the elimination of the 6-month reporting period for claims and registry reporting (for reporting individual measures via registry) will align the reporting periods of these mechanisms with the EHR reporting mechanism and the GPRO. We further believe that the elimination of the 6-month reporting period for claims and registry reporting (for reporting individual measures via registry) will help to streamline and simplify the reporting requirements for the Physician Quality Reporting System without substantial burden to eligible professionals who may still satisfactorily report using the 12-month reporting period.
We invited public comment on our proposal to eliminate the 6-month reporting period for claims and registry reporting (for reporting individual measures via registry). The following is a summary of the comments regarding this proposal.
Based on the comments received and for the reasons stated above, for 2012 and beyond, we are finalizing our proposal to modify 42 CFR 414.90(f)(1) to specify a 12-month reporting period (that is, January 1 through December 31of the respective program year) for the satisfactory reporting of Physician Quality Reporting System quality measures for claims, registry, and EHR-based reporting. In addition to the 12-month reporting period available for all reporting methods, we are also finalizing a 6-month reporting period (that is, July 1 through December 31 of the respective program year) for reporting measures groups via registry.
For the purpose of reporting quality measures under the Physician Quality Reporting System, we proposed (76 FR 42842) to retain the claims-based, registry-based, and EHR-based reporting mechanism for 2012 and beyond. Accordingly, we proposed to modify 42 CFR 414.9(f) to reflect this proposal. We proposed to retain these reporting mechanisms in order to provide eligible professionals with multiple mechanisms from which to satisfactorily report Physician Quality Reporting System quality measures. We hope that offering multiple reporting mechanisms will aid in encouraging participation in the Physician Quality Reporting System.
We invited public comment concerning the general, proposed reporting mechanisms for the Physician Quality Reporting System for 2012 and beyond. The following is a summary of the comments received that were related to our proposal to retain the claims, registry, and EHR-based reporting mechanisms for 2012 and beyond.
Based on the comments received and for the reasons explained previously, we are finalizing the claims, registry, and EHR-based reporting mechanisms under the Physician Quality Reporting System for 2012 and beyond.
As in previous years, the individual quality measures or measures groups an eligible professional selects will dictate the applicable reporting mechanism(s). In addition, while eligible professionals can attempt to qualify for a Physician Quality Reporting System incentive under multiple reporting mechanisms, the eligible professional must satisfy the criteria for satisfactory reporting for the respective program year, with respect to a single reporting mechanism to qualify for an incentive. We will not combine data submitted via multiple reporting mechanisms to determine incentive eligibility.
As we noted previously, we proposed (76 FR 42843) to retain the claims-based reporting mechanism for the Physician Quality Reporting System for 2012 and beyond. For eligible professionals who choose to participate in the Physician Quality Reporting System by submitting data on individual quality measures or measures groups through the claims-based reporting mechanism, we proposed (76 FR 42843) that the eligible professional be required to submit the appropriate Physician Quality Reporting
QDCs for the eligible professional's selected individual Physician Quality Reporting System quality measures or measures group may be submitted to CMS at any time during the reporting period for the respective program year. However, as required by section 1848(m)(1)(A) of the Act, all claims for services furnished during the reporting period, would need to be processed by no later than two months after the end of the reporting period, to be included in the program year's Physician Quality Reporting System analysis. For example, all claims for services furnished for the 2012 Physician Quality Reporting System would need to be processed by no later than two months after the end of the reporting period for the 2012 Physician Quality Reporting System, that is, processed by February 22, 2013 for the reporting period that ends December 31, 2012.
We invited public comment on our proposed requirements for eligible professionals who choose the claims-based reporting mechanism for 2012 and beyond. The following is a summary of the comments we received regarding this proposal.
Based on the comments received and for the reasons stated in our responses and above, we are finalizing our proposal to retain the claims-based reporting mechanism under the Physician Quality Reporting System for 2012 and beyond.
(A) Requirements for the Registry-based Reporting Mechanism—Individual Eligible Professionals
As stated previously, we proposed (76 FR 42843) to retain the registry-based reporting mechanism via a qualified registry (as defined in section VI.F.1.2.B.) for the Physician Quality Reporting System for 2012 and beyond. With regard to specific requirements for registry-based reporting for individual eligible professionals under the Physician Quality Reporting System, we proposed that, in order to report quality data on the Physician Quality Reporting System individual quality measures or measures groups for the respective program year through a qualified registry, an eligible professional or group practice would be required to enter into and maintain an appropriate legal arrangement with a qualified Physician Quality Reporting System registry. Such arrangements would provide for the registry's receipt of patient-specific data from the eligible professional and the registry's disclosure of quality measures results and numerator and denominator data on Physician Quality Reporting System quality measures or measures groups on behalf of the eligible professional to CMS. Thus, the registry would act as a Health Insurance Portability and Accountability Act of 1996 (Pub. L. 104-191) (HIPAA) Business Associate and agent of the eligible professional. Such agents are referred to as “data submission vendors.” The “data submission vendors” would have the requisite legal authority to provide clinical quality measures results and numerator and denominator data on individual quality measures or measures groups on behalf of the eligible professional for the Physician Quality Reporting System.
We proposed that the registry, acting as a data submission vendor, would submit CMS-defined, registry-derived measures information to our designated database for the Physician Quality Reporting System, using a CMS-specified record layout, which will be provided to the registry by CMS. Similarly, we proposed that eligible professionals choosing to participate in the Physician Quality Reporting System through the registry-based reporting mechanism for the respective program year must select a qualified Physician Quality Reporting System registry and submit information on Physician Quality Reporting System individual quality measures or measures groups to the selected registry in the form and manner and by the deadline specified by the registry.
We proposed to post a list of qualified registries for the Physician Quality Reporting System for the respective program year on the Physician Quality Reporting System section of the CMS Web site at
We invited public comment on our proposed process and requirements for using the registry-based reporting mechanism for individual eligible professionals. The following is a summary of the comments we received regarding this proposal.
Based on the comments received and for the reasons stated previously, we are finalizing the requirements described above for individual eligible professionals choosing the registry-based reporting option for the 2012 Physician Quality Reporting System and beyond.
Although we proposed to establish the registry-based reporting mechanism as a way to report Physician Quality Reporting System quality measures for 2012 and beyond, we proposed (76 FR 42843 through 42845) the following qualification requirements only apply for the 2012 program year. For the Physician Quality Reporting System in 2012, as in prior program years, we proposed to require a self-nomination process for registries wishing to submit Physician Quality Reporting System quality measures or measures groups on behalf of eligible professionals for services furnished during the applicable reporting periods in 2012. This qualification process allows us to ensure that registries are fully informed of the Physician Quality Reporting System reporting process and to ensure the registry is qualified, thereby improving the likelihood of accurate reporting.
We note that third party intermediaries may participate in various capacities under the Physician Quality Reporting System. In addition, in an effort to encourage the electronic submission of quality measures data from eligible professionals' EHRs, we proposed EHR-based reporting, as discussed later in this section. As a result, we believe it is important to distinguish entities that collect their data from an EHR from those entities that collect their data from other sources. As such, as discussed here and later in this section, we proposed, the following two categories of third party intermediaries that would be able to submit Physician Quality Reporting System measures data on behalf of eligible professional: (1) a registry, as defined at 42 CFR 414.90(b), which would be any data submission vendor submitting data from a source other than an EHR on behalf of eligible professionals that meets the proposed registry qualification requirements later in this section; and (2) EHR data submission vendors, which would be a data submission vendor that obtains its data from an eligible professional's EHR and that meets the 2012 EHR qualification requirements. However, for operational reasons, we may reserve the right to limit such entities to a single role such that the entity would need to decide whether it wants to serve as a registry or EHR data submission vendor but not both. We note that a registry could serve as an “EHR data submission vendor” to the extent that it obtains data from an eligible professional's EHR, but would need to meet the proposed 2012 EHR qualification requirements. To be considered a qualified registry for purposes of serving as a registry under the program and submitting individual quality measures on behalf of eligible professionals who choose the registry reporting mechanism for 2012, we proposed that both registries new to the Physician Quality Reporting System and those previously qualified must:
• Be in existence as of January 1, 2012.
• Have at least 25 participants by January 1, 2012.
• Provide at least 1 feedback report, based on the data submitted to them for the 2012 Physician Quality Reporting System incentive reporting period, but if technically feasible, provide at least 2 feedback reports throughout the year to participating eligible professionals. Although it is not a requirement that registries provide interim feedback reports, we believe it is in the stakeholder's interest to require early registry collection of data for purposes of providing a feedback report to eligible professionals before the end of the 2012 Physician Quality Reporting System incentive reporting period to determine what steps, if any, an eligible professional should take or may rectify to meet the criteria for satisfactory reporting.
• For purposes of distributing feedback reports to eligible professionals, collect an eligible professional's email addresses and have documentation from the eligible professional authorizing the release of his or her email address.
• Not be owned and managed by an individual locally-owned single-specialty group (in other words, single-specialty practices with only 1 practice location or solo practitioner practices are prohibited from self-nominating to become a qualified Physician Quality Reporting System registry).
• Participate in ongoing 2012 Physician Quality Reporting System mandatory support conference calls hosted by CMS (approximately 1 call per month), including an in-person registry kick-off meeting to be held at CMS headquarters in Baltimore, MD. Registries that miss more than one meeting will be precluded from submitting Physician Quality Reporting System data for the reporting year (2012).
• Be able to collect all needed data elements and transmit to CMS the data at the TIN/NPI level for at least 3 measures, which is the minimum amount of measures on which an eligible professional is required to report, in the 2012 Physician Quality Reporting System (according to the posted 2012 Physician Quality Reporting System Measure Specifications);
• Be able to calculate and submit measure-level reporting rates or, upon request, the data elements needed to calculate the reporting rates by TIN/NPI.
• Be able to calculate and submit, by TIN/NPI, a performance rate (that is, the percentage of a defined population who receive a particular process of care or achieve a particular outcome based on a calculation of the measure's numerator and denominator specifications) for each measure on which the TIN/NPI reports or, upon request the Medicare beneficiary data elements needed to calculate the performance rates.
• Be able to separate out and report on Medicare Part B FFS patients.
• Provide the name of the registry.
• Provide the reporting period start date the registry will cover.
• Provide the reporting period end date the registry will cover.
• Provide the measure numbers for the Physician Quality Reporting System quality measures on which the registry is reporting.
• Provide the measure title for the Physician Quality Reporting System quality measures on which the registry is reporting.
• Report the number of eligible instances (reporting denominator).
• Report the number of instances a quality service is performed (performance numerator).
• Report the number of performance exclusions, meaning the quality action was not performed for a valid reason as defined by the measure specification.
• Report the number of reported instances, performance not met (eligible professional receives credit for
• Be able to transmit this data in a CMS-approved XML format.
• Comply with a CMS-specified secure method for data submission, such as submitting the registry's data in an XML file through an identity management system specified by CMS or another CMS-approved method, such as use of appropriate Nationwide Health Information Network specifications, if technically feasible.
• Submit an acceptable “validation strategy” to CMS by March 31, 2012. A validation strategy ascertains whether eligible professionals have submitted accurately and on at least the minimum number (80 percent) of their eligible patients, visits, procedures, or episodes for a given measure, which, as described in section VI.F.1.e.2., is the minimum percentage of patients on which an eligible professional must report on any given measure. Acceptable validation strategies often include such provisions as the registry being able to conduct random sampling of their participant's data, but may also be based on other credible means of verifying the accuracy of data content and completeness of reporting or adherence to a required sampling method.
• Perform the validation outlined in the strategy and send the results to CMS by June 30, 2013 for the 2012 reporting year's data.
• Enter into and maintain with its participating professionals an appropriate Business Associate agreement that provides for the registry's receipt of patient-specific data from the eligible professionals, as well as the registry's disclosure of quality measure results and numerator and denominator data and/or patient-specific data on Medicare beneficiaries on behalf of eligible professionals who wish to participate in the Physician Quality Reporting System.
• Obtain and keep on file signed documentation that each holder of an NPI whose data are submitted to the registry has authorized the registry to submit quality measure results and numerator and denominator data and/or patient-specific data on Medicare beneficiaries to CMS for the purpose of Physician Quality Reporting System participation. This documentation must be obtained at the time the eligible professional signs up with the registry to submit Physician Quality Reporting System quality measures data to the registry and must meet any applicable laws, regulations, and contractual business associate agreements.
• Provide CMS access (upon request for health oversight purposes like validation) to review the Medicare beneficiary data on which 2012 Physician Quality Reporting System registry-based submissions are founded or provide to CMS a copy of the actual data (upon request).
• Provide CMS a signed, written attestation statement via mail or email which states that the quality measure results and any and all data including numerator and denominator data provided to CMS are accurate and complete.
• Use Physician Quality Reporting System measure specifications and the CMS provided measure calculation algorithm, or logic, to calculate reporting rates or performance rates unless otherwise stated. CMS will provide registries a standard set of logic to calculate each measure and/or measures group they intend to report in 2012.
• Provide a calculated result using the CMS supplied measure calculation logic and XML file for each measure that the registry intends to calculate. The registries will be required to show that they can calculate the proper measure results (that is, reporting and performance rates) using the CMS-supplied logic and send the calculated data back to CMS in the specified format.
In addition to meeting all the requirements specified previously for the reporting of individual quality measures via registry, for registries that intend to report on 2012 Physician Quality Reporting System measures groups, we proposed that both registries new to the Physician Quality Reporting System and those previously qualified must:
• Indicate the reporting period chosen for each eligible professional who chooses to submit data on measures groups.
• Base reported information on measures groups only on patients to whom services were furnished during the 2012 reporting period.
• Agree that the registry's data may be inspected or a copy requested by CMS and provided to CMS under our oversight authority.
• Be able to report consistent with the reporting criteria requirements, as specified in section IV.F.1.e.2.
We noted in the proposed rule that we intended to post the final 2012 Physician Quality Reporting System registry requirements on the Physician Quality Reporting System section of the CMS Web site at
Furthermore, we proposed (76 FR 42845) that registries that were “qualified” for 2011 and wish to continue to participate in 2012 will not need to be “re-qualified” for 2012, but instead are only required to demonstrate that they can meet the new 2012 data submission requirements. For technical reasons, however, we did not expect to be able to complete this vetting process for the new 2012 data submission requirements until mid-2012. Therefore, for 2012, we indicated we may not be able to post the names of registries that are qualified for the 2012 Physician Quality Reporting System until we have determined the previously qualified registries that wish to be qualified for the 2012 Physician Quality Reporting System are in compliance with the new registry requirements.
We proposed that registries “qualified” for 2011, who are successful in submitting 2011 Physician Quality Reporting System data, and wish to continue to participate in 2012 would indicate their desire to continue participation for 2012 by submitting a self-nomination statement via a web-based tool to CMS indicating their continued interest in being a Physician Quality Reporting System registry for 2012 and their compliance with the 2012 Physician Quality Reporting System registry requirements by no later than October 31, 2011. Additionally, registries that were qualified but unsuccessful in submitting 2011 Physician Quality Reporting System data (that is, fail to submit 2011 Physician Quality Reporting System data per the 2011 Physician Quality Reporting System registry requirements) must go through a full self-nomination vetting process for 2012.
We further proposed that by March 31, 2012, registries that are unsuccessful at submitting registry data in the correct data format for 2011 must be able to meet the 2012 Physician Quality Reporting System registry requirements and go through the full vetting process again. This would include CMS receiving the registry's self-nomination by March 31, 2012. We proposed that the aforementioned registry requirements would also apply for the purpose of a registry qualifying to submit the electronic prescribing measure for the 2012 eRx Incentive Program. We anticipate finalizing the list of 2012 Physician Quality Reporting System registries by Summer 2012.
For eligible professionals considering this reporting mechanism, we point out that even though a registry is listed as
We invited public comments on the proposed requirements to be considered a qualified registry for purposes of the 2012 Physician Quality Reporting System. We also sought comment on disallowing previously-qualified registries from submitting data on Physician Quality Reporting System quality measures in future years if it is found that the data the registries provide are found to be significantly inaccurate (76 FR 42845). The following is a summary of the comments received regarding those proposals.
Based on the comments received and for the reasons explained previously, we are finalizing the proposed requirements that registries must complete in order to be “qualified” for 2012. Although we proposed the use of a web-based tool, but it has not yet been developed to handle self-nomination requests; therefore, we are finalizing submission of this self-nomination statement via a letter to CMS.
As we indicated, we anticipate finalizing the list of 2012 Physician
For 2012 and beyond, we proposed (76 FR 42846) that eligible professionals who choose to participate in the Physician Quality Reporting System via the EHR-based reporting mechanism have the option of submitting quality measure data obtained from their Physician Quality Reporting System qualified EHR to CMS either: (1) Directly from his or her qualified EHR, in the CMS-specified manner, or (2) indirectly from a qualified EHR data submission vendor (on the eligible professional's behalf), in the CMS-specified manner. We invited but received no public comments on our proposal to allow for EHR-based reporting for 2012 and beyond via a qualified direct EHR-based reporting or qualified EHR data submission vendor. Therefore, we are finalizing our proposal to allow eligible professionals to submit quality measure data obtained from their Physician Quality Reporting System qualified EHR to CMS either: (1) Directly from his or her qualified EHR, in the CMS-specified manner or (2) indirectly from a qualified EHR data submission vendor (on the eligible professional's behalf), in the CMS-specified manner.
For 2012 and beyond, we proposed to retain the EHR-based reporting mechanism via a qualified EHR (as defined in section VI.F.1.d.(3).(b)) for the purpose of satisfactorily reporting Physician Quality Reporting System quality measures. We proposed the following requirements for individual eligible professionals associated with EHR-based reporting: (1) Selection of a Physician Quality Reporting System qualified EHR product and (2) submission of Medicare clinical quality data extracted from the EHR directly to CMS, in the CMS-specified manner.
We proposed (76 FR 42846) that, in addition to meeting the appropriate criteria for satisfactory reporting of individual measures for the 2012 Physician Quality Reporting System EHR reporting option, eligible professionals who choose the EHR-based reporting mechanism for the 2012 Physician Quality Reporting System would be required to have a Physician Quality Reporting System qualified EHR product. We understand that eligible professionals may have purchased Certified EHR Technology for purposes of reporting under the Medicare and Medicaid EHR Incentive Programs. Such Certified EHR Technology may or may not be qualified for purposes of the 2012 Physician Quality Reporting System. Eligible professionals would need to ensure that their Certified EHR Technology is also qualified for purposes of the 2012 Physician Quality Reporting System to participate in the Physician Quality Reporting System via the EHR-based reporting mechanism for 2012.
For 2012, we proposed to modify the current list of EHR vendors qualified under the Physician Quality Reporting System to indicate which of the qualified vendors' products have also received a certification for the purposes of the EHR Incentive Programs.
We invited public comment on the 2012 proposed qualifications for direct EHR-based reporting. The following is a summary of the comments we received regarding these proposals.
For the reasons stated previously, we are finalizing these requirements for individual eligible professionals choosing the direct EHR-based reporting-based reporting mechanism. We anticipate that testing for qualified direct EHR-based reporting products will occur in late 2012, immediately followed by the submission of the eligible professional's actual 2012 Physician Quality Reporting System data in early 2013. This entire final test/production data submission timeframe for 2012 is expected to be December 2012 through February 2013. We are currently vetting newly self-nominated EHR vendor products for possible qualification for the 2012 Physician Quality Reporting System program year. Similar to prior years, we expect to list the 2012 Physician Quality Reporting System qualified EHR products by January 2012.
For EHR-based reporting products to be qualified to be used to directly report 2012 Physician Quality Reporting System quality measures data on behalf of eligible professionals, we proposed (76 FR 42846) that a test of quality data submission from eligible professionals who wish to report 2012 quality measure data directly from their qualified EHR product would be required.
For EHR-based reporting vendors wishing to qualify EHR products for participation in the 2012 Physician Quality Reporting System-Medicare Incentive Pilot for the Medicare EHR Incentive Program (discussed in section VI.H. of this final rule with comment period), we proposed (76 FR 42846) a separate, accelerated vetting process for EHR vendors and their products. This vetting process would be the same process as the vetting process for EHR vendor products for the 2012 Physician Quality Reporting System that is currently underway. We will begin the vetting process for these additional EHR vendors and their products in the beginning of 2012 and anticipate that the vetting process be completed by Summer/Fall 2012.
We further proposed that any EHR vendor interested in having one or more of their products being “qualified” to submit quality data extracted from an EHR to CMS on eligible professionals' behalf for the 2012 Physician Quality Reporting System would be required to self-nominate. We anticipate that the self-nomination deadline will occur no later than December 31, 2011. We
We invited public comment on the proposed 2012 qualification requirements for EHR products capable of directly reporting. The following is a summary of the comments we received regarding this proposal.
Based on the comments received and for the reasons stated above, we are finalizing the qualification requirements as proposed for direct EHR products.
For 2012 and beyond, we proposed (76 FR 42846) a second EHR-based reporting mechanism via a qualified EHR data submission vendor (as defined in 42 CFR 414.90(b)) for the purpose of satisfactorily reporting Physician Quality Reporting System quality measures. We proposed the following requirements for individual eligible professionals associated with indirect EHR-based reporting-based reporting: (1) Selection of a Physician Quality Reporting System qualified EHR data submission vendor and (2) submission of Medicare clinical quality data extracted from the EHR to a qualified “EHR data submission vendor” (which may include some current registries, EHR vendors, and other entities that are able to receive and transmit clinical quality data extracted from an EHR) to CMS, in the CMS-specified manner. For eligible professionals who choose to electronically submit Medicare clinical quality data extracted from their EHR to a qualified EHR data submission vendor, the EHR data submission vendor would then submit the Physician Quality Reporting System measures data to CMS in a CMS-specified manner on the eligible professional's behalf for the respective program year.
For 2012, we proposed that in order for an eligible professional to submit Medicare clinical quality data extracted from his or her EHR to CMS via an EHR data submission vender, the eligible professional must enter into and maintain an appropriate legal arrangement with a qualified 2012 EHR data submission vendor that is capable of receiving and transmitting Medicare clinical quality data extracted from an EHR. Such arrangements would provide for the EHR data submission vendor's receipt of beneficiary-specific data from the eligible professional and the EHR data submission vendor's disclosure of the beneficiary-specific data on behalf of the eligible professional to CMS. Thus, the EHR data submission vendor would act as a Health Insurance Portability and Accountability Act of 1996 (Pub. L. 104-191) (HIPAA) Business Associate and agent of the eligible professional. Such agents are referred to as “EHR data submission vendors.” The “EHR data submission vendors” would have the requisite legal authority to provide beneficiary-specific data on the 2012 Physician Quality Reporting System EHR measures on behalf of the eligible professional to CMS for the Physician Quality Reporting System.
We also proposed that eligible professionals choosing to participate in the 2012 Physician Quality Reporting System through the EHR-based reporting mechanism via an EHR data submission vendor for 2012 must select a qualified Physician Quality Reporting System EHR data submission vendor and submit information on Physician Quality Reporting System EHR measures to the selected EHR data submission vendor in the form and manner, and by the deadline specified by the EHR data submission vendor.
We invited but received no public comments on the proposed requirements for individual eligible professionals using EHR data submission vendors to submit Physician Quality Reporting System quality measures data. Therefore, we are finalizing the 2012 qualification requirements as proposed for individual eligible professionals using EHR data submission vendors to submit Physician Quality Reporting System quality measures data.
We will also be vetting those self-nominated EHR data submission vendors for possible qualification to submit 2012 Physician Quality Reporting System measures on eligible professionals' behalf under the EHR-based reporting mechanism. We expect to list the entities that are EHR data submission vendors qualified to submit 2012 Physician Quality Reporting System EHR measures on eligible professionals' behalf by mid-2012.
Please note that we cannot assume responsibility for the successful submission of data from eligible professionals' EHRs. In addition, eligible professionals who decide to submit the Physician Quality Reporting System measures directly from his or
Similar to our 2012 qualification requirements for vendors that provide EHR products that are qualified as being capable of directly reporting, we proposed that qualified EHR data submission vendors that wish to submit 2012 quality measures data obtained from an eligible professional's qualified EHR product to CMS on the eligible professional's behalf would have to meet certain 2012 qualification requirements, explained in detail the proposed rule (76 FR 42847).
We invited public comment on the proposed qualification requirements on the 2012 for EHR data submission vendors who wish to submit Physician Quality Reporting System quality measures data. Please note that some of the issues raised by commenters regarding the 2012 qualification requirements for registries, which were addressed previously, were similar or the same as those raised about the qualification requirements for EHR data submission vendors. Therefore, we addressed many of those issues previously. The following is a summary of the comments we received regarding these ERH data submission vendor proposals.
Based on the comments received and for the reasons stated above, we are finalizing the 2012 qualification requirements as proposed for EHR data submission vendors who wish to submit Physician Quality Reporting System quality measures data.
EHR data submission vendors that wish to submit 2012 quality measures data obtained from an eligible professional's EHR product to CMS on the eligible professional's behalf must submit test data in late 2012 followed by the submission of the eligible professional's actual 2012 Physician Quality Reporting System data in early 2013.
For data submission vendors wishing to qualify for participation in the 2012 Physician Quality Reporting System-Medicare Incentive Pilot for the Medicare EHR Incentive Program (discussed in section VI.H. of this final rule with comment period), these data submission vendors must undergo a separate, accelerated vetting process for EHR data submission vendors. Although the requirements for becoming a qualified EHR data submission vendor are different than becoming a qualified EHR product for direct EHR-based reporting, the vetting process will be the same process as the vetting process for EHR vendor products for the 2012 Physician Quality Reporting System that is currently underway. We will begin the vetting process for these EHR data submission vendors in the beginning of 2012 and anticipate that the vetting process will be completed by Summer/Fall 2012.
Any EHR data submission vendor interested in being “qualified” to submit quality data extracted from an EHR to CMS on eligible professionals' behalf for the 2012 Physician Quality Reporting System is required to self-nominate. We anticipate that the self-nomination deadline will occur no later than December 31, 2011. We expect to post instructions for self-nomination by the 4th quarter of CY 2011 on the Physician Quality Reporting System section of CMS Web site.
EHR data submission vendors who wish to submit 2012 Physician Quality Reporting System quality measure data must also meet the following qualification requirements:
• Not be in a beta test form.
• Be in existence as of January 1, 2012
• Have at least 25 active users.
• Participate in ongoing Physician Quality Reporting mandatory support conference calls hosted by CMS (approximately one call per month). Failure to attend more than one call per year would result in the removal of the EHR data submission vendor from the 2012 EHR qualification process.
• Have access to the identity management system specified by CMS (such as, but not limited to, the Individuals Authorized Access to CMS Computer Systems, or IACS) to submit clinical quality data extracted to a CMS clinical data warehouse.
• Submit a test file containing dummy Medicare clinical quality data to a CMS clinical data warehouse via an identity management system specified by CMS during a timeframe specified by CMS. In 2011, the requirement to submit a test file could have contained real or dummy data. However, for privacy reasons, we have decided to only provide for the submission of test files containing dummy data. We have finalized revisions to 42 CFR 414.90 to reflect this change.
• Submit a file containing the eligible professional's 2012 Physician Quality Reporting System Medicare clinical quality data extracted from the EHR for the entire 12-month reporting period via the CMS-specified identify management system during the timeframe specified by us in early 2013.
• Provide at least 1 feedback report, based on the data submitted to them for the 2012 Physician Quality Reporting System incentive reporting period, but if technically feasible, provide at least 2 feedback reports throughout the year to participating eligible professionals.
• Be able to collect all needed data elements and transmit to CMS the data at the beneficiary level.
• Be able to separate out and report on Medicare Part B FFS patients.
• Provide the measure numbers for the quality measures on which the data submission vendor is reporting.
• Be able to transmit this data in a CMS-approved XML format utilizing a Clinical Document Architecture (CDA) standard such as Quality Reporting Data Architecture (QRDA).
• Comply with a CMS-specified secure method for data submission, such as submitting the EHR data submission vendor's data in an XML file through an identity management system specified by CMS or another approved method, such as use of appropriate Nationwide Health Information Network specifications, if technically feasible.
• Enter into and maintain with its participating professionals an appropriate Business Associate agreement that provides for the data submission vendor's receipt of patient-specific data from the eligible professionals, as well as the data submission vendor's disclosure of patient-specific data on Medicare beneficiaries on behalf of eligible professionals who wish to participate in the Physician Quality Reporting System.
• Obtain and keep on file signed documentation that each holder of an NPI whose data are submitted to the data submission vendor has authorized the data submission vendor to submit patient-specific data on Medicare beneficiaries to CMS for the purpose of Physician Quality Reporting System participation. This documentation must be obtained at the time the eligible professional signs up with the data submission vendor to submit Physician Quality Reporting System quality measures data to the data submission vendor and must meet any applicable laws, regulations, and contractual business associate agreements.
• Provide CMS access (upon request for health oversight purposes like validation) to review the Medicare beneficiary data on which 2012 Physician Quality Reporting System EHR-based submissions are founded or provide to CMS a copy of the actual data (upon request).
• Provide CMS a signed, written attestation statement via mail or email which states that the quality measure results and any and all data including numerator and denominator data provided to CMS are accurate and complete.
• Use Physician Quality Reporting System measure specifications and the CMS provided measure calculation algorithm, or logic, to calculate reporting rates or performance rates unless otherwise stated. CMS will provide EHR data submission vendors a standard set of logic to calculate each measure and/or measures group they intend to report in 2012.
• Provide a calculated result using the CMS supplied measure calculation logic and XML file for each measure that the EHR data submission vendor intends to calculate. The data submission vendors will be required to show that they can calculate the proper measure results (that is, reporting and performance rates) using the CMS-supplied logic and send the calculated data back to CMS in the specified format.
For EHR data submission vendors participating in the Physician Quality Reporting System-Medicare EHR Incentive Pilot for 2012 (discussed in section VI.H. of this final rule with comment period) and wish to also submit Medicare clinical quality data extracted from an EHR for the purposes of the 2012 Physician Quality Reporting System incentive, these EHR data submission vendors must meet the following requirements in addition to the requirements stated previously:
• Be able to collect all needed data elements and transmit to CMS the data at the TIN/NPI level.
• Be able to calculate and submit measure-level reporting rates or, upon request, the data elements needed to calculate the reporting rates by TIN/NPI.
• Be able to calculate and submit, by TIN/NPI, a performance rate (that is, the percentage of a defined population who receive a particular process of care or achieve a particular outcome based on a calculation of the measure's numerator and denominator specifications) for each measure on which the TIN/NPI reports or, upon request the Medicare beneficiary data elements needed to calculate the reporting rates.
• Report the number of eligible instances (reporting denominator).
• Report the number of instances a quality service is performed (reporting numerator).
• Report the number of performance exclusions, meaning the quality action was not performed for a valid reason as defined by the measure specification.
• Report the number of reported instances, performance not met (eligible professional receives credit for reporting, not for performance), meaning the quality action was not performed for no valid reason as defined by the measure specification.
• Be able to transmit this data in a CMS-approved XML format.
• Submit an acceptable “validation strategy” to CMS by March 31, 2012. A validation strategy ascertains whether eligible professionals have submitted accurately and on at least the minimum number (80 percent) of their eligible patients, visits, procedures, or episodes for a given measure, which, as described in section VI.F.1.e.2. of this final rule with comment period, is the minimum percentage of patients on which an eligible professional must report on any given measure. Acceptable validation strategies often include such provisions as the EHR data submission vendor being able to conduct random sampling of their participant's data, but may also be based on other credible means of verifying the accuracy of data content and completeness of reporting or adherence to a required sampling method.
• Perform the validation outlined in the strategy and send the results to CMS by June 30, 2013 for the 2012 reporting year's data.
• Enter into and maintain with its participating professionals an appropriate Business Associate agreement that provides for the data submission vendor's receipt of patient-specific data from the eligible professionals, as well as the data submission vendor's disclosure of quality measure results and numerator and denominator data on Medicare beneficiaries on behalf of eligible professionals who wish to participate in the Physician Quality Reporting System.
• Obtain and keep on file signed documentation that each holder of an NPI whose data are submitted to the data submission vendor has authorized the data submission vendor to submit quality measure results and numerator and denominator data on Medicare beneficiaries to CMS for the purpose of Physician Quality Reporting System participation. This documentation must be obtained at the time the eligible professional signs up with the data submission vendor to submit Physician Quality Reporting System quality measures data to the data submission vendor and must meet any applicable laws, regulations, and contractual business associate agreements.
• Use Physician Quality Reporting System measure specifications and the CMS provided measure calculation algorithm, or logic, to calculate reporting rates or performance rates unless otherwise stated.
• Provide a calculated result using the CMS supplied measure calculation logic and XML file for each measure that the EHR data submission vendor intends to calculate. The data submission vendors are required to show that they can calculate the proper measure results (that is, reporting and performance rates) using the CMS-supplied logic and send the calculated data back to CMS in the specified format.
For 2012, the EHR data submission vendor must submit clinical quality data on Medicare beneficiaries extracted from eligible professionals' EHRs to our designated database for the Physician Quality Reporting System using a CMS-specified record layout, which will be provided to the EHR data submission vendor by CMS. In addition, for purposes of also reporting 2012 Physician Quality Reporting System quality measures, the EHR data submission vendor must to submit patient level Medicare clinical quality data extracted from the eligible professional's EHR using the same CMS-specified record layout that qualified EHR products must be able to produce for purposes of an eligible professional directly submitting the 2012 Physician Quality Reporting System EHR measures to CMS.
As in prior years, unlike the qualification process for registries, EHR vendors, which include vendors that provide EHR products that qualify for direct EHR-based reporting and EHR data submission vendors, are tested for qualification a year ahead of the program year in which the EHR vendor intends to submit Physician Quality Reporting System quality measures on behalf of individual eligible professionals or where its product(s) are available for use by eligible professionals to submit Physician Quality Reporting System measures directly to CMS.
We proposed EHR vendor testing for the 2013 Physician Quality Reporting System program year to qualify new EHR vendors and EHR data submission vendors and their EHR products for submission of Medicare beneficiary quality data extracted from EHR products to the CMS Medicare clinical quality data warehouse for the 2013 Physician Quality Reporting System.
In order for EHR vendors to be qualified to report 2013 Physician Quality Reporting System data to CMS, we proposed that EHR vendors would be required to meet the following requirements:
• Not be in a beta test form.
• Be in existence as of January 1, 2012.
• Have at least 25 active users.
• Participate in ongoing Physician Quality Reporting mandatory support conference calls hosted by CMS (approximately one call per month). Failure to attend more than one call per year would result in the removal of the EHR data submission vendor from the 2012 EHR qualification process.
• Indicate the reporting option the vendor seeks to qualify for its users to submit in addition to individual measures.
• Have access to the identity management system specified by CMS (such as, but not limited to, the Individuals Authorized Access to CMS Computer Systems, or IACS) to submit Medicare clinical quality data extracted to a CMS clinical data warehouse.
• Submit a test file containing dummy Medicare clinical quality data to a CMS clinical data warehouse via an identity management system specified by CMS during a timeframe specified by CMS. In 2011, the requirement to submit a test file could have contained real or dummy data. However, for privacy reasons, we have decided to only provide for the submission of test files containing dummy data. We proposed revisions to 42 CFR 414.90 to reflect this change.
• Submit a file containing the eligible professional's 2012 Physician Quality Reporting System Medicare clinical quality data extracted from the EHR for the entire 12-month reporting period via the CMS-specified identify management system during the timeframe specified by us in early 2013.
• Provide at least 1 feedback report, based on the data submitted to them for the 2012 Physician Quality Reporting System incentive reporting period, and if technically feasible, provide at least two feedback reports throughout the year to participating eligible professionals.
• Be able to collect all needed data elements and transmit to CMS the data at the beneficiary level.
• Be able to separate out and report on Medicare Part B FFS patients.
• Provide the measure numbers for the quality measures on which the data submission vendor is reporting.
• Be able to transmit this data in a CMS-approved XML format utilizing a Clinical Document Architecture (CDA) standard such as Quality Reporting Data Architecture (QRDA).
• Comply with a CMS-specified secure method for data submission, such as submitting the EHR vendor's data in an XML file through an identity management system specified by CMS or another approved method, such as use of appropriate Nationwide Health Information Network specifications, if technically feasible.
• Enter into and maintain with its participating professionals an appropriate Business Associate agreement that provides for the data submission vendor's receipt of patient-specific data from the eligible professionals, as well as the data submission vendor's disclosure of patient-specific data on Medicare beneficiaries on behalf of eligible professionals who wish to participate in the Physician Quality Reporting System.
• Obtain and keep on file signed documentation that each holder of an NPI whose data are submitted to the data submission vendor has authorized the data submission vendor to submit patient-specific data on Medicare beneficiaries to CMS for the purpose of Physician Quality Reporting System participation. This documentation must be obtained at the time the eligible professional signs up with the data submission vendor to submit Physician Quality Reporting System quality measures data to the data submission vendor and must meet any applicable laws, regulations, and contractual business associate agreements.
• Provide CMS access (upon request for health oversight purposes like validation) to review the Medicare beneficiary data on which 2012 Physician Quality Reporting System EHR-based submissions are founded or provide to CMS a copy of the actual data (upon request).
• Provide CMS a signed, written attestation statement via mail or email which states that the quality measure results and any and all data including numerator and denominator data provided to CMS are accurate and complete.
• Use Physician Quality Reporting System measure specifications and the CMS provided measure calculation algorithm, or logic, to calculate reporting rates or performance rates unless otherwise stated. CMS would provide EHR vendors a standard set of logic to calculate each measure and/or measures group they intend to report in 2012.
• Provide a calculated result using the CMS supplied measure calculation logic and XML file for each measure that the EHR vendor intends to calculate. The data submission vendors would be required to show that they can calculate the proper measure results (that is, reporting and performance rates) using the CMS-supplied logic and send the calculated data back to CMS in the specified format.
This is the same self-nomination process described in the “Requirements for Electronic Health Record (EHR) Vendors to Participate in the 2012 Physician Quality Reporting System EHR Program,” posted on the Physician Quality Reporting System section of the CMS Web site at
We also proposed that if an EHR vendor misses more than one mandatory support call or meeting, the vendor and their product and/or EHR data submission vendor would be disqualified for the Physician Quality Reporting System reporting year, which is covered by the call.
For the 2013 Physician Quality Reporting System, we proposed that previously qualified and new vendors and/or EHR data submission vendors would need to incorporate any new EHR measures (that is, electronically-specified measures), as well as update their electronic measure specifications and data transmission schema should either or both change, finalized for the Physician Quality Reporting System for 2013 if they wish to maintain their Physician Quality Reporting System qualification.
We invited public comment related to our proposed qualification requirements for EHR direct and data submission vendors and their products for the 2013 Physician Quality Reporting System. The comments received regarding this proposal have been addressed previously.
Based on the comments received and for the reasons previously stated, we are finalizing the qualification requirements for EHR direct and data submission vendors and their products for the 2013 Physician Quality Reporting System.
Any EHR vendor interested in having one or more of their EHR products “qualified” to submit quality data extracted from their EHR products to the CMS Medicare clinical quality data warehouse for the 2013 Physician Quality Reporting System must submit their self-nomination statement by January 31, 2012. Whereas, in prior program years, EHR vendors have submitted self-nomination statements via mail, we proposed to have EHR vendors submit self-nomination statements via a web-based tool, if technically feasible for us to develop such a tool. However, at this time, it is not technically feasible to collect self-nomination statements via a web-based tool. Therefore, as we proposed as an alternative, we will accept self-nomination statements from EHR vendors that wish to be qualified for the 2013 Physician Quality Reporting System via email. We expect to post instructions for submitting the self-nomination statement and the 2013 EHR vendor requirements in the 4th quarter of CY 2011. Specifically, for the 2013 Physician Quality Reporting System, in order to ensure EHR vendors' interest in participating in the 2013 Physician Quality Reporting System, only EHR vendors that self-nominate by January 31, 2012 to participate in the EHR Program testing during calendar year 2012 will be considered qualified EHR vendors for the 2013 Physician Quality Reporting System.
In accordance with 42 CFR 414.90(c)(3), eligible professionals that satisfactorily report 2012 Physician Quality Reporting System measures can qualify for an incentive equal to 0.5 percent of the total estimated part B allowed charges for all covered professional services furnished by the eligible professional (or, in the case of a group practice participating in the GPRO, the group practice) during the applicable reporting period. We proposed (76 FR 42850) modifying the incentive payment language in 42 CFR 414.90(c) so that the language is more consistent with section 1848 of the Act. We are finalizing this proposal. We are also making technical changes to renumber the clauses under 42 CFR 414.90(c).
Section 1848(m)(3)(A) of the Act established the criteria for satisfactorily submitting data on individual quality measures as submitting data on at least three measures in at least 80 percent of the cases in which the measure is applicable. For claims-based reporting, if fewer than three measures are applicable to the services of the professional, the professional may meet the criteria by submitting data on one or two measures for at least 80 percent of applicable cases where the measures are reportable. For years after 2009, section 1848(m)(3)(D) of the Act authorizes the Secretary, in consultation with stakeholders and experts, to revise the criteria for satisfactorily reporting data on quality measures.
Accordingly, we proposed (76 FR 42850) the following criteria for satisfactory reporting via the claims-based reporting mechanism for individual eligible professionals specializing in internal medicine, family practice, general practice, or cardiology:
• Report on at least one Physician Quality Reporting System core measure as identified in Table 46 of this proposed rule.
• Report on at least two additional measures that apply to the services furnished by the professional.
• Report each measure for at least 50 percent of the eligible professional's Medicare Part B FFS patients for whom services were furnished during the reporting period to which the measure applies.
We proposed the requirement of the reporting of Physician Quality Reporting System core measures for certain specialties to introduce measures reporting according to specialty for eligible professionals specializing in internal medicine, family practice, general practice, or cardiology. However, we did not propose this core measure requirement for all other specialties. Therefore, for all other specialties, we proposed (76 FR 42851) to retain similar reporting criteria as finalized for the in the 2011 MPFS final rule. Specifically, we proposed the following criteria for satisfactory reporting via the claims-based reporting mechanism:
• Report on at least three measures that apply to the services furnished by the professional; and
• Report each measure for at least 50 percent of the eligible professional's Medicare Part B FFS patients for whom services were furnished during the reporting period to which the measure applies.
To the extent that an eligible professional has fewer than three Physician Quality Reporting System measures that apply to the eligible professional's services and the eligible professional is reporting via the claims-based reporting mechanism, we proposed (76 FR 42851) that the eligible
• Report on all measures that apply to the services furnished by the professional (that is one to two measures); and
• Report each measure for at least 50 percent of the eligible professional's Medicare Part B FFS patients for whom services were furnished during the reporting period to which the measure applies.
As in prior years, we also proposed (76 FR 42851) that, for 2012, an eligible professional who reports on fewer than three measures through the claims-based reporting mechanism may be subject to the Measure Applicability Validation (MAV) process, which would allow us to determine whether an eligible professional should have reported quality data codes for additional measures. This process was applied in prior years, including the 2011 Physician Quality Reporting System. We proposed that these criteria for satisfactorily reporting data on fewer than three individual quality measures would apply for the claims-based reporting mechanism only because, unlike registry and EHR-based reporting, the reporting of Physician Quality Reporting System quality measures via claims is not handled by an intermediary but rather directly by the eligible professional.
For 2012, in order to encourage reporting on measures that are applicable to the eligible professional's practice as well as encourage eligible professionals to perform the clinical quality actions specified in the measures, we proposed (76 FR 42851) not to count measures that are reported through claims that have a zero percent performance rate. That is, if the recommended clinical quality action, as indicated in the numerator of the quality measure, is not performed on at least one patient for a particular measure or measures group reported by the eligible professional via claims, we will not count the measure (or measures group) as a measure (or measures group) reported by an eligible professional. This requirement is also consistent with the registry and EHR-based reporting criteria for satisfactory reporting in section VI.F.1.e of this final rule with comment period.
We invited and received public comments on our proposed 2012 criteria for satisfactory reporting of data on individual Physician Quality Reporting System quality measures for individual eligible professionals via claims. We also sought public comment as to whether geriatricians should be included as a specialty required to report on 2012 Physician Quality Reporting System core measures. In addition, we sought public comment on whether other specialties should be included in the 2012 Physician Quality Reporting System core measure reporting requirement. The following is a summary of the comments we received regarding these proposals.
Based on the comments received and for the reasons stated previously, we are finalizing the 2012 criteria for satisfactory reporting of data on individual Physician Quality Reporting System quality measures via claims, described in Table 40. As we indicate above, Table 40 reflects the criteria for satisfactory reporting of data on Physician Quality Reporting System quality measures via claims for all eligible professionals.
In addition, an eligible professional who reports on fewer than three measures through the claims-based reporting mechanism may be subject to the Measure Applicability Validation (MAV) process, which will allow us to determine whether an eligible professional should have reported quality data codes for additional measures. Under the MAV process, when an eligible professional reports on fewer than 3 measures, we will perform a review to determine whether there are other closely related measures (such as those that share a common diagnosis or those that are representative of services typically provided by a particular type of eligible professional). If an eligible professional who reports on fewer than 3 measures in 2012 reports on a measure that is part of an identified cluster of closely related measures and does not report on any other measure that is part of that identified cluster of closely related measures, then the eligible professional will not qualify as a satisfactory reporter in the 2012 Physician Quality Reporting System or earn an incentive payment.
Under our authority of section 1848(m)(3)(D) of the Act to revise the reporting criteria for the satisfactory reporting of measures, we proposed (76 FR 42852) the following criteria for satisfactory reporting via the registry-based reporting mechanism: (1) criteria for individual eligible professionals practicing in internal medicine, family practice, general practice, or cardiology and (2) criteria for all other eligible professionals. For the reasons stated previously, we distinguished eligible professionals in internal medicine, family practice, general practice, or cardiology from all other eligible professionals for the purposes of establishing criteria for satisfactory reporting. Therefore, for eligible professionals specializing in internal medicine, family practice, general practice, or cardiology, we proposed (76 FR 42852) the following criteria for satisfactory reporting—
• Report on at least one Physician Quality Reporting System core measure as identified in Table 28 of the proposed rule (76 FR 42863);
• Report on at least two additional measures that apply to the services furnished by the professional; AND
• Report each measure for at least 80 percent of the eligible professional's Medicare Part B FFS patients for whom services were furnished during the reporting period to which the measure applies.
For the same reasons stated for establishing different reporting criteria for all other eligible professionals under the claims-based reporting mechanism, we proposed the following criteria for satisfactory reporting via the registry-based reporting mechanism—
• Report on at least three measures that apply to the services furnished by the professional; AND
• Report each measure for at least 80 percent of the eligible professional's Medicare Part B FFS patients for whom services were furnished during the reporting period to which the measure applies.
In addition, as in prior years, for 2012, we proposed not to count measures that are reported through registries that have a zero percent performance rate, calculated by dividing the measure's numerator by the measure's denominator. That is, if the recommended clinical quality action, that is the action denoted in the quality measure's numerator, is not performed on at least one patient for a particular measure or measures group reported by the eligible professional via registry, we will not count the measure (or measures group) as a measure (or measures group) reported by an eligible professional. We proposed to disregard measures (or measures groups) that are reported through a registry that have a zero percent performance rate in the 2012 Physician Quality Reporting System, because we are assuming that the measure was not applicable to the eligible professional and was likely reported from EHR-derived data (or from data mining) and was unintentionally submitted from the registry to us. We also sought to avoid the possibility of intentional submission of spurious data solely for the purpose
We invited public comment on the proposed criteria for satisfactory reporting of individual quality measures for individual eligible professionals via registry. The following is a summary of the comments we received. We also sought public comment as to whether geriatricians should be included as a specialty required to report all 2012 Physician Quality Reporting System core measures. In addition, we sought public comment on whether other specialties should be included in the 2012 Physician Quality Reporting System core measure reporting requirement. The following is a summary of the comments we received.
Based on the comments received and for the reasons stated previously, we are finalizing the 2012 criteria for satisfactory reporting of data on individual Physician Quality Reporting System quality measures for individual eligible professionals via registry described in Table 41. However, for the same operational reasons we discussed previously regarding claims-based reporting, we are not finalizing the criteria for satisfactory reporting that we proposed for eligible professionals practicing in internal medicine, family practice, general practice, and cardiology. Therefore, Table 41 reflects the criteria for satisfactory reporting of data on Physician Quality Reporting System quality measures via registry for all eligible professionals.
(3) Criteria for Satisfactory Reporting of Individual Quality Measures for Individual Eligible Professionals via EHR
Section 1848(m)(3)(A) of the Act established the criteria for satisfactorily submitting data on individual quality measures as at least three measures in at least 80 percent of the cases in which the measure is applicable. For years after 2009, section 1848(m)(3)(D) of the Act authorizes the Secretary, in consultation with stakeholders and experts, to revise the criteria for satisfactorily reporting data on quality measures. Accordingly, we proposed the following options for satisfactory reporting of individual quality measures by individual eligible professionals participating in the 2012 Physician Quality Reporting System via the EHR-based reporting mechanism:
First, we proposed (76 FR 42854) that an eligible professional would meet the criteria for satisfactory reporting under the Physician Quality Reporting System if the eligible professional, using a Physician Quality Reporting System “qualified” EHR product (if the eligible professional is also participating in the EHR Incentive Program via the Physician Quality Reporting System-EHR Incentive Pilot discussed in section VI.H. of this final rule with comment period, the eligible professional's EHR product must also be Certified EHR Technology), reports on three core measures for 80 percent of the eligible professional's Medicare Part B FFS patients seen during the reporting period to which each measure applies as identified in Table 28 of the proposed rule (76 FR 42863), which are identical to the Medicare EHR Incentive Program core measures included in Table 7 of the Medicare and Medicaid EHR Incentive Program final rule (75 FR 44410). For all core measures identified in Table 28 of the proposed rule except for the measures titled “Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-up” and “Measure pair: a. Tobacco Use Assessment, b. Tobacco Cessation Intervention”, insofar as the denominator for one or more of the core measures is 0, implying that the eligible professional's patient population is not addressed by these measures, we proposed (76 FR 42854) that eligible professionals would be required to report up to three alternate core measures as identified in Table 28 of the proposed rule and which are identical to the Medicare EHR Incentive Program alternate core measures included in Table 7 of the Medicare and Medicaid EHR Incentive Program final rule, (75 FR 44410). In addition, we proposed that the eligible professional would be required to report on three additional measures of their choosing that are available for the Medicare EHR Incentive Program in Table 6 of the Medicare and Medicaid EHR Incentive Program final rule (75 FR 44398 through 44408) (as identified in 29 of the proposed rule).
Section 1848(m)(7) of the Act (“Integration of Physician Quality Reporting and EHR Reporting”), as added by section 3002(d) of the Affordable Care Act, requires us to move towards the integration of EHR measures with respect to the Physician Quality Reporting System. Section 1848(m)(7) of the Act specifies that by
(A) The selection of measures, the reporting of which both would demonstrate—
(i) Meaningful use of an EHR for purposes of the Medicare EHR Incentive Program; and
(ii) Quality of care furnished to an individual; and
(B) Such other activities as specified by the Secretary.
We proposed the aforementioned criteria for satisfactory reporting via an EHR, which is identical to the criteria for achieving meaningful use for reporting clinical quality measures under the EHR Incentive Program as finalized in the Medicare and Medicaid Electronic Health Record Incentive Program final rule (75 FR 44409 through 44411), in an effort to align the Physician Quality Reporting System with the Medicare EHR Incentive Program.
In addition to the reporting criteria proposed (76 FR 42854) previously, we proposed alternative reporting criteria for satisfactory reporting using the EHR-based reporting mechanism that is similar to the criteria finalized in the CY 2011 MPFS Final Rule with comment period (75 FR 73497 through 73500). For the reasons set forth for establishing different criteria for satisfactory reporting via claims and registry, we proposed to adopt two different criteria for satisfactory reporting, depending on an eligible professional's specialty. For eligible professionals specializing in internal medicine, family practice, general practice, and cardiology, we proposed the following criteria:
• Report on ALL Physician Quality Reporting System core measure as identified in Table 28 of the proposed rule (76 FR 42863) AND
• Report each measure for at least 80 percent of the eligible professional's Medicare Part B FFS patients for whom services were furnished during the reporting period to which the measure applies.
We understood that by requiring eligible professionals specializing in internal medicine, family practice, general practice, and cardiology to report all Physician Quality Reporting System core measures, we would be requiring such professionals to report more measures than eligible professionals who do not practice within those specialties. We believe, however, that requiring these specialists to report on all Physician Quality Reporting System core measures would not add an additional burden to these eligible professionals because the reporting of measures is done entirely through the EHR. Furthermore, because we are proposing to require these specialties to report on all Physician Quality Reporting System core measures and recognize that some of the Physician Quality Reporting System core measures may not be applicable to all of these eligible professionals' specialties, we proposed to allow the reporting of these Physician Quality Reporting System core measures with a zero percent performance rate. That is, the reporting of a Physician Quality Reporting System core measure that is not applicable to the eligible professional's practice in this instance will not preclude an eligible professional from meeting the criteria for satisfactory reporting.
For the reasons we stated previously for creating separate reporting criteria for all other eligible professionals for claims and registry reporting, we proposed (76 FR 42854) the following criteria for satisfactory reporting using the EHR-based reporting mechanism—
• Report on at least three Physician Quality Reporting System EHR measures of the eligible professional's choosing; AND
• Report each measure for at least 80 percent of the eligible professional's Medicare Part B FFS patients for whom services were furnished during the reporting period to which the measure applies.
We invited public comment on the proposed criteria for satisfactory reporting of individual quality measures by individual eligible professionals via an EHR-based reporting mechanism in the 2012 Physician Quality Reporting System. We also sought public comment as to whether geriatricians should be included as a specialty required to report all 2012 Physician Quality Reporting System core measures. In addition, we sought public comment on whether other specialties should be included in the 2012 Physician Quality Reporting System core measure reporting requirement. In addition to the comments summarized and addressed previously regarding our proposal to require certain specialties to report on core measures, the following is a summary of the remaining comments we received regarding these proposals.
After considering the comments and for the reasons we stated previously, we are only finalizing the criteria for satisfactory reporting via EHR for the 2012 Physician Quality Reporting System described in Table 42. For the operational reasons discussed previously, we are not finalizing the criteria for satisfactory reporting via EHR that we proposed for eligible professionals practicing in internal medicine, family practice, general practice, and cardiology. Therefore, Table 42 reflects the criteria for satisfactory reporting of data on Physician Quality Reporting System quality measures via EHR for all eligible professionals.
Under § 414.90(b), “measures group” is defined as “a subset of four or more Physician Quality Reporting System measures that have a particular clinical condition or focus in common.” For 2012 and beyond, we proposed that individual eligible professionals have the option to report measures groups in addition to individual quality measures to qualify for the Physician Quality Reporting System incentive, using claims or registries.
For the reasons we proposed (76 FR 42855) different criteria for satisfactorily reporting individual quality measures depending on specialty, specifically our desire to introduce core measures applicable to certain specialties and promote cardiovascular care, we proposed two different criteria for
We proposed that eligible professionals specializing in internal medicine, family practice, general practice, and cardiology may meet the criteria for satisfactory reporting of Physician Quality Reporting System measures groups via claims by reporting in the following manner:
• Report at least one Physician Quality Reporting System measures group; AND
• If the measures group does not contain at least one Physician Quality Reporting System core measure, then one Physician Quality Reporting System core measure; AND
• For each measures group and, if applicable, Physician Quality Reporting System core measure reported, report on at least 30 Medicare Part B FFS patients for each measures group that is reported.
• Measures groups containing a measure with a zero percent performance rate will not be counted.
We also proposed that eligible professionals specializing in internal medicine, family practice, general practice, and cardiology may meet the criteria for satisfactorily reporting Physician Quality Reporting System measures groups via claims by reporting in the following manner:
• Report at least one Physician Quality Reporting System measures group; BUT
• If the measures group does not contain at least one Physician Quality Reporting System core measure, then one Physician Quality core measure.
• For each measures group and, if applicable, Physician Quality Reporting System core measure reported, report on at least 50 percent of the eligible professional's Medicare Part B FFS patients seen during the reporting period to whom the measures group applies; but report no less than 15 Medicare Part B PFS patients for each measures group reported.
• Measures groups containing a measure with a zero percent performance rate will not be counted.
For all other eligible professionals, in order to meet the criteria for satisfactory reporting of Physician Quality Reporting measures groups via claims, we proposed that the eligible professional must:
• Report at least one Physician Quality Reporting System measures group; AND
• Report on at least 30 Medicare Part B FFS patients for each measures group that is reported.
• Measures groups containing a measure with a zero percent performance rate will not be counted.
Alternatively, eligible professionals not specializing in internal medicine, family practice, general practice, and cardiology may meet the criteria for satisfactorily reporting Physician Quality Reporting System measures groups via claims by reporting in the following manner:
• Report at least one Physician Quality Reporting System measures group; AND
• For each measures group reported, report each on at least 50 percent of the eligible professional's Medicare Part B FFS patients seen during the reporting period to whom the measures group applies; BUT
• Report no less than 15 Medicare Part B PFS patients for each measures group reported.
• Measures groups containing a measure with a zero percent performance rate will not be counted.
Aside from the Physician Quality Reporting System core measure reporting requirement for eligible professionals specializing in internal medicine, family practice, general practice, or cardiology, we proposed to retain the same criteria for satisfactory reporting of measures groups via claims as the 2011 criteria for satisfactory reporting of measures groups via claims for the 12-month reporting period that was finalized in the 2011 MPFS Final Rule with comment period, because we believe consistent reporting criteria will in turn lead to a greater chance that eligible professionals meet the criteria for satisfactory reporting (76 FR 42854). Therefore, as in 2011, we proposed that an eligible professional must satisfactorily report on all individual measures within the measures group in order to meet the criteria for satisfactory reporting via measures groups.
For 2012, in order to ensure that the Physician Quality Reporting System measures on which eligible professionals report are applicable to their respective practices, we proposed (76 FR 42854) not to count measures within measures groups that are reported through claims or registry that have a zero percent performance rate. That is, if the recommended clinical quality action is not performed on at least one patient for a particular measure reported by the eligible professional via claims or registry, we will not count the measures group as a measures group reported by an eligible professional. Furthermore, this proposed requirement is consistent with the reporting options for individual quality measures, which are discussed previously. Since we proposed to retain the requirement that an eligible professional must satisfactorily report on all individual measures contained within a measures group in order to meet the criteria for satisfactory reporting via measures groups, if an eligible professional reports a measure contained within a measures group with a zero percent performance rate, the eligible professional will fail to meet the criteria for the satisfactory reporting of measures groups.
We invited public comment on the 2012 criteria for satisfactory reporting on measures groups via claims for individual eligible professionals. We also sought public comment as to whether geriatricians should be included as a specialty required to report at least 1 proposed 2012 Physician Quality Reporting System core measure for measures group reporting. In addition, we sought public comment on whether other specialties should be included in the 2012 Physician Quality Reporting System core measure reporting requirement for measures groups. The following is a summary of the comments we received.
Based on the comments received and for the reasons stated previously, we are finalizing the 2012 criteria for satisfactory reporting of measures groups via claims for individual eligible professionals described in Table 43. For the operational reasons discussed previously, however, we are not finalizing our proposals for eligible professionals practicing in internal medicine, family practice, general practice, and cardiology. Therefore, Table 43 reflects the final criteria for satisfactory reporting of data on Physician Quality Reporting System quality measures groups via claims for all eligible professionals.
An eligible professional could also potentially qualify for the Physician Quality Reporting System incentive payment by satisfactorily reporting both individual measures and measures groups. However, only one incentive payment will be made to the eligible professional.
As with the reporting of measures groups via claims, we proposed (76 FR 42857) different criteria for the satisfactory reporting of Physician Quality Reporting System measures groups via registry depending on the eligible professional's specialty. For eligible professionals specializing in internal medicine, family practice, general practice, or cardiology, in order to meet the criteria for the satisfactory reporting of Physician Quality Reporting measures groups via registry, during the 12-month reporting period, we proposed that the eligible professional must—
• Report at least 1 Physician Quality Reporting System measures group; AND
• If the measures group does not contain at least 1 Physician Quality Reporting System core measure, then 1 Physician Quality Reporting System core measure; AND
• Report on at least 30 Medicare Part B FFS patients for each measures group and, if applicable, Physician Quality Reporting System core measure reported.
• Measures groups containing a measure with a zero percent performance rate will not be counted.
Alternatively, we proposed that the eligible professional specializing in internal medicine, family practice, general practice, or cardiology may meet the criteria for the satisfactory reporting of Physician Quality measures groups via registry by doing the following during the 12-month reporting period:
• Report at least one Physician Quality Reporting System measures group; AND
• If the measures group does not contain at least 1 Physician Quality Reporting System core measure, then 1 Physician Quality Reporting System core measure; AND
• Report each measures group and, if applicable, Physician Quality Reporting System core measure for at least 80 percent of the eligible professional's Medicare Part B FFS patients seen during the reporting period to whom the measures group applies; BUT
• Report each measures group on no less than 15 Medicare Part B FFS patients seen during the reporting period to which the measures group applies.
• Measures groups containing a measure with a zero percent performance rate will not be counted.
In order to meet the criteria for the satisfactory reporting of Physician Quality Reporting measures groups via registry, during the 6-month reporting period, we proposed that the eligible professional must—
• Report at least one Physician Quality Reporting System measures group; AND
• If the measures group does not contain at least 1 Physician Quality core measure, then 1 Physician Quality core measure; AND
• Report each measures group and, if applicable, Physician Quality Reporting System core measure for at least 80 percent of the eligible professional's Medicare Part B FFS patients seen during the reporting period to whom the measures group applies; BUT
• Report each measures group on no less than 8 Medicare Part B FFS patients seen during the reporting period to which the measures group applies.
• Measures groups containing a measure with a zero percent performance rate will not be counted.
For all other eligible professionals, in order to meet the criteria for the satisfactory reporting of Physician Quality Reporting System measures groups via registry, we proposed that, during the 12-month reporting period, the eligible professional must—
• Report at least 1 Physician Quality Reporting System measures group; AND
• Report each measures group for at least 30 Medicare Part B FFS patients.
• Measures groups containing a measure with a zero percent performance rate will not be counted.
Alternatively, we proposed that an eligible professional not specializing in internal medicine, family practice, general practice, or cardiology may meet the criteria for the satisfactory reporting of Physician Quality Reporting System measures groups via registry by doing the following during the 12-month reporting period:
• Report at least one Physician Quality Reporting System measures group; AND
• For each measures group reported, report on at least 80 percent of the eligible professional's Medicare Part B FFS patients seen during the reporting period to whom the measures group applies; BUT
• Report no less than 15 patients for each measures group reported.
• Measures groups containing a measure with a zero percent performance rate will not be counted.
For all other eligible professionals, in order to meet the criteria for the satisfactory reporting of Physician Quality Reporting System measures groups via registry during the 6-month reporting period, we proposed that, during the proposed 6-month reporting period, the eligible professional must—
• Report at least 1 Physician Quality Reporting System measures group; AND
• For each measures group reported, report on at least 80 percent of the eligible professional's Medicare Part B FFS patients seen during the reporting period to whom the measures group applies; BUT
• Report each measures group on no less than least 8 Medicare Part B FFS patients for each measures group reported.
• Measures groups containing a measure with a zero percent performance rate will not be counted.
Aside from the Physician Quality Reporting System core measure reporting requirement for eligible professionals specializing in internal medicine, family practice, general practice, or cardiology, we proposed to retain the same criteria for satisfactory reporting of measures groups via registry as the 2011 criteria for satisfactory reporting of measures groups via registry finalized in the 2011 MPFS Final Rule with comment period. Therefore, as in 2011, an eligible professional must satisfactorily report on all individual measures within the measures group in order to meet the criteria for satisfactory reporting via measures groups. We proposed to retain the same criteria, because, since eligible professionals are already familiar with this reporting criteria, we believe having consistent reporting criteria will in turn lead to a greater chance that eligible professionals meet the criteria for satisfactory reporting.
For 2012, in order to ensure that the Physician Quality Reporting System measures on which eligible professionals report are applicable to their respective practices, we proposed not to count measures within measures groups that are reported through claims or registry that have a zero percent performance rate. That is, if the recommended clinical quality action is not performed on at least one patient for a particular measure reported by the eligible professional via claims or registry, we will not count the measures groups as a measures group reported by an eligible professional. Furthermore, this requirement is consistent with the reporting options for individual quality measures, which were discussed previously. Since we proposed to retain the requirement that an eligible professional must satisfactorily report on all individual measures contained within a measures group in order to meet the criteria for satisfactory reporting via measures groups, if an eligible professional reports a measure contained within a measures group with a zero percent performance rate, the eligible professional will fail to meet the criteria for the satisfactory reporting of measures groups.
We also sought public comment as to whether geriatricians should be included as a specialty required to report at least 1 proposed 2012 Physician Quality Reporting System core measure for measures group reporting. In addition, we sought public comment on whether other specialties should be included in the 2012 Physician Quality Reporting System core measure reporting requirement for measures groups. The summary of these comments and our responses was discussed previously in this final rule with comment period.
We invited but received no public comment on the proposed 2012 criteria for satisfactory reporting on measures groups via registry for individual eligible professionals. Therefore, for the reasons stated previously, we are finalizing the 2012 criteria for satisfactory reporting of data on measures groups via registry described in Table 44. However, for the operational reasons discussed previously, we are not finalizing our proposals regarding eligible professionals practicing in internal medicine, family practice, general practice, and cardiology. Therefore, Table 42 reflects the final criteria for satisfactory reporting of data on Physician Quality Reporting System quality measures via EHR for all eligible professionals.
An eligible professional could also potentially qualify for the Physician Quality Reporting System incentive payment by satisfactorily reporting both individual measures and measures groups. However, only one incentive payment will be made to the eligible professional.
(6) 2012 Criteria for Satisfactory Reporting on Physician Quality Reporting System Measures by Group Practices Under the Group Practice Reporting Option (GPRO)
Instead of participating as an individual eligible professional, an eligible professional in a group practice may participate in the Physician Quality Reporting System under the Physician Quality Reporting System GPRO. However, an individual eligible professional who is affiliated with a group practice participating in the Physician Quality Reporting System GPRO that satisfactorily submits Physician Quality Reporting System quality measures will only be able to earn an incentive as part of the group practice and not as an individual eligible professional.
We proposed (76 FR 42859) that group practices interested in participating in GPRO must self-nominate. As stated in section VI.F.1.e.6. of this final rule with comment period, for group practices selected to participate in the Physician Quality Reporting System GPRO for 2012, we finalized a 12-month reporting period beginning January 1, 2012. For 2012, we proposed (76 FR 32859) to use the same GPRO reporting methods that we have used in prior years. Specifically, we proposed that group practices participating in GPRO submit information on measures within a common set of 30 NQF-endorsed quality measures using a web interface based on the GPRO web interface used in the 2011 Physician Quality Reporting System GPRO. As part of the data submission process for 2012 GPRO, we proposed that during 2012, each group practice would be required to report quality measures with respect to services furnished during the 2012 reporting period (that is, January 1, 2012, through December 31, 2012) on an
In 2011, to distinguish the criteria in GPRO I and II for satisfactory reporting between small vs. large groups, we established different reporting criteria dependent on the group's size. Although we are consolidating the GPRO for 2012, we still recognize the need to equalize the reporting burden by establishing different reporting criteria for small vs. large groups. Therefore, we proposed to establish the following two criteria for the satisfactory reporting of Physician Quality Reporting System quality measures under the 2012 GPRO, based on the size of the group practice:
• For group practices comprised of 25-99 eligible professionals participating in the GPRO, we proposed that the group practice must report on all GPRO measures included in the web interface (listed in Table 55 of the proposed rule (76 FR 42880)). During the submission period, the group practice will need to access the web interface and populate the data fields necessary for capturing quality measure information on each of the assigned beneficiaries up to 218 beneficiaries (with an over-sample of 327 beneficiaries) for each disease module and preventive care measure. We further proposed that if the pool of eligible assigned beneficiaries for any disease module or preventive care measure is less than 218, then the group practice would need to populate the remaining data files for 100 percent of eligible assigned beneficiaries for that disease module or preventive care measure. For each disease module or preventive care measure, we proposed that the group practice must report information on the assigned patients in the order in which they appear in the group's sample (that is, consecutively).
• For group practices comprised of 100 or more eligible professionals, we proposed that the group practices must report on all Physician Quality Reporting System GPRO quality measures. During the submission period, the group practice would need to populate the remaining data fields in the web interface necessary for capturing quality measure information on each of the assigned beneficiaries up to 411 beneficiaries (with an over-sample of 616 beneficiaries) for each disease module and preventive care measure. We further proposed that if the pool of eligible assigned beneficiaries for any disease module or preventive care measure is less than 411, then the group practice must populate the remaining data fields for 100 percent of eligible assigned beneficiaries for that disease module or preventive care measure. For each disease module or preventive care measure, we proposed that the group practice must report information on the assigned patients in the order in which they appear in the group's sample (that is, consecutively). In determining the appropriate reporting criteria for group practices comprised of 100 or more eligible professionals, we sought to use the same criteria we finalized in the 2011 MPFS Final Rule with comment period for GPRO I (75 FR 73506) because group practices are already familiar with this reporting process. We hope that establishing the same process for reporting under the GPRO as used in prior years will provide a likelier chance for meeting the criteria for satisfactory reporting under the GPRO. In addition, we sought to align the criteria for satisfactory reporting under the Physician Quality Reporting System with CMS' PGP demonstration, which collects data from large group practices in an effort to coordinate the overall care delivered to Medicare patients.
As we discussed previously with our definition of group practice, we allow for fluctuation of the group practice's size throughout the reporting period, provided that the group size contains at least 25 eligible professionals, which is the minimum group practice size for participation in the Physician Quality Reporting System GPRO. However, as we established in 2011, for purposes of determining which reporting criteria the group must satisfy, a group practice's size will be the size of the group at the time the group's participation is approved by CMS (75 FR 73504). For example, if a group practice is comprised of 100 eligible professionals at the time it self-nominates for participation as a GPRO in 2012, and the group practice's size then drops to 99 eligible professionals at the time the group practice's participation is approved by CMS, the group practice would need to meet the reporting criteria for a group size of 99.
We invited public comment on the proposed requirements for satisfactory reporting via the Physician Quality Reporting System GPRO reporting option. The following is a summary of the comments we received that were related to the proposed 2012 criteria for satisfactory reporting for group practices in the Physician Quality Reporting System GPRO.
After considering the comments and for the reasons stated previously, we are finalizing all of the proposed 2012 criteria for satisfactory reporting for group practices participating in the Physician Quality GPRO. Table 45 summarizes the criteria for the satisfactory reporting of data on quality measures by group practice under the 2012 Physician Quality Reporting GPRO. Group practices participating in the 2012 Physician Quality Reporting System GPRO, regardless of size, are required to report on all of the measures listed in Table 71 of this final rule with comment period. These quality measures are grouped into preventive care measures and five disease modules: heart failure, diabetes, coronary artery disease, hypertension, and chronic obstructive pulmonary disease (COPD).
Furthermore, although we are requiring that the group practices participating in the GPRO to report on a certain number of consecutive patients, such as either 218 or 411 beneficiaries depending on the group's size, we will allow the “skipping” of patients for valid reasons, such as a beneficiary's medical records not being found or not being able to confirm a diagnosis. However, excessive skipping of patients may cause us to question the accuracy or validity of the data being reported to us by the group practices. Due to the variance in group patterns, measures, and disease modules, however, it is difficult to establish a “skip threshold” for the satisfactory reporting of GPRO measures. Therefore, it is our intent to examine each group practice's skip patterns. We may request the group to provide additional information to help explain or support the skips to help better inform us on what levels of skipping could potentially be considered excessive skipping in a future year.
We intend to post the final 2012 Physician Quality Reporting System GPRO participation requirements for group practices, including instructions for submitting the self-nomination statement and other requested information, on the Physician Quality Reporting System section of the CMS Web site at
The Physician Quality Reporting System GPRO web interface will be updated as needed to include the 2012 Physician Quality Reporting System GPRO measures (that is, to eliminate measures that have been retired as well as add additional measures that will be finalized for 2012). We intend to provide the selected physician groups with access to this pre-populated database by no later than the first quarter of 2012. For purposes of pre-populating this GPRO web interface, we will assign beneficiaries to each group practice using a patient assignment methodology modeled after the patient assignment methodology used in the PGP & MCMP demonstrations. We will use Medicare Part B claims data for dates of service on or after January 1, 2011, and submitted and processed by approximately October 31, 2011, to assign Medicare beneficiaries to each group practice. Assigned beneficiaries will be limited to those Medicare Part B FFS beneficiaries with Medicare Parts A and B claims for whom Medicare is the primary payer. Assigned beneficiaries will not include Medicare Advantage enrollees. A beneficiary will be assigned to the group practice that provides the plurality of a beneficiary's office or other outpatient office evaluation and management allowed charges. Beneficiaries with only one office visit to the group practice will be eliminated from the group practice's assigned patient sample for purposes of the 2012 Physician Quality Reporting System GPRO. We will pre-populate the GPRO web interface with the assigned beneficiaries' demographic and utilization information based on their Medicare claims data.
Under section 1848(k)(2)(C)(i) of the Act, the Physician Quality Reporting System quality measures shall be such measures selected by the Secretary from measures that have been endorsed by the entity with a contract with the Secretary under subsection 1890(a) of
The statutory requirements under section 1848(k)(2)(C) of the Act, subject to the exception noted previously, require only that the measures be selected from measures that have been endorsed by the entity with a contract with the Secretary under section 1890(a) (that is, the NQF) and are silent with respect to how the measures that are submitted to the NQF for endorsement were developed. The basic steps for developing measures applicable to physicians and other eligible professionals prior to submission of the measures for endorsement may be carried out by a variety of different organizations. We do not believe there needs to be any special restrictions on the type or make-up of the organizations carrying out this basic process of development of physician measures, such as restricting the initial development to physician-controlled organizations. Any such restriction would unduly limit the basic development of quality measures and the scope and utility of measures that may be considered for endorsement as voluntary consensus standards for purposes of the Physician Quality Reporting System.
The following is a summary of comments we received.
In addition to reviewing the 2011 Physician Quality Reporting System measures for purposes of developing the 2012 Physician Quality Reporting System measures, we reviewed and considered measure suggestions for the 2012 Physician Quality Reporting System.
With respect to the selection of new measures, we applied the following considerations, which include many of the same considerations applied to the selection of 2009, 2010 and 2011 Physician Quality Reporting System quality measures proposed (76 FR 42864) for inclusion in the 2012 Physician Quality Reporting System quality measure set previously described:
• High Impact on Healthcare.
++ Measures that are high impact and support CMS and HHS priorities for improved quality and efficiency of care for Medicare beneficiaries. These current and long term priority topics include the following: prevention; chronic conditions; high cost and high volume conditions; elimination of health disparities; healthcare-associated infections and other conditions; improved care coordination; improved outcomes; improved efficiency; improved patient and family experience of care; effective management of acute and chronic episodes of care; reduced unwarranted geographic variation in quality and efficiency; and adoption and use of interoperable HIT.
++ Measures that are included in, or facilitate alignment with, other Medicare, Medicaid, and CHIP programs in furtherance of overarching healthcare goals.
++ NQF Endorsement.
++ Measures must be NQF-endorsed by August 15, 2011, in order to be considered for inclusion in the 2012 Physician Quality Reporting System quality measure set except, as provided under section 1848(k)(2)(C)(ii) of the Act.
++ Section 1848(k)(2)(C)(ii) of the Act provides an exception to the requirement that the Secretary select measures that have been endorsed by the entity with a contract under section 1890(a) of the Act (that is, the NQF).
• Address Gaps in the Physician Quality Reporting System Measure Set.
++ Measures that increase the scope of applicability of the Physician Quality Reporting System measures to services furnished to Medicare beneficiaries and expand opportunities for eligible professionals to participate in the Physician Quality Reporting System.
• Measures of various aspects of clinical quality including outcome measures, where appropriate and feasible, process measures, structural measures, efficiency measures, and measures of patient experience of care.
Other considerations that we applied to the selection of proposed measures for 2012, regardless of whether the measure was a 2011 Physician Quality Reporting System measure or not, were—
• Measures that are functional, which is to say measures that can be technically implemented within the capacity of the CMS infrastructure for data collection, analysis, and calculation of reporting and performance rates;
• Measures that address gaps in the quality of care delivered to Medicare beneficiaries;
• Measures impacting chronic conditions (chronic kidney disease, diabetes mellitus, heart failure, hypertension and musculoskeletal);
• Measures involving care coordination;
• Measures applicable across care settings (such as, outpatient, nursing facilities, domiciliary, etc.);
• Measures conducive to leveraging capabilities of an electronic health record (EHR);
• Measures whose detailed specifications will be completed and ready for implementation in the 2012 Physician Quality Reporting System;
• Broadly applicable measures that could be used to create a core measure set required of all participating eligible professionals; and
• Measures groups that reflect the services furnished to beneficiaries by a particular specialty.
In the 2012 Physician Quality Reporting System, as in the 2011 Physician Quality Reporting System, for some measures that are useful, but where data submission is not feasible through all otherwise available Physician Quality Reporting System reporting mechanisms, we proposed that a measure may be included for reporting solely through specific reporting mechanism(s) in which its submission is feasible.
However, we stress that inclusion of measures that are not NQF endorsed or AQA adopted is an exception to the requirement under section 1848(k)(2)(C)(i) of the Act that measures be endorsed by the NQF. We may exercise this exception authority in a specified area or medical topic for which a feasible and practical measure has not been endorsed by NQF, so long as due consideration is given to measures that have been endorsed by the NQF.
We invited comments on our proposed approach in selecting measures. The following is a summary of the comments we received regarding other considerations we have taken into account with regard to selecting 2012 Physician Quality Reporting System measures.
• #135: Chronic Kidney Disease (CKD): Influenza Immunization.
• #79: End Stage Renal Disease (ESRD): Influenza immunization in Patients with ESRD.
• #175: Pediatric Stage Renal Disease (ESRD): Influenza Immunization.
The commenter stated that Physician Quality Reporting System measure no. 110 titled “Preventive Care and Screening: Influenza Immunization for Patients ≥ 50 Years Old” has been updated to incorporate the influenza immunization measures. Therefore, the commenter encouraged reporting of Physician Quality Reporting System measure no. 110 in lieu of these retired measures. Another commenter also supported retiring Physician Quality Reporting System measure #79.
• Focusing on including measures that are related to the following medical topics: anesthesia, hematology, cardiology, abdominal aortic aneurysm (AAA) screening, pelvic prolapsed, gynecologic cancer, chronic obstructive pulmonary disease (COPD), elevated blood pressure, and gastroenterology;
• Whether measures test an eligible professional's basic competencies, rather than providing meaningful data on patient care; and
• Whether measures focus on care coordination.
We typically host a Call for Measures each year and consider the measures provided for the next program year. However, we note that next year, we will not host a Call for Measures for measures to be included in the 2013 program year. This is due our need to concentrate our efforts to convert International Classification of Diseases (ICD) codes (which classify all diagnoses, symptoms, and procedures recording in conjunction with care in the United States) from ICD-9 to ICD-10. This conversion affects quality measures included in the Physician Quality Reporting System, as these measures currently contain ICD-9 codes. We believe that the transition from ICD-9 to ICD-10 is necessary to update care classifications. However, we urge these commenters to submit these specific measure suggestions for consideration in a future Call for Measures. Information on the Call for Measures will be available on the Physician Quality Reporting System Web site at
In addition, as in prior years, we again note that we do not use notice and comment rulemaking as a means to update or modify measure specifications. Quality measures that have completed the consensus process have a designated party (usually, the measure developer/owner) who has accepted responsibility for maintaining the measure. In general, it is the role of the measure owner, developer, or maintainer to make changes to a measure. Therefore, comments requesting changes to a specific Physician Quality Reporting System measure's title, definition, and detailed specifications or coding should be directed to the measure developer identified in Tables 52 through 55. Contact information for the 2011 Physician Quality Reporting System measure developers is listed in the “2011 Physician Quality Reporting System Quality Measures List,” which is available on the CMS Web site at
Based on the criteria previously discussed, we proposed (76 FR 42862 and 42863) to include the individual measures listed in Tables 29 through 31 in the 2012 Physician Quality Reporting System individual quality measure set. We believe that each measure we proposed and are finalizing for reporting under the 2012 Physician Quality Reporting System meets at least one criterion for the selection of Physician Quality Reporting System measures described previously. We are also proposed (76 FR 42873) to include 24 measures groups in the 2012 Physician Quality Reporting System quality measure set, which were listed in Tables 32 through 55 of the proposed rule. The proposed individual measures selected for the 2012 Physician Quality Reporting System were categorized as follows—
• 2012 Physician Quality Reporting System Core Measures Available for Either Claims, Registry, and/or EHR-based Reporting;
• 2012 Physician Quality Reporting System Individual Quality Measures Available for Either Claims-based Reporting and/or Registry-based Reporting; and
• 2012 Physician Quality Reporting System Measures Available for EHR-based Reporting.
Please note that some individual measures we proposed in Tables 32 through 55 of the proposed rule for reporting for the 2012 Physician Quality Reporting System may be available for reporting in other CMS programs, such as the Medicare and Medicaid EHR Incentive Program as well as the Medicare Shared Savings Program. Please note that, in some instances, we have made technical changes in measure titles because the respective measure owners have updated these measure titles. We note that measure titles, in some instances, may vary from program to program. If an eligible professional intends to report the same measures for multiple CMS programs, it is important to check the full measure specifications, NQF measure number (if applicable), as well as any other identifying measure features to determine whether the measures are the same.
This section focuses on the 2012 Physician Quality Reporting System Individual Measures available for reporting via claims, registry, and/or EHR-based reporting. For the proposed 2012 Physician Quality Reporting System measures that were selected for reporting in 2011, please note that detailed measure specifications, including the measure's title, for the 2012 individual Physician Quality Reporting System quality measures may have been updated or modified during the NQF endorsement process or for other reasons prior to 2012. The 2012 Physician Quality Reporting System quality measure specifications for any given individual quality measure may, therefore, be different from specifications for the same quality measure used in prior years. Specifications for all 2012 individual Physician Quality Reporting System quality measures, whether or not included in the 2011 Physician Quality Reporting System program, must be obtained from the specifications document for 2012 individual Physician Quality Reporting System quality measures, which will be available on the Physician Quality Reporting System section of the CMS Web site on or before December 31, 2011.
The following is a summary of general comments received that were related to the proposed 2012 Physician Quality Reporting System individual quality measures.
• NQF #492: Participation in a practice-based or individual quality database registry with a standard measure set (NQF #492);
• NEQ #493: Participation by a physician or other clinician in systematic clinical database registry that includes consensus endorsed quality measures;
• Measures related to fluid management; and
• Measures related to oncology.
We describe the individual quality measures we are finalizing for the 2012 Physician Quality Reporting System as follows: (The measures specifications for all finalized 2012 Physician Quality Reporting System measures will be available at
The prevention of cardiovascular conditions is a top priority for CMS and HHS. In fact, in 2011, HHS launched the Million Hearts campaign, which is aimed at preventing 1 million heart attacks and strokes across the next 5-years through clinical- and community-based prevention strategies. Therefore, in conjunction with the Million Hearts campaign and in an effort to encourage eligible professionals to monitor their performance with respect to the prevention of cardiovascular conditions, we proposed (76 FR 42863) to adopt a 2012 Physician Quality Reporting System set of core measures, identified in Table 28 of the proposed rule, aimed at promoting cardiovascular care.
We invited public comment on the proposed 2012 Physician Quality Reporting System core measures available for claims, registry, and/or EHR-based reporting. The following is a summary of those comments.
• Preventive Care and Screening: Blood Pressure Measurement; and
• Preventive Care: Cholesterol-LDL test performed.
• Coronary Artery Disease (CAD): Oral Antiplatelet Therapy Prescribed for Patients with CAD
• Diabetes Mellitus: High Blood Pressure Control in Diabetes Mellitus
• Coronary Artery Disease (CAD): Lipid Control
Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up
• A lipid profile measure
Based on the comments received and for the reasons stated previously, we are finalizing the 2012 Physician Quality Reporting System core measures listed in the following Table 46. Please note that the measure titled “Proportion of adults 18-years and older who have had their BP measured within the preceding 2-years” has been updated to “Preventive Care and Screening: Blood Pressure Measurement.” Therefore, this new measure title, when listed, will be used in Tables 47 through 72.
As stated previously, we are not requiring that eligible professionals report on these core measures. However, we view the reporting of these measures as a top priority to report and strongly encourage all eligible professionals to report on these measures. We are also listing these finalized Physician Quality
For 2012, we proposed (76 FR 42863) to retain all measures currently used in the 2011 Physician Quality Reporting System. We believe these 2011 Physician Quality Reporting System measures meet the statutory considerations as well as other factors we used in determining which measures to include for reporting under the 2012 Physician Quality Reporting System. The retention of these measures also promotes program consistency. These proposed measures included 55 registry-only measures currently used in the 2011 Physician Quality Reporting System, and 144 individual quality measures for either claims-based reporting or registry-based reporting (75 FR 40186 through 40190, and 52489 through 52490). These proposed measures do not include any measures that were proposed to be included as part of the following measures groups: Back Pain, COPD, IBD, Sleep Apnea, Epilepsy, Dementia, Parkinson's, Elevated Blood Pressure, and Cataracts.
As we stated in the proposed rule (76 FR 42864), in 2011, Physician Quality Reporting System measure #197 was titled “Coronary Artery Disease (CAD): Drug Therapy for Lowering LDL-Cholesterol.” For 2012, we are changing the title of measure #197 to “Coronary Artery Disease: Lipid Control”, because the measure owner, AMA-PCPI, has changed the title of the measure. Aside from the title change, measure #197's NQF number as well as its NQF-endorsement status has not changed. However, as noted previously, eligible professionals should check the measure specifications for measure #197, as the specifications on how to report on measure #197 for the 2012 Physician Quality Reporting System may change from 2011.
In addition, we proposed (76 FR 42864) the 26 new individual measures for inclusion in the 2012 Physician Quality Reporting System in order to provide eligible professionals with more Physician Quality Reporting System quality measures on which they can select from to report. The following 2 proposed measures are NQF-endorsed:
• Anticoagulation for Acute Pulmonary Embolus Patients.
• Pregnancy Test for Female Abdominal Pain Patients.
The remaining 24 measures we proposed (76 FR 42864) were either pending NQF endorsement or would have to be adopted under the exception to NQF endorsement provided under section 1848(k)(2)(C)(ii) of the Act. In selecting these proposed measures, we took into account other considerations listed in section VI.F.1.f.2.. of the proposed rule. Specifically, fwe proposed to include the following measures for reporting under the 2012 Physician Quality Reporting System because the measures impact chronic conditions:
• Chronic Wound Care: Use of Wound Surface Culture Technique in Patients with Chronic Skin Ulcers.
• Chronic Wound Care: Use of Wet to Dry Dressings in Patients with Chronic Skin Ulcers.
• Hypertension: Blood Pressure Control.
We proposed the following measures because these measures involve care coordination:
• Coronary Artery Disease (CAD): Symptom Management.
We proposed the following measures for reporting under the Physician Quality Reporting System because these measures are applicable across care settings:
• Substance Use Disorders: Counseling Regarding Psychosocial and Pharmacologic Treatment Options for Alcohol Dependence.
• Substance Use Disorders: Screening for Depression Among Patients with Substance Abuse or Dependence.
• Cardiac Rehabilitation Patient Referral From an Outpatient Setting.
We proposed (76 FR 42864) the following measures because we believe the measures address gaps in the Physician Quality Reporting System measure set:
• Barrett's Esophagus.
• Ultrasound Determination of Pregnancy Location for Pregnant Patients with Abdominal Pain.
• Rh Immunoglobulin (Rhogam) for Rh Negative Pregnant Women at Risk of Fetal Blood Exposure.
• Surveillance after Endovascular Abdominal Aortic Aneurysm Repair (EVAR).
• Referral for Otology Evaluation for Patients with Acute or Chronic Dizziness.
• Image Confirmation of Successful Excision of Image-Localized Breast Lesion.
• Improvement in Patient's Visual Function within 90-Days Following Cataract Surgery.
• Patient Satisfaction within 90-Days Following Cataract Surgery.
We proposed the following measures because we believe the measures increase the scope of applicability of the Physician Quality Reporting System measures to services furnished to Medicare beneficiaries and expand opportunities for eligible professionals to participate in the Physician Quality Reporting System:
• Radical Prostatectomy Pathology Reporting.
• Immunohistochemical (IHC) Evaluation of HER2 for Breast Cancer Patients .
We proposed the following measures because the measures are high impact and support CMS and HHS priorities for improved quality and efficiency of care for Medicare beneficiaries.
• Statin Therapy at Discharge after Lower Extremity Bypass (LEB).
• Rate of Open AAA Repair without Major Complications (discharged to home no later than post-operative day #7).
• Rate of EVAR without Major Complications (discharged to home no later than POD #2).
• Rate of Carotid Endarterectomy for Asymptomatic Patients, without Major Complications (discharged to home no later than post-operative day #2).
We proposed the following measures because the measures have a high impact on health care:
• Preoperative Diagnosis of Breast Cancer.
• Sentinel Lymph Node Biopsy for Invasive Breast Cancer.
• Biopsy Follow-up.
Of these newly proposed 26 measures, 13 would be reportable via registry-only. The remaining 13 measures would be available for claims and registry reporting. Although we proposed to designate certain measures as registry-only measures, we indicated we could not guarantee that there would be a registry qualified to submit each registry-only measure for 2012. We rely on registries to self-nominate and identify the measures for which they would like to be qualified to submit quality measures results and numerator and denominator data on quality measures. If no registry self-nominates to submit measure results and numerator and denominator data on a particular measure for 2012, then an eligible professional would not be able to report that particular measure.
We believe that the addition of Physician Quality Reporting System quality measures will encourage eligible professionals to participate in the Physician Quality Reporting System, as there are more measures that may be applicable to eligible professionals.
We invited public comment on the proposed 2012 Physician Quality Reporting System individual quality measures that are available for claims and/or registry-based reporting identified in Table 30 of the proposed rule (76 FR 42865). The following is a summary of the comments we received.
• End Stage Renal Disease (ESRD): Influenza Immunization in Patients with ESRD.
• End Stage Renal Disease (ESRD): Plan of Care for Inadequate Hemodialysis in ESRD Patients.
• End Stage Renal Disease (ESRD): Plan of Care for Inadequate Peritoneal Dialysis.
• Functional Deficit: Change in Risk-Adjusted Functional Status for Patients with Hip Impairments.
• Functional Deficit: Change in Risk-Adjusted Functional Status for Patients with Lower Leg, Foot or Ankle Impairments.
• Functional Deficit: Change in Risk-Adjusted Functional Status for Patients with Lumbar Spine Impairments.
• Functional Deficit: Change in Risk-Adjusted Functional Status for Patients with Shoulder Impairments.
• Functional Deficit: Change in Risk-Adjusted Functional Status for Patients with Elbow, Wrist or Hand Impairments.
• Functional Deficit: Change in Risk-Adjusted Functional Status for Patients with Neck, Cranium, Mandible, Thoracic Spine, Ribs, or Other General Orthopedic Impairments.
• Diabetes Mellitus: Urine Screening for Microalbumin or Medical Attention for Nephropathy in Diabetic Patients.
• Hemodialysis Vascular Access Decision-Making by Surgeon to Maximize Placement of Autogenous Arterial Venous (AV) Fistula.
• Referral for Otologic Evaluation for Patients with Congenital or Traumatic Deformity of the Ear.
• Measure pair: a. Tobacco Use Assessment, b. Tobacco Cessation Intervention.
• Preventive Care and Screening: Influenza Immunization for Patients ≥ 50 Years Old.
• Diabetes Mellitus: Hemoglobin A1c Poor Control in Diabetes Mellitus.
• Diabetes Mellitus: Low Density Lipoprotein (LDL-C) Control in Diabetes Mellitus.
• Diabetes Mellitus: High Blood Pressure Control in Diabetes Mellitus.
• Heart Failure: Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy for Left Ventricular Systolic Dysfunction (LVSD).
• Coronary Artery Disease (CAD): Beta-Blocker Therapy for CAD Patients with Prior Myocardial Infarction (MI).
• Preventive Care and Screening: Pneumonia Vaccination for Patients 65 Years and Older.
• Coronary Artery Disease (CAD): Oral Antiplatelet Therapy Prescribed for Patients with CAD.
• Heart Failure: Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD).
• Coronary Artery Disease (CAD): Lipid Control.
• Heart Failure: Warfarin Therapy for Patients with Atrial Fibrillation.
• Ischemic Vascular Disease (IVD): Blood Pressure Management.
• Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic.
• Endoscopy & Polyp Surveillance: Colonoscopy Interval for Patients with a History of Adenomatous Polyps—Avoidance of Inappropriate Use.
One commenter was opposed to the measure titled “End Stage Renal Disease (ESRD): Influenza Immunization in Patients with ESRD” because the commenter believes reporting of this measure will create a higher burden for dialysis facility staff.
• End Stage Renal Disease (ESRD): Influenza Immunization in Patients with ESRD
• Substance Use Disorders: Counseling Regarding Psychosocial and Pharmacologic Treatment Options for Alcohol Dependence;
• Substance Use Disorders: Screening for Depression Among Patients with Substance Abuse or Dependence;
• Cardiac Rehabilitation Patient Referral From an Outpatient Setting;
• Immunohistochemical (IHC) Evaluation of HER2 for Breast Cancer Patients;
• Image Confirmation of Successful Excision of Image-Localized Breast Lesion;
• Preoperative Diagnosis of Breast Cancer;
• Sentinel Lymph Node Biopsy for Invasive Breast Cancer;
• Biopsy Follow-up;
• Barrett's Esophagus;
• Radical Prostatectomy Pathology Reporting;
• Immunohistochemical (IHC) Evaluation of HER2 for Breast Cancer Patients;
• Substance Use Disorders: Counseling Regarding Psychosocial and Pharmacologic Treatment Options for Alcohol Dependence; and
• Substance Use Disorders: Screening for Depression Among Patients with Substance Abuse or Dependence.
• Cardiac Rehabilitation Patient Referral From an Outpatient Setting.
• Ultrasound Determination of Pregnancy Location for Pregnant Patients with Abdominal Pain.
• Rh Immunoglobulin (Rhogam) for Rh Negative Pregnant Women at Risk of Fetal Blood Exposure.
One commenter also requested that the measure titled “Rh Immunoglobulin (Rhogam) for Rh Negative Pregnant Women at Risk of Fetal Blood Exposure” be also be reported via claims, rather than only via the registry-based reporting mechanism.
In addition, we understand the concern that certain eligible professionals may not be able to report on registry-only measures. However, we believe it is beneficial that we provide as many measures as possible on which eligible professionals may report so as to increase participation and eligible professionals' reporting success rates. We believe the inclusion of registry-only measures provides a greater set of measures on which to satisfactorily report.
• Measure #7: Coronary Artery Disease (CAD): Beta-Blocker Therapy- Prior Myocardial Infarction (MI) or Left Ventricular Systolic Dysfunction (LVEF < 40 percent).
• Measure #53: Asthma: Pharmacologic Therapy for Persistent Asthma.
• Measure #64: Asthma: Assessment of Asthma Control.
• Measure #81: Adult Kidney Disease: Hemodialysis Adequacy: Solute.
• Measure #82: Adult Kidney Disease: Peritoneal Dialysis Adequacy: Solute.
• Measure #32: Stroke and Stroke Rehabilitation: Discharged on Antithrombotic Therapy.
• Measure #36: Stroke and Stroke Rehabilitation: Rehabilitation Services Ordered.
• Measure #224: Melanoma: Overutilization of Imaging Studies in Melanoma.
• Measure #121: Adult Kidney Disease: Laboratory Testing (Lipid Profile).
• Measure #122: Adult Kidney Disease: Blood Pressure Management.
• Measure #123: Adult Kidney Disease: Patients on Erythropoiesis-Stimulating Agent (ESA) Hemoglobin Level > 12.0 g/dL.
• Measure #197: Coronary Artery Disease (CAD): Lipid Control.
• Measure #110: Preventive Care and Screening: Influenza Immunization.
• Chronic Wound Care: Use of Wound Surface Culture Technique in Patients with Chronic Skin Ulcers.
• Chronic Wound Care: Use of Wet to Dry Dressings in Patients with Chronic Skin Ulcers.
The commenter believes that these measures will encourage eligible professionals to use more expensive dressings without improving quality of care.
For the reasons stated previously, we proposed to include, but are not finalizing, the following measures for claims and/or registry-based reporting in the 2012 Physician Quality Reporting System:
• # 135: Chronic Kidney Disease (CKD): Influenza Immunization.
• # 79: End Stage Renal Disease (ESRD): Influenza immunization in Patients with ESRD.
• # 175: Pediatric Stage Renal Disease (ESRD): Influenza Immunization.
Furthermore, as shown in the following Table 47, we are not finalizing the following measures for the following reasons:
• Physician Quality Reporting System measure #94 titled “Otitis Media with Effusion (OME): Diagnostic Evaluation—Assessment of Tympanic Membrane Mobility”: this measure underwent NQF review, but did not receive endorsement from the NQF.
• Physician Quality Reporting System measure #153 titled “Chronic Kidney Disease (CKD): Referral for Arteriovenous (AV) Fistula”: this measure owner has removed this measure for purposes of quality reporting.
• Physician Quality Reporting System measure #202 titled “Ischemic Vascular Disease (IVD): Complete Lipid Profile” and Physician Quality Reporting System measure #203 titled “Ischemic Vascular Disease (IVD): Low Density Lipoprotein (LDL-C) Control”: these measures have been combined into a single measure titled “Ischemic Vascular Disease (IVD): Complete Lipid Profile and LDL Control < 100.” This combined measure was listed in Table 55 of the proposed rule. This new individual measure (see Table 47) titled “Ischemic Vascular Disease (IVD): Complete Lipid Profile and LDL Control < 100” will be available for claims and registry-based reporting.
Based on the comments received and for the reasons stated previously, we are finalizing all measures in Table 47 for claims and/or registry-based reporting in the 2012 Physician Quality Reporting System. We proposed (76 FR 42877) an Epilepsy measures group for inclusion in the 2012 Physician Quality Reporting System. As described in further detail later in this section, we are not finalizing the proposed Epilepsy measures group. However, we are still finalizing three of the measures from this measures group for reporting as individual measures. Table 47 lists a total of 240 individual measures available for claims and/or registry-based reporting under the 2012 Physician Quality Reporting System.
We note that the final measures available for claims and/or registry-based reporting listed in Table 47 that do not have NQF measure numbers (as indicated by “N/A”) are not currently endorsed by the NQF. These measures are awaiting review and endorsement by the NQF. Therefore, for these measures, for reasons previously explained, we are exercising our authority under section 1848(k)(2)(C)(i) of the Act to include these measures for reporting via the claims and/or registry-based reporting mechanisms.
The 2012 Physician Quality Reporting System individual measures for either claims-based reporting or registry-based reporting are listed in Table 47 by their Physician Quality Reporting System Measure Number (to the extent the measure is part of the 2011 Physician Quality Reporting System measure set) and Title, along with the name of the measure's developer/owner and NQF measure number, if applicable. The Physician Quality Reporting System Measure Number is a unique identifier assigned by CMS to all measures in the Physician Quality Reporting System measure set. Once a Physician Quality Reporting System Measure Number is assigned to a measure, it will not be used again to identify a different measure, even if the original measure to which the number was assigned is subsequently retired from the Physician Quality Reporting System measure set. A description of the measures listed in Table 47 can be found in the “2011 Physician Quality Reporting System Quality Measures List,” which is available on the Measures and Codes page of the Physician Quality Reporting System section of the CMS Web site at
For 2012, we proposed (76 FR 42871) to again accept Physician Quality Reporting System data from EHRs for a limited subset of 2012 Physician Quality Reporting System quality measures.
Section 1848(m)(7) of the Act (“Integration of Physician Quality Reporting and EHR Reporting”), as added by section 3002(d) of the Affordable Care Act, requires that by no later than January 1, 2012, the Secretary shall develop a plan to integrate reporting on quality measures under the Physician Quality Reporting System with reporting requirements under the EHR Incentive Program under section 1848(o) of the Act relating to the meaningful use of EHRs. Such integration shall consist of the following:
(A) The selection of measures, the reporting of which would both demonstrate—
(i) Meaningful use of an EHR for purposes of the Medicare EHR Incentive Program; and
(ii) Quality of care furnished to an individual; and
(B) Such other activities as specified by the Secretary.
To align the Physician Quality Reporting System with the Medicare EHR Incentive Program, we proposed (76 FR 42871) to include all clinical quality measures available for reporting under the Medicare EHR Incentive Program (75 FR 44398 through 44408) -in the 2012 Physician Quality Reporting System for purposes of reporting data on quality measures under the EHR-based reporting option. In 2011, we included 14 of the 44 EHR Incentive Program measures under the 2011 Physician Quality Reporting System EHR reporting mechanism. In order to better align Physician Quality Reporting System measures with those under the EHR Incentive Program, for 2012, we proposed to have the rest of the 44 clinical quality measures in the Medicare EHR Incentive Program available for EHR-based reporting under the 2012 Physician Quality Reporting System.
Furthermore, for 2012, we proposed to retain the following 6 additional measures that were available for reporting under the EHR-based reporting mechanism under the 2011 Physician Quality Reporting System:
• Measure # 39: Screening or Therapy for Osteoporosis for Women Aged 65 Years and Older.
• Measure # 47: Advance Care Plan.
• Measure # 48: Urinary Incontinence: Assessment of Presence or Absence of Urinary Incontinence in Women Aged 65 Years and Older.
• Measure # 124: Health Information Technology (HIT): Adoption/Use of Electronic Health Records (EHR).
• Measure # 173: Preventive Care and Screening: Unhealthy Alcohol Use—Screening.
• Measure # 238: Drugs to be Avoided in the Elderly.
We believe these measures meet the criteria listed previously for inclusion for reporting under the Physician Quality Reporting System.
We invited public comment on the proposed EHR-based individual quality measures available for reporting under the 2012 Physician Quality Reporting System. The following is a summary of the comments we received.
• Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-up
• Hypertension (HTN): Blood Pressure Measurement
• Measure pair: a. Tobacco Use Assessment, b. Tobacco Cessation Intervention
• Preventive Care and Screening: Influenza Immunization for Patients ≥ 50 Years Old
• Diabetes Mellitus: Low Density Lipoprotein (LDL-C) Control in Diabetes Mellitus
• Heart Failure: Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy for Left Ventricular Systolic Dysfunction (LVSD)
• Coronary Artery Disease (CAD): Oral Antiplatelet Therapy Prescribed for Patients with CAD
• Heart Failure: Warfarin Therapy for Patients with Atrial Fibrillation
• Ischemic Vascular Disease (IVD): Blood Pressure Management
• Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic
We proposed to include but are not finalizing the following measure for EHR-based reporting in the 2012 Physician Quality Reporting System, because we believe that use of electronic health records is already addressed in most of the measures we are finalizing:
• “Health Information Technology: Adoption/Use of Electronic Health Records”
Based on the comments received and for the reasons stated previously, we are finalizing the 70 measures identified in Table 48 for EHR-based reporting under the 2012 Physician Quality Reporting System. As we stated previously, the final 2012 Physician Quality Reporting System core measures are also listed in Table 48.
We proposed (76 FR 42873) to retain the following 14 2011 Physician Quality Reporting System measures groups for the 2012 Physician Quality Reporting System: (1) Diabetes Mellitus; (2) Adult Kidney Disease (formerly CKD); (3) Preventive Care; (4) CABG; (5) Rheumatoid Arthritis; (6) Perioperative Care; (7) Back Pain; (8) CAD; (9) Heart Failure; (10) IVD; (11) Hepatitis C; (12) HIV/AIDS; (13) CAP, and (14) Asthma. For 2012, we proposed that the CABG, CAD, Heart Failure, and HIV/AIDS measures groups would continue to be reportable through the registry-based reporting mechanism only, while the remaining Diabetes Mellitus, CKD, Preventive Care, Rheumatoid Arthritis, Perioperative Care, Back Pain, IVD, Hepatitis C, CAP, and Asthma measures groups would continue to be reportable through either claims-based reporting or registry-based reporting. We proposed to retain these measures groups for the 2012 Physician Quality Reporting System particularly because we believe the measures groups reflect the services furnished to beneficiaries by a particular specialty. We also believe that retaining these measures groups would provide consistency from program year to program year.
In addition to the 14 measures groups previously discussed, we proposed (76 FR 42873 through 42879) the following 10 new measures groups for 2012 to provide eligible professionals with more measures groups on which to report:
• Chronic Obstructive Pulmonary Disease (COPD).
• Inflammatory Bowel Disease.
• Sleep Apnea.
• Epilepsy.
• Dementia.
• Parkinson's.
• Elevated Blood Pressure.
• Radiology.
• Cardiovascular Prevention, which contains individual measures from the Physician Quality Reporting System core measure set previously discussed.
• Cataracts.
These are the measures groups that were presented to us by measure owners and developers for inclusion for reporting under the 2012 Physician Quality Reporting System. Section 1848(k)(2)(C)(ii) of the Act provides an exception to the requirement that measures be endorsed by the NQF. We may exercise this exception authority in a specified area or medical topic for which a feasible and practical measure has not been endorsed by NQF, so long as due consideration is given to measures that have been endorsed by the NQF. For the measures contained within these measures groups that are not currently NQF-endorsed, we proposed to exercise this authority due to our interest in all of the proposed 10 measures group's topics. We believe that each of these additional measures groups address gaps in the Physician Quality Reporting System measures groups and will also allow for greater reporting options for individual eligible professionals, thereby increasing participation in the Physician Quality Reporting System.
Finally, as in previous program years, for 2012, we proposed (76 FR 42873) that the measures included in any proposed 2012 measures group be reportable either as individual measures or as part of a measures group, except for the Back Pain measures group, which would continue to be reportable only as part of a measures group and not as individual measures in 2012.
As with measures group reporting in prior program years, we proposed that each eligible professional electing to report a group of measures for 2012 must report all measures in the group that are applicable to each patient or encounter to which the measures group applies at least up to the minimum number of patients required by the applicable reporting criteria.
We invited public comment on our proposed retention of all 2011 Physician Quality Reporting System measures groups, as well as our newly proposed measures groups for the 2012 Physician Quality Reporting System. The following is a summary of the comments received that were related to the proposed 2012 Physician Quality Reporting System measures groups.
Furthermore, we note that, although we are finalizing the Parkinson's measures group, we are not finalizing the following measure contained within this measures group because the measure was reviewed by NQF but not endorsed: Parkinson's Disease Medical and Surgical Treatment Options.
Although we are finalizing the Elevated Blood Pressure measures group, we are not finalizing the following measures contained within this measures group because, because these measures differ from other Physician Quality Reporting System measures in that they are survey-based; therefore, it is not operationally feasible for us to analyze data collected under these measures:
• Overall Hypertension Care Satisfaction
• Patient Self-care Support
Based on the comments received and for the reasons stated in our responses, we are finalizing the measures groups that are identified in Tables 50 through 71. As we explained previously, we are finalizing all proposed 2012 Physician Quality Reporting System measures groups, except for the Epilepsy and Radiology measures groups.
We also note that, although we are finalizing these measures groups, we have made the following changes to these final 2012 Physician Quality Reporting System measures groups:
• Adult Kidney Disease measures group: As indicated in Table 50, we are not finalizing Physician Quality Reporting System #153 titled “Chronic Kidney Disease (CKD): Referral for Arteriovenous (AV) Fistula” for reporting in this measures group because, as we stated previously, the measure owner has removed this measure for reporting in 2012. Instead, we are adding Physician Quality Reporting System measure #110 titled “Preventive Care and Screening: Influenza Immunization” for reporting within the Adult Kidney Disease measures group.
• IVD measures group: As indicated in Table 58, we are not finalizing Physician Quality Reporting System measures #202 titled “Ischemic Vascular Disease (IVD): Complete Lipid Profile” and #203 titled “Ischemic Vascular Disease (IVD): Low Density Lipoprotein (LDL-C)” for reporting in the IVD measures group. As stated previously, these two measures have been combined into a single measure titled “Ischemic Vascular Disease (IVD): Complete Lipid Profile and LDL Control < 100.” Therefore, instead of reporting measures #202 and #203, we are requiring that eligible professionals report on this new measure in the IVD measures group.
• IBD Measures Group: As indicated in Table 64, we are updating measure title “Inflammatory Bowel Disease (IBD): Assessment of Inflammatory Bowel Disease Activity and Severity” to “Inflammatory Bowel Disease: Type Anatomic Location and Activity All Documented” as the measure owner has updated the title of this measure.
• Parkinson's Measures Group: As indicated in Table 67, we are not finalizing the measure titled “Parkinson's Disease Related Safety Issues Counseling” for reporting within the Parkinson's measures group.
• Elevated Blood Pressure: As indicated in Table 68, we are not finalizing the measures titled “Overall Hypertension Care Satisfaction” and “Patient Self-care Support” for reporting within this measures group.
Some measures in the 2012 measures groups are also 2011 individual Physician Quality Reporting System measures. Specifically, measures contained in the following measures groups will be available for reporting as individual measures: Diabetes Mellitus; Adult Kidney Disease; Preventive Care; CABG; Rheumatoid Arthritis; Perioperative Care; CAD; Heart Failure; IVD; Hepatitis C; HIV/AIDS; CAP, and Asthma.
The title of each such measure is preceded with its Physician Quality Reporting System Measure Number in Tables 50 through 71. As stated previously, the Physician Quality Reporting System Measure Number is a unique identifier assigned by us to all measures in the Physician Quality Reporting System measure set. Once a Physician Quality Reporting System Measure Number is assigned to a measure, it will not be used again, even if the measure is subsequently retired from the Physician Quality Reporting System measure set. Measures that are not preceded by a number (in other words, those preceded by “TBD”) in Tables 50 through 71 were never part of a Physician Quality Reporting System measure set prior to 2012. A number will be assigned to such measures for 2012. Furthermore, please note that, in some instances, the measure titles have been updated to reflect measure title updates by the respective measure owners.
As with measures group reporting in prior years of the Physician Quality Reporting System, each eligible professional electing to report a group of measures for 2012 must report all measures in the group that are applicable to each patient or encounter to which the measures group applies at least up to the minimum number of patients required by the applicable reporting criteria. We note that the specifications for measures groups do not necessarily contain all the specification elements of each individual measure making up the measures group. This is based on the need for a common set of denominator specifications for all the measures making up a measures group in order to define the applicability of the measures group. Therefore, the specifications and instructions for measures groups will be provided separately from the specifications and instructions for the individual 2012 Physician Quality Reporting System measures. We will post the detailed specifications and specific instructions for reporting measures groups on the Physician Quality Reporting System section of the CMS Web site at
Additionally, the detailed measure specifications and instructions for submitting data on these 2012 measures groups that were also included as 2011 Physician Quality Reporting System measures groups may be updated or modified by the measure developer prior to 2012. Therefore, the 2012 Physician Quality Reporting System measure specifications for any given measures group could be different from specifications and submission instructions for the same measures group used for 2011. For example, the measure developer may change the codes contained in the measure's denominator. These measure specification changes do not materially impact the intended meaning of the measures or the strength of the measures.
For 2012, we proposed (76 FR 42879) that group practices selected to participate in the 2012 Physician Quality Reporting System GPRO would be required to report on 41 proposed measures listed in Table 55 of the proposed rule. Specifically, for the 2012 Physician Quality Reporting System, we proposed to retain most of the measures available for reporting under the 2011 Physician Quality Reporting System GPRO because of our continued interest in the reporting of those measures, as well as to maintain program consistency from year to year. However, for 2012, we proposed to retire the following measures that were required under the 2010 and 2011 GPRO (that is, GPRO I for 2011):
• Diabetes Mellitus: Hemoglobin A1c Testing.
• Diabetes Mellitus: Lipid Profile
• Hypertension (HTN): Blood Pressure Measurement.
Furthermore, we proposed to add the following Physician Quality core measures that were not available for reporting via the GPRO for the 2011 Physician Quality Reporting System:
• Ischemic Vascular Disease (IVD): Use of Aspirin or another Antithrombotic.
• Measure pair: a. Tobacco Use Assessment, b. Tobacco Cessation Intervention.
• Ischemic Vascular Disease (IVD): Complete Lipid Profile and LDL Control < 100
• Proportion of adults 18 years and older who have had their blood pressure measured within the preceding 2-years.
In addition to adding the Physician Quality Reporting System core measures that were not available for reporting under the GPRO for the 2011 Physician Quality Reporting System, we proposed to add the following measures for reporting under the 2012 Physician Quality Reporting System GPRO:
• Chronic Obstructive Pulmonary Disease (COPD): Bronchodilator Therapy.
• Adult Weight Screening and Follow-up.
• Ischemic Vascular Disease (IVD): Blood Pressure Management Control.
• Chronic Obstructive Pulmonary Disease (COPD): Spirometry Evaluation.
• 30 Day Post Discharge Physician Visit.
• Medication Reconciliation: Reconciliation After Discharge from an Inpatient Facility.
• Diabetes: Aspirin Use.
• Falls: Screening for Fall Risk.
• Osteoporosis: Management Following Fracture of Hip, Spine or Distal Radius for Men and Women Aged 50 Years and Older.
• Diabetes Mellitus: Tobacco Non Use.
• Coronary Artery Disease (CAD): LDL-level < 100 mg/dl.
• Diabetes Mellitus: Hemoglobin A1c Poor Control in Diabetes Mellitus (less than 8 percent).
• Chronic Obstructive Pulmonary Disease (COPD): Smoking Cessation Counseling Received.
• Monthly International Normalized Ratio (INR) for Beneficiaries on Warfarin.
We proposed (76 FR 42879) these new measures because they are NQF-endorsed measures that are consistent with other CMS quality reporting initiatives. We believe it is in the stakeholders' interest to align measures in different initiatives. We proposed that group practices selected to participate in the Physician Quality Reporting System GPRO would be required to report on all measures listed in Table 55.
We invited public comment on the proposed 2012 Physician Quality Reporting System measures for group practices selected to participate in the 2012 Physician Quality Reporting System GPRO. The following is a summary of the comments we received.
• Diabetes Mellitus: Hemoglobin A1c Testing;
• Diabetes Mellitus: Lipid Profile; and
• Hypertension (HTN): Blood Pressure Measurement.
• Measure pair: a. Tobacco Use Assessment, b. Tobacco Cessation Intervention.
• Ischemic Vascular Disease (IVD): Blood Pressure Management Control.
• Adult Weigh Screening and Follow-up.
• Medication Reconciliation: Reconciliation After Discharge from an Inpatient Facility.
• Diabetes: Aspirin Use.
• Diabetes Mellitus: Tobacco Non-Use.
• Coronary Artery Disease (CAD): LDL-level < 100 mg/dl.
• Diabetes Mellitus: Hemoglobin A1c Poor Control in Diabetes Mellitus (<8%).
• Monthly INR for Beneficiaries on Warfarin.
• Diabetes Mellitus: Dilated Eye Exam in Diabetic Patient.
• Coronary Artery Disease (CAD): Beta-Blocker Therapy for CAD Patients with Prior Myocardial Infarction (MI).
• Ischemic Vascular Disease (IVD): Blood Pressure Management.
• Ischemic Vascular Disease (IVD): Blood Pressure Management Control.
• Coronary Artery Disease (CAD): LDL-level < 100 mg/dl.
• Coronary Artery Disease (CAD): Beta-Blocker Therapy for CAD Patients with Prior Myocardial Infarction (MI).
We are not retaining these measures because we seek to align the Physician Quality Reporting System GPRO with the Medicare Shared Savings Program. These measures were not included for reporting under the Medicare Shared Savings Program (“Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations” displayed in the October 20, 2011
Also due to our desire to align the measures available for reporting under the 2012 Physician Quality Reporting System GPRO with the measures available for reporting under the Medicare Shared Savings Program, we are not finalizing the following measures in the 2012 Physician Quality Reporting System GPRO measure set:
• Diabetes Mellitus: Urine Screening for Microalbumin for Medical Attention for Nephropathy in Diabetic Patients.
• Heart Failure: Weight Measurement.
• Heart Failure: Patient Education.
• Hypertension (HTN): Plan of Care.
• Chronic Obstructive Pulmonary Disease (COPD): Spirometry Evaluation.
• Ischemic Vascular Disease (IVD): Use of Aspirin of another Antithrombotic.
• 30-Day Post Discharge Physician Visit.
• Osteoporosis: Management Following Fracture of Hip, Spine or Distal Radius for Men and Women Aged 50 Years and Older.
• Coronary Artery Disease (CAD): LDL-level < 100 mg/dl.
• Chronic Obstructive Pulmonary Disease (COPD): Smoking Cessation Counseling Received.
We believe our effort to align various CMS programs will encourage participation in the Physician Quality Reporting System. Since increasing participation in the Physician Quality Reporting System is a top priority, we believe our desire to align various CMS programs outweighs our interest in maintaining measures that were previously available for reporting under the Physician Quality Reporting System. We further believe that the measures that we finalize for reporting under the 2012 Physician Quality Reporting System GPRO, as identified in Table 71, sufficiently address the conditions and care measured by the measures we are not finalizing.
Based on the comments received and for the reasons stated previously, we are finalizing the 29 measures for physician groups participating in the 2012 Physician Quality Reporting System GPRO listed in Table 71. Table 71 also indicates which measures are also available for reporting under the Medicare Shared Savings Program.
We also note that, in an effort to align the 2012 Physician Quality Reporting System GPRO measures with the measures available for group reporting under the Medicare Shared Savings Program, we are not finalizing the following measures for the 2012 Physician Quality Reporting System GPRO:
• Coronary Artery Disease (CAD): Beta-Blocker Therapy for CAD Patients with Prior Myocardial Infarction (MI)
• Diabetes Mellitus: Urine Screening for Microalbumin or Medical Attention for Nephropathy in Diabetic Patients
• Heart Failure: Weight Measurement
• Hypertension (HTN): Plan of Care
• Ischemic Vascular Disease (IVD): Blood Pressure Management Control
• Chronic Obstructive Pulmonary Disease (COPD): Spirometry Evaluation
• 30-Day Post Discharge Physician Visit
• Osteoperosis: Management Following Fracture of Hip, Spine or Distal Radius for Men and Women Aged 50 Years and Older
• Coronary Artery Disease (CAD): LDL-level < 100 mg/dl
• Chronic Obstructive Pulmonary Disease (COPD): Smoking Cessation Counseling Received
• Heart Failure: Warfarin Therapy for Patients with Atrial Fibrillation
We are also not finalizing the measure titled “Monthly INR for Beneficiaries on Warfarin” because, as we stated with Physician Quality Reporting System measure #200, the use of Warfarin to treat heart disease is no longer consistent with clinical guidelines.
We intend to provide a separate measures specifications document and other supporting documents for group practices participating in the 2012 Physician Quality Reporting System GPRO. We anticipate that the group practice measures specifications document will be available by November 15, 2011 or shortly thereafter on the Physician Quality Reporting System section of the CMS Web site at
Section 1848(k)(4) of the Act requires the Secretary to address a mechanism whereby an eligible professional may provide data on quality measures through a maintenance of certification program (Maintenance of Certification Program) operated by a specialty body of the American Board of Medical Specialties (ABMS). In addition, section 1848(m)(7) of the Act (“Additional Incentive Payment”) authorizes an additional 0.5 percent incentive payment for years 2011 through 2014 if certain requirements are met. In accordance with section 1848(m)(7)(B) of the Act governing the “Additional Incentive Payment,” in order to qualify for the additional incentive payment, an eligible professional must—
• Satisfactorily submit data on quality measures under the Physician Quality Reporting System for a year and have such data submitted—
++ On their behalf through a Maintenance of Certification Program that meets the criteria for a registry under the Physician Quality Reporting System; or
++ In an alternative form and manner determined appropriate by the Secretary; and
++ More frequently than is required to qualify for or maintain board certification status:
++ Participate in such a Maintenance of Certification Program for a year; and
++ Successfully completes a qualified Maintenance of Certification Program practice assessment for such year.
Section 1848(m)(7)(C)(i) of the Act defines “Maintenance of Certification Program” as a continuous assessment program, such as a qualified ABMS Maintenance of Certification Program, or an equivalent program (as determined by the Secretary), that advances quality and the lifelong learning and self-assessment of board certified specialty physicians by focusing on the competencies of patient care, medical knowledge, practice-based learning,
• Maintain a valid, unrestricted medical license in the United States.
• Participate in educational and self-assessment programs that require an assessment of what was learned.
• Demonstrate, through a formalized, secure examination, that the physician has the fundamental diagnostic skills, medical knowledge, and clinical judgment to provide quality care in their respective specialty.
• Successful completion of a qualified Maintenance of Certification Program practice assessment.
As defined in section 1848(m)(7)(C)(ii) of the Act, a “qualified Maintenance of Certification Program practice assessment” means an assessment of a physician's practice that—
• Includes an initial assessment of an eligible professional's practice that is designed to demonstrate the physician's use of evidence-based medicine;
• Includes a survey of patient experience with care; and
• Requires a physician to implement a quality improvement intervention to address a practice weakness identified in the initial assessment and then to remeasure to assess performance after such intervention.
To qualify for the additional incentive payment, section 1848(m)(7)(B)(iii) of the Act also requires the Maintenance of Certification Program to submit to CMS, on behalf of the eligible professional, information:
• In a form and manner specified by the Secretary, that the eligible professional more frequently than is required to qualify for or maintain board certification status, participates in the Maintenance of Certification Program for a year and successfully completes a qualified Maintenance of Certification Program practice assessment for such year;
• Upon request by the Secretary, information on the survey of patient experience with care; and
• As the Secretary may require, on the methods, measures, and data used under the Maintenance of Certification Program and the qualified Maintenance of Certification Program practice assessment.
In order to qualify for the additional 0.5 percent incentive payment in 2011, eligible professionals were required to participate more frequently in each of the following four parts of the Maintenance of Certification Program:
• Maintain a valid unrestricted license in the United States. For 2011, physicians simply needed to maintain a valid unrestricted license in the United States to meet the requirement for “more frequent” participation with respect to this part (75 FR 73541 through 73546).
• Participate in educational and self-assessment programs that require an assessment of what was learned.
• Demonstrate, through a formalized secure examination, that the physician has the fundamental diagnostic skills, medical knowledge, and clinical judgment to provide quality care in their respective specialty.
• Successfully complete a qualified maintenance of certification program practice assessment.
We received requests from the American Board of Medical Specialties, as well as various specialty organizations, to revise the criteria for satisfying the Maintenance of Certification Program additional incentive, because these entities believe that more frequent participation in all four parts of the Maintenance of Certification Program is too narrow. In the proposed rule, we noted that we further considered the language under section 1848(m)(7)(B)(ii)(I) of the Act and we believe it can be interpreted more broadly. In particular, we noted that the requirement that a professional “more frequently than is required to qualify for or maintain board certification status participates in such a Maintenance of Certification Program” could refer to the program as a whole, such that any element performed more frequently than is required satisfies the general requirement. The nature of the various components of the Maintenance of Certification Program also suggest that it is not necessary that each of the four elements of the program be performed more frequently. We previously stated we believe that the “more frequently” requirement does not apply to the first part, which states that a physician maintain a valid unrestricted license, as there is no way a physician may maintain a valid unrestricted license “more frequently.” As such, we believe that the more frequently requirement could be satisfied based on any of the other elements of the program (that is, educational and self-assessment program; secure examination; or practice assessment). Specifically, we believe that if a professional more frequently than is required satisfies one or more of those parts of a program, the more frequently requirement would be met. Accordingly, we proposed (76 FR 42881-42882) that in order to earn an additional 0.5 percent incentive for 2012 through 2014, for each respective year, an eligible professional must participate more frequently than is required in at least one of the following three parts of the Maintenance of Certification Program, as well as “more frequent” participation in the practice assessment component. With respect to how to assess whether a professional completes one of the elements of a program “more frequently,” we believe that this would be tied to the specific requirements of Board certification for the professional. Given that different specialties have different certification requirements (physician examination requirements to maintain Board certification varies widely depending on specialty), we do not believe it is appropriate to impose a uniform requirement for all professionals and therefore, we believe that the board could determine for a particular program element the more frequent requirement for the professional. However, we believe that a minimum threshold would need to be met such that the professional would have to do something more frequently or more than what is ordinarily required for a particular part of the program, as well as “more frequent” participation in the practice assessment component.
Therefore, in order to earn an additional 0.5 percent incentive for 2012 through 2014, an eligible professional would be required to participate more frequently than is required in at least one of the following three parts of the Maintenance of Certification Program, as well as “more frequent” successful completion of a qualified maintenance of certification program practice assessment:
• Maintain a valid unrestricted license in the United States. For 2011, physicians simply needed to maintain a valid unrestricted license in the United States to meet the requirement for “more frequent” participation with respect to this part (75 FR 73541 through 73546).
• Participate in educational and self-assessment programs that require an assessment of what was learned.
• Demonstrate, through a formalized secure examination, that the physician has the fundamental diagnostic skills, medical knowledge, and clinical judgment to provide quality care in their respective specialty.
Therefore, we proposed for 2012, 2013, and 2014 the following for each year (76 FR 42882 and 42883):
• An eligible professional wishing to be eligible for the additional Physician Quality Reporting System incentive payment of 0.5 percent must meet the requirements for satisfactory reporting for the Physician Quality Reporting
• For purposes of satisfactory reporting under the Physician Quality Reporting System, we proposed (76 FR 42882) that the eligible professional may participate as an individual eligible professional using either individual Physician Quality Reporting System measures or measures groups and submitting the Physician Quality Reporting System data via claims, a registry, or an EHR or participate under the GPRO option. As an alternative to this reporting option, we proposed that eligible professionals may satisfactorily report under the Physician Quality Reporting System based on submission of Physician Quality Reporting System data by a Maintenance of Certification Program, provided that the Maintenance of Certification Program has qualified as a Physician Quality Reporting System registry for 2012. As indicated previously, an eligible professional would not necessarily have to qualify for the Physician Quality Reporting System through a Maintenance of Certification Program serving as a registry. Rather, we proposed that an eligible professional may qualify for the additional incentive, without regard to the method by which the eligible professional has met the basic requirement of satisfactory reporting under the Physician Quality Reporting System. We received no comments regarding our proposal to allow eligible professionals to qualify for the additional incentive without regard to the method by which the eligible professional has met the basic requirement of satisfactory reporting under the Physician Quality Reporting System and are therefore, we are finalizing this proposal.
• In addition to meeting the requirements for satisfactory reporting for the Physician Quality Reporting System for a program year, the eligible professional must have data with respect to the eligible professional's participation in a Maintenance of Certification Program submitted on his or her behalf by a qualified medical specialty board or other entity sponsoring a Maintenance of Certification Program. For each eligible professional that wishes to qualify for the Maintenance of Certification Program Incentive, the qualified medical specialty board or other entity sponsoring a Maintenance of Certification Program must submit data to CMS with respect to the following:
• An eligible professional must, more frequently than is required to qualify for or maintain board certification, participate in a Maintenance of Certification Program for a year and successfully complete a qualified Maintenance of Certification Program practice assessment for such year. With regard to the “more frequently” requirement as it applies to the elements of a Maintenance of Certification Program itself (other than completing a qualified Maintenance of Certification Program practice assessment), the Maintenance of Certification Program must certify that the eligible professional has “more frequently” than is required to qualify for or maintain board certification “participated in a Maintenance of Certification Program for a year”. The Maintenance of Certification Program will determine what a physician must do to more frequently participate in a Maintenance of Certification Program and so certify that the eligible professional has met this requirement. While we do not believe that the “more frequently” requirement is applicable to the licensure requirement, given that one cannot be licensed “more frequently” than is required, the Maintenance of Certification Program has the discretion to determine which element(s) of a Maintenance of Certification Program must be completed more frequently. We believe that making this change will reduce burden on physicians and will increase participation while being consistent with the requirement to “more frequently” participate in a Maintenance of Certification Program.
• With respect to the Maintenance of Certification Program practice assessment, which is specifically delineated in section 1848(m)(7)(B)(ii) of the Act as being required more often than is necessary to qualify for or maintain board certification, we believe we need to be more specific regarding our interpretation of the phrase “more frequently.” Additionally, we are aware that some specialty boards have varying Maintenance of Certification Program requirements for physicians to maintain board certification, based on the date of original certification. Some, we believe, may not be required to participate in a Maintenance of Certification Program at all in order to maintain board certification. Accordingly, we recognize that “more often” may vary among physicians certified by the same specialty board. We interpret the statutory provisions as requiring participation in and successful completion of at least one Maintenance of Certification Program practice assessment per year. Therefore, as a basic requirement, the physician must participate and successfully complete at least one Maintenance of Certification Program practice assessment for each year the physician participates in the Maintenance of Certification Program Incentive, regardless of whether or how often the physician is required to participate in a Maintenance of Certification Program to maintain board certification.
We are also aware that ABMS boards are at various stages in implementing the practice assessment modules, and some may not have such assessment modules in place. However, inasmuch as we interpret the statute to require a Maintenance of Certification Program practice assessment at least once per program year as part of the Maintenance of Certification Program, eligible professionals who do not have available, through their boards or otherwise, a Maintenance of Certification Program practice assessment are not eligible for the 0.5 percent incentive.
We believe that the experience of care survey provides particularly valuable information and proposed that a qualified Maintenance of Certification Program practice assessment must include a survey of patient experience with care. The Secretary may request information on the survey of patient experience with care, under section 1848(m)(7)(B)(iii) of the Act. In view of the importance of this information, and the lack of readily available alternative sources, we proposed to require that Maintenance of Certification Programs submit information about the patient experience of care survey(s) used by physicians to fulfill the Maintenance of Certification Program practice assessment. We are not, at this time, requesting the results of the survey for the eligible professionals for whom information is being submitted by the Maintenance of Certification Program. We may, however, request such information for appropriate validation purposes and may propose to request such data for future years of the Maintenance of Certification Program Incentive.
Some Maintenance of Certification Programs underwent a self-nomination process in 2011 to enable their members to be eligible for this Physician Quality Reporting System Maintenance of Certification Program Incentive for 2011 Physician Quality Reporting System. We proposed (76 FR 42883) that a Maintenance of Certification Program that was approved after undergoing the self-nomination process in 2011 must submit a self-nomination statement for
For Maintenance of Certification Programs new for 2012, we proposed (76 FR 42883) that Maintenance of Certification Programs wishing to enable their diplomates to be eligible for an additional Physician Quality Reporting System incentive payment for the 2012 Physician Quality Reporting System would need to go through a self-nomination process by January 31, 2012. We proposed that the board must include all of the following information in their self-nomination statement to us:
• Provide detailed information regarding the Maintenance of Certification Program with reference to the statutory requirements for such program;
• Indicate the organization sponsoring the Maintenance of Certification Program, and whether the Maintenance of Certification Program is sponsored by an ABMS board. If not an ABMS board, indicate whether and how the program is substantially equivalent to the ABMS Maintenance of Certification Program process;
• Indicate that the program is in existence as of January 1, 2012;
• Indicate that the program has at least 1 active participant;
• The frequency of a cycle of Maintenance of Certification Program for the specific Maintenance of Certification Program of the sponsoring organization; including what constitutes “more frequently” for the Maintenance of Certification Program itself and for the practice assessment for the specific Maintenance of Certification Program of the sponsoring organization;
• Confirmation from the board that the practice assessment will occur and be completed in the year the physician is participating in the Maintenance of Certification Program Incentive;
• What was, is, or will be the first year of availability of the Maintenance of Certification Program practice assessment for completion by an eligible professional;
• What data is collected under the patient experience of care survey and how this information would be provided to CMS;
• Describe how the Maintenance of Certification Program monitors that an eligible professional has implemented a quality improvement process for their practice; and
• Describe the methods, and data used under the Maintenance of Certification Program, and provide a list of all measures used in the Maintenance of Certification Program for 2011 and to be used for 2012, including the title and descriptions of each measure, the owner of the measure, whether the measure is NQF endorsed, and a link to a Web site containing the detailed specifications of the measures, or an electronic file containing the detailed specifications of the measures.
We proposed (76 FR 42883) that sponsoring organizations who desire to participate as a Maintenance of Certification Program must provide CMS the following information below in a CMS-specified file format by no later than the end of the first quarter of 2012:.
• The name, NPI and applicable TIN(s) of the eligible professional who would like to participate in this process;
• Attestation from the board that the information provided to CMS is accurate and complete.
• The board has signed documentation from the eligible professional that the eligible professional wishes to have the information released to us;
• Information from the patient experience of care survey;
• Information certifying that the eligible professional has participated in a Maintenance of Certification Program for a year, more frequently than is required to qualify for or maintain board certification status, including the year that the physician met the board certification requirements for the Maintenance of Certification Program, and the year the eligible professional participated in a Maintenance of Certification Program “more frequently” than is required to maintain or qualify for board certification; and
• Information certifying that the eligible professional has completed the Maintenance of Certification Program practice assessment at least one time each year the eligible professional participates in the Maintenance of Certification Program Incentive.
We proposed (76 FR 42883) that specialty boards that also desire to send Physician Quality Reporting System information to us on behalf of eligible professionals must meet the requirements for registry data submission and should follow the directions for self-nomination to become a qualified registry. Boards may also participate as registries for Physician Quality Reporting System data provided that they meet the registry requirements. As an alternative to requiring boards to either operate a qualified Physician Quality Reporting System registry or to self-nominate to submit Maintenance of Certification Program data to us on behalf of their members, we proposed to continue to allow the various boards to submit the Maintenance of Certification Program data to the ABMS and having ABMS submit the information on behalf of the various boards and their member eligible professionals to CMS. We received no comments on our proposed requirements for specialty boards that wish to send Physician Quality Reporting System information to us on behalf of eligible professionals and therefore, we are finalizing these requirements.
To the extent an eligible professional participates in multiple Maintenance of Certification Programs and meets the requirements under section 1848(m)(7) of the Act (Additional Incentive Payment) under multiple programs, we note that the eligible professional can qualify for only one additional 0.5 percent incentive per year.
We invited public comment on the requirements we proposed for earning a 0.5 percent incentive for participation in the Maintenance of Certification Program incentive. The following is a summary of the comments we received related to the Maintenance of Certification Program incentive.
After considering the comments and for the reasons stated previously, we are finalizing our proposals regarding the Maintenance of Certification Program incentive. We are also finalizing the requirements for the 2013 and 2014 Maintenance of Certification Program additional incentive. With respect to dates specific to the Maintenance of Certification Program additional incentive, we are finalizing dates that correspond to the additional incentive year. Specifically, new Maintenance of Certification that wish to enable their diplomats to be eligible for the additional Physician Quality Reporting System 0.5 percent for 2013 and/or 2014 must go through the same nomination process by January 31, 2013 and January 31, 2014, respectively.
In addition, with respect to its self-nomination statement, a Maintenance of Certification Program wishing to enable its diplomats to earn a 2013 and 2014 Maintenance of Certification Program additional incentive must indicate that the program is in existence as of January 1, 2012 for the 2012 additional incentive, January 1, 2013 for the 2013 additional incentive, and January 1, 2014 for the 2014 additional incentive. With respect to the information required in the self-nomination statement, sponsoring organizations that desire to participate as a Maintenance of Certification Program must provide this information to CMS in a CMS-specified file format by no later than the end of the first quarter of 2013 and 2014 for the 2014 and 2014 Maintenance of Certification additional incentive.
Section 1848(m)(5)(H) of the Act requires the Secretary to provide timely feedback to eligible professionals on the performance of the eligible professional with respect to satisfactorily submitting data on quality measures. Since the inception of the program in 2007, the Physician Quality Reporting System has provided eligible professionals who have reported Physician Quality Reporting System data on quality measures feedback reports at the TIN/NPI level detailing participation in the Physician Quality Reporting System, including reporting rate and performance rate information. For 2008, we improved the format and content of feedback reports based on stakeholder input. We also developed an alternate report distribution method whereby each eligible professional can directly request and receive a feedback report. Starting in 2011, we provided an opportunity for eligible professionals to request their NPI-level feedback reports via the Communication Support Page at
In accordance with Section 1848(m)(5)(H) of the Act, we will continue to provide feedback reports to individuals and group practices that attempt to report on at least one Physician Quality Reporting System quality measure. We proposed (76 FR 42884) to provide feedback reports for 2012 and beyond, on or about the time of issuance of the incentive payments, consistent with our current practice.
We received the following comment regarding this proposal.
For the reasons stated previously, for 2012 and beyond, we are finalizing our proposal to provide feedback reports to individuals and group practices that attempt to report on at least one Physician Quality Reporting System quality measure on or about the time of issuance of the incentive payments.
In addition, we believe it would be beneficial for eligible professionals to also receive interim feedback reports. Therefore, we proposed (76 FR 42884) to provide interim feedback reports, which would be simplified versions of the feedback reports we currently provide, to eligible professionals reporting individual measures and measures groups through the claims-based reporting mechanism for 2012 and beyond, and issue them in the summer of the respective program year. We believe interim feedback reports would be particularly valuable to eligible professionals reporting measures groups, because it would let an eligible professional know how many more cases he or she needs to report to satisfy the criteria for satisfactory reporting for claims-based reporting of measures groups.
We invited public comment on our proposal to provide interim feedback reports related to reporting via the claims-based reporting mechanism for 2012 and beyond. The following is a summary of comments we received.
After considering the issues raised in the comments we received and for the reasons stated previously, we are finalizing our proposal to provide interim feedback reports for eligible professionals reporting individual measures and measures groups through the claims-based reporting mechanism for 2012 and beyond. These reports will be a simplified version of annual feedback reports that we currently provide for such eligible professionals and will be based on claims for dates of service occurring on or after January 1 and processed by March 31 of the respective program year (that is, January 1, 2012 and processed by March 31, 2012 for the 2012 program year). We expect that we would be able to make these interim feedback reports available to eligible professionals in the summer of the respective program year (that is, summer 2012 for the 2012 program year).
Under 42 CFR 414.90(i), eligible professionals or group practices may seek an informal review of the determination that the eligible professional or group practice did not satisfactorily submit data on quality measures under the Physician Quality Reporting System.
To maintain program consistency until we have further experience with the informal review process that we implemented for the 2011 Physician Quality Reporting System, we proposed (76 FR 42884) to largely retain the same informal review process that was finalized in the 2011 MPFS final rule with comment period (75 FR 73549 through 73551) for 2012 and beyond. Specifically, we proposed to base the informal process on our current inquiry process whereby an eligible professional can contact the Quality Net Help Desk (Help Desk) (via phone or email) for general Physician Quality Reporting System and eRx Incentive Program information, information on Physician Quality Reporting System feedback report availability and access, and/or information on Physician Quality Reporting System Portal password issues.
For purposes of the informal process required under section 1848(m)(5)(E) of the Act, we proposed the following inquiry process:
• An eligible professional electing to utilize the informal process must request an informal review within 90 days of the release of his or her feedback report, irrespective of when an eligible professional actually accesses his/her feedback report.
• An eligible professional may request an informal review through use of a web-based tool, if technically feasible. We believe use of the web-based tool will provide a more efficient way to record informal review requests, as the web-based tool will guide the eligible professional through the creation of an informal review requests. For example, the web-based tool will prompt an eligible professional of any necessary information s/he must provide. If not technically feasible, we proposed that an eligible professional may request the informal review by notifying the Quality Net Help Desk via email at
• We further proposed (76 FR 42884) that CMS would provide the eligible professional with a response to his or her request for an informal review within 90 days of receiving the original request. In 2011, we proposed to provide the eligible professional with a response to his or her request for an informal review within 60 days of receiving the original request. However, we anticipate that the volume of informal review requests will grow as participation in the Physician Quality Reporting System grows, particularly as we move towards the implementation of the 2015 payment adjustment. Furthermore, we believe that the time it takes for CMS to calculate data on Physician Quality Reporting System quality measures will be greater than in 2011, since we are proposing additional individual measures and measures groups. For these reasons, we proposed to amend 42 CFR 414.90(i)(2) to indicate that CMS will provide a written response within 90 days of the receipt of the original request for an informal review.
• As this process is informal and the statute does not require a formal appeals process, we will not include a hearing or evidence submission process, although the eligible professional may submit information to assist in the review.
• Based on our informal review, we will provide a written response. Where we find that the eligible professional did satisfactorily report, we proposed to provide the applicable incentive payment.
• Given that this is an informal review process and given the limitations on review under section 1848(m)(5)(E) of the Act, decisions based on the informal review will be final, and there will be no further review or appeal.
We invited public comment on the proposed informal review process for 2012 and beyond. The following is a summary of the comments regarding the informal review process.
Based on the comments received and for the reasons stated previously, for 2012 and beyond, we are finalizing the Physician Quality Reporting System informal review process, as proposed. Eligible professionals wishing to submit a request for an informal review are required to do so via a web-based tool, the Communication Support Page. Information on the Communication Support Page, including the link to the Page, will be available at
Beginning in 2015, a payment adjustment will apply under the Physician Quality Reporting System. Specifically, under section 1848(a)(8) of the Act, as added by section 3002(b) of the Affordable Care Act, with respect to covered professional services furnished by an eligible professional during 2015 or any subsequent year, if the eligible professional does not satisfactorily submit data on quality measures for covered professional services for the quality reporting period for the year, the fee schedule amount for services furnished by such professionals during the year shall be equal to the applicable percent of the fee schedule amount that would otherwise apply to such services. The applicable percent is—
• 98.5 percent for 2015; and
• 98.0 percent for 2016 and each subsequent year.
Under section 1848(a)(8)(C)(iii) of the Act provides that, for purposes of the payment adjustment, the “quality reporting period” with the respect to a year, is a period specified by the Secretary. In order to maintain consistency and program continuity, similar to the 12-month reporting period we are proposed for 2012, we proposed a 12-month reporting period for the 2015 payment adjustment. Specifically, in the proposed rule, we proposed (76 FR 42884-42885) that the reporting period for purposes of the 2015 payment adjustment would be the 2013 calendar year, that is, January 1, 2013 through December 31, 2013.
Section 1848(a)(8) of the Act requires that a payment adjustment be applied to covered professional services furnished by an eligible professional in in the particular payment adjustment year. Therefore, using 2015 as an example, we believe it is necessary to reduce the PFS amount concurrently for PFS allowed charges for covered professional services furnished in 2015. If we do not reduce the PFS amount concurrently with claims submissions in 2015, we would need to potentially recoup or provide added payments after the determination is made about whether the payment adjustment applies, or alternatively, hold claims until such a determination is made. In addition, we note that if such retroactive adjustments were made it may require a reconciliation of beneficiary co-payments. As a result, we need to determine whether eligible professionals have satisfactorily reported under the Physician Quality Reporting System based on a reporting period that occurs prior to 2015.
As for the suggestion that we use CY 2014 as the reporting period, we do not believe this would allow sufficient time for eligible professionals to report the Physician Quality reporting System measures, or allow us enough time to collect and analyze the data submitted by eligible professionals in order to avoid retroactive adjustments to payments in 2015, because we will not receive this data until months after the reporting period. Once we have completed our analysis, we also need time to make the necessary system changes to begin applying the payment adjustments to the appropriate individuals. All of this must occur prior to January 1, 2015, and so using a CY 2014 reporting period would not be feasible. We believe that the reporting period we proposed will allow a full calendar year for eligible professionals (which is consistent with the reporting periods finalized for the 2012 incentive) to meet the criteria for satisfactory reporting for purposes of the 2015 payment adjustment, while still providing us with enough time to collect and analyze the data submitted by eligible professionals for the 2015 payment adjustment without having to make retroactive payment adjustments in 2015. With regard to using a shorter reporting period (that is, less than 12 months), we may consider, in future notice and comment rulemaking, additional reporting periods that are less than 12 months for the 2015 payment adjustment, so that eligible professionals have additional opportunities to meet the requirements for the 2015 payment adjustment.
Therefore, for the reasons we've explained, we are finalizing our proposal to establish CY 2013 (that is, January 1, 2013 through December 31, 2013) as the reporting period for the 2015 payment adjustment. At this time, we are not aware of any viable alternatives that would allow us to address the issues we noted and still provide a full-year reporting period that falls after 2013. We will, however, continue to explore options for potentially using a reporting period closer to the time in which the payment adjustment is applied for future years of the payment adjustment.
Based on the reporting period we are finalizing in this final rule with comment period, if we determine that an eligible professional or group practice has not satisfactorily reported data on quality measures for the January 1, 2013 through December 31, 2013 reporting period for purposes of the 2015 payment adjustment, then the fee schedule amount for services furnished by the eligible professional or group practice during 2015 would be 98.5 percent of the fee schedule amount that would otherwise apply to such services. We intend to address the remaining requirements for the 2015 payment adjustment in future rulemaking.
Electronic prescribing is the transmission using electronic media, of prescription or prescription-related information between the prescriber, dispenser, pharmacy benefit manager (PBM), or health plan, either directly or through an intermediary, including an electronic prescribing network. To encourage the use of electronic prescribing among eligible professionals, section 132 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) amended section 1848(m) of the Act to establish the eRx Incentive Program. The eRx Incentive Program provides a combination of incentive payments and payment adjustments through 2014 to eligible professionals who are successful electronic prescribers. No eRx incentive payments or payment adjustments are authorized beyond 2014.
From 2009 through 2013, the Secretary is authorized to provide eligible professionals who are successful electronic prescribers an incentive payment equal to a percentage of the eligible professional's total estimated Medicare Part B PFS allowed charges (based on claims submitted not later than 2 months after the end of the reporting period) for all covered professional services furnished by the eligible professional during the respective reporting period. However, section 1848(m)(2)(D) of the Act, as added by section 4101(f)(2)(B) of Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5) (ARRA), which also authorized the Medicare EHR Incentive Program, specifies that the eRx incentive does not apply to an eligible professional, if, for the EHR reporting period, the eligible professional earns an incentive payment under the Medicare EHR Incentive Program beginning in 2011.
The applicable electronic prescribing percent for incentive payments under the eRx Incentive Program are as follows:
• 2.0 percent for 2009.
• 2.0 percent for 2010.
• 1.0 percent for 2011.
• 1.0 percent for 2012.
• 0.5 percent for 2013.
In addition, for years 2012 through 2014, under section 1848(a)(5)(A) of the Act, a PFS payment adjustment applies to eligible professionals who are not successful electronic prescribers at an increasing rate through 2014. Specifically, if the eligible professional is not a successful electronic prescriber for the respective reporting period for the year, the PFS amount for covered professional services during the year shall be a percentage less than the PFS amount that would otherwise apply. The applicable electronic prescribing percent for payment adjustments under the eRx Incentive Program are as follows:
• 1.0 percent in 2012.
• 1.5 percent in 2013.
• 2.0 percent in 2014.
We believe the purpose of the eRx Incentive Program for 2012 and beyond is to continue to encourage significant expansion of electronic prescribing by authorizing a combination of financial incentives and payment adjustments. We proposed to modify the incentive and payment adjustment language in 42 CFR 414.92 to provide language more consistent with section 1848 of the Act (please note that in the proposed rule we inadvertently listed “section 1848(k)” instead of “section 1848”).
We believe that the criteria used to determine who is a successful electronic prescriber for purposes of the eRx incentive are not required to be identical to the criteria used to determine the applicability of the eRx payment adjustment. In general, we believe that an incentive should be broadly available to encourage the widest possible adoption of electronic prescribing, even for low volume prescribers. On the other hand, we believe that a payment adjustment should be applied primarily to assure that those who have a large volume of prescribing do so electronically, without penalizing those for whom the adoption and use of an electronic prescribing system may be impractical given the low volume of prescribing. We also believe that eligible professionals who have met the requirements for receiving an incentive payment under the eRx Incentive Program for a particular year have sufficiently demonstrated their adoption and use of electronic prescribing technology and thus should not be subject to the payment adjustment in a future year.
Individual eligible professionals do not have to participate in the Physician Quality Reporting System in order to participate in the eRx Incentive Program (and vice versa). The provisions of the eRx Incentive Program are codified at 42 CFR 414.92.
In prior years, we have proposed and finalized the details of the eRx Incentive Program through an annual rulemaking process. Through this annual rulemaking process, we have previously established the criteria for avoiding the 2012 eRx payment adjustment in the 2011 PFS Final Rule with comment period (75 FR 73562 through 73565), as well as issued a final rule entitled “Changes to the Electronic Prescribing (eRx) Incentive Program” (76 FR 54953 through 54969), in which we proposed additional changes to the 2012 payment adjustment, as well as the electronic prescribing quality measure for certain reporting periods in 2011. We also established requirements for the 2013 eRx payment adjustment in the 2011 PFS Final Rule with comment period (75 FR 7356).
In this final rule with comment period, we are finalizing our comprehensive requirements for the 2012 and 2013 incentive payments, additional requirements for the 2013 payment adjustment, and requirements for the 2014 payment adjustment. We believe that finalizing criteria for the eRx Incentive Program for 2012 and beyond will provide eligible professionals with more time to familiarize themselves with the details of the eRx Incentive Program. We hope this will lead to increased, successful participation in the eRx Incentive Program. Details regarding requirements for the eRx Incentive Program for 2012 and 2013 incentive payments, additional requirements for the 2013 payment adjustment, and the requirements for the 2014 payment adjustment, including our rationale for finalizing such requirements, are described in the following section. We received comments that were not related to our specific proposals for the 2012 through 2014 eRx Incentive Program, and, while we appreciate the commenters' feedback, these comments are outside the scope of the issues addressed in this final rule with comment period and are not included.
For the 2012 and 2013 incentive payments and 2013 and 2014 payment adjustments, we proposed the following two ways eligible professionals may participate in the eRx Incentive Program: (1) as an individual eligible professional; or (2) as part of a group practice participating in the group practice reporting option (GPRO) for the eRx Incentive Program (eRx GPRO) (76 FR 42886). Professionals eligible to participate in the eRx Incentive Program are defined at 42 CFR 414.92(b) and more information is available on the eRx Incentive Program section of the CMS Web site at:
As in the 2011 eRx Incentive Program, we proposed that, for individual eligible professionals participating in the eRx Incentive Program for purposes of the 2012 and 2013 incentive payments and 2013 and 2014 payment adjustments, the determination of whether an eligible professional is a successful electronic prescriber will be made at the individual professional level, based on the National Provider Identifier (NPI) number (76 FR 42886). As some individuals (identified by NPIs) may be associated with more than one practice or Tax Identification Number (TIN), for the 2012 and 2013 incentive payments and 2013 and 2014 payment adjustments, we proposed that the determination of whether an eligible professional is a successful electronic prescriber will continue to be made for each unique TIN/NPI combination. Then, as in previous years, incentive payments would then be made to the applicable holder of the TIN. We proposed continuing to use the TIN/NPI combination as the unit of analysis to maintain program continuity, as individual eligible professionals are already familiar with this level of analysis and payment. We invited public comment on our proposal to continue analyzing data using the TIN/NPI combination while providing payment to the applicable holder of the TIN. We received no comments on our proposal to continue analyzing data using the TIN/NPI combination while providing payment to the applicable holder of the TIN and are therefore, finalizing this proposal.
As in prior program years, we proposed that individual eligible professionals who wish to participate in the eRx Incentive Program for purposes of the 2012 and 2013 incentive payments and 2013 and 2014 payment adjustments may simply start participating (76 FR 42886). Individual eligible professionals are not required to register or notify CMS they intend to participate; rather, they may simply begin to report the eRx measure. We invited public comment on the proposed process for individual eligible professionals to participate in the eRx Incentive Program. We received no comments regarding our proposal, and therefore, we are finalizing our proposal that individual eligible professionals who wish to participate in the eRx Incentive Program for purposes of the 2012 and 2013 incentive payments and 2013 and 2014 payment adjustments may simply start participating.
As required under section 1848(m)(3)(C) of the Act, we established a process under which eligible professionals in a group practice (as defined by the Secretary) would be treated as having met the requirements for submitting data on electronic prescribing quality measures for covered professional services for a reporting period (or, for purposes of the payment adjustment under section 1848(a)(5) of the Act, for a reporting period for a year) if, in lieu of reporting the electronic prescribing measure, the group practice reports measures determined appropriate by the Secretary, such as measures that target high-cost chronic conditions and preventive care, in a form and manner, and at a time specified by the Secretary. Specifically, we first established the eRx group practice reporting option (eRx GPRO) in 2010, which was further modified in the 2011 PFS Final Rule (75 FR 73502). In addition to determining whether an eligible professional is a successful electronic prescriber for incentive
Section 1848(m)(3)(C)(i) of the Act authorizes the Secretary to define “group practice,” which CMS defined by referencing our regulation at § 414.90 (b). For the 2011 eRx Incentive Program, under § 414.92(b), a group practice is—
(1) Defined at § 414.90(b), that is participating in the Physician Quality Reporting System; or
(2)(a) In a Medicare approved demonstration project that is deemed to be participating in the Physician Quality Reporting System group practice reporting option; and
(b) Has indicated its desire to participate in the electronic prescribing group practice option.
However, for purposes of determining whether a group practice is a successful electronic prescriber for CYs 2012 through 2014, we proposed to modify the definition of the “group practice” at 42 CFR 414.92(b) to be consistent with modifications we proposed for the definition of “group practice” at 42 CFR 414.90(b) for the 2012 Physician Quality Reporting System (76 FR 42886).
In particular, we proposed to modify the definition of group practice under the Physician Quality Reporting System definition at 42 CFR 414.90(b) by defining a group practice as a single TIN with at least 25 or more eligible professionals, as identified by their individual NPI, who have reassigned their Medicare billing rights to the TIN. Given that the definition of “group practice” at 42 CFR 414.92(b) follows the Physician Quality Reporting System definition, we proposed to apply the modification to the definition for group practice under the eRx Incentive Program.
Although we noted this proposed change would eliminate group practices comprised of 2 to 24 eligible professionals for the purpose of the eRx GPRO, we believed changing the definition of “group practice” would not pose a significant burden to these small group practices, because they could still participate as individual eligible professionals. For 2010, out of 107 group practices that self-nominated to participate in GPRO II for the Physician Quality Reporting System, 68 of these group practices qualified to participate in the eRx Incentive Program under GPRO II. However, during the opt-out period which ended on May 12, 2011, 6 of these 68 group practices dropped out of GPRO II participation, leaving only 62 group practices to participate in GPRO II for 2010. Due to the low participation of only 62 groups, we believed that participation in the eRx GPRO should be limited to only those group practices with 25 or more eligible professionals. We noted that participating under GPRO II may be more burdensome for very small group practices than participating as eligible professionals. For example, with respect to the payment adjustment, additional limitations may apply to eligible professionals as individuals that are not applied to group practices, which present an additional burden to the group practice.
We also proposed (76 FR 42866) to modify the language that references Medicare demonstrations to more broadly recognize other similar Medicare programs that group practices may be participating in so that such practices may be eligible to participate in the eRx Incentive Program. We received no comments related to our proposal to more broadly recognize Medicare programs other than the PQRS GPRO where group practices may be participating. Therefore, we are finalizing this modification at 42 CFR 414.92(b). We are also modifying 42 CFR 414.92 to make clear that all group practices must indicate their desire to participate in the eRx GPRO.
We invited public comment on our proposed definition of group practice and below is a summary of the comments we received and our responses.
Based on the comments received and for the reasons stated above, we are finalizing our proposed definition of group practice at § 414.92(b) for purposes of participating under the eRx GPRO. However, we are making minor technical changes to the clause numbers under 42 CFR 414.92(b) to more accurately reflect this changed definition of group practice.
We proposed (76 FR 42881) that if a group practice wishes to participate in the eRx Incentive Program under the eRx GPRO, the group practice must self-nominate to do so. To self-nominate, we proposed that the group practice follow the requirements for self-nomination under the Physician Quality Reporting System, as well as specifically indicate its intent to participate in the eRx Incentive Program as a group practice.
If a group practice self-nominates to participate in the eRx GPRO for a calendar year, then we proposed to consider that the group practice is participating in the eRx GPRO for purposes of both the incentive payment (with respect to any incentive payment reporting period that occurs during the calendar year) and the payment adjustment (with respect to any payment adjustment reporting period that occurs during the calendar year). For example, the 2013 payment adjustment reporting period occurs during calendar year 2012 (January 1, 2012 through June 30, 2012).
We invited public comment on the requirements for eligible professionals to participate as an eRx GPRO for purposes of the eRx Incentive Program. The following is a summary of the comments we received regarding this proposal.
After considering the comments received and for the reasons stated in our responses, we are finalizing our proposal that, in order for a group practice to participate as a group under the eRx GPRO, the group practice must self-nominate for each calendar year the group wishes to participate in the eRx GPRO. If a group practice self-nominates to participate in the eRx GPRO for a calendar year, then we will consider that the group practice to be participating in the eRx GPRO as a group practice for purposes of both the incentive payment and the payment adjustment. Therefore, if an eligible professional is part of a group practice participating in the eRx GPRO for a respective program year, the eligible professional in the group practice is precluded from participating as an individual eligible e professional for purposes of both the 2012 and 2013 incentives and 2013 and 2014 payment adjustments. For example, the 2013 payment adjustment reporting period occurs during calendar year 2012 (January 1, 2012 through June 30, 2012). Therefore, any group practice participating in the eRx GPRO during calendar year 2012 would be considered to be participating in the eRx GPRO for both the 2012 incentive and 2013 payment adjustment.
Also, as we clarified in the proposed rule (76 FR 42887), a group practice that is deemed to be participating in the Physician Quality Reporting System, such as an ACO participating under the Medicare Shared Savings Program, will not be deemed participating as a group practice in the eRx Incentive Program. To participate in the eRx Incentive Program under the eRx GPRO, such group practices must self-nominate to do so. Instructions for submitting the self-nomination statement are the same as the instructions for submitting a self-nomination statement for the Physician Quality Reporting System. Each year, we expect to notify a group practice of the selection decision with respect to participation in the eRx GPRO during the first quarter of the year.
Section 1848(m)(6)(C)(i)(II) of the Act defines “reporting period” under the eRx Incentive Program for years after 2008 to be the entire year. We also have authority under section 1848(m)(6)(C)(ii) of the Act to revise the reporting period if the Secretary determines such revision is appropriate, produces valid results on measures reported, and is consistent with the goals of maximizing scientific validity and reducing administrative burden. We proposed (76 FR 42887), the entire calendar year as the reporting period for purposes of the 2012 and 2013 incentive payment (January 1, 2012 through December 31, 2012 for the 2012 incentive and January 1, 2013 through December 31, 2013 for the 2013 incentive, respectively). Accordingly, we proposed to modify 42 CFR 414.92(d)(1).
We invited public comment on the proposed reporting periods for the 2012 and 2013 incentives. The following is a summary of the comment we received regarding these proposals.
Based on the comment received and for the reasons stated above, we are finalizing the reporting period for the 2012 incentive as the 12-month period of January 1, 2012 through December 31, 2012, and reporting period for the 2013 incentive as the 12-month period of January 1, 2013 through December 31, 2013, and finalizing the changes to the regulation at § 414.92(d)(1).
Under our authority under section 1848(m)(6)(C)(ii) of the Act, in the 2011 PFS final rule with comment period, we finalized two different reporting periods: A 6-month reporting period (between January 1, 2011 and June 30, 2011) for purposes of the 2012 payment adjustment for both individual eligible professionals and group practices participating in the eRx GPRO (75 FR 73562 through 73563) and a 12-month reporting period (between January 1, 2011 and December 31, 2011) for purposes of the 2013 payment adjustment for individual eligible professionals and group practices
In addition to the 12-month reporting period finalized in the 2011 PFS final rule with comment period, in the proposed rule we proposed (76 FR 32887), for both individual eligible professionals and group practices participating in the eRx GPRO, an additional 6-month reporting period (between January 1, 2012 and June 30, 2012) for purposes of the 2013 payment adjustment.
For similar reasons, for the 2014 payment adjustment, we proposed a 12-month reporting period (between January 1, 2012 and December 31, 2 012) that would apply to individual eligible professionals and a 6-month reporting period (between January 1, 2013 and June 30, 2013) that would apply to both individual eligible professionals and group practices, so that two different reporting periods would provide eligible professionals with two opportunities to be successful electronic prescribers.
We invited public comment on the proposed reporting periods for the 2013 and 2014 payment adjustments. The following is a summary of the comments we received regarding these proposals.
With respect to the suggested 9-month reporting period, for operational reasons, we cannot finalize a reporting period that ends later than June 30, 2012 for the 2013 payment adjustment and June 30, 2013 for the 2014 payment adjustment. The process required to perform a full analysis of eligible professionals' claims data can take more than five months to complete. This is due to numerous factors, including the allowance of a one month run-out for claims processing (for example, through July 29, 2012, for claims with dates of service of January 1, 2012, through June 30, 2012). Additionally, the time required to perform the data analyses to determine non-successful electronic prescribers, and to update the systems to make the appropriate reductions to Physician Fee Schedule payments for claims submitted on or after January 1, 2012 and January 1, 2013 respectively can take up to four months to complete. Taking into account these operational issues, we believe that finalizing a reporting period ending on June 30, 2012 and June 30, 2013 for the 2013 and 2014 respective payment adjustments will allow us to avoid having to recoup overpayments.
After considering the comments received and for the reasons explained in our responses, we are finalizing the 6-month reporting periods for the 2013 and 2014 payment adjustments. Specifically, in addition to the 12-month reporting period finalized in the 2011 PFS final rule with comment period, we are finalizing an additional 6-month reporting period (that is, January 1, 2012 through June 30, 2012) for purposes of the 2013 payment adjustment. For the 2014 payment adjustment, we are finalizing a 6-month reporting period (between January 1, 2013 and June 30, 2013) for both individual eligible professionals and group practices participating in the eRx GPRO. We also are finalizing a 12-month reporting period (between January 1, 2012 and December 31, 2012) for individual eligible professionals for the 2014 payment adjustment. As for group practices, we note that there was some ambiguity in the proposed rule (76 FR 42985), with regard to a 12-month reporting period for group practices participating in the eRx GPRO for the 2014 payment adjustment. Although we proposed criteria for being a successful electronic prescriber for group practices reporting from January 1, 2012 through December 31, 2012, for the 2014 payment adjustment (76 FR 42985 through 42986), we only proposed that the 12-month reporting period for the 2014 payment adjustment (that is, January 1, 2012 through December 31, 2012) would apply to individual eligible professionals (76 FR 42887). Additionally, at 42 CFR 414.92(f)(1), we proposed regulatory changes that would provide for this 12-month reporting period (76 FR 42946). Since, as discussed in section VI.F.1.e.(6). of this final rule with comment period, we are finalizing the proposed criteria for being a successful electronic prescriber pertaining to a 12-month period for group practices for purposes of the 2014 payment adjustment, we are also finalizing the 12-month reporting period (that is, January 1, 2012 through December 31, 2012) for group practices participating under the eRx GPRO for the 2014 payment adjustment. We believe this will afford group practices additional options for reporting for purposes of the 2014 payment adjustment.
Therefore, we are finalizing the proposed changes to the regulation at 42 CFR 414.92(f)(1).
Section 1848(m)(3)(B) of the Act governs the requirements for being a “successful electronic prescriber,” for
The second criterion, under section 1848(m)(3)(B)(iii) of the Act, is based on the electronic submission by the eligible professional of a sufficient number (as determined by the Secretary) of prescriptions under Part D during the reporting period. If the Secretary decides to use this standard, then, in accordance with section 1848(m)(3)(B)(iv) of the Act, the Secretary is authorized to use Part D data to assess whether a sufficient number of prescriptions have been submitted by eligible professionals. However, under section 1848(m)(3)(B)(i) of the Act, if the Secretary decides the standard based on a sufficient number of electronic Part D prescriptions applies for a particular reporting period, then the standard based on the reporting on electronic prescribing quality measures does not apply.
We considered use of the second criterion for determining successful prescribing under the eRx Incentive Program. While we recognize the benefits of using Part D data as the standard for determining successful electronic prescribers, we believe use of Part D prescriptions for analysis may be premature. For example, there is uncertainty as to the accuracies of reporting electronic prescribing activities using Part D data. For example, if an electronic prescription is converted to a facsimile when reaching the pharmacy on Part D data, the transmission is still reported as a pure, electronic prescribing event. Furthermore, use of Part D data would require a complete overhaul of the current requirements for the eRx Incentive Program. For instance, if we choose to shift to the use of Part D data, the program would have to adopt a new form of measurement, a new form of analysis other than use of an eligible professionals' TIN/NPI (TIN data is not available in Part D data sets), and new criteria for eligible professionals and eRx GPROs to become successful electronic prescribers. Therefore, we did not propose to use the second criterion.
For the reasons stated previously, we proposed (76 FR 42888) to continue to require eligible professionals to report on the electronic prescribing quality measure used in 2011 to determine whether an eligible professional is a successful electronic prescriber for the remainder of the eRx Incentive Program. We proposed, however, to modify the electronic prescribing quality measure's specifications and use modified reporting criteria based on the authority provided under section 1848(m)(3)(D) of the Act (76 FR 42888). We invited public comment on the continued use of reporting the electronic prescribing quality measure for purposes of the “successful electronic prescriber” determination under the program. We received no comments regarding our proposal to continue use of the electronic prescribing quality measure standard and therefore, we are finalizing our proposal to use the electronic prescribing quality measure standard for purposes of determining whether an eligible professional is a successful electronic prescriber. Our proposals and final decisions with regard to the criteria for being a successful electronic prescriber under this standard for the 2012 and 2013 eRx Incentives and the 2013 and 2014 eRx payment adjustments are discussed in the following sections VI.F.2.g.(2)., VI.F.2.g.(3)., and VI.F.2.h.(2). of this final rule with comment period.
The electronic prescribing quality measure, similar to the Physician Quality Reporting System measures, has two basic elements, which include: (1) A denominator that defines the patient population on which the eligible professional's performance is being measured; and (2) a reporting numerator, which identifies whether or not a clinical quality action was performed. The final details of the electronic prescribing measure specified later in this section apply to the following eRx Incentive Program years: The 2012 eRx incentive payment; the 2013 eRx incentive payment; the 2013 eRx payment adjustment; and the 2014 eRx payment adjustment.
Under section 1848(k)(2)(C)(i) of the Act, the electronic prescribing quality measure, which was initially introduced under the Physician Quality Reporting System, shall be a measure selected by the Secretary that has been endorsed by the entity with a contract with the Secretary under section 1890(a) of the Act. Currently, that entity is the National Quality Forum (NQF). The electronic prescribing measure we proposed to retain, NQF Measure #0486: Adoption of Medication e-Prescribing, was endorsed by the NQF in 2011. However, pursuant to the changes finalized in the 2011 “Changes to the Electronic Prescribing (eRx) Incentive Program” final rule, we modified the description statement of the NQF-endorsed electronic prescribing measure to allow for use of Certified EHR Technology to report the electronic prescribing quality measure (76 FR 54954-54956). This modification has not yet been reviewed by the NQF. In light of this, we are not aware of any other NQF-endorsed measure related to electronic prescribing by eligible professionals that would be appropriate for use in the eRx Incentive Program. Therefore, we believe that the use of this eRx measure falls within the exception under section 1848(k)(2)(C)(ii) of the Act.
The denominator for the electronic prescribing quality measure consists of specific billing codes for covered professional services.
As initially authorized under section 1848(k)(2)(A)(ii) of the Act, and further established through rulemaking and under section 1848(m)(2)(B)(i) of the Act, we may modify the codes making up the denominator of the electronic prescribing measure. For 2011, we expanded the scope of the denominator codes for 2010 to covered professional services outside the professional office and outpatient setting, such as professional services furnished in skilled nursing facilities or the home care setting (75 FR 73555). For purposes of reporting periods during CYs 2012 and 2013 (for the 2012 and 2013 incentives and the 2013 and 2014 payment adjustments), we proposed (76 FR 42888) to retain these CPT and HCPCS codes in the denominator of the electronic prescribing measure, because we believe that these codes represent the types of services for which prescriptions are likely to be generated. Therefore, if we were to measure an eligible professional's performance on the electronic prescribing measure, we would want to do so only for patients who saw the professional for such services. Although in prior years we
We invited public and only received the following comment on our proposal to retain the denominator codes contained in the 2011 electronic prescribing measure:
Based on the comment received and for the reasons explained in our responses, we are finalizing our proposal to retain the denominator codes contained in the 2011 electronic prescribing measure. Specifically, we are finalizing for the 2012 and 2013 eRx program years the following denominator CPT and HCPCS codes in the denominator of the electronic prescribing measure: 90801, 90802, 90804, 90805, 90806, 90807, 90808, 90809, 90862, 92002, 92004, 92012, 92014, 96150, 96151, 96152, 99201, 99202, 99203, 99204, 99205, 99211, 99212, 99213, 99214, 99215, 99304, 99305, 99306, 99307, 99308, 99309, 99310, 99315, 99316, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, G0101, G0108, and G0109 (75 FR 73555).
Currently, the electronic prescribing measure's numerator consists of a single code, G8553, which indicates that the prescription was generated and transmitted via a qualified electronic prescribing system (and below, we discuss in greater detail what constitutes a “qualified system”). For purposes of reporting the electronic prescribing quality measure for the 2012 and 2013 incentives and the 2013 and 2014 payment adjustment, we proposed (76 FR 42888-42889) that an eligible professional or group practice participating in the eRx GPRO can report the code associated with the measure's numerator whenever a prescription is generated and transmitted electronically. We invited public comment on the proposed numerator for the electronic prescribing measure for CYs 2012 through 2013 eRx Incentive Program, but, we did not receive any comments related to the proposed electronic prescribing measure's numerator G-code for CYs 2012 and 2013. Therefore, for CYs 2012 and 2013 of the eRx Incentive Program, we are finalizing G-8553 for electronic prescribing measure's numerator.
We intend to post the final electronic prescribing measure specifications on the “eRx Measure” page of the eRx Incentive Program section of the CMS Web site at
• December 31, 2011 for the reporting periods that occur during calendar year 2012.
• December 31, 2012 for the reporting periods that occur during calendar year 2013.
In the event that additional changes are needed to the measure specifications for years after 2012, we will do so via notice and comment rulemaking prior to posting the final measure specifications for that year.
As discussed in greater detail below, for purposes of the 2012 and 2013 incentive and 2013 and 2014 payment adjustment, we proposed (76 FR 42889) that when the eligible professional or group practice reports the measure's numerator G-code, the eligible professional or group practice must have and regularly use a “qualified” electronic prescribing system, which we further proposed to define as either a system with the four functionalities previously identified in the electronic prescribing measure specifications, or Certified EHR Technology, as defined at 42 CFR 495.4 and 45 CFR 170.102. We also made proposals with regard to the Part D electronic prescribing standards for the electronic prescribing measures. Our proposed technological requirements of the electronic prescribing quality measure are discussed below.
We are aware that there are significant numbers of eligible professionals who are interested in participating in the eRx Incentive Program but currently do not have an electronic prescribing system or Certified EHR Technology. Generally, the electronic prescribing measure does not require the use of any particular system or transmission network; only that the system be a “qualified” system. If the professional does not have general access to an electronic prescribing system or Certified EHR Technology in the practice setting, the eligible professional will not be able to report the electronic prescribing measure. In addition to not being eligible for an incentive payment, an eligible professional who does not report the electronic prescribing measure for 2012 or 2013 will be subject to the 2013 or 2014 eRx payment adjustment, unless an exception applies.
We proposed (76 FR 4289) to continue to recognize as a “qualified” electronic prescribing system for purposes of the electronic prescribing quality measure any system that can perform the four functionalities that were identified and required under the program in 2010 and 2011 (76 FR 42889). We invited public comment on our proposal that the definition of a “qualified electronic prescribing system,” include systems that have these four functionalities. We did not receive any comments regarding our proposal to retain the same functionalities. Therefore, for years 2012 through 2014 of the eRx Incentive Program, we are finalizing our decision to recognize as a “qualified” electronic prescribing system, a system that can do the following:
• Generate a complete active medication list incorporating electronic data received from applicable pharmacies and PBMs, if available.
• Enable eligible professionals to select medications, print prescriptions, electronically transmit prescriptions, as well as provide notifications (that is, signals to warn the prescriber of possible undesirable or unsafe situations including potentially inappropriate dose or route of administration of a drug, drug-drug interactions, allergy concerns, or warnings and cautions). This functionality must be enabled.
• Provide information related to lower cost, therapeutically appropriate alternatives (if any). The ability of an electronic prescribing system to receive tiered formulary information, if
• Provide information on formulary or tiered formulary medications, patient eligibility, and authorization requirements received electronically from the patient's drug plan (if available).
For reporting periods that occur in CYs 2012 and 2013, we also proposed to expand the definition of a “qualified” electronic prescribing system to include Certified EHR Technology, as defined at 42 CFR 495.4 and 45 CFR 170.102, because we believe the technological requirements for electronic prescribing under the EHR Incentive Program are similar to the technological requirements for the eRx Incentive Program. We believe expanding the definition of a “qualified” electronic prescribing system in this way will align the requirements of the eRx and the Medicare EHR Incentive Program and potentially reduce unnecessary investment in multiple technologies for purposes of meeting the requirements for each program. This proposal was consistent with changes we finalized for certain reporting periods in CY 2011 for the 2011 eRx incentive and the 2013 eRx payment adjustment in the September 6, 2011 final rule entitled “Medicare Program; Changes to the Electronic Prescribing (eRx) Incentive Program” (76 FR 54953, 54956).
We invited public comment on the proposed requirements of a “qualified” electronic prescribing system for purposes of reporting the electronic prescribing measure. The following is a summary of the comments we received regarding these proposals.
Therefore, in summary, for reporting periods that occur during CYs 2012 and 2013 of the eRx Incentive Program, we are finalizing our proposal that a “qualified” electronic prescribing system for the electronic prescribing quality measure is one that either meets the four functionalities noted, or is Certified EHR Technology, as defined at 42 CFR 495.4 and 45 CFR 170.102 (regardless of whether the Certified EHR Technology has all four functionalities noted).
Section 1848(m)(3)(B)(v) of the Act specifies that to the extent practicable, in determining whether an eligible professional is a successful electronic prescriber, “the Secretary shall ensure that eligible professionals utilize electronic prescribing systems in compliance with standards established for such systems pursuant to the Part D Electronic Prescribing Program under section 1860D-4(e) of the Act”. The Part D standards for electronic prescribing systems establish which electronic standards Part D sponsors, providers, and dispensers must use when they electronically transmit prescriptions and certain prescription related information for Part D covered drugs that are prescribed for Part D eligible individuals.
To be a qualified electronic prescribing system under the eRx Incentive Program, electronic systems must convey the information listed previously using the standards currently in effect for the Part D electronic prescribing program. The latest Part D electronic prescribing standards, and those that had previously been adopted, can be found on the CMS Web site at
To ensure that eligible professionals utilize electronic prescribing systems that meet these requirements, the electronic prescribing measure requires that those functionalities required for a “qualified” electronic prescribing system are equivalent to the adopted Part D electronic prescribing standards. We proposed (76 FR 42889 and 42890) to modify the Part D electronic prescribing standards required for a “qualified” electronic prescribing system under the eRx Incentive Program to have these standards consistent with current, CMS Part D electronic prescribing standards.
The Part D electronic prescribing standards currently in place that are relevant to the four functionalities described previously are as follows:
• Generate medication list—Use the National Council for Prescription Drug Programs (NCPDP) Prescriber/Pharmacist Interface SCRIPT Standard, Implementation Guide, Version 8 Release 1 or 10.6, October 2005 (hereinafter “NCPDP SCRIPT 8.1 or 10.6”) Medication History Standard. Use of NCPDP SCRIPT 10.6 is a new option for use in the eRx Incentive Program.
• Transmit prescriptions electronically—Use the NCPDP SCRIPT 8.1or 10.6 for the transactions listed at § 423.160(b)(2).
• Provide information on lower cost alternatives—Use the NCPDP Formulary and Benefits Standard, Implementation Guide, Version 1, Release 0 (Version 1.0), October 2005 (hereinafter “NCPDP Formulary and Benefits 1.0”).
• Provide information on formulary or tiered formulary medications, patient eligibility, and authorization requirements received electronically from the patient's drug plan use:
++ NCPDP Formulary and Benefits 1.0 for communicating formulary and benefits information between prescribers and plans.
++ Accredited Standards Committee (ASC) X12N 270/271-Health Care Eligibility Benefit Inquiry and Response, Version 4010, May 2000, Washington Publishing Company, 004010X092 and Addenda to Health Care Eligibility Benefit Inquiry and Response, Version 4010A1, October 2002, Washington Publishing Company, 004010X092A1 for communicating eligibility information between the plan and prescribers.
++ NCPDP Telecommunication Standard Specification, Version 5, Release 1 (Version 5.1), September 1999, and equivalent NCPDP Batch Standard Batch Implementation Guide, Version 1, Release 1 (Version 1.1), January 2000 for communicating eligibility information between the plan and dispensers.
We did not receive any comments regarding our proposals related to part D electronic prescribing standards and therefore, we are finalizing our proposal that, for purposes of the 2012 and 2013 eRx Incentive Program, “qualified” electronic prescribing systems must meet all of the part D electronic prescribing standards specified.
Above, we specified the current Part D electronic prescribing standards that are relevant to the four functionalities. Should these Part D electronic prescribing standards subsequently change, we note that the eligible professional's electronic prescribing system must, at all times during the respective reporting period, comply with the current Part D electronic prescribing standards. For example, on October 24, 2011, CMS proposed to update some of the previously stated Part D electronic prescribing standards to the four functionalities (76 FR 65916). Specifically, CMS proposed to update
There are Part D electronic prescribing standards that are in effect for functionalities that are not commonly utilized at this time. One example is Rx Fill Notification, which is discussed in the Part D electronic prescribing final rule (73 FR 18926). For purposes of the eRx Incentive Program for CYs 2012 through 2014, we again are not requiring that an electronic prescribing system contain all functionalities for which there are available Part D electronic prescribing standards since many of these functionalities are not commonly available. For those “qualified” electronic prescribing systems that have the four
There are other aspects of the functionalities for a “qualified” system that are not dependent on electronic messaging and are part of the software of the electronic prescribing system, for which Part D standards for electronic prescribing do not pertain and are not required for purposes of the eRx Incentive Program. For example, the requirements in the second functionality that require the system to allow professionals to select medications, print prescriptions, and conduct alerts are functions included in the particular software, for which Part D standards for electronic messaging do not apply.
As stated previously, in this final rule with comment period, we are finalizing our proposal to expand the definition of a “qualified” electronic prescribing system under the electronic prescribing quality measure to also recognize Certified EHR Technology. Among other requirements, Certified EHR Technology must be able to electronically generate and transmit prescriptions and prescription-related information in accordance with certain standards, some of which have been adopted for purposes of electronic prescribing under Part D. Similar to the electronic prescribing systems that have the four functionalities previously noted, Certified EHR Technology also must be able to check for drug-drug interactions and check whether drugs are in a formulary or a preferred drug list, although the certification criteria do not specify any standards for the performance of those functions. We believe that it is acceptable that not all of the Part D eRx standards are required for Certified EHR Technology in light of our desire to better align the requirements of the eRx and the Medicare EHR Incentive Programs, and potentially reduce unnecessary investment in multiple technologies for purposes of meeting the requirements for each program. Furthermore, to the extent that an eligible professional uses Certified EHR Technology to electronically prescribe under Part D, he or she would still be required to comply with the applicable Part D standards to do so.
For purposes of the January 1, 2011 through December 31, 2011 reporting period for the 2011 incentive payment and 2013 payment adjustment, an eligible professional (and eRx GPRO, for purposes of the 2011 incentive) may report on the electronic prescribing measure to meet the criteria for being a successful electronic prescriber via three reporting mechanisms—claims, qualified registry, and qualified EHR product. However, for purposes of the 2012 payment adjustment, due to operational limitations, only the claims-based reporting mechanism was available for purposes of reporting on the electronic prescribing measure for the 2012 payment adjustment (75 FR 73563).
For reporting periods that occur during CY 2012 and 2013, to provide eligible professionals and groups practices with multiple mechanisms to report on the electronic prescribing measure for purposes of reporting the electronic prescribing measure for the 2012 and 2013 incentive payments and 2013 and 2014 payment adjustments, we proposed (76 FR 42890) the following three reporting mechanisms—claims, qualified registry, and qualified EHR (including both direct EHR-based reporting and EHR data submission vendors). However, as in the past, we indicated we would not combine data on the electronic prescribing measure submitted via multiple reporting mechanisms. Combining data received via multiple reporting mechanisms would add significant complexity to our analytics and potentially delay incentive payments. Therefore, we proposed that an eligible professional or eRx GPRO would need to meet the relevant reporting criteria for the incentive or payment adjustment using a single reporting mechanism.
For reporting periods that occur during CYs 2012 and 2013, we also proposed that a group practice that wishes to participate in the eRx Incentive Program as an eRx GPRO for a particular calendar year would have to indicate which reporting mechanism the group practice intends to use to report the electronic prescribing measure. That is, the group practice would need to indicate at the time it self-nominates which reporting mechanism (claims, qualified registry, qualified direct EHR-based reporting, or qualified EHR data submission vendor) the group practice intends to use for purposes of participating in the eRx GPRO.
The following is a summary of the comments we received regarding these proposals.
We do not believe that the lack of registry and EHR-based reporting mechanisms for the 6-month reporting periods for the 2013 and 2014 payment adjustments would substantially prevent eligible professionals and group practices from meeting the criteria for being successful electronic prescribers, because eligible professionals may still report on the electronic prescribing measure during these reporting periods via claims and via all three reporting mechanisms (claims, registry, and EHR) for the 12-month 2014 payment adjustment reporting period. We note that, according to the 2009 Reporting Experience available on our Web site at
After considering the comments received and for the reasons stated in our responses, we are finalizing the following reporting mechanisms for the 12-month reporting periods for the 2012 and 2013 incentives, and the 2014 payment adjustment: claims, registry, and EHR. The requirements for each reporting mechanism with respect to the 2012 and 2013 incentives and 2013 and 2014 payment adjustments are described below. In this final rule, we also are finalizing the claims-based reporting mechanism for the 6-month reporting periods pertaining to the 2013 and 2014 payment adjustments; however, as we explained previously, we are not finalizing registry or EHR-based reporting for these 6-month reporting periods. We are therefore modifying 42 CFR 414.92 to reflect that only the claims-based reporting mechanism may be used for purposes of the 6-month 2013 and 2014 payment adjustment reporting periods.
For purposes of reporting the electronic prescribing quality measure for the 2012 and 2013 incentives and the 2013 and 2014 payment adjustments, we proposed (75 FR 42890 and 42891) to again retain the claims-based reporting mechanism that has been used since the implementation of the eRx Incentive Program in 2009. We did not propose any prerequisites, such as registration, to begin reporting on the electronic prescribing quality measure via claims. Retaining the claims-based mechanism allows eligible professionals and group practices to begin to report on the electronic prescribing quality measure without the added cost of submitting data to a registry or purchasing an EHR system (if the eligible professional is using a standalone eRx system) as eligible professionals already report PFS charges via claims.
The following is a summary of the only comment we received regarding this proposal.
We are finalizing the claims-based reporting mechanism for purposes of reporting the electronic prescribing quality measure for the 2012 and 2013 incentives and the 2013 and 2014 payment adjustments. Accordingly, we are modifying 42 CFR 414.92 to reflect our decision to finalize this proposal.
In the proposed rule, we also proposed that if an eligible professional or group practice chooses the claims-based reporting mechanism, the eligible professional or group practice must directly submit data on the electronic prescribing quality measure (76 FR 42890). For eligible professionals and group practices participating in the eRx GPRO using the claims-based reporting mechanism for purposes of reporting the electronic prescribing measure during a 12-month incentive or payment adjustment reporting period, we proposed that all claims for services must be processed by us no later than two months after the respective reporting period, for the claim to be included in our data analysis. (For example, for an eligible professional using the 12-month, 2014 payment adjustment reporting period, all claims for services between January 1, 2012 and December 31, 2012 must be processed no later than February 22, 2013 to be included in our data analysis.) For eligible professionals and group practices using the claims-based reporting mechanism for purposes of reporting the electronic prescribing measure during a 6-month payment adjustment reporting period, we proposed that all claims for services must be processed by us by no later than one month after the respective reporting period, for the claim to be included in our data analysis. (For example, for an eligible professional using the 6-month, 2013 payment adjustment reporting period, all claims for services between January 1, 2012 and June 30, 2012 must be processed no later than July 27, 2012, for the claims to be included in our data analysis.) We invited but did not receive any public comment regarding the processing of claims. Therefore, for the reasons explained, we are finalizing these requirements. We believe that these requirements for using the claims-based reporting mechanism will allow sufficient time for eligible professionals to report the electronic prescribing measure, allow us to collect and analyze the data submitted by eligible professionals, and avoid retroactive adjustments of payments.
For purposes of reporting for the 2012 and 2013 incentives and the 2013 and 2014 payment adjustments, we proposed (76 FR 42891) to continue the registry-based reporting mechanism first introduced under the 2010 eRx Incentive Program. We believed this would provide an opportunity for individual eligible professionals and group practices who choose to participate in the Physician Quality Reporting System via registry to use the same reporting mechanism for reporting the electronic prescribing measure, and this would provide eligible professionals and group practices with another alternative reporting mechanism. In addition, unlike claims-based reporting, although there may be a cost associated with submitting data to a registry, reporting of the electronic prescribing measure to CMS is done entirely by the registry.
We also proposed that only registries qualified to submit quality measure results and numerator and denominator data on quality measures on behalf of eligible professionals for the Physician Quality Reporting System for the applicable calendar year would be qualified to submit measure results and numerator and denominator data on the
Some registries that self-nominate to become a qualified registry for the Physician Quality Reporting System may not choose to self-nominate to become a qualified registry for purposes for the eRx Incentive Program. We proposed that registries that want to qualify would need to submit measure results and numerator and denominator data on the electronic prescribing measure for reporting periods that occur during CYs 2012 and 2013 at the time that they submit their self-nomination letter for the 2012 and 2013 Physician Quality Reporting System, respectively. The self-nomination process and requirements for registries for the Physician Quality Reporting System, which also will apply to the registries for the eRx Incentive Program, are discussed in the Physician Quality Reporting System section VI.F.1.(d).(2). of this final rule with comment period. We will post a final list of qualified registries for the eRx Incentive Program for CYs 2012 and 2013 on the eRx Incentive Program section of the CMS Web site at
Since we proposed a 12-month reporting period for purposes of the 2012 and 2013 incentive and 6 and 12- month reporting periods for purposes of the 2013 and 2014 payment adjustments (as described in the section previously), we further proposed that qualified registries would need to submit the electronic prescribing measure for the eRx Incentive Program to us in two separate transmissions, based on the proposed reporting periods for the 2012 and 2013 incentive payments and 2013 and 2014 payment adjustments. Specifically, we proposed that qualified registries would need to submit 2012 and 2013 data on the electronic prescribing measure in two separate submissions:
• Following the end of the respective 6-month payment adjustment reporting period (between July 1, 2012 and August 19, 2012, for purposes of the 2013 eRx payment adjustment, and between July 1, 2013 and August 19, 2013, for purposes of the 2014 eRx payment adjustment); and
• Following the end of the 12-month reporting period for the 2012 and 2013 incentives and 2014 payment adjustment.
We invited public comment but received no comments on our proposed requirements for registry-based reporting for purposes of reporting for the 2012 and 2013 incentives, as well as for reporting during the 6-month and 12-month reporting periods for the 2013 and 2014 payment adjustments. We are modifying 42 CFR 414.92 to finalize the requirements for registry-based reporting for purpose of the 12-month reporting periods for the 2012 and 2013 incentives, and the 2014 payment adjustment. As stated previously, due to the operational issues associated with ensuring that qualified registries are able to allow for an additional submission instance, we are not finalizing registry-based reporting for the 6-month reporting periods for the 2013 and 2014 payment adjustments, and therefore, are not finalizing the corresponding registry requirements that we proposed. Therefore, qualified registries must submit the electronic prescribing quality measure for the eRx Incentive Program to us in one transmission, for the 12-month reporting periods applicable for the 2012 and 2013 incentive payments and the 2013 and 2014 payment adjustments. Specifically, qualified registries must submit 2012 and 2013 data on the electronic prescribing quality measure following the end of the respective 12-month reporting period for the 2012 and 2013 incentives and the 2014 payment adjustment.
For purposes of reporting for the 2012 and 2013 incentives and the 2014 payment adjustment, we proposed (76 FR 42891-42892) to retain the EHR-based reporting mechanism to encourage the use of EHR technology as well as provide eligible professionals and group practices with a third reporting option. We proposed this reporting mechanism to provide an opportunity for eligible professionals and group practices who choose to participate in the Physician Quality Reporting System via EHR, as well as eligible professionals who participate in the Medicaid or Medicare EHR Incentive Program, to use the same reporting mechanism for reporting the electronic prescribing measure under the eRx Incentive Program.
We proposed that EHR technology and EHR data submission vendors (as described by the Physician Quality Reporting System) “qualified” to submit extracted Medicare clinical quality data to us for the Physician Quality Reporting System would be able to be used by an eligible professional or group practice to submit data on the electronic prescribing measure for the 2012 and 2013 incentives and 2014 payment adjustment. The proposed self-nomination process and requirements for direct EHR-based reporting products and EHR data submission vendors for the Physician Quality Reporting System as discussed previously the proposed rule (76 FR 42846) would apply to the EHR products and EHR data submission vendors for the eRx Incentive Program. We hoped this third reporting option for eligible professionals and group practices would encourage the use of EHR technology.
We also proposed that direct EHR-based reporting vendors and EHR data submission vendors must indicate their desire to have one or more of their EHR products approved for use in the eRx Incentive Program for the reporting periods that occur in CYs 2012 and 2013 at the same time they self-nominate for the respective 2012 and 2013 Physician Quality Reporting System. We further noted that a list of approved EHR technology, their vendors (including the technology's version that is approved) for the eRx Incentive Program would be posted on the eRx Incentive Program section of the CMS Web site at
We also proposed that eligible professionals using their approved EHR systems must submit the electronic prescribing measure for the eRx Incentive Program to us in two separate submissions—
• Following the end of the respective 6-month payment adjustment reporting period (between July 1, 2012 and August 19, 2012, for purposes of the 2013 eRx payment adjustment, and between July 1, 2013 and August 19, 2013, for purposes of the 2014 eRx payment adjustment); and
• Following the end of the 12-month reporting period for the 2012 and 2013 incentives and 2014 payment adjustment.
Similarly, we proposed that EHR data submission vendors must submit the electronic prescribing measure to on behalf of eligible professionals to us in two separate submissions:
• Following the end of the respective 6-month payment adjustment reporting period (between July 1, 2012 and August 19, 2012, for purposes of the 2013 eRx payment adjustment, and between July 1, 2013 and August 19, 2013, for purposes of the 2014 eRx payment adjustment); and
• Following the end of the 12-month reporting period for the 2012 and 2013
We invited public comment but received no comments on our proposed requirements for EHR-based reporting for purposes of reporting for the 2012 and 2013 incentives and the 2013 and 2014 payment adjustments. As noted previously, however, we are not finalizing EHR-based reporting for the 6-month reporting periods for the 2013 and 2014 payment adjustments. Therefore, in this final rule with comment period, we are only finalizing the requirements discussed previously for reporting the electronic prescribing measure via the EHR-based reporting mechanism for the 12-month reporting period for the 2012 and 2013 incentives and the 2014 payment adjustment. We are modifying 42 CFR 414.92 to reflect these final requirements for EHR-based reporting.
42 CFR 414.92(d) governs the requirements for individual eligible professionals to qualify to receive an incentive payment. We proposed (76 FR 42892) to modify 42 CFR 414.92(d) to add the words “being a,” so that the provision reads:
In order to be considered a successful electronic prescriber and qualify to earn an electronic prescribing incentive payment (subject to paragraph (c)(3) of this section), an individual eligible professional, as identified by a unique TIN/NPI combination, must meet the criteria for being a successful electronic prescriber under section 1848(m)(3)(B) of the Act and as specified by CMS during the reporting period specified in paragraph (d)(1) of this section and using one of the reporting mechanisms specified in paragraph (d)(2) of this section. Although an eligible professional may attempt to qualify for the electronic prescribing incentive payment using more than one reporting mechanism (as specified in paragraph (d)(2) of this section), the eligible professional will receive only one electronic prescribing incentive payment per TIN/NPI combination for a program year.
We invited but did not receive any public comment on our proposal to make the technical change to 42 CFR 414.92(d). Therefore, since we believe this change provides more clarity to the provision, we are finalizing this proposed change.
Section 1848(m)(2)(B) of the Act imposes a limitation on the applicability of the eRx incentive payment. The Secretary is authorized to choose 1 of 2 possible criteria for determining whether or not the limitation applies to an eligible professional (or group practice)—
• Whether Medicare Part B allowed charges for covered professional services furnished by the eligible professional (or group practice) for the codes to which the electronic prescribing quality measure applies are less than 10 percent of the total Medicare Part B PFS allowed charges for all such covered professional services furnished by the eligible professional during the reporting period; OR
• Whether the eligible professional submits (both electronically and non-electronically) a sufficient number (as determined by the Secretary) of prescriptions under Part D (which can, again, be assessed using Part D drug claims data). If the Secretary decides to use this criterion, the criterion based on the reporting on electronic prescribing measures would no longer apply.
Based on our proposal to make the determination of whether an eligible professional or group practice is a “successful electronic prescriber” based on submission of the electronic prescribing measure (the first criterion), we proposed (76 FR 42892) to apply the criterion under section 1848(m)(2)(B)(i) of the Act for the limitation for both the 2012 and 2013 incentives. We invited but received no public comment on our proposal. Therefore, the 2012 and/or 2013 incentive is not applicable if the Medicare Part B allowed charges for covered professional services furnished by the eligible professional (or group practice) for the codes to which the electronic prescribing quality measure applies are less than 10 percent of the total Medicare Part B PFS allowed charges for all covered professional services furnished by the eligible professional or group practice during the reporting period.
For purposes of the 2012 and 2013 incentives, this analysis would be performed during the first quarters of 2013 and 2014 respectively by dividing the eligible professional's or participating group practice's total 2012 and 2013 respective Medicare Part B PFS allowed charges for all such covered professional services submitted for the measure's denominator codes by the eligible professional's or group practices' total Medicare Part B PFS allowed charges for all covered professional services. If the result is 10 percent or more, then the statutory limitation will not apply and a successful electronic prescriber would qualify to earn the electronic prescribing incentive payment. If the result is less than 10 percent, then the statutory limitation will apply, and the eligible professional or group practice will not earn an electronic prescribing incentive payment even if he or she meets the reporting criteria for being a successful electronic prescriber. Although an individual eligible professional or group practice may decide to conduct his or her own assessment of how likely this statutory limitation is expected to apply to him or her before deciding whether or not to report the electronic prescribing measure, an individual eligible professional or group practice may report the electronic prescribing measure without regard to the statutory limitation for the incentive payment.
Section 1848(m)(3)(D) of the Act authorizes the Secretary to revise the criteria for submitting data on the electronic prescribing measure under section 1848(m)(3)(B)(ii) of the Act, which requires the measure to be reported in at least 50 percent of the cases in which the measure is reportable.
For the 2012 and 2013 incentives, to maintain program consistency from year to year, we proposed (76 FR 42892) to make the determination of whether an individual eligible professional is a successful electronic prescriber for purposes of the incentive based on a count of the number of times (minimum threshold of 25) an eligible professional reports that at least one prescription created during the denominator-eligible encounter is generated using a qualified electronic prescribing system, which would include Certified EHR Technology (that is, reports the G8553 code when the eligible professional bills for one of the services included in the measure's denominator). We believe this criterion adequately addresses the goal of the eRx Incentive Program, specifically to promote the use of electronic prescribing systems.
We invited public comment on the proposed criteria for successful electronic prescriber and the following is a summary of the comments we received.
After considering the comments received and for the reasons stated in our responses, for the 2012 and 2013 incentives, we are finalizing the criteria for being a successful electronic prescriber as proposed for individual eligible professionals . A summary of the finalized criteria for being a successful electronic prescriber for purposes of the 2012 and 2013 incentives are described in the following Tables 73 and 74.
Under section 1848(m)(3)(B) of the Act, in order to qualify for the incentive payment, an eligible professional or group practice must be a “successful electronic prescriber.” To simplify the reporting criteria for group practices using the eRx GPRO used in prior years, we proposed (76 FR 42893) that, for the 2012 and 2013 incentive payments, to be a successful prescriber, a group practice using the eRx GPRO must report the electronic prescribing measure's numerator for at least 625 unique visits (for group practices comprised of 25-99 eligible professionals) or 2,500 unique visits (for group practices comprised of 100 or more eligible professionals) during the applicable reporting period. To obtain these reporting criteria, we multiplied the smallest group practice size for each respective threshold (that is, 25 for the first threshold and 100 for the second threshold) by the number of unique visits (25) an individual eligible professional must report on the electronic prescribing measure in order to qualify for an incentive payment. Although this may be a higher reporting threshold for group practices using the eRx GPRO comprised of 25-50 eligible professionals and group practices using the eRx GPRO comprised of 101-199 eligible professionals than in 2011, we believe it is still quite feasible for these group practices to meet the respective reporting threshold as this would be the reporting threshold should the members of the group practice choose to participate in the eRx Incentive Program as individual eligible professionals.
We invited but received no public comments on the proposed criteria for determining successful electronic prescribers for group practices reporting under the eRx GPRO reporting option for purposes of earning the 2012 and 2013 incentives. Therefore, we are finalizing the criteria as proposed. The
We are prohibited from making double payments under section 1848(m)(3)(C)(iii) of the Act, which requires that payments to a group practice shall be in lieu of the payments that would otherwise be made under the eRx Incentive Program to eligible professionals individually in the group practice for being a successful electronic prescriber. Accordingly, we proposed (76 FR 42893) to make incentive payments to group practices based on the determination that the group practice, as a whole, is a successful electronic prescriber for the respective program year. An individual eligible professional who is affiliated with a group practice participating in the eRx GPRO reporting option that meets the requirements of being a successful electronic prescriber under a group practice would not be eligible to earn a separate eRx incentive payment on the basis of the individual eligible professional meeting the criteria for successful electronic reporter at the individual level.
We invited but received no public comment on our proposal to prohibit double payments and are therefore finalizing this proposal. We also proposed to make a technical change to 42 CFR 414.92(g)(5)(ii) to modify “another” to “a” to clarify the provision. However, we inadvertently listed the wrong provision. The provision that we intended to modify was 42 CFR 414.92(e)(2)(ii). Since we believe this technical change will not substantively affect the regulation and believe this technical change will clarify this provision, we are making a technical change to modify “another” to “a” under 42 CFR 414.92(e)(2)(ii).
As previously stated, for 2012, 2013, and 2014, if the eligible professional is not a successful electronic prescriber for the reporting period for the year, the PFS amount for covered professional services furnished by such professionals during the year shall be less than the PFS amount that would otherwise apply by—
• 1.0 percent for 2012;
• 1.5 percent for 2013; and
• 2.0 percent for 2014.
We proposed (76 FR 42893) to modify 42 CFR 414.92 to provide further explanation of the requirements for individual eligible professionals and group practices for the 2013 and 2014 payment adjustment, as described later in this section. Paragraph 42 CFR 414.92(f) was designated to address “public reporting of an eligible professional's or group practice's Electronic Prescribing Incentive Program data.” However, we are redesignating this paragraph as 42 CFR 414.92(g). In its place, we are redesignating paragraph (f) so that 414.92(f) addresses the requirements for the 2013 and 2014 payment adjustments.
Whereas we believe that an incentive should be broadly available to encourage the widest possible adoption of electronic prescribing, even for low volume prescribers, we believe that a payment adjustment should be applied primarily to assure that those who have a large volume of prescribing do so electronically, without penalizing those for whom the adoption and use of an electronic prescribing system may be impractical given the low volume of prescribing. We proposed (76 FR 42893 through 42899) limitations on the applicability of the 2013 and 2014 payment adjustments. Specifically, we proposed that the 2013 and 2014 payment adjustments would not apply if:
• An eligible professional is not an MD, DO, podiatrist, nurse practitioner, or physician assistant as of June 30, 2012, for purposes of the 2013 payment adjustment and June 30, 2013, for purposes of the 2014 payment adjustment. Since these eligible professionals do not generally prescribe, we have excluded these eligible professionals from the eRx Incentive Program.
For purposes of determining whether an eligible professional is an MD, DO, podiatrist, nurse practitioner, or physician assistant we would use National Plan and Provider Enumeration System (NPPES) data. It is an eligible professional's responsibility to ensure that his or her primary taxonomy code in NPPES is accurate. However, in 2011, we also established a G-code, (G8644) that eligible professionals can use to report to us that they do not have prescribing privileges. We proposed to retain the reporting of this G-code for purposes of the 2013 and 2014 payment adjustments. For purposes of the 2013 payment adjustment, we proposed that eligible professionals who report this G-code must do so on a claim with dates of services during the 6-month reporting period (January 1, 2012 and June 30, 2012). For purposes of the 2014 payment adjustment, we proposed that eligible professionals who report this G-code must do so on a claim with dates of services during the 6-month reporting period (January 1, 2013 and June 30, 2013) so that we are able to distinguish whether a professional is reporting this G-code for the 2013 payment adjustment or the 2014 payment adjustment.
• The eligible professional's Medicare Part B allowed charges for covered professional services to which the electronic prescribing quality measure applies are less than 10 percent of the total Medicare Part B PFS allowed charges for all covered professional services furnished by the eligible professional during the respective payment adjustment reporting period. This is a required limitation under section 1848(m)(2)(B) of the Act. This calculation will be performed by dividing the eligible professional's total 2011 Medicare Part B PFS allowed charges for all such covered professional services submitted for the measure's denominator codes by the eligible professional's total Medicare Part B PFS allowed charges for all covered professional services (as assessed at the TIN/NPI level). If the result is 10 percent or more, then the statutory limitation will not apply. If the result is less than 10 percent, then the statutory limitation will apply. For the 12-month incentive and payment adjustment reporting periods, this calculation is expected to take place in the first quarter of the year following the reporting period (for example, in the first quarter of 2013 for the 12-month reporting period for the 2012 incentive). For the 6-month payment adjustment reporting period, this calculation is expected to take place within the calendar year for the respective 6-month reporting period (for example, within 2012 for the 6-month reporting period for the 2013 payment adjustment).
• An eligible professional does not have at least 100 cases (that is, claims for patient services) containing an encounter code that falls within the denominator of the electronic prescribing measure for dates of service during: the 6-month reporting period (January 1, 2012 through June 30, 2012) for the 2013 payment adjustment or the 6-month reporting period (January 1, 2013 through June 30, 2013) for the 2014 payment adjustment. If an eligible professional has less than 100 denominator-eligible instances in a 6-month period, this will be an indicator to us that the professional likely has a small Medicare patient population.
We invited but received no public comment on our proposed limitations to the 2013 and 2014 eRx payment adjustments for individual eligible professionals. Therefore, we are finalizing all of the above limitations to the 2013 and 2014 eRx payment adjustments for individual eligible professionals as proposed, as set forth at 42 CFR 414.92.
Section 1848(a)(5) of the Act requires a payment adjustment to be applied with respect to covered professional services furnished by an eligible professional in 2013 and 2014, if the eligible professional is not a successful electronic prescriber, as set forth in section 1848(m)(3)(B) of the Act, for the reporting period for the year. Section 1848(m)(3)(D) of the Act authorizes the Secretary to revise the criteria for submitting data on the electronic prescribing quality measure. In the 2011 PFS Final Rule with comment period, we established the same reporting criteria for being a successful electronic prescriber for purposes of the 2011 incentive and the 2013 payment adjustment, based on a 12-month reporting period in 2011 (75 FR 73565). In order to create another opportunity for an eligible professional to become a successful electronic prescriber for purposes of the 2013 payment adjustment, we proposed (76 FR 42894) that, based on the proposed 6-month reporting period, an eligible professional would be a successful electronic prescriber if he/she reports the electronic prescribing measure's numerator, that is, at least 1 prescription for Medicare Part B PFS patients was created during an encounter was generated and transmitted electronically using a qualified electronic prescribing system at least 10 times during the 6-month payment adjustment reporting period (that is, January 1, 2012 through June 30, 2012). Unlike the reporting criteria for the incentive payments where the numerator must be reported in connection with a denominator-eligible visit, for purposes of the 2013 and 2014 payment adjustments, we proposed that an eligible professional would be able to report the measure's numerator for any Medicare Part B PFS service provided during the reporting period, regardless of whether the code for such service appears in the denominator, because we recognize that eligible professionals may generate prescriptions during encounters that are not necessarily included in the measure's denominator.
We also sought to provide more than one opportunity for eligible professionals to avoid the 2014 payment adjustment by becoming a successful electronic prescriber. Therefore, consistent with the final criteria for successful electronic prescribing for purposes of the 2013 payment adjustment, we proposed (76 FR 42894 and 42895) the following criteria for an
As with the 2012 and 2013 incentive payments, we proposed that the determination of whether an eligible professional is subject to the payment adjustment would be made at the individual professional level, based on the NPI and for each unique TIN/NPI combination.
We proposed the previous criteria for being a successful electronic prescriber for purposes of the 2013 and 2014 payment adjustments because, aside from not requiring the reporting of the electronic prescribing measure's numerator for denominator-eligible encounters (which only applies to the 6-month, 2013 and 2014 payment adjustment reporting periods), they are consistent with the criteria for being a successful electronic prescriber for purposes of the 2012 and 2013 payment adjustments that were finalized in the CY 2011 PFS final rule with comment period (75 FR 73562 through 73565).
We invited public comment on the proposed criteria for being a successful electronic prescriber for the 2013 and 2014 payment adjustments for individual eligible professionals. The following is a summary of the comments received regarding these proposals.
After considering the comments received and for the reasons stated above, we are finalizing the proposed criteria for individual eligible professionals to be successful electronic prescribers for purposes of the 2013 and 2014 payment adjustments. Specifically, for purposes of the 2013 payment adjustment, an individual eligible professional is a successful electronic prescriber if an eligible professional reports the electronic prescribing measure's numerator at least 10 times during the 6-month 2013 payment adjustment reporting period (that is, January 1, 2012 through June 30, 2012, regardless of whether the encounter is associated with at least one denominator code of the electronic prescribing measure). For purposes of the 2014 payment adjustment, an eligible professional is a successful electronic prescriber if: (1) An eligible professional reports that at least one prescription for Medicare Part B PFS patients created during an encounter was generated and transmitted electronically using a qualified electronic prescribing system for at least 25 denominator-eligible visits during the 12-month payment adjustment reporting period (that is, January 1, 2012 through December 31, 2012) (note that this is the same criteria for the 2013 incentive); or (2) an eligible professional reports the electronic prescribing measure's numerator at least 10 times during the 6-month payment adjustment reporting period (that is, January 1, 2013 through June 30, 2013). Tables 77 and 78 reflect the final criteria we are adopting in this final rule with comment period for being a successful electronic prescriber for an individual eligible professional for purposes of the 2013 and 2014 payment adjustments, respectively.
Under section 1848(m)(3)(C) of the Act, we are also required to establish and have in place a process under which eligible professionals in a group practice shall be treated as a successful electronic prescriber for purposes of the payment adjustment. For purposes of the 2013 and 2014 payment adjustments, we proposed (76 FR 42895) that if a group practice chooses to participate in the eRx GPRO during CYs 2012 and 2013, respectively, then the group practice would be evaluated for applicability of the 2013 and 2014 payment adjustment as a group practice.
We proposed (76 FR 42895) an eRx GPRO would be a successful electronic prescriber for purposes of the 2013 payment adjustment if, during the 6-month reporting period (January 1, 2012 through June 30, 2012), a group practice reports the electronic prescribing measure's numerator (that is, that at least 1 prescription for Medicare Part B PFS patients created during an encounter was generated and transmitted electronically using a qualified electronic prescribing system) at least 625 times (for group practices comprised of 25 to 99 eligible professionals) or 2,500 times (for group practices comprised of 100+ eligible professionals).
Similarly, for the 2014 payment adjustment, we proposed (76 FR 42895) the following: A group practice would be a successful electronic prescriber if the group practice meets the 2012 criteria for being a successful electronic prescriber for purposes of the 2012 incentive payment. In other words, the group practice would need to report the electronic prescribing measure's numerator for at least 625 (for group practices comprised of 25 to 99 eligible professionals) or 2,500 (for group practices comprised of 100 or more eligible professionals) times for encounters associated with at least 1 of the denominator code that occurs between January 1, 2012 and December 31, 2012. In addition, we proposed that a group practice would also be a successful electronic prescriber for purposes of the 2014 payment adjustment if, during the 6-month reporting period (January 1, 2013 through June 30, 2013), a group practice reports the electronic prescribing measure's numerator (that is, that at least 1 prescription for Medicare Part B PFS patients created during an encounter was generated and transmitted electronically using a qualified electronic prescribing system) at least 625 times (for group practices with 25 to 99 eligible professionals) or 2,500 times (for group practices with 100+ eligible professionals).
We invited but received no public comments on the proposed criteria for being a successful electronic prescriber for group practices under the eRx GPROs for the 2013 and 2014 electronic prescribing payment adjustments. Therefore, we are finalizing our proposed criteria for the 2013 and 2014 payment adjustment as proposed. 79 and 80 summarize the criteria for being a successful electronic prescriber for a group practice for purposes of the 2013 and 2014 payment adjustments, respectively.
In addition, in accordance with the limitation under section 1848(m)(2)(B)(i) of the Act, the 2013 or 2014 payment adjustment does not apply to a group practice in which less than 10 percent of the group practice's estimated total allowed charges for the respective 6-month or 12-month payment adjustment reporting period are comprised of services which appear in the denominator of the 2012 or 2013 electronic prescribing measure. To be consistent with how this limitation is applied to group practices for purposes of the incentive, we proposed to determine whether this limitation applies to a group practice for the payment adjustment at the TIN level. Because we received no public comment on this proposal, we are finalizing this proposal as proposed.
Section 1848(a)(5)(B) of the Act provides that the Secretary may, on a case-by-case basis, exempt an eligible professional from the application of the payment adjustment, if the Secretary determines, subject to annual renewal, that compliance with the requirement for being a successful electronic prescriber would result in a significant hardship.
In the CY 2011 PFS final rule with comment period (75 FR 73564 through 75 FR 73565), we finalized two circumstances under which an eligible professional or eRx GPRO can request consideration for a significant hardship exemption for the 2012 eRx payment adjustment:
• The eligible professional or group practice practices in a rural area with limited high speed internet access.
• The eligible professional or group practice practices in an area with limited available pharmacies for electronic prescribing.
For the 2013 and 2014 payment adjustments, we proposed (76 FR 42896) to retain these two significant hardship exemption categories.
After publication of the CY 2011 PFS Final Rule with comment period, we received numerous requests to expand the categories under the significant hardship exemption for the payment adjustment. Some stakeholders recommended specific circumstances of significant hardship for our consideration (for example, eligible professionals who have prescribing privileges but do not prescribe under their NPI, eligible professionals who prescribe a high volume of narcotics, and eligible professionals who electronically prescribe but typically do not do so for any of the services included in the electronic prescribing measure's denominator), while others strongly suggested we consider increasing the number of specific hardship exemption categories. We believe that many of the circumstances raised by stakeholders may pose a significant hardship and limit eligible professionals and group practices in their ability to meet the requirements for being successful electronic prescribers either because of the nature of their practice or because of the limitations of the electronic prescribing measure itself, and as a result, such professionals might be unfairly penalized. Therefore, in the final rule entitled “Medicare Program; Changes to the Electronic Prescribing (eRx) Incentive Program” that was published in the September 6, 2011
• Inability to electronically prescribe due to local, state, or Federal law or regulation
• Eligible professionals who prescribe fewer than 100 prescriptions during a 6-month, payment adjustment reporting period
We proposed (76 FR 42896-42897) that, to the extent that local, State, or Federal law or regulation limits or prevents an eligible professional or group practice that otherwise has general prescribing authority from electronically prescribing (for example, eligible professionals who prescribe a large volume of narcotics, which may not be electronically prescribed in some states, or eligible professionals who practice in a State that prohibits or limits the transmission of electronic prescriptions via a third party network such as Surescripts), the eligible professional or group practice would be able to request consideration for an exemption from application of the 2013 and/or 2014 payment adjustments, which would be reviewed on a case-by-case basis. We believe eligible professionals in this situation face a significant hardship with regard to the requirements for being successful electronic prescribers because while they may meet the 10 percent threshold for applicability of the payment adjustment, or the 100 denominator-eligible cases limit in a 6-month payment adjustment reporting period, they may not have sufficient opportunities to meet the requirements for being a successful electronic prescriber because Federal, State, or local law or regulation limit the number of opportunities that an eligible professional or group practice has to electronically prescribe.
We proposed (76 FR 42897) that an eligible professional who has prescribing privileges, but prescribes fewer than 100 prescriptions during a 6-month, payment adjustment reporting period (for example, a nurse practitioner who may not write prescriptions under his or her own NPI, a physician who decides to let his Drug Enforcement Administration registration expire during the reporting period without renewing it, or, for purposes of the 2013 payment adjustment, an eligible professional who prescribed fewer than 100 prescriptions between January 1, 2012 and June 30, 2012 regardless of whether the prescriptions were electronically prescribed or not), yet
We invited public comments on our proposal to modify 42 CFR 414.92 to include the significant hardship exemption categories we proposed for the 2013 and 2014 payment adjustments. The following is a summary of the comments we received.
Specifically, with respect to eligible professionals who are over 60, eligible for social security benefits, or nearing retirement, we believe that these eligible professionals still have the ability to use electronic prescribing systems. With respect to eligible professionals who practice off-site, such as those practicing in nursing homes, we note that although these eligible professionals may not readily have an electronic prescribing system available, these eligible professionals still have the ability to provide an electronic prescription. With respect to system errors, in general, we understand that problems may occur with regard to successful reporting of the eRx measure. However, we do not believe that such errors constitute a significant hardship under section 1848(a)(5)(B) of the Act. Rather, these are reporting errors that may have prevented an eligible professional from successfully reporting the eRx measure.
Based on the comments received and for the reasons stated in our responses, we are finalizing the following significant hardship exemption categories for the 2013 and 2014 payment adjustments, which will be reflected under 42 CFR 414.92:
• The eligible professional or group practice practices in a rural area with limited high speed internet access.
• The eligible professional or group practice practices in an area with limited available pharmacies for electronic prescribing.
• Inability to electronically prescribe due to local, state, or Federal law or regulation.
• Eligible professionals who prescribe fewer than 100 prescriptions during a 6-month, payment adjustment reporting period.
To request a significant hardship exemption for any of the proposed categories, we proposed (76 FR 42897) that an eligible professional provide to us by the end of the 2013 and/or 2014 payment adjustment reporting periods (that is June 30, 2012 for the 2013 payment adjustment and June 30, 2013 for the 2014 payment adjustment), the following:
• The name of the practice and other identifying information (for example: TIN, NPI, mailing address, and email address of all affected eligible professionals.
• The significant hardship exemption category(ies) that apply.
• A justification statement describing how compliance with the requirement for being a successful electronic prescriber for the respective 2013 and/or 2014 payment adjustment during the reporting period would result in a significant hardship to the eligible professional. And that the justification statement be specific as to the category under which the eligible professional or group practice is submitting its request and include an explanation how the exemption applies.
• An attestation of the accuracy of the information provided.
We also proposed that eligible professionals or group practices would be able to submit significant hardship exemption requests using the web-based tool or interface (that we are also using for requests for exemptions due to significant hardships for the 2012 payment adjustment). We proposed that the following two hardships also be reportable by G-code on claims in addition to using the web-based tool or interface:
• The eligible professional or group practice practices in a rural area with limited high speed internet access (report G-code G9642).
• The eligible professional or group practice practices in an area with limited available pharmacies for electronic prescribing (report G-code G8643).
We also proposed that once we have completed our review of the eligible professional's or group practice's request and made a decision, we will notify the eligible professional or group practice of our decision and all such decisions would be final. Eligible professionals or group practices will not have the opportunity to request reconsiderations of their requests for significant hardship exemption. We invited public comment on the proposed process for individual eligible professionals and group practices for submitting these requests for significant hardship exemptions to us (including comments on the type of information we proposed eligible professionals must submit, the proposed options for how the information could be submitted, and the proposed timeframes for submission). The following is a summary of the comments received related to our proposed process for submitting requests for significant hardship exemptions.
Based on the comments received and for the reasons stated previously, we are finalizing the following process for submitting a request for a significant hardship exemption under the significant hardship exemption categories we are finalizing for the 2013 and 2014 payment adjustments.
Eligible professionals and group practices may report the following G-codes for the following significant hardship exemption categories on claims for services rendered during the respective 2013 and 2014 6-month reporting periods.
• The eligible professional or group practice practices in a rural area with limited high speed internet access (report G-code G9642).
• The eligible professional or group practice practices in an area with limited available pharmacies for electronic prescribing (report G-code G8643).
Eligible professionals may submit requests for a significant hardship exemption category with respect to any of the finalized significant hardship exemption categories via a web-based tool, the Communication Support Page, which is available at
• The name of the practice and other identifying information (for example: TIN, individual NPI, mailing address, and email address of all affected eligible professionals;
• The significant hardship exemption category(ies) that apply;
• A justification statement describing how compliance with the requirement for being a successful electronic prescriber for the respective 2013 and/or 2014 payment adjustment during the reporting period would result in a significant hardship to the eligible professional; and
• An attestation of the accuracy of the information provided—
++ The justification statement should be specific to the category under which the eligible professional or group practice is submitting its request and must explain how the exemption applies to the professional. For example, if the eligible professional is requesting a significant hardship exemption due to Federal, State, or local law or regulation, he or she must cite the applicable law and how the law restricts the eligible professional's ability to electronically prescribe. We will review the information submitted by each eligible professional on a case-by-case basis. In addition, an eligible professional or group practice must, upon request, provide additional supporting documentation if there is insufficient information (such as, but not limited to, a TIN or NPI that we cannot match to the Medicare claims, a certification number for the Certified EHR Technology that does not appear on the list of Certified EHR Technology, or an incomplete justification for the significant hardship exemption request) to justify the request or make the determination of whether a significant hardship exists.
Section 10331(a)(1) of the Affordable Care Act (42 U.S.C. 1395w-5 note) requires that, by no later than January 1, 2011, we develop a Physician Compare Internet Web site with information on physicians enrolled in the Medicare program under section 1866(j) of the Act as well as information on other eligible professionals who participate in the Physician Quality Reporting System under section 1848 of the Act (42 U.S.C. 1395w-4). Public reporting of performance results on standardized quality measures currently exists on
• Hospitals (Hospital Compare).
• Dialysis facilities (Dialysis Facility Compare).
• Nursing homes (Nursing Home Compare).
• Home health facilities (Home Health Compare).
As an initial step towards providing information on the quality of care for services furnished by physicians and other professionals to Medicare beneficiaries, we have enhanced the existing Physician and Other Health Care Professionals directory at
Section 10331(a)(2) of the Affordable Care Act also requires that, no later than January 1, 2013, and with respect to reporting periods that begin no earlier than January 1, 2012, we implement a plan for making information on physician performance publicly available through the Physician Compare Web site. To the extent that scientifically sound measures are developed and are available, we are required to include, to the extent practicable, the following types of measures for public reporting:
• Measures collected under the Physician Quality Reporting System.
• An assessment of patient health outcomes and functional status of patients.
• An assessment of the continuity and coordination of care and care transitions, including episodes of care and risk-adjusted resource use.
• An assessment of efficiency.
• An assessment of patient experience and patient, caregiver, and family engagement.
• An assessment of the safety, effectiveness, and timeliness of care.
• Other information as determined appropriate by the Secretary.
• Processes to ensure that data made public are statistically valid, reliable, and accurate, including risk adjustment mechanisms used by the Secretary.
• Processes for physicians and eligible professionals whose information is being publically reported to have a reasonable opportunity, as determined by the Secretary, to review their results before posting to Physician Compare.
• Processes to ensure the data published on Physician Compare provides a robust and accurate portrayal of a physician's performance.
• Data that reflects the care provided to all patients seen by physicians, under both the Medicare program and, to the extent applicable, other payers, to the extent such information would provide a more accurate portrayal of physician performance.
• Processes to ensure appropriate attribution of care when multiple and other providers are involved in the care of the patient.
• Processes to ensure timely statistical performance feedback is provided to physicians concerning the data published on Physician Compare.
• Implementation of computer and data infrastructure and systems used to support valid, reliable, and accurate reporting activities.
Section 10331(d) of the Affordable Care Act requires us to consider input from multi-stakeholder groups in selecting quality measures for Physician Compare. In developing the plan for making information on physician performance publicly available through the Physician Compare Web site, section 10331(e) of the Affordable Care Act requires the Secretary, as the Secretary deems appropriate, to consider the plan to transition to value-based purchasing for physicians and other practitioners that was developed under section 131(d) of the Medicare Improvements for Patients and Providers Act of 2008.
We are required, under section 10331(f) of the Affordable Care Act, to submit a report to the Congress by January 1, 2015 on the Physician Compare Web site developed, and include information on the efforts and plans to collect and publish data on physician quality and efficiency and on patient experience of care in support of value-based purchasing and consumer choice. Section 10331(g) of the Affordable Care Act provides that any time before that date, we may continue to expand the information made available on Physician Compare.
We believe section 10331 of the Affordable Care Act supports our overarching goals to foster transparency and public reporting by providing consumers with quality of care information to make informed decisions about their health care, while encouraging clinicians to improve on the quality of care they provide to their patients. In accordance with section 10331 of the Affordable Care Act, we intend to utilize the Physician Compare Web site to publicly report physician performance results.
For purposes of implementing a plan to publicly report physician performance, we plan to use data reported under the existing Physician Quality Reporting System as an initial step for making public physician “measure performance” information on Physician Compare. By “measure performance,” we mean the percent of times that a particular clinical quality action was reported as being performed, or a particular outcome was attained, for the applicable persons to whom a measure applies as described in the denominator for the measure.
The Physician Quality Reporting System is a readily available source of measures performance data. First implemented in 2007, the program has grown to include over 200 measures (see tables 47 through 72 in section VI.F.1.f. of this final rule with comment period for a list of the measures available for reporting in 2012). The measures used in the Physician Quality Reporting System cover a wide range of health conditions and topics and include measures applicable to most physician specialties and other clinicians. Work is underway to ensure consistency of quality measures reported under the Physician Quality Reporting System and the EHR Incentive Program.
The first phase of the plan to make information on physicians and other eligible professionals who participate in the Physician Quality Reporting System publically available was completed through the launch of the Physician Compare Web site and the posting of the names of those eligible professionals who satisfactorily participated in the Physician Quality Reporting System.
During the second phase of the plan, occurring in 2011 through 2012, we will continue to work towards the development and improvement of the Web site. Our plans for Physician Compare Web site development during this second phase include monthly data refreshes and a semiannual Web site release to incorporate updates and improvements to the Web site. Updates will include the addition of the names of eligible professionals who are successful electronic prescribers, as required by section 1848(m)(5)(G) of the Act, as well as the names of those eligible professionals who participate in the EHR Incentive Program, as required by section 1848(o)(3)(D) of the Act. Additional enhancements planned include the addition of links to specialty board Web sites that can provide more information on an eligible professional's board certification status and improved Web site functionality and layout.
Moving towards the reporting of physician performance information, we proposed to take an initial step by making public the performance rates of the quality measures that group practices submit under the 2012 Physician Quality Reporting System group practice reporting option (GPRO) (76 FR 42899). We also proposed to publicly report the performance rates of the quality measures that the group practices participating in the Physician Group Practice demonstration report on the Physician Compare Web site as early as 2013 for performance information collected in CY 2012. We would make public the measure performance for each of the measures included in the 2012 Physician Quality Reporting System GPRO. Since the quality measures in GPRO are reported for the group as a whole, the information on measure performance would also apply to the group as a whole, rather than to individual physicians within a group.
Public reporting of the group practices' 2012 measure performance results at the group practice level would begin public reporting at the earliest time specified by the statute. We believe the design of the GPRO (see section VI.F.b.2. of this final rule with comment pe) facilitates making public groups' performance results. All groups participating in the GPRO would be reporting on the same set of clinical quality measures, which allows for comparison of the results across groups.
To eliminate the risk of calculating performance rates based on a small denominator, we proposed to set a minimum patient sample size threshold (76 FR 42899). A minimum threshold of 25 patients would have to be met in order for the group practice's measure performance rate to be reported on the Physician Compare Web site. If the threshold of 25 patients is not met for a particular measure, the group's performance rate for that measure would be suppressed and not publicly reported. In determining the minimum patient sample size, we took into consideration the minimum patient sample size used by other Compare Web sites that publicly report measure performance data. We wanted to ensure that we used a number large enough to accurately reflect measure performance, but not so large that it would limit the number of groups for which measure performance could be reported. In taking into consideration the minimum patient sample size used by other Compare Web sites that publicly report measure performance data, we also considered a minimum patient sample size of 10 patients, 20 patients and 30 patients. As we are proposing to report measure performance at a group level and a majority of the other Compare Web sites use minimum sample sizes of between 20 and 30 patients, we concluded that a minimum patient sample size of 25 would meet our criteria (76 FR 42899).
We also proposed that group practices participating in the 2012 Physician Quality Reporting System GPRO would agree in advance to have their reporting performance results publicly reported as part of their self-nomination to participate in the 2012 Physician Quality Reporting System GPRO. Finally, we proposed to modify the GPRO web interface for 2012 to calculate the numerator, denominator, and measure performance rate for each measure from the data that the group practices use to populate the tool and provide each group practice this information at the time of data submission. This feature would allow the group practice the opportunity to review their measure performance results before they are made public in accordance with section 10331(b) of the Affordable Care Act. For groups reporting using GPRO information that is made public in 2013, we did not propose to post information with respect to the measure performance of individual physicians or eligible professionals associated with the group. However, we proposed to identify the individual eligible professionals who were associated with the group during the reporting period.
We believe a staged approach to public reporting of physician information allows for the use of information currently available while we develop the infrastructure necessary to support the collection of additional types of measures and public reporting of individual physicians' quality measure performance results. Implementation of subsequent phases of the plan will need to be developed and addressed in future notice and comment rulemaking, as needed. We invited comments regarding our proposals to: (1) To publicly report group practices' measure performance results in 2013 based on group practices' 2012 Physician Quality Reporting System performance results under GPRO; and (2) utilize a minimum patient sample size of 25 for reporting and displaying measure performance on the Physician Compare Web site.
We received several comments from the public on the CY 2012 PFS proposed rule related to the Physician Compare Web site. General comments about the Physician Compare Web site are addressed as follows.
Upon consideration of the comments and for the reasons we previously explained, we are finalizing our proposal to publicly report group practices' measure performance results in 2013 based on group practices' 2012 Physician Quality Reporting System performance results under GPRO. We are finalizing our proposal to use a minimum sample size of 25 patients for reporting and displaying measure performance on the Physician Compare Web site. Group practices participating in 2012 Physician Quality Reporting System GPRO must agree in advance to have their reporting performance results publicly reported as part of their self-nomination to participate in the 2012 Physician Quality Reporting System GPRO. We are also finalizing our proposal to modify the GPRO web
We proposed (76 FR 42899) changes to the method by which eligible professionals (EPs) would report clinical quality measures (CQMs) for the 2012 payment year for the Medicare EHR Incentive Program. Specifically, we proposed (76 FR 42900) that eligible professionals may satisfy the meaningful use objective to report CQMs to CMS by reporting them through: (1) Attestation; or (2)participation in the Physician Quality Reporting System-Medicare EHR Incentive Pilot. We received some comments that were not related to our proposals for the Medicare EHR Incentive Program for payment year 2012. While we appreciate the commenters' feedback, these comments are outside the scope of the issues addressed in this final rule.
We proposed (76 FR 42900) that for the 2012 payment year, EPs may continue to report CQM results as calculated by Certified EHR Technology by attestation, as for the 2011 payment year.
Based on the comments received and for the reasons stated in our responses, we are finalizing our proposal to allow EPs to continue to report CQM results as calculated by Certified EHR Technology by attestation for the 2012 payment year as proposed. We are revising 42 CFR 495.8(a)(2)(ii) as proposed.
In addition to attestation, we proposed (76 FR 42900) to establish a Pilot mechanism through which EPs participating in the Medicare EHR Incentive Program may report CQM information electronically using Certified EHR Technology for the 2012 payment year.
We proposed to modify 42 CFR 495.8(a)(2) by adding a new paragraph to allow for the reporting of CQMs for the Medicare EHR Incentive Program via the Physician Quality Reporting System-Medicare EHR Incentive Pilot. Section 1848(o)(2)(B)(ii) of the Act provides authority for the Secretary to accept information on CQMs electronically on a Pilot basis. We proposed that EPs may participate in the Pilot on a voluntary basis, and that those EPs who choose not to participate may instead continue to attest to the results of the CQMs as calculated by Certified EHR Technology, consistent with the CQM reporting method for the 2011 payment year. However, we encourage participation in the Pilot based on our desire to adequately pilot electronic submission of CQMs and to move to a system of reporting where EPs can satisfy both the CQM reporting requirements for the EHR Incentive Program and the reporting requirements for the Physician Quality Reporting System EHR-based reporting mechanism with a single submission to their respective EHR systems, who will then provide calculated results to CMS in the form and manner specified for each respective program. To participate in the Physician Quality Reporting System-Medicare EHR Incentive Pilot, we proposed that EPs would be required to electronically report the CQMs using Certified EHR Technology via one of two options that are based on the existing reporting platforms of the Physician Quality Reporting System. As described later in this section, one option would be based on the infrastructure used for the Physician Quality Reporting System EHR data submission vendor reporting mechanism as described in section VI.F.1.d.3.B of this final rule with comment period. The second option would be based on the infrastructure used for the Physician Quality Reporting System EHR reporting mechanism as described in section VI.F.1.d.3.A of this final rule with comment period. EPs who seek to participate in the Physician Quality Reporting System-Medicare EHR Incentive Pilot must also participate in the Physician Quality Reporting System itself, because the Pilot will rely on the infrastructure used for the Physician Quality Reporting System.
To move towards the integration of reporting on quality measures under the Physician Quality Reporting System with the reporting requirements of the Medicare EHR Incentive Program, as required by section 1848(m)(7) of the Act (“Integration of Physician Quality Reporting and EHR Reporting”), we proposed that participation in the Physician Quality Reporting System-Medicare EHR Incentive Pilot would require EPs to submit information on the same CQMs that were adopted for EPs for the Medicare EHR Incentive Program and included in Tables 6 and 7 of the July 28, 2010 final rule (75 FR 44398 through 44410). We proposed that EPs participating in this Pilot must submit information on the three core measures included in Table 7, up to
To participate in the Physician Quality Reporting System-Medicare EHR Incentive Pilot, we proposed EPs would be required to electronically report the CQMs by choosing one of the options described later in this section. By submitting the required information through the Pilot, we proposed that an EP could submit data on the same sample of beneficiaries to his/her EHR system to meet the core objective for reporting CQMs for the Medicare EHR Incentive Program for the 2012 payment year and the requirements for satisfactory reporting under the Physician Quality Reporting System. After attesting to all other meaningful use objectives, the EP's attestation file would be placed in a holding status with respect to the CQM objective only, until the EP reports the CQMs via one of the Physician Quality Reporting System-Medicare EHR Incentive Pilot options. Thus, the EP would not know if he/she successfully met the requirements for the Medicare EHR Incentive Program with respect to the CQM objective until the CQMs are received at the end of the submission period for measures for the Physician Quality Reporting System (we expect this would be 2 months after the close of the reporting period, which is the CY 2012, and no later than February 28, 2013). As explained later in this section, any EP participating in this Pilot would be required to report CQMs based on a full calendar year, regardless of the EP's year of participation in the Medicare EHR Incentive Program.
We also proposed (76 FR 42901) that an EP who selects one of the Pilot options and subsequently determines that completion of the Pilot is unfeasible may go back into the Medicare EHR Incentive Program attestation module on the CMS Web site and complete attestation for the CQMs assuming it is within the reporting timeframes established under the EHR Incentive Program. Although it is possible that an EP may find completion of the Pilot unfeasible, we note that participating in the Pilot provides the following advantage to EPs: participation in this Physician Quality Reporting System-Medicare EHR Incentive Pilot would allow for the receipt of EHR Incentive Program and Physician Quality Reporting System incentives, provided an EP meets the provisions described later in this section. We noted that although the EHR Incentive Program requires EPs to use Certified EHR Technology, for purposes of participating in the Physician Quality Reporting System-Medicare EHR Incentive Pilot, an EP's Certified EHR Technology must also conform to the qualifications for an EHR under the Physician Quality Reporting System.
Please note that if an EP chooses to report CQMs through attestation and also participate in the Physician Quality Reporting System-Medicare EHR Incentive Pilot, for purposes of receiving an EHR Incentive Program incentive, an EP's attestation file would not need to be placed in a holding status for the CQM objective. However, as stated previously, the analysis of data for purposes of the Physician Quality Reporting System incentive will not be made until after the submission period for measures for the Physician Quality Reporting System.
Based on the comments received and for the reasons stated in our responses, we are finalizing our proposal to allow EPs to report CQMs for the EHR Incentive Program through the Physician Quality Reporting System-Medicare EHR Incentive Pilot for the 2012 payment year as proposed.
As discussed further in the Physician Quality Reporting System section VI.F.1(d).(3).(b). of this final rule with comment period, we proposed (76 FR 42901) that EPs participating in the Physician Quality Reporting System may choose to report the Physician Quality Reporting System measures to CMS via a Physician Quality Reporting System qualified EHR data submission vendor. For purposes of the Physician Quality Reporting System, a Physician Quality Reporting System qualified EHR data submission vendor will receive data from an EP's EHR and subsequently reformat and transmit the data in aggregate form on behalf of the EP to CMS. We noted that we expect to post a list of the 2012 Physician Quality Reporting System EHR data submission vendors that are qualified to submit data from an EP's Certified EHR Technology to CMS on the EP's behalf on the Physician Quality Reporting System section of the CMS Web site (
Under this option, the Physician Quality Reporting System qualified EHR data submission vendor would calculate the CQMs from the EP's Certified EHR Technology and then submit the calculated results to CMS on the EP's behalf via a secure portal for purposes of this Pilot. We explained that under this option, the calculated results would be different from what is required by the July 28, 2010 final rule in that the data would be: (1) Limited to Medicare patients rather than all patients; and (2) based on a CQM reporting period of 1 calendar year regardless of the EP's year of participation in the Medicare EHR Incentive Program.
The following is a summary of the comments we received on the proposed EHR data submission vendor-based reporting option under the Physician Quality Reporting System-Medicare EHR Incentive Pilot.
Based on the comments received and for the reasons stated in our responses, we are finalizing the EHR data submission vendor-based reporting option for the Physician Quality Reporting System-Medicare EHR Incentive Pilot as proposed.
As discussed further in the Physician Quality Reporting System section VI.F.1.(d).(3).(a). of this final rule with comment period, we proposed (76 FR 42901) that EPs participating in the Physician Quality Reporting System via the direct EHR-based reporting mechanism can choose to report the Physician Quality Reporting System measures to CMS directly from the EP's EHR. Therefore, under this direct EHR-based reporting option, we proposed (76 FR 42901) that an EP participating in the Physician Quality Reporting System-Medicare EHR Incentive Pilot would submit CQM data directly from his or her Certified EHR Technology to CMS via a secure portal using the infrastructure of the Physician Quality Reporting System EHR reporting mechanism. We proposed that in order to participate in the Physician Quality Reporting System-Medicare EHR Incentive Pilot under this option, the
Under this direct EHR-based reporting option, the data would be different from what is required by the July 28, 2010 final rule in that it would be: (1) limited to Medicare patients rather than all patients; (2) patient-level
In addition, we proposed (76 FR 42901) that if an EP successfully submits all required CQM data from Certified EHR Technology, which also must be a Physician Quality Reporting System qualified EHR product, directly to CMS, then the EP would also meet the criteria for satisfactory reporting under the 2012 Physician Quality Reporting System, which would also qualify the EP for an incentive under the 2012 Physician Quality Reporting System.
The following is a summary of the comments we received related to the direct EHR-based reporting option under the Physician Quality Reporting System-Medicare EHR Incentive Pilot.
We note that there are EHR systems that are both “qualified” to report Physician Quality Reporting System quality measures and classified as Certified EHR Technology for purposes of reporting under the EHR Incentive Program. A list of EHR products that are both “qualified” and Certified EHR Technology will be made available on the Physician Quality Reporting System Web site, available at
Based on the comments received and for the reasons stated in our responses, we are finalizing the EHR-based reporting option under the Physician Quality Reporting System-Medicare EHR Incentive Pilot as proposed.
The Medicare EHR Incentive Program clinical quality measures, including the core and alternate core measures, and the 38 additional measures, are found in the Physician Quality Reporting System's Table 48 of this final rule with comment period.
We proposed (76 FR 42902) that EPs who wish to participate in the Physician Quality Reporting System-Medicare EHR Incentive Pilot would be able to indicate within the EHR Incentive Program attestation module their intent to fulfill the meaningful use objective of reporting CQMs by participating in the Physician Quality Reporting System-Medicare EHR Incentive Pilot. The EHR Incentive Program attestation module is available on the CMS Web site at
Based on the comments received and for the reasons stated previously, we are finalizing our method to indicate election to participate in the Physician Quality Reporting System-Medicare EHR Incentive Pilot as proposed.
In the proposed rule, we described the statutory requirements governing the Physician Feedback Program and the Physician Value-Based Payment Modifier (“value modifier”), which will be applied to the Physician Fee Schedule starting in 2015 for certain physicians and groups of physicians and, starting in 2017 for all physicians and other eligible professionals as the Secretary determines appropriate (76 FR 42908). In particular, we proposed that certain of the quality of care measures in the Physician Quality Reporting System and the Electronic Health Records (EHR) Incentive Program be used to evaluate the quality of care in the value modifier (76 FR 42909 through 42912). In addition, we described how the quality of care measures that
In this final rule with comment period, we emphasize the connection between our physician quality programs—the Physician Quality Reporting System, the EHR Incentive Program, the value modifier, and the Physician Feedback Program. Our primary interests in aligning these programs are to increase the quality of care for Medicare beneficiaries, to provide a common basis to do so that does not increase physician reporting burden, and to provide fair and meaningful information to physicians on ways to improve the quality of care they furnish.
We also emphasized in the proposed rule that given the complexity of measuring physician performance and calculating the value modifier, we are proceeding cautiously with transparency and outreach in a variety of ways to obtain stakeholder input. We discuss in this final rule with comment period several ways we plan to engage stakeholders to obtain input as we move forward to implement the value modifier over the coming years.
Section 1848(p) of the Act requires the Secretary to “establish a payment modifier that provides for differential payment to a physician or a group of physicians” under the physician fee schedule “based upon the quality of care furnished compared to cost * * * during a performance period.” The provision requires that “such payment modifier be separate from the geographic adjustment factors” established for the physician fee schedule. In addition, section 1848(p)(4)(C) of the Act requires that the value modifier be implemented in a budget-neutral manner. Budget neutrality means that payments will increase for some physicians but decrease for others, but the aggregate amount of Medicare spending in any given year for physicians' services will not change as a result of application of the value modifier.
Section 1848(p)(4)(B)(iii) of the Act requires the Secretary to apply the value modifier beginning January 1, 2015 to specific physicians and groups of physicians the Secretary determines appropriate. This section also requires the Secretary to apply the value modifier with respect to all physicians and groups of physicians (and may apply to eligible professionals as defined in subsection (k)(3)(B) of the Act as the Secretary determines appropriate) beginning not later than January 1, 2017.
We view the value modifier as an important component in revamping how care and services are paid for under the physician fee schedule. Currently, payments under the physician fee schedule are generally based on the relative resources involved with furnishing each service, and are adjusted for differences in resource inputs among geographic areas. Thus, all physicians in a geographic area are paid the same amount for individual services regardless of the quality of care or outcomes of services they furnish.
Although the fee schedule payments will soon be adjusted depending upon whether eligible professionals are satisfactory reporters of Physician Quality Reporting System quality measures, successful electronic prescribers and meaningful users of electronic health records (EHRs), these adjustments do not currently take into account performance on the quality measures collected under these programs. In addition, the fee schedule does not take into account the overall costs of services furnished or ordered by physicians for individual Medicare beneficiaries. These limitations mean that the physician fee schedule does not contain incentives for physicians to focus on: (1) The quality and outcomes of all the care furnished to beneficiaries; (2) the relative value of each service they furnish or order; or (3) the cumulative costs of their own services and the services that their beneficiaries receive from other providers.
We noted in the proposed rule that Medicare is beginning to implement value-based payment adjustments for other types of services, including hospital services, skilled nursing facilities, home health agencies, and ambulatory surgical centers (76 FR 42908). In implementing value-based purchasing initiatives generally, we seek to meet the following goals:
• Improving quality.
++ Value-based payment systems and public reporting should rely on a mix of standards, processes, outcomes, and patient experience measures, including measures of care transitions and changes in patient functional status. Across all programs, we seek to move as quickly as possible to the use of outcome and patient experience measures. To the extent practicable and appropriate, we believe these outcome and patient experience measures should be adjusted for risk or other appropriate patient population or provider characteristics.
++ To the extent possible, and recognizing differences in payment system readiness and statutory requirements and authorities, measures should be aligned across Medicare and Medicaid's public reporting and payment systems. We seek to evolve a focused core set of measures appropriate to each specific provider category that reflects the level of care and the most important areas of service and measures for a particular provider.
++ The collection of information should minimize the burden on providers to the extent possible. As part of that effort, we will continuously seek to align our measures with the adoption of meaningful use standards for health information technology (HIT), so the collection of performance information is part of care delivery.
++ To the extent practicable, measures used by us should be nationally endorsed by a multi-stakeholder organization. Measures should be aligned with best practices among other payers and the needs of the end users of the measures.
• Lowering per-capita growth in expenditures.
++ Providers should be accountable for the costs of care, and be rewarded for reducing unnecessary expenditures and be responsible for excess expenditures.
++ In reducing excess expenditures, reductions should not compromise patient care and providers should continually improve the quality of care they deliver.
++ To the extent possible, and recognizing differences in payers' value based purchasing initiatives, providers should apply -quality-improving and cost-reducing redesigned care processes to their entire patient population.
Section 1848(p)(4)(A) of the Act requires us to publish, not later than January 1, 2012, three items related to the establishment of the value modifier: (a) the quality of care and cost measures established by the Secretary for purposes of the modifier; (b) the dates for implementation of the value modifier; and (c) the initial performance period for application of the value modifier in 2015. In the proposed rule we made proposals for each of these requirements and we discuss each below.
Section 1848(p)(2) of the Act requires that physician quality of care be
For purposes of section 1848(p)(4)(A)(i) of the Act, we proposed to use performance on: (1) The measures in the core set of the Physician Quality Reporting System for 2012; (2) all measures in the Group Practice Reporting Option of the Physician Quality Reporting System for 2012; and (3) the core measures, alternate core, and 38 additional measures in the EHR Incentive Program measures for 2012 (76 FR 42909). We requested comment on the proposed measures, on our interest to establish a core measure set for the value modifier, and whether to include additional (or exclude) measures from the Physician Quality Reporting System in the quality of care measures for the value modifier.
We also proposed that, to the extent that the 2013 measures adopted for the Physician Quality Reporting System and EHR Incentive Program are different than those used in 2012, we would consider, through rulemaking next year, revising the value modifier quality measures applicable to 2013 to be consistent with the revisions made to the measures for those programs.
MedPAC suggested that “the use of a large number of [quality] measures in the value modifier could increase the year-to-year statistical variability, and therefore uncertainty, into the annual calculation of each physician's or physician group's value modifier.” MedPAC recommended that we concentrate on a few key population-based outcomes, patient experience, and clinical process measures. A few commenters supported including outcome measures that assess the rate of potentially preventable hospital admissions for six ambulatory care sensitive conditions at the group practice level: diabetes, bacterial pneumonia, dehydration, COPD, urinary tract infection, and heart failure.
Many physician specialty societies indicated that the proposed quality measures did not have measures relevant to the practice of their physicians or to the conditions they treat and, therefore, it would not be possible to calculate a quality composite for them. Most prominently in this category were surgeons and surgical specialties, hospital-based physicians, and medical subspecialists. Some medical specialists, for example cardiologists and endocrinologists, commented that proposed measures which seemed applicable to them did not measure the quality of care provided by subspecialists. These commenters stated that they would work with us to develop relevant clinical measures and to assist in obtaining National Quality Forum endorsement of new measures.
Of the proposed measures in the EHR Incentive program set for 2012, several commenters opposed including PQRS measure #200 (Heart Failure: Warfarin Therapy for Patients with Atrial Fibrillation) because clinical guidelines have been updated and those changes are not currently reflected in the PQRS measure.
A number of commenters suggested that the value modifier's quality of care measures should directly correspond to the proposed condition-specific cost measures. One commenter suggested that for hospital-based physicians, CMS align the quality measures in the hospital value-based purchasing program with the physician value modifier.
We agree with commenters' concerns about PQRS measure #200 and we will not include it in the value modifier for the initial performance period because its specifications have not been updated.
We anticipate assessing physician performance for more conditions and/or by specialty in subsequent years after the methodological issues surrounding the value modifier are finalized. We believe that we will ultimately need to include quality of care measures applicable to most physicians and highly prevalent conditions, as well as measures for specific types of physicians, in order to calculate a value modifier for every physician by 2017. We agree with commenters that we should concentrate on outcome, patient experience, and clinical process measures in the value modifier. As a first step in that direction, we will include outcome measures that assess the rate of potentially preventable hospital admissions for two of the six ambulatory care sensitive conditions at the group practice level that we have used in the Physician Feedback Program reports: heart failure and chronic obstructive pulmonary disease. We have chosen these two measures because they are important conditions among Medicare FFS beneficiaries and, based on our 2010 Physician Feedback Program group reports, contain sample sizes sufficient for reliable measurement.
In addition, we also clarify that we do not seek to evaluate individual physicians on each measure we proposed or include in a future set of measures, but rather to assess physician performance using quality of care measures for the types of care they provide and the measures they report.
Nonetheless, we agree with commenters that we should match our quality of care measures with the cost measures that we have proposed for specific conditions. In the discussion below, we proposed per capita cost measures for beneficiaries with four chronic conditions (chronic obstructive pulmonary disease; heart failure; coronary artery disease; and diabetes) in the value modifier. To match these cost measures with the quality of care measures, we anticipate that we will propose in next year's rulemaking to include the additional measures for each of these conditions from the Physician Quality Reporting System measure groups that are not already included in the measure set we are finalizing in this final rule with comment period.
We agree that we should use NQF-endorsed measures of quality where appropriate. In addition, we will reach out to physician specialty organizations for conditions where we lack measures or for conditions where we have cost measures but insufficient quality measures in order to develop a robust value modifier.
We are finalizing our proposal, for individual physicians to whom the value modifier will apply, to include the core set of the Physician Quality Reporting System for 2012 and the core measures, alternate core, and additional measures in the EHR incentive program for 2012 (except for PQRS measure #200 as discussed previously). These measures are listed in Table 80.
For physicians practicing in groups, the measures we are finalizing for the value modifier include all measures in the Group Practice Reporting Option of the Physician Quality Reporting System for 2012 and the rates of potentially preventable hospital admissions for two ambulatory care sensitive conditions at the group practice level: heart failure and chronic obstructive pulmonary disease. These measures are listed in Table 81.
We expect to update these quality of care measures based on the measures finalized in subsequent rulemaking under the Physician Quality Reporting System and the EHR Incentive Program for the initial performance year. By doing so, we anticipate the value modifier would use the same quality of care measures that are included in the Physician Quality Reporting System and/or the EHR Incentive Program for the initial performance year. To the extent physicians are already reporting the quality of care measures under the Physician Quality Reporting System and/or the EHR Incentive Program, this step would reduce program inconsistencies and reduce the reporting burden on physicians.
We explained in the proposed rule that one of the goals of this notice and comment rulemaking is to identify potential measures that could provide a richer picture of the quality of care furnished by a physician (76 FR 42911). For example, we indicated that we are interested in quality measures that assess the care provided by specialists. We specifically requested comment from specialists about measures that were not included in the list of proposed measures. In addition, we also requested comment on outcome, care coordination/transition, patient safety, patient experience, and functional status measures (which are discussed below) as well as the 28 administrative claims measures (described below with respect to the 2010 Physician Feedback reports disseminated in 2011) and whether we should include them in the value modifier. We especially urged the physician community and private payers that have been engaged in pay-for-performance programs to identify other quality measures that they have used and to describe their experience with these measures. We requested comment on how these measures align with current private sector quality measurement initiatives.
As discussed previously, we sought comment on the use of measures in the future that assess the rate of potentially preventable hospital admissions for six ambulatory care-sensitive conditions at the practice group level: diabetes, bacterial pneumonia, dehydration, chronic obstructive pulmonary disease (COPD), urinary tract infection, and heart failure (76 FR 42912). We also sought comment on an all-cause hospital readmission measure.
We also sought suggestions on other outcome measures that would be appropriate measures of the quality of care furnished for purposes of the value modifier, such as measures that examine emergency room use for ambulatory care sensitive conditions. We indicated we were interested in outcome measures that can be calculated from existing Medicare claims data and do not require additional reporting by physicians. In addition, we stated we were particularly interested in comments on potential measures of complications that would be appropriate to include in the value modifier (76 FR 42912).
We also noted in the proposed rule that care transitions such as transition of a beneficiary from an inpatient setting to the community or to a post-acute setting are important aspects of quality of care furnished (76 FR 42912). We requested input about these and other potential aspects of care coordination/transitions for which measures could be developed and/or used for purposes of the value modifier.
We explained in the proposed rule that measures of patient safety, patient experience, and functional status were important dimensions of care for the value modifier (76 FR 42912). We sought comment about potential patient safety measures that could be developed and/or used for purposes of the value modifier. To the extent commenters were aware of potential measures of patient safety, patient experience, or functional status that we could use, we welcomed such suggestions.
Section 1848(p)(3) of the Act requires that cost measures used in the value modifier be evaluated, to the extent practicable, based on a composite of appropriate measures of costs established by the Secretary. This composite would eliminate the effect of geographic adjustments in payment rates and account for risk factors and other factors so that physicians and groups of physicians would be compared on an equal basis. In other words, comparisons of the quality of care furnished compared to cost would be on an “apples-to-apples” basis so that physicians in high cost areas would not be penalized unfairly and
We proposed to use total per capita cost measures and per capita cost measures for beneficiaries with four chronic conditions (COPD; heart failure; coronary artery disease; and diabetes) in the value modifier (76 FR 42913). Our 2010 Physician Feedback Program reports use a total per capita cost measure and per capita cost measures for the overall costs for beneficiaries with these four chronic conditions. These per capita cost measures are adjusted for geographic differences and they are risk adjusted to ensure geographic and clinical comparability, as required by section 1848(p)(3) of the Act.
We explained that these cost measures would be compared to the quality of care furnished for use in determining the value modifier.
Several commenters questioned CMS' methodology to eliminate geographic differences in Medicare's payment and, in particular, how the Geographic Price Cost Indices (GPCIs) would be handled. In addition, commenters stated that the risk adjustment methodology we currently use for the cost measures in the Physician Feedback Program was not sufficiently robust to adequately account for the differences among patient populations especially those that cared for high acuity populations. Many commenters said that until a risk adjustment methodology could adequately adjust for patient factors outside of the physician's control like severity of disease or patient adherence, it would not be possible to calculate a meaningful composite of cost for the value modifier. Many commenters expressed the desire for increased communication and transparency about the methodology for the composites that will comprise the value modifier.
We believe that the current risk adjustment methodology, the hierarchal condition categories model (HCC), reasonably predicts high- and low-cost beneficiaries.
The methodology we currently use in the Physician Feedback Program reports to ensure we compare Medicare payments on an “apples-to-apples” basis equalizes the differences in payment rates due to geography among the same class of providers.
We agree with commenters that our risk adjustment and price standardization methodologies must be transparent. In the next several months, we will host public events to further gather input on the value modifier and explain the price standardization and risk adjustment methodologies so that physicians and other stakeholders have a full understanding of our efforts to ensure fair and accurate calculation of per capita costs.
After consideration of the public comments we received, we are finalizing our proposal to use total per capita cost measures and per capita cost measures for beneficiaries with four specific chronic conditions (chronic obstructive pulmonary disease, heart failure, coronary artery disease, and diabetes) in the value modifier.
Section 1848(n)(9)(A) of the Act requires us to develop by January 1, 2012, an episode grouper that combines separate, but clinically related items and services into an episode of care for an individual, as appropriate. We explained that during 2012 we will test and plan how to use an “episode grouper” (76 FR 42913).
As a transition to implementing the episode grouper, we explained that we could use cost measures based on the inpatient hospital Medicare Severity Diagnosis Related Groups (MS-DRG) classification system. We requested comment on whether we should pursue the MS-DRG approach in the near term while we develop episode-based cost measures for a significant number of high-cost and high-volume conditions in the Medicare program. In addition, we specifically sought comment on the resource and cost measures used in private sector initiatives and how they are used to profile physicians compared to the quality of care provided.
We explained in the proposed rule that there a number of issues related to the implementation of the value modifier including steps for both measurement of performance and application of payment adjustments (76 FR 42913). Although we did not make
We realize that for some physicians, the transition to a focus on value will require a new way of thinking about the practice of medicine. And, it is important that value is being assessed in a manner which acknowledges and takes into account the diversity of patient conditions and physician practices. Given this backdrop, we stated that we intend to move deliberately and carefully because we recognize the complexities of calculating a reliable and valid measure of value that could be used to differentiate payment.
Notwithstanding this caution, we have used the 2010 Physician Feedback Program reports to help develop attribution methodologies for physicians and physician groups and to use them as a mechanism to gain feedback into the value modifier and its methodologies. In addition, we have standardized Medicare costs and applied the HCC risk adjustment model to physician per capita costs in these reports. As discussed previously, we will be convening public events to further explore these issues and to gather stakeholder input based on these reports and the methodologies we have applied.
We also will use the next several months, before the 2013 physician fee schedule rulemaking process begins, to explore various ways to develop composites of cost and quality that could be used in the value modifier and to hold listening sessions and engage in other activities with stakeholders to gain input into the value modifier. We will continue our work to implement the statutory directives and plan to propose in next year's physician fee schedule rulemaking a methodology for the value modifier.
Section 1848(p)(4)(B)(ii)(I) of the Act requires the Secretary to specify an initial performance period for the application of the value modifier with respect to 2015. We proposed that the initial performance period be the full calendar year 2013, that is, January 1, 2013 through December 31, 2013 (76 FR 42913). The value modifier that would apply to items and services furnished by specific physicians and groups of physicians under the 2015 physician fee schedule would be based on performance during 2013. We proposed this performance period because some claims for 2013 (which could be used in cost or quality measures) may not be fully processed until 2014. As such, we will need adequate lead time to collect performance data, assess performance, and construct and compute the value modifier during 2014 so that it can be applied to specific physicians starting January 1, 2015, as required by statute. As we have done in other payment systems, we plan to use claims that are paid within a specified time period, such as, 90 days after 2013, for assessment of performance and application of the value modifier for 2015. We will propose the specific cut-off period as part of the more detailed methodology for computation and application of the value modifier in future rulemaking(s). We requested comment on this proposed performance period.
We explored using 2015 as the performance period and making retroactive adjustments in 2016 to claims paid for care furnished in 2015. This retroactive approach would require us to reprocess all 2015 claims so that each claim shows actual amounts paid. Additionally, retroactive adjustments affect beneficiary cost sharing amounts, which also would need to be adjusted retrospectively. Requiring physicians to collect or refund small cost sharing amounts is operationally complex and confusing for beneficiaries. These same two issues arise if we were to use calendar year 2014 as the performance period for the 2015 payment adjustment year.
We also examined whether we could use an abbreviated period (such as, 6 months) or a period that crossed years (such as, July 1-June 30) as the performance period. The former approach is unlikely to yield sufficient volume of cases to develop reliable measures for individual physicians and the latter approach is inconsistent with reporting periods currently established for the Physician Quality Reporting System and the EHR Incentive Program.
Despite these challenges, we are still seeking other ways to close the gap between the performance period and the payment adjustment period. In the interim, however, we are finalizing our proposal that calendar year 2013 be the initial performance period, because it aligns with the Physician Quality Reporting System and the EHR Incentive Program and because the alternatives are more onerous to physicians and beneficiaries than our original proposal. We will reexamine the initial performance period in future rulemakings as we seek to provide more timely feedback to physicians.
We also requested comment on two issues related to the development of the value modifier, although we did not make proposals to address either issue in the proposed rule. First, section 1848(p)(5) of the Act requires the Secretary, as appropriate, to apply the value-based modifier in a manner that promotes systems-based care. We sought comment on how we might determine the scope of systems-based care and how best to promote it in applying the value modifier. Second, section 1848(p)(6) of the Act requires the Secretary in applying the value modifier, as appropriate, to take into account the special circumstances of physicians or groups of physicians in rural areas and other underserved communities. We requested comment on how we should identify physicians or groups of physicians in rural areas and other underserved communities, the specific special circumstances they face, and once identified, how these special circumstances should be taken into account for purposes of applying the value modifier (76 FR 42914).
Section 1848(n) requires us to provide confidential reports to physicians that measure the resources involved in furnishing care to Medicare beneficiaries. Section 1848(n)(1)(A)(iii) of the Act also authorizes us to include information on the quality of care furnished to Medicare beneficiaries by a physician or group of physicians. We have completed two phases of the Physician Feedback Program. By the end of 2011, we intend to implement Phase III of the Physician Feedback Program by providing reports on both resource use and quality measures to physician groups that participated in the Group Practice Reporting Option (GPRO-1) in 2010 and to physicians practicing in the following States: Iowa, Kansas, Missouri, and Nebraska. As we explained previously, many of the methodological issues that we are addressing in the Physician Feedback Program reports will assist us as we implement the value modifier.
We explained in the proposed rule that we are using the quality measures reported in the Physician Quality Reporting System in the Physician Feedback Program reports that we disseminate this year (76 FR 42903). We took this step because use of Physician Quality Reporting System measures aligns both quality initiatives and reduces potential program inconsistencies, ensures we do not measure the same clinical process or outcome using different data sources or methodologies, and does not place new reporting burdens on physicians. Although we did not make any proposals in this area, we requested
We described in the proposed rule how we intended to create physician feedback reports for the 35 large medical group practices (each with 200 or more physicians) that chose to participate in the Physician Quality Reporting System Group Practice Reporting Option (GPRO-1) in 2010 (76 FR 42903). In addition, we described how we planned to disseminate Physician Feedback Program reports to individual physicians paid under the Physician Fee Schedule within four States: Iowa, Kansas, Missouri, and Nebraska (76 FR 42904). We explained that we chose these four States because the Medicare Administrative Contractor serving these States could assist us in emailing these reports to a substantial number of physicians because of its robust electronic communications infrastructure.
We stated in the proposed rule that deciding which physician(s) is/are responsible for the care of which beneficiaries is an important aspect of measurement (76 FR 42907). When attributing beneficiary cost information to physicians, we stated that we must balance between costs for delivered services that are within the physician's control and costs for delivered services that are not within their control. We recognized that attribution rules have the potential to alter incentives regarding how physicians coordinate and deliver care to beneficiaries and seek to encourage better care coordination and accountability for patient outcomes. In addition, determining how to make relevant comparisons of physicians to a standard or to their peers is also an important policy aspect of the Physician Feedback Program.
In light of these issues, we indicated that the individual physician reports that we are disseminating this year will allow more Medicare beneficiaries to be matched to physicians for purposes of assessing the quality of care furnished and the associated resources. In addition, we indicated that the reports will stratify physicians by specialty and by the conditions they treat, which allow both cost and clinical measures to reflect procedures and services that best portray physician practice patterns. Finally, we stated we intended to examine whether to provide reports to groups of physicians who submit Medicare claims under a single tax identification number (TIN) to see if we can provide feedback reports that cover more physicians. Although we did not make any proposals in this area, we requested comment on these and any other issues to ensure that the future Physician Feedback Program reports provide meaningful and actionable information.
• Use methodological approaches that increase the number of physicians eligible to receive a report, such as (a) multiple provider attribution methods, which could also enhance credibility of the reports with physicians and (b) distributing feedback reports that include only resource use information, if quality information is unavailable.
• Conduct statistical analyses of the impact of key methodological decisions on reliability.
• Identify factors that may have prevented physicians from accessing their reports and, as applicable, develop strategies to improve the process for distributing reports and facilitating physicians' access to them.
• Obtain input from a sample of physicians who received feedback reports on the usefulness and credibility of the performance measures contained in the reports and consider using this information to revise future reports.
As we discussed with GAO, we are taking steps this year to address many of the issues that they raised regarding the first two phases of the Physician Feedback program.
For example, on September 26, 2011, we distributed physician reports to the physician groups that participated in the Group Reporting Option in the Physician Quality Reporting System in 2010. These reports represent the first time performance on a wide-range of quality of care and cost measures can be viewed in the same report for Medicare beneficiaries in large group practices across the country. As recommended by the GAO, we invited all report recipients to provide us input on the usefulness and credibility of the performance measures contained in the report so that we could improve the reports for future years. We will be releasing publicly the general findings from these reports. This analysis will include statistical analysis of the impact of key methodological decisions on reliability that the GAO recommended that we conduct.
In addition, the reports that we are producing for individual physicians in Iowa, Kansas, Missouri, and Nebraska will contain quality performance data on the 28 administrative claims-based measures described in the proposed rule (76 FR 42904 through 42907) for all physicians and performance on the Physician Quality Reporting System
This approach addresses the GAO's recommendations to use methodological approaches to increase the number of physicians eligible to receive a report. We will invite report recipients to provide us input to increase the usefulness and credibility of future individual physician reports and we will be conducting statistical analysis of the impact of our methodological decisions on reliability as recommended by the GAO. In addition, we have taken steps this year to overcome the barriers that have prevented physicians from accessing their reports in the past and we will be working on developing future strategies to improve the process for distributing the reports in the future, as recommended by the GAO.
Section 1877 of the Act prohibits a physician from referring a Medicare beneficiary for certain designated health services (DHS) to an entity with which the physician (or a member of the physician's immediate family) has a financial relationship, unless an exception applies. Section 1877 of the Act also prohibits the DHS entity from submitting claims to Medicare or billing the beneficiary or any other entity for Medicare DHS that are furnished as a result of a prohibited referral.
Section 1877(h)(6) of the Act and § 411.351 of our regulations specify that the following services are DHS:
• Clinical laboratory services.
• Physical therapy services.
• Occupational therapy services.
• Outpatient speech-language pathology services.
• Radiology services.
• Radiation therapy services and supplies.
• Durable medical equipment and supplies.
• Parenteral and enteral nutrients, equipment, and supplies.
• Prosthetics, orthotics, and prosthetic devices and supplies.
• Home health services.
• Outpatient prescription drugs.
• Inpatient and outpatient hospital services.
In § 411.351, we specify that the entire scope of four DHS categories is defined in a list of CPT/HCPCS codes (the Code List), which is updated annually to account for changes in the most recent CPT and HCPCS publications. The DHS categories defined and updated in this manner are as follows:
• Clinical laboratory services.
• Physical therapy, occupational therapy, and outpatient speech-language pathology services.
• Radiology and certain other imaging services.
• Radiation therapy services and supplies.
The Code List also identifies those items and services that may qualify for either of the following two exceptions to the physician self-referral prohibition:
• Dialysis-related drugs furnished in or by an ESRD facility (§ 411.355(g)).
• Preventive screening tests, immunizations, or vaccines (§ 411.355(h)).
The definition of DHS at § 411.351 excludes services that are reimbursed by Medicare as part of a composite rate (unless the services are specifically identified as DHS and are themselves payable through a composite rate, such as home health and inpatient and outpatient hospital services). Effective January 1, 2011, EPO and other dialysis-related drugs furnished by an ESRD facility (except drugs for which there are no injectable equivalents or other forms of administration) are being paid under the ESRD PPS promulgated in the final rule published on August 12, 2010 in the
The Code List was last updated in Addendum J of the CY 2011 PFS final rule with comment period (75 FR 73831 through 73841) and revised in a subsequent correction notice (76 FR 1670).
We received no public comments relating to the Code List that became effective January 1, 2011.
The updated, comprehensive Code List effective January 1, 2012, is listed as Addendum J in this final rule with comment period and is available on our Web site at
Additions and deletions to the Code List conform the Code List to the most recent publications of CPT and HCPCS and to changes in Medicare coverage policy and payment status.
The following Tables 83 and 84, identify the additions and deletions, respectively, to the comprehensive Code List that become effective January 1, 2012. Tables 83 and 84 also identify the additions and deletions to the list of codes used to identify the items and services that may qualify for the exception in § 411.355(g) (regarding dialysis-related outpatient prescription drugs furnished in or by an ESRD facility) and in § 411.355(h) (regarding preventive screening tests, immunizations, and vaccines).
In Table 82, we specify additions that reflect new CPT and HCPCS codes that become effective January 1, 2012, or that became effective since our last update. We also include additions that reflect changes in Medicare coverage policy or
Table 83 reflects the deletions necessary to conform the Code List to the most recent publications of the CPT and HCPCS, and to changes in Medicare coverage policy and payment status. In addition, we are deleting CPT code 96110 from the category of “physical therapy, occupational therapy, and outpatient speech-language pathology services” because the code was revised. It has been replaced by HCPCS code G0451, which is listed in Table 82.
We will consider comments regarding the codes listed in 83 and 84. Comments will be considered if we receive them by the date specified in the “DATES” section of this final rule with comment period. We will not consider any comment that advocates a substantive change to any of the DHS defined in § 411.351.
We proposed and are now finalizing a technical correction to the heading of the condition of coverage at § 410.62(b) for outpatient speech-language pathology services. The heading was inadvertently changed in the course of rulemaking for CY 2009 when a new paragraph was added at § 410.62(c) to recognize speech-language pathologists in private practice. The section heading at § 410.62(b) currently reads “Special provisions for services furnished by speech-language pathologists in private practice.” We did not receive public comments on our proposal to make a technical correction to § 410.62(b), as such, we are finalizing the change to reinstate the correct heading at § 410.62(b) to read “Condition for coverage of outpatient speech-language pathology services furnished to certain inpatients of a hospital or a CAH or SNF.”
We proposed to make two technical corrections to Subpart H of the regulations for Outpatient Diabetes Self-Management Training and Diabetes Outcome Measurements at § 410.140 to the definition of “deemed entity” and at § 410.141(b)(1) entitled “training orders”. We did not receive public comments on either proposal; as a result we are finalizing both of these technical corrections as proposed and discussed below.
a. Changes to the Definition of Deemed Entity
We proposed and are now finalizing the following technical corrections to the definition of “deemed entity” in § 410.140 to—
• Remove the following phrases to clarify the purpose of the reference to an approved entity:
++ “[B]y CMS to furnish and receive Medicare payment for the training”.
++ “Upon being approved”.
++ “CMS refers to this entity as an “approved entity””.
• Remove an incorrect reference to § 410.141(e) and replacing it with § 410.145(b).
The final revisions read as follows:
We proposed and are now finalizing the following technical correction to § 410.141(b)(1) entitled “training orders” to:
• Remove the cross-reference “§ 410.32(a)” and adding the cross-reference “§ 410.32(a)(2)”.
• Remove the term “it” and adding the phrase “the training” in its place.
The final revisions read as follows:
In the CY 2012 PFS proposed rule (76 FR 42920), we proposed technical corrections to the regulation at § 414.22(b) to include examples of the settings in which the facility or nonfacility practice expense (PE) RVUs are applied and to clarify that the settings list was not exhaustive. We proposed adding “hospice” after “community mental health center” under § 414.22(b)(5)(i)(A) as a setting in which facility PE RVUs apply. We proposed revising the language under § 414.22(b)(5)(i)(B) to include “comprehensive outpatient rehabilitation facility (CORF)” as a setting in which nonfacility PE RVUs are applied, and we proposed to revise the description of outpatient therapy services.
We are finalizing the following technical corrections to the regulation at § 414.22(b):
• In paragraphs (b)(5)(i)(A) and (B), we—
++ Included additional examples of the settings in which the facility or nonfacility practice expense (PE) RVUs are applied, respectively; and
++ Clarified that the lists of settings are not exhaustive; and amended these lists to include additional place of service examples.
• In paragraph (b)(5)(i)(A) we added “hospice” to the list of places of service after “community mental health center.”
• In paragraph (b)(5)(i)(B), we—
++ Revised the language to be more consistent with (b)(5)(i)(A) and to include the “comprehensive outpatient rehabilitation facility (CORF)” as a place of service example; and
++ Clarified this provision by removing the text regarding the use of the nonfacility PE RVUs for services in “ * * * a facility or institution other than the hospital, skilled nursing facility, community mental health center, or ASC” because this phrase does not accurately reflect the places of service where the nonfacility PE RVUs are applied.
• In paragraph (b)(5)(i)(C), we—
++ Revised the paragraph introduction by adding “and CORF” after “outpatient therapy” and before “services” and, to more accurately define the term “outpatient therapy services,” to add “(including physical therapy, occupational therapy and speech-language pathology services)” after “therapy services” and before “CORF services billed under * * *”.
The final revisions to § 414.22(b)(5)(i)(A), (B), and (C) read as follows:
(A)
(B)
(C)
We ordinarily publish a notice of proposed rulemaking in the
We utilize HCPCS codes for Medicare payment purposes. The HCPCS is a national drug coding system comprised of Level I (CPT) codes and Level II (HCPCS National Codes) that are intended to provide uniformity to coding procedures, services, and supplies across all types of medical providers and suppliers. Level I (CPT) codes are copyrighted by the AMA and consist of several categories, including Category I codes which are 5-digit numeric codes, and Category III codes which are temporary codes to track emerging technology, services, and procedures. The AMA issues an annual update of the CPT code set each Fall, with January 1 as the effective date for implementing the updated CPT codes. The HCPCS, including both Level I and Level II codes, is similarly updated annually on a CY basis. Annual coding changes are not available to the public until the Fall immediately preceding the annual January update of the PFS. Because of the timing of the release of these new codes, it is impracticable for us to provide prior notice and solicit comment on these codes and the RVUs assigned to them in advance of publication of the final rule that implements the PFS. Yet, it is imperative that these coding changes be
For the reasons previously outlined in this section, we find good cause to waive the notice of proposed rulemaking for the interim RVUs for selected procedure codes identified in Addendum C and to establish RVUs for these codes on an interim final basis. We are providing a 60-day public comment period.
Section II.C. of this final rule with comment period discusses the identification and review of potentially misvalued codes by the AMA RUC, as well as our review and decisions regarding the AMA RUC recommendations. Similar to the AMA RUC recommendations for new and revised codes previously discussed, due to the timing of the AMA RUC recommendations for the potentially misvalued codes, it was impracticable for CMS to solicit public comment regarding specific proposals for revision prior to this final rule with comment period. We believe it is in the public interest to implement the revised RVUs for the codes that were identified as misvalued, and that have been reviewed and re-evaluated by the AMA RUC, on an interim final basis for CY 2012. The revisions of RVUs for these codes will establish a more appropriate payment that better corresponds to the relative resources associated with furnishing these services. A delay in implementing revised values for these misvalued codes would not only perpetuate the known misvaluation for these services, it would also perpetuate a distortion in the payment for other services under the PFS. Implementing the changes now allows for a more equitable distribution of payments across all PFS services. We believe a delay in implementation of these revisions would be contrary to the public interest, particularly since the AMA RUC process allows for an assessment of the valuation of these services by the medical community prior to the AMA RUC's recommendation to CMS. For the reasons previously described, we find good cause to waive notice and comment procedures with respect to the misvalued codes identified in Tables 19 through 22 and to revise RVUs for these codes on an interim final basis. We are providing a 60-day public comment period.
We ordinarily provide a 60-day delay in the effective date of the provisions of a rule in accordance with the Administrative Procedure Act (APA) (5 U.S.C. 553(d)), which requires a 30-day delayed effective date, and the Congressional Review Act (5 U.S.C. 801(a)(3)), which requires a 60-day delayed effective date for major rules. However, we can waive the delay in the effective date if the Secretary finds, for good cause, that the delay is impracticable, unnecessary, or contrary to the public interest, and incorporates a statement of the finding and the reasons in the rule issued (5 U.S.C. 553(d)(3); 5 U.S.C. 808(2)).
Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our estimate of the information collection burden.
• The quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
Section 4103 of the Affordable Care Act expanded Medicare Part B to include coverage for an annual wellness visit providing personalized prevention plan services (hereinafter referred to as an annual wellness visit) in section 1861(s)(2)(FF) of the Act, effective January 1, 2011. In 42 CFR 410.15, we adopted the components of the annual wellness visit, consistent with the statutory elements described in section 1861(hhh)(2) of the Act. The first and subsequent annual wellness visits, as defined in 42 CFR 410.15(a), are meant to represent a beneficiary visit focused on prevention. Among other things, the annual wellness visit encourages beneficiaries to obtain the preventive services covered by Medicare that are appropriate for them. First and subsequent annual wellness visits also include elements that focus on the furnishing of personalized health advice and referral, as appropriate, to health education, preventive counseling services, programs aimed at improving self-management, and community-based lifestyle interventions.
Medicare beneficiaries will likely need assistance from physician office staff in completing an HRA as envisioned in the CDC interim guidance. The physician office staff time for assisting a beneficiary in completing an HRA is estimated to be 10 minutes (.16 hours) for a first annual wellness visit. During subsequent annual wellness visits, we would typically expect that the HRA would be updated, making physician staff time estimated at 5 minutes (.08 hours). The number of beneficiaries that received the annual wellness visit during the first 10 months of 2011 was 1.6 million. Based on this information, the estimated hour burden for the initial HRA is 256,000 total hours. However, for purposes of OMB review and approval, the average annual burden which accounts both the initial HRA and subsequent HRAs is 200,000
The final rule with comment period imposes collection of information requirements as outlined in the regulation text and specified in various section of this final rule with comment period. However, this final rule with comment period also makes reference to several associated information collections that are not discussed in the regulation text contained in this document. The following is a discussion of these information collections, some of which have already received OMB approval.
The discussion of average sales price (ASP) issues in section VI.A.1 of this final rule with comment period pertains to payment for Medicare Part B drugs and biologicals under the ASP methodology. Drug manufacturers are required to submit ASP data to us on a quarterly basis. The ASP reporting requirements are set forth in section 1927(b) of the Act. In order to facilitate more accurate and consistent ASP data reporting from manufacturers, we proposed the following:
• To revise existing reporting fields and add new fields to the Addendum A template.
• To add a macro to the Addendum A template that will allow manufacturers to validate the format of their data prior to submission.
• To maintain a list of HCPCS codes for which manufacturer's report ASPs for NDCs on the basis of a specified unit.
• A clarification to existing regulation text at § 414.802. Current regulation text states that “Unit means the product represented by the 11 digit National Drug Code.” We proposed to update the definition to account for situations when an alternative unit of reporting must be used.
Additionally, we will also be revising our instructions for the reporting of dermal grafting products in a user guide available on the ASP Web site at:
The burden associated with this requirement is the time and effort required by manufacturers of Medicare Part B drugs and biologicals to calculate, record, and submit the required data to CMS. The Addendum A template is currently approved under OMB control number 0938-0921. For the first year, we estimate that collection of the additional data elements will take approximately 2 additional hours for each submission of data, or 12 hours per response, at a cost of $252 per response. Based on the current number of respondents, we estimate that this requirement will affect approximately 180 manufacturers. Since manufacturers will respond 4 times per year, we estimate that, on an annual basis, the annual number of responses will be 720 (180 manufacturers × 4 responses) and the total annual hours burden will be 8,640 hours (720 annual responses × 12 annual hours per response). Please note that this is a corrected annual hour burden estimate; the 34,560 hour estimate in the proposed rule (76 FR 42921) resulted from a mathematical error. We estimate the annual cost burden to be $181,440 ($252 per response × 720 responses). Once manufacturers adjust to the changes associated with electronic reporting after the first year, we anticipate that the burden estimate will decrease.
We invited comments on this burden analysis, including the underlying assumptions used in developing our burden estimates and received no comments. We have corrected a mathematical error associated with the total annual burden which decreases the hourly burden. The cost estimate remains unchanged. Operational aspects and comments regarding the ASP template were discussed in section VI.A.3 of this rule where we finalized our proposal to amend the Addendum A template, including the use of a data validation macro with the expansion of the “Alternate ID” field. A companion Users' Guide, and other documents will be posted on the CMS ASP Web site.
Section VI.F.1. of this final rule with comment period discusses the background of the Physician Quality Reporting System, provides information about the measures and reporting mechanisms that will be available to eligible professionals and group practices who choose to participate in the 2012 Physician Quality Reporting System, and the criteria for satisfactory reporting in 2012.
With respect to satisfactory submission of data on quality measures by eligible professionals, eligible professionals include physicians, other practitioners as described in section 1842(b)(18)(c) of the Act, physical and occupational therapists, qualified speech-language pathologists, and qualified audiologists. Eligible professionals may choose whether to participate and, to the extent they satisfactorily submit data on quality measures for covered professional services, they can qualify to receive an incentive payment. To qualify to receive an incentive payment for 2012, the eligible professional (or group practice) must meet one of the criteria for satisfactory reporting described in section VI.F.1.e. or VI.F.1.f. of this final rule with comment period (or section VI.F.1.g. for group practices).
Because this is a voluntary program, it is difficult to accurately estimate how many eligible professionals will opt to participate in the Physician Quality Reporting System in CY 2012. Information from the “Physician Quality Reporting System 2009 Reporting Experience Report” (hereinafter 2009 Experience Report) which is available on the Physician Quality Reporting System section of the CMS Web site at
We invited but received no public comment on our estimates regarding the projected participation in the 2012 Physician Quality Reporting System. However, for the reasons explained below, we believe that more eligible professionals will participate in the Physician Quality Reporting System in 2012 than in 2009.
According to the 2009 Experience Report, the number of eligible professionals eligible to participate and actually participating in the Physician Quality Reporting System has increased each year from 2007 through 2009. Participation in the Physician Quality Reporting System has increased from 98,696 out of 621,840 eligible professionals in 2007 to 164,828 out of 977,415 eligible professionals in 2008 to 221,858 out of 1,042,260 eligible professionals in 2009.
With respect to participation in 2008, 66,132 more eligible professionals participated in the 2008 Physician Quality Reporting System (then called the Physician Quality Reporting Initiative or PQRI) than in 2007. The percentage of eligible professionals participating in 2008 also increased from 16 percent in 2007 to 17 percent in 2008. We believe that this increase
• An increased number of professionals eligible to participate in the Physician Quality Reporting System in 2008: The number of professionals eligible to participate increased from 621,840 to 977,415 professionals from 2007 to 2008.
• Increased familiarity with the program: The Physician Quality Reporting System was first implemented in 2007. As such, we believe that our efforts to educate the public on the Physician Quality Reporting System through education and outreach efforts as well as general increased familiarity of the availability of earning incentives by satisfactorily reporting Physician Quality Reporting System measures led to an increase in program participation.
• The introduction of the registry-based reporting mechanism: In 2007, the claims-based reporting mechanism was the only reporting mechanism available for reporting Physician Quality Reporting System quality measures. In 2008, eligible professionals were able to submit data on Physician Quality Reporting System quality measures via the registry-based reporting mechanism as well.
• The introduction of reporting Physician Quality Reporting System quality measures via measures groups in addition to reporting measures individually: The reporting of Physician Quality Reporting System quality measures via measures groups was not available in 2007. However, in 2008, eligible professionals had the option of reporting Physician Quality Reporting System quality measures via measures groups via claims and registry.
• An increased number of measures and measures groups available for reporting under the Physician Quality Reporting System.
With respect to participation in 2009, 64,648 more eligible professionals participated in the 2009 Physician Quality Reporting System (then called the Physician Quality Reporting Initiative or PQRI) than in 2008. The percentage of eligible professionals participating in 2008 also increased from 17 percent in 2008 to 21 percent in 2009. We believe that this increase was due to a number of factors, including but not exclusive to:
• An increased number of professionals eligible to participate in the Physician Quality Reporting System in 2008: The number of professionals eligible to participate increased from 977,415 to 1,042,260 professionals from 2008 to 2009.
• Increased familiarity with the program.
• An increased incentive payment amount for satisfactory reporting from 1.5 percent in 2008 to 2.0 percent in 2009.
• An increased number of measures and measures groups available for reporting under the Physician Quality Reporting System.
Accordingly, we expect participation in the 2012 Physician Quality Reporting System to increase due to a number of factors, including but not exclusive to:
• Increased familiarity with the program: 2012 will mark the 6th year since the Physician Quality Reporting System was first implemented.
• The availability of the EHR-based reporting mechanism: As described in further detail in section VI.F.1.d.3 of this final rule with comment period, for 2012, we finalized two options under EHR-based reporting mechanism by which eligible professionals may utilize to submit data on Physician Quality Reporting System quality measures: The EHR data submission vendor and direct EHR options.
• An increased number of measures and measures groups available for reporting under the Physician Quality Reporting System: As described in further detail in section VI.F.1.f of this final rule with comment period, we have added additional measures available for claims, registry, and/or EHR-based reporting as well as additional measures groups available for claims and/or registry reporting.
• The establishment of CY 2013 as the reporting period for the 2015 payment adjustment. As described in greater detail in section VI.F.1.j of this final rule with comment period, we finalized our proposal to establish CY 2013 as the reporting period for the 2015 payment adjustment. We expect that more eligible professionals will attempt to meet the criteria for satisfactory reporting in 2012 before the 2015 payment adjustment reporting period commences on January 1, 2013.
• Alignment and incorporation of certain Physician Quality Reporting System reporting requirements under other CMS programs, such as the EHR Incentive Program and the Medicare Shared Savings Program. In an effort to align various CMS quality reporting programs, we have created reporting requirements under other CMS programs that are similar or identical to those required under the Physician Quality Reporting System. For example, as described in greater detail under section VI.F.1.e.3 of this final rule with comment period, we established reporting criteria that satisfy both the Physician Quality Reporting System incentive and fulfill the CQM requirement for achieving meaningful use under the EHR Incentive Program (75 FR 44409 through 44411). In addition, as described in section VI.F.4 of this final rule with comment period, the EHR Incentive Program established the Physician Quality Reporting System-Medicare EHR Incentive Pilot, whereby eligible professionals may data on the same sample of beneficiaries to fulfill the requirements for satisfactory reporting under the Physician Quality Reporting System while also fulfilling the CQM reporting requirements for achieving meaningful use under the EHR Incentive Program.
As finalized in the final rule entitled “Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations,” displayed in the
Furthermore, as stated in section VI.I of this final rule, under the Physician Feedback Program, we plan to use the Physician Quality Reporting System quality measures in the Physician Feedback reports we disseminate, and we are finalizing certain measures from the Physician Quality Repoting System and EHR Incentive Program for purposes of the Physician value modifier, which will be applied beginning in CY 2015.
According to the 2009 Experience Report, we have seen a 1 percent and 4 percent increase in participation in the Physician Quality Reporting System from 2007 to 2008 and 2008 to 2009 respectively. Based on our above assumptions, we believe we will see at least a 1 percent increase in the number of eligible professionals participating in the Physician Quality Reporting System from 2011 to 2012. Information on participation rates for the 2010 and 2011 Physician Quality Reporting System is not yet available. Therefore, for purposes of determining how many eligible professionals will participate in 2012, we will assume a 1 percent increase in participation each program year from 2009 through 2012. Therefore, we assume that 224,076 eligible professionals (a 1 percent increase from 221,858) participated in the 2010 Physician Quality Reporting System. We then assume that 226,316 eligible professionals participated in the 2011 Physician Quality Reporting System (a 1
As we stated in the proposed rule (76 FR 42921), we believe that the burden for eligible professionals who are participating in the Physician Quality Reporting System for the first time in 2012 will be considerably higher than the burden for eligible professionals who have participated in the Physician Quality Reporting System in prior years. As described below, some preparatory steps are needed to begin participating in the Physician Quality Reporting System. To the extent that we did not retire the measures that an eligible professional has reported in a prior year and there are no changes to the measure's specifications from a prior year, such preparatory steps will not need to be repeated in subsequent years.
For individual eligible professionals, in the proposed rule (76 FR 42922), we noted that the burden associated with the requirements of this reporting initiative will be the time and effort associated with eligible professional's practice identifying applicable Physician Quality Reporting System quality measures for which they can report the necessary information, collecting the necessary information, and reporting the information needed to report the eligible professional's or group practice's measures.
We believe it is difficult to definitively quantify the burden because eligible professionals may have different processes for integrating the data collection for the Physician Quality Reporting System measures into their practice's work flows. Moreover, we expect that the time needed for an eligible professional to review the quality measures and other information, select measures applicable to his or her patients and the services he or she furnishes to them, and incorporate the use of quality data codes into the office work flows will vary along with the number of measures that are potentially applicable to a given professional's practice.
Since a majority of eligible professionals participate via claims or registry-based reporting of individual measures, they will generally be required to report on at least three measures to earn a Physician Quality Reporting System incentive. Therefore, we will assume that each eligible professional who attempts to submit Physician Quality Reporting System quality measures data via claims or registry reporting is attempting to earn a Physician Quality Reporting System incentive payment and reports on an average of three measures for this burden analysis.
This burden analysis focuses on those new to the Physician Quality Reporting System. We will assign 5 hours as the amount of time needed for eligible professionals to review the 2012 Physician Quality Reporting System Measures List, review the various reporting options, select the most appropriate reporting option, identify the applicable measures or measures groups for which they can report the necessary information, review the measure specifications for the selected measures or measures groups, and incorporate reporting of the selected measures or measures groups into the office work flows. This estimate is based on our assumption that an eligible professional will need up to 2 hours to review the 2012 Physician Quality Reporting System Measures List, review the reporting options, and select a reporting option and measures on which to report and 3 hours to review the measure specifications for up to 3 selected measures or up to 1 selected measures group and to develop a mechanism for incorporating reporting of the selected measures or measures group into the office work flows.
In the proposed rule (76 FR 42922), based on information from the Physician Voluntary Reporting Program (PVRP), which was a predecessor to the Physician Quality Reporting System, we provided an estimated labor cost of $60/hour. However, in an effort to provide a more accurate labor cost estimate of participation for the 2012 Physician Quality Reporting System, we conducted an informal poll among a small sample of participants in the 2011 Physician Quality Reporting System to determine what employees within an eligible professional's practice are involved with Physician Quality Reporting System activities. The poll revealed that a billing clerk typically handles administrative details with respect to participating under the Physician Quality Reporting System (such as submitting self-nomination statements), whereas a computer analyst typically handles the reporting of Physician Quality Reporting System quality measures. Based on this information, we are changing our estimated labor costs associated with participating in the Physician Quality Reporting System.
For purposes of this burden estimate, we will assume that a billing clerk will handle the administrative duties associated with participating in the 2012 Physician Quality Reporting System. According to information published by the Bureau of Labor Statistics, available at
In addition, for purposes of this burden estimate, we will assume that a computer analyst will engage in the duties associated with the reporting of 2012 Physician Quality Reporting System quality measures. According to information published by the Bureau of Labor Statistics, available at
We continue to expect the ongoing costs associated with Physician Quality Reporting System participation to decline based on an eligible professional's familiarity with and understanding of the Physician Quality Reporting System, experience with participating in the Physician Quality Reporting System, and increased efforts by CMS and stakeholders to disseminate useful educational resources and best practices. We also continue to expect the ongoing costs associated with Physician Quality Reporting System participation to decline as we align the participation requirements in the Physician Quality Reporting System with the reporting requirements in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program such that an eligible professional may only need to submit data to CMS one time for multiple purposes.
We believe the burden associated with actually reporting the Physician Quality Reporting System quality measures will vary depending on the reporting mechanism selected by the eligible professional.
For the claims-based reporting option being finalized, eligible professionals must gather the required information, select the appropriate quality data codes
Based on our experience with the PVRP, we continue to estimate that the time needed to perform all the steps necessary to report each measure (that is, reporting the relevant quality data code(s) for a measure) on claims will ranges from 15 seconds (0.25 minutes) to over 12 minutes for complicated cases and/or measures, with the median time being 1.75 minutes. At an average labor cost of $40/hour per practice, the cost associated with this burden will range from $0.17 in labor to about $8.00 in labor time for more complicated cases and/or measures, with the cost for the median practice being $1.67.
The total estimated annual burden for this requirement will also vary along with the volume of claims on which quality data is reported. In previous years, when we required reporting on 80 percent of eligible cases for claims-based reporting, we found that on average, the median number of reporting instances for each of the Physician Quality Reporting System measures was 9. Since we are reducing the required reporting rate by over one-third to 50 percent in this final rule, then for purposes of this burden analysis we will assume that an eligible professional will need to report each selected measure for 6 reporting instances. The actual number of cases on which an eligible professional is required to report quality measures data will vary, however, with the eligible professional's patient population and the types of measures on which the eligible professional chooses to report (each measure's specifications includes a required reporting frequency).
Based on the assumptions discussed previously, we estimate the total annual reporting burden per individual eligible professional associated with claims-based reporting will range from 4.5 minutes (0.25 minutes per measure × 3 measures × 6 cases per measure) to 180 minutes (12 minutes per measure × 3 measures × 6 cases per measure), with the burden to the median practice being 31.5 minutes (1.75 minutes per measure × 3 measures × 6 cases). We estimate the total annual reporting cost per eligible professional associated with claims-based reporting will range from $3.06 ($0.17 per measure × 3 measures × 6 cases per measure) to $144.00 ($8.00 per measure × 3 measures × 6 cases per measure), with the cost to the median practice being $30.06 per eligible professional ($1.67 per measure × 3 measures × 6 cases per measure).
For registry-based reporting, there will be no additional time burden for eligible professionals to report data to a registry as eligible professionals opting for registry-based reporting will more than likely already be reporting data to the registry for other purposes and the registry will merely be re-packaging the data for use in the Physician Quality Reporting System. Little, if any, additional data will need to be reported to the registry solely for purposes of participation in the 2012 Physician Quality Reporting System. However, eligible professionals will need to authorize or instruct the registry to submit quality measures results and numerator and denominator data on quality measures to CMS on their behalf. We estimate that the time and effort associated with this will be approximately 5 minutes per eligible professional.
Registries interested in submitting quality measures results and numerator and denominator data on quality measures to CMS on their participants' behalf in 2012 will need to complete a self-nomination process in order to be considered qualified to submit on behalf of eligible professionals unless the registry was qualified to submit on behalf of eligible professionals for prior program years and did so successfully. We estimate that the self-nomination process for qualifying additional registries to submit on behalf of eligible professionals for the 2012 Physician Quality Reporting System will involve approximately 1 hour per registry to draft the letter of intent for self-nomination. We estimate that each self-nominated entity will also spend 2 hours for the interview with CMS officials and 2 hours calculating numerators, denominators, and measure results for each measure the registry wishes to report using a CMS-provided measure flow. However, the time it takes to produce calculated numerators, denominators, and measure results using the CMS-provided measure flows could vary depending on the registry's experience and the number and type of measures for which the registry wishes to submit on behalf of eligible professionals. Additionally, part of the self-nomination process involves the completion of an XML submission by the registry, which we estimate to take approximately 5 hours, but may vary depending on the registry's experience. We estimate that the registry staff involved in the registry self-nomination process will have an average labor cost of $16/hour. Therefore, assuming the total burden hours per registry associated with the registry self-nomination process is 10 hours, we estimate that the total cost to a registry associated with the registry self-nomination process will be approximately $160 ($16 per hour × 10 hours per registry).
The burden associated with the registry-based reporting requirements of the Physician Quality Reporting System will be the time and effort associated with the registry calculating quality measures results from the data submitted to the registry by its participants and submitting the quality measures results and numerator and denominator data on quality measures to CMS on behalf of their participants. We expect that the time needed for a registry to review the quality measures and other information, calculate the measures results, and submit the measures results and numerator and denominator data on the quality measures on their participants' behalf will vary along with the number of eligible professionals reporting data to the registry and the number of applicable measures. However, we believe that registries already perform many of these activities for their participants. Therefore, there may not necessarily be a burden on a particular registry associated with calculating the measure results and submitting the measures results and numerator and denominator data on the quality measures to CMS on behalf of their participants. Whether there is any additional burden to the registry as a result of the registry's participation in the Physician Quality Reporting System will depend on the number of measures that the registry intends to report to CMS and how similar the registry's measures are to CMS' Physician Quality Reporting System measures.
For EHR-based reporting for the CY 2012 Physician Quality Reporting System, the individual eligible professional may either submit the quality measures data directly to CMS
An EHR vendor interested in having their product(s) used by eligible professionals to submit the Physician Quality Reporting System quality measures data to CMS or interested in submitting data obtained from an EHR to CMS on behalf of eligible professionals is required to complete a self-nomination process in order for the vendor and/or its product(s) to be considered qualified for 2012. It is difficult to definitively quantify the burden associated with the EHR self-nomination process as there is variation regarding the technical capabilities and experience among vendors. For purposes of this burden analysis, however, we estimate that the time required for an EHR vendor to complete the self-nomination process will be similar to the time required for registries to self-nominate, which is approximately 10 hours at $16/hour for a total of $160/EHR vendor ($16/hour × 10 hours/EHR vendor).
The burden associated with the EHR vendor programming its EHR product(s) to extract the clinical data that the eligible professional must submit to CMS for purposes of reporting 2012 Physician Quality Reporting System quality measures will be dependent on the EHR vendor's familiarity with the Physician Quality Reporting System, the vendor's system capabilities, as well as the vendor's programming capabilities. Some vendors already have these necessary capabilities and for such vendors, we estimate that the total burden hours will be 40 hours at a rate of $40/hour for a total burden estimate of $1,600 ($40/hour × 40 hours per vendor). However, given the variability in the capabilities of the vendors, we believe those vendors with minimal experience will have a burden of approximately 200 hours at $40/hour, for a total estimate of $8,000 per vendor ($40/hour × 200 hours/EHR vendor).
With respect to the criteria for satisfactorily reporting data on the quality measures for group practices under the 2012 Physician Quality Reporting System discussed in section VI.F.1. of this final rule with comment period, group practices interested in participating in the 2012 Physician Quality Reporting System through the group practice reporting option (GPRO) must complete a self-nomination process similar to the self-nomination process required of registries and EHR vendors. Therefore, assuming it takes 2 hours for a group practice to decide whether to participate as a group or individually, approximately 2 hours per group practice to draft the letter of intent for self-nomination, gather the requested information, and provide this requested information, and an additional 2 hours undergoing the vetting process with CMS officials, we estimate a total of 6 hours associated with the self-nomination process. Assuming that the group practice staff involved in the group practice self-nomination process have the same average practice labor cost as the average practice labor cost estimates we used for individual eligible professionals of $16/hour, we estimate that the total cost to a group practice associated with the group practice self-nomination process will be approximately $96 ($16/hour × 6 hours per group practice).
The burden associated with the group practice reporting requirements for the 2012 Physician Quality Reporting System is the time and effort associated with the group practice submitting the quality measures data. For practices participating under the GPRO, this will be the time associated with the physician group completing the data collection tool. The information collection components of this data collection tool have been reviewed by OMB and are currently approved under OMB control number 0938-0941, with an expiration date of December 31, 2011, for use in the Physician Group Practice, Medicare Care Management Performance (MCMP), and EHR demonstrations. Based on burden estimates for the PGP demonstration, which uses the same data submission methods, we estimate the burden associated with a physician group completing the data collection tool will be approximately 79 hours per physician group. Based on an average labor cost of $40 per physician group, we estimate the cost of data submission per physician group associated with participating in the 2012 Physician Quality Reporting System GPRO will be $3,160 ($40/hour × 79 hours per group practice).
Eligible professionals who wish to qualify for the additional 0.5 percent incentive payment authorized under section 1848(m)(7) of the Act (“Additional Incentive Payments”) for 2012 will need to more frequently than is required to qualify for or maintain board certification status participate in a qualified Maintenance of Certification Program for 2012 and successfully complete a qualified Maintenance of Certification Program practice assessment for 2012. We believe that a majority of the eligible professionals who will attempt to qualify for this additional 0.5 percent incentive payment will be those who are already enrolled and participating in a Maintenance of Certification Board. The amount of time that it will take for the eligible professional to participate in the Maintenance of Certification Program more frequently than is required to qualify for or maintain board certification status will vary based on what each individual board determines constitutes “more frequently.” We expect that the amount of time needed to complete a qualified Maintenance of Certification Program practice assessment will be spread out over time since a quality improvement component is often required. Information from an informal poll of a few ABMS member
We requested comments on this burden analysis for physicians participating in the Maintenance of Certification Program incentive, including the underlying assumptions used in developing our burden estimates. Below is a summary of the comments we received.
The electronic prescribing measure was first reportable under the Physician Quality Reporting System before it was used for the eRx Incentive Program, which began in 2009. According to the 2009 Experience Report, the number of eligible professionals participating reporting the electronic prescribing measure increased from 4,973 out of approximately 500,000 eligible professionals to 92,132 out of 670,000 eligible professionals from 2008 to 2009. This is an increase of least 12 percent (from 1 percent in 2008 to 13 percent in 2009). As discussed in section VI.F.2.h.1 in this final rule, we finalized limitations whereby a 2013 or 2014 payment adjustment will not apply to an eligible professional. However, we still believe that, due to the implementation of the 2013 and 2014 payment adjustments, as well as the expansion of the reporting mechanisms for purposes of reporting the electronic prescribing measure for the 2013 and 2014 payment adjustments, we expect that there will be a significant increase in eligible professionals who participate in the eRx Incentive Program for CYs 2012 through 2014 from 2009 participation rates. Therefore, for purposes of conducting a burden analysis for the 2012 through 2014 eRx Incentive Program, we will assume that, based on participation rates in 2009, there will be an increase of at least 12 percent of eligible professionals participating in the eRx Incentive Program from 2012 through 2014. Therefore, for purposes of this burden analysis, we estimate that more than 100,800 unique TIN/NPI combinations will participate in the 2012, 2013, and 2014 eRx Incentive Program for purposes of the 2013 and 2014 payment adjustment (see the “2009 Reporting Experience,” which is available on the Physician Quality Reporting System section of the CMS Web site at
Section VI.F.2. of this final rule with comment period discusses the background of the eRx Incentive Program. For the programs for 2012 through 2014, eligible professionals and group practices may choose whether to participate and, to the extent they meet—(1) certain thresholds with respect to the volume of covered professional services furnished; and (2) the criteria for being a successful electronic prescriber described in section VI.F.2. of this final rule with comment period, they will qualify to receive an incentive payment for 2012 and 2013 and/or avoid being subject to the 2013 and 2014 payment adjustment.
In section VI.F.2.g. of this final rule with comment period, we describe the requirements for eligible professionals and group practices to be successful electronic prescribers in order to earn a 2012 and/or 2013 incentive payment. For the 2012 and 2013 incentives, as discussed in section VI.F.2.g.2. of this final rule with comment period, each eligible professional must to report the electronic prescribing measure's numerator indicating that at least one prescription generated during an encounter was electronically submitted at least 25 instances during the reporting period in association with a denominator-eligible visit.
In section VI.F.2.h. of this final rule with comment period, we finalized additional requirements for eligible professionals and group practices can meet for the 2013 payment adjustment, as well as finalized requirements for being a successful electronic prescriber for the 2014 payment adjustment. For the 2013 and 2014 payment adjustment, each eligible professional must report the electronic prescribing measure's numerator at least 10 instances during the reporting period.
We expect the ongoing costs associated with participation in the eRx Incentive Program to decline based on an eligible professional's understanding of the eRx Incentive Program, experience with participating in the eRx Incentive Program, and increased efforts by CMS and stakeholders to disseminate useful educational resources and best practices.
Similar to the Physician Quality Reporting System, one factor in the burden to individual eligible professionals is the time and effort associated with individual eligible professionals reviewing the electronic prescribing measure to determine whether it is applicable to them, reviewing and selecting one of the available reporting options (for purposes of the 2012 and 2013 incentives and the 2013 and 2014 payment adjustments, the electronic prescribing quality measure is reportable through claims-based reporting, registry-based reporting, or through EHRs) and selecting one, gathering the required information, and incorporating reporting of the measure into their office work flows. Since the eRx Incentive Program consists of only 1 measure to report, we estimate 2 hours as the amount of time that will be needed for individual eligible professionals to prepare for participation in the eRx Incentive Program. At an average cost of approximately $40/hour per practice, we estimate the total preparation costs to individual eligible professionals will be approximately $80 (2 hours × $40/hour).
Another factor that we believe influences the burden to eligible professionals is how they choose to report the electronic prescribing
For eligible professionals who choose to do so via claims, we estimate that the burden associated with the requirements of this incentive program will be the time and effort associated with gathering the required information and identifying when it is appropriate to include the measure's quality data code (QDC) on the claims they submit for payment. For claims-based reporting, the measure's QDC will be collected as additional (optional) line items on the existing HIPAA transaction 837-P and/or CMS Form 1500. We do not anticipate any new forms and or modifications to the existing transaction or form. We also do not anticipate changes to the 837-P or CMS Form 1500 for CY 2012.
Based on the information from the PVRP for the amount of time it takes a median practice to report one measure one time on claims (1.75 minutes) and our requirement that eligible professionals report the measure 25 times for purposes of the incentive payment, we estimate the burden associated with claims-based data submission to will be 43.75 minutes (1.75 minutes per case × 1 measure × 25 cases per measure). This equates to a cost of approximately $29.17 (1.75 minutes per case × 1 measure × 25 cases per measure × $40/hour) per individual eligible professional. For purposes of the 2013 and 2014 eRx payment adjustment, an eligible professional is required to report the measure only 10 times, and therefore, we estimate the burden associated with claims-based submission will be 17.5 minutes (1.75 minutes per case × 1 measure × 10 cases per measure). This equates to a cost of approximately $9.67 (1.75 minutes per case × 1 measure × 10 cases per measure × $40/hour) per individual eligible professional.
Because registry-based reporting of the electronic prescribing measure to CMS was added to the eRx Incentive Program for 2010 and eligible professionals are not required to indicate how they plan to report the electronic prescribing measure each year, it is difficult to accurately estimate how many eligible professionals will opt to participate in the eRx Incentive Program through the registry-based reporting mechanism in CYs 2012 through 2014. We do not anticipate, however, any additional burden for eligible professionals to report data to a registry as eligible professionals opting for registry-based reporting will more than likely already be reporting data to the registry for other purposes. Little, if any, additional data will need to be reported to the registry for purposes of participation in the 2012, 2013, and 2014 eRx Incentive Program since the only information that the registry will need to report to us is the number of times the eligible professional electronically prescribed. However, eligible professionals will need to authorize or instruct the registry to submit quality measures results and numerator and denominator data on the electronic prescribing measure to CMS on their behalf. We estimate that the time and effort associated with this will be approximately 5 minutes for each eligible professional that wishes to authorize or instruct the registry to submit quality measures results and numerator and denominator data on the electronic prescribing measure to CMS on their behalf.
Based on our final decision to consider only registries qualified to submit Physician Quality Reporting System quality measures results and numerator and denominator data on quality measures to CMS on their participants' behalf for the 2012 and 2013 Physician Quality Reporting System reporting periods to be qualified to submit results and numerator and denominator data on the electronic prescribing measure for the respective eRx Incentive Program reporting periods that occur in 2012 and 2013, there will be no need for a registry to undergo a separate self-nomination process for the eRx Incentive Program and therefore, no additional burden associated with the registry self-nomination process.
There will also be a burden to the registry associated with the registry calculating results for the electronic prescribing measure from the data submitted to the registry by its participants and submitting the quality measures results and numerator and denominator data on the electronic prescribing quality measure to CMS on behalf of their participants. We expect that the time needed for a registry to review the electronic prescribing measure's specifications, calculate the measure's results, and submit the measure's results and numerator and denominator data on their participants' behalf will vary along with the number of eligible professionals reporting data to the registry. However, we believe that registries already perform many of these activities for their participants. Since the eRx Incentive Program consists of only one measure, we believe that the burden associated with the registry reporting the measure's results and numerator and denominator to CMS on behalf of their participants will be minimal.
For the EHR-based reporting mechanism, the eligible professional must either extract the necessary clinical data from his or her EHR and submit the necessary data to the CMS-designated clinical data warehouse or have an EHR data submission vendor extract the necessary clinical data from his or her EHR and submit the necessary data to CMS on the professional's behalf. Because this manner of reporting quality data to CMS was first added to the eRx Incentive Program in 2010 and eligible professionals are not required to (and were not previously required to) indicate to us how they intend to report the electronic prescribing measure, it is difficult to estimate how many eligible professionals will opt to participate in the eRx Incentive Program through the EHR-based reporting mechanism for reporting periods that occur in CYs 2012 and 2013. We believe that once an eligible professional's EHR is programmed by the vendor to allow data submission to CMS, the burden to the eligible professional associated with submission of data on the electronic prescribing measure should be minimal. The eligible professional who chooses to submit the electronic prescribing measure data directly to CMS from his or her EHR will have to have access to a CMS-specified identity management system, such as IACS. We believe it takes less than 1 hour to obtain access to the identity management system.
Because only EHR products and data submission vendors qualified for 2012 and 2013 Physician Quality Reporting System reporting periods may be used to submit data on the electronic prescribing measure for the respective eRx Incentive Program reporting periods that occur in CYs 2012 and 2013, there is no need for EHR vendors and/or their products to undergo a separate self-nomination process for the eRx Incentive Program and therefore, no
There will also be a burden to the EHR vendor associated with the EHR vendor programming its EHR product(s) to extract the clinical data that the eligible professional and/or vendor will need to submit to CMS for purposes of reporting the electronic prescribing measure. The time needed for an EHR vendor to review the measure's specifications and program its product to submit data on the measure to the CMS-designated clinical data warehouse will be dependent on the EHR vendor's familiarity with the electronic prescribing measure, the vendor's system capabilities, as well as the vendor's programming capabilities. Since only EHR products qualified for 2012 and 2013 Physician Quality Reporting System reporting periods will qualify for the respective eRx Incentive Program reporting periods that occur in CY 2012 or 2013, and the eRx Incentive Program consists of only one measure, we believe that any burden associated with the EHR vendor to program its product(s) to submit data on the electronic prescribing measure to the CMS-designated clinical data warehouse will be minimal.
Finally, with respect to the criteria for group practices to be successful electronic prescribers for the 2012 and 2013 incentive, as well as with regard to the 2013 and 2014 payment adjustments, as discussed in section VI.F.2. of this final rule with comment period, respectively, group practices have the same options as individual eligible professionals in terms of the form and manner for reporting the electronic prescribing measure (that is, group practices have the option of reporting the measure through claims, a qualified registry, or a qualified EHR product). There are only 2 differences between the requirements for an individual eligible professional and a group practice: (1) The fact that a group practice must self-nominate; and (2) a difference in the number of times that a group practice must report the electronic prescribing measure.
We do not anticipate any additional burden associated with the group practice self-nomination process since we limit the group practices to those selected to participate in the Physician Quality Reporting System GPRO. The practice only will need to indicate its desire to participate in the eRx GPRO at the same time it self-nominates for the Physician Quality Reporting System GPRO and indicate how it intends to report the electronic prescribing measure.
In terms of the burden to group practices comprised of 25 to 99 eligible professionals associated with submission of the electronic prescribing measure, we believe that this will be similar to the burden to individual eligible professionals for submitting the electronic prescribing measure. In fact, overall, there could be less burden associated with a practice participating as a group rather than as individual eligible professionals because the total number of reporting instances required by the group could be less than the total number of reporting instances that will be required if each member of the group separately reported the electronic prescribing measure. Thus, we believe that the burden to a group practice associated with reporting the electronic prescribing measure could range from almost no burden (for groups who choose to do so through a qualified EHR or registry) to 18.22 hours (1.75 minutes per measure × 1 measure × 625 cases per measure) for a group practice that chooses to report the electronic prescribing measures through the claims submission process. Consequently, the total estimated cost per group practice to report the electronic prescribing measure could be as high as $1,043.75 ($1.67 per measure × 1 measure × 625 cases per measure).
In terms of the burden to group practices comprised of 100 or more eligible professionals associated with submission of the electronic prescribing measure, we believe that this will be similar to the burden to individual eligible professionals for submitting the electronic prescribing measure. In fact, overall, there could be less burden associated with a practice participating as a group rather than as individual eligible professionals because the total number of reporting instances required by the group could be less than the total number of reporting instances that will be required if each member of the group separately reported the electronic prescribing measure. Thus, we believe that the burden to a group practice associated with reporting the electronic prescribing measure could range from almost no burden (for groups who choose to do so through a qualified EHR or registry) to 72.92 hours (1.75 minutes per measure × 1 measure × 2500 cases per measure) for a group practice that chooses to report the electronic prescribing measures through the claims submission process. Consequently, the total estimated cost per group practice to report the electronic prescribing measure could be as high as $4,175 ($1.67 per measure × 1 measure × 2500 cases per measure).
As with individual eligible professionals, we believe that group practices that choose to participate in the eRx GPRO through the registry-based reporting mechanism of the electronic prescribing measure will more than likely already be reporting data to the registry. Little, if any, additional data will need to be reported to the registry for purposes of participation in the eRx Incentive Program for CYs 2012 through 2014 beyond authorizing or instructing the registry to submit quality measures results and numerator and denominator data on the electronic prescribing measure to CMS on their behalf. We estimate that the time and effort associated with this registry option will be approximately 5 minutes for each group practice that wishes to authorize or instruct the registry to submit quality measures results and numerator and denominator data on the electronic prescribing measure to CMS on their behalf.
For group practices that choose to participate in the eRx Incentive Program for CYs 2012 through 2014 via the EHR-based reporting of the electronic prescribing mechanism, once the EHR is programmed by the vendor to allow data submission to CMS, the burden to the group practice associated with submission of data on the electronic prescribing measure should be minimal.
The EHR Incentive Program (discussed in section VI.H. of this final rule with comment period) is a voluntary program whereby eligible professionals (EPs) may earn an incentive payment for demonstrating meaningful use of certified EHR technology, which includes among other requirements, the submission of clinical quality measures (CQMs). The “Electronic Health Record Incentive Program” final rule (75 FR 44314 through 75 FR 44588) describes the CQMs and the CQM reporting mechanisms that will be available to EPs who choose to participate in the EHR Incentive Program (75 FR 44380) and established the criteria for achieving meaningful use in Stage 1, which includes CY 2012. In that final rule, for CY 2012, we estimated that approximately 385,954 Medicare EPs will be eligible to receive an incentive under the EHR Incentive Program (75 FR 44518). Section VI.H.2. of this final rule with comment period finalizes
Because the EHR Incentive Program is a voluntary program, EPs may choose whether to participate and attest that they have met the meaningful use objectives and measures. Registration for the EHR Incentive Program opened in January 2011. At this time, we do not have sufficient data available on participation in the EHR Incentive Program by EPs to revise the final rule's estimate of how many EPs will opt to participate in the EHR Incentive Program for payment year 2012.
We believe the burden associated with actually reporting CQMs will vary depending on the reporting mechanism selected by the EP. Attestation to the objectives and measures is the only method available for EPs to demonstrate that they have met the meaningful use criteria in 2011. Attestation was first available on April 18, 2011 and we do not yet have sufficient data on the 2011 participation in the EHR Incentive Program. Therefore, it is difficult to estimate the level of participation in the Pilot versus the number of EPs that will prefer to attest to the CQMs. However, we believe that the number of EPs who choose to participate via attestation will largely be those who are not participating in both the EHR Incentive Program and Physician Quality Reporting System. This is because EPs participating in the Physician Quality Reporting System will be more likely to participate in the Pilot.
As we estimated in the EHR Incentive Program final rule, we estimate that it will take 8 hours and 52 minutes for an EP to attest that during the EHR reporting period, the EP used certified EHR technology, specify the technology, and satisfied all Stage 1 meaningful use core criteria for payment year 2012 (75 FR 44518). We estimate that it will further take an additional 0.5 hours to select and attest to the clinical quality measures, in the format and manner specified by CMS (75 FR 44517).
There will be no additional time burden for eligible professionals to report CQM data to a qualified EHR data submission vendor as EPs who choose this option for the Pilot will more than likely already be reporting data to the qualified EHR data submission vendor for other purposes, such as the Physician Quality Reporting System, and the qualified EHR data submission vendor will merely be re-packaging the data for use in the EHR Incentive Program. Furthermore, EPs more than likely will not need to authorize or instruct the qualified EHR data submission vendor to submit CQM data to CMS on their behalf because this likely will have already been done as a requirement for reporting via a qualified EHR data submission vendor under the Physician Quality Reporting System.
Qualified EHR data submission vendors interested in submitting CQM data to CMS on their participants' behalf will not need to complete a self-nomination process in order to be considered qualified to submit on behalf of EPs as this process will have already been performed for the Physician Quality Reporting System. Therefore, we believe that there is no additional burden aside from the burden associated with being a Physician Qualified Reporting System qualified EHR data submission vendor for such vendors to submit CQMs on behalf of EPs.
For EPs who choose to participate in the Pilot via direct data submission to CMS from the EP's certified EHR technology, an EP must have access to a CMS-specified identity management system, such as IACS, to participate in the Physician Quality Reporting System or eRx Incentive Program. EPs that choose the EHR-based reporting pilot to report CQMs will do so only if they are participating in the Physician Quality Reporting System. As such, we believe there will be no additional burden on EPs to have access to a CMS-specified identity management system if the EP is already participating in the Physician Quality Reporting System. With respect to submitting the actual 2012 data file in 2013, we believe that this will take an EP no more than 2 hours, depending on the number of patients on which the EP is submitting. We believe that once the EHR is programmed by the vendor to allow data submission to CMS and the EP participates in the Physician Quality Reporting System, the additional burden to the EP associated with electronic submission of the CQMs should be minimal. Since this is a new reporting mechanism for the EHR Incentive Program 2012 payment year, it is difficult to predict the level of participation in EHR-based reporting. However, we believe that the number of EPs who choose to participate in the EHR-based reporting option for the Pilot will be the same as the number of eligible professionals who choose the EHR-based reporting mechanism for the Physician Quality Reporting System. This is primarily because in addition to being certified EHR technology, the technology used under this reporting option will need to be qualified according to the Physician Quality Reporting System qualification process.
The burden associated with the EHR vendor programming its EHR product(s) to extract the clinical data that the EP or vendor needs to submit to CMS for purposes of reporting CQMs will be dependent on the EHR vendor's familiarity with the EHR Incentive Program and Physician Quality Reporting System, the vendor's system capabilities, as well as the vendor's programming capabilities. As we already are requiring qualified EHRs vendors to perform these functions under the Physician Quality Reporting System, the burden for submitting CQMs under the EHR Incentive Program will be similar to the EHR vendor reporting burden under the Physician Quality Reporting System. For vendors who already have these necessary capabilities, we estimate the total burden hours to be 40 hours at a rate of $40/hour for a total burden estimate of $800 ($40/hour × 40 hours per vendor). However, given the variability in the capabilities of the vendors, those vendors with minimal experience will have a burden of approximately 200 hours at $40/hour, for a total estimate of $8,000 per vendor ($40/hour × 200 hours per EHR vendor).
To obtain copies of the supporting statement and any related forms for the paperwork collections referenced above, access CMS' Web site at
If you comment on these information collection and recordkeeping requirements, please do either of the following:
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This final rule with comment period is necessary in order to make payment and policy changes under the Medicare PFS and to make required statutory changes under the Affordable Care Act and MIPPA and other statutory changes. This final rule with comment period is also necessary to make changes to the Part B drug payment policy and other related Part B related policies.
We have examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This final rule with comment period has been designated as “economically” significant, under section 3(f)(1) of Executive Order 12866 and hence also a major rule under the Congressional Review Act. Accordingly, the rule has been reviewed by the Office of Management and Budget. We have prepared an RIA, that to the best of our ability presents the costs and benefits of the final rule with comment period. We solicited comment on the RIA provided. We received one comment regarding the RIA.
The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $7.0 million to $34.5 million in any 1 year (for details see the SBA's Web site at
For purposes of the RFA, physicians, NPPs, and suppliers including IDTFs are considered small businesses if they generate revenues of $10 million or less based on SBA size standards. Approximately 95 percent of physicians are considered to be small entities. There are over 1 million physicians, other practitioners, and medical suppliers that receive Medicare payment under the PFS.
Because we acknowledge that many of the affected entities are small entities, the analysis provided here and throughout the preamble of this final rule with comment period constitutes our Final Regulatory Flexibility Act (FRFA) analysis for the remaining provisions. This includes alternatives considered for the various final policies in this rule. We solicited public comment on the IRFA analysis provided in the proposed rule, but did not receive any comments that were in scope. We conclude that this final rule with comment has a significant impact on a substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because the Secretary has determined that this final rule with comment period would not have a significant impact on the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2011, that threshold is approximately $136 million. This final rule with comment period does not contain mandates that will impose any costs on State, local, or tribal governments in aggregate, or by the private sector, of $136 million respectively.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This final rule with comment period will not have a substantial direct effect on State or local governments, preempt States, or otherwise have a Federalism implication.
We have prepared the following analysis, which together with the information provided in the rest of this preamble, meets all assessment requirements. The analysis explains the rationale for and purposes of this final rule with comment period; details the costs and benefits of the rule; analyzes alternatives; and presents the measures we would use to minimize the burden on small entities. As indicated elsewhere in this final rule with comment period, we are implementing a variety of changes to our regulations, payments, or payment policies to ensure that our payment systems reflect changes in medical practice and the relative value of services. We provide information for each of the policy changes in the relevant sections of this final rule with comment period. We are unaware of any relevant Federal rules that duplicate, overlap, or conflict with this final rule with comment period. The relevant sections of this final rule with comment period contain a
Section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or decreases in RVUs may not cause the amount of expenditures for the year to differ by more than $20 million from what expenditures would have been in the absence of these changes. If this threshold is exceeded, we make adjustments to preserve budget neutrality.
Our estimates of changes in Medicare revenues for PFS services compare payment rates for CY 2011 with final payment rates for CY 2012 using CY 2010 Medicare utilization for all years. To the extent that there are year-to-year changes in the volume and mix of services provided by physicians, the actual impact on total Medicare revenues will be different than those shown in Table 84. The payment impacts reflect averages for each specialty based on Medicare utilization. The payment impact for an individual physician would be different from the average, based on the mix of services the physician furnishes. The average change in total revenues would be less than the impact displayed here because physicians furnish services to both Medicare and non-Medicare patients and specialties may receive substantial Medicare revenues for services that are not paid under the PFS. For instance, independent laboratories receive approximately 85 percent of their Medicare revenues from clinical laboratory services that are not paid under the PFS.
Table 84 shows only the payment impact on PFS services. We note that these impacts do not include the effect of the January 2012 conversion factor changes under current law. The annual update to the PFS conversion factor is calculated based on a statutory formula that measures actual versus allowed or “target” expenditures, and applies a sustainable growth rate (SGR) calculation intended to control growth in aggregate Medicare expenditures for physicians' services. This update methodology is typically referred to as the “SGR” methodology, although the SGR is only one component of the formula. Medicare physician fee schedule payments for services are not withheld if the percentage increase in actual expenditures exceeds the SGR. Rather, the PFS update, as specified in section 1848(d)(4) of the Act, is adjusted to eventually bring actual expenditures back in line with targets. If actual expenditures exceed allowed expenditures, the update is reduced. If actual expenditures are less than allowed expenditures, the update is increased. We currently estimate that the statutory formula used to determine the physician update will result in a CY 2012 conversion factor of 24.6712 which represents a PFS update of −27.4 percent. By law, we are required to make these reductions in accordance with section 1848(d) and (f) of the Act, and these reductions can only be averted by an Act of the Congress. While the Congress has provided temporary relief from these reductions for every year since 2003, a long-term solution is critical. We are committed to working with the Congress to permanently reform the SGR methodology for Medicare physician fee schedule updates so doctors and patients no longer have to worry about the stability and adequacy of their payments from Medicare.
The following is an explanation of the information represented in Table 84:
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The most widespread specialty impacts of the RVU changes are generally related to several factors. First, as discussed in section II.A.2. of this final rule with comment period, we are currently implementing the third year of the 4-year transition to new PE RVUs using the PPIS data that were adopted in the CY 2010 PFS final rule with comment period. The impacts of the third year of the transition are generally consistent with the impacts that would be expected based on the impacts displayed in the CY 2011 PFS final rule with comment period.
The second general factor contributing to the CY 2012 impacts shown in Table 84 is a secondary effect of the CY 2011 rescaling of the RVUs so that, in the aggregate, they match the work, PE, and malpractice proportions in the revised and rebased MEI for CY 2011. That is, the rebased MEI had a greater proportion attributable to malpractice and PE and, correspondingly, a lesser proportion attributable to work. Specialties that have a high proportion of total RVUs attributable to work, such as emergency medicine, experienced a decrease in aggregate payments as a result of this rescaling, while specialties that have a high proportion attributable to PE, such as diagnostic testing facilities, experienced an increase in aggregate payments. (For further details on the MEI rebasing, see the discussion beginning on (75 FR 73262) in the CY 2011 PFS final rule.)
Table 86 also includes the impacts resulting from our expansion of the current MPPR policy to the professional component of advanced imaging services. We estimate that this policy will redistribute approximately $50 million through a small increase in the conversion factor and a small adjustment to all PE RVUs. We estimate that this change would primarily reduce payments to the specialties of radiology and interventional radiology. Finally, Table 84 also reflects the impacts of our final adjustments to improve the accuracy of the time associated with the work RVUs for certain services, including group therapy services, as discussed previously in section II.A. of this final rule with comment period.
Column G of Table 84 displays the estimated CY 2012 combined impact on total allowed charges by specialty of all the final RVU and MPPR changes. These impacts range from an increase of 4 percent for physical/occupational therapy and portable x-ray suppliers to
Table 85 shows the estimated impact on total payments for selected high-volume procedures of all of the changes discussed previously. We have included CY 2012 payment rates with and without the effect of the CY 2012 negative PFS CF update for comparison purposes. We selected these procedures because they are the most commonly furnished by a broad spectrum of physician specialties. There are separate columns that show the change in the facility rates and the nonfacility rates. For an explanation of facility and nonfacility PE, we refer readers to Addendum A of this final rule with comment period.
The process we are adopting in this final rule with comment period to consolidate the Five-Year Reviews of Work and PE RVUs with the annual review of potentially misvalued codes, is not anticipated to have a budgetary impact in CY 2012. As noted previously, to the extent that we have finalized revised RVUs for codes identified under the potentially misvalued codes initiative for CY 2012, Table 84 includes the estimated CY 2012 impact on total allowed charges of the changes in the RVUs for these codes.
As discussed in section III.B.3.b. of this final rule with comment period, we revised the malpractice risk factors assigned to a limited number of cardiothoracic surgery services. The utilization of many of these services is zero, while the others have a very low utilization. Therefore, we estimate no significant budgetary impact from the final changes to the MP RVUs due to the very low utilization of these services.
As discussed in section II.D. of this final rule with comment period, we are required to update the GPCI values at least every 3 years and phase in the adjustment over 2 years (if there has not been an adjustment in the past year). For CY 2012, we are finalizing revisions to the PE GPCIs for each Medicare locality, as well as the cost share weights for all three GPCI components. Moreover, the final revised PE GPCI values are a result of our analysis of the PE methodology as required by section 1848(e)(1)(H)(iv) of the Act. The final GPCIs rely upon the 2006-2008 American Community Survey (ACS) data to determine the relative cost differences in the office rent component of the PE GPCIs. In addition, we are finalizing the use of 2006-2008 Bureau of Labor and Statistics (BLS) Occupational Employment Statistics (OES) data to determine the employee compensation component. Further, we are finalizing that the occupations to be used in the calculation of the employee compensation component will include the full range of non-physician occupations which are employed within the offices of physicians industry. Lastly, we are finalizing a purchased services index that will be used to geographically adjust for differences in the labor-related share of the industries occupying the “All Other Services” and “Other Professional Expenses” 2006-based MEI categories.
We are finalizing a cost share weight for the PE GPCIs of 47.439 percent. For the employee compensation portion of the PE GPCIs, we are using the non-physician employee compensation category weight of 19.153 percent. The fixed capital and utilities MEI categories were combined to achieve a total office rent weight of 10.223 percent. In order to calculate the purchased services index, we are finalizing our proposal to merge the corresponding weights of the “All Other Services” and “Other Professional Expenses” MEI categories to form a combined purchased services weight of 8.095. We are finalizing a cost share weight for the medical equipment, supplies, and other miscellaneous expenses component of 9.968 percent. Furthermore, the physician compensation cost category and its weight of 48.266 percent reflects the work GPCI cost share weight; the professional liability insurance weight of 4.295 percent reflects the malpractice GPCI cost share weight. A more detailed discussion on the final CY 2012 GPCI cost share weights can be found in section II.D. of this final rule with comment period.
Additionally, section 1848(e)(1)(E) of the Act (as amended by section 103 of the Medicare and Medicaid Extenders Act of 2010) extended the 1.000 work GPCI floor through December 31, 2011. Therefore, the CY 2012 GPCIs reflect the sunset of the 1.000 work GPCI floor. Section 1848(e)(1)(G) of the Act (as amended by section 134(b) of the MIPPA) established a permanent 1.500 work GPCI floor in Alaska beginning January 1, 2009; therefore, the 1.500 work GPCI floor in Alaska will remain in place for CY 2012. Moreover, section 1848(e)(1)(I) of the Act (as added by section 10324(c) of the Affordable Care Act) established a permanent 1.000 PE GPCI floor for services furnished in frontier States effective January 1, 2011.
Addendum D to this final rule with comment period shows the estimated effects of the revised GPCIs on locality Geographic Adjustment Factors (GAFs) for CY 2012. The GAFs reflect the use of revised GPCI data and the updated cost share weights. The GAFs are a weighted composite of each locality's work, PE, and malpractice GPCIs using the national GPCI cost share weights. While we do not actually use the GAFs in computing the PFS payment for a specific service, they are useful in comparing the estimated overall costs and payments for different localities. The cumulative effects of all of the GPCI revisions, including the updated underlying GPCI data, updated cost share weights, and provisions of the Affordable Care Act, are reflected in the CY 2012 GPCI values that are displayed in Addendum E in this final rule with comment period.
Table 86 illustrates the impact of moving from the current law CY 2011 GAFs to the final CY 2012 GAFs by PFS locality. The table first shows the impact under current law and regulation, and then shows the impact due to the final rule modifications. As shown in the table, the primary driver of the CY 2012 impact is the current law expiration of the non-budget neutral increases to the CY 2011 GPCIs for lower cost areas that was required by the Affordable Care Act and the MMEA. The table is sorted by total impact from largest reductions to largest increases. When the overall impacts directly resulting from our final changes to the PE GPCI are isolated, these final rule impacts are much smaller (Column F) than the impacts due to current law and regulation. Specifically, the PE GPCI final rule changes cause a change in GAF values of less than or equal to one percentage point for approximately nine out of ten localities. The following description explains the information represented in Table 86 in more detail:
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As discussed in section II.E. of this final rule with comment period, we are finalizing our policy to add several new codes to the list of telehealth services and revise the criteria for adding services to the list of telehealth services. While we expect these changes to increase access to care in rural areas, based on recent utilization of similar services already on the telehealth list, we estimate no significant budgetary impact from the additions. In addition, the final revision to the telehealth criteria will be effective for CY 2013 PFS telehealth services, with no impact in CY 2012.
Application of our proposals for “ASP Reporting Template Update” and “Reporting of ASP Units and Sales Volume for Certain Products,” as discussed in section VI.A. of this final rule with comment period involve revisions to the existing ASP reporting template which will facilitate the accuracy and efficiency of data transfer from manufacturers. Any impacts are dependent on the status and quality of quarterly manufacturer data submissions, so we cannot quantify associated savings.
Finally, as discussed in section VI.A. of this final rule with comment period, we provided for appropriate price substitutions that account for market-related pricing changes and would allow Medicare to pay based off lower market prices for those drugs and biologicals that consistently exceed the applicable threshold percentage. Based on estimates published in various OIG reports (see section VI.A. for a list of citations), we believe that this proposal will generate minor savings for the Medicare program and its beneficiaries since any substituted prices would be for amounts less than the calculated 106 percent of the ASP.
As discussed in section VI.B. of this final rule with comment period, we are continuing the recoupment of the $50 million in expenditures from this demonstration in order to satisfy the budget neutrality requirement in section 651(f)(1)(b) of the MMA. We initiated this recoupment in CY 2010 and this will be the third year. As discussed in the CY 2010 PFS final rule with comment period, we finalized a policy to recoup $10 million each year through adjustments to the PFS for all chiropractors in CYs 2010 through 2014. To implement this required budget neutrality adjustment, we are recouping $10 million in CY 2012 by reducing the payment amount under the PFS for the chiropractic CPT codes (that is, CPT codes 98940, 98941, and 98942) by approximately 2 percent.
As discussed in section V.A. of this final rule with comment period, we are implementing the provision that specifies that for services furnished after December 31, 2011, an independent laboratory may not bill the Medicare contractor for the TC of physician pathology services furnished to a hospital inpatient or outpatient. The savings associated with implementing this provision are estimated to be approximately $80 million for CY 2012.
As discussed in section VI.E. of this final rule with comment period, section 1861(s)(2)(FF) of the Act, as described more fully in section 1861(hhh), of the Act (as added by section 4103 of the Affordable Care Act) provides Medicare coverage for an annual wellness visit. Regulations for Medicare coverage of the AWV are established at 42 CFR 410.15. The annual wellness visit is covered with no coinsurance or deductible when furnished by a health professional as that term is defined in 42 CFR 410.15. The annual wellness visit entails the creation of a personalized prevention plan for an individual and includes elements, such as updating medical and family history, identifying providers that regularly provide medical care to the individual, measurement of height, weight, and body mass index, identification of risk factors, the provision of personalized health advice, and development of a screening schedule (such as a checklist), and referrals as appropriate for additional preventive services. Section 1861(hhh)(1)(A) of the Act specifies that a personalized prevention plan for an individual includes a HRA that meets the guidelines established by the Secretary and takes into account the results of a HRA. We are proposing to incorporate the use and results of an HRA as part of the provision of personalized prevention plan services during the AWV. The estimated impact of incorporating the HRA as part of the
• The impact of use of the HRA on health professional practices.
• The burden on health professional practices of incorporating an HRA into subsequent AWVs, as well as the first AWV.
• The impact of the elements included in the definitions of first and subsequent AWVs.
• Modification of those AWV elements for which the Secretary has authority to determine appropriateness.
A discussion of the comments we received, our responses, and our final policy for CY 2012 is available in section VI.E. of this final rule with comment period. Our final policy to increase payment for the AWV to acknowledge the increased clinical staff time required to incorporate the HRA into the AWV is subject to budget neutrality.
As discussed in section VI.F.1 of this final rule with comment period, we are finalizing several different reporting options for eligible professionals who wish to participate in the 2012 Physician Quality Reporting System. Although there may be some cost incurred by CMS for maintaining the Physician Quality Reporting System measures and their associated code sets, and for expanding an existing clinical data warehouse to accommodate the final registry-based reporting, EHR-based reporting, and group practice reporting options for the 2012 Physician Quality Reporting System, we do not anticipate a significant cost impact on the Medicare program.
With respect to the potential incentive payments that may be made to satisfactory reporters under the 2012 Physician Quality Reporting System, we estimate this amount for individual eligible professionals would be approximately $60 million. This estimate is derived from looking at our 2009 incentive payment of approximately $235 million and then accounting for the fact that the 2009 incentive payment was 2.0 percent of an eligible professional's total estimated Medicare Part B PFS allowed charges for all such covered professional services furnished by the eligible professional during the 2009 reporting period. For 2012, the incentive payment is 0.5 percent of an eligible professional's total estimated Medicare Part B PFS allowed charges for all covered professional services furnished by an eligible professional during the 2012 reporting period. Although we expect that the lower incentive payment percentage for 2012 would reduce the total outlay by approximately one-fourth, we also expect more eligible professionals to participate in the 2012 Physician Quality Reporting System because we are finalizing multiple methods of data submission, additional alternative reporting methods, methods to align the Physician Quality Reporting System with the EHR Incentive Program and the Medicare Shared Savings Program, and CY 2013 as the reporting period for the 2015 payment adjustment. We also believe that some eligible professionals will qualify for the additional 0.5 percent incentive authorized under section 1848(m)(7) of the Act (“Additional Incentive Payment”).
With respect to estimated costs associated with reporting by individual eligible professionals, one factor that influences the cost to individual eligible professionals is the time and effort associated with identifying applicable Physician Quality Reporting System quality measures and reviewing and selecting a reporting option. This burden will vary with each individual eligible professional by the number of applicable measures, the eligible professional's understanding of the Physician Quality Reporting System, experience with Physician Quality Reporting System participation, and the method(s) selected by the eligible professional for reporting of the measures, and incorporating the reporting of the measures into the office work flows.
In the proposed rule (72 FR 42938), we estimated an average practice labor cost of $40/hour for our impact analysis. However, in an effort to provide a more accurate labor cost estimate of participation for the 2012 Physician Quality Reporting System, we conducted an informal poll among a small sample of participants in the 2011 Physician Quality Reporting System to determine what employees within an eligible professional's practice are involved with Physician Quality Reporting System activities. The poll revealed that a billing clerk typically handles administrative details with respect to participating under the Physician Quality Reporting System (such as submitting self-nomination statements), whereas a computer analyst typically handles the reporting of Physician Quality Reporting System quality measures. Based on this information, we are changing our estimated labor costs associated with participating in the Physician Quality Reporting System.
For purposes of this impact analysis, we will assume that a billing clerk will handle the administrative duties associated with participating in the 2012 Physician Quality Reporting System. According to information published by the Bureau of Labor Statistics, available at
In addition, for purposes of this impact analysis, we will assume that a computer analyst will engage in the duties associated with the reporting of 2012 Physician Quality Reporting System quality measures. According to information published by the Bureau of Labor Statistics, available at
Participation in the CY 2012 Physician Quality Reporting System by individual eligible professionals and group practices is voluntary and individual eligible professionals and group practices may have different processes for integrating the collection of the Physician Quality Reporting System measures into their practice's work flows. Given this variability and the multiple reporting options that we provide, it is difficult to definitively estimate the impact of the Physician Quality Reporting System on providers. Furthermore, we believe that costs for eligible professionals who are participating in the Physician Quality Reporting System for the first time in 2012 would be considerably higher than the cost for eligible professionals who participated in the Physician Quality Reporting System in prior years. Some preparatory steps are needed to begin participating in the Physician Quality Reporting System. To the extent that we are retaining measures that an eligible professional has reported in a prior year and there are no changes to the measure's specifications from a prior year, such preparatory steps do not need to be repeated in subsequent years. In addition, for many eligible professionals, the cost of participating in the Physician Quality Reporting System is offset by the incentive payment, if earned.
Assuming that it takes an individual eligible professional approximately 5 hours to review the Physician Quality
Another factor that influences the cost to individual eligible professionals is how they choose to report the Physician Quality Reporting System measures (that is, whether they select the claims-based, registry-based or EHR-based reporting mechanism we are finalizing). For the claims-based reporting mechanism, estimates from the PVRP indicate the time needed to perform all the steps necessary to report quality data codes (QDCs) for 1 measure on a claim ranges from 15 seconds (0.25 minutes) to 12 minutes for complicated cases or measures. In previous years, when we required reporting on 80 percent of eligible cases for claims-based reporting, we found that on average, the median number of reporting instances for each of the Physician Quality Reporting System measures was 9. Since we reduced the required reporting rate by over one-third to 50 percent, then for purposes of this impact analysis we will assume that an eligible professional will need to report each selected measure for 6 reporting instances, or 6 cases. Assuming that an eligible professional, on average, will report 3 measures since a majority of eligible professionals participate in the Physician Quality Reporting System by reporting individual measures via claims or registry and that an eligible professional reports on an average of 6 reporting instances per measure, we estimate that the cost to an individual eligible professional associated with the claims-based reporting option of Physician Quality Reporting System measures will range from approximately $2.64 (0.25 minutes per reporting instance × 6 reporting instances per measure × 3 measures × $40/hour) to $144.00 (12 minutes per reporting instance × 6 reporting instances per measure × 3 measures × $40/hour). If an eligible professional satisfactorily reports, these costs will more than likely be negated by the incentive, if earned. For the 2009 Physician Quality Reporting System, which had a 2.0 percent incentive, the mean incentive amount was close to $2,000 for an individual eligible professional. For the registry-based reporting option, individual eligible professionals will generally incur a cost to submit data to registries. We estimate that fees for using a qualified registry will range from no charge, or a nominal charge, for an individual eligible professional to use a registry to several thousand dollars, with a majority of registries charging fees ranging from $500 to $1,000. However, our impact analysis is limited to the incremental costs associated with Physician Quality Reporting System reporting, which we believe are minimal. We believe that many eligible professionals who select the registry-based reporting option will already be utilizing the registry for other purposes and will not need to report additional data to the registry specifically for Physician Quality Reporting System. The registries also often provide the eligible professional services above and beyond what is required for the Physician Quality Reporting System.
For the EHR-based reporting option, an individual eligible professional generally will incur a cost associated with purchasing an EHR product. Although we do not believe that the majority of eligible professionals will purchase an EHR solely for the purpose of participating in Physician Quality Reporting System, cost estimates for EHR adoption by eligible professionals from the EHR Incentive Program final rule (75 FR 44549) show that an individual eligible professional who chooses to do so will have to spend anywhere from $25,000 to $54,000 to purchase and implement an EHR and up to $18,000 annually for ongoing maintenance.
Although we believe that the majority of eligible professionals attempting to qualify for the additional 0.5 percent incentive payment authorized by section 1848(m)(7) of the Act will be those who are already required by their Boards to participate in a Maintenance of Certification Program, individual eligible professionals who wish to qualify for the additional 0.5 percent incentive payment and are not currently participating in a Maintenance of Certification Program will also have to incur a cost for participating in a Maintenance of Certification Program. The manner in which fees are charged for participating in a Maintenance of Certification Program vary by specialty. Some Boards charge a single fee for participation in the full cycle of Maintenance of Certification Program. Such fees appear to range anywhere from over $1,100 to nearly $1,800 per cycle. Some Boards have annual fees that are paid by their diplomates. On average, ABMS diplomates pay approximately $200.00 per year for participating in Maintenance of Certification Program. Some Boards have an additional fee for the Maintenance of Certification Program Part III secure examination, but most Boards do not have additional charges for participation in practice/quality improvement activities.
With respect to the final group practice requirements for satisfactorily submitting quality measures data for the CY 2012 Physician Quality Reporting System discussed in section VI.F.1 of this final rule with comment period, group practices interested in participating in the CY 2012 Physician Quality Reporting System through the group practice reporting option (GPRO) may also incur a cost. However, for groups that satisfactorily report for the 2012 Physician Quality Reporting System, we believe these costs will be completely offset if the group practice earns the incentive payment since the group practice will be eligible for an incentive payment equal to 0.5 percent of the entire group's total estimated Medicare Part B PFS allowed charges for covered professional services furnished by the group practice during the reporting period.
One factor in the cost to group practices will be the costs associated with the self-nomination process. Similar to our estimates for staff involved with the claims-based reporting option for individual eligible professionals, we also estimate that the group practice staff involved in the group practice self-nomination process will have an average administrative labor cost of $16/hour. Therefore, assuming 2 hours for a group practice to decide whether to participate as a group or have members of the practice participate individually and 4 hours for the self-nomination process, we estimate the total cost to a group practice associated with the group practice self-nomination process will be approximately $96 ($16/hour × 6 hours per group practice).
For groups participating under the GPRO process that are comprised of 25 or more eligible professionals, another factor in the cost to the group will be the time and effort associated with the group practice completing and submitting the GPRO web interface. Based on the Physician Group Practice (PGP) demonstration's estimate that it takes approximately 79 hours for a group practice to complete the data collection, which uses the same data submission methods as those we have finalized, we estimate the cost
In addition to costs incurred by individual eligible professionals and group practices, registries and EHR vendors may also incur some costs related to the final requirements for the 2012 Physician Quality Reporting System. Registries interested in becoming “qualified” to submit on behalf of individual eligible professionals will also have to incur a cost associated with the vetting process, calculating quality measures results from the data submitted to the registry by its participants, and submitting the quality measures results, as well as numerator and denominator data on quality measures, to CMS on behalf of their participants. We estimate the registry self-nomination process will cost approximately $400 per registry ($40 per hour × 10 hours per registry). This cost estimate includes the cost of submitting the self-nomination letter to CMS and completing the final CMS vetting process. Our estimate of $40 per hour average labor cost for registries is based on the assumption that registry staff include computer analysts. We do not believe that there are any additional costs for registries associated with a registry calculating quality measures results from the data submitted to the registry by its participants and submitting the quality measures results and numerator and denominator data on quality measures to CMS on behalf of their participants under the final program for 2012. We believe that the majority of registries already perform these functions for their participants.
An EHR vendor interested in having its product(s) be used by individual eligible professionals to submit the final Physician Quality Reporting System measures to CMS for 2012 will have to complete the vetting process during 2012 and program its EHR product(s) to extract the clinical data that the eligible professional will need to submit to CMS for purposes of reporting the final 2012 quality measures in 2013 as well. Previously qualified vendors will need to only update their electronic measure specifications and data transmission schema during 2012 to incorporate any new EHR measures we are finalizing to maintain their qualification for the 2012 Physician Quality Reporting System. Therefore, for EHR vendors that were not previously qualified, we estimate the cost associated with completing the self-nomination process, including the vetting process with CMS officials, will be $400 ($40/hour × 10 hours per EHR vendor). Our estimate of a $40 per hour average labor cost for EHR vendors is based on the assumption that vendor staff include computer analysts. We believe that the cost associated with the time and effort needed for an EHR vendor to review the quality measures and other information and program the EHR product to enable individual eligible professionals to submit Physician Quality Reporting System quality measures data to the CMS-designated clinical warehouse will be dependent on the EHR vendor's familiarity with the Physician Quality Reporting System, the vendor's system's capabilities, as well as the vendor's programming capabilities. Some vendors already have the necessary capabilities and for such vendors, we estimate the total cost will be approximately $1,600 ($40/hour × 40 hours per vendor). However, given the variability in the capabilities of the vendors, we believe an estimate for those vendors with minimal experience will be approximately $8,000 per vendor ($40/hour × 200 hours per EHR vendor).
Section VI.F.2. of this final rule with comment period describes the Electronic Prescribing (eRx) Incentive Programs finalized for CYs 2012 through 2014. To be considered a successful electronic prescriber in CYs 2012 through 2014, an individual eligible professional must meet the final requirements described in section VI.F.2. of this final rule with comment period.
From 2009, over 90,000 eligible professionals participated in the eRx Incentive Program. We anticipate that despite a decrease in the applicable quality incentive percent from 2 percent in 2009 to 1 percent (of total estimated Medicare Part B allowed charges for covered professional services) in 2012 and 0.5 percent in 2013, more eligible professionals (and group practices) will choose to participate in the eRx Incentive Program due to the 2013 and 2014 payment adjustments of 1.5 percent and 2.0 percent, respectively (reduction of the physician fee schedule amount that would otherwise apply to such services in 2013 and 2014), for eligible professionals who are not successful electronic prescribers. In order to become a successful electronic prescriber for purposes of the 2013 and 2014 payment adjustments under the 6-month payment adjustment reporting periods, we are finalizing more opportunities to report on the electronic prescribing measure by concentrating only on the numerator of the measure. Similar to the percentage increase from the 2008 to 2009 eRx Incentive Program, as well as taking into account the limitations and significant hardship exemptions we are finalizing for the 2013 and 2014 payment adjustments, we anticipate a 12 percent increase in the number of eligible professionals participating in the eRx Incentive Program from 2012 through 2014. Therefore, for purposes of this burden analysis, we estimate that more than 100,800 unique TIN/NPI combinations will participate in the 2012, 2013, and 2014 eRx Incentive Program
Although, as we stated previously, we expect participation in the eRx Incentive Program to increase due to the implementation of the 2013 and 2014 payment adjustments, we do not believe this expected increase in participation will affect the number of eligible professionals participating in the eRx Incentive Program for purposes of earning an incentive. For the 2009 eRx Incentive Program, based on an incentive of 2.0 percent of eligible professionals' total estimated Medicare Part B allowed charges for covered professional services, approximately $148 million in total incentives were paid to eligible professionals with a mean incentive amount of approximately $3,000. Whereas the applicable quality incentive percent for 2009 was 2.0 percent, the applicable percent for the 2012 and 2013 incentives are 1.0 percent and 0.5 percent, respectively. Since the applicable quality percent for the 2012 incentive is half that of the 2009 incentive, we estimate that $74 million in total incentives will be paid to eligible professionals for the 2012 incentive. Since the applicable quality percent for the 2013 incentive is one-fourth that of the 2009 incentive, we estimate that $37 million in total incentives will be paid to eligible professionals for the 2013 incentive. Therefore, for the 2012 and 2013 incentives, we estimate that a total of $111 million will be distributed to eligible professionals who become successful electronic prescribers.
With respect to the costs of participating in the eRx Incentive Program for eligible professionals and group practices, we estimate that the cost impact of the eRx Incentive Programs for CYs 2012 through 2014 on the Medicare program will be the cost incurred for maintaining the electronic prescribing measure and its associated code set, and for maintaining the existing clinical data warehouse to accommodate the registry-based reporting and EHR-based reporting options for the electronic prescribing measure. However, we do not believe that the program for CYs 2012 through 2014 have a significant administrative cost impact on the Medicare program since much of this infrastructure has already been established for the eRx Incentive Program.
Individual eligible professionals and group practices may have different processes for integrating data collection on the electronic prescribing measure into their practices' work workflows. Given this variability and the multiple reporting options that we are finalizing, it is difficult to accurately estimate the impact of the eRx Incentive Program for CYs 2012 through 2014 on providers. Furthermore, we believe that costs for eligible professionals who will participate in the eRx Incentive Program for the first time will be considerably higher than the cost for eligible professionals who participated in the eRx Incentive Program in prior years, as there are preparatory steps that an eligible professional will need to take to begin participating in the program. In addition, for many eligible professionals (especially those who participated in the eRx Incentive Program in prior years), we believe the cost of participating in the eRx Incentive Program in 2012 or 2013 will be offset by the incentive payment, if earned. As a result of the payment adjustment that begins in 2012 and continues until 2014, the cost of not participating in the eRx Incentive Program for CYs 2012 through 2014 could be higher than the cost of participating in the form of reduced Medicare payments as a result of the payment adjustment (if applicable).
Any eligible professional who wishes to participate in the eRx Incentive Program must have a qualified electronic prescribing system in order to participate. Therefore, a one-time potential cost to some individual eligible professionals will be the cost of purchasing and using an electronic prescribing system, which varies by the commercial software package selected, the level at which the professional currently employs information technology in his or her practice and the training needed. One study indicated that a midrange complete electronic medical record with electronic prescribing functionality costs $2,500 per license with an annual fee of $90 per license for quarterly updates of the drug database after setup costs while standalone prescribing, messaging, and problem list system may cost $1,200 per physician per year after setup costs. Hardware costs and setup fees substantially add to the final cost of any software package. (Corley, S.T. (2003). “Electronic prescribing: a review of costs and benefits.” Topics in Health Information Management 24(1):29-38.). These are the estimates that we are using for our impact analysis.
Similar to the Physician Quality Reporting System, one factor in the cost to individual eligible professionals is the time and effort associated with individual eligible professionals reviewing the electronic prescribing measure to determine whether it is applicable to them, reviewing the available reporting options and selecting one, gathering the required information, and incorporating reporting of the measure into their office work flows. Since the eRx Incentive Program consists of only 1 quality measure, we estimate 2 hours as the amount of time needed for individual eligible professionals to prepare for participation in the eRx Incentive Program. Information obtained from the PVRP, which was a predecessor to the Physician Quality Reporting System and was the first step for physician quality
Another factor that influences the cost to individual eligible professionals is how they choose to report the electronic prescribing measure (that is, whether they select the claims-based, registry-based or EHR-based reporting mechanism). For claims-based reporting, there will be a cost associated with reporting the appropriate QDC on the claims an individual eligible professional submits for payment. Based on the information from the PVRP described previously for the amount of time it takes a median practice to report one measure one time (1.75 minutes) and the requirement to report 25 electronic prescribing events during 2012, we estimate the annual estimated cost per individual eligible professional to report the electronic prescribing measure via claims-submission will be $43.75 (1.75 minutes per case × 1 measure × 25 cases per measure × $40/hour). We believe that for most successful electronic prescribers who earn an incentive, these costs will be negated by the incentive payment received given that the average incentive for eligible professionals who qualified for a 2009 eRx incentive was around $3,000.
For eligible professionals who select the registry-based reporting mechanism, we do not anticipate any additional cost for individual eligible professionals to report data to a registry, as individual eligible professionals opting for registry-based reporting are more than likely already reporting data to the registry. Little if any, additional data will need to be reported to the registry for purposes of participation in the eRx Incentive Program for CYs 2012 through 2014. Individual eligible professionals using registries for Physician Quality Reporting System will likely experience minimal, if any, increased costs charged by the registry to report this 1 additional measure.
For EHR-based reporting, the eligible professional must extract the necessary clinical data from his or her EHR, and submit the necessary data to the CMS-designated clinical data warehouse. Once the EHR is programmed by the vendor to allow data submission to CMS, the cost to the individual eligible professional associated with the time and effort to submit data on the electronic prescribing measure should be minimal.
With respect to the requirements for group practices for the 2012 and 2013 incentives and 2013 and 2014 payment adjustments discussed in section VI.F.2. of this final rule with comment period, group practices have the same options as individual eligible professionals in terms of the form and manner for reporting the electronic prescribing measure (that is, group practices have the option of reporting the measure through claims, a qualified registry, or a qualified EHR product). There are only 2 differences between the requirements for an individual eligible professional and a group practice: (1) the fact that a group practice must self-nominate; and (2) the number of times a group practice must report the electronic prescribing measure. Overall, there could be less cost associated with a practice participating in the eRx Incentive Program as a group rather than the individual members of the group separately participating. We do not believe that there are any additional costs associated with the group practice self-nomination process since we are limiting the group practices to those selected to participate in the 2012, 2013, and/or 2014 respective Physician Quality Reporting System GPRO. The practices only must indicate their desire to participate in the eRx GPRO at the time they self-nominate for the Physician Quality Reporting System GPRO.
The costs for a group practice reporting to an EHR or registry should be similar to the costs associated with registry and EHR reporting for an individual eligible professional, as the process is the same with the exception that more electronic prescribing events must be reported by the group. For similar reasons, the costs for a group practice reporting via claims should also be similar to the costs associated with claims-based reporting for an individual eligible professional. Therefore, we estimate that the costs for group practices who are selected to participate in the eRx Incentive Program for CYs 2012 through 2014 will range from $799.17 (1.75 minutes per case × 1 measure × 625 cases per measure × $40/hour) for groups comprised of 25-99 eligible professionals participating to $2,916.67 (1.75 minutes per case × 2500 cases per measure × $40/hour) for the groups comprised of 100 or more eligible professionals.
We believe that the costs to individual eligible professionals and group practices associated with meeting the requirements for the 2013 and 2014 payment adjustments will be similar to the costs of an eligible professional or group practice reporting the electronic prescribing measure for purposes of the 2012 and 2013 incentives. Specifically, we believe that the cost of reporting the electronic prescribing measure in one instance for purposes of the payment adjustment is identical to the cost of reporting the electronic prescribing measure for one instance on claims for purposes of the incentive payment. The only difference will be in the total costs for an individual eligible professional. Group practices are required to report the electronic prescribing measure for the same number of electronic prescribing events for both the 2012 and 2013 incentives and the 2013 and 2014 payment adjustments. Individual eligible professionals, however, are required to report the electronic prescribing measure for only 10 electronic prescribing events for purposes of the 2013 and 2014 payment adjustments, as opposed to 25 electronic prescribing events for purposes of the 2012 and 2013 incentives.
Based on our decision to consider only registries qualified to submit quality measures results and numerator and denominator data on quality measures to CMS on their participant's behalf for the 2012, 2013, and 2014 Physician Quality Reporting System to be qualified to submit results and numerator and denominator data on the electronic prescribing measure for eRx Incentive Program for CYs 2012, 2013, and 2014, respectively, we do not estimate any cost to the registry associated with becoming a registry qualified to submit the electronic prescribing measure for CYs 2012 through 2014.
The cost for the registry will be the time and effort associated with the registry calculating results for the electronic prescribing measure from the data submitted to the registry by its participants and submitting the quality measures results and numerator and denominator data on the eRx quality measure to CMS on behalf of their participants. We believe such costs will be minimal as registries will already be required to perform these activities for Physician Quality Reporting System.
Likewise, based on our decision to consider only EHR products qualified for the Physician Quality Reporting System for CYs 2012, 2013, and 2014 to be qualified to submit results and numerator and denominator data on the electronic prescribing measure for the eRx Incentive Program for CYs 2012, 2013, and 2014, there is no need for
The cost to the EHR vendor associated with the proposed EHR-based reporting requirements of this reporting initiative is the time and effort associated with the EHR vendor programming its EHR product(s) to extract the clinical data that the individual eligible professional needs to submit to CMS for reporting the electronic prescribing measure. Since we determined that only EHR products qualified for the Physician Quality Reporting System are qualified for the eRx Incentive Program, and the eRx Incentive Program consists of only one measure, we believe that any burden associated with the EHR vendor to program its product(s) to enable individual eligible professionals to submit data on the electronic prescribing measure to the CMS-designated clinical data warehouse will be minimal.
Section VI.G.2. of this final rule with comment period discusses the background of the Physician Compare Web site. As described in section VI.G.2. of this final rule with comment period, we are developing aspects of the Physician Compare Web Site in stages. We are finalizing our proposal to include performance information with respect to the 2012 Physician Quality Reporting System GPRO measures. As reporting of physician performance rates on the Physician Compare Web Site will be performed directly by us using the data that we collect under the 2012 Physician Quality Reporting System GPRO, we do not anticipate any notable impact on eligible professionals with respect to the posting of information on the Physician Compare Web Site.
Section VI.H.2. of this final rule with period finalizes changes to the EHR Incentive Program for EPs for the 2012 payment year with respect to the reporting of CQMs for achieving meaningful use. Aside from continuing the attestation method of reporting CQMs, we are allowing the reporting of CQMs for purposes of demonstrating meaningful use through participation in the Physician Quality Reporting System-Medicare EHR Incentive Pilot via— (1) a Physician Quality Reporting System qualified EHR data submission vendor or (2) using an EP's certified EHR technology, which also must be a Physician Quality Reporting System qualified EHR.
We believe the impact associated with actually reporting CQMs will vary depending on how the EP chooses to do so. We believe that the number of EPs who choose to participate via attestation will largely be those who are not participating in both the EHR Incentive Program and Physician Quality Reporting System as this is the method of reporting most favorable to EPs not participating in the Physician Quality Reporting System. EPs participating in the Physician Quality Reporting System will be more likely to participate in the pilot. Therefore, based on the previously mentioned assumptions, we do not believe there will be any additional impact on EPs that is specific to participation in the pilot. EPs must participate in the Physician Quality Reporting System in order to participate in the pilot.
The changes to the Physician Feedback Program in section VI.I. of this final rule with comment period would not impact CY 2012 physician payments under the Physician Fee Schedule. However, we expect that our decision to use the Physician Quality Reporting System quality measures in the Physician Feedback reports and in the value modifier to be implemented in CY 2015 may result in increased participation in the Physician Quality Reporting System in CY 2012. We anticipate that as we approach implementation of the value modifier, physicians will increasingly participate in the Physician Quality Reporting System to determine and understand how the value modifier could affect their payments.
Medicare collects ownership information obtained in the 855A and 855B enrollment forms completed upon a facility or a practitioner's Medicare enrollment. The 855 forms are self-selecting enrollment forms that may be updated as necessary. The enrollment forms do not specifically require complete information on whether a physician office is wholly owned or wholly operated by a hospital. While we believe that most hospital owned entities providing physician services will be considered part of the hospital and operating as hospital outpatient departments; there will be at least some hospital owned or operated entities that will meet the definition of “wholly-owned or wholly-operated” and will be subject to the 3-day payment window policy. We are unable to accurately estimate and verify the number of wholly owned or wholly operated entities enrolled in Medicare and furnishing health services to Medicare beneficiaries that will be subject to the 3-day payment window policy under the PFS because the 855 forms do not explicitly capture information on sole ownership or operation. We do not believe that our discussion in section V.B. of this final rule with comment period regarding the entities to which this policy applies changes our assessment that this policy would impact a small number of providers/suppliers. We note that the application of the 3-day window policy is limited to diagnostic or related nondiagnostic services that are provided during the defined payment window by entities that are wholly owned or operated by the hospital to which the patient is ultimately admitted. The 3-day payment window policy would not apply to the majority of services provided by a hospital's wholly-owned or wholly-operated physician offices. Furthermore, the effects of applying the 3-day window policy would be limited to the practice expense component of the payment rate, and the professional component is not affected by the 3-day window payment policy. We are unable to estimate the impact of this final policy at this time. However, we note that if we were able to estimate the effects of this policy on Part B payments, the program savings would be redistributed across all other services paid under the PFS in accordance with due to the PFS budget neutrality provisions.
As discussed in section VI.D. of this final rule with comment period, we are retracting the policy that was finalized in the CY 2011 PFS final rule with comment period, which required a physician's or NPP's signature on a requisition for clinical diagnostic laboratory tests paid under the CLFS and are reinstating our prior policy that the signature of the physician or NPP is not required on a requisition for a clinical diagnostic laboratory test paid under the CLFS for Medicare purposes. There are no expenditures or fiscal impact on the Medicare program associated with this policy. While this policy may have an effect on beneficiaries, we believe that any effect would be positive because we are changing a requirement that might have
This final rule with comment period contains a range of policies, including some provisions related to specific statutory provisions. The preceding preamble provides descriptions of the statutory provisions that are addressed, identifies those policies when discretion has been exercised, presents rationale for our policies and, where relevant, alternatives that were considered.
There are a number of changes in this final rule with comment period that would have an effect on beneficiaries. In general, we believe that many of the final changes, including the refinements of the Physician Quality Reporting System with its focus on measuring, submitting, and analyzing quality data will have a positive impact and improve the quality and value of care provided to Medicare beneficiaries.
The regulatory provisions may affect beneficiary liability in some cases. Most changes in aggregate beneficiary liability due to a particular provision would be a function of the coinsurance (20 percent if applicable for the particular provision after the beneficiary has met the deductible). To illustrate this point, as shown in Table 87, the CY 2011 national payment amount in the nonfacility setting for CPT code 99203 (Office/outpatient visit, new) is $102.95, which means that in CY 2011 a beneficiary would be responsible for 20 percent of this amount, or $20.59. Based on this final rule with comment period, including the negative update, the CY 2012 national payment amount in the nonfacility setting for CPT code 99203, as shown in Table 87, is $76.23, which means that, in CY 2012, the beneficiary coinsurance for this service would be $15.25. Most policies discussed in this final rule with comment period that impact payment rates, such as the expansion of the MPPR to the professional component of imaging procedures, would similarly impact beneficiaries' coinsurance.
As required by OMB Circular A-4 (available at
The analysis in the previous sections, together with the remainder of this preamble, provides a Final Regulatory Flexibility Act Analysis. The previous analysis, together with the remainder of this preamble, provides a Regulatory Impact Analysis.
This section lists the Addenda referred to throughout the preamble of this final rule with comment period. Beginning with the CY 2012 PFS proposed rule, the PFS Addenda A, B, C, D, E, F, G, and H will no longer appear in the
Readers who experience any problems accessing any of the Addenda that are posted on the CMS Web sites identified in this section should contact Erin Smith at (410) 786-4497.
The following PFS Addenda for CY 2012 PFS final rule with comment period rule with are available through the Internet on the CMS Web site at
The Designated Health Services Code List Addendum for CY 2012 PFS final rule with comment period entitled “Addendum J: List of CPT
Health facilities, Health professions, Kidney diseases, Laboratories, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays.
Administrative practice and procedure, Health facilities, Health professions, Kidney diseases, Medicare, Reporting and recordkeeping.
Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
Administrative practice and procedure, Electronic health records, Health facilities, Health professions, Health maintenance organizations (HMO), Medicaid, Medicare, Penalties, Privacy, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble of this final rule with comment period, the Centers for Medicare & Medicaid Services amends 42 CFR chapter IV as set forth below:
Secs. 1102, 1834, 1871, and 1893 of the Social Security Act (42 U.S.C. 1302, 1395m, 1395hh, and 1395ddd).
The revisions and additions read as follows:
(a) * * *
(i) Review (and administration if needed) of a health risk assessment (as defined in this section).
(viii) * * *
(A) A written screening schedule for the individual such as a checklist for the next 5 to 10 years, as appropriate, based on recommendations of the United States Preventive Services Task Force and the Advisory Committee on Immunization Practices, and the individual's health risk assessment (as that term is defined in this section), health status, screening history, and age-appropriate preventive services covered by Medicare.
(i) Collects self-reported information about the beneficiary.
(ii) Can be administered independently by the beneficiary or administered by a health professional prior to or as part of the AWV encounter.
(iii) Is appropriately tailored to and takes into account the communication needs of underserved populations, persons with limited English proficiency, and persons with health literacy needs.
(iv) Takes no more than 20 minutes to complete.
(v) Addresses, at a minimum, the following topics:
(A) Demographic data, including but not limited to age, gender, race, and ethnicity.
(B) Self assessment of health status, frailty, and physical functioning.
(C) Psychosocial risks, including but not limited to, depression/life satisfaction, stress, anger, loneliness/social isolation, pain, and fatigue.
(D) Behavioral risks, including but not limited to, tobacco use, physical activity, nutrition and oral health, alcohol consumption, sexual health, motor vehicle safety (seat belt use), and home safety.
(E) Activities of daily living (ADLs), including but not limited to, dressing, feeding, toileting, grooming, physical ambulation (including balance/risk of falls), and bathing.
(F) Instrumental activities of daily living (IADLs), including but not limited to, shopping, food preparation, using the telephone, housekeeping, laundry, mode of transportation, responsibility for own medications, and ability to handle finances.
(i) Review (and administration, if needed) of an updated health risk assessment (as defined in this section).
(iii) An update of the list of current providers and suppliers that are regularly involved in providing medical care to the individual as that list was developed for the first annual wellness visit providing personalized prevention plan services or the previous subsequent annual wellness visit providing personalized prevention plan services.
(vi) * * *
(B) The list of risk factors and conditions for which primary, secondary or tertiary interventions are recommended or are underway for the individual as that list was developed at the first annual wellness visit providing personalized prevention plan services or the previous subsequent annual wellness visit providing personalized prevention plan services.
(b)
4. In § 410.78, amend paragraph (b) introductory text by removing the phrase “and individual and group health and behavior assessment and intervention services furnished by an interactive telecommunications system if the following conditions are met:” and adding in its place the phrase “individual and group health and behavior assessment and intervention
Secs. 1102, 1871, and 1881(b)(l) of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)).
(b) * * *
(5) * * *
(i) * * *
(A)
(B)
(C)
The revisions and additions read as follows:
(b) * * *
(c) * * *
(2) For purposes of this paragraph—
(4) For purposes of this paragraph—
(f) * * *
(1)
(i) The 12-month period from January 1 through December 31 of such program year.
(ii) A 6-month period from July 1 through December 31 of such program year.
(A) For 2011, such 6-month reporting period is not available for EHR-based reporting of individual Physician Quality Reporting System quality measures.
(B) For 2012 and subsequent program years, such 6-month reporting period from July 1 through December 31 of such program year is only available for registry-based reporting of Physician Quality Reporting System measures groups by eligible professionals.
(2)
(g) * * *
(1) Meets the participation requirements specified by CMS for the Physician Quality Reporting System group practice reporting option;
(3) Reports measures in the form and manner specified by CMS;
(4) For purposes of paragraph (g), the reporting period is the 12-month period from January 1 through December 31 of such program year;
(6) Payments to a group practice under this paragraph must be in lieu of the payments that would otherwise be made under the Physician Quality Reporting System to eligible
(i) If an eligible professional, as identified by an individual NPI, has reassigned his or her Medicare billing rights to a TIN selected to participate in the Physician Quality Reporting System group practice reporting option for a program year, then for that program year the eligible professional must participate in the Physician Quality Reporting System via the group practice reporting option. For any program year in which the TIN is selected to participate in the Physician Quality Reporting System group practice reporting option, the eligible professional cannot individually qualify for a Physician Quality Reporting System incentive payment by meeting the requirements specified in paragraph (f) of this section.
(ii) If, for the program year, the eligible professional participates in the Physician Quality Reporting System under a TIN that is not selected to participate in the Physician Quality Reporting System group practice reporting option for that program year, then the eligible professional may individually qualify for a Physician Quality Reporting System incentive by meeting the requirements specified in paragraph (f) of this section under that TIN.
(i) * * *
(1) To request an informal review, an eligible professional (or in the case of reporting under paragraph (g) of this section, group practices) must submit a request to CMS within 90 days of the release of the feedback reports. The request must be submitted in writing and summarize the concern(s) and reasons for requesting an informal review and may also include information to assist in the review.
(2) CMS will provide a written response within 90 days of the receipt of the original request.
(b) * * *
(i) * * *
(B) In a Medicare-approved demonstration project or other Medicare program, under which Physician Quality Reporting System requirements and incentives have been incorporated; and
(c) * * *
(2)
(ii) * * *
(A) From the 2012 payment adjustments by meeting one of the following:
(B) From the 2013 and 2014 payment adjustments by meeting one of the following:
(
(
(
(
(iii)
(A) The eligible professional is not an MD, DO, podiatrist, nurse practitioner, or physician assistant.
(B) The eligible professional does not have at least 100 cases containing an encounter code that falls within the denominator of the electronic prescribing measure for dates of service during the 6-month reporting period specified in paragraph (f)(1) of this section.
(f)
(1)
(A) The 12-month period from January 1, 2011 through December 31, 2011.
(B) The 6-month period from January 1, 2012 through June 30, 2012.
(ii) For purposes of this paragraph (f), the reporting period for the 2014 payment adjustment is either of the following:
(A) The 12-month period from January 1, 2012 through December 31, 2012.
(B) The 6-month period from January 1, 2013 through June 30, 2013.
(2)
(i) For the 6- and 12-month reporting periods under paragraph (f)(1) of this section, CMS, by no later than 2 months after the end of the applicable 12-month reporting period or by no later than 1 month after the end of the applicable 6-month reporting period, on the eligible professional's Medicare Part B claims for covered professional services furnished by the eligible professional during the reporting period specified in paragraph (f)(1) of this section.
(ii) For the 12-month reporting period under paragraph (f)(1) of this section, a qualified registry (as defined in paragraph (b) of this section) in the form and manner and by the deadline specified by the qualified registry selected by the eligible professional. The selected qualified registry submits information, as required by CMS, for covered professional services furnished by the eligible professional during the reporting period specified in paragraph (f)(1) of this section to CMS on the eligible professional's behalf.
(iii) For the 12-month reporting period under paragraph (f)(1) of this section, CMS by extracting clinical data using a secure data submission method, as required by CMS, from a qualified electronic health record product (as defined in paragraph (b) of this section) by the deadline specified by CMS for covered professional services furnished by the eligible professional during the reporting period specified in paragraph (f)(1) of this section. Prior to actual data submission for a given program year and by a date specified by CMS, the eligible professional must submit a test file containing dummy clinical quality data extracted from the qualified electronic health record product selected by the eligible professional using a secure data submission method, as required by CMS.
(d) * * *
(3)
(i) The payment amount substitution will be applied at the next average sales price payment amount calculation period after the Inspector General informs the Secretary (at such times specified by the Secretary) about billing codes for which the average sales price has exceeded the average manufacturer price by the applicable threshold percentage, and will remain in effect for 1 quarter after publication.
(ii) Payment at 103 percent of the average manufacturer price for a billing code will be applied at such times when—
(A) The threshold for making price substitutions, as defined in paragraph (d)(3)(iii) of this section is met; and
(B) 103 percent of the average manufacturer price is less than the 106 percent of the average sales price for the quarter in which the substitution would be applied.
(iii) The applicable percentage threshold for average manufacturer price comparisons for CYs 2005 through 2011 is 5 percent. For CY 2012, the applicable percentage threshold for average sales price comparisons is reached when—
(A) The average sales price for the billing code has exceeded the average manufacturer price for the billing code by 5 percent or more in 2 consecutive quarters, or 3 of the previous 4 quarters immediately preceding the quarter to which the price substitution would be applied; and
(B) The average manufacturer price for the billing code is calculated using the same set of National Drug Codes used for the average sales price for the billing code.
(iv) The applicable percentage threshold for widely available market price comparisons for CYs 2005 through 2012 is 5 percent.
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
(a) * * *
(2) * * *
(v)
(A) Submission of data extracted from the EP's certified EHR technology through a Physician Quality Reporting System qualified EHR data submission vendor; or
(B) Submission of data extracted from the EP's certified EHR technology, which must also be through a Physician Quality Reporting System qualified EHR.