Forest Service
Natural Resources Conservation Service
Engineers Corps
National Foundation on the Arts and the Humanities
Minority Business Development Agency
National Oceanic and Atmospheric Administration
National Telecommunications and Information Administration
Air Force Department
Army Department
Engineers Corps
Federal Energy Regulatory Commission
Trade Representative, Office of United States
Centers for Disease Control and Prevention
Food and Drug Administration
Health Care Financing Administration
Indian Health Service
Fish and Wildlife Service
Indian Affairs Bureau
Land Management Bureau
Minerals Management Service
National Park Service
Antitrust Division
Employment and Training Administration
Mine Safety and Health Administration
Trade Representative, Office of United States
Centers for Disease Control and Prevention
Food and Drug Administration
Indian Health Service
Coast Guard
Federal Aviation Administration
Saint Lawrence Seaway Development Corporation
Alcohol, Tobacco and Firearms Bureau
Customs Service
Internal Revenue Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
Office of the United States Trade Representative.
Final rule.
The Office of the United States Trade Representative (“USTR”) hereby issues a final rule providing for the establishment of an export certificate procedure to assist in the orderly marketing of lamb meat imports from countries provided a specific import allocation under the temporary tariff-rate quota that the President has imposed on those products.
The effective date of this final rule is June 29, 2000.
Mark Sloan, Director of Agricultural Affairs, Office of the United States Trade Representative, 600 17th Street NW., Washington, DC 20506, (202) 395-6127.
On July 7, 1999, the President issued Proclamation 7208, 64 FR 37387 (July 9, 1999), which established a temporary tariff-rate quota (“TRQ”) and increased duties, effective July 22, 1999, on lamb meat imports to facilitate the domestic industry's adjustment to import competition. In order to provide for the efficient and fair administration of the TRQ, on July 30, 1999, the President issued Proclamation 7214, 64 FR 42265 (Aug. 4, 1999), which delegated authority to administer the TRQ to the United States Trade Representative.
To provide for the efficient and fair administration of the TRQ, USTR has established a procedure under which countries that have been allotted an in-quota allocation under the TRQ may use a system of export certificates to ensure that only those of its lamb meat exports specifically designated for the United States market are counted against the country's in-quota allocation. USTR published an interim rule and request for comments on this subject in the
Under the final rule, as under the interim rule, a country that was provided a specific in-quota allocation under the TRQ may elect to have the United States Customs Service (“U.S. Customs”) determine which lamb meat imports are to be counted against the country's in-quota allocation, and thus be assessed the lower rate of duty applicable to in-quota imports, based on whether the country has issued (or authorized issuance of) an export certificate for that lamb meat. Two countries, Australia and New Zealand, were provided specific in-quota allocations under the TRQ. Both governments have requested USTR to establish an export certificate procedure to assist in the orderly marketing of their lamb meat exports to the United States while the TRQ is in effect.
A country wishing to avail itself of the export certificate procedure must notify USTR and provide the necessary supporting information. Australia and New Zealand have provided the requisite supporting information, and USTR determine in the
U.S. Customs will ensure that no imports of lamb meat from a participating country are counted against that country's in-quota allocation unless the importer declares that there is a valid export certificate for that lamb meat. In the absence of such a declaration, the imports will not be eligible for the in-quota rate of duty.
U.S. Customs will separately issue regulations governing its implementation of this rule.
USTR received comments on the interim rule from representatives of the Australian lamb meat industry (Meat and Livestock Australia, or “MLA”) and the Embassy of New Zealand.
MLA supported implementation of the export certificate system, and therefore supported the interim rule. MLA had no substantive comments on the interim rule.
The Embassy of New Zealand also supported the export certificate system. However, it recommended the following three changes to the interim rule:
(i) That the wording of § 2014.3(b)(2) be amended by replacing “calendar year” with “quota year;”
(ii) That the wording of § 2014.3(b)(4) be amended by replacing “in the calendar year” with “for quota year;” and
(iii) That the term “quota year” be defined in § 2014.2 as “the period between 22 July 1999 and 21 July 2000, inclusive, and such subsequent periods as set forth in Presidential Proclamations 7208 (64 FR 37387) and 7214 (64 FR 42265) during which lamb meat is exported.”
USTR has adopted all of the changes suggested by the Embassy of New Zealand, and has amended its interim rule accordingly.
Export certificates, Imports, Lamb meat, Tariff-rate quotas.
19 U.S.C. 2253(g); Proclamation 7208, 64 FR 37387, July 9, 1999; Proclamation 7214, 64 FR 42265, Aug. 4, 1999.
The purpose of this part is to provide for the implementation of the tariff-rate quota for imports of lamb meat established in Proclamation 7208 (64 FR 37387) (July 9, 1999) and modified in Proclamation 7214 (64 FR 42265) (Aug. 4, 1999). In particular, this part provides for the administration of export certificates where a country that has an allocation of the in-quota quantity under
Unless the context otherwise requires, for the purpose of this part, the following terms shall have the meanings assigned as follows:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(a) In-quota lamb meat may only be entered as a product of a participating country if the United States importer makes a declaration to the United States Customs Service, in the form and manner determined by the United States Customs Service, that a valid export certificate is in effect with respect to that lamb meat product.
(b) To be valid, an export certificate shall:
(1) Be issued by or under the supervision of the government of the participating country;
(2) Specify the name of the exporter, the product description and quantity, and the quota year for which the export certificate is in effect;
(3) Be distinct and uniquely identifiable; and
(4) Be used for the quota year for which it is in effect.
Bureau of Alcohol, Tobacco and Firearms (ATF), Department of the Treasury.
Temporary rule (Treasury decision).
In Treasury Decision ATF-424, ATF issued temporary regulations requiring manufacturers and importers to mark packages of roll-your-own tobacco as either “roll-your-own tobacco” or “Tax Class J.” The temporary regulations provided a use-up period until April 1, 2000 for manufacturers who used packages that did not meet the marking requirements, provided they used the packages before January 1, 2000. In this temporary rule, ATF is extending the date by which manufacturers of roll-your-own tobacco must comply with the package marking requirements. ATF is also adding regulations to provide the same compliance date for importers of roll-your-own tobacco.
Effective date: June 29, 2000. This temporary rule extends the compliance date for both manufacturers and importers until October 1, 2000.
Robert P. Ruhf, Regulations Division, 650 Massachusetts Avenue, NW., Washington, DC 20226; (202) 927-8210; or alctob@atfhq.atf.treas.gov.
This temporary rule extends the date stated in 27 CFR 270.216b(c) and 295.45c for manufacturers to comply with the requirements that packages be marked as “roll-your-own tobacco” or “Tax Class J” from April 1, 2000, to October 1, 2000. This temporary rule also adds a new section, 27 CFR 275.72c, that will allow importers to have this same benefit. We are taking this action as a result of comments from the Pipe Tobacco Council, Washington, DC. These comments were received in response to the notice of proposed rulemaking, Notice No. 889 (
The Pipe Tobacco Council submitted written comments concerning the inability of manufacturers and importers of roll-your-own tobacco to comply with the April 1, 2000 deadline. The Pipe Tobacco Council stated that they represented manufacturers and importers who account for more than 90 percent of the roll-your-own tobacco sold in the United States. The Pipe Tobacco Council stated that since there is a long lead time for acquiring new packaging of at least 5 to 6 months, most manufacturers and importers would be unable to meet the April 1, 2000 deadline for marking packages as “roll-your-own tobacco” or “Tax Class J”. In addition, they stated that although manufacturers and importers could place stickers on the packages with “roll-your-own tobacco” or “Tax Class J” markings, the amount of hand labor involved would make this very costly. The Pipe Tobacco Council requested an extension of the compliance date to October 1, 2000, to allow all manufacturers and importers a reasonable time to comply with this requirement to mark packages “roll-your-own tobacco” or “Tax Class J”.
We have considered the jeopardy to the revenue in extending the compliance date with these package markings and the costs that would be incurred. Since the jeopardy to the revenue is minimal and the costs would be comparatively large for manufacturers and importers to comply, we have decided to extend the use-up date from April 1, 2000, to October 1, 2000.
We note that the Pipe Tobacco Council letter also requested that “cigarette tobacco,” be allowed as an alternative marking designation on packages of roll-your-own tobacco. We are not addressing this issue at this time. We will address this issue after we have analyzed all comments received during the 60-day comment period to Notice No. 889 (64 FR 71935), which was issued concurrently with the temporary rule T.D. ATF-424 (64 FR 71929) published December 22, 1999.
Because no notice of proposed rulemaking is required for this temporary rule, according to the provisions of the Regulatory Flexibility Act (5 U.S.C. 601
It has been determined that this temporary rule is not a significant regulatory action as defined by Executive Order 12866 because any economic effects flow directly from the underlying statute and not from this rule. Therefore, a regulatory assessment is not required.
This rule does not impose any collection of information as defined in the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(j)). Consequently, this rule is being issued without prior notice and public procedure pursuant to the Administrative Procedure Act (5 U.S.C. 553).
Because this document merely extends the date when manufacturers and importers must comply with certain marking requirements, and because immediate guidance is necessary to implement this extension, it is found to be impracticable to issue this Treasury decision with notice and public procedure under 5 U.S.C. 553(b) or subject to the effective date limitation under 5 U.S.C. 553(d).
The principal author of this document is Robert P. Ruhf, of the Regulations Division, Bureau of Alcohol, Tobacco and Firearms.
Administrative practice and procedure, Authority delegations, Cigarette papers and tubes, Claims, Electronic fund transfer, Excise taxes, Labeling, Packaging and containers, Penalties, Reporting requirements, Seizures and forfeitures, Surety bonds, Tobacco products.
Administrative practice and procedure, Authority delegations, Cigarette papers and tubes, Claims, Electronic fund transfer, Customs duties and inspection, Excise taxes, Imports, Labeling, Packaging and containers, Penalties, Reporting requirements, Seizures and forfeitures, Surety bonds, Tobacco products, U.S. possessions, Warehouses.
Administrative practice and procedure, Authority delegations, Cigarette papers and tubes, Excise taxes, Labeling, Packaging and containers, Tobacco products.
26 U.S.C. 5142, 5143, 5146, 5701, 5703-5705, 5711-5713, 5721-5723, 5731, 5741, 5751, 5753, 5761-5763, 6061, 6065, 6109, 6151, 6301, 6302, 6311, 6313, 6402, 6404, 6423, 6676, 6806, 7011, 7212, 7325, 7342, 7502, 7503, 7606, 7805, 31 U.S.C. 9301, 9303, 9304, 9306.
(a) A manufacturer must have used such packaging for roll-your-own tobacco before January 1, 2000.
(b) A manufacturer of roll-your-own tobacco may continue to place roll-your-own tobacco in packages that do not meet the marking requirements of §§ 270.212 and 270.216b(b) until April 1, 2000.
(c) A manufacturer of roll-your-tobacco may continue to place roll-your-tobacco in packages that do not meet the requirements of § 270.216b(a) until October 1, 2000.
18 U.S.C. 2342; 26 U.S.C. 5701, 5703-5705, 5708, 5712, 5713, 5722, 5723, 5741, 5754, 5761-5763, 6301, 6302, 6313, 6404, 7101, 7212, 7342, 7606, 7652, 7805; 31 U.S.C. 9301, 9303, 9304, 9306.
(a) An importer must have used such packaging for roll-your-own tobacco before January 1, 2000.
(b) An importer of roll-your-own tobacco may continue to place roll-your-own tobacco in packages that do not meet the marking requirements of § 275.72b(b) until April 1, 2000.
(c) An importer of roll-your-own tobacco may continue to place roll-your-own tobacco in packages that do not meet the requirements of § 275.72b(a) until October 1, 2000.
26 U.S.C. 5703, 5704, 5705, 5723, 5741, 5751, 5762, 5763, 6313, 7212, 7342, 7606, 7805, 44 U.S.C. 3504(h).
(a) A manufacturer must have used such packaging for roll-your-own tobacco before January 1, 2000.
(b) A manufacturer of roll-your-own tobacco, may continue to place roll-your-own tobacco in packages that do not meet the marking requirements of §§ 270.212 and 270.216b(b) until April 1, 2000.
(c) A manufacturer of roll-your-own tobacco may continue to place roll-your-own tobacco in packages that do not meet the marking requirements of § 270.216b(a) until October 1, 2000.
Minerals Management Service (MMS), Interior.
Correction to final regulations.
This document corrects the final rule titled “Update of Documents Incorporated by Reference,” which was published Tuesday, January 4, 2000 (65
February 3, 2000. The incorporation by reference of publications listed in the regulation is approved by the Director of the
Alexis London, Rules Processing Team, Engineering and Operations Division, (703) 787-1600.
The final regulations that are the subject of these corrections updated one API document incorporated by reference (API RP 500) and added a new document incorporated by reference (API RP 505). These regulations affect all operators and lessees on the Outer Continental Shelf.
The regulation at 30 CFR 250.410(e) on safety precautions in mud-handling areas currently incorporates by reference the out-of-date document “API RP 500B.” The final regulations should have revised § 250.410(e) to reference “API RP 500” or “API RP 505” as it did for various other sections of our regulations. The list of citations for API RP 500 and API RP 505 in the table of documents incorporated by reference in § 250.198(e) should have then included § 250.410(e).
As published, the final regulations contain errors that may prove to be misleading and are in need of clarification.
(e) * * *
On page 219, in the 3rd column following the amendment to § 250.1629, an amendment to § 250.410 is added as follows:
9. In § 250.410, in paragraph (e), the title of the document incorporated by reference “API RP 500B” is revised to read “API RP 500 or API RP 505”.
Coast Guard, DOT.
Final rule.
This rule makes editorial and technical changes throughout Title 33 of the Code of Federal Regulations (CFR) to update the title before it is recodified on July 1, 2000. It corrects addresses, updates cross-references, makes conforming amendments, and makes other technical corrections. This rule will have no substantive effect on the regulated public.
This final rule is effective June 30, 2000.
Documents as indicated in this preamble are available for inspection or copying at the Docket Management Facility, [USCG-2000-7223], U.S. Department of Transportation, room PL-401, 400 Seventh Street SW., Washington, DC, 20590-0001, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also find this docket on the Internet at http://dms.dot.gov.
For questions on this rule, contact Ms. Janet Walton, Project Manager, Standards Evaluation and Development Division (G-MSR-2), Coast Guard, telephone 202-267-0257. For questions on viewing, or submitting material to, the docket, contact Dorothy Beard, Chief, Dockets, Department of Transportation, telephone 202-366-9329.
Each year Title 33 of the Code of Federal Regulations is recodified on July 1. This rule makes editorial changes throughout the title, corrects addresses, updates cross-references, and makes other technical and editorial corrections to be included in the recodification. Some editorial changes are discussed individually in the following paragraphs. This rule does not change any substantive requirements of existing regulations.
We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. This rule consists only of corrections and editorial and conforming amendments to Title 33 of the Code of Federal Regulations. These changes will have no substantive effect on the public and publishing an NPRM and providing an opportunity for public comment is
The Coast Guard published an Interim Rule, Rules of Practice, Procedure, and Evidence for Administrative Proceedings of the Coast Guard, on May 24, 1999 [USCG-1998-3472] [64 FR 28054]. We published a correction to the Interim Rule, on June 28, 1999, that corrected Table 20.304(D)—How To Serve Filed Documents. With the publication of the July 1, 1999, codification of 33 CFR, we discovered that the table was still printed incorrectly. This rulemaking sets out the table the way it was intended.
On December 1, 1999, the Coast Guard published a Direct Final Rule, Update of Standards from the American Society for Testing and Materials (ASTM) [USCG-1999-5151] [64 FR 67170]. On March 1, 2000, we published a confirmation of effective date for the rule [65 FR 10943]. Because we did not change the sections in the CFR where the standard numbers did not contain a year date, we are now adding a cross-reference back to the Incorporation by reference section in each part for each of the sections listed.
The Frequency of Inspection Final Rule [USCG-1999-4976], published on February 9, 2000 (65 FR 6494), established a 5-year Certificate of Inspection cycle to harmonize the Coast Guard's inspections with internationally required certificates. We published the final rule to establish the frequency of inspection requirements to meet the International Convention for the Safety of Life at Sea, 1974, and the International Convention on Load Line compliance date of February 3, 2000. This rule changes section 151.19 to conform to the February final rule.
This rule updates the addresses and telephone numbers in Table 1, Addresses and Telephone Numbers of Coast Guard District Offices and EPA Regional Offices.
This rule sets out paragraph (e)(3)(iii) with the correct location of the words “classified” and “classification”. The words are reversed in the current codification.
This rule is not a significant regulatory action under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. It has not been reviewed by the Office of Management and Budget under that Order. It is not significant under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040; February 26, 1979). We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary. As this rule involves internal agency practices and procedures, it will not impose any costs on the public.
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
We have analyzed this rule under E.O. 13132 and have determined that this rule does not have implications for federalism under that Order.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or tribal government or the private sector to incur direct costs without the Federal Government's having first provided the funds to pay those costs. This proposed rule would not impose an unfunded mandate.
This rule will not effect a taking of private property or otherwise have taking implications under E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under E.O. 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.
We considered the environmental impact of this rule and concluded that, under figure 2-1, paragraph (34)(a) and (b) of Commandant Instruction M16475.lC, this rule is categorically excluded from further environmental documentation. This exclusion is in accordance with paragraphs (34)(a) and (b), concerning regulations that are editorial or procedural and concerning internal agency functions or organization. A “Categorical Exclusion Determination” is available in the docket where indicated under
Administrative practice and procedure, Authority delegations (Government agencies), Freedom of information, Penalties.
Organization and functions (Government agencies).
Administrative law judges, Administrative practice and procedure, Appeals, Discovery, Evidence, Hearings.
Navigation (water).
Intergovernmental relations, Navigation (water), Reporting and recordkeeping requirements.
Continental shelf, Navigation (water), Reporting and recordkeeping requirements.
Navigation (water), Penalties.
Navigation (water).
Navigation (water), Treaties, Waterways.
Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.
Bridges.
Bridges.
Bridges.
Fire prevention, Harbors, Natural gas, Reporting and recordkeeping requirements, Security measures.
Continental shelf, Marine safety, Occupational safety and health.
Administrative practice and procedure, Oil pollution, Penalties, Reporting and recordkeeping requirements, Water pollution control.
Hazardous substances, Oil pollution, Reporting and recordkeeping requirements, Water pollution control.
Fire prevention, Hazardous substances, Oil pollution, Reporting and recordkeeping requirements.
Cargo vessels, Oil pollution, Reporting and recordkeeping requirements.
Administrative practice and procedure, Harbors, Hazardous materials transportation, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Vessels, Waterways.
Harbors, Navigation (water), Reporting and recordkeeping requirements, Vessels, Waterways.
Navigation (water), Waterways.
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
Labeling, Marine safety, Reporting and recordkeeping requirements.
Marine safety.
14 U.S.C. 633; Sec. 6079(d), Pub. L. 100-690, 102 Stat. 4181; 49 CFR 1.46.
(b) Reports of any investigation conducted by the Coast Guard or received from any other agency which indicate that a violation may have occurred may be forwarded to a District Commander or other designated official for further action. This is normally the District Commander of the District in which the violation is believed to have occurred, or the District in which the reporting unit or agency is found. The report is reviewed to determine if there is sufficient evidence to establish a
14 U.S.C. 633; 49 CFR 1.45, 1.46.
33 U.S.C. 1321; 42 U.S.C. 9609; 46 U.S.C. 7701, 7702; 49 CFR 1.46.
(d) * * *
14 U.S.C. 85; 33 U.S.C. 1233; 43 U.S.C. 1333; 49 CFR 1.46.
14 U.S.C. 83, 85; 43 U.S.C. 1333; 49 CFR 1.46.
(b) Notices to Mariners which concern the establishment, disestablishment, or change of State aids to navigation, including regulatory markers, may be published whenever the aids to navigation concerned are covered by navigational charts or maps issued by the U.S. Coast and Geodetic Survey or the U.S. Army Corps of Engineers.
14 U.S.C. 85, 633; 43 U.S.C. 1333; 49 CFR 1.46.
Secs. 14, 16, 30 Stat. 1152, 1153; secs. 84, 86, 92, 633, 642, 63 Stat. 500, 501, 503, 545, 547 (33 U.S.C. 408, 411, 412; 14 U.S.C. 84, 86, 92, 633, 642).
14 U.S.C. 81, 85, 86, 92, 93, 141, 633, 642, 647; 49 CFR 1.46(b).
14 U.S.C. 2; 14 U.S.C. 633; 33 U.S.C. 151(a); 49 CFR 1.46.
(h) A line drawn from Cape May Inlet East Jetty Light 4 to Cape May Inlet West Jetty Light 5.
33 U.S.C. 1233 through 1236; 49 CFR 1.46; 33 CFR 100.35.
a. In the entry for New York: 6.5, remove the word “years” and add, in its place, the word “yards”;
(a) * * *
(e) * * *
33 U.S.C. 401, 491, 499, 521, 525, and 535; 14 U.S.C. 633; 49 U.S.C. 1655(g); 49 CFR 1.46(c).
33 U.S.C. 499; 49 CFR 1.46; 33 CFR 1.05-1(g); section 117.255 also issued under the authority of Pub. L. 102-587, 106 Stat. 5039.
The draw of the Washington State Parks and Recreation Commission bridge across the South Fork Willapa River, mile 0.3, at Raymond, shall open on signal if at least 24 hours notice is given.
33 U.S.C. 494; 14 U.S.C. 85, 633; 49 CFR 1.46(b) and (c)
33 U.S.C. 1231; 49 CFR 1.46.
43 U.S.C. 1333d; 46 U.S.C. 3102(a); 46 CFR 1.46.
33 U.S.C. 1321 and 1903; Pub. L. 104-227 (110 Stat. 3034), E.O. 12777, 3 CFR, 1991 Comp. p. 351; 49 CFR 1.46.
(e) The IOPP Certificate for each U.S. inspected ship is valid for a period not to exceed five years from the date of issue, and for each U.S. uninspected ship the IOPP Certificate is valid for a period not to exceed five years from the date of issue, except as follows—
14 U.S.C. 633; 33 U.S.C. 1321; 42 U.S.C. 9615; E.O. 12580, 3 CFR, 1987 Comp., p. 193; E.O. 12777, 3 CFR, 1991 Comp., p. 351; 49 CFR 1.45 and 1.46.
33 U.S.C. 1231, 1321(j)(1)(C), (j)(5), (j)(6), and (m)(2); sec. 2, E.O. 12777, 56 FR 54757; 49 CFR 1.46. Subpart F is also issued under 33 U.S.C. 2735.
(e) * * *
(3) * * *
(iii) * * *
For oil spill removal organization(s) classified by the Coast Guard, the classification must be noted in this section of the plan. * * *
33 U.S.C. 1903; 46 U.S.C. 3703, 3703a (note); 49 CFR 1.46. Subparts G, H, and I are also issued under section 4115(b), Pub. L. 101-380, 104 Stat. 520; Pub. L. 104-55, 109 Stat. 546.
33 U.S.C. 1223, 1231; 49 CFR 1.46. Subpart D is also issued under the authority of 33 U.S.C. 1225 AND 46 U.S.C. 3715.
33 U.S.C. 1231; 33 U.S.C. 1223; 49 CFR 1.46.
33 U.S.C. 1231; 49 CFR 1.46.
33 U.S.C. 1231; 50 U.S.C. 191, 33 CFR 1.05-1(g), 6.04-1, 6.04-6, 160.5; 49 CFR 1.46.
(d) In an emergency, vessels shall advise the Captain of the Port, Houston-
46 U.S.C. 4302 and 4310; 49 CFR 1.46
(b) * * *
46 U.S.C. 4302; 49 CFR 1.46.
(b) * * *
(a) * * *
(2) ASTM Standard D 471. American Society for Testing and Materials, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959.
(3) UL Standard 1128, Underwriters Laboratories, Incorporated, 12 Laboratory Drive, Research Triangle Park, NC 27709-3995.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Closure.
NMFS announces that the directed fishery for
Effective 0001 hours, July 2, 2000, through 0001 hours, September 1, 2000.
Allison Ferreira, Fishery Management Specialist, 978-281-9103, fax 978-281-9135, e mail allison.ferreira@noaa.gov.
Regulations governing the
The 2000 specification of DAH for
Section 648.22 requires the closure of the directed
The regulations at 50 CFR 648.22 require NMFS to close the
This action is required by 50 CFR part 648 and is exempt from review under E.O. 12866.
16 U.S.C. 1801
Board of Governors of the Federal Reserve System.
Proposed rule; official staff interpretation.
The Board is publishing for comment a proposal to revise the Official Staff Commentary to Regulation E (Electronic Fund Transfers). The commentary interprets the requirements of Regulation E to facilitate compliance by financial institutions that offer electronic fund transfer services to consumers. The proposed revisions provide guidance on electronic authorization of recurring debits from a consumer's account, Regulation E coverage of electronic check conversion transactions, telephone-initiated fund transfers, and other issues.
Comments must be received on or before August 31, 2000.
Comments, which should refer to Docket No. R-1074, may be mailed to Jennifer J. Johnson, Secretary, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue, NW., Washington, DC 20551 or mailed electronically to regs.comments@federalreserve.gov. Comments addressed to Ms. Johnson may also be delivered to the Board's mail room between 8:45 a.m. and 5:15 p.m. weekdays, and to the security control room at all other times. The mail room and the security control room, both in the Board's Eccles Building, are accessible from the courtyard entrance on 20th Street between Constitution Avenue and C Street, NW. Comments may be inspected in room MP-500 in the Board's Martin Building between 9:00 a.m. and 5:00 p.m., pursuant to the Board's Rules Regarding the Availability of Information, 12 CFR part 261.
Kyung Cho-Miller, Natalie E. Taylor, or John C. Wood, Counsels, Division of Consumer and Community Affairs, Board of Governors of the Federal Reserve System, Washington, DC 20551, at (202) 452-2412 or (202) 452-3667. For the hearing impaired
The Electronic Fund Transfer Act (EFTA) (15 U.S.C. 1693
The Official Staff Commentary (12 CFR part 205 (Supp. I)) is designed to facilitate compliance and provide protection from civil liability, under § 915(d)(1) of the act, for financial institutions. The commentary is updated periodically, as necessary, to address significant questions that arise.
Several issues under Regulation E are raised by check conversion programs that allow a merchant to use a consumer's check as a source document to provide the routing, serial, and account numbers used to initiate an EFT. The Board has been asked whether the type of transaction described herein is covered by Regulation E and whether the check is an access device under Regulation E. Such a transaction is generally covered by Regulation E, but proposed comment 2(a)-2 would be added to clarify that a check used as a source document to initiate an EFT is not an access device. Proposed comment 3(b)-1(v) also addresses check conversion programs.
Comment 2(h)-2 states that a POS terminal that captures data electronically is an electronic terminal if a debit card is used to initiate an EFT. Some have interpreted the provision narrowly to apply only when a debit card is used to initiate an EFT. Comment 2(h)-2 would be revised to reflect that a POS terminal that captures data electronically to initiate electronic transfers is an electronic terminal even if no access device is used to initiate an EFT such as when a check is used as a source document. Thus, the receipt requirements of § 205.9 would apply.
Section 205.2(k) defines a “preauthorized electronic fund transfer” as “an EFT authorized in advance to recur at substantially regular intervals.” Beyond that authorization, no further action by the consumer is required to initiate the transfer. Proposed comment 2(k)-1 would be added to clarify the definition.
Payments such as payroll or government benefits often are made by direct deposit to a consumer's account through the ACH. Rules of the National Automated Clearing House Association (NACHA) permit reversal of payments made in error in limited circumstances. Proposed comment 2(m)-5 would be added to clarify that reversals of certain direct deposits that were made in error are not unauthorized electronic transfers.
NACHA has established rules for a program in which a merchant may obtain information from a consumer's check to initiate a one-time ACH debit from the consumer's account for
NACHA has also considered rules for a variation on the electronic check conversion program described above in which the consumer provides a check, and the merchant or the merchant's financial institution would retain the check after it had been scanned. NACHA has solicited comment on this “merchant or financial institution-as-keeper” type of program, but has not yet approved its use. Some merchants, however, may be conducting electronic check programs of this type.
Regulation E applies where the consumer provides a blank or partially completed check as a source document that is scanned and retained by the merchant or the merchant's financial institution. To clarify the rights and responsibilities of the parties to a transaction where the check used as a source document is completed and signed by the consumer and is scanned and retained by the merchant, the transaction is an EFT and thus subject to Regulation E if the consumer authorizes it as such. (See cf. comment 3b-1(i).) Specific comment is solicited on this position and the extent to which merchants are currently carrying out transactions of the sort described.
NACHA has established rules for a pilot referred to as the “lock-box” program in which a merchant converts completed and signed checks received by mail to ACH debits. Consumers are informed of how the check payment will be processed. These transactions would not be covered by Regulation E since transfers originated by check are excluded from coverage. See § 205.3(c)(1).
Proposed comment 3(b)-1(vi) would be added to provide guidance on the regulation's coverage of bill-payment services where a consumer initiates payments via computer and the financial institution carries out the payment by check or draft. The definition of “electronic fund transfer” in § 205.3(b) covers these payments unless the terms of the bill-payment service explicitly state that payment by the bill payer will be made solely via check, draft or similar paper instrument.
Proposed comment 3(c)(1)-1 would be added to provide guidance on NACHA's re-presented check entry (RCK) program, in which merchant payees (or their financial institutions or agents) re-present returned checks electronically. Written authorization from the consumer for the RCK debit is not obtained, although, the merchant payee usually has provided notice to the consumer that any returned item may be collected electronically if returned for insufficient or uncollected funds. The comment would clarify that an RCK transaction is not covered by Regulation E because the transfer is originated by check.
In some cases, a payee may impose a fee on the consumer, such as a collection or NSF fee, because the consumer's check was returned. The NACHA rules provide that the RCK debit must be in the amount of the original check. Therefore, the amount of the RCK debit may not be increased to include a fee, and the payee would have to initiate a separate debit to collect the fee electronically. Because an electronically debited fee would not be a part of the RCK debit, and appears to meet the definition of an EFT under Regulation E, it would be covered by the regulation and must be authorized by the consumer.
Proposed comment 3(c)(1)-2 would be added to provide a cross reference to proposed comment 3(b)-1(v), which provides guidance on the regulation's coverage of an EFT at POS where a consumer provides a check as a source document.
A transfer initiated by telephone is covered by Regulation E if it occurs pursuant to a telephone bill-payment or other written plan. Comment 3(c)(6)-1 would be revised to provide additional guidance on what constitutes a written plan. Proposed comment 3(c)(6)-2(v) would be added to clarify coverage of transfers initiated by audio or voice response telephone systems.
Section 205.6 provides rules for a consumer's liability for an unauthorized transfer. The limitation on the consumer's liability depends, in part, on whether the unauthorized transfer takes place within or after two business days of the consumer's learning of the loss or theft of the access device. Proposed comment 6(b)(1)-3 would be added to clarify the timing on the two-business-day period.
The regulation generally requires that disclosures be provided at the time the consumer contracts for an EFT service or before the first transfer is made to or from the consumer's account. Comment 7(a)-2 currently provides an exception to the disclosure timing rules when the first EFT is a direct deposit. If the account-holding institution does not have prior notice of a direct deposit arrangement between the consumer and a third party, the institution must provide the Regulation E disclosures as soon as reasonably possible after the first direct deposit.
Comment 7(a)-2 would be revised to clarify that the special timing rules apply both to single and to recurring debits or credits. The account-holding institution may not always receive prior notice of a one-time or recurring credit to or debit from the consumer's account. For example, the consumer may authorize a third party to debit the account (without notifying the institution), and the third party's financial institution may fail to send prior notice to the consumer's institution.
An error resolution notice must be provided as a part of a financial institution's initial disclosures under § 205.7 and annually under § 205.8. Comment 7(b)(10)-2 provides that a financial institution must have disclosed the longer error resolution time periods for resolving errors under § 205.11(c)(3) in order to use the longer times. In September 1998, § 205.11(c)(3) was amended to extend the error resolution time periods for new accounts (63 FR 5211, September 29, 1998). Comment 7(b)(10)-2 would be revised to reflect the amendment to § 205.11(c)(3).
If an institution seeks to use the longer error resolution time periods in § 205.11(c)(3), it must disclose them in the annual error resolution notice. Comment 8(b)-2 would be added to cross reference comment 7(b)(10)-2, which provides this guidance.
Section 205.9(a)(5) requires that an ATM or POS terminal receipt contain the location of the terminal where the transfer is initiated, or an identification such as a code or terminal number. This section has been interpreted by some institutions to require a full description of the location (such as the street address) rather than simply a code. Comment 9(a)(5)-1 would be revised to clarify that a code may be disclosed. Comments 9(a)(5)(iv)-1 and -2 would be redesignated as comments 9(a)(5)-3 and -4.
Comment 9(b)-4 provides that an institution may permit, but not require, consumers to “call for” periodic statements. For clarity, the comment would be revised by changing the reference “call for” to “pick up;” no substantive change is intended.
Section 205.9(c) lists the circumstances in which a periodic statement for EFT transactions is not required. Proposed comment 9(c)(1)-1 would be added to provide further guidance on the exceptions to the periodic statement requirements.
Proposed comment 9(c)(1)-2 would be added to clarify that the exceptions in § 205.9(c) apply to reversals of deposits made in error. (See also proposed comment 2(m)-5.)
Section 205.10(b) provides that recurring electronic debits from a consumer's account “may be authorized only by a writing signed or similarly authenticated by the consumer.” The phrase “similarly authenticated” was added to Regulation E in 1996 (61 FR 19678, May 2, 1996), and was intended to permit electronic authorizations. The supplemental information indicated that the authentication method should provide the same assurance as a signature in a paper-based system, and cited security codes and digital signatures as examples of authentication devices that could meet the requirements of § 205.10(b); and comment 10(b)-5 was added to the staff commentary to provide guidance on electronic authorizations.
The issue of electronic authentication methods has been further discussed in two Regulation E rulemakings in the past two years—first, in a March 1998 rulemaking in which the Board issued an interim rule permitting financial institutions to deliver electronically disclosures that are required to be given in writing (63 FR 14528); and second, in a September 1999 rulemaking in which the Board proposed more comprehensive rules for providing electronic disclosures under Regulation E (64 FR 49699) and certain other Board regulations. In these rulemakings, the Board again gave examples of authentication devices and expressed interest in learning about other electronic authentication methods.
Industry commenters suggested various alternatives for verifying a consumer's identity such as alphanumeric codes (combination of letters and numbers) or combination of unique identifiers (such as account numbers combined with a number representing algorithms of the account numbers). Some commenters requested additional examples of appropriate electronic authentication devices; many stated their concern that limiting the examples to security codes and digital signatures could be viewed as the Board's endorsement of particular methods, which could hinder the development of alternative authentication mechanisms. Other commenters disfavored examples of particular authentication mechanisms; they recommended that the Board defer to general principles set forth in various state and federal laws and legislative proposals. Consumer advocates, on the other hand, suggested that the Board should limit authentication methods to those that prevent documents from being altered without detection after the authentication is affixed, such as digital signatures.
The Congress has passed electronic commerce legislation that addresses, among other things, the use and acceptance of electronic signatures (broadly defined in the legislation) and records for electronic commerce in general. If the legislation becomes law, the “similarly authenticated” standard in Regulation E may become unnecessary. In the meantime, to ensure that institutions have flexibility in establishing authentication methods for purposes of § 205.10(b), comment 10(b)-5 would be revised. Any authentication mechanism that provides similar assurance to a paper-based signature (such as a mechanism that identifies the consumer and evidences the consumer's assent to the authorization) will satisfy the “similarly authenticated” standard. The word “text” is also substituted by “term,” no substantive change is intended.
The comment currently states that the person obtaining an electronic authorization from a consumer must make a paper copy of the authorization available to the consumer, either automatically or upon request. For consistency with Board rulemakings permitting the electronic delivery of disclosures, comment 10(b)-5 would also be revised to permit the person obtaining the authorization to provide a copy of the authorization to the consumer either in paper form or electronically.
The supplementary information to the Official Staff Commentary, discussing comment 10(b)-5 at the time of its adoption in 1996, stated that for home-banking systems, a security code used to “similarly authenticate” preauthorized transfers pursuant to § 205.10(b) must originate with the paying (account-holding) institution. The Board's position reflected concerns about the potential for increased liability for account-holding institutions associated with unauthorized use when a party other than the institution issued the code. Under NACHA operating rules, however (as well as operating rules of debit card networks), an account-holding institution is permitted to charge back to the payee's financial institution any transaction that was not properly authorized; thus, the payee's institution (or the payee) would bear the liability for unauthorized transfers. Accordingly, it seems unnecessary to require that a security code originate with the paying institution, provided the code meets the general standards for similar authentication discussed above.
Proposed comment 10(b)-7 would be added to address a situation where a consumer authorizes recurring charges against a credit card but in fact provides information for the consumer's debit card, for example, in an on-line transaction or in a telephone conversation with a merchant. Unlike Regulation E, Regulation Z and the Truth in Lending Act (12 CFR part 226) do not require a written, signed or “similarly authenticated” authorization for recurring charges to a consumer's credit card account. The proposed comment would clarify that when the consumer's account in fact involves a debit card, the payee is required to obtain an authorization in accordance with § 205.10(b), but may rely on the bona fide error provision in section
Section 205.10(e) prohibits a person from requiring a consumer to establish an account with a particular institution to receive electronic transfers, as a condition of employment. Comment 10(e)(2)-1 would be revised to clarify that an employer (including a financial institution) may specify an institution to receive direct deposits provided the employer also gives employees the option to receive their salary by check or cash.
Comment 11(a)-2 would be revised to provide additional examples of when the error resolution rules are inapplicable because the consumer has not asserted an error.
Comment 12(a)-1 would be revised to distinguish between two types of unauthorized transfers: those where a consumer's access device is used to withdraw funds from a checking account with an overdraft protection feature, and those where the consumer's access device is also a credit card separately used to obtain cash advances. Examples would illustrate how these rules apply in various situations.
The Board has been asked about the possible application of Regulation E to a service sometimes referred to as “aggregation” or “screen-scraping.” Aggregation is a service made available to consumers through an Internet web site, in which consumers are able to view their financial information from multiple sources, such as credit card, securities, and deposit accounts at a number of institutions. To enable the service provider (the “aggregator”) to obtain the information and make it available to the consumer at the aggregator's web site, the consumer may provide the aggregator with account numbers and passwords to access the consumer's accounts. In addition to allowing consumers to view accounts in one location, aggregators may offer consumers EFT services such as bill-payment.
To assist the Board in providing any needed guidance on Regulation E's potential coverage, comment is solicited on how these services that aggregate consumer financial information operate or plan to operate. Are aggregators providing or planning to provide bill-payment or other EFT services (in addition to information services)? To what extent do agreements exist between aggregators and account-holding institutions, governing matters such as procedures for access to information and for electronic transfers?
In addition, comment is solicited on the implications of a determination that aggregators are or are not financial institutions for purposes of Regulation E generally or under § 205.14. Typically, only one access device is contemplated to initiate an EFT to or from a consumer's account. Nevertheless, if a consumer enters a security code issued by the aggregator to access information on the aggregator's web site and the consumer initiates an EFT using a security code provided by the account-holding institution, the security code issued by the aggregator arguably meets the definition of an “access device.” Two access codes (the one provided by the aggregator and the other by the account-holding institution) are needed to initiate electronic transfers from the consumer's account from the aggregator's web site. Thus, the aggregator would be a financial institution for purposes of Regulation E.
If the aggregator is not a financial institution and an unauthorized EFT occurs through an aggregator's service, comment 2(m)-2 could be read to suggest that a consumer who has given the aggregator access to the consumer's account assumes liability for the transfers. The guidance in the comment, however, was not originally provided to address this situation.
Comment letters should refer to Docket No. R-1074, and when possible, should use a standard typeface with a type size of 10 or 12 characters per inch. This will enable the Board to convert the text into machine-readable form through electronic scanning, and will facilitate automated retrieval of comments for review. Also, if accompanied by an original document in paper form, comments may be submitted on 3
Consumer protection, Electronic fund transfers, Federal Reserve System, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Board proposes to amend the Official Staff Commentary, 12 CFR part 205, as set forth below. Certain conventions have been used to highlight the proposed changes to the commentary. New language is shown inside bold-faced arrows, while language that would be deleted is set off with bold-faced brackets.
1. The authority citation for part 205 would be revised to read as follows:
15 U.S.C. 1693b.
2. In Supplement I to Part 205, the following amendments would be made:
a. Under
b. Under
c. Under
d. Under
e. Under
f. Under
g. Under
h. Under
i. Under
j. Under
k. Under
l. Under
m. Under
n. Under
o. Under
p. Under
q. Under
r. Under
s. Under
t. Under
u. Under
2.
1.
i. A credit made to the wrong consumer's account;
ii. A duplicate credit made to a consumer's account; or
iii. A credit in the wrong amount made to a consumer's account (for example, when the amount credited differs from the amount in the transmittal instructions). If, however, there is a dispute whether the account holder is entitled to a certain amount (for example, a salary or a government benefit payment) the reversal may be an unauthorized EFT, depending on the facts and circumstances.
1.
vi. A payment made by a bill payer under a bill-payment service available to a consumer via computer or other electronic means, unless the terms of the bill-payment service explicitly state that payment will be solely by check, draft, or similar paper instrument.
1.
2.
1.
i. A hold-harmless agreement on a signature card that protects the institution if the consumer requests a transfer.
ii. A legend on a signature card, periodic statement, or passbook that limits the number of telephone-initiated transfers the consumer can make from a savings account because of reserve requirements under Regulation D (12 CFR part 204).
iii. An agreement permitting the consumer to approve by telephone the rollover of funds at the maturity of an instrument.
2.
▸3.
2. [
2.
new accounts,◂ transfers initiated outside the United States, or resulting from POS debit-card transactions), a financial institution must have disclosed these longer time periods. Similarly, an institution that relies on the exception from provisional crediting in § 205.11(c)(2) for accounts subject to Regulation T (12 CFR part 220) must disclose accordingly.
▸2.
1. [
(i) The city, state or foreign country, and the information in §§ 205.9(a)(5)(i), (ii), or (iii), or
(ii) A number or a code identifying the terminal. If the institution chooses the second option, the◂ [A] code or terminal number identifying the terminal where the transfer is initiated may be given as part of a transaction code.
▸3.
i. All the terminals owned or operated by the financial institution providing the statement (or by the system in which it participates) are located in that state, or
ii. All transfers occur at terminals located within 50 miles of the financial institution's main office.
4.
4. ▸
▸1.
2.
5.
▸or other electronic communication system. An authentication device or procedure satisfies the “similarly authenticated” requirement if it provides similar assurance to a written signature (such as a device or procedure that verifies the consumer's identity and evidences the consumer's assent to the authorization). Examples include, but are not limited to, digital signatures and security codes.◂ [To satisfy the requirements of this section, there must be some means to identify the consumer (such as a security code) and to make available a paper copy of the authorization (automatically or upon request).] The [text] ▸terms◂ of the electronic authorization would have to be displayed on a computer screen or other visual display which enables the consumer to read the communication. ▸The person that obtains the authorization must provide a copy of the terms of the authorization to the consumer.◂ Only the consumer may authorize the transfer and not, for example, a third-party merchant on behalf of the consumer.
▸7.
1.
2.
1.
▸ ii. The following examples illustrate these principles:
A. A consumer has a card that can be used either as a credit card or a debit card. When used as a debit card, the card draws on the consumer's checking account. When used as a credit card, the card draws only on a separate line of credit. If the card is stolen and used as a credit card to make purchases or to get cash advances from ATMs, the liability limits and error resolution provisions of Regulation Z apply; Regulation E does not apply.
B. In the same situation, if the card is stolen and is instead used as a debit card to make purchases or to get cash withdrawals from ATMs, the liability limits and error resolution provisions of Regulation E apply; Regulation Z does not apply.
C. In the same situation, the card is stolen and used both as a debit card and as a credit card; for example, the thief makes some purchases using the card as a debit card, and other purchases using the card as a credit card. Here, the liability limits and error resolution provisions of Regulation E apply to the unauthorized transactions in which the card was used as a debit card, and the corresponding provisions of Regulation Z apply to the unauthorized transactions in which the card was used as a credit card.
D. Assume a somewhat different type of card, one that draws on the consumer's checking account and can also draw on an overdraft line of credit attached to the checking account. There is no separate line of credit, other than the overdraft line, associated with the card. In this situation, if the card is stolen and used, the liability limits and the error resolution provisions of Regulation E apply. In addition, if the use of the card has resulted in accessing the overdraft line of credit, the error resolution provisions of § 226.13(d) and (g) of Regulation Z also apply; however, the other error resolution provisions of Regulation Z do not apply. ◂
By order of the Board of Governors of the Federal Reserve System, acting through the Director of the Division of Consumer and Community Affairs under delegated authority, June 22, 2000.
Customs Service, Department of the Treasury.
Notice of proposed rulemaking.
This document proposes to amend the Customs Regulations concerning the duty-free entry of civil aircraft merchandise to reflect amendments to General Note 6 of the Harmonized Tariff Schedule of the United States made by the Miscellaneous Trade and Technical Corrections Act of 1996. This document invites the public to comment on the proposed changes.
Comments must be received on or before August 28, 2000.
Written comments (preferably in triplicate), regarding both the substantive aspects of the proposed rule and how it may be made easier to understand, may be submitted to and inspected at the Regulations Branch, Office of Regulations and Rulings, U.S. Customs Service, 1300 Pennsylvania Avenue, NW., 3rd Floor, Washington, DC 20229.
Ms. Dixie Staple, Office of Field Operations, at (202) 927-1131.
This document proposes to amend § 10.183 of the Customs Regulations (19 CFR 10.183), which concerns Customs duty-free treatment of civil aircraft merchandise. Section 10.183 implements General Note 6 of the Harmonized Tariff Schedule of the United States (HTSUS) (19 U.S.C. 1202), which implements the Agreement on Trade in Civil Aircraft (Title VI of the Trade Agreements Act of 1979, Pub. L. 96-39, 93 Stat. 144, July 26, 1979), to provide duty-free treatment for qualifying civil aircraft merchandise upon compliance with certain requirements.
General Note 6 of the HTSUS was amended by section 12 of the Miscellaneous Trade and Technical Corrections Act of 1996 (the Act), Pub. L. 104-295, 110 Stat. 3514 (October 11, 1996). Prior to the amendment, General Note 6, HTSUS, required that an importer entering merchandise duty-free thereunder must file with Customs a written statement certifying that the merchandise (i) Is civil aircraft or has been imported for use in civil aircraft, (ii) will be so used, and (iii) has been approved for civil aircraft use by, or an application for approval has been submitted to, the Administrator of the Federal Aviation Administration (FAA) (or has been approved by an airworthiness authority in the country of exportation if such approval is recognized by the FAA). General Note 6 defined the term “civil aircraft” as all aircraft other than aircraft purchased for use by the Department of Defense or the United States Coast Guard.
Prior to the amendment of General Note 6, HTSUS, § 10.183 of the Customs Regulations (19 CFR 10.183) provided that the written statement required under General Note 6, HTSUS (referred to in the regulation as a certificate or certification), must be filed with each entry summary or be on file with Customs at the time of entry as a blanket statement at the port where the entry is filed (19 CFR 10.183(c)). The regulation also provided that the statement could not be treated as a missing document for which a bond could be posted pending its later production (under 19 CFR 141.66), and that failure to timely file the statement or to have a valid blanket statement on file at the port would result in a dutiable entry (19 CFR 10.183(c)(2)).
The Act amended General Note 6, HTSUS, to eliminate the statement (certification) filing requirement and to provide that an importer makes a claim for duty-free treatment under the General Note by entering the merchandise under a tariff provision for which the program indicator “Free (C)” appears in the “Special” subcolumn of the tariff. This is accomplished by
These statutory amendments to General Note 6, HTSUS, establish the basis for the amendments to § 10.183 proposed in this document. The proposed amendments to the regulation expand its coverage, eliminate the requirement that supporting documentation be filed with each entry summary, require that supporting documentation be maintained in the importer's records, eliminate the statement (certification) filing requirement, allow an importer to make a claim under General Note 6, HTSUS, after the filing of an entry but before its liquidation becomes final, and provide that no interest attaches to refunds of duty resulting from post-entry claims.
Before adopting this proposal as a final rule, consideration will be given to any written comments timely submitted to Customs. Comments submitted will be available for public inspection in accordance with the Freedom of Information Act (5 U.S.C. 552), § 1.4 of the Treasury Department Regulations (31 CFR 1.4), and § 103.11(b) of the Customs Regulations (19 CFR 103.11(b)) on regular business days between the hours of 9 a.m. and 4:30 p.m. at the Regulations Branch, Office of Regulations and Rulings, U.S. Customs Service, 1300 Pennsylvania Avenue, NW., 3rd Floor, Washington, DC
This document does not meet the criteria for a “significant regulatory action” as specified in E.O. 12866.
Adoption of the proposed amendments regarding civil aircraft will make importations of such merchandise less burdensome for importers than is the case under current regulations. Accordingly, pursuant to the provisions of the Regulatory Flexibility Act (5 U.S.C. 601
The collection of information contained in this notice has previously been reviewed and approved by the Office of Management and Budget (OMB) under OMB control number 1515-0065 (Entry Summary), 1515-0069 (Immediate Delivery Application), and 1515-0144 (Customs Bond Structure). This rule does not propose any substantive changes to the existing approved information collection.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.
The principal author of this document was Bill Conrad, Office of Regulations and Rulings, U.S. Customs Service. However, personnel from other offices contributed in its development.
Aircraft, Customs duties and inspection, Entry, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, part 10 of the Customs Regulations (19 CFR Part 10) is proposed to be amended as follows:
1. The general authority citation for part 10 continues to read, and the specific authority citation for § 10.183 is added, as follows:
19 U.S.C. 66, 1202 (General Note 20, Harmonized Tariff Schedule of the United States (HTSUS)), 1321,1481,1484,1498,1508,1623, 1624, 3314;
Section 10.183 also issued under 19 U.S.C. 1202 (General Note 6, HTSUS);
2. Section 10.183 is revised to read as follows:
(a)
(1) The aircraft, aircraft engines, ground flight simulators, or parts, components, and subassemblies thereof, are used as original or replacement equipment in the design, development, testing, evaluation, manufacture, repair, maintenance, rebuilding, modification, or conversion of aircraft; and
(2) They are either:
(i) Manufactured or operated pursuant to a certificate issued by the Administrator of the Federal Aviation Administration (FAA) under 49 U.S.C. 44704, or pursuant to the approval of the airworthiness authority in the country of exportation, if such approval is recognized by the FAA as an acceptable substitute for the FAA certificate;
(ii) Covered by an application for such certificate, submitted to and accepted by the FAA, filed by an existing type and production certificate holder pursuant to 49 U.S.C. 44702 and implementing regulations (Federal Aviation Administration Regulations, title 14, Code of Federal Regulations); or
(iii) Covered by an application for such approval or certificate which will be submitted in the future by an existing type and production certificate holder, pending the completion of design or other technical requirements stipulated by the FAA (applicable only to the quantities of parts, components, and subassemblies as are required to meet the stipulation).
(b)
(c)
(d)
(e)
(f)
(g)
Coast Guard, DOT.
Supplemental notice of proposed rulemaking; termination.
The Coast Guard is terminating its rulemaking intended to amend its regulations on the identification number placed on the hull of a vessel. There is no consensus on the format for an expanded HIN and the Coast Guard lacks sufficient data to demonstrate that the benefits clearly outweigh the costs and burdens, particularly for small entities and the builders of high-volume, low cost boats.
This proposed rulemaking is terminated on June 29, 2000.
Alston Colihan, Office of Boating Safety, Recreational Boating Product Assurance Division, 202-267-0981.
The Coast Guard published a Notice of Proposed Rulemaking in the
Major objections to the proposed 19-character HIN were received based on the increased information collection burdens, particularly on small entities and the builders of high-volume, low cost boats, such as canoes, kayaks, and inflatables. In addition, the International Standards Organization (ISO) had finalized an HIN standard consisting of the existing Coast Guard 12-character HIN format preceded by a 2-character country code and a hyphen. Manufacturers in the U.S. who export to Europe would be using the ISO HIN standard beginning with the 1996 model year. Builders would have to affix HINs in two different formats or know in advance whether a boat would be sold in the U.S. or in Europe.
In consideration of the objections received about information-collection burdens, we published a Supplemental Notice of Proposed Rulemaking (SNPRM) in the
Therefore, in an attempt to gather information to resolve conflicting issues, we published a Request for Comments in the
We received 31 comments, only one of which contained any economic data which could be used to determine the benefits of a requirement for an expanded HIN containing vessel-specific characters and a check digit. Only four comments were in favor of allowing exceptions for small entities and the builders of high-volume, low cost boats, such as canoes, kayaks, and inflatable boats. None of the comments contained information about the estimated burdens and costs to boat manufacturers.
This proposed rulemaking is terminated because of (1) the lack of substantive information about the benefits to society with a requirement for an expanded HIN containing vessel-specific characters and a check digit,
We are initiating a study to gather data on the costs and benefits of an expanded HIN format and potential adverse impacts on small entities. We will review the results of the study and decide whether or not to open a new regulatory project in the future.
Saint Lawrence Seaway Development Corporation, DOT.
Notice of proposed rulemaking.
The Saint Lawrence Seaway Development Corporation (SLSDC) and the St. Lawrence Seaway Management Corporation of Canada (SLSMC) publish joint Seaway Regulations. The SLSDC and the SLSMC have determined that a number of existing regulations need to be amended. Only four of the amendments in this proposal are substantive and of applicability in both U.S. and Canadian waters. Accordingly, comments are invited on only these four proposed amendments. (See
The remaining amendments are merely editorial, ministerial, for clarification without substantive change in interpretation, or applicable only in Canada. The Canada Marine Act has abolished the Saint Lawrence Seaway Authority of Canada and replaced it with the SLSMC, made changes in the manner in which the SLSMC conducts or may conduct its operations as compared to the Authority, and made minor changes in some of the terminology used in the Canadian law applicable to the Seaway. Accordingly, most of the amendments in this proposal are strictly editorial, reflect procedures undertaken unilaterally by the SLSMC, or otherwise are applicable only in Canada because of unilateral action by the SLSMC or Canadian law. Accordingly, the SLSDC is not requesting comments on these amendments, even though they appear in this proposal. Other changes are due strictly to Canadian circumstances or unilateral action, such as: removal of reference to bridges that no longer exist; removal of references to the Canadian entity in the rules on detention and sale; and adding provisions that are only applicable on Canadian property. Some minor changes in numbering and lettering also are being made.
Any party wishing to present views on the proposed amendments may file comments with the Corporation on or before July 31, 2000.
Signed, written comments should refer to the docket number appearing at the top of this document and must be submitted to the Docket Clerk, U.S. DOT Dockets, Room PL-401, 400 Seventh Street, SW, Washington, DC 20590-0001. Written comments may also be submitted electronically by using the submission form at
Marc C. Owen, Chief Counsel, Saint Lawrence Seaway Development Corporation, 400 Seventh Street, SW, Washington, DC 20590, (202) 366-6823.
As a result of discussions with the Saint Lawrence Seaway Management Corporation of Canada, the Saint Lawrence Seaway Development Corporation proposes to amend the Seaway Regulations and Rules in 33 CFR part 401 as described in the following summary.
Only four of the amendments in this proposal are substantive and of applicability in both U.S. and Canadian waters. Accordingly, comments are invited on only these four proposed amendments, which are as follows.
Section 401.3, “Maximum vessel dimensions”, would be amended by revising paragraph (e) to allow a vessel with a beam in excess of 23.2 m, but not more than 23.8 m. and an overall length in excess of 222.5 m, but not more than 225.5 m, to be considered for transit upon application to the SLSMC and SLSDC. This proposal follows successful feasibility testing by both corporations. Section 410.10, “Mooring lines”, would be amended by adding a new paragraph (a)(2) requiring mooring lines to have a diameter not greater than 28 mm. This is in response to safety concerns for linehandling personnel of both corporations. The larger, heavier mooring lines that have been used by some vessels are difficult to handle and may cause back injuries.
Section 401.13, “Hand lines”, would be amended by changing the minimum diameter from 12 mm to 15 mm, the maximum diameter from 20 mm to 17 mm, and the minimum length from 35 m to 30 m for similar safety of linehandling personnel reasons. Schedule III, “Calling-In Table”, would be amended by changing a number of reporting requirements at certain calling-in points. The SLSDC and the SLSMC now share the same computer database, which eliminates the need for vessels to report particulars more than once unless a change has occurred.
The remaining amendments, described in the rest of this preamble, are merely editorial, ministerial, for clarification without substantive change in interpretation, or applicable only in Canada. Some minor changes in numbering and lettering also are being made.
The Canada Marine Act has abolished the Saint Lawrence Seaway Authority of Canada and replaced it with the SLSMC, made changes in the manner in which the SLSMC conducts or may conduct its operations as compared to the Authority, and made minor changes in some of the terminology used in the Canadian law applicable to the Seaway. Accordingly, most of the amendments in this proposal are strictly editorial, reflect procedures undertaken unilaterally by the SLSMC, or otherwise are applicable only in Canada because of unilateral action by the SLSMC or Canadian law. Accordingly, the SLSDC is not requesting comments on these amendments, even though they appear in this proposal. The principal change of this type is wherever the terms “Saint Lawrence Seaway Authority”, “Authority”,
There are a number of changes that merely reflect current Canadian practice
Other changes are due strictly to Canadian circumstances or unilateral action include: removal of the reference to Bridges 20 and 21 in paragraph 401.52(b) is removed because the bridges no longer exist; removal of references to the Canadian entity in the rules on detention and sale, sections 401.86, 401.87, and 401.88, which the SLSMC will no longer use, but which remain of current and prospective use by the SLSDC. Finally, new paragraphs (b) and (c) are being added to section 401.90, “Boarding for inspection”, which are only applicable on Canadian property.
This proposed regulation involves a foreign affairs function of the United States, and therefore, Executive Order 12866 does not apply. This proposed regulation has also been evaluated under the Department of Transportation's Regulatory Policies and Procedures and the proposed regulation is not considered significant under those procedures and its economic impact is expected to be so minimal that a full economic evaluation is not warranted.
The Saint Lawrence Seaway Development Corporation certifies that this proposed regulation, if adopted, would not have a significant economic impact on a substantial number of small entities. The St. Lawrence Seaway Regulations and Rules primarily relate to the activities of commercial users of the Seaway, the vast majority of whom are foreign vessel operators. Therefore, any resulting costs will be borne mostly by foreign vessels.
This proposed regulation does not require an environmental impact statement under the National Environmental Policy Act (49 U.S.C. 4321,
The Corporation has analyzed this rule under the principles and criteria in Executive Order 13132, Dated August 4, 1999, and has determined that it will not have a substantial, direct effect on the States or on the distribution of power and responsibilities among various levels of government. The rule will not limit the policymaking discretion of the States. Nothing in it would directly preempt any State law or regulation. Because the rule will have no significant effect on State or local governments, no consultations with those governments on this rule were necessary.
This proposal has been analyzed under the Paperwork Reduction Act of 1995 and does not contain new or modified information collection requirements subject to the Office of Management and Budget review.
Hazardous materials transportation, Navigation (water), Radio reporting and record keeping requirements, Vessels, Waterways.
Accordingly, the Saint Lawrence Seaway Development Corporation proposes to amend Part 401—Seaway Regulations and Rules (33 CFR Part 401) as follows:
1. The authority citation for part 401, subpart A, would be revised to read as follows:
33 U.S.C. 983(a) and 984(a)(4), as amended; 49 CFR 1.50a, unless otherwise noted.
2. Section 401.1 would be amended by adding the parenthetical phrase “(the Practices and Procedures in Canada)” after the words “Seaway Regulations”.
3. Section 401.2 would be amended as follows:
a. Remove paragraph (a).
b. Redesignate paragraphs (b) and (c) as paragraphs (a) and (b).
c. Add a new paragraph (c).
d. Redesignate current paragraphs (m) through (p) as paragraphs (o) and (r).
e. Add new paragraphs (m) and (n).
f. In newly redesignated paragraph (q), add the parenthetical phrase “(‘ship’ in Canada)” after the word “Vessel”.
g. In newly redesignated paragraph (q), add the parenthetical phrase “(‘ship traffic controller’ in Canada)” after the word “controller”.
The additions read as follows:
(c) “Manager” means the St. Lawrence Seaway Management Corporation;
(m) “Tariff of Tolls” means the same as “Schedule of Tolls in Canada.”
(n) “Tolls(s)” or “tolls and charges” is included in the definition of “fees” in Canada.
4. Section 401.3 would be amended by revising paragraph (e) to read as follows:
(e) A vessel having a beam width in excess of 23.2 m, but not more than 23.8 m, and having dimensions that do not exceed the limits set out in the block diagram in appendix I of this part or overall length in excess of 222.5 m, but not more than 225.5 m, shall, on application to the Manager or Corporation, be considered for transit in accordance with directions issued by the Manager and Corporation.
5. Section 401.10 would be amended by redesignating current paragraphs (a)(2), (3), and (4) as paragraphs (a)(3), (4), and (5) and by adding a new paragraph (a)(2) to read as follows:
(a) * * *
(2) Have a diameter not greater than 28mm;
6. Section 401.13 would be amended by revising paragraph (b) to read as follows:
(b) Be of uniform thickness and have a diameter of not less than 15 mm and not more than 17 mm and a minimum length of 30 m.
7. Section 401.22 would be amended by removing the words “the Corporation or” the first time they appear in paragraph (a).
8. Section 401.24 would be amended by adding the parenthetical phrase “(3 copies)” after the word “form”.
9. Section 401.25 would be amended by removing the words “in writing” in paragraph (a).
10. Section 401.26 would be revised to read as follows:
(a) Before transit by a vessel to which the requirement of preclearance applies, security for the payment of tolls in accordance with the “St. Lawrence Seaway Tariff of Tolls” as well as security for any other charges, shall be provided by the representative by means of:
(1) A deposit of money with the Manager;
(2) A deposit of money to the credit of the Manager with a bank in the United States or a member of the Canadian Payments Association, a corporation established by section 3 of the Canadian Payments Association Act, or a local cooperative credit society that is a member of a central cooperative credit society having membership in the Canadian Payments Association;
(3) A deposit with the Manager of negotiable bonds of the Government of the United States or the Government of Canada; or
(4) A letter of guarantee to the Manager given by an institution referred to in paragraph (a)(2) of this section.
(5) A letter of guarantee or bond given to the Manager by an acceptable Bonding Company. Bonding companies may be accepted if they:
(i) Appear on the list of acceptable bonding companies as issued by the Treasury Board of Canada; and
(ii) Meet financial soundness requirements as may be defined by the Manager at the time of the request.
(b) The security for the tolls of a vessel shall be sufficient to cover the tolls established in the “St. Lawrence Seaway Tariff of Tolls” for
(c) Where a number of vessels:
(1) For each of which preclearance has been given;
(2) Are owned or controlled by the same individual or company; and
(3) Have the same representative, the security for the tolls is not required if the individual, company, or representative has paid every toll invoice received in the preceding five years within the period set out in § 401.75(a).
(d) Notwithstanding paragraph (c) of this section, where a number of vessels, for each of which a preclearance has been given, are owned or controlled by the same individual or company and have the same representative, the security for tolls may be reduced or eliminated provided the representative has paid every toll invoice received in the preceding five years within the period set out in § 401.75(a). The representative must provide the Manager with a financial statement that meets the requirements established by the Manager.
(e) Where, in the opinion of the Manager, the security provided by the representative is insufficient to secure the tolls and charges incurred or likely to be incurred by a vessel, the Manager may suspend the preclearance of the vessel.
11. Section 401.28 would be amended by revising paragraphs (a) and (b) to read as follows:
(a) The maximum speed over the bottom for a vessel of more than 12 m in overall length shall be regulated so as not to adversely affect other vessels or shore property, and in no event shall such a vessel proceeding in any area between the place set out in Column I of an item of Schedule II to this part and a place set out in Column II of that item exceed the speed set out in Column III or Column IV of that item, whichever speed is designated by the Corporation and the Manager in a Seaway Notice from time to time as being appropriate to existing water levels.
(b) Where the Corporation or the Manager designate any speed less than the maximum speeds set out in Schedule II of this part, that speed shall be transmitted as transit instructions referred to in § 401.27.
12. Section 401.29 would be amended by revising paragraph (b) to read as follows:
(b) The draft of a vessel shall not, in any case, exceed 79.2 dm or the maximum permissible draft designated in a Seaway Notice by the Corporation and the Manager for the part of the Seaway in which a vessel is passing.
13. Section 401.33 would be revised to read as follows:
No vessel of unusual design, vessel, or part of a vessel under tow, or vessel whose dimensions exceed the maximum vessel dimensions § 401.3 shall transit the Seaway except in accordance with special instructions of the Corporation or the Manager given on the application of the representative of the vessel.
14. Section 401.37 would be amended by inserting the words “U.S. Coast Guard or Canadian approved” after the word “wear”.
15. Section 401.52 would be amended by removing the phrase “or at Bridges 20 and 21 on the Welland Canal”.
16. Section 401.54 would be amended by removing the words “moored to” in paragraph (a) and adding in their place the words “used as moorings”.
17. Section 401.59 would be amended by adding the words “by the vessel” after the word “kept” in paragraph (c).
18. Section 401.68 would be amended by removing the word “Authority” and adding in its place the words “Management Corporation” in paragraph (c).
19. Section 401.74 would be amended by revising paragraphs (a), (e), (f) and (g) to read as follows:
(a) A Seaway Transit Declaration Form (Cargo and Passenger) shall be forwarded to the Manager by the representative of a vessel, for each vessel that has an approved preclearance except non-cargo vessels within fourteen days after the vessel enters the Seaway on any upbound or downbound transit. The form may be obtained from the Saint Lawrence Seaway Development Corporation, P.O. Box 520, Massena, New York 13662, or the St. Lawrence Seaway Management Corporation, 202 Pitt Street, Cornwall, Ontario K6J 3P7.
(e) Where a Seaway Transit Declaration Form is found to be inaccurate concerning the destination, cargo or passengers, the representative shall immediately forward to the Manager a revised Declaration Form.
(f) Seaway Transit Declaration Forms shall be used in assessing toll charges in accordance with the St. Lawrence Seaway Tariff of Tolls and toll accounts shall be forwarded in duplicate to the representative or its designated agent.
(g) Where government aid cargo is declared, appropriate Canadian (Revenue Canada Customs and Excise form B-13) or U.S. (Shippers Export Declaration form 7525) customs form or a stamped and signed certification letter from the U.S. or Canada Customs must accompany the transit declaration form.
20. Section 401.75 would be amended by removing the phrase “Or American funds, as indicated on the invoice,” and adding in their place the word “funds” in paragraph (a).
21. Section 401.81 would be amended by revising paragraph (a) to read as follows:
(a) Where a vessel on the Seaway is involved in an accident, the master of the vessel shall report the accident to the nearest Seaway station immediately or as soon as the vessel can make radio contact with the station.
22. Section 401.84 would be amended by removing the number “401.21” and adding in its place the number “401.19” in paragraph (c).
23. In Sections 401.86, 401.87, and 401.88, remove the words “or the Authority” wherever they appear in the following places;
a. Section 401.86(a), (b), and (c).
b. Section 401.87(c), (d), and (d)(3).
c. Section 401.88(a)(2) and (b).
24. Section 401.89 would be amended by removing the number “401.6” and adding in its place the number “401.5” and removing the number “401.21” and adding in its place the number “401.19” in paragraph (a)(1).
25. Section 401.90 would be revised to read as follows:
(a) For the purpose of enforcing these Regulations in this part in both Canadian and U.S. waters, an officer may board any vessel and:
(1) Examine the vessel and its cargo; and
(2) Determine that the vessel is adequately manned.
(b) In addition to § 401.90(a)(1) and (2) in Canadian waters, a Manager's officer may also:
(1) Require any person appearing to be in charge of the vessel to produce for inspection, or for the purpose of making copies or extracts, any log book, document or paper; and
(2) In carrying out an inspection:
(i) Use or cause to be used any computer system or data processing system on the vessel to examine any data contained in, or available to, the system;
(ii) Reproduce any record, or cause it to be reproduced from the data, in the form of a print-out or other intelligible output and remove the print-out or other output for examination or copying; and
(iii) Use or cause to be used any copying equipment in the vessel to make copies of any books, records, electronic data or other documents.
(c) In Canadian waters, the owner or person who is in possession or control of a vessel that is inspected, and every person who is found on the vessel, shall:
(1) Give the officer all reasonable assistance to enable the officer to carry out the inspection and exercise any power conferred by the Canada Marine Act; and
(2) Provide the officer with any information relevant to the administration of these practices and procedures that the officer may reasonable require.
26. Section 401.93 would be amended by adding the words “or its successor” after the words “
27. The heading for § 401.94 would be amended by removing the word “copy” and adding in its place the word “copies”.
28. Schedule III to subpart A, part 401 would be amended as follows:
a. Amend item 5 by removing items 3, 4, and 5 in the third column, under the heading “Message Content”, and redesignating item 6 in that column as item 3.
b. Amend item 8 by removing the words “and call sign” from item 1 in the third column, under the heading “Message Content”, by removing items 5 and 6 in that column, and adding a new item 5 in that column to read as follows, “5. All ports of call”.
c. Amend item 19 by removing items 3, 4, 5, and 6 in the third column, under the heading “Message Content”, and redesignating item 7 in that column as item 3.
d. Amend item 35 by removing item 3 in the third column, under the heading “Message Content”.
e. Amend item 36 by removing items 3, 4, and 5 in the third column, under the heading “Message Content”, and 20 redesignating items 6 and 7 in that column as items 3 and 4.
f. Amend item 40 by removing items 3, 4, and 5 in the third column, under the heading “Message Content”. §§ 401.2, 401.12, 401.13, 401.22, 401.24, 401.25, 401.31, 401.34, 401.54, 401.59, 401.66, 401.72, 401.78, 401.91, 401.92, 401.93, 401.96, 401.97, and Schedule II to subpart A [Amended]
29. In addition to the amendments set forth above, in 33 CFR part 401 remove the word “Authority” and add in its place the word “Manager” in the following places:
a. Section 401.2(d), (e), (h), (j), and (k);
b. Section 401.12(a)(2) and (a)(4)(ii);
c. Section 401.13(a);
d. Section 401.22(a);
e. Section 401.24;
f. Section 401.25;
g. Section 401.31(b);
h. Section 401.34;
i. Section 401.54(b);
j. Section 401.59(d);
k. Section 401.66(b);
l. Section 401.72(e);
m. Section 401.78(b);
n. Section 401.91;
o. Section 401.92;
p. Section 401.93(a) and (b);
q. Section 401.96(a), (b), (c), and (e);
r. Section 401.97(a), (b)(2), and (d); and
s. Footnote 1 to Schedule II to subpart A, “Table of Speeds”.
Saint Lawrence Seaway Development Corporation.
Fish and Wildlife Service, Interior.
Proposed rule; reopening of comment period and notice of availability of draft economic analysis.
The U.S. Fish and Wildlife Service announces the availability of the draft economic analysis for the proposed designation of critical habitat for the coastal California gnatcatcher (
The original comment period on the critical habitat proposal closed on April 7, 2000. The comment period is again reopened and we will accept comments until July 31, 2000. Comments must be received by 5:00 p.m. on the closing date. Any comments that are received after the closing date may not be considered in the final decision on this proposal.
Copies of the draft economic analysis are available on the Internet at “www.r1.fws.gov.” or by writing to the Field Supervisor, U.S. Fish and Wildlife Service, Carlsbad Fish and Wildlife Office, 2730 Loker Avenue West, Carlsbad, California, 92008. Written comments should be sent to the Field Supervisor at the above address. You may also send comments by electronic mail (e-mail) to “http://pacific.fws.gov/crithab/cg.” Please submit electronic comments in ASCII file format and avoid the use of special characters and encryption. Please include “Attn: [RIN 1018-AF32]” and your name and return address in your e-mail message. If you do not receive a confirmation from the system that we have received your e-mail message, contact us directly by calling our Carlsbad Fish and Wildlife Office at phone number 760-431-9440. Comments and materials received will be available for public inspection, by appointment, during normal business hours at the above Service address.
Douglas Krofta, Fish and Wildlife Biologist, Carlsbad Fish and Wildlife Office, at the above address (telephone 760-431-9440; facsimile 760-431-9624).
The coastal California gnatcatcher is a small, insect-eating bird with dark blue-gray plumage above and grayish-white plumage below. The tail is mostly black above and below. The male has a distinctive black cap which is absent during the winter. Both sexes have a distinctive white eye-ring. The coastal California gnatcatcher is primarily restricted to sage scrub and scrub habitats found in coastal southern California and northwestern Baja California, Mexico, from Ventura and San Bernardino counties, California, south to approximately El Rosario, Mexico, at about 30° north latitude. The once-common species was federally listed as threatened in March 1993, due to habitat loss and fragmentation resulting from urban and agricultural development, and the cumulative effects of cowbird parasitism and predation (58 FR 16742). On February 7, 2000, we published a determination proposing 323,726 hectares (799,916 acres) of sage scrub and scrub habitats as critical habitat for the coastal California gnatcatcher in the
Section 4(b)(2) of the Act requires that the Secretary shall designate or revise critical habitat based upon the best scientific and commercial data available and after taking into consideration the economic impact of specifying any particular area as critical habitat. Based upon the previously published proposal to designate critical habitat for the coastal California gnatcatcher and comments received during the previous comment period, we have prepared a draft economic analysis of the proposed critical habitat designation, which is available at the above Internet and mailing address. We have reopened the comment period at this time in order to accept the best and most current scientific and commercial data available regarding the proposed critical habitat and the draft economic analysis. We will accept written comments during this reopened comment period. Previously submitted oral or written comments on this critical habitat proposal need not be resubmitted. The current comment period on this proposal closes on July 31, 2000. Written comments may be submitted to the Carlsbad Fish and Wildlife Office in the
The primary author of this notice is Douglas Krofta (see
The authority for this action is the Endangered Species Act of 1973 (16 U.S.C. 1531
U.S. Agency for International Development (USAID) is making efforts to reduce the paperwork burden. USAID invites the general public and other Federal agencies to take this opportunity to comment on the following proposed and/or continuing information collections, as required by the Paperwork Reduction Act for 1995. Comments are requested concerning: (a) Whether the proposed or continuing collections 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 burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; and (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.
Submit comments on or before August 28, 2000.
Beverly Johnson, Bureau for Management, Office of Administrative Services, Information and Records Division, U.S. Agency for International Development, Room 2.07-106, RRB, Washington, DC, 20523, (202) 712-1365 or via e-mail bjohnson@usaid.gov.
Annual Reporting Burden:
Forest Service, USDA.
Notice.
In accordance with the Paperwork Reduction Act of 1995, the Forest Service announces its intention to extend the information collection, FS-2800-14—Application for Prospecting Permit. The collected information enables the Forest Service to effectively and efficiently process oil and gas prospecting permits. Information will be collected from oil and gas companies, lessees, exploration companies, and independent, exploration operators expressing an interest in conducting geophysical operations on National Forest System lands.
Comments must be received in writing on or before August 28, 2000.
All comments should be addressed to Director, Minerals and Geology Management Staff, Attn: Mr. W. Dean Crandell, Fluid Minerals Program Manager, Forest Service, USDA, P.O. Box 96090, Washington, D.C. 20090-6090.
Comments also may be submitted via facsimile to (202) 205-1405 or by email to dcrandel@fs.fed.us.
The public may inspect comments received at the Office of the Director, Minerals and Geology Management Staff, Forest Service, USDA, 201 14th Street, S.W., Washington, D.C. 20024. Visitors are encouraged to call ahead to facilitate entrance into the building.
W. Dean Crandell, Minerals and Geology Staff, at (202) 205-1405.
The Mineral Leasing Act (30 U.S.C. 181, as amended) authorizes the Forest Service to permit oil and gas companies, lessees, exploration companies, and independent, exploration operators to conduct geophysical exploration on or off lease on National Forest System lands.
Three regulations govern geophysical operations on National Forest System lands: (1) Title 36 of the Code of Federal Regulations, Part 251, Subpart E provides direction for geophysical operations on lease (operations within the legal land description of an oil and gas lease); (2) Title 36 of the Code of Federal Regulations, Part 251, Subpart A, § 251.15, provides direction for geophysical operations on reserved mineral rights (operations where the Forest Service manages the surface resources but the mineral resources (subsurface) is owned by someone other than the Federal government); and (3) Title 36 of the Code of Federal Regulations, Part 251, Subpart B, provides authorization for geophysical operations off lease (operations on all Forest Service managed lands not included in the preceding two categories).
The following describes the information collection to be extended:
Oil and gas companies, lessees, exploration companies, or independent, energy exploration operators apply to conduct geophysical operations by completing the form, FS-2800-14, Application for Prospecting Permit, or by supplying the same information in a format of their choice.
Oil and gas companies, lessees, exploration companies, or independent, energy exploration operators are asked to provide information that includes the type and size of the proposed activity, the location of the proposed geophysical operation, the equipment that will be used in the proposed geophysical operation, the timing of the operation, and administrative information, such as the applicant's mailing address, the applicant's telephone number, and the applicant's responsible local operator or company representative.
Data gathered in this information collection are not available from other sources.
The agency invites comments on the following: (a) Whether the proposed collection of information is necessary for the stated purposes and the proper performance of the functions of the agency, including whether the information will have practical or scientific utility; (b) 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; (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 the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
All comments received in response to this notice, including names and addresses when provided, will become a matter of public record. Comments will be summarized and included in the request for Office of Management and Budget approval.
Forest Service, USDA.
Notice; intent to prepare an environmental impact statement.
The project area is located on Forest Service Lands within the Spring Creek and Lower Big Piney Creek watersheds east of Fort Leonard Wood Military Reservation and Big Piney River, and south and west of Flat, Missouri, T34N, R9W, Sections 4-6; T35N, R9W, Sections 28-34; T35N, R10W, Sections 1-3, 8-17, 21-27, 35, 36; and, T36N, R10W, Sections 34-36, Fifth Principal Meridian.
The Forest Service will prepare an environmental impact statement (EIS) to analyze and disclose the environmental effects of the project.
The primary purpose of this project is to maintain the project area's forest ecosystems ecological structure and function within a natural condition utilizing vegetative management and other restoration activities. The existing condition does not meet the desired future conditions (DFC) described in the Mark Twain National Forest Plan (MTFP) and the projected successional stages are not anticipated to meet the DFC described in the Mark Twain National Forest Plan.
Initial comments concerning the scope of the analysis should be received on or before July 31, 2000 to receive timely consideration in the preparation of the draft EIS.
Send written comments and suggestions on the proposed action or requests to be placed on the project mailing list to: John C. Bisbee, District Ranger, Houston/Rolla/Cedar Creek Ranger District, 108 South Sam Houston Boulevard, Houston, Missouri 65483. E-mail should have a subject line that reads “NEPA Houston” and be sent to: mailroom_r9 mark_twain@fs.fed.us
Mark Hamel, Project Leader/NEPA Coordinator, Houston/Rolla/Cedar Creek Ranger District, 108 South Sam Houston Boulevard, Houston, Missouri 65483, phone (417) 967-4194.
The following proposed projects would move the Crossroads area towards the desired future condition for the area (Mark Twain Forest Plan pg. IV-115 to IV-123). Note: several activities may occur on the same acre. The Forest Service's proposed action includes the following possible actions: (1) Designate approximately 1,500 acres of old growth, (2) maintain early successional habitat on approximately 650 acres through mechanical means (haying, bush hogging,) and/or grazing, (3) maintain early successional habitat through burning on approximately 1,600 acres, (4) restore and develop savanna habitat on approximately 150 acres through firewood cutting and burning, (5) restore glade habitat on approximately 130 acres through mechanical treatment and burning, (6) restore bottomland riparian habitat by planting hardwoods on approximately 50 acres, (7) for forest health and fuels management, prescribe burn approximately 2,100 acres, (8) plant approximately 50 acres of gamma grass for wildlife habitat, (9) treat approximately 1,400 acres with unevenage management (including group selection and group shelterwood) to meet woodland habitat objectives that exhibit a condition of 20-30 percent forbs, grass and shrub age class requirements, (10) treat approximately 700 acres with regeneration cuts (shelterwood and clearcut) to meet the
The overall objective is to move Management Area 3.4-18 toward the desired future condition outlined in the Mark Twain Forest Plan.
The scope of this analysis is limited to activities related to the purpose and need and measures necessary to mitigate the effects these activities may have on the environment. The decision will include if, when, how, and where to schedule: wildlife habitat improvement activities, watershed, glade, and savanna improvement activities, temporary road construction and closure, forest habitat treatments, prescribed burning, recreation site improvement and access management, resource protection measures, monitoring, and other follow-up activities.
A project in the same vicinity was originally presented to the public for review and comment (scoping) in April of 1997 (Project Name: MA 3.4-18) prior to undertaking preparation of an Environmental Assessment (EA). In 1999 after modification to the MA 3.4-18 project boundary, the project was presented to the public again (Project Name: Crossroads Projects). Since September 1999, additional changes have been made to the proposal and today the decision has been made to prepare an EIS. Many years of experience implementing similar types of activities in the same vicinity have shown us that the effects are not significant. We therefore do not feel that an EIS is required. However, due to the increase in appeals and litigation over the last few years and for wise fiscal efficiency, we have decided to try a new public participation approach for this particular project and prepare an EIS. This Notice of Intent serves as notice of the intent to prepare an EIS for the Crossroads Project. The comments received as a result of the public participation for the analysis will be brought forward for the EIS.
Preliminary comments made by the public and agencies were considered in the development of the tentative or preliminary issues. These are as follows: effects on Threatened, Endangered, and Sensitive (TES) species and Management Indicator Species (MIS); concern over new road construction, and road closures; concern over motorized recreational access; direct, indirect and cumulative effects; current and designated old growth; forest health, in relation to the current vegetative patterns, structures, and species composition; and, effects of restoration activities to the overall watershed.
Public participation will continue to be an important part of the project, commencing with the EIS initial scoping process (40 CFR 1501.7), which starts with publication of this notice and continues for the next 30 days. In addition, the public is encouraged to visit with Forest Service officials at any time during the analysis and prior to the decision. The Forest Service will be seeking information, comments, and assistance from Federal, State, and local agencies, the Osage Tribe, and other individuals or organizations that may be interested in or affected by the proposed action.
Comments from the public and other agencies will be used in preparation of the draft EIS. The scoping process will be used to: identify potential issues; identify additional alternatives to the proposed action; and, identify potential environmental effects of the proposed action and alternatives (i.e., direct, indirect, and cumulative effects).
While public participation in this analysis is welcome at any time, comments received within 30 days of the publication of this notice will be especially useful in the preparation of the draft EIS, which is expected top be filed with the Environmental Protection Agency and available for public review in August 2000. A 45-day comment period will follow publication of a Notice of Availability of the draft EIS in the
The Forest Service believes it is important at this early stage to give reviews notice of several court rulings related to public participation in the environmental review process. First, reviewers of the draft EIS must structure their participation in the environmental review of the proposal in such a way that it is meaningful and alerts an agency to the reviewer's position and contentions.
The responsible official for this environmental impact statement is Randy Moore, Forest Supervisor, Mark Twain National Forest.
It is the intention of the NRCS in South Dakota to issue revised conservation practice standards in Section IV of the FOTG for the practice “Animal Trails and Walkways.”
Comments on this notice must be received within 30 days from the publication date in the
All comments concerning the proposed conservation practice standard changes should be addressed to: Dean Fisher, State Conservationist, NRCS, 200 Fourth Street SW, Huron, South Dakota 57350. A copy of this standard will be made available upon written request.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights, that a meeting of the Rhode Island Advisory Committee to the Commission will convene at 9 a.m. and adjourn at 12:30 p.m. on Friday, July 21, 2000, at the Rhode Island State House, Providence, Rhode Island 02601. The Committee will release its report,
Persons desiring additional information, or planning a presentation to the Committee, should contact Committee Chairperson Olga Noguera, 401-464-1876, or Ki-Taek Chun, Director of the Eastern Regional Office, 202-376-7533 (TDD 202-376-8116). 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.
The meeting will be conducted pursuant to the provisions of the rules and regulations of the Commission.
Minority Business Development Agency, Commerce.
Notice.
The Minority Business Development Agency (MBDA) published a document in the
The closing date for receipt of applications has been extended until July 24, 2000.
Applicants must submit one signed original plus two (2) copies of the application. Completed application packages must be submitted to: Office of Financial Access, Room 5600, Minority Business Development Agency, U.S. Department of Commerce, 14th & Constitution Avenue, NW, Washington, DC 20230.
Jason Everett at (202) 482-1940.
In the
Fish and Wildlife Servce, Interior; National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice to re-open public comment period.
This notice advises other agencies and the public that the Fish and Wildlife Service (USFWS) and National Marine Fisheries Service (NMFS) (collectively, the Services) are re-opening the initial 30-day public comment period and will hold three additional scoping workshops to assist in gathering information for the preparation of an Environmental Impact Statement (EIS). This EIS pertains to the proposed issuance of Incidental Take Permits by NMFS and USFWS, and Enhancement of Survival Permits by USFWS (collectively, Permits) to nonindustrial forest landowners for forest-management activities conducted in Lewis County, WA. The proposed Permits would authorize take of federally listed species in accordance with the Endangered Species Act of 1973, as amended (Act), and certain other unlisted species should they be listed in the future. As required by the Act, a Conservation Plan is being prepared in voluntary cooperation with interested Lewis County parties. Since the Permits are likely to involve multiple landowners, the Conservation Plan will be developed as a programmatic Plan, titled the Family Forest Conservation Project (Plan). The USFWS will also use additional landowner agreements available under Section 10 of the Act, such as Enhancement of Survival Permits for Safe Harbor Agreements and Candidate Conservation Agreements with Assurances, as appropriate. This notice supplements the notice of intent published in the September 23, 1999,
Written comments regarding the scope of issues and potential alternatives to be included in the EIS should be received on or before September 1, 2000. Public meetings will be held at the following locations and times: Lacey, WA on July 26, 2000, at the USFWS/NMFS office on the St. Martins College Campus at 510 Desmond Drive, SE (Sawyer Hall) from 3:00-5:00 pm and 6:00-8:00 pm; and in Chehalis, WA on August 15, 2000, at the Lewis and Clark State Park from 6:00-8:00 pm. The Lewis and Clark State Park is located 12 miles south of Chehalis on Jackson Highway (4583 Jackson Highway).
Written comments, questions, or requests for additional information, including maps for the workshop locations, should be addressed to Mark Ostwald, USFWS, 510 Desmond Drive, SE, Suite 102, Lacey, WA 98503-1273, telephone (360) 753-9564, facsimile (360) 753-9518; or Mike Parton, NMFS, 510 Desmond Drive, SE, Suite 103, Lacey, WA 98503-1273, telephone (360) 753-4650, facsimile (360) 453-9517. Comments received will be available for public inspection by appointment during normal business hours (8:00 am to 5:00 pm, Monday through Friday).
See
Section 9 of the Act prohibits the “take” of species listed as threatened or endangered. The term take is defined under the Act to mean harm, harass, pursue, hunt, shoot, wound, kill, trap, capture or collect, or to attempt to engage in any such conduct. Harm is defined to include significant habitat modification or degradation where it actually kills or injures wildlife by significantly impairing essential behavioral patterns, including breeding, spawning, rearing, feeding, and sheltering.
The Services may issue Permits, under limited circumstances, to take listed species incidental to, and not the purpose of, otherwise lawful activities. The USFWS regulations governing Permits for endangered species are promulgated in 50 CFR 17.22 and regulations governing Permits for threatened species are promulgated in 50 CFR 17.32. The NMFS regulations governing Permits for threatened and endangered species are promulgated in 50 CFR 222.22.
Interested parties have held meetings and field visits with the Services. Scoping workshops on this Plan and EIS were held by the Services on September 22 and September 23, 1999, in Olympia and Chehalis, WA, respectively. As a further opportunity for interested persons to comment on this planning effort, the comment period is being re-opened and additional scoping workshops are scheduled as announced above.
Pursuant to the Act, a collaborative planning effort has been initiated in cooperation with the Services involving landowners, landowner associations, state and federal agencies, universities, and environmental groups. As a result, an EIS will be prepared to address this programmatic Plan and the effects of issuing Permits to landowners engaged in forest-management activities. We expect the proposed Plan to include several options available for landowners toward achieving a specified desired future condition in Lewis County and to be utilized to address State Forest Practices, Clean Water Act, and Endangered Species Act concerns. We expect that the proposed Plan and EIS will evaluate the potential take of several listed species that occur in Lewis County. These may include, but are not limited to, the northern spotted owl (
The Services are exploring two options for the ultimate structure of the permitting regime for this project. These are: (1) One single entity (e.g., state or local agency, or organization, etc.) receives the Incidental Take Permit and upon completion and approval by this entity of detailed, site-specific plans that implement the terms of the programmatic Plan, participating landowners will receive permit coverage under section 10(a)(1)(B) of the Act through individual Certificates of Inclusion; or (2) an individual Incidental Take Permit or Enhancement of Survival Permit is issued to each landowner that provides and receives approval by the Services of a detailed, site-specific plan that implements the terms detailed in the programmatic Plan.
The USFWS is considering the use of Incidental Take Permits and Certificates of Inclusion under Section 10(a)(1)(B) of the Endangered Species Act, as well as Enhancement of Survival Permits for Safe Harbor and Candidate Conservation under Section 10(a)(1)(A). The NMFS is considering the use of Incidental Take Permits and Certificates of Inclusion under Section 10(a)(1)(B) of the Act, but is not proposing to utilize Enhancement of Survival Permits for Safe Harbor and/or Candidate Conservation for any of the species under its jurisdiction.
The Services invite comments and suggestions from all interested parties to ensure that the full range of issues related to these proposed actions are addressed and that all significant issues are identified. We request that comments be as specific as possible. In particular, we request comments regarding: the direct, indirect, and cumulative impacts that implementation of the proposal could have on endangered and threatened species and their habitats; other possible alternatives; permitting regime; portions of Lewis County to be included; total acreage covered by each individual, landowner Permit; total number of Permits to be issued; duration of Permits; potential adaptive management and/or monitoring provisions; funding issues; baseline environmental conditions in Lewis County; other plans or projects that might be relevant to this project; and minimization and mitigation efforts. In addition to considering impacts on species and their habitat, the EIS must include information on impacts resulting from the alternatives on other components of the human environment. These other components include, but are not limited to, air quality, water quality and quantity, geology and soils, cultural resources, other fish and wildlife species, social resources, and economic resources.
The environmental review of this project will be conducted in accordance with the requirements of the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4321 et seq.), the Council on Environmental Quality Regulations (40 CFR 1500-1508) and other appropriate Federal laws and
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting; correction.
The Gulf of Mexico Fishery Management Council published a document in the
Wayne E. Swingle, Executive Director, Gulf of Mexico Fishery Management Council; telephone: 813-228-2815.
In the
“The Committee will hear a NOAA General Counsel legal opinion regarding the stone crab amendment and will discuss possible responses to that legal opinion.”
In the
3:30 p.m.-5 p.m.—Convene the Habitat Protection Committee to hear a presentation on the Williams Gas Pipeline Project, the Gulfstream Gas Pipeline Project, and a review of the proposed Destination Broadwater Draft EIS.
National Telecommunications and Information Administration, Department of Commerce.
Notice of public meeting, request for public comment.
The Assistant Secretary for Communications and Information and Administrator of the National Telecommunications and Information Administration (NTIA), Gregory L. Rohde, in cooperation with the All-Hazard Warning Interagency Working Group, will host a roundtable discussion on July 17, 2000 that will be open to the public to explore hazard warning systems. Recent technological advances are fostering new and innovative methods of bringing warning messages to the public. This notice, through a series of questions, requests public comment on issues relating to the means by which government agencies and public and private sectors can work together to ensure that hazard warning systems are developed to save more lives.
The All-Hazard Warning Roundtable will be held from 9:30-11:30 a.m., Monday, July 17, 2000. Written comments must be filed on or before August 18, 2000. Written reply comments must be filed on or before September 1, 2000.
The All-Hazard Warning Roundtable will be held from 9:30-11:30 a.m. on July 17, 2000, at the U.S. Department of Commerce, Room 4830, 1401 Constitution Avenue, NW., Washington, DC 20230. The meeting will be open to the public. For current information on the roundtable, please see NTIA's website at
The Department invites the public to submit written comments on paper or electronic form. Comments may be mailed to Jeng Mao, Public Safety Program, National Telecommunications and Information Administration (NTIA), U.S. Department of Commerce, Room 4624, 1401 Constitution Avenue, NW., Washington, DC 20230. In the alternative, comments may be submitted in electronic form to the following electronic mail address: <warnings@ntia.doc.gov>.
Paper submissions should include three paper copies and a version on a diskette in PDF, ASCII, WordPerfect (please specify version) or Microsoft Word (please specify version) format. Diskettes should be labeled with the name of the party, and the name and version of the word processing program used to create the document. Comments and reply comments submitted via e-mail to <warnings@ntia.doc.gov> should also be submitted in the formats specified above.
All comments and reply comments should be captioned “All-Hazard Warning—Comment [or Reply Comment], Docket No. 000609173-0173-01.” Comments and reply comments should be numbered and organized in response to the questions set forth in this Notice.
Comments and reply comments received will be posted on the NTIA web site at
Jeng Mao, Public Safety Program, National Telecommunications and Information Administration at either telephone number (202) 501-0342 or electronic mail <jmao@ntia.doc.gov>.
Media inquiries should be directed to NTIA's Office of Public Affairs at (202) 482-7002.
In 1998, Vice President Gore's National Partnership for Reinventing Government (NPR) brought together representatives from more than a dozen Federal agencies to form an inter-agency working group to explore ways of improving the Nation's hazard warning systems to save lives. This group is working to do this by finding combined solutions to give people better, faster, and more effective hazard warnings. As a result of its efforts, the inter-agency working group published
Currently, the National Oceanic and Atmospheric Administration (NOAA) Weather Radio is the most direct way to warn people about all impending
Interested parties are requested to submit written comments on any issue of fact, law, or policy that may inform the U.S. Department of Commerce on hazard warnings. Specifically, comments are requested on the questions below. These questions are designed to assist the public and should not be construed as a limitation on the issues on which public comments may be submitted. Comments should cite the number of the question(s) being addressed. Please provide copies of any studies, research and other empirical data referenced in the comments.
1. Is it technologically feasible today to deliver hazard warnings: to wireless devices, such as cell phones and pagers; over the Internet to users who are online; to standard telephones in the form of a call warning; to broadcast television; to satellite services; to cable television; and to emerging and developing technologies?
2. What are the tradeoffs among technology options?
3. What are the economic impediments, if any, to the use of any of the technologies that might be used to disseminate hazard warnings?
4. What are the legal impediments, if any, to the use of any of the technologies that might be used to disseminate hazard warnings?
5. What legal measures, if any, should be taken to foster the delivery of hazard warnings?
6. What economic and technological policy measures, if any, should be taken to foster the dissemination of hazard warnings?
The All-Hazard Warning Roundtable is open to the public on a first-come, first-served basis and physically accessible to people with disabilities. To facilitate entry into the Department of Commerce building, please have a photo identification available and/or a U.S. Government building pass if applicable. Any member of the public wishing to attend and requiring special services, such as a sign language interpretation or other ancillary aids, should contact Jeng Mao, Public Safety Program, U.S. Department of Commerce, at least five (5) working days prior to the All-Hazard Warning Roundtable, at either telephone number (202) 501-0342 or electronic mail at <jmao@ntia.doc.gov>.
National Telecommunications and Information Administration, U.S. Department of Commerce
Notice of public meeting, request for public comment.
The Assistant Secretary for Communications and Information and Administrator of the National Telecommunications and Information Administration (NTIA), Gregory L. Rohde, will host a roundtable discussion open to the public on minority media ownership in a changing industry. NTIA also requests public comment on ways to preserve diversity in the media. With relaxation of the local broadcast ownership caps and elimination of the national station limit under the Telecommunications Act of 1996, concentration in the broadcasting industry has increased. Although access to investment capital remains a challenge for many minority entrepreneurs seeking to buy broadcast stations, the convergence of traditional broadcasting and new telecommunications technologies may present new opportunities for media ownership. Therefore, the roundtable discussion will also explore ways to improve prospects for minorities to acquire media properties. In addition, this notice will present a series of questions to solicit public comment on these issues.
NTIA will hold the Minority Media Ownership Roundtable from 9:00 a.m. until 12:45 p.m. on Tuesday, July 18, 2000. The deadline for written comments is July 28, 2000 and the deadline for reply comments is August 8, 2000.
NTIA will hold the Minority Media Ownership Roundtable from 9:00 a.m. until 12:45 p.m. on July 18, 2000 at the U.S. Department of Commerce, Room 4830, 1401 Consti-tution Avenue, NW., Washington, DC 20230. The meeting will be open to the public. For current information on the roundtable, please visit NTIA's website at http://www.ntia.doc.gov/ntiahome/minoritymediaroundtable/.
The Department invites the public to submit written comments in paper or electronic form. Please mail comments to Maureen Lewis, Director, Minority Telecommunications Development Program, National Telecommunications and Information Administration, U.S. Department of Commerce, Room 4720, 1401 Constitution Avenue, NW., Washington, DC 20230. In the alternative, commenters may submit their views electronically to the following electronic mail address: minoritymedia@ntia.doc.gov.
Paper submissions should include an original and two paper copies and a version on a 3.5 inch write protected diskette in one of the following formats: PDF, ASCII, Word Perfect (please specify version) or Microsoft Word (please specify version). Please label all diskettes with the name of the party submitting the comments, and the name and version of the word processing program used to create the document. Comments and reply comments submitted by electronic mail to <minoritymedia@ntia.doc.gov> should also be submitted in one of the formats specified above. Caption all comments and reply comments “Minority Media Ownership—Comment [or Reply Comment], Docket No. 000608169-0169-01” and organize each submission in response to the questions set forth in this Notice. NTIA will post comments and reply comments to its web site at <http://www.ntia.doc.gov>.
Maureen Lewis, Director, Minority Telecommunications Development Program, National Telecommunications and Information Administration; telephone (202) 482-8056; or electronic mail <mlewis@ntia.doc.gov.> The NTIA Office of Public Affairs will answer
In its most recent report on minority media ownership titled “Minority Commercial Broadcast Ownership in the United States,” published in August 1998, NTIA found that “financial barriers, increased competition, and higher station prices, are likely to be significant obstacles to new minority entrants to this marketplace.” The report also identified increasing media concentration as a factor likely to cause small station owners with less investment capital to exit the industry as they find it more difficult to compete against station group owners. In addition, increased competition from non-minority group owners for syndicated programming, advertising revenues, and station personnel, such as on-air talent and managers, were other challenges some minority station owners described in the 1998 report. NTIA is seeking public comment on whether the trends described in the 1998 report are continuing to affect adversely minority media ownership. NTIA is also requesting suggestions about ways to reverse any such negative trends. Since the 1998 report, multibillion dollar mergers of large radio station groups and unions between cable companies, multimedia conglomerates and telecommunications companies have been announced or consummated. Traditional distinctions between the broadcast, cable and telecommunications industries appear to be disappearing as new technologies, such as digital radio, satellite radio, audio and video streaming over the Internet, and interactive television emerge. Given this, NTIA is also interested in obtaining comments on the viability of these and other new technologies to enhance ownership opportunities for incumbent media owners and new entrants. This topic, and the effect on minority media ownership of media concentration and access to capital will be integral parts of NTIA's roundtable discussion.
NTIA requests that interested parties submit written comments on any issue of fact, law, or policy that may inform the U.S. Department of Commerce on opportunities for increased minority media ownership. Although the Department specifically seeks information on the questions set forth below, the purpose of these questions is to assist the public. These questions do not, nor should they be construed to, limit the issues on which the public may submit comments. Comments and reply comments should cite the number of the question(s) addressed. Please provide copies of any studies, research, or other empirical data referenced in the comments.
1. What criteria should the federal government use to define minority ownership of broadcast or other media properties?
2. What changes, if any, have occurred in minority broadcast ownership since passage of the Telecommunications Act of 1996?
3. What legal impediments, if any, exist to minority media ownership?
4. What economic impediments, if any, exist to minority media ownership?
5. What policies or programs, if any, should the federal government implement to promote minority media ownership?
6. What legal or regulatory measures would promote minority media ownership?
7. What media ownership opportunities do new technologies offer to minority entrepreneurs?
8. What policies or programs should the federal government implement to promote opportunities for minority entrepreneurs to own “new media” ventures, such as webcasting firms or Internet portals?
Information collected in response to this
The Minority Media Ownership Roundtable is open to the public on a first-come, first-served basis and is physically accessible to people with disabilities. To facilitate entry into the Department of Commerce building, please have a photo identification available and/or a U.S. Government building pass if applicable. Any member of the public wishing to attend and requiring special services, such as a sign language interpretation or other ancillary aids, should contact Maureen Lewis, Director, Minority Telecommunications Development Program, National Telecommunications and Information Administration at least five (5) working days prior to the Minority Media Ownership Roundtable by telephone at (202) 482-8056, or by electronic mail at <mlewis@ntia.doc.gov.>
Commodity Futures Trading Commission.
Notice of extension of public comment period for the proposed amendments.
The Chicago Board of Trade (CBT or Exchange) has proposed amendments to the Exchange's corn, corn yield insurance (six contracts), oats, rough rice, soybeans, soybean meal, soybean oil, wheat, kilo gold, 100 ounce gold, 1000 ounce silver, and 5000 ounce silver futures contracts. On June 8, 2000, the Commission published a request for public comment on the proposed amendments for a 15-day comment period ending on June 23, 2000. The Acting Director of the Division of Economic Analysis (Division), acting pursuant to the authority delegated by Commission Regulation 140.96, has determined that extension of the comment period for an additional thirty (30) days is in the public interest, will assist the Commission in considering the views of interested persons, and is consistent with the purposes of the Commodity Exchange Act.
Comments must be received on or before July 24, 2000.
Interested persons should submit their views and comments to Jean A. Webb, Secretary, Commodity Futures Trading Commission, Three Lafayette Centre, 21st Street, NW, Washington, DC 20581. In addition, comments may be sent by facsimile transmission to facsimile number (202) 418-5521, or by electronic mail to secretary@cftc.gov. Reference should be made to the proposed amendments to the maximum daily price fluctuation limits for the CBT's futures contracts.
Please contact John Bird of the Division of Economic Analysis, Commodity Futures Trading Commission, Three Lafayette Centre, 21st Street NW, Washington, DC 20581, telephone (202) 418-5274. Facsimile number: (202) 418-5527. Electronic mail: jbird@cftc.gov.
The Acting Director, acting on behalf of the
Below is a list of individuals who are eligible to serve on the Performance Review Boards for the Department of the Air Force in accordance with the Air Force Senior Executive Appraisal and Awards System.
U.S. Army Medical Research and Material Command, Department of the Army, DoD.
Notice.
In accordance with 37 CFR 404.6, announcement is made of the availability for licensing of U.S. Patent Application Serial No. 09/377,743 entitled “Novel HIV Suppressor Factor Derived from Scrub Typhus,” filed August 20, 1999. This patent has been assigned to the United States Government as represented by the Secretary of the Army.
Commander, U.S. Army Medical Research and Material Command, ATTN: Command Judge Advocate, MCMR-JA, 504 Scott Street, Fort Detrick, Frederick, Maryland 21702-5012.
Elizabeth Arwine, Patent Attorney, (301) 619-2065 or telefax (301) 619-5034.
The invention takes advantage of the anti-HIV effects of an inhibitory factor produced during scrub typhus infection. It is the object of the invention to provide a method of inducing an immunogenic response to human immunodeficiency virus (HIV), in particular to HIV-1. It is a further object of the invention to provide a suppressor factor derived from scrub typhus infection in the form of purified sera, plasma, or immunogolobulin which is suitable for administration to patents at rink for , or infected with, HIV either alone or in combination with other agents. It is a particular object of the invention to provide an isolated suppressor factor from sera or plasma taken from patients with scrub typhus which has anti-HIV activity. It is also a further object in the invention to provide peptides from inhibitory strains of scrub typhus, which peptides function as antigens and can be used to produce antibodies effective for the prophylaxis and treatment of HIV infection.
U.S. Army Corps of Engineers, DoD.
Notice (Announcement of Public Hearing Date).
The Draft EIS/EIR will be released for public review on or about June 30, 2000. The Environmental Protection Agency plans to publish a Notice of Availability of the Draft EIS/EIR in the
Commander, U.S. Army Corps of Engineers, Los Angeles District, Ecosystem Planning Section, P.O. Box 532711, Los Angeles, CA 90053-2325.
Mr. Larry Smith, Technical Manager, phone (213) 452-3846.
The purpose of the Upper Newport Bay Ecosystem Restoration Project is to develop a long-term management plan to control sediment deposition in the Upper Bay to preserve the health of Upper Newport Bay's habitats. Sediment will continue to deposit in the Bay no matter what control measures are implemented in the watershed. Therefore, one of the most important components of this project is to develop a plan to control sediments by designing one or two in-bay basins in which the bulk of the sediment will settle. In addition to developing a plan for sediment control, the Upper Newport Bay Restoration project includes several other measures to improve habitat quality in the Upper Bay.
The proposed project would involve deepening and expanding the existing sediment basins. Additional ecosystem restoration measures would be included to enhance the overall habitat value of Upper Newport Bay.
The EIS/EIR evaluates four alternatives carried forward for detailed environmental analysis. In general, the major differences among alternatives are the basin and channel depths. During the Preliminary Engineering Design (PED) phase, modifications to further reduce the loss of intertidal mudflat habitat will be investigated.
No Action: No dredging would occur within the Upper Bay ecological reserve.
Recommended Plan: The recommended plan includes the expansion and deepening of the Unit I/III basin and the Unit II basin to -20 feet (−6 m) MSL, with an approach channel between the two basins dredged to −14 feet (−4.2 m) MSL; a 100-foot wide approach channel below the Unit II
Dredging Methods: Two dredge types were evaluated: hydraulic and clamshell. The contractor will select a dredge type based on availability and cost. Impacts associated with the use of the two dredge types are evaluated in the EIS/R.
4. The USACOE and the County of Orange, the local sponsor, will consider public concerns on the Draft EIS/EIR. Summary of the Public Hearing and written comment letters and responses will be incorporated in the Final EIS/EIR as appropriate.
The Public Hearing is scheduled for Tuesday, July 18, 2000, at 7:00 PM, at the Newport Beach City Hall Council Chambers, 3300 Newport Boulevard, Newport Beach, California.
U.S. Army Corps of Engineers, DoD.
Notice of open meeting.
In accordance with 10(a)(2) of the Federal Advisory Committee Act, Public Law (92-463) announcement is made of the next meeting of the Inland Waterways Users Board. The meeting will be held on July 27, 2000, in Portland, Oregon, Doubletree Hotel—Columbia River, 1401 N. Hayden Island Drive (Tel. (503) 283-2111). Registration will begin at 9 a.m. and the meeting is scheduled to adjourn at 4 p.m. The meeting is open to the public. Any interested person may attend, appear before, or file statements with the committee at the time and in the manner permitted by the committee.
Mr. Norman T. Edwards, Headquarters, U.S. Army Corps of Engineers, CECW-PF, Washington, DC 20314-1000.
None.
Department of Education.
The Leader, Regulatory Information Management, Office of the Chief Information Officer, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995.
Interested persons are invited to submit comments on or before August 28, 2000.
Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. 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 Leader, Regulatory Information Management, Office of the Chief Information Officer, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested,
Businesses or other for-profit (primary).
Not-for-profit institutions.
Requests for copies of the proposed information collection request may be accessed from
Requests for copies of the proposed information collection request may be accessed from
Take notice that on June 19, 2000, ANR Pipeline Company, (ANR) petitioned the Commission pursuant to Rule 207 of the Commission's Rules of Practice and Procedure, 18 CFR 385.207 for authorization to reacquire certain firm transportation capacity that it has historically held on Viking Gas Transmission Company (Viking).
In its Petition, ANR explained that the capacity at issue was released/assigned by ANR to its former sales customers at the direction of the Commission as part of the Order No. 636 restructuring process. ANR also advised that, although some of that Viking capacity is no longer desired by those customers, it is still required by ANR to ensure its ability to obtain flowing gas volumes in order to meet its existing firm service requirements in certain parties of western Wisconsin. ANR has requested that the Commission act on its Petition no later than September 1, 2000.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE, Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed on or before June 29, 2000. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. Copies of this filing are on file with the Commission and are available for public inspection in the Public Reference Room. This filing may be viewed on the web at http://www.ferc.fed.us/online/rims.htm (call 202-208-2222 for assistance).
Take notice that on June 14, 2000, Avista Corporation, tendered for filing with the Federal Energy Regulatory Commission pursuant to section 35.12 of the Commissions, 18 CFR 35.12, an executed Netting and Close-Out Agreement with Aquila Energy Marketing Corporation effective June 1, 2000.
Notice of the filing has been served upon Aquila Energy Marketing Corporation.
Any person desiring to be heard or to protest such filing should file a motion to intervene or protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). All such motions and protests should be filed on or before July 5, 2000. protests will be considered by the Commission to determine the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. Copies of this filing are on file with the Commission and are available for public inspection. This filing may also be viewed on the Internet at http://www.ferc.fed.us/online/rims.htm (call 202-208-2222 for assistance).
Take notice that on June 16, 2000, Columbia Gas Transmission Corporation (Columbia), 12801 Fair Lakes Parkway, Fairfax, Virginia 22030-0146, filed an abbreviated application pursuant to section 7(b) of the Natural Gas Act (NGA) requesting the issuance of an
Columbia states that the compressor stations consist of seven compressor units with a cumulative horsepower (hp) rating of 2,900; four dehydration systems; various compressor, office, and auxiliary buildings; 0.5 mile of 6 and 8-inch station piping; and various ancillary systems necessary to support the station operation, as more fully described in the application.
Columbia states that as result of Order Nos. 436 and 636, it has experienced a shift from primarily a merchant function to that of transporter. As a result, Columbia is taking steps to redefine its pipeline system. Columbia further states that the facilities proposed for abandonment are not an integral part of its transmission system and that the long term needs of its customers will be best served through abandonment of assets no longer required to support Columbia's role as a transporter.
Columbia does not propose the abandonment of service to any customer as a result of the facility abandonment, nor does it propose any construction in connection with the abandonment. All ground disturbance will be limited to those activities necessary to abandon the facilities.
Any person desiring to be heard or to protest this application should file a motion to intervene or protest with the Federal Energy Regulatory Commission, 888 First Street, N.E., Washington, D.C. 20426, in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Commission's Regulations under the Natural Gas Act (18 CFR 157.10). All such motions or protests must be filed on or before July 14, 2000. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party to a proceeding must file a motion to intervene in accordance with the commission's Rules and Regulations. Copies of this application are on file with the Commission and are available for public inspection in the Public Reference Room.
Take further notice that, pursuant to the authority contained in and subject to the jurisdiction conferred upon the Commission by sections 7 and 15 of the Natural Gas Act and the Commission's Rules of Practice and Procedure, a hearing will be held without further notice before the Commission if no intervention or protest is filed within the time frame required herein, if the Commission on its own review of the matter finds that permission and approval for the proposed abandonment are required by the public convenience and necessity. If a motion for leave to intervene is timely filed, or if the Commission on its own motion believes that a formal hearing is required, further notice of such hearing will be duly given.
Under the procedure herein provided for, unless otherwise advised, it will be necessary for Applicant to appear or be represented at the hearing.
Take notice that on June 13, 2000, ONEOK WestTex Transmission, Inc. (WesTex), 100 West Fifth Street, P.O. Box 871, Tulsa, Oklahoma 74102, a Hinshaw pipeline, filed in Docket No. CP00-389-000 an application pursuant to section 284.224(b) of the Commission's regulations, seeking confirmation that it has a blanket certificate, or in the alternative to grant such a blanket certificate. This filing may be viewed on the web at
Any person desiring to be heard or to make any protest with reference to said application should on or before July 10, 2000, file with the Federal Energy Regulatory Commission, Washington, DC 20426, a motion to intervene or a protest in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the Natural Gas Act (18 CFR 157.10). All protests filed with the Commission will be considered by it in determining the appropriate action to be taken but will not serve to make the protestants parties to the proceeding. Any person wishing to become a party to a proceeding or to participate as a party in any hearing therein must file a motion to intervene in accordance with the Commission's Rules.
Take notice that on June 19, 2000, Stanfield Hub Services, LLC (Stanfield), 200 S.W. Market Street, Suite 1750, Portland, Oregon 97201, filed in Docket No. CP00-392-000, a petition, pursuant to Rule 207(a)(5) of the Commission's Rules of Practice and Procedure (18 CFR 387.207(a)(5)), and section 7(c)(1)(B) of the Natural Gas Act, seeking approval of a temporary exemption from certificate requirements, all as more fully set forth in this petition which is on file with the Commission and open to public inspection. This filing may be viewed on the web at http://www.ferc.us/online/rims.htm (call 202-208-2222 for assistance). The Stanfield has requested expedited consideration of this Petition.
Specifically, Stanfield seeks authorization to drill up to eight test wells located in Benton County, Washington. Stanfield states that the test wells and related testing and developments are necessary to enable Stanfield to investigate the feasibility of developing an underground natural gas storage project.
Any questions regarding this petition should be directed to Michael C. Dotten or Natalie L. Hocken; Counsel to Stanfield Hub Services, LLC; 200 S.W. Market, Suite 1750, Portland, Oregon 97201-5718 at (508) 227-7400 (Voice) or (503) 241-0950 (FAX).
Any person desiring to be heard or making any protest with reference to said petition should on or before July 14, 2000, file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a motion to intervene or protest in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the Natural
Take further notice that, pursuant to the authority contained in and subject to the jurisdiction conferred upon the Federal Energy Regulatory Commission by Sections 7 and 15 of the NGA and the Commission's Rules of Practice and Procedure, a hearing will be held without further notice before the Commission or its designee on this petition if no motion to intervene is filed within the time required herein, if the Commission on its own review of the matter finds that a grant of the requested exemption is required by the public convenience and necessity. If a motion for leave to intervene is timely filed, of if the Commission on its own motion believes that a formal hearing is required, further notice of such hearing will be duly given.
Under the procedure herein provided for, unless otherwise advised, it will be uncessary for Stanfield to appear or be represented at the hearing.
Take notice that on June 20, 2000, Wyoming Interstate Company, LTD. (WIC), Post Office box 1087, Colorado Springs, Colorado 80944, filed a request with the Commission in Docket No. CP00-393-000, pursuant to section 157.205, 157.211 and/or 157.216(b) of the Commission's Regulations under the Natural Gas Act (NGA) for authorization to construct a new meter station for delivery of gas to Coastal Chem, Inc. authorized in blanket certificate issued in Docket No. CP83-22-000, all as more fully set forth in the request on file with the Commission and open to public inspection. This filing may be viewed on the web at http://www.ferc.fed.us/online/rims.htm (call 202-208-2222 for assistance).
WIC states that Coastal Chem, Inc. a manufacturer of nitrogen based fertilizer to provide fuel gas for their processing facility in Laramie County, Wyoming. The proposed WIC delivery facility would consist of an eight-inch meter run with four-inch flow control valve and appurtenant facilities at an estimated cost of $240,000 plus tax gross up. Coastal Chem, Inc. would pay for the facility. The Coastal Chem, Inc. manufacturing facility is currently served by Cheyenne Light, Fuel and Power Company, a local distribution company.
Any person for the Commission's staff may, within 45 days after the Commission has issued this notice, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention and pursuant to Section 157.205 of the Regulations under the NGA (18 CFR 157.205) a protest to the request. If no protest is filed within the allowed time, the proposed activity shall be deemed to be authorized effective the day after the time allowed for filing a protest. If a protest is filed and not withdrawn within 30 days after the time allowed for filing a protest, the instant request shall be treated as an application for authorization pursuant to Section 7 of the NGA.
Take notice that the following filings have been made with the Commission:
Take notice that on June 15, 2000, American Electric Power Company and Central and South West Corporation made their compliance filing as required under Ordering Paragraph (A) of the Commission's May 31, 2000 order in the referenced dockets.
Take notice that on June 13, 2000, The United Illuminating Company (UI) and Quinnipiac Energy, LLC (Quinnipiac Energy) (the Applicants) jointly submitted for filing, pursuant to section 203 of the Federal Power Act, and Part 33 of the Commission's regulations, an application for the disposition of certain transmission facilities in connection with the sale by UI of its currently non-operating, oil-fired generating facility known as English Station, located in New Haven, Connecticut, to Quinnipiac Energy, pursuant to a Purchase and Sale Agreement dated March 2, 2000. Copies of the entire filing have been served on the Connecticut Department of Public Utility Control.
Take notice that on June 19, 2000, Newark Bay Cogeneration Partnership, L.P. (NBCP), 414-462 Avenue P, Newark, New Jersey, 07105, filed with the Federal Energy Regulatory Commission (Commission) an Application for Determination of Exempt Wholesale Generator Status pursuant to part 365 of the Commission's Regulations and Section 32 of the Public Utility Holding Company Act, as amended (the Application).
The Application seeks a determination that NBCP qualified for Exempt Wholesale Generator status. NBCP is a Delaware limited partnership that owns and operates a gas-fired combined cycle cogeneration facility rated at 123 MW summer and 147 MW winter capacity. NBCP historically has engaged in the sale of electricity to Public Service Electric and Gas Company (PSE&G) as a Qualifying Facility (QF) under the Public Utility Regulatory Policies Act of 1978 (PURPA). Upon NBCP's determination as an EWG, the facility will be used for the generation of electricity exclusively for sale at wholesale.
Copies of the application have been served upon the New Jersey Board of
Take notice that on June 16, 2000, ISO New England Inc. (the ISO) filed a Report of Compliance pursuant to the Federal Energy Regulatory Commission's (Commission) order issued on May 19, 2000 in the above-referenced proceeding.
Copies of said filing have been served on all parties to this proceeding.
Take notice that on June 19, 2000, PJM Interconnection, L.L.C. (PJM), submitted an application pursuant to section 204 of the Federal Power Act seeking authorization to issue securities in an amount not to exceed $191 million.
PJM also requests a waiver from the Commission's competitive bidding and negotiated placement requirements in 18 CFR 34.2.
Take notice that on June 16, 2000, the Mid-Continent Area Power Pool (MAPP) notified the Commission of certain procedural changes regarding MAPP Schedule F to the Restated Agreement.
A copy of the notification was served on all parties in the above-referenced proceedings and the state public service commissions located in the MAPP region.
Take notice that on June 16, 2000, New Century Services, Inc. (NCS), on behalf of Southwestern Public Service Company (SPS), tendered for filing executed Network Integration Transmission Service and Network Operating Agreements between Golden Spread Electric Cooperative, Inc. and SPS. NCS also submitted executed Network Integration Transmission Service and Network Operating Agreements between South Plains Electric Cooperative, Inc. and SPS.
NCS has requested that all of the agreements become effective on April 20, 2000.
Take notice that on June 16, 2000, Milford Power Limited Partnership tendered for filing an amendment to its petition filed in the above referenced dockets on May 23, 2000. The amendment serves to amend the Revised FERC Electric Tariff No.1 attached as Appendix A to the petition to provide that Milford will not sell energy or capacity to any affiliate with a franchised service area pursuant to such rate schedule, and will only engage in such sales pursuant to a separate filing approved by the Commission under Section 205 of the Federal Power Act.
Take notice that on June 16, 2000, Midwest Independent Transmission System Operator, Inc., tendered for filing an executed signature pages to the “Agreement of the Transmission Facilities Owners to Organize the Midwest Independent Transmission System Operator, Inc., A Delaware Non-Stock Corporation,” and the “Agency Agreement for Open Access Transmission Service Offered by the Midwest ISO for Nontransferred Transmission Facilities' executed by Northern States Power Company-Minnesota and Northern States Power Company-Wisconsin were filed with the Commission.
A copy of this filing was served on all affected state commission.
Take notice that on June 16, 2000, Illinois Power Company (Illinois Power), 500 South 27th Street, Decatur, Illinois 62526, tendered for filing firm and non-firm transmission agreements under which British Columbia Power Exchange Corporation will take transmission service pursuant to its open access transmission tariff. The agreements are based on the Form of Service Agreement in Illinois Power's tariff.
Illinois Power has requested an effective date of June 15, 2000.
Take notice that on June 16, 2000, Allegheny Energy Service Corporation on behalf of Allegheny Energy Supply Company, LLC (Allegheny Energy Supply), tendered for filing Service Agreement No. 76 to add one (1) new Customer to the Market Rate Tariff under which Allegheny Energy Supply offers generation services.
Allegheny Energy Supply requests a waiver of notice requirements to make service available as of May 17, 2000 to East Kentucky Power Cooperative, Inc.
Copies of the filing have been provided to the Public Utilities Commission of Ohio, the Pennsylvania Public Utility Commission, the Maryland Public Service Commission, the Virginia State Corporation Commission, the West Virginia Public Service Commission, and all parties of record.
Take notice that on June 16, 2000, Pacific Gas and Electric Company (PGandE Company), tendered for filing the Emergency Demand Relief Service Agreement between Pacific Gas and Electric Company and City and County of San Francisco (CCSF). This agreement is intended to facilitate CCSF's participation in the California Independent System Operator (CAISO) Demand Relief Program to support reliability of the electric grid in California this summer. Under this agreement, PGandE Company will provide information to the CAISO regarding curtailment of loads designated by CCSF when requested by CAISO to meet reserve and reliability requirements, and pass through payments from CAISO to CCSF.
PGandE Company has requested certain waivers.
Copies of this filing have been served upon City, the CAISO, The California Electricity Oversight Board, the CPUC and the Service List for Docket No. EL00-75-000.
Take notice that on June 16, 2000, Virginia Electric and Power Company (Virginia Power), tendered for filing a Network Integration Transmission Service and Network Operating Agreement with The Wholesale Power Group under the Company's Open Access Transmission Tariff to Eligible Purchasers dated July 14, 1997. Under the tendered agreements, Virginia Power will provide network integration transmission service in accordance with the rates, terms and conditions of the Open Access Transmission Tariff.
Virginia Power requests an effective date of June 1, 2000, the date service was first provided to the customer.
Copies of the filing were served upon The Wholesale Power Group, the Virginia State Corporation Commission and the North Carolina Utilities Commission.
Take notice that on June 16, 2000, Wisconsin Public Service Corporation tendered for filing an executed service agreement with Enron Power Marketing, Inc. (EPMI) under its Market-Based Rate Tariff, FERC Electric Tariff Volume No. 10.
Copies of this filing were served upon EPMI, the Public Service Commission of Wisconsin and the Michigan Public Service Commission.
Take notice that on June 16, 2000, Cook Inlet Energy Supply L.L.C., tendered for filing a Notice of Change in Status related to a change in its ownership.
Take notice that on June 16, 2000, Consumers Energy Company (Consumers), tendered for filing a Facility Engineering Authorization Agreement Between Consumers and Covert Generating Company, L.L.C. [Covert] (Agreement), dated May 26, 2000 (Agreement). Under the Agreement, Consumers is to perform engineering and other preliminary work associated with providing an electrical connection between Consumers' transmission system and a generating plant to be built by Covert.
Consumers requested that the Agreement be allowed to become effective May 26, 2000.
Copies of the filing were served upon Covert and the Michigan Public Service Commission.
Take notice that on June 16, 2000, Duke Energy Vermillion, LLC (Duke Vermillion), tendered for filing a Service Agreement with Duke Energy Trenton, LLC and Cincap VIII, LLC pursuant to Duke Vermillion's Market-Based Rate Tariff.
Duke Vermillion requests an effective date for the Service Agreement of May 15, 2000.
Take notice that on June 16, 2000, Duke Energy Madison, LLC (Duke Madison), tendered for filing a Service Agreement with Duke Energy Trenton, LLC and Cincap VIII, LLC pursuant to Duke Madison's Market-Based Rate Tariff.
Duke Madison requests an effective date for the Service Agreement of May 29, 2000.
Take notice that on June 16, 2000, Calcasieu Power, LLC, tendered for filing an unexecuted Power Sales Agreement for short-term transactions between Calcasieu Power, LLC and Entergy Services, Inc. (as agent Entergy Gulf States, Inc.) to be in effect as of May 17, 2000.
Take notice that on June 16, 2000, Consumers Energy Company (Consumers) tendered for filing a Facilities Agreement Between Consumers Energy Company and CMS Distributed Power, L.L.C., (Facilities Agreement). Under the Facilities Agreement, Consumers is to construct, operate and maintain various interconnection facilities. The Facilities Agreement is dated May 31, 2000.
Consumers requested that the Agreements be allowed to become effective by May 31, 2000.
Copies of the filing were served upon CMS Distributed Power, L.L.C. and upon the Michigan Public Service Commission.
Take notice that on June 16, 2000, Otter Tail Power Company (Otter Tail), tendered for filing a letter notifying the Federal Energy Regulatory Commission that Otter Tail proposes to modify its open access transmission tariff as of May 1, 2000, to incorporate the Mid-Continent Power Pool's Line Loading Relief (LLR) procedures as required by the Commission's May 26, 2000 Order in the same docket.
E. Any person desiring to be heard or to protest such filing should file a motion to intervene or protest with the Federal Energy Regulatory Commission, 888 First Street, NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). All such motions or protests should be filed on or before the comment date. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a motion to intervene. Copies of these filings are on file with the Commission and are available for public inspection. This filing may also be viewed on the Internet at http://
An environmental assessment (EA) is available for public review. The EA analyzes the environmental impacts of Grand River Dam Authority's (GRDA) application to grant a permit to John W. Mayes (applicant) to install 9 boat docks with 84 slips in Grand Lake O' The Cherokees (Grand Lake), the reservoir for the Pensacola Hydroelectric Project. GRDA's proposed permit would also allow the applicant to dredge about 33,557 cubic yards of sediment to improve boat access from the docks to Grand Lake. The Pensacola Project is on the Grand (Nesho) River in Craig, Delaware, Mayes, and Ottawa Counties, Oklahoma.
The EA was written by staff in the Office of Energy Projects, Federal Energy Regulatory Commission. In the EA, Commission staff conclude that approving GRDA's application to grant the permit would not constitute a major federal action significantly affecting the quality of the human environment. Copies of the EA can be viewed on the web at
Take notice that the following hydroelectric applications have been filed with Commission and are available for public inspection:
a. Type of Applications: New Major Licenses.
b. Projects: Soda Project No. 20-019, Grace-Cove Project No. 2401-007, and Oneida Project No. 472-017.
c. Date filed: September 27, 1999.
d. Applicant: PacifiCorp.
e. Location: On the Bear River in Caribou and Franklin Counties, Idaho. The projects are partially on United States lands administered by the Bureau of Land Management.
f. Filed Pursuant to: Federal Power Act, 16 USC 791(a)-825(r).
g. Applicant Contact: Randy Landolt, Director, Hydro Resources, PacifiCorp, 825 N.E. Multnomah Street, Suite 1500, Portland, OR 97232, (503) 813-6650, or, Thomas H. Nelson, 825 Multnomah Street, Suite 925, Portland, OR 97232, (503) 813-5890.
h. FERC Contact: Susan O'Brien, susan.obrien@ferc.fed.us, (202) 219-2840.
i. Deadline for filing scoping comments: September 14, 2000.
All documents (original and eight copies) should be filed with: David P. Boergers, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE, Washington, DC 20426.
The Commission's Rules of Practice and Procedure require all interveners filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervener files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
j. This application is not ready for environmental analysis at this time.
k. The existing Soda Project consists of: (1) the 103-foot-high and 433-foot-long concrete gravity Soda Dam with a 114-foot-long spillway section; (2) the Soda Reservoir with a surface area of 1,100 acres, an active storage capacity of 16,300 acre-feet, and a maximum water elevation of 5,720 feet; (3) the Soda Powerhouse containing two units with a total installed capacity of 14 megawatts (MW); and (4) other appurtenances.
The existing Grace Development consists of: (1) a 51-foot-high and 180-foot-long rock filled timber crib dam that creates a 250 acre-feet usable storage capacity forebay; (2) a 26,000-foot-long flowline and surge tanks; and (3) a powerhouse with three units with total installed capacity of 33 MW. The Cove Development consists of: (1) a 26.5-foot-high and 141-foot-long concrete dam creating a 60-acre-foot forebay; (2) a 6,125-foot-long concrete and wood flume; (3) a 500-foot-long steel penstock; and (4) a powerhouse with a 7.5-MW unit.
The existing Oneida Project consists of: (1) the 111-foot-high and 456-foot-long concrete gravity Oneida Dam; (2) the Oneida Reservoir with an active storage of 10,880 acre-feet and a surface area of 480 acres; (3) an 16-foot-diameter, 2,240-foot-long flowline; (4) a surge tank; (5) three 12-foot-diameter, 120-foot-diameter, 120-foot-long steel penstocks; (6) the Oneida Powerhouse with three units with a total installed capacity of 30 MW; and (7) other appurtenances.
l. A copy of the application is available for inspection and reproduction at the Commission's Public Reference Room, located at 888 First Street, NE, Room 2A, Washington, DC 20426, or by calling (202) 208-1371. The application may be viewed on http://www.ferc.fed.us/rims.htm (call (202) 208-2222 for assistance). A copy is also available for inspection and reproduction at the address in item g above.
m. Scoping Process
The Commission intends to prepare an Environmental Impact Statement (EIS) on the project in accordance with the National Environmental Policy Act. The EIS will consider both site-specific and cumulative environmental impacts and reasonable alternatives to the proposed action.
A scoping meeting will be held on Tuesday, August 14, 2000 from 7:00 p.m. until 10 p.m. at the Caribou County Senior Citizens Center, 60 South Main Street, Soda Springs, Idaho. A project site visit will be scheduled for Tuesday, August 14, 2000 at 9 am, if there is any interest. If you would like to attend, please call Susan O'Brien, FERC Team Leader, at (202) 219-2840, no later than Thursday, July 27, 2000.
Copies of the Scoping Document (SDI) outlining the subject areas to be addressed in the EIS were distributed to the parties on the Commission's mailing list. Copies of the SDI will be available at the scoping meeting in August or may be viewed on http://www.ferc.fed.us/
The Commission held scoping meetings, one in the daytime and one in the evening, to help identify the scope of issues to be addressed in the EIS. The daytime scoping meeting was held on June 15, 2000 at the Holiday Inn, 1399 Bench Road, Pocatello, Idaho, and focused on resource agency concerns. The evening scoping meeting was held on June 14, 2000 at the Caribou County Senior Citizens Center, 60 South Main Street, Soda Spring, Idaho, and was primarily for public input. The applicant and Commission staff also conducted a project site visit on Friday, June 16, 2000.
It was the Commission's intent that all interested individuals, organizations, and agencies be invited to attend one or both of the meetings and the site visit, and to assist the staff in identifying the scope of the environmental issues that should be analyzed in the EIS. These meetings and site visit were not noticed in the
The scoping comment period will be extended from July 16, 2000 until September 14, 2000. Please follow procedures in item i. above.
Individuals, organizations, and agencies with environmental expertise and concerns are encouraged to attend the meeting and to assist the staff in defining and clarifying the issues to be addressed in the EIS.
At the scoping meetings, the staff will: (1) Summarize the environmental issues tentatively identified for analysis in the EIS; (2) solicit from the meeting participants all available information, especially quantifiable data, on the resources at issue; (3) encourage statememts from experts and the public on issues that should be analyzed in the EIS, including viewpoints in opposition to, or in support of, the staff's preliminary views; (4) determine the resource issues to be addressed in the EIS; and (5) identify those issues that require a detailed analysis, as well as those issues that do not require a detailed analysis.
The meetings are recorded by a stenographer and become part of the formal record of the Commission proceeding on the project.
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
Comments must be submitted on or before July 31, 2000.
For a copy of the ICR contact Sandy Farmer at EPA by phone at (202) 260-2740, by E-Mail at Farmer.Sandy@epamail.epa.gov or download off the Internet at
For slabstock foam producers, these requirements include an initial notification, notification of compliance status, and semiannual reports thereafter. In addition, respondents are required to submit a pre-compliance report that describes the HAP compliance procedures, and recordkeeping procedures. Respondents electing to comply with the slabstock foam emission limitation using recovery devices must measure and record emissions as specified in section 63.1297 of the final rule. Molded and rebond foam producers have only to submit a notification of compliance status report.
Owners or operators of slabstock flexible polyurethane foam production facilities must maintain a copy of all HAP usage records onsite for a minimum of five years. All reports are to be submitted upon request to EPA or the enforcement authority by EPA. The information is used to determine whether or not all sources subject to the MACT are achieving the standards.
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 numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR Chapter 15. The
Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the following addresses. Please refer to EPA ICR No.1783.02 and OMB Control No. 2060-0357 in any correspondence.
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
Additional comments may be submitted on or before July 31, 2000.
Sandy Farmer by phone at 202-260-2740, or via e-mail at “farmer.sandy@epa.gov”, or using the address indicated below. Please refer to EPA ICR No. 1249.06. and OMB Control No. 2070-0074.
Send comments, referencing EPA ICR No. 1249.06 and OMB Control No. 2070-0074, to the following addresses: Ms. Sandy Farmer, U.S. Environmental Protection Agency, Collection Strategies Division (2822), 1200 Pennsylvania Avenue, NW., Washington, DC 20460; and to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.
Applicators maintain records, and the registrants/lead agencies do monitoring studies and submit the reports. These records are monitored by either the: (a) State lead agencies; (b) EPA regional offices; or (c) the registrants. The Environmental Protection Agency (EPA, the Agency) receives annual monitoring reports from registrants or State lead agencies. 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 numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR Chapter 15.
According to the procedures prescribed in 5 CFR 1320.12, EPA has submitted this ICR to OMB for review and approval. Any comments related to the renewal of this ICR should be submitted within 30 days of this document, as described above.
Environmental Protection Agency (EPA).
Notice of adequacy.
In this document, EPA is notifying the public that we have found that the motor vehicle emissions budgets for oxides of nitrogen and volatile organic compounds for the year 2010 in the Ozone Redesignation Request and Maintenance State Implementation Plan (SIP) submitted by the Commonwealth of Kentucky for Northern Kentucky are adequate for transportation conformity purposes. On March 2, 1999, the D.C. Circuit Court ruled that submitted SIPs cannot be used for conformity determinations until EPA has affirmatively found them adequate. As a result of our finding, the motor vehicle emissions budgets in the submitted Northern Kentucky Ozone Redesignation Request and Maintenance SIP must be used for future conformity determinations.
These budgets are effective July 14, 2000.
The finding will be available at EPA's conformity website:
The SIP is available for public viewing at the United States Environmental Protection Agency, 61 Forsyth Street, SW., Atlanta, Georgia 30303. You can request a copy of the SIP submission by contacting Dr. Robert W. Goodwin, Regulatory Planning Section, United States Environmental Protection Agency, 61 Forsyth Street, SW., Atlanta, Georgia 30303, Phone: (404) 562-9044, Fax: (404) 562-9019, E-smail: Goodwin.Robert@EPA.gov.
Today's document is simply an announcement of a finding that we have already made. EPA Region 4 sent a letter to the Kentucky Division for Air Quality on May 24, 2000, stating that the motor vehicle emissions budgets in the submitted Northern Kentucky Ozone Redesignation Request and Maintenance SIP for the year 2010 are adequate. This finding will also be announced on EPA's conformity website:
Transportation conformity is required by section 176(c) of the Clean Air Act. EPA's conformity rule requires that transportation plans, programs, and projects conform to state air quality implementation plans (SIPs) and establishes the criteria and procedures for determining whether or not they do. Conformity to a SIP means that transportation activities will not produce new air quality violations, worsen existing violations, or delay timely attainment of the national ambient air quality standards.
The criteria by which we determine whether a SIP's motor vehicle emission budgets are adequate for conformity purposes are outlined in 40 CFR 93.118(e)(4). We've described our process for determining the adequacy of submitted SIP budgets in guidance (May 14, 1999 memo titled “Conformity Guidance on Implementation of March 2, 1999 Conformity Court Decision”). We followed this guidance in making our adequacy determination.
42 U.S.C. 7401-7671q.
Environmental Protection Agency.
Notice of proposed settlement.
Under sections 104, 106(a), 107 and 122 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), Agrico Chemical Company and PCS Joint Venture, Ltd. (Respondents) entered into an Administrative Order on Consent (AOC) with the Environmental Protection Agency (EPA), whereby Respondents agreed to perform response activities at the Landia Chemical Company Site (Site) located in Lakeland, Florida. Section VII of the AOC provides for the reimbursement of EPA's past response costs by Respondents. Under the terms of the AOC, section VII is subject to section 122(i) of CERCLA, which requires EPA to publish notice of the proposed settlement in the
Written comment may be submitted to Mr. Greg Armstrong at the above address within 30 days of the date of publication.
The Federal Communications Commission (FCC) has received Office of Management and Budget (OMB) approval for the following public information collections pursuant to the Paperwork Reduction Act of 1995, Public Law 104-13. 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 control number. For further information contact Shoko B. Hair, Federal Communications Commission, (202) 418-1379.
Section 64.604(c)(1) requires states to maintain a log of consumer complaints including all complaints about TRS in the state, whether filed with the TRS provider or the State, and must retain the log until the next application for certification is granted. The log shall include, at a minimum, the date the complaint was filed, the nature of the complaint, the date of resolution, and an explanation of the resolution. Summaries of logs must be submitted annually to the Commission. (No. of respondents: 52 respondents; hours per response: 2 hours; total annual burden: 104 hours). Pursuant to Section 64.604(c)(2) states must submit to the Commission a contact person or office for TRS consumer information and complaints about intrastate TRS. Providers of interstate TRS must submit to the Commission a contact person or office for TRS consumer information and complaints about the provider's service. This submission must include, at a minimum, the name and address of the office that receives complaints, grievances, inquiries and suggestions, voice and TTY telephone numbers, fax number, e-mail address, and physical address to which correspondence should be sent. (No. of respondents: 52 respondents; hours per response: 1 hour; total annual burden: 52 hours). Pursuant to 47 CFR 64.604(b)(2) TRS providers must answer 85% of all relay calls within 10 seconds by a CA prepared to place the TRS call at the time. The calculation of whether a provider is in compliance with the “85-10 rule” must be performed on at least a daily basis. (No. of respondents: 31 respondents; hours per response: 365 hours; total annual burden: 11,315 hours). Pursuant to 47 CFR 64.604(a)(2), STS CAs may retain information from a particular call in order to facilitate the completion of consecutive calls, at the request of the user. The CA may retain the information only for as long as it takes to complete the subsequent calls. Relay providers must offer STS users the option to maintain at the relay center a list of names and telephone numbers which the STS users call. When the STS users requests one of these names, the CA must repeat the name and state the telephone number to the STS users. See 47 CFR 64.604(a)(7). Pursuant to Section 64.604(b)(6), relay providers shall electronically capture recorded messages and retain them for the length of the call. See 47 CFR 64.604(b)(6). (No. of respondents: 31; hours per response: 1 hour; total annual burden: 31 hours). 47 CFR 64.604(c)(3) requires carriers, through publications in their directories, periodic billing inserts, placement of TRS instructions in telephone directories, through directory assistance services, and incorporation of TTY numbers in telephone directories, shall assure that callers in their service areas are aware of the availability and use of all forms of TRS. (No. of respondents: 5,000 respondents: hours per response: 1 hour; total annual burden: 5,000 hours). 47 CFR 64.604(c)(iii)(5)(C) requires TRS providers to provide the administrator with true and adequate data necessary to determine TRS fund revenue requirements and payments. TRS providers must provide the following: total TRS minutes of use, total interstate TRS minutes of use, total TRS operating expenses and total TRS investment in general accordance with Part 32 and other historical or projected information reasonably requested by the administrator for purposes of computing payments and revenue requirements. (No. of respondents: 13; hours per response: 3 hours; total annual burden; 39 hours). Pursuant to 47 CFR 64.604(c)(iii)(5)(E), in addition to the data required under paragraph (c)(5)(ii)(C) all TRS providers, including providers who are not interexchange carriers, local exchange carriers, or certified state relay providers, must submit reports of interstate TRS minutes of use to the administrator in order to receive payments. TRS providers receiving payments shall file a form prescribed by the administrator. (No. of respondents: 13; hours per response: 4 hours; total annual burden: 52 hours). 47 CFR 64.604(c)(iii)(5)(F) lists TRS providers who are eligible for receiving payments from the TRS fund. These providers must notify the administrator of their intent to participate in the TRS Fund thirty days prior to submitting reports of TRS interstate minutes of use in order to receive payment settlements for interstate TRS. Failure to file may exclude the TRS provider from eligibility for the year. (See 47 CFR 64.604(c)(iii)(5)(G)). Payments will only be made to eligible TRS providers operating in compliance with the mandatory minimum standards set forth
The companies listed in this notice have given notice under section 4 of the Bank Holding Company Act (12 U.S.C. 1843) (BHC Act) and Regulation Y, (12 CFR part 225) to engage de novo, or to acquire or control voting securities or assets of a company, including the companies listed below, that engages either directly or through a subsidiary or other company, in a nonbanking activity that is listed in § 225.28 of Regulation Y (12 CFR 225.28) or that the Board has determined by Order to be closely related to banking and permissible for bank holding companies. Unless otherwise noted, these activities will be conducted throughout the United States.
Each notice is available for inspection at the Federal Reserve Bank indicated. The notice also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the question whether the proposal complies with the standards of section 4 of the BHC Act. Additional information on all bank holding companies may be obtained from the National Information Center website at www.ffiec.gov/nic/.
Unless otherwise noted, comments regarding the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than July 14, 2000.
A. Federal Reserve Bank of Chicago (Phillip Jackson, Applications Officer) 230 South LaSalle Street, Chicago, Illinois 60690-1414:
1. Byron Bancshares, Inc., Byron, Illinois; to continue to engage de novo through its subsidiary, Byron Bank Financial Services, Byron, Illinois, in the sale of mutual funds pursuant to § 225.28(b)(7)(i) of Regulation Y.
Board of Governors of the Federal Reserve System, June 23, 2000.
The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639-7090. Send written comments to CDC, Desk Officer; Human Resources and Housing Branch, New Executive Office Building, Room 10235; Washington, DC 20503. Written comments should be received within 30 days of this notice.
1. National Ambulatory Medical Care Survey—(0920-0234)—Revision—(NCHS)—The National Ambulatory Medical Care Survey (NAMCS) was conducted annually from 1973 to 1981, again in 1985, and resumed as an annual survey in 1989. It is directed by the Division of Health Care Statistics, National Center for Health Statistics, Centers for Disease Control and Prevention. The purpose of NAMCS is to meet the needs and demands for statistical information about the provision of ambulatory medical care services in the United States. Ambulatory services are rendered in a wide variety of settings, including physicians' offices and hospital outpatient and emergency departments. The NAMCS target population consists of all office visits within the United States made by ambulatory patients to non-Federal, office-based physicians (excluding those in the specialties of anesthesiology, radiology, and pathology) who are engaged in direct patient care. Since more than 80 percent of all direct ambulatory medical care visits occur in physicians' offices, the NAMCS provides data on the majority of ambulatory medical care services. To complement these data, in 1992 NCHS initiated the National Hospital Ambulatory Medical Care Survey (NHAMCS, OMB No. 0920-0278) to provide data concerning patient visits to hospital outpatient and emergency departments. The NAMCS, together with the NHAMCS, constitute the ambulatory component of the National Health Care Survey (NHCS) and will provide coverage of more than 90 percent of ambulatory medical care.
The NAMCS provides a range of baseline data on the characteristics of the users and providers of ambulatory medical care. Data collected include the patients' demographic characteristics and reason(s) for visit, and the physicians' diagnosis(es) and diagnostic services, medications and disposition. These data, together with trend data, may be used to monitor the effects of change in the health care system, provide new insights into ambulatory medical care, and stimulate further research on the use, organization, and delivery of ambulatory care.
Users of NAMCS data include, but are not limited to, congressional and other federal government agencies such as NIH and FDA, state and local governments, medical schools, schools of public health, colleges and universities, private businesses, nonprofit foundations and corporations, professional associations, as well as individual practitioners, researchers, administrators and health planners. Uses vary from the inclusion of a few selected statistics in a large research effort, to an in-depth analysis of the entire NAMCS data set covering several years.
To calculate the burden hours, the number of respondents for NAMCS is based on a sample of 6,000 physicians with a 50 percent participation rate (this includes physicians who are out-of-scope as well as those who refuse). The total annualized burden is estimated to be 11,225 hours.
The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639-7090. Send written comments to CDC, Desk Officer; Human Resources and Housing Branch, New Executive Office Building, Room 10235; Washington, DC 20503. Written comments should be received within 30 days of this notice.
1. Survey of Laboratory Practices for Nucleic Acid Amplification Tests for Mycobacterium tuberculosis (M.tb NAA)—New—As part of the continuing effort to support public health objectives of treatment, disease prevention and surveillance programs, the Public Health Practice Program Office (PHPPO), Centers for Disease Control and Prevention (CDC) seeks to collect information from both public health and private sector laboratories performing nucleic acid amplification tests for Mycobacterium tuberculosis. Mycobacterium tuberculosis (TB) infection has reemerged as a significant public health concern in the United States. Since TB is easily transmitted, early detection of infection is imperative for control and prevention. CDC guidelines have advocated the use of the acid-fast bacilli smear (AFB), followed by culture, to confirm a diagnosis of tuberculosis. However, research and development have led to the design and marketing of nucleic acid amplification-based methods for the rapid detection of Mycobacterium tuberculosis (M.tb) directly from clinical sputum specimens. Since the FDA approval of two commercial M.tb NAA, CDC has become keenly interested in the analytic accuracy and clinical utility of these tests, especially from the standpoint of early detection and control of tuberculosis.
Literature reports indicate variability in sensitivities, specificities, and predictive values for M.tb NAA, depending on the experimental design, the population being studied, and the test methodology. Overall, both sensitivity and specificity are reported to be relatively high compared with AFB smear and culture results. However, there are several important potential sources of error including contamination problems inherent to nucleic acid technology, cross-contamination with other mycobacteria, sub-optimal laboratory practices, and unknown factors. The use of M.tb NAA tests for rapidly diagnosis may be useful for controlling TB, particularly in high prevalence populations. However, the clinical utility and efficacy of M.tb NAA tests remains in question. Because of the uncertainty surrounding the analytical accuracy and clinical validity of the tests, the potential sources of error, and the subsequent potential expense of incorrect treatment.
The goal of the proposed project is to collect laboratory practice data, in conjunction with performance data, through a survey administered to current participants in the CDC's M.tb NAA Performance Evaluation Program, to determine if laboratory practices are associated with the risk of errors in these tests. Information collected in the survey will be on test methods, quality assurance, quality control and reporting practices, and test utilization. The survey will also collect demographic information regarding the types of laboratories where testing is performed. CDC will use this data as a primary source of critical information to develop laboratory guidelines and recommendations for performance and utilization of M.tb NAA tests. The benefit of this data and the subsequent recommendations to public health will be the utilization of enhanced testing practices in the control and elimination of M. tuberculosis infection in the United States. The total annualized burden is estimated to be 55 hours.
The Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) announce the availability of fiscal year (FY) 2000 funds for a cooperative agreement program with the Minority Health Professions Foundation (MHPF). The purpose of the program is to assist the Minority Health Professions Foundation in the following manner:
1. To improve the practice of public health at member schools by strengthening their public health infrastructure;
2. To enhance the quantitative and qualitative analytic research infrastructure of the participating institutions;
3. To strengthen the educational and professional development of minority health professionals and educators;
4. To support student training initiatives, in order to introduce public health to minority students;
5. To provide health education and outreach for decreasing the needs of the poor, minority, and under-served populations; and
6. To enhance the interactions between the Minority Health Professions Foundation schools, the historically black colleges and universities and public health institutions.
This program addresses the commitments of the CDC and ATSDR in achieving the health promotion and disease prevention objectives of “Healthy People 2010”, a national activity to reduce morbidity and mortality, while improving the quality of life. This announcement is related to the 2010 objectives, which specify improving the health of groups of people bearing a disproportionate burden of poor health, as compared to the total population. The framework of “Healthy People 2010” consists of two broad goals which are to:
1. Increase quality and years of healthy life; and
2. Eliminate health disparities.
The goals of “Healthy People 2010” have been established as the Nation's prevention goals and as a scorecard for monitoring health status. The nations goals and objectives established in “Healthy People 2010” will build upon the foundation for establishing a small set of leading health indicators that could be presented to the general public and non-health professionals as an introduction to “Healthy People”. “Healthy People 2010” will be a tool for monitoring America's health. For the conference copy of “Health People 2010” visit the internet site: <http://www.health.gov/healthypeople>.
Eliminating disparities by the year 2010 will require new knowledge about the determinants of disease and effective interventions for prevention and treatment. It will also require improved access for all to the resources that influence health. Reaching this goal will necessitate improved collection and use of standardized data to correctly identify all high-risk populations and monitor the effectiveness of health interventions targeting these groups. Research dedicated to a better understanding of the relationships between health status and income, education, race and ethnicity, cultural influences, environment, and access to quality medical services will help us acquire new insights into eliminating the disparities and developing new ways to apply our existing knowledge toward this goal. Improving access to quality health care and the delivery of preventive and treatment services will require working more closely with communities to identify culturally sensitive implementation strategies.
While the nation has made remarkable progress in understanding the causes and risks for developing diseases that have important implications for the health of all Americans, the health status of the nation's minority and poor lag considerably behind that of White Americans. The contributing factors for many disparities include inadequate family incomes, lack of access to medical care, and environmental hazards. The greatest opportunities for improvement and the greatest threats to the future health status of the Nation reside in the population groups that have historically been disadvantaged economically, educationally and politically. In partnering with different racial and ethnic groups, the CDC can work closely with institutions, organizations, and communities to help eliminate disparities in health while meeting the goals of “Healthy People 2010”.
Assistance will be provided only to the Minority Health Professions Foundation (MHPF). No other applications are solicited.
The MHPF is the most appropriate and qualified organization to provide services specified under this cooperative agreement because:
1. The MHPF is dedicated to supporting the organizational growth of minority health professional schools to ensure the advancement of specific research in minority health, the education and professional development of minority health care professionals and educators, and the continuing provision of health services in minority and poor communities;
2. The MHPF represents twelve member institutions which include medical, dental, pharmacy, and veterinary medicine schools in historically African-American colleges and universities. Collectively, these institutions have trained one out of every two African American physicians, dentists, and pharmacists; and three out of every four African American veterinarians. The member institutions have also trained a substantial number of other minority and non-minority health professionals;
3. The MHPF member institutions are comprised of the Historically Black Colleges and Universities (HBCUs) that not only house the health professions schools, but three of which house schools of public health;
4. The primary objective of the MHPF and the nine Historically Black Colleges and Universities is to address the health needs of African American and other minority population groups;
5. The MHPF institutional members have significantly fostered and advanced dramatic growth and expansion of its member institution's collaborative efforts, bolstered and supported considerable increase in public health, medical and scientific research, and assisted in amplifying minority health community education and outreach nationally;
6. The MHPF and its member schools have the capacity to conduct basic sciences and clinical research, and are attacking the various diseases and conditions that disproportionately
7. The MHPF member institutions were founded specifically to improve the health status of medically underserved African Americans and other ethnic minority groups, and play a critical role in building the nation's health care workforce.
Approximately $200,000 is available in FY 2000 to fund this cooperative agreement. Sub-awards will be funded through CDC and ATSDR. A cumulative award of approximately $2,000,000 to the MHPF is expected during FY 2000. Subawards will range from $25,000 to $450,000. It is expected that the awards will begin on September 30, 2000. Funding estimates may vary and are subject to change. Continuation awards within the project period will be made on the basis of satisfactory progress and the availability of funds.
Applications that exceed the funding cap of $450,000 will be excluded from the competition and returned to the applicant.
A complete program description and information on application procedures are contained in the application package. Business management technical assistance may be obtained from Sheri Disler, Senior Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road, Room 3000, MS E-15, Koger Center, Colgate Building, Atlanta, Georgia 30341-3724. Telephone 770-488-2756. E-mail address sjd9@cdc.gov.
Program technical assistance may be obtained from Karen E. Harris, Senior Advisor for Research Projects, Office of the Associate Director for Minority Health, Office of the Director, Centers for Disease Control and Prevention, 1600 Clifton Road, Northeast, Mailstop D-39, Atlanta, Georgia 30333. Telephone (404) 639-4313, E-mail address keh2@cdc.gov.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Submit written comments on the collection of information by July 31, 2000.
Submit written comments on the collection of information to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Wendy Taylor, Desk Officer for FDA.
JonnaLynn P. Capezutto, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Section 801 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 381) charges FDA with the following responsibilities: (1) Ensuring that foreign-origin FDA-regulated foods, drugs, cosmetics, medical devices, and radiological health products offered for import into the United States meet the same requirements of the act as do domestic products; and (2) preventing shipments from entering the country if they are not in compliance.
The information collected by FDA consists of the following: (1) Product code, an alpha-numeric series of characters that identifies each product FDA regulates; (2) FDA country of origin, the country where the FDA-registered or FDA-responsible firm is located; (3) FDA manufacturer, the party who manufactured, grew, assembled, or otherwise processed the goods (if more than one, the last party who substantially transformed the product); (4) shipper, the party responsible for packing, consolidating, or arranging the shipment of the goods to their final destination; (5) quantity and value of the shipment; and (6) if appropriate, affirmation of compliance, a code that conveys specific FDA information, such as registration number, foreign government certification, etc. This information is collected electronically by the entry filer via the U.S. Customs Service's Automated Commercial System at the same time he/she files an entry for import with the U.S. Customs Service. FDA uses the information to make admissibility decisions about FDA-regulated products offered for import into the United States.
The annual reporting burden is derived from the basic processes and procedures used in fiscal year (FY) 1995. The total number of entries submitted to the automated system in FY 1999 was 5,077,493. The total number of entries less the disclaimer entries will represent the total FDA products entered into the automated system. A total of 51 percent of all entries entered into the automated system were entries dealing with FDA-regulated products. The number of respondents is a count of filers who submit entry data for foreign-origin FDA-regulated products. The estimated reporting burden is based on information obtained by FDA contacting some potential respondents. Disclaimer entries are not FDA commodities.
FDA estimates the burden of this collection of information as follows:
In the
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Submit written comments on the collection of information by July 31, 2000.
Submit written comments on the collection of information to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Wendy Taylor, Desk Officer for FDA.
Karen L. Nelson, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482.
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
FDA is requesting OMB approval for the reporting requirements contained in FDA's regulation “Environmental Impact Considerations” (part 25).
The National Environmental Policy Act (NEPA) (42 U.S.C. 4321-4347) states national environmental objectives and imposes upon each Federal agency the duty to consider the environmental effects of its actions. Section 102(2)(C) of NEPA requires the preparation of an environmental impact statement (EIS) for every major Federal action that will significantly affect the quality of the human environment.
FDA's NEPA regulations are at part 25. All applications or petitions requesting agency action require the submission of an Environmental Assessment (EA) or a claim of categorical exclusion. Section 25.15(a) and (d) specify the procedures for submitting to FDA a claim for a categorical exclusion (certain classes of FDA-regulated actions have little or no potential to cause significant environmental effects and are excluded from the requirements to prepare an EA or EIS). Section 25.40(a) and (c) specify the content requirements for EA's for nonexcluded actions.
This collection of information is used by FDA to assess the environmental impact of agency actions and to ensure that the public is informed of environmental analyses. Firms wishing to manufacture and market substances regulated under statutes for which FDA is responsible must, in most instances, submit applications requesting approval. Environmental information must be included in such applications (when not eligible for categorical exclusion) for the purpose of determining whether the proposed action may have a significant impact on the environment. Where significant adverse effects cannot be avoided, the agency uses the submitted information as the basis for preparing and circulating to the public an EIS, made available through a
Under 21 CFR 312.23(a)(7)(iv)(
Under 21 CFR 71.1, 170.39, and 171.1, food additive petitions, color additive petitions, and requests for exemption from regulation as a food additive must contain a claim of categorical exclusion under § 25.30 or § 25.32 or an EA under § 25.40. In 1998, FDA received 57 food additive petitions, 9 color additive petitions, and 26 threshold of regulation exemption requests. FDA estimates that it received approximately 80 claims of categorical exclusions as required under § 25.15(a) and (d), and 12 EA's as required under § 25.40(a) and (c). FDA estimates that it takes petitioners or requesters approximately 8 hours to prepare a claim of categorical exclusion and approximately 210 hours to prepare an EA.
The Food and Drug Administration Modernization Act of 1997 (Public Law 105-115) amended section 409 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348) to establish a premarket notification process as the primary method for authorizing a new use of a food additive that is a food contact substance. Section 409(h)(6) of the act defines a food contact substance as any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in food. Under the notification process, FDA must be notified at least 120 days prior to the marketing of a food contact substance. If FDA does not object within 120 days to the use of a food contact substance that is the subject of a notification, the substance may be legally marketed for the notified use. FDA expects that the majority of new uses of food contact substances that will be the subject of premarket notifications would previously have been regulated under the food additive petition process or exempted from the requirement of a regulation under the threshold of regulation process. FDA has provided in a separate
Under 21 CFR part 814, premarket approvals (original PMA's and supplementals) must contain a claim for categorical exclusion under § 25.30 or § 25.31 or an EA under § 25.40. In 1998, FDA received 568 claims (original PMA's and supplementals) for categorical exclusions as required under § 25.15(a) and (d), and 0 (zero) EA's as required under § 25.40(a) and (c). Based on information provided by less than 10 sponsors, FDA estimates that it takes approximately less than 1 hour to prepare a claim for a categorical exclusion and an unknown number of hours to prepare an EA.
Under 21 CFR 312(a)(7)(iv)(
FDA estimates that it receives approximately 660 claims for categorical exclusion as required under § 25.15(a) and (d), and 2 EA's as required under § 25.40(a) and (c). Based on information provided by industry, FDA estimates that it takes sponsors and applicants approximately 8 hours to prepare a claim for categorical exclusion and approximately 3,400 hours to prepare an EA.
Under 21 CFR 514.1(b)(14) new animal drug applications (NADA's) and abbreviated new animal drug application (ANADA), 514.8(a)(1) supplemental NADA's and ANADA's, 511.1(b)(10) investigational new animal drug applications, 570.35(c)(1)(viii) generally recognized as safe, affirmation petitions, and 571.1(c) food additive petitions must contain a claim for categorical exclusion under § 25.30 or § 25.31 or an EA under § 25.40. Since the last OMB approval of the subject collections of information, the Center for Veterinary Medicine has received approximately 545 claims for categorical exclusions as required under § 25.15(a) and (d), and 32 EA's as required under § 25.40(a) and (c). Based on information provided by industry, FDA estimates that it takes sponsors/applicants approximately 8 hours to prepare a claim for a categorical exclusion and approximately 2,160 hours to prepare an EA.
Based on information provided by industry, FDA estimates that the combined burden for the Environmental Impact Considerations—Part 25 are as follows:
In the
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.
FDA regrets that it was unable to publish this notice 15 days prior to the July 13 and 14, 2000, Pharmacy Compounding Advisory Committee meeting. Because the agency believes there is some urgency to bring these issues to public discussion and qualified members of the Pharmacy Compounding Advisory Compounding Advisory Committee meeting were available at this time, the Commissioner of Food and Drugs concluded that it was in the public interest to hold this meeting even if there was not sufficient time for the customary 15-day public notice.
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 announcing the availability of the draft guidance for industry (#86) entitled “How to Use E-Mail to Submit a Notice of Final Disposition of Animals Not Intended for Immediate Slaughter” in the Center for Veterinary Medicine (CVM). This draft guidance is neither final nor is it in effect at this time. The draft guidance document is intended to provide guidance to new animal drug sponsors (sponsors) on how to submit a notice of final disposition of animals not intended for immediate slaughter (NFDA) as an e-mail attachment by Internet. These electronic submissions are part of CVM's ongoing initiative to provide a method for paperless submissions. This draft guidance implements provisions of the Government Paperwork Elimination Act (GPEA).
Submit written comments on the draft guidance at any time, however, comments should be submitted by August 28, 2000 to ensure their adequate consideration in preparation of the final document. Submit written comments on the information collection requirements by August 28, 2000.
Submit written comments on the draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with the full title of the draft guidance document and the docket number found in brackets in the heading of this document.
Copies of the draft guidance document entitled “How to Use E-Mail to Submit a Notice of Final Disposition of Animals Not Intended for Immediate Slaughter” may be obtained on the
Submit written comments on the collection of information requirements to the Dockets Management Branch (address above). Comments should be identified with the docket number found in brackets in the heading of this document.
Janis R. Messenheimer, Center for Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7578, e-mail: jmessenh@cvm.fda.gov.
In the
The electronic submission of NFDA's is part of CVM's ongoing initiative to provide a method for paperless submissions. It reflects the principles behind the GPEA. The GPEA of 1998 (Public Law 105-277) requires Federal agencies, by October 21, 2003, to provide: (1) For the option of the electronic maintenance, submission, or disclosure of information, if practicable, as a substitute for paper; and (2) for the use and acceptance of electronic signatures, when practicable.
In order to submit NFDA's by e-mail, sponsors should first register and follow the instructions in draft guidance for industry (#108) entitled “How to Use E-Mail to Submit Information to the Center for Veterinary Medicine” when it becomes final.
CVM monitors the final disposition of food animals treated with investigational new animal drugs in situations where the treated animals do not enter the human food chain immediately at the completion of the investigational study. Monitoring of the final disposition of such food animals is consistent with its responsibility to protect the public health under the Federal Food, Drug, and Cosmetic Act (the act). In addition, acceptable standards of study conduct such as those set out in § 514.117 (21 CFR 514.117) would include sponsors accounting for the disposition of all animals treated with investigational new animal drugs. Furthermore, CVM requests this information because some animals are held for 30 days after the investigational drug withdrawal period ends and CVM does not request a notice of intent to slaughter for human food purposes for these animals. Animals held for this period may still be sent for slaughter, however. CVM issues a slaughter authorization letter to investigational new animal drug sponsors that sets the terms under which animals treated with investigational new animal drugs may be slaughtered (§ 511.1(b)(5) (21 CFR 511.1(b)(5))). Also in this letter, CVM requests that sponsors submit NFDA's for animals that are treated with investigational new animal drugs and are not intended for immediate slaughter. NFDA's have historically been submitted to CVM on paper. This draft guidance will give sponsors the option to submit an NFDA as an e-mail attachment to CVM via the Internet.
This Level 1 draft guidance is being issued consistent with FDA's good guidance practices (62 FR 8961, February 27, 1997). The draft guidance represents the agency's current thinking about using e-mail to submit an NFDA. It does not create or confer any rights for or on any person and will not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes, regulations, or both.
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA'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 respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
The draft guidance document describes the procedures for persons who are sponsors of new animal drugs who wish to file an NFDA electronically on FDA Form #3487. The information sponsors should include on the form includes the sponsor's name and
FDA estimates the burden of this collection of information as follows:
The estimates in Table 1 of this document resulted from discussions with new animal drug sponsors. The estimated burden includes NFDA's submitted on paper and by e-mail.
This draft guidance document is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Dockets Management Branch (address above) written comments regarding this draft guidance document. Submit written comments by August 28, 2000, to ensure adequate consideration in preparation of the final document. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document.
Submit written comments concerning the information collection requirements to the Dockets Management Branch by August 28, 2000. A copy of the document and received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry (#87) entitled “How to Use E-Mail to Submit a Notice of Intent to Slaughter for Human Food Purposes” in the Center for Veterinary Medicine (CVM) and U.S. Department of Agriculture (USDA). This draft guidance is neither final nor is it in effect at this time. The purpose of this draft guidance document is to provide guidance to new animal drug sponsors (sponsors) on how to submit a notice of intent to slaughter for human food purposes (slaughter notices) as an e-mail attachment by Internet. This electronic submission is part of CVM's ongoing initiative to provide a method for paperless submissions. This draft guidance implements provisions of the Government Paperwork Elimination Act (GPEA).
Submit written comments on the draft guidance at any time, however, comments should be submitted by August 28, 2000 to ensure their adequate consideration in preparation of the final document. Submit written comments on the collection of information requirements by August 28, 2000.
Submit written comments on the draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with the full title of the draft guidance and the docket number found in brackets in the heading of this document.
Copies of the draft guidance document entitled “How to Use E-Mail to Submit a Notice of Intent to Slaughter for Human Food Purposes” may be obtained on the Internet from the CVM home page at http://www.fda.gov/cvm. Persons without Internet access may submit written requests for single copies of the draft guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests.
Submit written comments on the collection of information requirements to the Dockets Management Branch (address above). Comments should be identified with the docket number found in brackets in the heading of this document.
Janis R. Messenheimer, Center for Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7578, e-mail: jmessenh@cvm.fda.gov.
In the
The electronic submission of slaughter notices is part of CVM's ongoing initiative to provide a method for paperless submissions. The draft guidance implements provisions of the GPEA. The GPEA of 1998 (Public Law 105-277) requires Federal agencies, by October 21, 2003, to provide for: (1) The option of the electronic maintenance, submission, or disclosure of information, if practicable, as a substitute for paper; and (2) the use and acceptance of electronic signatures, when practicable. In order to submit slaughter notices by e-mail, sponsors should first register and follow the instructions in draft guidance for industry (#108) “How to Use E-Mail to Submit Information to the Center for
Section 512(j) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(j)) gives FDA the authority to issue regulations setting out conditions for marketing animals treated with investigational new animal drugs for food use. Under this authority, FDA issued § 511.1(b)(4) (21 CFR 511.1(b)(4)) that requires that sponsor obtain authorization to slaughter these animals for food. Under § 511.1(b)(5), CVM issues a slaughter authorization letter to sponsors that sets the terms under which the animals treated with investigational new animal drugs may be slaughtered. USDA also monitors the slaughter of animals treated with investigational new animal drugs under the authority of the Meat Inspection Act (21 U.S.C. 601-95). To assist CVM and USDA with this monitoring, the slaughter authorization states that sponsors must submit slaughter notices each time such animals are to be slaughtered unless CVM waives the notice in the authorization letter. Currently, slaughter notices are submitted to CVM on paper. This guidance will give sponsors the option to submit a slaughter notice as an e-mail attachment to CVM and USDA by the Internet.
This Level 1 draft guidance is being issued consistent with FDA's good guidance practices (62 FR 8961, February 27, 1997). The draft guidance represents the agency's current thinking about using e-mail to submit a slaughter notice. It does not create or confer any rights for or on any person and will not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA'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 respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
The draft guidance describes the procedures for persons who are sponsors of new animal drugs and who wish to file a slaughter notice on FDA Form No. 3488 by e-mail. The information that should be filed on the form includes: Identify the sponsor, the animals to be slaughtered, and the compound used to treat the animals. The likely respondents to this collection of information are sponsors who have conducted clinical investigations under § 511.1(b).
FDA estimates the burden of this collection of information as follows:
Submitting a slaughter notice electronically represents a new medium for submission of information currently submitted on paper. The reporting burden for compilation and submission of this information on paper is included in OMB clearance of the information collection provisions of § 511.1 (OMB Control No. 0910-0117). The estimates in table 1 of this document reflect the burden associated with putting the same information on FDA Form No. 3488 and resulted from discussions with sponsors about the time necessary to complete this form.
This draft guidance document is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Dockets Management Branch (address above) written comments regarding this draft guidance. Submit written comments by August 28, 2000, to ensure adequate consideration in preparation of the final guidance. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Written comments concerning the information collection requirements must be received by August 28, 2000. A copy of the draft guidance and received comments are available for public examination in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry (#88) entitled “How to Use E-Mail to Submit a Request for a Meeting or Teleconference to the Office of New Animal Drug Evaluation” in the Center for Veterinary Medicine (CVM). This draft guidance is neither final nor is it in effect at this time. The purpose of this draft guidance document is to provide guidance to new animal drug sponsors (sponsors) on how to submit a request for a meeting or teleconference about a new animal drug submission as an e-mail attachment by Internet. These electronic submissions are part of CVM's ongoing initiative to provide a method for paperless submissions. This draft guidance implements provisions of the Government Paperwork Elimination Act (GPEA).
Submit written comments on the draft guidance at any time, however, comments should be submitted by August 28, 2000, to ensure their adequate consideration in preparation of the final document. Submit written comments on the collection of information requirements by August 28, 2000.
Submit written comments on the draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with the full title of the draft guidance and the docket number found in brackets in the heading of this document.
Copies of the draft guidance document entitled “How to Use E-Mail to Submit a Request for a Meeting or Teleconference to the Office of New Animal Drug Evaluation” may be obtained on the Internet from the CVM home page at http://www.fda.gov/cvm/. Persons without Internet access may submit written requests for single copies of the draft guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests.
Submit written comments on the collection of information requirements to the Dockets Management Branch (address above). Comments should be identified with the docket number found in brackets in the heading of this document.
Janis R. Messenheimer, Center for Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7578, e-mail: jmessenh@cvm.fda.gov.
In the
The electronic submission of requests for meetings and teleconferences is part of CVM's ongoing initiative to provide a method for paperless submissions. The draft guidance implements provisions of the GPEA. The GPEA of 1998 (Public Law 105-277) requires Federal agencies, by October 21, 2003, to provide for: (1) The option of the electronic maintenance, submission, or disclosure of information, if practicable, as a substitute for paper; and (2) the use and acceptance of electronic signatures, when practicable.
In order to submit requests for meetings or teleconferences by e-mail, sponsors should first register and follow the instructions in draft guidance for industry (#108) “How to Use E-Mail to Submit Information to CVM” when it becomes final.
On request, CVM will hold meetings and/or teleconferences to assist sponsors with new animal drug submissions and general questions. Currently, meeting and teleconference requests are submitted to CVM on paper. CVM would like to allow sponsors to request meetings and teleconferences in a manner more efficient and time saving to them. This draft guidance will give sponsors the option to submit a request for a meeting or teleconference as an e-mail attachment by the Internet.
This Level 1 draft guidance is being issued consistent with FDA's good guidance practices (62 FR 8961, February 27, 1997). The draft guidance represents the agency's current thinking on submitting a request for a meeting or teleconference about new animal drug submissions by e-mail. It does not create or confer any rights for or on any person and will not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA'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 respondents, including through the use of automated collection techniques,
This draft guidance describes the procedure for persons who are new animal drug sponsors to submit a request for a meeting or teleconference to the Office of New Animal Drug Evaluation by e-mail on FDA Form No. 3489. The information of the sponsors should include on the form: The sponsor's name and address, a list of requested participants, an indication of audio-visual needs, and an agenda. The likely respondents to this collection of information are sponsors who will be conducting clinical investigations under 21 CFR 511.1(b).
FDA estimates the burden of this collection of information as follows:
The estimates in table 1 of this document resulted from discussions with new animal drug sponsors. The estimated burden includes requests for meetings or teleconferences submitted by e-mail and on paper.
This draft guidance document is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Dockets Management Branch (address above) written comments regarding this draft guidance document. Submit written comments by August 28, 2000, to ensure adequate consideration in preparation of the final guidance. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Written comments concerning the information collection requirements must be received by August 28, 2000. A copy of the draft guidance and received comments are available for public examination in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry (#108) entitled “How to Use E-Mail to Submit Information to the Center for Veterinary Medicine.” This draft guidance is neither final nor is it in effect at this time. The draft guidance document is intended to provide guidance on how to submit information to the Center for Veterinary Medicine (CVM) as an e-mail attachment by Internet. These electronic submissions are part of CVM's ongoing initiative to provide a method for paperless submissions. This draft guidance implements provisions of the Government Paperwork Elimination Act (GPEA).
Submit written comments on the draft guidance at any time, however, comments should be submitted by August 28, 2000, to ensure their adequate consideration in preparation of the final document. Submit written comments on the information collection requirements by August 28, 2000.
Submit written comments on the draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with the full title of the draft guidance document and the docket number found in brackets in the heading of this document.
Copies of the draft guidance document entitled “How to Use E-Mail to Submit Information to the Center for Veterinary Medicine” may be obtained on the Internet from the CVM home page at http://www.fda.gov/cvm/. Persons without Internet access may submit written requests for single copies of the draft guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests.
Submit written comments on the collection of information requirements to the Dockets Management Branch (address above). Comments should be identified with the docket number found in brackets in the heading of this document.
Janis R. Messenheimer, Center for Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7578, e-mail: jmessenh@cvm.fda.gov.
In the
CVM accepts certain types of submissions by e-mail with no requirement for a paper copy. These types of documents are listed in public docket number 92S-0251 as required by § 11.2. CVM's ability to receive and process information submitted electronically is limited by its current information technology capabilities and the requirements of the electronic records and electronic signatures regulation. This guidance outlines general standards which should be used for the submission of any information by e-mail.
This Level 1 draft guidance is being issued consistent with FDA's good guidance practices (62 FR 8961, February 27, 1997). The draft guidance represent's the agency's current thinking about using e-mail to submit information electronically. It does not create or confer any rights for or on any person and will not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulation, or both.
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA'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 respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
The draft guidance document describes the procedures for persons who are sponsors of new animal drugs who wish to file submissions by e-mail. The draft guidance instructs those who wish to submit information to CVM by e-mail to first register with them. Registration entails sending a letter to CVM with a sponsor password and the names, phone numbers, and mail and e-mail addresses of a sponsor coordinator and any person who will submit information electronically to CVM. This letter is sent on paper and electronically. Other information collection provisions described in the guidance are the submission of e-mails with the individual passwords of those who submit information electronically and e-mails with any changes to the sponsor's registration. CVM will use all the information submitted to process electronic submissions.
FDA estimates the burden of this collection of information as follows:
The estimates in table 1 of this document resulted from discussions with new animal drug sponsors.
The draft guidance document is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Dockets Management Branch (address above) written comments regarding this draft guidance document. Submit written comments by August 28, 2000, to ensure adequate consideration in preparation of the final document. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document.
Submit written comments concerning the information collection requirements to the Dockets Management Branch by August 28, 2000. A copy of the document and received comments are available for public examination in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Health Care Financing Administration, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Health Care Financing Administration (HCFA), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
We are, however, requesting an emergency review of the Information collections referenced below. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted to the Office of Management and Budget (OMB) the following requirements for emergency review. We are requesting an emergency review because the collection of this information is needed prior to the expiration of the normal time limits under OMB's regulations at 5 CFR part 1320. This collection of information will be used to test the effectiveness of three possible Medicare smoking cessation benefits and to make inferences that are generalizable to the Medicare program. Using a comparison trial with restricted randomization of study locales, this study will compare three variations in a potential Medicare smoking cessation benefit on smoking cessation and abstinence rates. Smoking cessation for seniors is currently receiving attention from Congress and the White House. Senator Graham (D-FL) has proposed a smoking cessation Medicare benefit, while the White House provides for a smoking cessation demonstration in the
HCFA is requesting OMB review and approval of this collection by July 5, 2000, with a 180-day approval period. Written comments and recommendations will be accepted from the public if received by the individuals designated below by July 3, 2000. During this 180-day period, we will publish a separate
To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access HCFA's Web Site address at http://www.hcfa.gov/regs/prdact95.htm, or E-mail your request, including your address, phone number, to Paperwork@hcfa.gov, or call the Reports Clearance Office on (410) 786-1326.
Interested persons are invited to send comments regarding the burden or any other aspect of these collections of Information requirements. However, as noted above, comments on these Information collection and recordkeeping requirements must be mailed and/or faxed to the designees referenced below, by July 3, 2000: Health Care Financing Administration, Office of Information Services, Security and Standards Group, Division of HCFA Enterprise Standards Attention: Dawn Willinghan, Room N2-14-26, 7500 Security Boulevard, Baltimore, Maryland 21244-1850; and
Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503, Fax Number: (202) 395-6974 or (202) 395-5167, Attn: Allison Herron Eydt, HCFA Desk Officer.
Health Care Financing Administration, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Health Care Financing Administration (HCFA), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send
To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access HCFA's Web Site address at http://www.hcfa.gov/regs/prdact95.htm, or E-mail your request, including your address, phone number, OMB number, and HCFA document identifier, to Paperwork@hcfa.gov, or call the Reports Clearance Office on (410) 786-1326. Written comments and recommendations for the proposed information collections must be mailed within 60 days of this notice directly to the HCFA Paperwork Clearance Officer designated at the following address: HCFA, Office of Information Services, Security and Standards Group, Division of HCFA Enterprise Standards, Attention: Dawn Willinghan, Room N2-14-26, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
Health Care Financing Administration (HCFA), HHS.
Notice.
This notice announces that 30 days after the publication of the Medicare+Choice (M+C) final rule, we will begin to accept applications from private accrediting organizations who seek M+C deeming authority.
This notice is effective on July 31, 2000.
Patricia Kurtz, (410) 786-4670.
Section 4001 of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33), enacted on August 5, 1987, added section 1852(e)(4) to the Social Security Act (the Act), which gives us the authority to determine that a Medicare+Choice Organization (M+CO) is “deemed” to be in compliance with certain Medicare requirements if the M+CO has been accredited (and is periodically reaccredited) by an accrediting organization that we have determined applies and enforces requirements at least as stringent as those the M+CO would be deemed to meet. Section 518 of the Balance Budget Refinement Act of 1999 (BBRA) (Pub. L. 106-113), enacted on November 29, 1999, amended section 1852(e)(4) of the Act to expand the scope of deeming from two to six areas. Accrediting organizations may seek authority for any of the categories. The BBRA specified that we cannot require an accrediting entity to be able to certify plans for all the deeming categories. It also required us to determine, within 210 days from the day the application is determined to be complete, the eligibilty of the accrediting organizations to be granted deeming authority. Conditions and procedures for granting deeming authority to accrediting organizations are outlined in § 422.157 and § 422.158 of title 42 of the Code of Federal Regulations.
This notice announces that 30 days after the publication of the M+C final rule, we will begin to accept applications from national private accrediting organizations who seek M+C deeming authority. To receive an application packet, please contact Patricia Kurtz at (410) 786-4670 or via e-mail at pkurtz@hcfa.gov or mail your inquires to: Patricia Kurtz, Health Care Financing Administration, Health Plan Administration Group, Room C4-24-04, 7500 Security Blvd., Baltimore, MD. 21244.
Section 1852(e)(4) of the Social Security Act (42 U.S.C. 1395w-22(e)(4)) (Catalog of Federal Domestic Assistance Program No. 93.773 Medicare—Hospital Insurance Program; and No. 93.774, Medicare—Supplementary Medical Insurance Program)
Bureau of Indian Affairs, DOI and Indian Health Service, DHHS.
30-Day Notice of Submission to OMB.
The Department of the Interior and the Department of Health and Human Services announce submission to the Office of Management and Budget (OMB) of a request for reinstatement of information collection, OMB #1076-0136, “Indian Self-Determination and Education Assistance Act Programs.” The information collection will be used to process contracts, grants or cooperative agreements for award by the Bureau of Indian Affairs and the Indian Health Service as authorized by the Indian Self-Determination and Education Assistance Act as amended and set forth
Interested persons are invited to submit comments on or before July 31, 2000.
If you wish to comment, you may submit your comments to Attn: Desk Officer for Department of the Interior, Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW, Washington, DC 20503. Please send copy of comments to James Thomas, Office of Tribal Services, Bureau of Indian Affairs, Department of the Interior, 1849 C Street NW, MS 4660 MIB, Washington, DC 20240.
James Thomas, Office of Tribal Services, Bureau of Indian Affairs, Department of the Interior, 1849 C Street NW, MS 4660 MIB, Washington, DC 20240, or (202) 208-5727.
Representatives of the Department of the Interior, the Department of Health and Human Services and the tribes developed a joint rule, 25 CFR part 900, to implement section 107 of the Indian Self-Determination and Education Assistance Act, as amended by, Public Law 103-413, the Indian Self-Determination Contract Reform Act of 1994. Section 107(a)(2)(A)(ii) of the Indian Self-Determination Contract Reform Act requires the joint rule to permit contracts and grants be awarded to Indian tribes without the unnecessary burden or confusion associated with two sets of rules and information collection requirements when there is a single program legislation involved. The burden hours for this collection have been reduced as a result of tribes contracting multiple programs under a single contract, as authorized under 25 CFR 900.8, tribes administering ‘mature’ contracts which require fewer reports and, tribes entering into Self-Governance ‘compacts,’ under which Self-Governance tribes may combine all programs under a single self-governance compact.
The information requirements for this joint rule represent significant differences from other agencies in several respects. Both the Bureau of Indian Affairs and the Indian Health Service let contracts for multiple programs whereas other agencies usually award single grants to tribes. Under the Indian Self-Determination and Education Assistance Act, as amended by the Indian Self-Determination Contract Reform Act of 1994, tribes are entitled to contract and may renew contracts annually where other agencies provide grants on a discretionary/competitive basis.
The proposal and other supporting documentation identified in this information collection is used by the Department of the Interior and the Department of Health and Human Services to determine applicant eligibility, evaluate applicant capabilities, protect the service population, safeguard Federal funds and other resources, and permit the Federal agencies to administer and evaluate contract programs. Tribal governments or tribal organizations provide the information by submitting Public Law 93-638 contract or grant proposals to the appropriate Federal agency. No third party notification or public disclosure burden is associated with this collection.
Please submit any comments to the contact in the
Fish and Wildlife Service, Interior.
Notice.
We have submitted the information collection requirements to renew approval of the collection of information for special use permit applications on national wildlife refuges in Alaska to OMB for approval under the provisions of the Paperwork Reduction Act of 1995.
Submit comments on or before July 31, 2000.
Send comments and suggestions on specific requirements directly to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention: Department of the Interior Desk Officer, 725 17th Street, NW, Washington, DC
Leslie Marler, Management Analyst, Branch of Policy and Planning, Division of Refuges, (703) 358-2397; or Tony Booth, Refuge Program Specialist, Division of Refuges, Anchorage, AK (907) 786-3384.
We submitted the following proposed information collection clearance requirement to OMB for review and approval under the Paperwork Reduction Act of 1995 (Pub. L. 104-13). OMB has up to 60 days to approve or disapprove information collection. To ensure maximum consideration, OMB should receive public comments by July 31, 2000. We may not conduct or sponsor a collection of information, and a person is not required to respond to a request for information unless it displays a currently valid OMB control number. We previously published a 60-day notice inviting public comment on this information collection in the
We invite comments on: (1) 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; (2) the accuracy of the agency's estimate of burden, 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.
The National Wildlife Refuge System Improvement Act of 1997 (Pub. L. 105-57) that amends the National Wildlife Refuge Administration Act of 1966 (16 U.S.C. 668 dd-ee) requires that we authorize economic or other special privileges on any national wildlife refuge by permit only when we determine the activity will be compatible with the purposes for which the refuge was established and the mission of the National Wildlife Refuge System. The Alaska National Interest Lands Conservation Act (ANILCA) (16 U.S.C. 3101
We will provide the permit applications as requested by interested Alaska citizens. We will use information provided on the required written forms and/or verbal applications to determine if the proposed activity is compatible with refuge purposes and ensure that the applicant is eligible for a permit. In the case of competitively awarded permits, we will use the information to determine the most qualified applicant to receive benefits of a refuge permit. In the case of “1307” permits, we will use the information to determine whether the applicant is: A member of a Native Corporation; a local resident; engaged in adequately providing visitors services on or before January 1, 1979; or eligible to receive Cook Inlet Region rights.
We make provision in our general refuge regulations for public entry for specialized purposes, including economic activities such as the operation of guiding and other visitor services on refuges by concessionaires or cooperators under appropriate contracts or legal agreements (found in 50 CFR 25.61) or special use permits (found in 50 CFR 26.22(b), 26.25, 36.37, and 36.41). These rules provide the authorities and procedures for selecting permittees on Alaska refuges, the vast majority of which are providers of services and facilities to the public. We will issue permits for a specific period as determined by the type and location of the use or visitor service provided.
We are making several minor modifications to the Special Use Permit application form:
1. On page one, Part 1 of the form, we changed cc:mail address to e-mail address.
2. On page two, Part 2 of the form, we eliminated Aleutian Islands Unit/Alaska Maritime NWR from the list of National Wildlife Refuge Code Acronyms because there is no need for separate entry for the Aleutian Islands Unit of the refuge.
3. On page two, Part 2 of the form, we also revised the list of Activity Codes to provide more effective and clearer identification of the types of commercial visitor service uses that we most commonly permit on Alaska refuges. We changed the activity codes from two-letter codes to three-letter codes.
4. On page three, Part 4 of the form, we revised the instructions that state, “List the MAKE, MODEL, WHEEL/FLOAT/SKI, COLOR and TAIL NUMBER of all the aircraft you own/lease/operate:” We added to this statement the phrase, “* * * that you will use in your proposed activity:” to clarify that we only need information about aircraft the applicant will use for activities permitted on the refuge.
5. In addition to the revisions identified above, we made several minor editorial changes on the application form for clarification and plain language requirements. The editorial revisions do not affect information requirements of the application.
Notice of Receipt of Applications.
The following applicants have applied for a permit to conduct certain activities with endangered species. This notice is provided pursuant to section 10(a) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531,
Applicant: Bureau of Land Management, Lake Havasu City, Arizona.
Applicant requests authorization for recovery purposes to conduct activities for the southwestern willow flycatcher (
Applicant: Aaron D. Flesch, Tucson, Arizona.
Applicant requests authorization for recovery purposes to conduct presence/absence surveys for the southwestern willow flycatcher (
Applicant: John A. Kugler, Sonoita, Arizona.
Applicant requests authorization for recovery purposes to conduct presence/absence surveys for the Gila topminnow (
Applicant: Bureau of Land Management, Arizona Strip Field Office, St. George, Utah.
Applicant requests authorization for recovery purposes to conduct presence/absence surveys for the Mexican spotted owl (
Applicant: Jean Krejca, Austin, Texas.
Applicant requests authorization for scientific research and recovery purposes to collect the following endangered or threatened species in Texas:
The following species will not be collected but potentially impacted.
Applicant: Chris Thibodaux, Austin, Texas.
Applicant requests authorization for scientific research and recovery purposes to collect the following endangered or threatened species in Texas:
The following species will not be collected but potentially impacted.
Applicant: Arizona Department of Transportation—Environmental Planning Group, Phoenix, Arizona.
Applicant requests authorization for recovery purposes to conduct presence/absence surveys for the following endangered and threatened species in various counties in Arizona:
Written comments on these permit applications must be received on or before July 31, 2000.
Written data or comments should be submitted to the Legal Instruments Examiner, Division of Endangered Species/Permits, Ecological Services, P.O. Box 1306, Albuquerque, New Mexico 87103. Please refer to the respective permit number for each application when submitting comments. All comments received, including names and addresses, will become part of the official administrative record and may be made available to the public.
The U.S. Fish and Wildlife Service, Ecological Services, Division of Endangered Species/Permits, P.O. Box 1306, Albuquerque, New Mexico 87103. Please refer to the respective permit number for each application when requesting copies of documents. 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 within 30 days of the date of publication of this notice, to the address above.
The following applicants have applied for a permit to conduct certain activities with endangered species. This notice is provided pursuant to Section 10© of the Endangered Species Act of 1973,
The applicant requests a permit to import one captive-born male mandrill (
The applicant requests a permit to import the sport-hunted trophy of one male bontebok (
The applicant requests a permit to import the sport-hunted trophy of one male bontebok (
The applicant requests a permit to import the sport-hunted trophy of one male bontebok (
The applicant requests a permit to import the sport-hunted trophy of one male bontebok (
The applicant requests a permit to import three male and three female Chinese Dhole (
The applicant requests a permit to import two female Jaguars (
The applicant requests a permit to import a polar bear (
Written data or comments should be submitted to the Director, U.S. Fish and Wildlife Service, Office of Management Authority, 4401 North Fairfax Drive, Room 700, Arlington, Virginia 22203 and must be received by the Director within 30 days of the date of this publication.
Documents and other information submitted with these applications are available for review,
Bureau of Indian Affairs, Interior.
Notice.
The Bureau of Indian Affairs (BIA) is announcing that it will conduct tribal consultation meetings to obtain oral and written comments concerning potential issues in Indian Education Programs. This notice announces the dates and locations of the consultation meetings.
Written comments must be received on or before August 18, 2000. The consultation meetings will be held on July 11, 13, 18, 20, and 21, 2000. Several dates and locations were scheduled to coincide with meetings of various Indian education organizations. All meetings will begin at 9 a.m. and continue until 3 p.m. (local time) or until all meeting participants have had an opportunity to make comments.
Send written comments to the Bureau of Indian Affairs, Office of Indian Education Programs, Attention: Mr. William Mehojah, Jr., MS-3512-MIB, OIE-32, 1849 C Street, NW, Washington, DC 20240, or you may hand-deliver them to Room 3512 at the same address. Comments may also be telefaxed to 202-208-3312. See
Mr. Kenneth Whitehorn or Georgia Braun, 202-208-4976.
The meetings are a follow-up to similar meetings conducted by the Office of Indian Education Programs since 1990. The purpose of the consultation, as required by 25 U.S.C. 2010(b), is to provide Indian tribes, school boards, parents, Indian organizations, and other interested parties an opportunity to comment on potential issues raised during previous consultation meetings or issues being considered by the BIA regarding Indian education programs.
The potential issues which will be set forth in a tribal consultation booklet to be issued prior to the meetings are as follows:
(1) Charter Schools;
(2) Program Management Funding for Facilities;
(3) Transfer Facilities Construction Project Management Funds from the Office of Facilities Management and Construction to the Office of Indian Education Programs;
(4) Other Consultation Items;
(5) Form a Separate Rental Receipts Account in the Federal Finance System;
(6) “Open Season” for All New Facilities Space Activities;
(7) Comprehensive Federal Indian Draft Policy; and (8) Indian Student Equalization Program.
A consultation booklet for the July meetings is being distributed to federally-recognized Indian tribes, Bureau Regional and Agency Offices, and Bureau-funded schools. The booklets will also be available from local contact persons at each meeting.
We will hold consultations at the following locations on the dates specified:
Comments, including names, street addresses, and other contact information of respondents, will be available for public review at the address listed under
This notice is published in accordance with the authority delegated by the Secretary of the Interior to the Assistant Secretary—Indian Affairs by 209 DM 8.
Bureau of Land Management, Interior.
Notice of Availability (NOA) of Record of Decision.
The Bureau of Land Management (BLM) announces the availability of the Record of Decision (ROD) for the Environmental Impact Statement (EIS) for the Horse Creek Coal Lease Application. That EIS analyzes the potential impacts of leasing and mining Federal coal on lands in Campbell County, Wyoming. BLM's decision was to approve the Selected Alternative, which analyzed the impacts of offering for competitive lease sale approximately 2,819 acres containing approximately 356 million tons of in-place Federal coal.
BLM received 13 written comments during the two scoping periods on the Horse Creek lease application. These comments are on file in the Casper and Cheyenne offices of the BLM. Nine written comments were received on the draft EIS, and these were included, with written responses, in the final EIS. The transcript of the formal hearing is on file in the Casper and Cheyenne Offices of the BLM. One written comment was received on the final EIS. All comments that were received during the process were considered in the preparation of the draft and final EIS's, and in the ROD.
BLM NOAs for the draft EIS and for the final EIS for this project were published in the
The ROD was signed by the Associate State Director on June 23, 2000. Parties in interest have the right to appeal that decision pursuant to 43 CFR part 4, within 30 days from the date of publication of this NOA in the
Melvin Schlagel, 307-775-6257. Copies of the ROD may be obtained from the following BLM offices: Casper Field Office, 2987 Prospector Drive, Casper, Wyoming 82604, 307-261-7600 and Wyoming State Office, 5353 Yellowstone Road, Cheyenne, Wyoming 82009, 307-775-6256.
Bureau of Land Management, Interior.
Public Land Order.
This order opens, subject to the provisions of Section 24 of the Federal Power Act, 40 acres of public land withdrawn by an Executive order which established Bureau of Land Management Power Site Reserve No. 92. This action will permit consummation of a pending land exchange and retain the power rights to the United States. The land has been and will remain open to mineral leasing and, under the provisions of the Mining Claims Rights Restoration Act of 1955, to mining.
September 28, 2000.
Doris E. Chelius, BLM Colorado State Office, 2850 Youngfield Street, Lakewood, Colorado 80215-7093, 303-239-3706.
By virtue of the authority vested in the Secretary of the Interior by the Act of June 10, 1920, Section 24, as amended, 16 U.S.C. 818 (1994), and pursuant to the determination of the Federal Energy Regulatory Commission in DVCO-556-000, it is ordered as follows:
1. At 9 a.m. on September 28, 2000, the following described public land withdrawn by the Executive Order dated July 2, 1910, which established Power Site Reserve No. 92, will be opened to disposal subject to the provisions of Section 24 of the Federal Power Act as specified by the Federal Energy Regulatory Commission determination DVCO-556-000, and subject to valid existing rights, the provisions of existing withdrawals, other segregations of record, and the requirements of applicable law:
The area described contains 40 acres in Chaffee County.
2. The State of Colorado has a preference right for public highway rights-of-way or material sites for a period of 90 days from the date of publication of this order and any location, entry, selection, or subsequent patent shall be subject to any rights granted the State as provided by the Act of June 10, 1920, Section 24, as amended, 16 U.S.C. 818 (1994).
Bureau of Land Management, Interior.
Public land order.
This order withdraws 19.09 acres of public land from surface entry and mining for a period of 20 years to protect the Bureau of Land Management's Burley Administrative Site. The land has been and will remain open to mineral leasing.
June 29, 2000.
Jackie Simmons, BLM Idaho State Office, 1387 S. Vinnell Way, Boise, Idaho 83709, 208-373-3867.
By virtue of the authority vested in the Secretary of the Interior by Section 204 of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714 (1994), it is ordered as follows:
1. Subject to valid existing rights, the following described public land is hereby withdrawn from settlement, sale, location, or entry, under the general land laws, including the United States mining laws (30 U.S.C., Ch. 2 (1994)), but not from leasing under the mineral leasing laws, to protect the Bureau of Land Management's Burley Administrative Site:
A parcel of land lying in the E
Beginning at a point 1500.4 feet north and 33.0 feet west of the quarter section corner common to sec. 32, T. 10 S., R. 23 E., and sec. 5, T. 11 S., R. 23 E., said point being on the west right-of-way line of State Highway No. 27; thence N. 0°22′03″ E. along the highway right-of-way a distance of 515.12 feet; thence N. 89°27′57″ W. a distance 1184.19 feet to the centerline of the U.S.R.S. “H” Canal; thence S. 35°17′24″ W. along the canal centerline a distance of 80.64 feet; thence S. 21°20′41″ W. along the canal centerline a distance of 89.13 feet; thence S. 11°08′55″ W. along the canal centerline a distance of 221.23 feet to the west quarter section boundary of said sec. 23; thence S. 0°18′27″ E. along the quarter section boundary 501.81 feet; thence S.89°26′03″ E. a distance of 496.15 feet ; thence N. 0°36′56″ E. a distance of 355.45 feet; thence S.89°21′29″ E. a distance of 800 feet to the point of beginning.
The area described contains 19.09 acres, more or less, in Cassia County.
2. The withdrawal made by this order does not alter the applicability of those public land laws governing the use of the land under lease, license, or permit, or governing the disposal of the mineral or vegetable resources other than under the mining laws.
3. This withdrawal will expire 20 years from the effective date of this order, unless as a result of a review conducted before the expiration date pursuant to section 204(f) of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714(f) (1994), the Secretary determines that the withdrawal shall be extended.
Bureau of Land Management, Interior.
Public land order.
This order partially revokes two Secretarial orders insofar as they affect 7.5 acres of land withdrawn for use by the Bureau of Reclamation for the Minidoka Reclamation Project. The land is no longer needed for the purpose for which it was withdrawn. The land has been conveyed out of Federal ownership pursuant to Public Law 105-351. This action is for record clearing purposes only.
June 29, 2000.
Jackie Simmons, BLM Idaho State Office, 1387 S. Vinnell Way, Boise, Idaho 83709, 208-373-3867.
By virtue of the authority vested in the Secretary of the Interior by Section 204 of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714 (1994), it is ordered as follows:
1. Secretarial Orders dated September 27, 1909 and August 12, 1912, which withdrew public land for the Minidoka Reclamation Project, are hereby revoked insofar as they affect the following described land:
The area described aggregates 7.5 acres in Cassia County.
Bureau of Land Management, Interior.
Proposed supplementary rules.
The Bureau of Land Management (BLM), Bakersfield (California) Field Office proposes the rules listed below to protect natural resources and provide for the safety of visitors, and property on public land located in eastern Tulare County adjacent to the towns of Three Rivers and Hammond, California. These supplementary rules will be posted on public land in the applicable areas and made available at the Bakersfield Field Office. The policy of the Department of Interior is, whenever practicable, to afford the public an opportunity to participate in the rulemaking process. Accordingly, BLM invites interested persons to submit written comments, suggestions, or objections regarding the proposed supplementary rules to the location identified in the
Mail or hand deliver comments to Field Office Manager, Bureau of Land Management, Bakersfield Field Office, 3801 Pegasus Drive, Bakersfield, CA 93308; telephone (661) 391-6120.
Pursuant to 43 CFR 8365.1-6 (Supplementary Rules), 43 CFR 8364.1 (Closure and restriction orders), and 8341.2 (Special rules) the following supplementary rules are in effect on public land managed by the BLM within Case Mountain/Milk Ranch Peak area defined as: Township 17 South, Range 29 East, MDB&M and Township 18 South, Range 29 East, MDB&M or the North Fork of the Kaweah Special Management Area defined as: Township 15 South, Range 28 East, MDB&M; Township 16 South, Range 28 East, MDB&M; and, Township 17 South, Range 28 East, MDB&M.
A. Target shooting is permitted within the Case Mountain/Milk Ranch Peak area provided that the firearm is discharged toward a proper backstop sufficient to stop the projectile's forward progress beyond the intended target. Target shooting may not occur within one mile of any private residence or occupied structure. Targets shall be constructed of cardboard and paper or similar non-breakable materials. All targets must be removed and properly discarded after use. No projectile may be intentionally fired into any tree.
B. All roads, trails, and routes of travel on public land within the North Fork of the Kaweah Special Management Area are closed to off-highway vehicles registered or identified under Section 38020 of the California Vehicle Code except as permitted by the Authorized Officer.
C. All roads, trails, and routes of travel within the Case Mountain/Milk Ranch Peak area are closed to the operation of any motor vehicle, except for access to private real estate by property owners or persons they designate as having access to their property, public employees, public agency volunteers in the course of their duties, or such access as authorized under permit, easement, or lease by the authorized officer.
D. The operation of motor vehicles within the North Fork of the Kaweah Special Management Area is limited to designated roads. Designated roads include roads maintained by federal, state, or local government, roads leading to parking areas created by the BLM, Shepherd's Saddle Road, and Overlook Road. Overlook Road extends west from Shepherd's Saddle Road 0.8 miles from the intersection of Shepherd's Saddle Road and North Fork Drive. Designated roads may not be used for off-highway vehicle free-play. Vehicles may not be parked in a way which restricts the flow of traffic through parking areas or on roads. Vehicles parked in a way which obstructs other passenger vehicles or fire vehicles may be towed and stored at the owner's expense.
E. Within the Case Mountain/Milk Ranch Peak area, and the North Fork of the Kaweah Special Management Area, property may not be left unattended for more than three days without the prior approval of the Authorized Officer. Any such unattended property will be considered abandoned, and may be removed and stored by law enforcement personnel at the owner's expense.
F. Within the Case Mountain/Milk Ranch Peak area, and the North Fork of the Kaweah Special Management Area, all litter, trash, and refuse must be kept within a container or receptacle and removed when leaving public land. Litter, waste, or refuse may not be thrown onto or stored on the ground.
G. Within the Case Mountain/Milk Ranch Peak area, and the North Fork of the Kaweah Special Management Area, a permit or written authorization from BLM shall be required for all research activities which involve the taking, or placement of, any natural or man-made object, thing, plant, or animal on these lands. A permit or written authorization shall also be required if the research involves the disturbance of any animal, plant, cultural or historic resource, soil, or federal property. Restrictions regarding the disturbance of animal and plant resources do not apply to the California Department of Fish and Game or the U.S. Fish and Wildlife Service as long as the activities are in accordance with their trustee responsibilities for managing wildlife resources. Leisure activities such as astronomy, or bird watching are not intended to be covered by this supplementary rule.
H. Within the Case Mountain/Milk Ranch Peak area, a state of California Fire Permit is required for any camping, cooking, or warming fire ignited on these lands. Portable gas or propane stoves are exempted from this requirements. If any more restrictive fire provisions are established by any governing authority or public officer having jurisdiction, then persons must comply with these.
I. Within the Case Mountain/Milk Ranch Peak area, and the North Fork of the Kaweah Special Management Area, all laws of the State of California applicable to the possession, use, or distribution of controlled substances and/or the protection of persons or property are in effect. These laws may not be violated by any person.
J. Within the Case Mountain/Milk Branch Peak area and the North Fork of the Kaweah Special Management Area, no person may be under the influence of a controlled substance. No person may be under the influence of alcohol to the extent that their ability to be responsible for their own safety is impaired.
The above supplementary rules are being implemented for the following purposes: The above defined lands contain valuable watershed resources, groves of Sequois Trees, and regionally significant recreational resources. Improved public access through acquired easements has increased visitation. These supplementary rules are effected to maintain the area's traditional uses consistent with hiking, bicycle riding, equestrian use, and other low impact recreational activities. The concerns of local residents and property
This order is in no way intended to affect the rights or existing privileges of private land owners or their interests within the defined public land. Existing public easements, county roads, state highways, private lanes or driveways, and private real estate is exempt from these supplementary rules. Further, this order does not infer any Bureau of Land Management jurisdiction over private or state owned lands. These supplementary rules will be in effect until replaced by a more comprehensive recreational management plan for the areas. These supplementary rules are in compliance with the Caliente Resource Management Plan of May 1997.
Federal, State, and local law enforcement officers and California peace officers, as defined in Chapter 4.5 of the California Penal Code, are exempt from these supplementary rules in the course of their official duties. Limitations upon the use of motorized vehicles do not apply to emergency vehicles, fire suppression and rescue vehicles, law enforcement vehicles, and other vehicles performing official duties, or as approved by an authorized officer of the BLM.
These supplementary rules will take effect following review of public comment, and publication as final supplementary rule making in the
The authorities for these closures and supplementary rules are 43 CFR 8341.2, 8364.1, and 8365.1-6. Violations of these supplementary rules are punishable by fines of up to $1,000 and/or imprisonment not to exceed 12 months as well as the penalties provided under State law.
Ronald D. Fellows, Bureau of Land Management, Bakersfield Field Officer Manager, 3801 Pegasus Drive, Bakersfield, CA 93308
Bureau of Land Management, Interior.
Notice of public meeting.
This notice sets forth the schedule and agenda for a forthcoming meeting on the Forest Service withdrawal application for the Spanish Peaks Planning Area for the protection of natural resources. This meeting will provide the opportunity for public involvement in this proposed action as required by regulation. All comments will be considered when a final determination is made on whether this land should be withdrawn.
Meeting will be held on September 12, 2000, at 7:00 p.m. All comments or requests to be heard should be received by close of business on September 7, 2000, at the Colorado State Office.
The meeting will be held at the Walsenburg Community Center, Walsenburg, Colorado, 81089.
Doris E. Chelius, BLM Colorado State Office, (303) 239-3706.
The Notice of Proposed Withdrawal for the Spanish Peaks Planning Area which was published in the
This meeting will be open to all interested persons; those who desire to be heard in person and those who desire to submit written comments on this subject. All comments and requests to be heard should be submitted to the Colorado State Director, Bureau of Land Management, 2850 Youngfield Street, Lakewood, Colorado 80215-7093, by September 7, 2000.
Department of the Interior, National Park Service, Urban and Adjacent Parks.
Notice and request for comments.
The National Park Service (NPS) is proposing in 2000 and 2001 to conduct surveys of persons living in the metropolitan areas of Boston, MA, Los Angeles, CA, Miami, FL, and New Orleans, LA where the following urban national parks are located: Boston African-American National Historic Site, Santa Monica Mountains National Recreation Area, Biscayne National Park, and Jean Lafitte National Historical Park and Preserve. In these surveys, persons will be asked about their knowledge of the urban national park located in their metropolitan area, and their familiarity with community outreach efforts that the urban national park has instituted.
Under provisions of the Paperwork Reduction Act of 1995 and 5 CFR part 1320, Reporting and Recordkeeping Requirements, the National Park Service is soliciting comments on the need for gathering the information in the proposed surveys. The NPS also is asking for comments on the practical utility of the information being gathered; the accuracy of the burden hour estimate; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden to respondents, including use of automated information collection techniques or other forms of information technology.
The NPS goal in conducting these surveys is to assess the effectiveness of community outreach programs of urban national parks to residents within selected metropolitan areas
Public comments will be accepted on or before August 28, 2000.
Ronald J. Vogel, Nelson Mandela School of Public Policy, Higgins Hall, Southern
Ronald J. Vogel. Voice: 225-771-3103, e-mail:
United States International Trade Commission.
Suspension of investigation.
On June 16, 2000, the Department of Commerce published notice in the
June 16, 2000.
Karen Taylor (202-708-4101), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (http://www.usitc.gov).
This investigation is being suspended under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.40 of the Commission's rules (19 CFR 207.40).
By order of the Commission.
In accordance with Departmental policy, 28 CFR 50.7, 38 FR 19029, and 42 U.S.C. 9622(d), notice is hereby given that on June 14, 2000, a proposed Consent Decree (“Decree”) in the consolidated cases entitled
Under the terms of the Decree, the settling parties will make a cash payment of $50,000, to be divided equally between the United States and certain prior settling parties currently performing EPA's selected remedy at the Site (“performing parties”), within 5 days of execution of the Decree by the United States. The F.I.C.A. settling parties shall also permit and cooperate in the sale of various parcels of real property owned by the F.I.C.A. partnership, proceeds from which are to be paid, after deduction of real estate closing costs and satisfaction of back property taxes, equally to the United States and the performing parties. Terms of the sales of the properties are subject to the approval of the United States and the performing parties. The Decree further provides that the United States shall designate $60,000 of its share of the proceeds to be applied as a civil penalty and punitive damages, pursuant to sections 106(b)(1) and 107(c)(3) of CERCLA, 42 U.S.C. 9606(b)(1) and 9607(c)(3), in satisfaction of the United States' claim that F.I.C.A. failed or refused to comply with Administrative Order No. II CERCLA-20217 in connection with the Site. Within 30 days of entry of the Decree, F.I.C.A. will pay the State $2,000 in satisfaction of the State's claim for reimbursement of its response costs at the Site. The
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, U.S. Department of Justice, Washington, DC 20530, and should refer to
The proposed Decree may be examined at the Office of the United States Attorney, 445 Broadway, Room 231, Albany, New York 12207 and at the Region II Office of the Environmental Protection Agency, 290 Broadway, New York, New York 10007-1866. A copy of the Decree may also be obtained by mail from the Consent Decree Library, Department of Justice, P.O. Box 7611, Washington, DC 20044-7611. In requesting a copy, please refer to the referenced case and enclose a check in the amount of $11.00 (25 cents per page reproduction costs) made payable to Consent Decree Library.
Notice is hereby given that, on March 28, 2000, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Notice is hereby given that, on January 19, 2000, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and Application Service Provider Industry Consortium, Inc. intends to file additional written notification disclosing all changes in membership.
On July 28, 1999, Application Service Provider Industry Consortium, Inc. filed its original notification pursuant to section 6(a) of the Act. A notice has not yet been published in the
The last notification was filed with the Department on October 21, 1999. A notice has not yet been published in the
Notice is hereby given that, on March 31, 2000, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and CommerceNet Consortium, Inc. intends to file additional written notification disclosing all changes in membership.
On June 13, 1994, CommerceNet Consortium, Inc. filed its original notification pursuant to section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on February 4, 2000. A notice has not yet been published in the
Notice is hereby given that, on January 14, 2000, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned
On June 13, 1994, CommerceNet Consortium, Inc. filed its original notification pursuant to section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on December 2, 1999. A notice has not yet been published in the
Notice is hereby given that, on January 12, 2000, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and Corporation For National Research Initiatives: Cross Industry Working Team (“XIWT”) intends to file additional written notification disclosing all changes in membership.
On September 28, 1993, the Corporation For National Research Initiatives: Cross Industry Working Team (“XIWT”) filed its original notification pursuant to section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on January 20, 1999. A notice was published in the
Notice is hereby given that, on March 31, 2000, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and Die Products Consortium (DPC) intends to file additional written notification disclosing all changes in membership.
On November 15, 1999, Die Products Consortium (DPC) filed its original notification pursuant to section 6(a) of the Act. A notice has not yet been published in the
Notice is hereby given that, on February 11, 2000, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and Digital Imaging Group, Inc. intends to file additional written notification disclosing all changes in membership.
On September 25, 1997, Digital Imaging Group, Inc. filed its original
The last notification was filed with the Department on December 2, 1999. A notice was published in the
Notice is hereby given that, on October 21, 1999, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and Enterprise Computer Telephony Form (“ECTF”) intends to file additional written notification disclosing all changes in membership.
On February 20, 1996, Enterprise Computer Telephony Forum (“ECTF”) filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on July 8, 1999. A notice has not yet been published in the
Notice is hereby given that, on March 13, 2000, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and Microelectronics and Computer Technology Corporation (“MCC”) intends to file additional written notification disclosing all changes in membership.
On December 21, 1984, Microelectronics and Computer Technology Corporation (“MCC”) filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on June 16, 1999. A notice was published in the
Notice is hereby given that, on November 12, 1999, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Also, Applied Intelligent Systems, Inc., Ann Arbor, MI; Deneb Robotics Inc., Auburn Hills, MI; Diffracto, Windsor, Ontario, CANADA; Cardell Corporation, Auburn Hills, MI; Circo Craft Company, Pointe-Claire, Quebec, CANADA; Concentra Corporation, Burlington, MA; Giddings & Lewis, Inc.,
Active Touch Systems, Inc., has changed its name to Web Ex, Inc., Santa Clara, CA; Flavors Technology, Inc., has changed its name to R. Morley, Inc., Milford, NH; The MacNealSchwendler Corporation has changed its name to MSC.Software Corporation, Costa Mesa, CA; Ramtech Group, Inc., has changed its name to Bencym West, LLC, North Highlands, CA; and Industrial Technology Institute has changed its name to Michigan Manufacturing Technology Center, Ann Arbor, MI. Chrysler Corporation merged with Daimler-Benz AG and is now known as DaimlerChrysler AG, Auburn Hills, MI.
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and National Center for Manufacturing Sciences, Inc. (“NCMS”) intends to file additional written notification disclosing all changes in membership.
On February 20, 1987, National Center for Manufacturing Sciences, Inc. (“NCMS”) filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on April 1, 1999. A notice was published in the
Notice is hereby given that, on January 14, 2000, pursuant to section 6(a) of the National Cooperative Research Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and NEMI intends to file additional written notification disclosing all changes in membership.
On June 6, 1996, NEMI filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on October 8, 1998. A notice was published in the
Notice is hereby given that, on March 27, 2000, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Notice is hereby given that, on March 3, 2000, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned
On September 10, 1997, OBI Consortium, Inc. filed its original notification pursuant to section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on November 26, 1999. A notice was published in the
Notice is hereby given that, on March 20, 2000, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and Salutation Consortium, Inc. intends to file additional written notification disclosing all changes in membership.
On March 30, 1995, Salutation Consortium, Inc. filed its original notification pursuant to section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on December 6, 1999. A notice was published in the
Notice is hereby given that, on April 26, 2000, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and Southwest Research Institute (“SwRI”): Clean Diesel III intends to file additional written notification disclosing all changes in membership.
On January 12, 2000, Southwest Research Institute (“SwRI”): Clean Diesel III filed its original notification pursuant to section 6(a) of the Act. A notice has not yet been published in the
Notice is hereby given that, on January 28, 2000, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and Telematics Suppliers Consortium, Inc. intends to file additional written notification disclosing all changes in membership.
On March 12, 1999, Telematics Suppliers Consortium, Inc. filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice has not yet published a notice in the
The last notification was filed with the Department on November 3, 1999. A notice was published in the
Notice is hereby given that, on March 12, 1999, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Notice is hereby given that, on October 5, 1999, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and Wireless Application Protocol Forum, Ltd. (“The WAP Forum”) intends to file additional written notification disclosing all changes in membership.
On March 18, 1998, Wireless Application Protocol Forum, Ltd. (“The WAP Forum”) filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on July 9, 1999. A notice was published in the
Notice is hereby given that, on January 13, 2000, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and Wireless Application Protocol Forum, Ltd. (“The WAP Forum”) intends to file additional written notification disclosing all changes in membership.
On March 18, 1998, Wireless Application Portocol Forum, Ltd. (“The WAP Forum”) filed its original notification pursuant to section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on October 5, 1999. A notice has not yet been published in the
In accordance with section 223 of the Trade Act of 1974, as amended, the Department of Labor herein presents summaries of determinations regarding eligibility to apply for trade adjustment assistance for workers (TA-W) issued during the period of June, 2000.
In order for an affirmative determination to be made and a certification of eligibility to apply for worker adjustment assistance to be issued, each of the group eligibility requirements of Section 222 of the Act must be met.
(1) that a significant number or proportion of the workers in the workers' firm, or an appropriate subdivision thereof, have become totally or partially separated,
(2) that sales or production, or both, of the firm or subdivision have decreased absolutely, and
(3) that increases of imports of articles like or directly competitive with articles produced by the firm or appropriate subdivision have contributed importantly to the separations, or threat thereof, and to the absolute decline in sales or production.
In each of the following cases the investigation revealed that criterion (3) has not been met. A survey of customers indicated that increased imports did not contribute importantly to worker separations at the firm.
In the following cases, the investigation revealed that the criteria for eligibility have not been met for the reasons specified.
The workers firm does not produce an article as required for certification under Section 222 of the Trade Act of 1974.
Increased imports did not contribute importantly to worker separations at the firm.
The investigation revealed that criteria (2) and criteria (3) have not been met. Sales or production did not decline during the relevant period as required for certification. Increases of imports of articles like or directly competitive with articles produced by the firm or an appropriate subdivision have not contributed importantly to the separations of threat thereof, and the absolute decline in sales or production.
The investigation revealed that criteria (2) has not been met. Sales or production did not decline during the relevant period as required for certification.
The following certifications have been issued; the date following the company name and location of each determination references the impact date for all workers of such determination.
Also, pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance hereinafter called (NAFTA-TAA) and in accordance with Section 250(a), Subchapter D, Chapter 2, Title II, of the Trade Act as amended, the Department of Labor presents summaries of determinations regarding eligibility to apply for NAFTA-TAA issued during the month of June, 2000.
In order for an affirmative determination to be made and a certification of eligibility to apply for NAFTA-TAA the following group eligibility requirements of Section 250 of the Trade Act must be met:
(1) That is a significant number or proportion of the workers in the workers' firm, or an appropriate subdivision thereof, (including workers in any agricultural firm or appropriate subdivision thereof) have become totally or partially separated from employment and either—
(2) That sales or production, or both, of such firm or subdivision have decreased absolutely,
(3) That imports from Mexico or Canada of articles like or directly competitive with articles produced by such firm or subdivision have increased, and that the increases imports contributed importantly to such workers' separations or threat of separation and to the decline in sales or production of such firm or subdivision; or
(4) That there has been a shift in production by such workers' firm or subdivision to Mexico or Canada of articles like or directly competitive with articles which are produced by the firm or subdivision.
In each of the following cases the investigation revealed that criteria (3) and (4) were not met. Imports from Canada or Mexico did not contribute importantly to workers' separations. There was no shift in production from the subject firm to Canada or Mexico during the relevant period.
The investigation revealed that the criteria for eligibility have not been met for the reasons specified.
The investigation revealed that workers of the subject firm did not produce an article within the meaning of Section 250(a) of the Trade Act, as amended.
I hereby certify that the aforementioned determinations were issued during the month of June 2000. Copies of these determinations are available for inspection in Room C-4318, U.Ss. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210 during normal business hours or will be mailed to persons who write to the above address.
Pursuant to 29 CFR 90.18(C) an application for administrative reconsideration was filed with the Director of the Division of Trade Adjustment Assistance for workers at Westwood Lighting, El Paso, Texas. The application contained no new substantial information which would bear importantly on the Department's determination. Therefore, dismissal of the application was issued.
Pursuant to Section 221 of the Trade Act of 1974, investigations were initiated on January 18, 2000 and May 22, 2000, in response to a worker petitions which were filed on behalf of workers at Beloit Millpro Service Center, Hattiesburg, Mississippi (TA-W-37,251) and Beloit Manhattan, Neenah, Wisconsin (TA-W-37,703), respectively.
During the investigations, it was discovered that both facilities are under existing investigations. The workers are currently under the following investigations: Beloit Millpro Service Center, Hattiesburg, Mississippi (TA-W-37,562G) and Beloit Manhattan, Neenah, Wisconsin (TA-W-37,562J).
Consequently further investigations in these cases (TA-W-37,251 and TA-W-37,703) would serve no purpose, and the investigations have been terminated.
Pursuant to section 221 of the Trade Act of 1974, an investigation was initiated on April 24, 2000, in response to a petition filed by a company official on behalf of workers at Chavez Signs, Incorporated, El Paso, Texas.
The company official submitting the petition has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Section 221 of the Trade Act of 1974, an investigation was initiated on May 15, 2000, in response to a petition filed on the same date on behalf of workers at Chick Orchards, Inc., Chic-A-Dee Packing Corporation, Monmouth, Maine.
The company official submitting the petition has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
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, Division of Trade Adjustment Assistance, at the address shown below, not later than July 10, 2000.
Interested persons are invited to submit written comments regarding the subject matter of the investigations to the Director, Division of Trade Adjustment Assistance, at the address shown below, not later than July 10, 2000.
The petitions filed in this case are available for inspection at the Office of the Director, Division of Trade Adjustment Assistance, Employment and Training Administration, U.S. Department of Labor, 200 Constitution Avenue, NW, Washington, DC 20210.
In accordance with Section 223 of the Trade Act of 1974 (19 U.S.C. 2273) the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance on February 1, 2000, applicable to workers of Hampton Industries, Inc., Warrenton, North Carolina. The notice was published in the
At the request of the company, the Department reviewed the certification for workers of the subject firm. New findings show that worker separations will occur at Hampton Industries' Washington, North Carolina facility when it closes in August, 2000. The workers are engaged in the production of men's and boys' casual shirts.
Accordingly, the Department is amending the certification to cover workers at Hampton Industries, Inc., Washington, North Carolina. The intent of the Department's certification is to include all workers of Hampton Industries, Inc. adversely affected by increased imports.
The amended notice applicable to TA-W-37,268 is hereby issued as follows:
“All workers of Hampton Industries, Inc., Warrenton, North Carolina (TA-W-37,268) and Washington, North Carolina (TA-W-37,268A) who became totally or partially separated from employment on or after January 24, 1999 through February 1, 2002 are eligible to apply for adjustment assistance under Section 223 of the Trade Act of 1974.”
Pursuant to section 221 of the Trade Act of 1974, an investigation was initiated on May 22, 2000, in response to a petition filed by a company official on behalf of workers at Scientific Research Company, Portland, Oregon.
The company official submitting the petition has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to 29 CFR 90.18(C) an application for administrative reconsideration was filed with the Director of the Division of Trade Adjustment Assistance for workers at Shell Chemical Company, Point Pleasant Polyester Plant, Apple Grove, West Virginia. The application contained no new substantial information which would bear importantly on the Department's determination. Therefore, dismissal of the application was issued.
TA-W-37, 314; Shell Chemical Company, Point Pleasant Polyester Plant, Apple Grove, West Virginia (June 12, 2000).
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, Division of Trade Adjustment Assistance, at the address shown below, not later than July 10, 2000.
Interested persons are invited to submit written comments regarding the subject matter of the investigations to the Director, Division of Trade Adjustment Assistance, at the address shown below, not later than July 10, 2000.
The petitions filed in this case are available for inspection at the Office of the Director, Division of Trade Adjustment Assistance, Employment and Training Administration, U.S. Department of Labor, 200 Constitution Avenue, NW, Washington, DC 20210.
Pursuant to section 221 of the Trade Act of 1974, an investigation was initiated on April 24, 2000, in response to a worker petition which was filed by a company official on behalf of its workers at Furniture Crafters, Grants Pass, Oregon.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called (NAFTA-TAA), and in accordance with Section 250(a), Subchapter D, Chapter 2, Title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on May 1, 2000 in response to a petition filed on behalf of workers at Johnson Controls, Incorporated, Goshen, Georgia.
In a letter dated May 31, 2000, the petitioners requested that the petition for NAFTA-TAA be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
The following party has filed petitions to modify the application of the existing safety standard under section 101(c) of the Federal Mine Safety and Health Act of 1977.
Anthracite Underground Rescue, Inc., 44 Crescent Street, Tremont, Pennsylvania 17981 has filed petitions to modify the application of 30 CFR 49.2 (availability of mine rescue teams) on behalf of the following Anthracite Underground Mines: (1) M & H Coal Co., (I.D. No. 36-01920), Docket No. M-2000-057-C; (2) UAE Coalcorp Assoc. (I.D. No. 36-07838), Docket No. M-2000-058-C; (3) M & M Coal Company (I.D. No. 36-08744), Docket No. M-2000-059-C; (4) H & R Coal Company (I.D. No. 36-08288), Docket No. M-2000-060-C; (5) AL Coal Company (I.D. No. 36-07018), Docket No. M-2000-061-C; (6) West End Coal Company (I.D. No. 36-07859), Docket No. M-2000-062-C; (7) Three W-M Coal Company (I.D. No. 36-08806), Docket No. M-2000-063-C); (8) Summit Anthracite, Inc., (I.D. No. 36-07328), Docket No. M-2000-064-C; (9) Snyder Rattling Run (I.D. No. 36-08713), Docket No. M-2000-065-C; (10) Snyder Coal Company, N&L Slope (I.D. No. 36-02203), Docket No. M-2000-066-C; (11) S & M Coal Company (I.D. No. 36-02022), Docket No. M-2000-067-C; (12) R S & W Coal Company (I.D. No. 36-01818), Docket No. M-2000-068-C; (13) Rhen Coal Company (I.D. No. 36-08031), Docket No. M-2000-069-C; (14) R & D Coal Company (I.D. No. 36-02053), Docket No. M-2000-070-C); (15) Primrose Coal Company (I.D. No. 36-08698), Docket No. M-2000-071-C; (16) Nowacki Coal Company (I.D. No. 36-07592), Docket No. M-2000-072-C; (17) Morgan Run Coal Company (I.D. No. 36-08559), Docket No. M-2000-073-C; (18) Little Rock Coal Company (I.D. No. 36-08320), Docket No. M-2000-074-C; (19) Little Buck Coal Company (I.D. No. 36-08568), Docket No. M-2000-075-C; (20) Jordan Coal Company (I.D. No. 36-07681), Docket No. M-2000-076-C; (21) Joliett Coal Company (I.D. No. 36-08702), Docket No. M-2000-077-C; (22) H L & W Coal Company (I.D. No. 36-07269), Docket No. M-2000-078-C; (23) B & L Coal Company (I.D. No. 36-08498), Docket No. M-2000-079-C; (24) FKZ Coal Company (I.D. No. 36-08637), Docket No. M-2000-080-C; (25) DJT Coal Company (I.D. No. 36-08454), Docket No. M-2000-081-C; (26) D & D (I.D. No. 36-08341), Docket No. M-2000-082-C; and (27) Chestnut Coal Company (I.D. No. 36-07059), Docket No. M-2000-083-C. The petitioner requests a modification of the standard to permit the reduction of two mine rescue teams with five members and one alternate each, to two mine rescue teams of three members with one alternate for either team for the Anthracite Underground Mines listed above. The petitioner asserts that application of the existing standard would result in a diminution of safety to the miners and that the proposed alternative method would provide at least the same measure of protection as the existing standard.
Persons interested in these petitions are encouraged to submit comments via e-mail to “comments@msha.gov,” or on a computer disk along with an original hard copy to the Office of Standards, Regulations, and Variances, Mine Safety and Health Administration, 4015 Wilson Boulevard, Room 627, Arlington, Virginia 22203. All comments must be postmarked or received in that office on or before July 31, 2000. Copies of these petitions are available for inspection at that address.
The following parties have filed petitions to modify the application of existing safety standards under section 101(c) of the Federal Mine Safety and Health Act of 1977.
Plateau Mining Company, One Oxford Centre, 301 Grant Street, 20th Floor,
Bowie Resources, Ltd., P.O. Box 1488, 1720 4010 Drive, Paonia, Colorado 81428 has filed a petition to modify the application of 30 CFR 75.701 (grounding metallic frames, casings, and other enclosures of electric equipment) to its Bowie Mine (I.D. No. 05-04591) located in Delta County, Colorado. The petitioner proposes to use a 460 KW, 480 volt, wye connected diesel powered generator for utility power and to move electrically powered mining equipment throughout the mine. The petitioner asserts that the proposed alternative method would provide at least the same measure of protection as the existing standard.
Bowie Resources, Ltd., P.O. Box 1488, 1720 4010 Drive, Paonia, Colorado 81428 has filed a petition to modify the application of 30 CFR 75.901(a) (protection of low-and medium-voltage three-phase circuits used underground) to its Bowie Mine (I.D. No. 05-04591) located in Delta County, Colorado. The petitioner proposes to use a 460 KW, 480 volt, wye connected diesel powered generator to move and operate electrically powered mobile equipment and stationary equipment throughout the mine. The petitioner asserts that the proposed alternative method would provide at least the same measure of protection as the existing standard.
Bowie Resources, Ltd., P.O. Box 1488, 1720 4010 Drive, Paonia, Colorado 81428 has filed a petition to modify the application of 30 CFR 75.500(d) (permissible electric equipment) to its Bowie Mine (I.D. No. 05-04591) located in Delta County, Colorado. The petitioner proposes to use the following nonpermissible low-voltage or battery powered electronic testing and diagnostic equipment inby the last open crosscut: lap top computers, oscilloscopes, vibration analysis machines, cable fault detectors, point temperature probes, infrared temperature devices, resistance measurement devices, recorders, pressure and flow measurement devices, current measurement devices, signal analyzer devices, thickness gauges, power analyzers, component testers, electronic tachometers, and volt ohm meters. The petitioner has listed in this petition for modification specific procedures that would be followed when using this equipment. The petitioner asserts that the proposed alternative method would provide at least the same measure of protection as the existing standard.
Bowie Resources, Ltd., P.O. Box 1488, 1720 4010 Drive, Paonia, Colorado 81428 has filed a petition to modify the application of 30 CFR 75.1002-1(a) (location of trolley wires, trolley feeder wires, high-voltage cables and transformers) to its Bowie Mine (I.D. No. 05-04591) located in Delta County, Colorado. The petitioner proposes to use the following nonpermissible low-voltage or battery powered electronic testing and diagnostic equipment inby the last open crosscut: lap top computers, oscilloscopes, vibration analysis machines, cable fault detectors, point temperature probes, infrared temperature devices, resistance measurement devices, recorders, pressure and flow measurement devices, current measurement devices, signal analyzer devices, thickness gauges, power analyzers, component testers, electronic tachometers, and volt ohm meters. The petitioner has listed in this petition for modification specific procedures that would be followed when using this equipment. The petitioner asserts that the proposed alternative method would provide at least the same measure of protection as the existing standard.
Alex Energy, Inc., P.O. Box 857, Summersville, West Virginia 26651 has filed a petition to modify the application of 30 CFR 75.1002 (location of trolley wires, trolley feeder wires, high-voltage cables and transformers) to its Jerry Fork Eagle Mine (I.D. No. 46-08787) located in Nicholas County, West Virginia. The petitioner proposes to use high-voltage longwall mining equipment, with the nominal voltage of the longwall power circuits not to exceed 4,160 volts. The petitioner asserts that the proposed alternative method would provide at least the same measure of protection as the existing standard.
Perry County Coal Corporation, P.O. Box 5001, Hazard, Kentucky 41702 has filed a petition to modify the application of 30 CFR 75.1911(d) (fire suppression systems for diesel-powered equipment and fuel transportation units) to its Eas #1 Mine (I.D. No. 15-02085) located in Perry County, Kentucky. The petitioner proposes to use either manual fire suppression actuators or the automatic fire suppression system, without the automatic engine shut-down portion, on the 35 ton locomotives and the 12 ton locomotives which haul coal and empty mine cars for all rail haulage. The petitioner asserts that if the diesel locomotive engines were to shut down, the brakes would lock up, causing the coal cars to create a train reaction and derail the locomotive causing injury to the locomotive operator. The petitioner asserts that the proposed alternative method would provide at least the same measure of protection as the existing standard.
Rustler Coal Company, 66 South Tremont Street, Zerbe, Pennsylvania 17981 has filed a petition to modify the application of 30 CFR 49.2(b) (availability of mine rescue teams) to its Orchard Slope Mine (I.D. No. 36-08346) located in Schuylkill County, Pennsylvania. The petitioner requests a modification of the standard to permit the reduction of two mine rescue teams with five members and one alternate each, to two mine rescue teams of three members with one alternate for either team. The petitioner asserts that application of the existing standard would result in a diminution of safety to the miners and members of the rescue team and that the proposed alternative method would provide at least the same measure of protection as the existing standard.
Wayne Processing, Inc., 22 Hampton Road, Buckhannon, West Virginia 26201
RAG Cumberland Resources LP, One Oxford Centre, 301 Grant Street, 20th Floor, Pittsburgh, Pennsylvania 15219-1410 has filed a petition to modify the application of 30 CFR 75.1002 (location of trolley wires, trolley feeder wires, high-voltage cables and transformers) to its Cumberland Mine (I.D. No. 36-05018) located in Greene County, Pennsylvania. The petitioner requests that the Proposed Decision and Order (PDO) for its previously granted petition, docket number M-92-99-C, be amended. The petitioner requests that Item #29 of the PDO be amended to allow the widths and lengths of its panels to be increased, and that Item #31 of the PDO be amended to read as follows: A primary escapeway maintained in accordance with 30 CFR 75.380 shall be provided on the headgate end of all longwall panels. The petitioner asserts that the proposed alternative method would provide at least the same measure of protection as the existing standard.
Dominion Coal Corporation, P.O. Box 70, Vansant, Virginia 24656 has filed a petition to modify the application of 30 CFR 77.214(a) (refuse piles; general) to its Dominion Mine No. 22 (I.D. No. 44-06645) located in Buchanan County, Virginia. The petitioner requests a modification of the existing standard to allow abandoned mine openings to be covered with coarse refuse material for the Dominion Mine No. 22, MSHA Site ID #1211-VA5-0335-01. The petitioner proposes to construct a refuse bench fill in abandoned mine openings using the specific plans and procedures outlined in this petition for modification. The petitioner asserts that the proposed alternative method would provide at least the same measure of protection as the existing standard.
Basic Mining Corp., P.O. Box 1197, Vansant, Virginia 24656 has filed a petition to modify the application of 30 CFR 75.1710-1(a) (canopies or cabs; self-propelled diesel-powered and electric face equipment; installation requirements) to its Mine No. 2 (I.D. No. 44-05032) located in Dickenson County, Virginia. The petitioner requests a modification of the existing standard to permit its Joy 21 SC Shuttle Cars, Joy 14CM Miners, and Long Airdox LRB15A Roof Drills to be operated without canopies. The petitioner asserts that application of the existing standard would result in a diminution of safety of the miners and that the proposed alternative method would provide at least the same measure of protection as the existing standard.
FMC Corporation, P.O. Box 872, Green River, Wyoming 82935 has filed a petition to modify the application of 30 CFR 57.22305 (approved Equipment (III mines)) to its Westvaco Mine (I.D. No. 48-00152) located in Sweetwater County, Wyoming. The petitioner proposes to use a cordless drill or other equivalent drills to install surveying spads in the mine roof to minimize the potential of developing cumulative trauma disorders in the wrists, elbows, and shoulders of the surveyors. The petitioner states that methane will be tested before using the drills and if one percent or more of methane is found, drilling will not begin and that drilling will cease if one percent or more of methane is found during drilling. The petitioner asserts that the proposed alternative method would provide at least the same measure of protection as the existing standard.
Greer Industries, Inc., P.O. Box 1900, Morgantown, West Virginia 26507-1900 has filed a petition to modify the application of 30 CFR part 48 (training and retraining of miners working at surface mines and surface areas of underground mines) to the Deckers Creek Limestone Company, Deckers Creek Mine (I.D. No. 46-00029) and the Greer Limestone Company, Greer Mine and Mill (I.D. No. 46-00016) both located in Monongalia County, West Virginia. The petitioner requests a modification of the existing standard to allow over-the-road contracted delivery trucks used to ship limestone material to go to an underground stockpile area to be loaded for a limited time and purpose. The petitioner states that the truck drivers would not be allowed out of their trucks at any time while receiving their load, the Greer Industries alternative safety plan would provide adequate protection to ensure the safety of all contracted delivery trucks drivers, and that all delivery truck drivers would receive site specific hazard training. The petitioner asserts that the proposed alternative method would provide at least the same measure of protection as the existing standard.
Frontier-Kemper Constructors, Inc., P.O. Box 460, Kearny, Arizona 85237 has filed a petition to modify the application of 30 CFR 57.9360 (shelter holes) to the Asarco Mineral Creek Water Diversion Tunnel at the Asarco Ray Complex (I.D. No. 02-00150), P.O. Box 8, Hayden, Arizona 85236, located in Pinal County, Arizona. The petitioner proposes to construct a tunnel 18 feet, 10 inches in diameter using a CTS Tunnel Boring Machine, Model 490-013, with ground support provided by the installation of segmented 6-inch ring steel flush to the excavated circumference. The petitioner states that the tunnel boring process, a 24-inch elevated conveyor will run from the Tunnel Boring Machine trailing gear to the portal and mounted to the rib and narrow gauge, 36-inch rails will run down the center of the tunnel, pedestrian traffic within the tunnel will be limited to necessary personnel for periodic inspections and/or maintenance; Asarco's production area will not be a part of the tunnel; and all miners at Frontier-Kemper Constructors, Inc. will be transported to the face by rail-mounted conveyance. The petitioner asserts the proposed alternative method would allow for the use of Safety Platforms instead of shelter-holes and would provide at least the same measure of protection as the existing standard.
Persons interested in these petitions are encouraged to submit comments via e-mail to “comments@msha.gov,” or on a computer disk along with an original hard copy to the Office of Standards, Regulations, and Variances, Mine Safety and Health Administration, 4015 Wilson Boulevard, Room 627,
National Endowment for the Arts.
Notification of availability.
The National Endowment for the Arts is requesting proposals leading to one (1) award of a Cooperative Agreement to a nonprofit organization for continued management of ArtsLink. ArtsLink is a public-private partnership that offers opportunities for artistic exchange between the United States and the countries of Eastern and Central Europe and the former Soviet Union. The project awards grants to U.S. artists and arts organizations, and supports residencies. The work includes managing all phases of proposal review, artists and residency placements, and the financial award process, including the management of logistical arrangements for residencies, in regard to participants' arrival, lodging, and transfer to host organization locations. The successful recipient of the Cooperative Agreement will be expected to contribute matching funds of at least $75,000. Those interested in receiving the Solicitation package should reference Program Solicitation PS 00-07 in their written request and include two (2) self-addressed labels. Verbal requests for the Solicitation will not be honored. It is anticipated that the Program Solicitation will also be posted on the Endowment's Web site at http://www.arts.gov.
Program Solicitation PS 00-07 is scheduled for release approximately July 17, 2000 with proposals due on August 17, 2000.
Requests for the Solicitation should be addressed to the National Endowment for the Arts, Grants & Contracts Office, Room 618, 1100 Pennsylvania Ave., NW, Washington, D.C. 20506.
William Hummel, Grants & Contracts Office, National Endowment for the Arts, Room 618, 1100 Pennsylvania Ave., NW, Washington, D.C. 20506 (202/682-5482).
Generic Survey Clearance of the Science Resources Studies Survey Improvement Projects and Quick Response Studies.
Under the Paperwork Reduction Act of 1995, Pub. L. 104-13 (44 U.S.C. 3506(c)(2)(A)), and as part of its continuing effort to reduce paperwork and respondent burden, the National Science Foundation invites the general public and other Federal agencies to take this opportunity to comment on this new information collection.
Written comments should be received by August 28, 2000 to be assured of consideration. Comments received after that date will be considered to the extent practicable.
Written comments regarding the information collection and requests for copies of the proposed information collection request should be addressed to Suzanne Plimpton, Reports Clearance Officer, National Science Foundation, 4201 Wilson Blvd., Rm. 295, Arlington, VA 22230, or by e-mail to splimpto@nsf.gov.
Suzanne Plimpton, the NSF Reports Clearance Officer, phone (703) 306-1125, or send e-mail to splimpto@nsf.gov. You may also obtain a copy of the data collection plans and instruments from Ms. Suzanne Plimpton, NSF Reports Clearance Officer, National Science Foundation, 4201 Wilson Blvd., Suite 295, Arlington, VA 22230, phone (703) 306-1125. Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8 a.m. and 8 p.m., Eastern time, Monday through Friday.
Generic Survey Clearance of the Science Resources Studies Survey Improvement Projects and Quick Response Studies. The National Science Foundation's (NSF) Division of Science Resources Studies (SRS) needs to collect timely data on constant changes in the science and technology sector and to provide the information to policy makers in Congress and throughout the Government. SRS will sponsor quick response surveys and workshops on science and technology subjects, perform cognitive testing to improve survey methodology and questionnaires, and pretest questions for future large-scale surveys.
The respondents will be from industry, academia, nonprofit organizations, members of the public, and Federal agencies. Data and information collection will be by mail, Internet, World Wide Web, telephone, visits, and/or workshops. As the table below shows, as many as 355 institutions will be contacted. No institution will be contacted more than twice in one year. Members of the public may be contacted for a survey of public attitudes toward science.
The information from the respondents is needed to provide policy makers with updates of the economic, financial, employment, and education situation in the science and technology sector of industry, academia, and nonprofit organizations. The information will also help NSF improve its current data collection instruments and processes.
To minimize burden on small entities and to make sure that a high proportion of the science and technology universe is captured, most respondent selection will be designed with probability proportional to size. It is possible that during the 3 years of the survey clearance, NSF will study an issue that focuses on small entities, such as start-up high-technology companies. In this case, every effort will be made to use technology to limit the burden on respondents from small entities.
Information being collected is not considered to be sensitive. In general, assurance of data confidentiality will not be provided to respondents to the Generic Survey Clearance of the Science Resources Studies Survey Improvement Projects and Quick Response Studies. Instead, respondents have the option of requesting that any and all data they submit be kept confidential.
The purpose of these studies is to collect information on the science and technology sector to respond to questions from policy makers and to improve the current NSF science and technology surveys. NSF will publish a separate report on the findings and also
NSF estimates that a total reporting and recordkeeping burden of 5,860 hours will result from the collection of information. The calculation is:
We invite comments specifically on:
(a) 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;
(b) The accuracy of the Agency's estimate of the burden 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 collection of information on respondents, including through the use of appropriate automated, electronic, mechanical, or other technological 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.
Nuclear Regulatory Commission.
Notice of receipt of Quivira Mining Company's Application for establishing Alternate Concentration Limits in Source Material License SUA-1473 for the Ambrosia Lake, New Mexico, facility and notice of opportunity for a hearing.
Notice is hereby given that the U.S. Nuclear Regulatory Commission (NRC) has received, by letter dated February 17, 2000, an application from Quivira Mining Company (Quivira) to establish Alternate Concentration Limits and amend the Source Material License No. SUA-1473 for the Ambrosia Lake uranium mill facility.
Jill S. Caverly, Fuel Cycle Licensing Branch, Division of Fuel Cycle Safely and Safeguards U.S. Nuclear Regulatory Commission, Washington, DC 20555. Telephone (301) 415-6699.
The NRC hereby provides notice of an opportunity for a hearing on the license amendment under the provisions of 10 CFR Part 2, Subpart L, “Informal Hearing Procedures for Adjudications in Materials and Operator Licensing Proceedings.” Pursuant to § 2.1205(a), any person whose interest may be affected by this proceeding may file a request for a hearing. In accordance with § 2.1205(d), a request for hearing must be filed within 30 days of the publication of this notice in the
(1) By delivery to the Docketing and Service Branch of the Office of the Secretary at One White Flint North, 11555 Rockville Pike, Rockville, MD 20852; or
(2) By mail or telegram addressed to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docketing and Service Branch.
In accordance with 10 CFR 2.1205(f), each request for a hearing must also be served, by delivering it personally or by mail, to:
(1) The applicant, Quivira Mining Company, 6305 Waterford Blvd., Suite 325, Oklahoma City, Oklahoma 73118, Attention: William Paul Goranson; and
(2) The NRC staff, by delivery to the General Counsel, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852, or by mail addressed to the General Counsel, U.S. Nuclear Regulatory Commission, Washington, DC 20555.
In addition to meeting other applicable requirements of 10 CFR part 2 of the NRC's regulations, a request for a hearing filed by a person other than an applicant must describe in detail:
(1) The interest of the requestor in the proceeding;
(2) How that interest may be affected by the results of the proceeding, including the reasons why the requestor should be permitted a hearing, with particular reference to the factors set out in § 2.1205(h);
(3) The requestor's areas of concern about the licensing activity that is the subject matter of the proceeding; and
(4) The circumstances establishing that the request for a hearing is timely in accordance with § 2.1205(d).
The request must also set forth the specific aspect or aspects of the subject matter of the proceeding as to which petitioner wishes a hearing.
In addition, members of the public may provide comments on the subject application within 30 days of the publication of this notice in the
For the U.S. Nuclear Regulatory Commission.
United States Postal Service Board of Governors
10:00 a.m., Monday, July 10, 2000; 8:30 a.m., Tuesday, July 11, 2000.
Washington, DC, at U.S. Postal Service Headquarters, 475 L'Enfant Plaza, SW., in the Benjamin Franklin Room.
July 10 (Closed); July 11 (Open).
David G. Hunter, Secretary of the Board, U.S. Postal Service, 475 L'Enfant Plaza, SW., Washington, DC 20260-1000. Telephone (202) 268-4800.
In accordance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which provides opportunity for public comment on new or revised data collections, the Railroad Retirement Board (RRB) will publish periodic summaries of proposed data collections.
Job Information Report, OMB 3220-0193.
In July of 1997, the Railroad Retirement Board (RRB) adopted standards for the adjudication of occupational disabilities under the Railroad Retirement Act (RRA). As part of these standards, the RRB requests job information to determine an applicants eligibility for an occupational disability. The job information received from the railroad employer and railroad employee is compared, reconciled (if needed), and then used in the occupational disability determination process. The process of obtaining information from railroad employers used to determine an applicant's eligibility for an occupational disability is outlined in 20 CFR 220.13.
To determine an occupational disability, the RRB determines if an employee is precluded from performing the full range of duties of his or her regular railroad occupation. This is accomplished by comparing the restrictions on impairment(s) causes against an employee's ability to perform his/her normal duties. To collect information needed to determine the effect of a disability on an applicant's ability to work, the RRB needs the applicant's work history. The RRB currently utilizes Form G-251,
Form G-251 is provided to
In accordance with the standards, the RRB also requests pertinent job information from employers. The employer is given thirty days from the date of the notice to respond. The responses are not required, but are voluntary. If the job information is received timely, it is compared to the job information provided by the employee. Any material differences are resolved by an RRB disability examiner. Once resolved, the information is compared to the restrictions caused by the medical impairment. If the restrictions prohibit the performance of the regular railroad occupation, the claimant is found occupationally disabled.
The RRB uses two forms to secure job information data from the railroad employer. RRB Form G-251a, Employer Job Information (job description), is released to an employer when an application for an occupational disability is filed by an employee whose regular railroad occupation is one of the more common types of railroad jobs (locomotive engineer, conductor, switchman,
The generic job descriptions were prepared and approved by a joint committee consisting of representatives of railroad labor and railroad management.
Proposes Form G-251b, Employer Fob Information (general), is released to an employer when an application for an RRB occupational disability is filed by an employee whose regular railroad occupation does not have a generic job description. It notifies the employer that the employee has filed for a disability annuity and that, if the employer wishes, it may provide the RRB with job duty information. The type of information RRB is seeking is outlined on the form. the employer has thirty days from the date the form is released to reply.
The RRB proposes minor non-burden impacting changes to Form-251a and G-251b. The completion time for Form G-251a and G-251b is estimated at 20 minutes. Completion is voluntary. The RRB estimates that approximately 125
To request more information or to obtain a copy of the information collection justification, forms, and/or supporting material, please call the RRB Clearance Officer at (312) 751-3363. Comments regarding the information collection should be addressed to Ronald J. Hodapp, Railroad Retirement Board, 844 N. Rush Street, Chicago, Illinois 60611-2092. Written comments should be received within 60 days of this notice.
Securities and Exchange Commission (“SEC”).
Notice of application for an order of exemption under section 6(c) of the Investment Company Act of 1940 (“1940 Act”) for exemption from sections 9(a), 13(a), 15(a) and 15(b) of the 1940 Act and Rules 6e-2(b)(15) and 6e-3(T)(b)(15) thereunder.
Applicants seek an order pursuant to section 6(c) of the 1940 Act for exemptions from the provisions of sections 9(a), 13(a) and 15(b) of the 1940 Act and Rules 6e-2(b)(15) and 6e-3(T)(b)(15) thereunder to the extent necessary to permit shares of any current or future series of the Fund and shares of any other investment company that is designed to fund variable insurance products and for which Rafferty Asset Management, LLC (“Rafferty”), or any of its affiliates, may serve now or in the future, as investment adviser (the Fund and such other investment companies referred to collectively as the “Insurance Products Funds”) to be offered and sold to, and held by variable annuity and variable life insurance separate accounts of both affiliated and unaffiliated insurance companies (“Participating insurance Companies”), qualified pension and retirement plans outside of the separate account context (“Qualified Plans”), and Rafferty or any of its affiliates (representing seed money investments in the insurance Products Funds)(“Order”).
Potomac Insurance Trust (“Fund”) and Rafferty Asset Management, LLC (“Rafferty”)
This application was filed on March 24, 2000.
An Order granting the application will be issued unless the Commission orders a hearing. Interested persons may request a hearing is the application or ask to be notified if a hearing is ordered. Any requests must be received by the Commission by 5:30 p.m. on July 17, 2000. You may request a hearing in writing, giving the nature of your interest, the reason for your request, and the issues you contest, and accompany such request with proof of service on the Applicants in the form of an affidavit or, for lawyers, a certificate of service. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.
Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549. Applicants, Daniel D. O'Neill, Esq., Managing Director, Rafferty Asset Management, LLC, 1311 Mamaroneck Avenue, White Plains, New York 10605.
Lorna MacLeod, Senior Counsel, or Keith Carpenter, Branch Chief, Office of Insurance Products, Division of Investment Management, at (202) 942-0670.
The following is a summary of the application, the complete Application is available for a fee from the Commission's Public Reference Branch, 450 Fifth Street, NW., Washington, DC 20549-0102 (tel. (202) 942-8090).
1. The Fund is a Massachusetts business trust registered under the 1940 Act as an open-end management company. The Fund currently is comprised of thirteen separately managed series, each of which has its own investment objective and policies.
2. Rafferty is registered under the Investment Advisers Act of 1940 and serves as the investment adviser for the Fund.
3. Shares of the Insurance Products Funds are or will be offered to separate accounts of Participating Insurance Companies to serve as investment vehicles for variable annuity and variable life insurance contracts (including single, premium, scheduled premium, modified single premium and flexible premium contracts) (collectively, “Variable Contracts”). These separate accounts either will be registered as investment companies under the 1940 Act or will be exempt from such registration. Shares of the Insurance Product Funds also are or will be offered to Qualified Plans.
4. The Participating Insurance Companies establish their own separate accounts and design their own Variable Contracts. Each Participating Insurance Company will have the legal obligation of satisfying all applicable requirements under the federal securities laws. The role of the Insurance Products Funds will be limited to that of offering their shares to separate accounts of Participating Insurance Companies and to Qualified Plans and fulfilling the conditions set forth in the application and described later in this notice. Each Participating Insurance Company will enter into a fund participating agreement with the Insurance Products Fund in which the Participating Insurance Company invests.
1. Applicants request that the Commission issue an order under section 6(c) of the 1940 Act granting exemptions from sections 9(a), 13(a), 15(a) and 15(b) thereof and Rules 6e-2(b)(15) and 6e-3(T)(b)(15) thereunder, to the extent necessary to permit shares of the Insurance Products Funds to be offered and sold to, and held by (a) variable annuity and variable life insurance separate accounts of the same life insurance company or of any affiliated life insurance company (“mixed funding”); (b) separate accounts of unaffiliated life insurance companies (including both variable annuity and variable life separate accounts) (“shared funding”); (c) qualified pension and retirement plans outside the separate account context; and (d) the Adviser or any of its affiliates (representing seed money investments in the Insurance Products Funds).
2. In connection with the funding of scheduled premium variable life insurance contracts issued through a separate account registered under the 1940 Act as a unit investment trust, Rule 6e-2(b)(15) provides partial exemptions from section 9(a), 13(a), 15(a) and 15(b) of the 1940 Act. These
3. In connection with the funding of flexible premium variable life insurance contracts issued through a separate account registered under the 1940 Act as a unit investment trust, Rule 6e-3(T)(b)(15) provides partial exemptions from sections 9(a), 13(a), 15(a) and 15(b) of the 1940 Act. These exemptions are available only where all of the assets of the separate account consists of the shares of one or more registered management investment companies which offer their shares exclusively to separate accounts of the life insurer, or any affiliated life insurance company, offering either scheduled premium variable life insurance contracts or flexible premium variable life insurance contracts, or both; or which also offer their shares to variable annuity separate accounts of the life insurer or of an affiliated life insurance company. Therefore, the exemptions provided by Rule 6e-3(T)(b)(15) are available if the underlying fund is engaged in mixed funding, but are not available if the fund is engaged in shared funding or if the fund sells its shares to Qualified Plans.
4. Applicants state that the current tax law permits the Insurance Products Funds to increase their assets base through the sale of shares to Qualified Plans. Section 817(h) of the Internal Revenue Code of 1986, as amended (the “Code”), imposes certain diversification standards on the underlying assets of Variable Contracts. The Code provides that such contracts shall not be treated as an annuity contract or life insurance contract for any period (and any subsequent period) during which the investments are not adequately diversified in accordance with regulations prescribed by the Treasury Department. Treasury regulations provide that, to meet the diversification requirements, all of the beneficial interests in an investment company must be held by the segregated assets accounts of one or more insurance companies. The regulations do contain certain exceptions to this requirement, however, one of which permits shares of an investment company to be held by the trustee of a qualified pension or retirement plan without adversely affecting the ability of shares in the same investment company also to be held by the separate accounts of insurance companies in connection with their variable annuity and variable life contracts (Treas. Reg. 1.817.5(f)(3)(iii)).
5. Applicants state that the promulgation of Rules 6e-2 and 6e-3(T) preceded the issuance of these Treasury regulations. Applicants assert that, given the then current tax law, the sale of shares of the same underlying fund to separate accounts and to Plans could not have been envisioned at the time of the adoption of rules 6e-2(b)(15) and 6e-3(T)(b)(15).
6. Applicants request relief for a class or classes of persons and transactions consisting of Participating Insurance Companies and their scheduled premium variable life insurance separate accounts and flexible premium variable life insurance separate accounts (and, to the extent necessary, any investment adviser, principal underwriter and depositor of such separate accounts) investing in any of the Insurance Products Funds.
7. Section 6(c) authorizes the Commission to grant exemptions from the provisions of the 1940 Act, and rules thereunder, if and to the extent that an exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the 1940 Act. Applicants assert that the requested exemptions are appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the 1940 Act.
8. Section 9(a)(3) of the 1940 Act provides that it is unlawful for any company to act as investment adviser to or principal underwriter of any registered open-end investment company if an affiliated person of that company is subject to a disqualification enumerated in Sections 9(a)(1) or (2). Rules 6e-2(b)(15)(i) and (ii), and 6c-3(T)(b)(15)(i) and (ii) provide partial exemptions from section 9(a) under certain circumstances, subject to the limitations on mixed and shared funding. These exemptions limit the application of eligibility restrictions to affiliated individuals or companies that directly participate in the management or administration of the underlying investment company.
9. Applicants state that the relief from section 9(a) provided by Rules 6e-2(b)(15) and 6c-3(T)(b)(15), in effect, limits the amount of monitoring necessary to ensure compliance with section 9 to that which is appropriate in light of the policy and purposes of Section 9. Applicants assert that it is not necessary for the protection of investors or the purposes fairly intended by the policy and provisions of the 1940 Act to apply the provisions of section 9(a) to the many individuals who do not directly participate in the administration or management of the Insurance Products Funds, who are employed by the various unaffiliated insurance companies (or affiliated companies of Participating Insurance Companies) that may utilize the Insurance Products Funds as the funding medium for Variable Contracts. Applicants do not expect the Participating Insurance Companies to play any role in the management or administration of the Insurance Products Funds. Applicants assert, therefore, that applying the restrictions of section 9(a) to individuals employed by Participating Insurance Companies serves no regulatory purpose.
10. Applicants state that the relief requested should not be affected by the proposed sale of Insurance Products Funds to Qualified Plans because such plans are not investment companies and will not be deemed affiliates solely by virtue of their shareholdings.
11. Applicants submit that Rule 6e-2(b)(15)(iii) and 6e-3(T)(b)(15)(iii) assume the existence of a “pass-through voting” requirement with respect to management investment company shares held by a separate account. Applicants state that Rule 6e-2(b)(15)(iii) and 6e-3(T)(b)(15)(iii) provide exceptions from the pass-through voting requirements in limited situations, assuming the limitations on mixed and shared funding imposed by the 1940 Act and the rules thereunder are observed. More specifically, Rules 6e-2(b)(15)(iii)(A) and 6e-3(T)(b)(15)(iii)(A) provide that the insurance company may disregard the voting instructions of its contract owners in connection with the voting of shares of an underlying investment company if such instructions would
12. Shares of the Insurances Products funds sold to Qualified Plans will be held by the trustees of such plans as required by section 403(a) of the Employee Retirement Income Security Act of 1974 (“ERISA”). Section 403(a) also provides that the trustees must have exclusive authority and discretion to manage and control the Qualified Plan with two exceptions: (a) when the Qualified Plan expressly provides that the trustees are subject to the direction of a named fiduciary who is not a trustee, in which case the trustees are subject to proper directions made in accordance with the terms of the Qualified Plan and not contrary to ERISA; and (b) when the authority to manage, acquire or dispose of assets of the Qualified Plan is delegated to one or more investment managers pursuant to section 402(c)(3) of ERISA. Unless one of the two exceptions stated in section 403(a) applies, the Qualified Plan trustees have exclusive authority and responsibility for voting proxies. Where a named fiduciary appoints an investment manager, the investment manager has the responsibility to vote the shares held unless the right to vote such shares is reserved to the trustees or the named fiduciary. The Qualified Plans may have their trustees or other fiduciaries exercise voting rights attributable to investment securities held by the Qualified Plans in their discretion. Where a Qualified Plan does not provide its participants with the right to give voting instructions, Applicants state that they do not see any potential for irreconcilable material conflicts of interest between or among Variable Contract holders and Plan participants with respect to voting of the respective Insurance Products Funds shares. Accordingly, Applicants note that, unlike the case with insurance company separate accounts, the issue of the resolution of material irreconcilable conflicts with respect to voting is not present with respect to Qualified Plans since such plans are not entitled to pass-through voting privileges. Even if a Qualified Plan were to hold a controlling interest in an insurance Products Fund, the Applicants do not believe that such control would disadvantage other investors in such Insurance Products Fund to any greater extent than is the case when any institutional shareholder holds a majority of the voting securities of any open-end management investment company. In this regard, the Applicants submit that investment in an Insurance Products Fund by a Qualified Plan will not create any of the voting complications occasioned by mixed funding or shared funding.
13. Applicants state that some of the Qualified Plans may provide for the trustee(s), an investment adviser(s) or another named fiduciary to exercise voting rights in accordance with instructions from Qualified Plan participants. Applicants state that, in such cases, the purchase of shares by such Qualified Plans does not present any complications not otherwise occasioned by mixed or shared funding.
14. Applicants state that no increased conflict of interest would be presented by the granting of the requested relief. Applicants submit that shared funding does not present any issues that do not already exist where a single insurance company is licensed to do business in several states. In this regard, Applicants note that when different Participating Insurance Companies are domiciled in different states, it is possible that the state insurance regulatory body in a state in which one Participating Insurance Company is domiciled could require action that is inconsistent with the requirements of other insurance regulators in one or more other states in which other Participating Insurance Companies are domiciled. The possibility however, is no different or greater than exists when a single insurer and its affiliates offer their insurance products in several states, as is currently permitted.
15. Applicants state that affiliation does not reduce the potential if any exists, for differences in state regulatory requirements. In any event, the conditions set forth in the application and later in this notice (which are adapted from the conditions included in Rule 6e-3(T)(b)(5)) are designed to safeguard against any adverse effects that differences among state regulatory requirements may produce. If a particular sate insurance regulator's decision conflicts with the majority of other state regulators, the affected insurer may be required to withdraw its separate account's investment in the relevant Insurance Products Funds.
16. Applicants also assert that affiliation does not eliminate the potential, if any exists, for divergent judgments as to when a Participating Insurance Company could disregard Variable Contract owner voting instructions. The potential for disagreement is limited by the requirements that disregarding voting instructions be reasonable and based on specified good faith determinations. However, if the Participating Insurance Company's decision to disregard Variable Contract owner voting instructions represents a minority position or would preclude a majority vote approving a particular change, such Participating Insurance Company may be required, at the election of the relevant Insurance Products Fund, to withdraw its separate account's investment in that Insurance Products Fund and no charge or penalty will be imposed upon the Variable Contract owners as a result of such withdrawal.
17. Applicants submit that there is no reason why the investment policies of an Insurance Products Fund with mixed funding would or should be materially different from what those policies would or should be if such Insurance Products Fund or series thereof funded only variable annuity or variable life insurance contracts. In this regard, Applicants note that a fund's adviser is legally obligated to manage the fund in accordance with the fund's investment objectives, policies and restrictions as well as any guidelines established by the fund's board. Applicants submit that no one investment strategy can be identified as appropriate to a particular insurance product or to a Plan. Each pool of variable annuity and variable life insurance contract owners is composed of individuals of diverse financial status, age, insurance and investment goals. A fund supporting even one type of insurance product must accommodate these diverse factors in order to attract and retain purchasers. Applicants submit that permitting mixed and shared funding will provide economic support for the continuation of the Insurance Products Funds. In addition, permitting mixed and shared funding also will facilitate the establishment of additional series of Insurance Product Funds serving diverse goals.
18. As noted above, section 817(h) of the Code imposes certain diversification standards on the underlying assets of variable annuity contracts and variable
19. While there are differences in the manner in which distributions are taxed for variable annuity contracts, variable life insurance contracts and Qualified Plans, Applicants state that the tax consequences do not raise any conflict of interests. When distributions are to be made, and the separate account of the Participating Insurance Company or Qualified Plan cannot net purchase payments to make the distributions, the separate account or Qualified Plan will redeem shares of the Insurance Products Funds at their respective net asset values. The Qualified Plan will then make distributions in accordance with the terms of the Qualified Plan and the Participating Insurance Company will make distributions in accordance with the terms of the Variable Contract.
20. Applicants submit that the ability of the Insurance Products Funds to sell their respective shares directly to Qualified Plans does not create a “senior security,” as such term is defined under section 18(g) of the 1940 Act, with respect to any Variable Contract owner as opposed to a participant under a Qualified Plan. As noted above, regardless of the rights and benefits of participants under the Qualified Plans, or Variable Contract owners under their Variable Contracts, the Qualified Plans and the separate accounts of Participating Insurance Companies have rights only with respect to their respective shares of the Insurance Products Funds. They can redeem such shares at their net asset value. No shareholder of any of the Insurance Products Funds has any preference over any other shareholder with respect to distribution of assets or payments of dividends.
21. Applicants assert that there are no conflicts between the Variable Contract owners and the Plan participants with respect to state insurance commissioners' veto powers over investment objectives. The basic premise of shareholder voting is that not all shareholders may agree with a particular proposal. While time-consuming, complex transactions must be undertaken to accomplish redemptions and transfers by separate accounts, trustees of Qualified Plans can quickly redeem shares from Insurance Products Funds and reinvest in other funding vehicles without the same regulatory impediments or, as in the case with most Qualified Plans, even hold cash or other liquid assets pending suitable alternative investment. Applicants maintain that even if there should arise issues where the interest of Variable Contract owners and the interests of participants in Plans are in conflict, the issues can be almost immediately resolved because the trustees of the Plans can, on their own, redeem shares out of the Insurance Products Funds.
22. Applicants submit that mixed and shared funding should provide benefits to Variable Contract owners by eliminating a significant portion of the costs of establishing and administering separate funds. Participating Insurance Companies will benefit not only from the investment and administrative expertise of the Adviser and any sub-advisers, but also from the cost efficiencies and investment flexibility afforded by a larger pool of assets. Mixed and shared funding also would permit a greater amount of assets available for investment by the Insurance Products Funds, thereby promoting economics of scale, by permitting increased safety through greater diversification and by making the addition of new series more feasible. Therefore, making the Insurance Products Funds available for mixed and shared funding will encourage more insurance companies to offer Variable Contracts, and this should result in increased competition with respect to both Variable Contract design and pricing, which can be expected to result in more product variation and lower charges.
To the extent required by the Commission, Applicants consent to the following conditions.
1. A majority of each Insurance Products Fund's Board of Trustees or Directors (each, a “Board”) shall consist of persons who are not “interested persons” thereof, as defined by Section 2(a)(19) of the 1940 Act and the Rules thereunder, and as modified by any applicable orders of the Commission, except that if this condition is not met by reason of the death, disqualification, or bona fide resignation of any Board member, then the operation of this condition shall be suspended: (a) For a period of 45 days, if the vacancy or vacancies may be filled by the Board; (b) for a period of 60 days, if a vote of shareholders is required to fill the vacancy or vacancies; or (c) for such longer period as the Commission may prescribe by order upon application.
2. Each Board will monitor its respective Insurance Products Funds for the existence of any material irreconcilable conflict between and among the interests of the Variable Contract owners of all Participating Separate Accounts and Qualified Plans participants investing in the Insurance Products Funds, and determine what action, if any, should be taken in response to such conflicts. A material irreconcilable conflict may arise for a variety of reasons, including: (a) An action by any state insurance regulatory authority; (b) a change in applicable federal or state insurance, tax, or securities laws or regulations, or a public ruling, private letter ruling, no-action or interpretive letter, or any similar action by insurance, tax, or securities regulatory authorities; (c) an administrative or judicial decision in any relevant proceeding; (d) the manner in which the investments of the Insurance Products Funds are being managed; (e) a difference in voting instructions given by variable annuity contract owners and variable life insurance contract owners and trustees of the Qualified Plans; (f) a decision by a Participating Insurance Company to disregard the voting instructions of contract owners; or (g) if applicable, a decision by a Qualified Plan to disregard the voting instructions of its participants.
3. Rafferty (or any other investment adviser of an Insurance Products Fund), any Participating Insurance Company and any Qualified Plan that executes a fund participating agreement upon becoming an owner of 10% or more of an Insurance Product Fund (“Participants”) will report any potential or existing conflicts to the Board of any relevant Insurance Products Fund. Participants will be obligated to assist the appropriate Board in carrying out its responsibilities under these conditions by providing the Board with all information reasonably necessary for the Board to consider any issues raised. This responsibility includes, but is not limited to, an obligation of each Participating Insurance Company to inform the Board whenever Variable Contract owner voting instructions are disregarded and, if pass-through voting is applicable, an obligation by each Qualified Plan to
4. If a majority of an Insurance Products Fund's Board members, or a majority of the disinterested Board members, determine that a material irreconcilable conflict exists, the relevant Participating Insurance Companies and Qualified Plans, at their expense and to the extent reasonably practicable (as determined by a majority of the disinterested Board members), shall take whatever steps are necessary to remedy or eliminate the material irreconcilable conflict, including: (a) Withdrawing the assets allocable to some or all of the Participating Separate Accounts from the Insurance Products Fund or any series thereof and reinvesting such assets in a different investment medium, which may include another series of an Insurance Products Fund; (b) in the case of Participating Insurance Companies, submitting the question of whether such segregation should be implemented to a vote of all affected Variable Contract owners and, as appropriate, segregating the assets of any appropriate group (
The responsibility to take remedial action in the event of a Board determination of a material irreconcilable conflict and to bear the cost of such remedial action shall be a contractual obligation of all Participating Insurance Companies and Qualified Plans under their agreements governing participation in the Insurance Products Funds and these responsibilities shall be carried out with a view only to the interests of the Variable Contract owners and, as applicable, Qualified Plan participants.
For purposes of this Condition 4, a majority of the disinterested members of the applicable Board shall determine whether or not any proposed action adequately remedies any material irreconcilable conflict, but in no event will the Insurance Products Fund or Rafferty (or any other investment adviser of the Insurance Products Funds) be required to establish a new funding medium for any Variable Contract. No Participating Insurance Company shall be required by this Condition 4 to establish a new funding medium for any Variable Contract if a majority of Variable Contract owners materially and adversely affected by the material irreconcilable conflict vote to decline such offer. No Qualified Plan shall be required by Condition 4 to establish a new funding medium for such Qualified Plan if (a) a majority of Qualified Plan participants materially and adversely affected by the material irreconcilable conflict vote to decline such offer or (b) pursuant to governing Qualified Plan documents and applicable law, the Qualified Plan makes such decision without Qualified Plan participant vote.
5. Participants will be informed promptly in writing of a Board's determination of existence of a material irreconcilable conflict and its implications.
6. Participating Insurance Companies will provide pass-through voting privileges to all Variable Contract owners so long as the Commission interprets the 1940 Act to require pass-through voting for Variable Contracts owners. Accordingly, such Participating Insurance Companies, where applicable, will vote shares of the Insurance Products Fund held in their Participating Separate Accounts in a manner consistent with voting instructions timely received from Variable Contract owners. In addition, each Participating Insurance Company will vote shares of the Insurance Products Fund held in its Participating Separate Account for which it has not received timely voting instructions from Variable Contract owners, as well as shares it owns, in the same proportion as those shares for which it has received voting instructions. Participating Insurance Companies will be responsible for assuring that each of their Participating Separate Accounts investing in an Insurance Products Fund calculates voting privileges in a manner consistent with all other Participating Insurance Companies. The obligation to vote an Insurance Products Fund's shares and calculate voting privileges in a manner consistent with all other separate accounts investing in the Insurance Products Fund will be a contractual obligation of all Participating Insurance Companies under the agreements governing participating in the Insurance Products Fund. Each Qualified Plan will vote as required by applicable law and governing Qualified Plan documents.
7. As long as the Commission continues to interpret the 1940 Act as requiring pass-through voting privileges for Variable Contract owners, Rafferty (or any of its affiliates) will vote its shares in any series of any Insurance Products Fund in the same proportion as all Variable Contract owners having voting rights with respect to that series; provided, however, that Rafferty (or any of its affiliates) shall vote its shares in such other manner as may be required by the Commission or its staff.
8. All reports of potential or existing conflicts received by a Board, and all Board action with regard to (a) Determining the existence of a conflict, (b) notifying Participants of a conflict and (c) determining whether any proposed action adequately remedies a conflict, will be properly recorded in the minutes of the meetings of the appropriate Board or other appropriate records. Such minutes or other records shall be made available to the Commission upon request.
9. Each Insurance Products Fund will notify all Participating Insurance Companies that separate account prospectus disclosure regarding the potential risks of mixed and shared funding may be appropriate. Each Insurance Products Fund shall disclose in its prospectus that: (a) Its shares may be offered to insurance company separate accounts that fund both variable annuity and variable life
10. Each Insurance Products fund will comply with all provisions of the 1940 Act requiring voting by shareholders (for these purposes, the persons having a voting interest in shares of the Insurance Products Fund). In particular, each such Insurance Products Fund either will provide for annual shareholder meetings (except insofar as the Commission may interpret Section 16 of the 1940 Act not to require such meetings) or comply with section 16(c) of the 1940 Act (although none of the Insurance Products Fund shall be one of the trusts described in section 16(c) of the 1940 Act), as well as with sections 16(a) of the 1940 Act and, if and when applicable, section 16(b) of the 1940 Act. Further, each insurance Products Fund will act in accordance with the Commission's interpretation of the requirements of section 16(a) with respect to periodic elections of Board members and with whatever rules the Commission may promulgate with respect thereto.
11. If and to the extent that Rules 6e-2 and 6e-3(T) are amended, or Rule 6e-3 under the 1940 Act is adopted, to provide exemptive relief from any provision of the 1940 Act, or the rules promulgated thereunder, with respect to mixed or shared funding, on terms and conditions materially different from any exemptions granted in the Order requested in this Application, then the Insurance Products Funds and/or Participants, as appropriate, shall take such steps as may be necessary to comply with Rules 6e-2 and 6e-3(T), as amended, and Rule 6e-3, as adopted, to the extent such Rules are applicable.
12. The Participants, at least annually, shall submit to the Board such reports, materials, or data as the Board may reasonably request so that such Board may fully carry out the obligations imposed upon them by the conditions stated in this Application. Such reports, materials, and data shall be submitted more frequently if deemed appropriate by the applicable Board. The obligations of the Participants to provide these reports, materials, and data to the Boards shall be a contractual obligation of all Participants under the agreements governing their participation in the Insurance Products Funds.
13. If a Qualified Plan or Qualified Plan participant should become an owner of 10% or more of the assets of an Insurance Products Fund, such Qualified Plan will execute a fund participation agreement which includes the conditions set forth herein to the extent applicable. A Qualified Plan or Qualified Plan participant will execute an application containing an acknowledgment of this condition upon such plan's initial purchase of shares of any Insurance Products Fund.
For the reasons stated above, Applicants believe that the requested exemptions, in accordance with the standards of section 6(c) of the 1940 Act, are appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the 1940 Act.
For the Commission, by the Division of Investment Management, pursuant to delegated authority.
In compliance with Public Law 104-13, the Paperwork Reduction Act of 1995, SSA is providing notice of its information collections that require submission to the Office of Management and Budget (OMB). 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 on ways to minimize burden on respondents, including the use of automated collection techniques or other forms of information technology.
I. The information collections listed below will be submitted to OMB within 60 days from the date of this notice. Therefore, comments and recommendations regarding the information collections would be most useful if received by the Agency within 60 days from the date of this publication. Comments should be directed to the SSA Reports Clearance Officer at the address listed at the end of this publication. You can obtain a copy of the collection instruments by calling the SSA Reports Clearance Officer on (410) 965-4145, or by writing to him at the address listed at the end of this publication.
1. Application for Lump Sum Death Payment—0960-0013. The information collected on form SSA-8 by the Social Security Administration is required to authorize payment of a lump-sum death benefit to a widow, widower, or children as defined in Section 202(i) of the Social Security Act. The respondents are widows, widowers or children who apply for a lump-sum death payment.
2. Application for Special Age 72-or-Over Monthly Payments—0960-0096. Form SSA-19-F6 is needed by the Social Security Administration (SSA) to determine whether an individual is entitled to Special Age-72 payments. Eligibility requirements will be evaluated by the data collected on this form. The respondents are individuals who attained age 72 before 1972.
3. Request for Self-Employment Information, Request for Employee Information, Request for Employer Information_0960-0508. SSA needs the information collected on Forms SSA-L2765, SSA-L3365 and SSA-L4002 in order to credit the reported earnings to the proper earnings record. When W-2 wage data for an individual cannot be identified, the data are placed in the earnings suspense file, and SSA sends decentralized correspondence (DECOR) to the employee (in certain instances to the employer) in an attempt to obtain his/her correct name and SSN. The respondents are employees, employers or self-employed individuals being requested to furnish additional information for individuals for whom earnings were reported.
4. State Agency Report of Obligations for SSA Disability Programs_0960-0421. The data collected on Form SSA-4513 are necessary for detailed analysis and evolution of costs incurred by Disability Determination Services (DDS) in making disability determinations for SSA. The data collected also help to
5. Statement For Determining Continuing Eligibility or Supplemental Security Income Payments—0960-0416. Form SSA-8203-BK (printed in both English and Spanish) is used by SSA for high-error-profile (HEP) redeterminations. It is completed in field offices by personal contact (face-to-face or telephone interview) and is not supposed to be mailed to recipients to be completed and returned. The form is used only when a systems limitation prevents the interview from being conducted using the automated Modernized SSI Claim System. A tear-off sheet (Pages 7 and 8 of the form) is given to recipients at the conclusion of a face-to-face interview or is mailed to recipients at the completion of the telephone interview. The tear-off includes information about how, what, when, where, and why Supplemental Security Income (SSI) recipients report when there is a change in income, resources, or living arrangements. The respondents are recipients of title XVI SSI benefits.
II. The information collections listed below have been submitted to OMB for clearance. Written comments and recommendations on the information collections would be most useful if received within 30 days from the date of this publication. Comments should be directed to the SSA Reports Clearance Officer and the OMB Desk Officer at the addresses listed at the end of this publication. You can obtain a copy of the OMB clearance packages by calling the SSA Reports Clearance Officer on (410) 965-4145, or by writing to him.
1. Supplement to Claim of Person Outside the United States—0960-0051. The information collected on Form SSA-21 is used by the Social Security Administration (SSA) to determine continuing entitlement to Social Security benefits and the proper benefit amounts of alien beneficiaries living outside the United States (U.S.). It is also used to determine whether benefits are subject to withholding tax. The respondents are comprised of individuals entitled to Social Security benefits, who are, will be, or have been residing outside the U.S.
2. Statement of Care and Responsibility for Beneficiary—0960-0109. SSA uses Form SSA-788 to select the most qualified representative payee who will apply the benefits in the beneficiary's best interests. The respondents are individuals who have custody of a beneficiary where someone else has filed to be the beneficiary's payee.
The Office of Global Educational Programs of the Bureau of Educational and Cultural Affairs in the Department of State announces an open competition for an assistance award program. Accredited, post-secondary educational institutions meeting the provisions described in IRS regulation 26 CFR 1.5019(C) may apply to pursue institutional or departmental objectives in partnership with foreign counterpart institutions with support from the College and University Affiliations Program. These objectives should support the overall goal of the Program: to strengthen mutual understanding and cooperation among U.S. and foreign educational institutions on specified themes of common interest to the United States and to the participating colleges and universities. The means for achieving the objectives of the applicant and its partner(s) may include teaching, scholarship, and outreach to professionals and other members of the communities served by the participating institutions.
Underlying the specific institutional objectives of projects funded by this program should be the goals of encouraging the growth of freedom and democracy, economic stability and prosperity, or environmental cooperation. Innovative strategies to address these underlying concerns in the pursuit of clearly defined institutional objectives are encouraged. Outreach from academic institutions to larger communities of citizens and practitioners to extend understanding about these issues is also encouraged.
The Bureau supports institutional linkages in higher education through the College and University Affiliations Program, for which this Request for Proposals invites applications for funding in FY2001. The College and University Affiliations Program operates in cooperation with the Fulbright Senior Scholar Program; the U.S. institutions of current and former participants in the Fulbright Program are encouraged to apply. Other college and university teachers and administrators with knowledge of educational institutions in other countries are also encouraged to build on this knowledge with support from the Bureau through the College and University Affiliations Program.
Separate Requests for Proposals for institutional linkages in higher education with the New Independent States of the former Soviet Union (N.I.S. College and University Partnerships Program and the N.I.S. Community College Partnerships Program) are being published this fiscal year. For further information about these N.I.S. programs, refer to the “Foreign Country and Location Eligibility” section of this solicitation.
While the benefits of the project to each of the participating institutions may differ significantly in nature and scope, proposals should outline well-reasoned strategies leading to specific objectives for each participating U.S. and foreign department or institution as a whole.
For example, proposals may describe the parameters and possible content of new courses, new research or teaching capacities or methodologies, new or
Partner institutions may pursue their institutional objectives through exchanges of teachers, researchers, administrators or, in limited circumstances, students for any appropriate combination of teaching, consultation, research, and outreach. The length of time for each exchange may range from one week to an academic year. The strategy for achieving project objectives may include exchange visits in one or both directions, but no single formula is prescribed for the duration, sequence, or number of these visits. Visits of one semester or more for participants from at least one of the institutional partners are strongly encouraged. The number of visits of less than two weeks' duration should not exceed one visit in each direction over the course of the project. To provide adequate time to meet institutional project objectives, the Program awards grants for periods of approximately three years (36 months to 40 months).
Although strong budgetary and programmatic emphasis may be given to visits in one direction over another, the benefits of all these visits to the sending as well as the receiving sides should be clearly explained. Exchange visits for the purpose of attending conferences are not encouraged except in combination with other grant activities and in support of specific educational objectives at one or more of the participating institutions.
In addition to demonstrating how each participating institution can assist its partner(s) to meet institutional goals, proposals should also explain how this cooperation will enable each of the institutions to address its own needs. Accordingly, applicants are encouraged to describe the needs and deficiencies as well as the strengths and capabilities of each participating department and institution. Proposals that realistically assess institutional capacities will be better able to justify the request for support. Effective proposals will demonstrate that the proposed partnership institutions understand one another and are committed to support and cooperate with one another in project implementation. Accordingly, proposals should reflect substantial awareness of the foreign as well as the U.S. partner(s). Proposals that benefit only one institutional partner are not eligible for funding.
If the proposed partnership would occur within the context of a previous or ongoing project, the proposal should explain how the request for Bureau funding would build upon the pre-existing relationship or complement previous and concurrent projects, which must be listed and described with details about the amounts and sources of external support. Previous projects should be described in the proposal, and the results of the evaluation of previous cooperative efforts should be summarized.
Proposals should outline and budget for a methodology for project evaluation. The evaluation plan should include an updated assessment of the current status of each participating department's and institution's needs at the time of program inception; ongoing formative evaluation to allow for mid-course revisions in the implementation strategy; and, at the conclusion of the project, summative evaluation of the degree to which the project's objectives have been achieved together with observations about the project's influence within the participating institutions and their surrounding communities or societies. The final evaluation should also include recommendations about how to build upon project achievements, both with and without the Bureau's support. Evaluative observations by external consultants with appropriate subject or regional expertise are especially encouraged.
The commitment of all partner institutions to the proposed project should be reflected in the cost-sharing which they offer in the context of their respective institutional capacities. Although the contributions offered by U.S. and foreign institutions with relatively few resources may be less than those offered by applicants with greater resources at their disposal, all participating institutions are expected to identify costs that they will contribute. These costs may include the estimated costs of in-kind contributions. Consistent with the “Review Criteria” for this competition listed elsewhere in this document and with specific reference to “Cost-Sharing” and “Institutional Commitment to Cooperation,” proposed cost-sharing will be considered an important indicator of each participating institution's interest in the project and of the institution's potential to benefit from it.
Proposals must be submitted by the U.S. institutional partner and must include letters of commitment from all institutional partners. The letters should be signed by persons authorized to commit institutional resources to the project.
The Bureau's support may be used to defray the costs of the exchange visits as well as the costs (up to a maximum of 20 percent of the total grant) of the administration of the project at any partner institution, including administrative salaries and direct administrative costs but excluding indirect costs. Although the grants will be awarded to the lead U.S. institutional partner, adequate provision in the proposal for the administrative costs of the project at all partner institutions, including the foreign partner(s), is encouraged.
Administrative salaries may include salary support for project directors and administrative assistants for administrative activity within the 20 percent maximum that may be allocated to administrative costs, but the Bureau will not fund salaries, stipends, or honoraria for program participants. However, in proposals for Sub-Saharan Africa, faculty replacement costs are allowable once in a three-year grant period if they facilitate the work of a U.S. faculty member at an African partner institution for one quarter or one semester. (See sections of this document on “U.S. Partner and Participant Eligibility” and “Foreign Partner and Participant Eligibility” for additional details.) The fees of outside consultants reporting on the degree to which project objectives have been achieved are allowable as a program expense.
The proposal may include a request for funding to reinforce the activities of exchange participants through the establishment and maintenance of Internet and/or electronic mail communication facilities as well as through interactive technology or non-technology-based distance-learning programs. However, projects focusing primarily on technology or physical infrastructure development are not encouraged. Proposals that include Internet, electronic mail, and other interactive technologies should discuss how the foreign partner institution will support the costs of such technologies after the project ends. Applicants may propose other project activities not specifically mentioned in this solicitation if the activities reinforce the impact of the project.
With the exception of projects with Sub-Saharan Africa, the maximum award in the FY2001 competition will be $120,000; for projects with Sub-Saharan Africa, the maximum award will be $180,000. Requests for amounts smaller than the maximum are eligible.
Grants are subject to the availability of funds for Fiscal Year 2001. The amount of funding available for proposals to the College and University Affiliations Program in FY2001 has not yet been determined. In Fiscal Year 1999, 66 eligible proposals were submitted to the College and University Affiliations Program, and 17 awards were made. The response to Requests for Proposals to the Bureau to support institutional linkages in higher education has been unusually strong in recent years and, except for Sub-Saharan Africa and the New Independent States of the former Soviet Union, the funds available have fallen significantly short of the demand for them.
However, additional funding may be available in Fiscal Year 2001 to award a limited number of grants under the College and University Affiliations Program to enable current and former Fulbright scholars to build on their experiences as individual Fulbright grantees through broadened institutional cooperation.
Eligible fields are the social, political, and economic sciences; environmental studies; law; business; public administration; and educational development or administration (excluding educational projects in the physical, technical, or health sciences, as well as the Teaching of English as a Foreign Language). Within the eligible fields, themes of special interest are described in additional detail in this document under the heading “Foreign Country and Location Eligibility.”
In the United States, participation in the program is open to accredited two-and four-year colleges and universities, including graduate schools. Applications from community colleges, minority-serving institutions, undergraduate liberal arts colleges, research universities, and combinations of these types of institutions are eligible. Applications from consortia or other combinations of U.S. colleges and universities are eligible. Secondary U.S. partners may include non-governmental organizations as well as non-profit service and professional organizations. The lead U.S. organization in the consortium or other combination of cooperating institutions is responsible for submitting the application. Each application must document the lead organization's authority to represent all U.S. cooperating partners.
With the exception of outside consultants reporting on the degree to which project objectives have been achieved, participants representing the U.S. institution who are traveling under the Bureau's grant funds must be teachers, graduate student teaching or research assistants, or administrators from the participating institution(s). Participants representing the U.S. institution must be U.S. citizens. Graduate student teaching or research assistants are eligible for Bureau-funded participation in this program only if they are working under the direction of an accompanying faculty participant or project director on the achievement of project objectives.
In other countries, participation is open to recognized institutions of post-secondary education, which may include independent research institutes. Secondary foreign partners may include relevant governmental and non-governmental organizations, as well as non-profit service and professional organizations.
With the exception of outside consultants reporting on the degree to which project objectives have been achieved, participants representing the foreign institutions must be teachers, administrators, or student teaching or research assistants who are working under the supervision of an accompanying faculty participant or project director on the achievement of project objectives. Foreign participants must be citizens, nationals, or permanent residents of the country of the foreign partner and must be qualified to hold a valid passport and a U.S. J-1 visa.
To increase the chances that competitive proposals can be funded, the number of eligible countries and locations is limited. However, country eligibility is expected to rotate within most of the following seven world regions according to a three-year cycle as outlined below. Countries may be added to the countries listed for FY2002 and FY2003; countries listed as anticipated for eligibility are expected to be eligible in the year(s) for which they are listed. Separate Requests for Proposals will be issued in the spring of 2001 for FY2002 and in the spring of 2002 for FY2003.
Eligible for FY2001: Benin, Burkina Faso, Cameroon, Chad, Cote d'Ivoire, Ghana, Guinea, Madagascar, Mali, Mauritius, Niger, Nigeria, Senegal, South Africa, Togo, and Rwanda. In addition, multilateral proposals involving institutions in not more than four of the following countries are also eligible: Benin, Burkina Faso, Cameroon, Chad, Cote d'Ivoire, Guinea, Madagascar, Mali, Mauritius, Niger, Senegal, Togo, and Rwanda. These proposals should clearly outline a pattern of involvement and cooperation with all the participating African institutions and should indicate anticipated benefits to all the institutional partners.
Anticipated eligibility for FY2002: Kenya, Mozambique, Namibia, Nigeria, Tanzania, Uganda, and Zimbabwe. Subjects to be determined.
Anticipated eligibility for FY2003: Countries and subjects to be determined.
Eligible for FY2001: Argentina, Barbados, Brazil, Chile, Jamaica, Paraguay, Trinidad and Tobago, and Uruguay.
In addition to bilateral proposals with any one of these countries, proposals for projects involving educational institutions in two or more countries belonging to the South American
Anticipated Eligibility for FY2002: Costa Rica, El Salvador, Mexico, Guatemala, Honduras, Nicaragua, Panama, and trilateral projects including both Canada and Mexico. Subjects to be determined.
Anticipated Eligibility for FY2003: Bolivia, Colombia, Dominican Republic, Ecuador, Haiti, Peru, and Venezuela. Subjects to be determined.
Eligible for FY2001: China, Indonesia, Malaysia, Philippines, Thailand, and Vietnam.
Anticipated Eligibility for FY2002: China, Korea, Mongolia, and Taiwan. Subjects to be determined.
Anticipated Eligibility for FY2003: Cambodia, China, Indonesia, and Laos. Subjects to be determined.
Eligible for FY2001: Albania, Bosnia and Herzegovina, Croatia, Hungary, Slovakia, Slovenia, and Turkey.
Anticipated Eligibility for FY 2002: Bulgaria, Czech Republic, Estonia, Latvia, and Lithuania. Subjects to be determined.
Anticipated Eligibility for FY2003: Former Yugoslav Republic of Macedonia, Poland, and Romania. Subjects to be determined.
Eligible for FY2001: Egypt, Gaza, Israel, Jordan, Tunisia, West Bank, and Morocco.
Anticipated Eligibility for FY2002: Bahrain, Lebanon, Syria, and Tunisia. Subjects to be determined.
Anticipated Eligibility for FY2003: Algeria, Gaza, Qatar, Saudi Arabia, and West Bank. Subjects to be determined.
Eligible for FY2001: India, Nepal, and Sri Lanka.
Anticipated Eligibility for FY2002: India, Pakistan, and Bangladesh. Subjects to be determined.
Anticipated Eligibility for FY2003: Countries and subjects to be determined.
A proposal may be deemed technically ineligible if:
(1) It does not fully adhere to the guidelines established herein and in the Solicitation Package;
(2) It is not received by the deadline;
(3) It is not submitted by the U.S. partner;
(4) One of the partner institutions is ineligible;
(5) The foreign country or geographic location is ineligible;
(6) It involves a request to fund exchanges between the United States and more than one other country with the exceptions noted in the sections on country eligibility for the Western Hemisphere and for Sub-Saharan Africa.
(7) The amount requested from the Bureau exceeds $120,000 with the exception of proposals for Sub-Sahara Africa, where the maximum is $180,000.
Overall grant-making authority for this program is contained in the Mutual Educational and Cultural Exchange Act of 1961, Public Law 87-256, as amended, also known as the Fulbright-Hays Act. The purpose of the Act is “to enable the Government of the United States to increase mutual understanding between the people of the United States and the people of other countries * * *; to strengthen the ties which unite us with other nations by demonstrating the educational and cultural interests, developments, and achievements of the people of the United States and other nations * * * and thus to assist in the development of friendly, sympathetic and peaceful relations between the United States and the other countries of the world.” The funding authority for the program cited above is provided through the
Projects must conform with the Bureau's requirements and guidelines outlined in the solicitation package for this RFP, which can be obtained by following the instructions given in the section below entitled “For Further Information.” The “Project Objectives, Goals, and Implementation” (hereafter, POGI) and the “Project Specific Instructions (hereafter, PSI), which contain additional guidelines, are included in the Solicitation Package. Proposals that do not follow RFP requirements and the guidelines appearing in the POGI and PSI may be excluded from consideration due to technical ineligibility.
All communications with the Bureau concerning this announcement should refer to the College and University Affiliations Program and reference number ECA/A/S/U-01-02.
All copies must be received at the Bureau of Educational and Cultural Affairs by 5 p.m. Washington, D.C. time on Monday, November 13, 2000. Faxed documents will not be accepted, nor will documents postmarked on Monday, November 13, 2000 but received on a later date.
Contact the Humphrey Fellowships and Institutional Linkages Branch (College and University Affiliations Program); Office of Global Educational Programs; Bureau of Educational and Cultural Affairs; ECA/A/S/U, Room 349; U.S. Department of State; SA-44, 301 Fourth Street, S.W.; Washington, D.C. 20547; phone: (202) 619-5289, fax: (202) 401-1433. Applicants may also send a message to affiliation@pd.state.gov to request a Solicitation Package. The Solicitation Package includes more detailed award criteria; all application forms; and guidelines for preparing proposals, including specific criteria for preparation of the proposal budget.
The entire Solicitation Package may be downloaded from the Bureau's website at
Please read all information before downloading.
Please specify “College and University Affiliations Program Officer” on all inquiries and correspondence. Prospective applicants should read the complete
Applicants must follow all instructions given in the Solicitation Package. The original and 10 copies of the complete application should be sent to:
All copies should include the documents specified under Tabs A through E in the “Project Objectives, Goals, and Implementation” (POGI) section of the Solicitation Package. The documents under Tab F of the POGI should be submitted with the original application and with one of the ten copies.
Applicants must also submit the “Executive Summary” and “Proposal Narrative” sections of the proposal on a 3.5″ diskette, formatted for DOS. This material must be provided in ASCII text (DOS) format with a maximum line length of 65 characters. The Bureau will transmit these files electronically to the Public Affairs Sections at U.S. Embassies for review, with the goal of reducing the time needed to make the comments of overseas posts available in the Bureau's grant review process.
Pursuant to the Bureau's authorizing legislation, projects must maintain a non-political character and should be balanced and representative of the diversity of American political, social, and cultural life. “Diversity” should be interpreted in the broadest sense and encompass differences including, but not limited to ethnicity, race, gender, religion, geographic location, socio-economic status, and physical challenges. Applicants are strongly encouraged to adhere to the advancement of this principle both in program administration and in program content. Please refer to the review criteria under the “Support for Diversity” section for specific suggestions on incorporating diversity into the total proposal. Public Law 104-319 provides that “in carrying out programs of educational and cultural exchange in countries whose people do not fully enjoy freedom and democracy,” the Bureau “shall take appropriate steps to provide opportunities for participation in such programs to human rights and democracy leaders of such countries.” Proposals should account for advancement of this goal, in their program contents, to the full extent deemed feasible.
The Year 2000 (Y2K) issue is a broad operational and accounting problem that could potentially prohibit organizations from processing information in accordance with Federal management and program specific requirements including data exchange with the Department of State. The inability to process information in accordance with Federal requirements could result in grantees' being required to return funds that have not been accounted for properly.
The Department of State therefore requires all organizations use Y2K compliant systems including hardware, software, and firmware. Systems must accurately process data and dates (calculating, comparing and sequencing) both before and after the beginning of the year 2000 and correctly adjust for leap years.
Additional information addressing the Y2K issue may be found at the General Services Administration's Office of Information Technology website at http://www.itpolicy.gsa.gov.
The Bureau will acknowledge receipt of all proposals and will review them for technical eligibility. Proposals will be deemed ineligible if they do not fully adhere to the guidelines stated herein and in the Solicitation Package. All eligible proposals will be evaluated by independent external reviewers. In addition, all eligible proposals will be reviewed by internal Bureau and U.S. Embassy or Fulbright Commission officers for non-binding advisory comment.
The independent external reviewers, who will be professional, scholarly, or educational experts with appropriate regional and thematic knowledge, will provide recommendations and assessments for consideration by the Bureau. The Bureau will consider for funding only those proposals which are recommended for further consideration by the independent external reviewers.
Proposals may also be reviewed by the Office of the Legal Advisor or by other offices of the U.S. Department of State. Funding decisions will be made at the discretion of the Under Secretary of State for Public Diplomacy and Public Affairs. Final technical authority for assistance awards (grants or cooperative agreements) will reside with a contracts officer with competency for Bureau programs.
All reviewers will use the criteria below to reach funding recommendations and decisions. Technically eligible applications will be reviewed competitively according to these criteria, which are not rank-ordered or weighted.
(1) Broad Significance of Institutional Objectives: Project objectives should have significant but realistically anticipated ongoing consequences for the participating institutions and for their surrounding societies or communities through a deepened mutual understanding of one another and of issues pertaining to freedom and democracy, economic stability and prosperity, or environmental cooperation.
(2) Clarity and Relevance of Project Objectives to Institutional Needs: Proposed projects should outline clearly formulated objectives that relate specifically to the needs of the participating institutions.
(3) Creativity and Feasibility of Strategy to Achieve Project Objectives: Strategies to achieve project objectives should demonstrate the feasibility of doing so during a three-year period by utilizing and reinforcing exchange activities realistically and with creativity.
(4) Institutional Commitment to Cooperation: Proposals should demonstrate significant understanding at each institution of its own needs and capacities and of the needs and capacities of its proposed partner(s), together with a strong commitment, during and after the period of grant activity, to cooperate with one another in the mutual pursuit of institutional objectives.
(5) Project Evaluation: Proposals should outline a methodology for determining the degree to which a project meets its objectives, both while the project is underway and at its conclusion. The final project evaluation should include an external component and should provide observations about the project's influence within the participating institutions as well as their surrounding communities or societies.
(6) Cost-effectiveness: Administrative and program costs should be reasonable and appropriate with cost-sharing provided by all participating institutions within the context of their respective capacities and as a reflection of their commitment to cooperate with one another in pursuing project objectives. Although indirect costs are eligible for inclusion as cost-sharing by the applicant, contributions should not be limited to indirect costs.
(7) Support of Diversity: Proposals should demonstrate substantive support of the Bureau's policy on diversity by explaining how issues of diversity relate thematically to project objectives for all institutional partners and how these issues will be addressed during project implementation. Proposals should also outline the institutional profile of each participating institution with regard to issues of diversity.
The terms and conditions published in this RFP are binding and may not be modified by any State Department representative. Explanatory information provided by the Department of State that contradicts published language will not be binding. Issuance of the RFP does not constitute an award commitment on the part of the Government. The Bureau reserves the right to reduce, revise, or increase proposal budgets in accordance with the needs of the program and the availability of funds. Awards made will be subject to periodic reporting and evaluation requirements.
Final awards cannot be made until funds have been appropriated by Congress, allocated and committed through internal Bureau procedures.
The Office of Global Educational Programs of the Bureau of Educational and Cultural Affairs in the Department of State announces an open competition for an award program to assist Meio University, Okinawa, Japan, in strengthening its curriculum in convention and conference management in ways that will contribute to the prefecture's long-term international development goals and to building closer U.S.-Japanese people-to-people relations in Okinawa. Accredited, post-secondary educational institutions meeting the provisions described in IRS regulation 26 CFR 1.501(c) may submit proposals that address this objective. The means for achieving this objective may include teaching, distance learning, practicums and student internships of up to 12 months, and professional outreach from the U.S. and Okinawan institutions participating in this project.
The program is designed to assist Meio University to strengthen its curriculum in convention and conference management education to promote greater diversification and economic development in the prefecture of Okinawa, which is attempting to expand its economy internationally, including its international conference and convention capabilities. The prefecture is in the process of building the physical infrastructure to support tourism. New conference and convention facilities are being constructed, hotels are being upgraded, and telecommunications are being improved to accommodate tourists. However, there is a need to prepare qualified professionals in the fields of convention and conference management to utilize the prefecture's infrastructure resources more effectively.
The objective of this Department of State assistance program is to reinforce these efforts and to build closer U.S.-Japanese people-to-people relations in Okinawa by awarding one grant of up to $125,000 for a partnership in the fields of convention and conference management between a U.S. college or university and Meio University, Okinawa. Grants will not be awarded to organizations with less than four years of experience in conducting international exchange programs. The funds will be awarded for a period up to three years to defray the costs of either one-or two-way exchanges, to provide education materials, and to provide approximately 20 percent of the grand total to defray the costs of the project administration.
The project should pursue this objective through a strategy which coordinates the participation of faculty, administrators or, in limited circumstances, students for any appropriate combination of teaching, consultation, mentoring, student internships, and outreach, for exchange visits ranging from one week to an academic year. Two-way exchanges are encouraged, but no single formula is anticipated for the duration, sequence or number of these visits. One semester visits or more for participants from at least one of the institutional partners are strongly encouraged. Participants should make their training and personnel resources available to government, non-governmental organizations, and business practitioners.
The U.S. grantee organization will be responsible for most arrangements associated with this project. These include providing international and domestic travel arrangements for all participants, making lodging and local transportation arrangements for visitors, orienting and debriefing participants, and preparing any necessary support material.
Programs must comply with J-1 visa regulations including those pertaining to insurance. Please refer to Solicitation Package for further information. Administration of the program must be in compliance with reporting and withholding regulations for Federal, state, and local taxes as applicable. Recipient organizations should demonstrate tax regulation adherence in the proposal narrative and budget.
In the United States, participation in the program is open to accredited two-and four-year colleges and universities, including graduate schools. Applications from community colleges, minority-serving institutions, undergraduate liberal arts colleges, and combinations of these types of institutions are eligible. Applications from consortia or other combinations of U.S. colleges and universities are eligible. Secondary U.S. partners may include non-governmental organizations as well as non-profit service and professional organizations. The lead U.S. organization in the consortium or other combination of cooperating institutions is responsible for submitting the application. Each application must document the lead organization's authority to represent all U.S. cooperating partners.
With the exception of outside consultants reporting on the degree to which project objectives have been achieved, participants representing the U.S. institution who are traveling under the Bureau's grant funds should be teachers, students, or administrators from the participating institution(s). Participants representing the U.S. institution must be U.S. citizens. Students are eligible for Bureau-funded participation in this program.
In Japan, the partner is Meio University, Okinawa, which has a curriculum in management and a four-year tourism program under its Faculty of International Studies. Additional information is provided in the “Project Objectives, Goals, and Implementation (POGI)” guidelines for this solicitation.
Secondary foreign partners may include relevant governmental and non-governmental organizations, as well as non-profit service and professional organizations.
With the exception of outside consultants reporting on the degree to which project objectives have been achieved, participants representing the foreign institution must be teachers, administrators, or students from Meio University. Foreign participants must be citizens, nationals, or permanent residents of Japan and must be qualified to hold a valid passport and a U.S. J-1 visa.
Applicants must submit a comprehensive budget for the entire project. The maximum award in this competition will be for one grant in the amount of $125,000. Requests for an amount smaller than the maximum are eligible. Budget and budget notes should carefully justify the amounts needed. There must be a summary budget as well as a break-down reflecting the program and administrative budgets. Proposals with substantial private sector support will be rated as more highly competitive in this regard than those without such support. Cost-sharing will be considered an important indicator of institutional commitment. Proposals whose administrative request from the Bureau is less than 20 percent of the total amount of funds requested from the Bureau will receive more favorable consideration. Applicants may provide separate sub-budgets for each program component, phase, participants involved, or activity to provide clarification. Please refer to the Solicitation Package for complete guidelines and formatting instructions.
All correspondence with the Bureau of Educational and Cultural Affairs concerning this RFP should reference the program title “Curriculum Development in Convention and Conference Management Project at Meio University, Okinawa, Japan” and number ECA/A/S/U-01-07.
Contact the Humphrey Fellowships and Institutional Linkages Branch, Office of Global Educational Programs, Bureau of Educational and Cultural Affairs; ECA/A/S/U, Room 349, SA-44; U.S. Department of State, 301 4th Street, SW, Washington, DC 20547, phone (202) 619-5289, fax: (202) 401-1433, e-mail: affiliation@pd.state.gov to request a Solicitation Package. The Solicitation Package contains detailed award criteria, required application forms, and guidelines for preparing proposals, including specific criteria for preparation of the proposal budget. Please specify “Reference number ECA/A/S/U-01-07” on all inquiries and correspondence.
Please read the complete RFP announcement before sending inquiries or submitting proposals. Once the RFP deadline has passed, Bureau staff may not discuss this competition with applicants until the proposal review process has been completed.
The entire Solicitation Package may be downloaded from the Bureau's website at http://exchanges.state.gov/education/rfps. Please read all information before downloading.
All proposal copies must be received at the State Department's Bureau of Educational and Cultural Affairs by 5 p.m. Washington DC time on Friday, September 29, 2000. Faxed documents will not be accepted at any time. Documents postmarked by the due date but received on a later date will not be accepted. It is the responsibility of each applicant to ensure compliance with the deadline.
Grants should begin on or about January 1, 2001.
January 1, 2001 to December 31, 2004 or before.
Proposals must be submitted by the U.S. institutional partner and must include letters of commitment from all U.S. institutional partners. The letters should be signed by persons authorized to commit institutional resources to the project.
Applicants must follow all instructions in the Solicitation Package. The original and 10 copies of the application should be sent to:
All copies should include the documents specified under Tabs A through E in the “Project Objectives, Goals, and Implementation” (POGI) section of the Solicitation Package. The documents under Tab F of the POGI should be submitted with the original application and with one of the ten copies. Proposals that do not follow RFP requirements and the guidelines appearing in the POGI and PSI may be excluded from consideration due to technical ineligibility.
Applicants must also submit the “Executive Summary” and “Proposal Narrative” Sections of the proposal on a 3.5″ diskette, formatted for DOS. This material must be provided in ASCII text (DOS) format with a maximum line length of 65 characters. The Bureau will transmit these files electronically to the Public Affairs Section of the U.S. Embassy in Tokyo for its review, with the goal of reducing time it takes to get the post's comments for the Bureau's grants review process.
Pursuant to the Bureau's authorizing legislation, projects must maintain a non-political character and should be balanced and representative of the diversity of American political, social, and cultural life. “Diversity” should be interpreted in the broadest sense and encompass differences including, but not limited to ethnicity, race, gender, religion, geographic location, socio-economic status, and physical challenges. Applicants are strongly encouraged to adhere to the advancement of this principle both in program administration and in program content. Please refer to the review criteria under the “Support for Diversity” section for specific suggestions on incorporating diversity into the total proposal. Public Law 104-319 provides that “in carrying out programs of educational and cultural exchange in countries whose people do not fully enjoy freedom and democracy,” the Bureau “shall take appropriate steps to provide opportunities for participation in such programs to human rights and democracy leaders of such countries.” Proposals should account for advancement of this goal, in their program contents, to the full extent deemed feasible.
The Year 2000 (Y2K) issue is a broad operational and accounting problem that could potentially prohibit organizations from processing information in accordance with Federal management and program specific requirements including data exchange with the Department of State. The inability to process information in accordance with Federal requirements could result in grantees' being required to return funds that have not been accounted for properly.
The Department of State therefore requires all organizations use Y2K compliant systems including hardware, software, and firmware. Systems must accurately process data and dates (calculating, comparing and sequencing) both before and after the beginning of the year 2000 and correctly adjust for leap years.
Additional information addressing the Y2K issue may be found at the General Services Administration's Office of Information Technology website at http://www.itpolicy.gsa.gov.
State Department officers in Washington, DC and overseas will use the criteria below to reach funding recommendations and decisions. Technically eligible applications will be competitively reviewed according to the criteria stated below. These criteria are not rank-ordered or weighed.
Proposals should exhibit originality, substance, precision, and resourcefulness. Proposals should have reasonable and feasible project objectives which are relevant to strengthening Meio University's curriculum in convention and conference management. Proposals should describe projected benefits to the institutions involved as well as for wider communities of educators and practitioners in Okinawa and the United States.
Proposals should include realistic and feasible program plans and a detailed schedule which should include a well-reasoned combination of useful and appropriate mentoring, teaching, faculty and/or staff development, curriculum development (including distance learning if conditions allows it), and workshops with business practitioners in Okinawa.
Proposals should demonstrate substantive support of the Bureau's policy on diversity by explaining how issues of diversity relate to project objectives and how these issues will be addressed during the project implementation. Proposals should also outline the institutional profile of each participating institution with regard to issues of diversity.
Proposals should demonstrate significant understanding of the institutional needs and capacities of Meio University as well as the U.S. institution's capacities, and demonstrate a strong commitment, during and after the period of the grant activity, to achieve program goals. Relevant factors include: The match between partner departments and schools; and availability of sufficient number of faculty and/or administrators willing and able to participate in any combination of teaching, mentoring and outreach activities. Proposals should demonstrate promise of sustainability and long-term impact which will be reflected in a plan for continued, non-U.S. government support and follow-on activities.
Proposals should demonstrate an institutional record of successful exchange programs, including responsible fiscal management and full compliance with all reporting requirements for past Bureau grants as determined by the State Department's Office of Contracts. The Bureau will consider the past performance of prior recipients and all reviewers will consider the demonstrated potential of new applicants. Reviewers will also consider the quality of exchange participants' academic credentials, skills, and experience relative to the goals and activities of the project plan.
The proposal should outline a methodology to assess progress made in supporting a program to strengthen a curriculum in conference and convention management at Meio University. The final evaluation should include an external component and should provide observations about the anticipated long-term impact on diversification and economic development in the prefecture of Okinawa.
Administrative and program costs should be reasonable and appropriate with cost-sharing provided by all participating institutions within the context of their respective capacities and as a reflection of their commitment to cooperation with one another in pursuing project objectives. Although indirect costs are eligible for inclusion among other shared costs, a proposed contribution of indirect costs will not be considered a primary indicator of institutional interest or commitment. Proposals with substantial private sector support and those whose administrative request from the Bureau is less than 20 percent of the amount requested will be considered more highly competitive in this regard.
Overall grant making authority for this program is contained in the Mutual Educational and Cultural Exchange Act of 1961, Public Law 87-256, as amended, also known as the Fulbright-Hays Act. The purpose of the Act is “to enable the Government of the United States to increase mutual understanding between the people of the United States and the people of other countries* * *; to strengthen the ties which unite us with other nations by demonstrating the educational and cultural interests, developments, and achievements of the people of the United States and other nations* * * and thus to assist in the development of friendly, sympathetic and peaceful relations between the United States and the other countries of the world.” The funding authority for the program cited above is provided through the Fulbright-Hays Act.
The terms and conditions published in this RFP are binding and may not be modified by any Bureau representative. Explanatory information provided by the Bureau that contradicts published language will not be binding. Issuance of the RFP does not constitute an award commitment on the part of the Government. The Bureau reserves the right to reduce, revise, or increase proposals in accordance with the needs of the program and the availability of funds. Awards made will be subject to periodic reporting and evaluation requirements.
Projects must conform with Department of State requirements and guidelines outlined in the solicitation Package. The POGI, a document describing this project's objectives, goals, and implementation is included in the Solicitation Package.
Final awards cannot be made until funds have been appropriated by Congress, allocated and committed through internal Bureau procedures.
Tennessee Valley Authority
Submission for Office of Management and Budget (OMB) Review; comment request.
The proposed information collection described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended). The Tennessee Valley Authority is soliciting public comments on this proposed collection as provided by 5 CFR 1320.8(d)(1). Requests for information, including copies of the information collection proposed and supporting documentation, should be directed to the Agency Clearance Officer: Wilma H. McCauley, Tennessee Valley Authority, 1101 Market Street (EB 5B), Chattanooga, Tennessee 37402-2801; (423) 751-2523.
Comments should be sent to OMB Office of Information and Regulatory Affairs, Attention: Desk Officer for Tennessee Valley Authority no later than July 31, 2000.
Type of Request: Regular submission, proposal to reinstate, with change, a previously approved collection for which approval has expired.
Coast Guard, DOT.
Notice of public meeting and request for comments.
The Coast Guard, the Environmental Protection Agency, the Research and Special Programs Administration and the Minerals Management Service, in concert with the states, the oil industry and concerned citizens, developed the Preparedness for Response Exercise Program (PREP). This notice announces the date, time, and location for the next PREP workshop. Federal, state, and local agencies and the public, are encouraged to participate and provide oral and written comments.
The meeting will be held on August 29, 2000, from 7:30 a.m. to 5 p.m. Written comments must reach the Docket Management Facility on or before September 15, 2000.
The workshop will be held at the U.S. Department of Transportation Nassif Building, Room 2230, 400 Seventh St. SW Washington, DC 20590. To make sure your comments and related materials do not enter the docket more than once, please submit them (labeled with the docket number, USCG 2000-7514) by only one of the following means:
(1) By mail to the Docket Management Facility, U.S. Department of Transportation, room PL-401, 400 Seventh Street SW., Washington, DC 20590-0001.
(2) By delivery to room PL-401 on the Plaza level of the Nassif Building, 400 Seventh Street SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is 202-366-9329.
(3) By fax to the Docket Management Facility at 202-493-2251.
(4) Electronically through the Web Site for the Docket Management System at
The Docket Management Facility maintains the public docket for this notice. Comments and material received from the public will become part of this docket and will be available for inspection or copying at room PL-401 on the Plaza level of the Nassif Building, 400 Seventh Street SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also access the public docket on the Internet at
For general information regarding the PREP program and the schedule, contact Mr. Bob Pond, Marine Safety and Environmental Protection Directorate, Office of Response, (G-MOR-2), (202) 267-6603.
The 1994 PREP Guidelines are available for downloading from the World Wide Web at
For questions on viewing or submitting material to the docket, call Dorothy Beard, Chief, Dockets, Department of Transportation, phone 202-366-9329.
We encourage you to participate in this program assessment by submitting comments and related material. If you do so, please include your name and address, identify the docket number for this notice (USCG-2000-7514), indicate the specific section of this document to which each comment applies, and give the reason for each comment. You may submit your comments and material by mail, delivery, fax, or electronic means to the Docket Management Facility at the address under
The Coast Guard, the Environmental Protection Agency (EPA), the Research and Special Programs Administration (RSPA), and the Minerals Management Service (MMS), in concert with the states, the oil industry and concerned citizens, developed the Preparedness for Response Exercise Program (PREP). PREP was developed to establish a workable oil pollution response exercise program, which meets the intent of section 4204(a) of the Oil Pollution Act of 1990. PREP provides a mechanism for compliance with the exercise requirements, while being economically feasible for the government and oil industry to adopt and sustain. Since the inception of PREP, public meetings have been held periodically to assess the continuing vitality of the program. The last meeting, in August of 1997, concluded that no changes were necessary to the program at that time. Since then, several changes have been proposed or implemented which influence the way government and industry prepare for and respond to oil and hazardous substance incidents in the United States. As a result, some changes to the PREP program may be appropriate.
Therefore, the Coast Guard, EPA, RSPA, and MMS are holding a public workshop to conduct an assessment of the current PREP program. At the workshop, each agency will briefly outline its concerns with the current program and solicit participant input on resolution of those concerns, either through amendment of the PREP Guidelines or other means. Other participating stakeholders, including states and industry, will be invited to discuss their concerns as well. The workshop will reaffirm the vitality of the PREP program as it currently exists or identify outstanding concerns and gain commitment on the part of participants to a plan of action to resolve those concerns. It is anticipated that one or more additional workshops may be scheduled in order to resolve any outstanding concerns.
The workshop will address current concerns with PREP, specifically: What should the PREP goals be for the next 5 years? Is the program sufficiently dynamic and robust to address the needs of plan holders, area committees and the response community in general? In order to discuss these issues, we will follow the agenda in Table 1.
The meeting will be an informal workshop open to the public. It is intended to bring together people who are knowledgeable about the issues addressed in this notice to assist us in enhancing PREP.
Individuals or groups desiring to make presentations about their concerns during the workshop are asked to notify Mr. Bob Pond at the address or phone number under
For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact Mr. Bob Pond at the address or phone number under
Federal Aviation Administration, DOT.
Notice of issuance of advisory circular.
This notice announces the issuance of Advisory Circular (AC) 25.22, Certification of Transport Airplane Mechanical Systems. This AC sets forth an acceptable means, but not the only means, of demonstrating compliance with the provisions of part 25 of the Federal Aviation Regulations (FAR) related to the mechanical systems and equipment installations for transport category airplanes. Like all ACs, it is not regulatory but is to provide guidance for applicants in demonstrating compliance with the objective safety standards set forth in the rule.
Advisory Circular 25.22 was issued by the Manager, Transport Airplane Directorate, Aircraft Certification Service, ANM-100, on March 14, 2000.
A copy may be obtained by writing to the U.S. Department of Transportation, Subsequent Distribution Office, DOT Warehouse, SVC-121.23, 3341Q 75th Ave., Landover, MD 20785, telephone 301-322-5377, or faxing your request to the warehouse at 301-386-5394. This AC can be found and downloaded from the Internet at http://www.faa.gov/avr/air/airhome.htm, at the link titled “Advisory Circulars.”
The Department of Treasury has submitted the following public information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Copies of the submission(s) may be obtained by calling the Treasury Bureau Clearance Officer listed. Comments regarding this information collection should be addressed to the OMB reviewer listed and to the Treasury Department Clearance Officer, Department of the Treasury, Room 2110, 1425 New York Avenue, NW., Washington, DC 20220.
Written comments should be received on or before July 31, 2000 to be assured of consideration.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, 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, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 2220, Underpayment of Estimated Tax by Corporations.
Written comments should be received on or before August 28, 2000 to be assured of consideration.
Direct all written comments to Garrick R. Shear, Internal Revenue Service, room 5244, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Larnice Mack, (202) 622-3179, Internal Revenue Service, room 5244, 1111 Constitution Avenue NW., Washington, DC 20224.
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the 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 collection of information; (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 respondents, 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 provide information.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, 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, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 1099-PATR, Taxable Distributions Received From Cooperatives.
Written comments should be received on or before August 28, 2000 to be assured of consideration.
Direct all written comments to Garrick R. Shear, Internal Revenue Service, room 5244, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Larnice Mack, (202) 622-3179, Internal Revenue Service, room 5244, 1111 Constitution Avenue NW., Washington, DC 20224.
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the 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 collection of information; (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 respondents, 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 provide information.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, 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, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 8633, Application to Participate in the IRS e-file Program.
Written comments should be received on or before August 28, 2000 to be assured of consideration.
Direct all written comments to Garrick R. Shear, Internal Revenue Service, room 5244, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Carol Savage, (202) 622-3945, Internal Revenue Service, room 5242, 1111 Constitution Avenue NW., Washington, DC 20224.
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the 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 collection of information; (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 respondents, 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 provide information.
Internal Revenue Service (IRS), Treasury.
Notice.
The Internal Revenue Service (IRS) is requesting nominations for members to serve on the Internal Revenue Service Advisory Council (IRSAC). Nominations will be accepted for current vacancies and vacancies that will or may occur during the next 12 months. To ensure appropriate balance of membership, final selection from among qualified candidates will be determined based on experience, qualifications, and other expertise.
July 31, 2000.
Send all applications to—Merci del Toro, Office of Public Liaison and Small Business Affairs, CL:PL, Room 7559 IR, 1111 Constitution Avenue, NW, Washington, DC 20224, Fax: 202-622-5886, E-mail: *public_liaison@irs.gov. The application package will be uploaded to the IRS web site with fill in the blank capabilities at the following addresses: Tax Professionals Corner—
Lorenza Wilds, Telephone: 202-622-6440, not a toll-free number.
IRS is requesting nominations for members to
The IRSAC provides an organized public forum for discussion of relevant tax administration issues between IRS officials and representatives of the public. Through the years, IRSAC has focused on broad tax administration policy matters. Various groups have suggested operational improvements, offered constructive observations about IRS' current or proposed policies, programs, and procedures, and advised the Commissioner of Internal Revenue on particular issues having substantive effect on Federal Tax Administration. It is important that IRSAC membership continue to represent the range and make-up of broad and diverse taxpayer and stakeholder base.
Applicants shall be well-rounded, with a strong tax or business background and excellent communications skills, bring years of practical experience and knowledge to the group, and able to interact well in a diversified environment. Applicant's background should include several of the following experiences: applying tax law knowledge in the resolution of complex tax issues; developing and implementing customer service initiatives and tools, systems management and improvement, and change management; advising and/or as business owners and entrepreneurs; those who have established successful strategic partnerships; and, those who have the ability to examine situations from a “macro” viewpoint.
Interested persons may nominate themselves and/or one or more qualified persons for membership on the IRSAC. Application packages are available on the IRS' Internet Site, on the Tax Professionals Corner—
or
Applicants may also request an application package by calling Lorenza Wilds at 202-622-6440 (not a toll-free number). Federal income tax, FBI, and practitioner checks (if applicable), are required of all applicants. 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.
In proposed rule document 00-9980 beginning on page 26664 in the issue of Monday, May 8, 2000, make the following corrections:
1. On page 26664, in the first column, in the
2. On page 26684, in the first table, in the fifth column under the heading “Totals”, “863” should be under the heading “Total annual burden hours”.
3. On page 26689, in §23.7(a), in the table, in the second column, in the ninth line, the E-mail address “r9IA OMA@fws.gov” should read “r9IA_OMA@fws.gov”.
4. On page 26695, in §23.18(c), in the table, in the second column, in the first entry, remove the second “is”.
5. On page 26700, in §23.22(b)(1)(i), in the table, in the second column, in the first entry, remove the second “Export”.
In notice document 00-15610 beginning on page 38572 in the issue of Wednesday, June 21, 2000, make the following correction:
On page 38572, in the second column, in the
In rule document 00-9838 beginning on page 21301, in the issue of Friday, April 21, 2000, make the following correction:
On page 21302, in the first column, §71.1, under the heading
Health Care Financing Administration (HCFA), HHS.
Final rule with comment period.
This final rule with comment period responds to comments on the June 26, 1998 interim final rule that implemented the Medicare+Choice (M+C) program and makes revisions to those regulations where warranted. We also are making revisions to the regulations that are necessary to reflect the changes to the M+C program resulting from the Balanced Budget Refinement Act of 1999 (BBRA). Revisions to the regulations reflecting changes in the law made by the BBRA are subject to public comment. Issues discussed in this rule include eligibility, election, and enrollment policies; marketing requirements; access requirements; service area and benefit policy; quality improvement standards; payment rates, risk adjustment methodology, and encounter data submission; provider participation rules; beneficiary appeals and grievances; contractual requirements; and preemption of State law by Federal law.
This final rule also addresses comments on the interim final rule published on December 2, 1997, which implemented user fees for section 1876 risk contractors for 1998, and formed the basis for the M+C user fee provisions in the June 26, 1998 interim final rule, and the provider-sponsored organization (PSO) interim final rule published April 14, 1998.
Mail written comments (one original and three copies) to the following address ONLY: Health Care Financing Administration, Department of Health and Human Services, Attention: HCFA-1030-FC, P.O. Box 8013, Baltimore, MD 21244-8013.
Since comments must be received by the date specified above, please allow sufficient time for mailed comments to be received timely in the event of delivery delays.
If you prefer, you may deliver by courier, your written comments (one original and three copies) to one of the following addresses: Room 443-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW, Washington, DC 20201; or C5-14-03, Central Building, 7500 Security Boulevard, Baltimore, MD 21244-1850.
Comments mailed to the two above addresses may be delayed and received too late to be considered. Because of staffing and resource limitations, we cannot accept comments by facsimile (FAX) transmission. In commenting, please refer to file code HCFA-1030-FC.
Comments received timely will be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, in Room 443-G of the Department's offices at 200 Independence Avenue, SW, Washington, DC, on Monday through Friday of each week from 8:30 a.m. to 5 p.m. (Phone (202) 690-7890).
For comments that relate to information collection requirements, see section IV of the
Marty Abeln (410) 786-1032 (for issues related to user fees, service area, point-of-service option, PSOs, and intermediate sanctions).
Wendy Burger (410) 786-1566 and Lynn Orlosky (410) 786-5930 (for issues related to eligibility, elections, and enrollment).
Carol Barnes (410) 786-5496 (for issues related to continuation areas and marketing).
Anne Manley (410) 786-1096 (for issues related to emergency and urgently needed services, provider participation rules, and Federal preemption).
Eileen Zerhusen (410) 786-7803 (for issues related to post-stabilization care).
Tony Hausner (410) 786-1093 (for issues related to access, discrimination, and physician incentive rules).
Amy Chapper (410) 786-0367 (for issues related to information disclosure and confidentiality).
Brian Agnew (410) 786-5964 (for issues related to quality assurance and accreditation).
Al D'Alberto (410) 786-1100 (for issues related to payments, premiums, and ACRs).
James Hart (410) 786-4474 (for issues related to risk adjustment and encounter data).
Chris Eisenberg (410) 786-5509 (for issues related to contracts and contract appeals).
Michele Edmondson (410) 786-6478 (for issues related to beneficiary appeals).
Anita Heygster (410) 786-4486 (for issues related to M+C private fee-for-service plans).
Cindy Mason (410) 786-6680 (for issues related to M+C MSA plans).
For the convenience of the reader, we are providing a complete outline of this final rule, including a topical listing of the major areas raised by the comments, along with numerical regulatory citations.
Section 4001 of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33), enacted August 5, 1997, added sections 1851 through 1859 to the Social Security Act (the Act) to establish a new Part C of the Medicare program, known as the “Medicare+Choice (M+C) Program.” (The previous Part C of the statute, which included provisions in section 1876 of the Act governing existing Medicare health maintenance
As its name implies, the primary goal of the M+C program is to provide Medicare beneficiaries with a wider range of health plan choices through which to obtain their Medicare benefits. The M+C statute authorizes a variety of private health plan options for beneficiaries, including both the traditional managed care plans (such as those offered by HMOs) that traditionally have been offered under section 1876 of the Act, and new options that were not previously authorized. Specifically, section 1851(a)(2) of the Act describes three types of M+C plans authorized under Part C:
• M+C coordinated care plans, including HMO plans (with or without point of service options), provider-sponsored organization (PSO) plans, and preferred provider organization (PPO) plans.
• M+C medical savings account (MSA) plans (that is, combinations of a high-deductible M+C health insurance plan and a contribution to an M+C MSA).
• M+C private fee-for-service plans.
An entity contracting with us to offer any of the above plans to Medicare beneficiaries is called an “M+C organization.”
In addition to expanding the types of health plans that can be offered to Medicare beneficiaries, the M+C program introduces several other fundamental changes to the managed care component of the Medicare program. These changes include:
• Establishment of an expanded array of quality assurance standards and other consumer protection requirements;
• Introduction of an annual coordinated enrollment period, in conjunction with the distribution by us of uniform, comprehensive information about M+C plans that is needed to promote informed choices by beneficiaries;
• Revisions in the way we calculate payment rates to M+C organizations that will narrow the range of payment variation across the country and increase incentives for organizations to offer M+C plans in diverse geographic areas; and
• Establishment of requirements concerning provider participation procedures.
On June 26, 1998, we published in the
• Subpart A—Definitions, including definitions of types of plans, application process, and user fees.
• Subpart B—Requirements concerning beneficiary eligibility, election, enrollment and disenrollment procedures, and plan information and marketing materials.
• Subpart C—Requirements concerning benefits, point of service options, access to services (including rules on enrollee assessments and notification upon termination of specialists), and others.
• Subpart D—Quality assurance standards, external review, and deeming of accredited organizations.
• Subpart E—Provider participation rules and the prohibition against interference with health care professionals' advice to enrollees.
• Subpart F—Payment methodology for M+C organizations, risk adjustment, and encounter data requirements.
• Subpart G—Requirements concerning premiums, cost-sharing, and determination of adjusted community rate.
• Subpart H—Requirements concerning PSOs.
• Subpart I—Organization compliance with State law and preemption by Federal law.
• Subpart K—Contract requirements.
• Subpart L—Change of ownership rules.
• Subpart M—Beneficiary grievances, organization determinations, and appeals.
• Subpart N—Contractor appeals of nonrenewals or terminations of contracts.
• Subpart O—Procedures for imposing intermediate sanctions.
On October 1, 1998, we issued a correction notice in the
Additionally, on February 17, 1999, we published a final rule in the
On November 29, 1999, as we were completing the development of this final rule, the Balanced Budget Refinement Act of 1999 (Pub. L. 106-113) (BBRA) was enacted. The BBRA includes a number of provisions that affect the M+C program, and these provisions have necessitated a number of corresponding changes so that the changes in the law made by the BBRA are reflected in the text of the M+C regulations. For the most part, the statutory changes are self-explanatory, and have already taken effect. As noted above, we are accepting public comment on conforming changes to the M+C regulations made as a result of the BBRA provisions. We are revising the regulations to reflect the provisions of the BBRA as follows:
Section 1851(e)(4) of the Act establishes special election periods during which M+C-eligible individuals may disenroll from an M+C plan or elect another M+C plan, including a special election period when an M+C organization or we have terminated a plan or the organization has otherwise discontinued providing the plan in the area in which the individual resides. Section 501(a)(1) of the BBRA revised section 1851(e)(4) to specify that this special election period now becomes available either upon termination or discontinuation or when the organization “has notified the individual of an impending termination or discontinuation of such a plan.” We have revised § 422.62(b)(1) to reflect this earlier opportunity for an affected
Section 1851(e) of the Act establishes the time frames, or election periods, for making or changing elections. Section 501(b) of the BBRA amended section 1851(e)(2) of the Act by adding a new subparagraph (D), which provides for continuous open enrollment for institutionalized individuals after 2001. Thus, on or after January 1, 2002 (which represents the first day when limitations are placed on an M+C-eligible individual's enrollment and disenrollment opportunities), M+C-eligible individuals who are institutionalized, as defined by HCFA, may continue to change from original Medicare to an M+C plan, from an M+C plan to original Medicare, or from one M+C plan to another. We have added § 422.62(a)(6) to reflect this provision, with conforming changes at § 422.62(a)(4)(i) and § 422.62(a)(5)(i). We intend to provide guidance on the meaning of the term “institutionalized” in due time to permit orderly implementation of this change before it takes effect in 2002.
Section 1851(b)(1) of the Act establishes the residence requirements for eligibility to elect an M+C plan. Section 501(c) of the BBRA amended section 1851(b)(1) of the Act by adding a new subparagraph (C) to allow an individual to choose to continue enrollment in an M+C plan offered by the organization if (1) the M+C organization eliminates the M+C plan in the service area in which the individual resides and, (2) no other M+C plan is offered in the service area at the time of the elimination of the M+C plan in the service area and, (3) the M+C organization chooses to allow the option to continue enrollment in an M+C plan offered by the organization. If the individual chooses to retain his or her enrollment in the M+C plan, the M+C organization may require that he or she agree to obtain the full range of basic benefits (excluding emergency and urgently needed care) through facilities designated by the organization within the plan's HCFA-approved service area. In the case of home health services, since this is a basic benefit that by its nature involves receipt of services in the home, while the provider of the home health services may be located in the service area, actual services would have to be offered in the beneficiary's home. We have reflected this provision in § 422.74(b)(3), with a conforming change made in § 422.66(e)(2).
Section 1851(f) of the Act establishes the effective dates for elections and changes to elections made during the various enrollment periods. Prior to enactment of the BBRA, section 1851(f)(2) stated that an election made during an open enrollment period was effective the first day of the following calendar month. Section of the 502 BBRA amended section 1851(f)(2) of the Act to state that an election made during an open enrollment period is effective the first day of the following calendar month, except that if the election or change in election is made after the 10th day of the calendar month, the election is effective the first day of the second calendar month following the date the election or change in election is made. We have revised § 422.68(c) to reflect this provision.
Section 503 of the BBRA amended section 1876(h)(5)(B) of the Act to permit the extension or renewal of Medicare cost contracts for an additional 2 years, that is, through December 31, 2004. We are revising § 417.402(b) to effect this change.
Consistent with section 1853(a) of the Act, § 422.256 of the M+C regulations provides that M+C capitation payments are adjusted for age, gender, institutional status, and other appropriate factors, including health status, beginning January 1, 2000. In the January 15, 1999, Advance Notice of Methodological Changes for the CY 2000 M+C Payment Rates, we announced the risk adjustment methodology to implement this requirement. One element of the risk adjustment methodology we developed was a transition period during which M+C payments would be based on a blend of payment amounts under the previous system of demographic adjustments and payment amounts based on principal inpatient hospital diagnoses (the PIP-DCG risk adjustment methodology). Under a blend, payment amounts for each enrollee are separately determined using the demographic and risk methodologies, respectively. Those payment amounts are then blended according to the percentages for the transition year. On January 15, 1999, we announced the following transition schedule:
Section 511(a) of the BBRA revised the original transition schedule for 2000 and 2001 to provide that the blend percentages will be:
This provision does not require any changes in the existing M+C regulations, but we have described it here for the convenience of the reader.
Section 512 of the BBRA amended section 1853 of the Act by adding a new paragraph (i) to provide for “new entry bonus” payments to encourage M+C organizations to offer plans in payment areas (generally, counties) that currently do not have M+C plans serving the area. Under this provision, which we are incorporating into regulations under § 422.250(g), the amount of the monthly payment otherwise made to an M+C organization that offers the first M+C plan in a previously unserved county will be increased by 5 percent for the first 12 months that the plan is offered and by 3 percent for the second 12 months. These bonus payments will be available only for plans that are first offered during the 2-year period beginning January 1, 2000, and only in counties where no M+C plan has been offered, or where any plan offered was no longer offered as of January 1, 2000.
New section 1853(i)(3) specifies that if more than one M+C organization first
Section 513(a) of the BBRA amended section 1857(c)(4) of the Act to reduce from 5 to 2 years the period during which an M+C organization that has terminated its M+C contract at the organization's request is barred from re-entering into an M+C contract (absent our finding of special circumstances warranting an exception). Section 513(b)(1) further amended section 1857(c)(4) to provide for a new exception to this general exclusion period if, during the 6-month period after an M+C organization notified us of its intention to terminate an M+C contract, a legislative or regulatory change was adopted that resulted in increased Medicare payment amounts for the given payment area. In addition, section 513(b)(2) of the BBRA expressly states that the creation of the new exception does not affect our existing authority to grant an exception to this rule where “circumstances which warrant special consideration,” including in the circumstances identified in OPL #103 (OPL 99.103). OPL 99.103 states that we will grant an exception, for example, when an organization proposes to offer a different M+C plan type than it had previously offered, or an organization is proposing to introduce an M+C plan (1) in a geographic area currently served by two or fewer M+C plans, or (2) in an area other than that from which the organization had previously withdrawn when it ended its earlier contract with the Medicare program. We have incorporated the BBRA's revisions to section 1857(c)(4) of the Act into § 422.501(b)(5).
Section 515 of the BBRA amended section 1854 of the Act to permit M+C organizations to elect to apply the premium and benefit provisions of section 1854 of the Act uniformly to separate segments of a service area, provided that the segments are composed of one or more M+C payment areas. This change, which is effective for contract years beginning on or after January 1, 2001, is largely consistent with our existing administrative policy, under which an M+C organization may offer multiple M+C plans, each with its own HCFA-approved service area, but must offer uniform benefits and premiums within each plan. For a full discussion of the implications of this change, and the conforming changes to the M+C regulations, we refer the reader to section II.C.3 of this preamble.
Section 516 of the BBRA amended section 1854(a)(1) of the Act to delay the annual deadline for submission of adjusted community rate (ACR) proposals and information about enrollment capacity from May 1 to July 1. The statute provides that this change was effective for information submitted by M+C organizations in 1999 for benefits in calendar year 2000, and we are making changes to §§ 422.60(b)(1), 422.300(b)(2), and 422.306(a)(1) to reflect the new law.
An important element in the methodology used to calculate M+C payment rates involves the determination by the Secretary under section 1853(c)(6) of the Act of a “national per capita M+C growth percentage.” Each year, when determining M+C capitation rates, as explained in detail in the June 1998 interim final rule (63 FR 35004), this national growth percentage is applied to the area-specific component of the blended rate and to the minimum amount, also referred to as the “floor”. The national per capita growth percentage is HCFA's estimate of the per capita rate of growth in expenditures. Section 1853(c)(6)(B) of the Act provided that in years from 1998 through 2002, the national per capita M+C growth percentage would be reduced, by 0.8 percentage points in 1998 and 0.5 percentage points in 1999 through 2002. Section 517 of the BBRA amended section 1853(c)(6)(B)(v) of the Act to change the adjustment for 2002 from 0.5 percentage point reduction to a reduction of 0.3 percentage points, and we are revising § 422.254(b)(2) to reflect this change.
Section 518 of the BBRA amended section 1852(e)(4) of the Act to set forth several changes related to (1) the process by which an M+C organization can be deemed, based on an accreditation organization's findings, to meet M+C requirements and (2) the standards for which such deeming is permissible. Revised section 1852(e)(4) now includes the following among requirements that must be deemed met if an accreditation body applies and enforces standards at least as stringent as those in this part: those requirements derived from section 1852(b) (concerning antidiscrimination), section 1852(d) (concerning access to services), section 1852(i) (concerning information on advance directives), and section 1852(j) (concerning provider participation rules), in addition to the requirements under section 1852(e)(1) and (2) concerning an M+C organization's quality assurance program and under 1852(h) concerning the confidentiality and accuracy of enrollee records. We are revising § 422.156(b) to add these requirements. In addition, new section 1852(e)(4) specifies that the Secretary must make a determination within 210 days on a private accrediting organization's application to act as an accrediting organization for M+C requirements. This provision in effect mandates the same approval time frame that applies to original Medicare accreditation under section 1865(b) of the Act, and we are incorporating this requirement into § 422.158(e).
Section 520 of the BBRA amended section 1852(e)(2) of the Act to change the quality assurance requirements for PPO plans, effective for contract years beginning on or after January 1, 2000. In the past, PPO plans had been treated under the M+C statute and regulations in the same manner as all other M+C coordinated care plans. New section 1852(e)(2)(D) establishes that, for purposes of the M+C quality assurance requirements, a PPO plan is an M+C plan that (1) has a network of providers that have agreed to a contractually specified reimbursement for covered benefits with the organization offering the plan; (2) provides for reimbursement for all covered benefits regardless of whether such benefits are provided within such network of providers; and (3) is offered by an organization that is not licensed or organized under State law as a health maintenance organization. We are incorporating this definition into the M+C regulations at § 422.4. The quality assurance requirements that now will apply for PPO plans are identical to the existing requirements for non-network M+C MSA plans and M+C private fee-for-service plans. Thus, as set forth under revised § 422.152, M+C organizations are no longer required to conduct performance improvement projects relative to their PPO plans, or to have their PPO plans meet minimum performance levels. M+C organizations offering PPO plans must still report on standard measures, however, and continue to comply with the quality assessment and performance improvement requirements that apply to all plans, such as those relating to health information and program review. See section II.E of this preamble for further detail on the quality assurance requirements for various types of plans.
Under section 1857(e)(2) of the Act, the Secretary is directed to collect “user fees” from M+C organizations in order to pay for the costs associated with the enrollment and information distribution activities required for the M+C program under section 1851 of the Act and for the health insurance counseling and assistance programs under section 4360 of the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 103-66). Before enactment of the BBRA, the aggregate amount to be collected from all M+C organizations was the lesser of (1) the estimated costs to be incurred by the Secretary in carrying out the applicable information dissemination activities or (2) an amount contingent upon the enactment of appropriations. An individual M+C organization's user fee was equal to its pro rata share of the aggregate amount of fees to be collected from all M+C organizations. Section 522 of the BBRA amended section 1857(e)(2) of the Act to provide that the aggregate amount of user fees to be collected from M+C organizations to carry out the required beneficiary education activities will be based on the lesser of the estimated costs of information dissemination or, for 2001 and thereafter, the “M+C portion” of $100 million, with the M+C portion representing the Secretary's estimate of the ratio of the average number of M+C enrollees for a fiscal year to the average total number of Medicare beneficiaries for the fiscal year. We are revising § 422.10 to reflect the new statutory provisions. Consistent with section 522(b) of the BBRA, these changes are effective for user fees charged on or after January 1, 2001, and the Secretary may not increase the user fees for the 3-month period beginning October 2000, above those in effect during the previous 9 months. While we will comply with this latter limitation, we are not including it in regulations text, just as Congress did not include it in the text of section 1857(e).
Section 523 of the BBRA amended section 1859(e)(2) of the Act to clarify that a religious fraternal benefit (RFB) society may offer any type of M+C plan, not just an M+C coordinated care plan. We are revising the definition of an RFB plan in § 422.2 to reflect this change.
Section 524 of the BBRA amended section 1877(b)(3) of the Act to specify that certain Medicare rules establishing prohibitions on physician referrals do not apply for purposes of M+C organizations offering M+C coordinated care plans, although they do apply for purposes of M+C MSA plans and private fee-for-service plans. As discussed in section II.E.10 of this preamble, this policy was incorporated into § 411.355(c)(5) of the Medicare regulations through our June 26, 1998 interim final rule.
We received 87 items of correspondence containing hundreds of specific comments on the June 26, 1998 interim final rule. Commenters included managed care organizations and other industry representatives, representatives of physicians and other health care professionals, beneficiary advocacy groups, representatives of hospitals and other providers, insurance companies, States, accrediting and peer review organizations, members of the Congress, and others. Consistent with the scope of the June 26, 1998 rule, most of the comments addressed multiple issues, often in great detail. Listed below are the five areas of the regulation that generated the most concern:
• Access issues, including requirements concerning coordination of care, initial assessments of enrollees' health care needs, timely pre-approval of post-stabilization services, and notification responsibilities when an organization terminates its relationship with a specialist.
• Quality improvement standards.
• Payment rates and service area policy.
• Provider participation rules.
• Beneficiary appeals and grievances.
Among the other issues that generated substantial numbers of comments were:
• Eligibility, election, and enrollment policies.
• Marketing restrictions.
• Risk adjustment methodology and encounter data submission.
• Contractual requirements.
• Preemption of State law by Federal law.
• Deadline for ACR submissions and capacity waivers.
In the February 17, 1999 final rule, we attempted to address those issues raised by public commenters where we were convinced that changes were needed and could quickly develop policies necessary to implement the changes. We also included policy clarifications for certain areas in which the material in the interim final rule had been misinterpreted. Also, to the extent possible, we addressed time-sensitive issues, such as those that needed to be resolved before publication of this comprehensive M+C final rule or those that could affect plans or beneficiaries in areas where Medicare risk contractors
In this comprehensive M+C final rule with comment period, we address all comments received on the interim final rule that were not addressed in the February 17, 1999 final rule. (As noted above, we are also incorporating changes necessitated by the BBRA, subject to public comment.) For the most part, we will address issues according to the numerical order of the related regulation sections. However, many of the comments raise interrelated issues that involve multiple sections of the regulations. In these cases, we generally address all comments on these issues together, whenever the first relevant section of the regulations arises. Also, we note that all comments on the definitions set forth in § 422.2 are addressed in the context of the requirements with which the applicable definitions are associated.
We received two comments on various aspects of the M+C rulemaking process, as discussed below.
Another commenter commended us on our success in issuing comprehensive regulations for a complex new program in a short period of time.
We do not believe that the APA—or certain court decisions cited by the commenter—require us to discuss in the preamble every possible alternative that might have been considered to the approaches taken in the rule, but only to explain our reasons for the choices we made. To the extent we have received specific comments advocating alternative approaches, we explain in this final rule why we have not adopted these suggestions, where this is the case.
With respect to the specific requirement that M+C organizations have a plan in place for ensuring compliance with applicable State and Federal laws, we indicated in the preamble that we believe that such a plan was part of the administrative and managerial capabilities that should be in place to carry out the contract and
As to the requirement for certifications as to the accuracy of data, we clearly explained in the preamble that we believed that since payments to M+C organizations are based on such data, the submission of the data is part of a “claim” for payment in the amount dictated by the data in question. We further explained that a certification of the accuracy of this information will help ensure accurate data submissions, and assist us and the DHHS Office of Inspector General in anti-fraud activities. We believe this is a clear and logical explanation of reasoned decision making in imposing this requirement.
We disagree with the commenter's contention that we were required to provide prior notice and comment before publishing final regulations. Section 1856(a)(1) gives the Secretary the authority to promulgate regulations establishing the standards that will apply under the M+C program, and that the Secretary is authorized to “promulgate regulations that
The commenter's interpretation that section 1856(b)(1) of the Act applies only to the repromulgation of existing 1876 standards is also contradicted by other references in the BBA to this rulemaking authority. For example, section 1876(k)(2), added by section 4002 of the BBA, provides for rules dealing with “grandfathered” Part B only enrollees. Since Part B only enrollees were permitted under section 1876, there were no section 1876 standards addressing the treatment of “grandfathered” enrollees. Yet, section
The commenter's contention that we cannot avail ourselves of the interim final rule authority because the rule was not published by June 1, 1998, is illogical. If the Congress authorized interim final regulations because it wanted the rules to be in place by June 1, it would not wish regulations that have already missed this deadline to be delayed further by notice and comment rulemaking. Indeed, the fact that rules were not published by June 1 made the desirability and necessity of issuance in interim final form with an opportunity for public comment all the
Finally, with respect to our instructions, we intend only to issue instructions that implement or interpret substantive provisions included in these regulations. To the extent the commenter believes that subsequent instructions are issued that should have been subjected to notice and comment, it can make this argument at that time. The fact that we require compliance with guidance we issue to implement these rules is fully consistent with the APA.
A coordinated care plan is a plan that includes a network of providers that are under contract or arrangement with the M+C organization to deliver the benefit package approved by us. The network is approved by us to ensure that all applicable requirements are met, including access and availability, service area, and quality. Coordinated care plans may include mechanisms to control utilization, such as referrals from a gatekeeper for an enrollee to receive services within the plan, and financial arrangements that offer incentives to providers to furnish high quality and cost-effective care. Coordinated care plans include plans offered by HMOs, PSOs, and PPOs, as well as other types of network plans (except network MSA plans). We received no comments on our definition of coordinated care plan.
One specific type of M+C plan authorized by the BBA is a religious and fraternal benefit society plan (RFB plan), which is defined in section 1859(e) of the Act. An RFB plan is a new plan that may be offered under the M+C program. In § 422.2, an RFB society is defined as an organization that (1) is described in section 501(c)(8) of the Internal Revenue Code of 1986 and is exempt from taxation under section 501(a) of that Act and (2) is affiliated with, carries out the tenets of, and shares a religious bond with, a church or convention or association of churches or an affiliated group of churches. As noted above, an RFB plan was defined in the BBA as a coordinated care plan that is offered by an RFB society. We received two comments regarding RFB plans.
The comments received regarding M+C MSA plans are discussed in section III of this preamble. iv. Multiple Plans (§ 422.4(b))
In the interim final rule, we specified that under its contract, an M+C organization may offer multiple plans, regardless of type, provided that the M+C organization is licensed or approved under State law to provide those types of plans (or, in the case of a PSO offering a coordinated care plan, has received from us a waiver of the State licensing requirement).
These sections set forth application requirements for entities that seek a contract as an M+C organization offering an M+C plan. One of the new requirements we set forth in the interim final rule was that organizations wishing to contract with us must submit documentation of their appropriate State licensure, or submit documentation of State certification that the entity is, in fact, able to offer health insurance or health benefits coverage meeting State fiscal solvency standards and is authorized to accept prepaid capitation for providing, arranging, or paying for comprehensive health care services. We further specified that entities meeting the definition of a PSO can be exempted from this requirement if they meet conditions for a waiver, which can be granted by us in accordance with subpart H of part 422. Section 422.8 of the interim final rule describes the application requirements for entities seeking to contract with us to offer M+C plans, as well as our application evaluation procedures.
We likewise agree with the comment that organizations that have received approval to operate as an M+C organization should uniformly be called an “M+C organization.” Accordingly, we have revised applicable subsections of § 422.8 to uniformly use the term “M+C organization” to refer to an existing contractor under the Medicare+Choice program.
This section implements section 1857(e)(2) of the Act, as revised by section 522 of the BBRA. Section 1857(e)(2) requires that M+C organizations share in costs associated with beneficiary enrollment in M+C plans, including the costs of providing information and counseling on plan choices. It sets forth the maximum amount of the aggregate “user fees” that can be collected from M+C organizations as well as the procedures that we follow to assess and collect these amounts from M+C organizations.
In the June 26, 1998 interim final rule, we referred to interim final regulations published on December 2, 1997, which implemented section 1857(e)(2) for risk contractors under section 1876. (Under section 1876(k)(4)(D), the obligation under section 1857(e)(2) applied to section 1876 contractors in 1998.) These December 1997 interim final regulations set forth a methodology for determining an individual organization's “pro rata share” of the beneficiary costs to be assessed (62 FR 63669). We also explained in the June 26, 1998 interim final rule that we were simply adopting at § 422.10, for purposes of the M+C program, the user fee provisions previously set forth in § 417.472(h) of the December 1997 interim final rule. As we indicated in the June 26, 1998 interim final rule, we are addressing the comments received on the substance of the December 1997 interim final rule in this comprehensive M+C final rule. (Since there are no remaining section 1876 risk contractors, § 417.472(h) itself no longer has any applicability.)
As described above, section 522 of the BBRA subsequently amended the user fee provisions set forth in section 1857(e)(2) of the Act, effective for user fees charged on or after January 1, 2001. Revised section 1857(e)(2) now establishes that beginning in the year 2001 the maximum amount of aggregate user fees that we may collect during a fiscal year from M+C organizations will be determined by the percentage of Medicare enrollees in M+C plans. Specifically, we will calculate: the annual average number of Medicare beneficiaries enrolled in M+C plans during a fiscal year divided by the average number of individuals entitled to benefits under part A, and enrolled under part B, during the fiscal year. This ratio will be multiplied by $100,000,000 to determine the maximum aggregate user fees we may collect from all M+C organizations in a given fiscal year. (Under section 1857(e)(2), we collect the lesser of (1) the actual costs of carrying out the required information dissemination activities or (2) the maximum aggregate amount permitted under the Act.)
We received five letters of comment regarding the interim final rule of December 2, 1997, which established the assessment method under which all M+C organizations are assessed the same fixed percentage of their total monthly Medicare payments, in order to collect the M+C user fee. Two commenters supported the user fee assessment methodology selected by us and considered that it was equitable both to organizations and beneficiaries; three commenters opposed the methodology. We also received six letters commenting on the same methodology in response to the interim final M+C regulation of June 26, 1998. Again, three commenters argued that the user fee was unfair to M+C organizations since it resulted in these organizations funding an information campaign for all Medicare beneficiaries, not just those enrolled in M+C organizations. These latter concerns are now moot in light of the BBRA amendments limiting M+C user fees to the percentage of information dissemination costs representing the percentage of total Medicare beneficiaries that are M+C enrollees. Comments that remain relevant are discussed below.
Section 1851(a) of the Act sets forth the criteria for an individual to be eligible to elect an M+C plan. Consistent with the statute, § 422.50 specifies that an individual is eligible to elect an M+C plan if he or she:
• Is entitled to Medicare under Part A and enrolled in Part B (except that an individual entitled only to Part B and who was enrolled in an HMO or Competitive Medical Plan (CMP) with a risk contract under part 417 on December 31, 1998 may continue to be enrolled in the M+C organization as an M+C plan enrollee);
• Has not been medically determined to have end-stage renal disease, except that an individual who develops end-stage renal disease while enrolled in an M+C plan or other health plan offered by an M+C organization may continue to be enrolled in the M+C plan, or if enrolled in another health plan, may enroll in an M+C plan offered by the organization, if the individual is otherwise eligible to enroll in the M+C plan;
• Resides in the service area of the plan, except that an individual who resides in a continuation area of an M+C plan while enrolled in a health plan offered by the M+C organization may continue to be enrolled with the M+C organization as an M+C plan enrollee under the terms that apply to enrollees in the continuation area;
• Completes and signs an election form and gives information required for enrollment; and
• Agrees to abide by the rules of the M+C organization after they are disclosed to him or her in connection with the election process.
We specified in the interim final rule that an M+C-eligible individual may not be enrolled in more than one M+C plan at any given time. Comments on the M+C eligibility rules are discussed below.
Based on the comments we received on the interim final rule, however, as well as the reluctance of M+C organizations to establish formal continuation areas, we have become convinced that the regulations should be amended to provide for additional choices for beneficiaries. Thus, we are amending § 422.50 (with conforming changes to §§ 422.66(d)(1) and 422.74(b)(2) and (b)(4)) to permit M+C organizations to offer a “seamless conversion” option to individuals who, upon becoming entitled to Medicare, live outside of an M+C plan's service area but are already enrolled in a commercial health plan offered by the same organization. If an M+C organization chooses to offer this option, it must offer the option to all individuals who were enrolled in a commercial health plan offered by the organization at the time they become Medicare-eligible. We do not believe it is appropriate to limit the availability of this option only to beneficiaries who had previously been enrolled in employer group health care plans, but instead are providing that both individual and employer group members of commercial health plans may elect to remain enrolled with their organization under an M+C plan under an expanded “seamless conversion” option. Similarly, we note that this expanded eligibility requirement is not limited to situations in which an enrollee becomes eligible for Medicare by virtue of age (referred to in the past as “age in” enrollees), but will apply to all newly eligible Medicare beneficiaries, including the ESRD and disabled population. (As noted above, we previously determined, in the interim final rule, that people with ESRD who are enrolled with an organization before becoming Medicare eligible may remain enrolled with the organization as an M+C plan enrollee.) We note that organizations that wish to offer this option must meet the M+C access standards under § 422.112, and must furnish the same benefits to these enrollees as to enrollees who reside in the plan service area. Such enrollees should be made aware by the M+C organization of the extent to which they will need to travel into the plan service area to obtain service.
Section 1851(b)(1)(B) of the Act permits M+C organizations to offer enrollees the option of continued enrollment in an M+C plan when enrollees leave the plan's service area to reside elsewhere (that is, in the “continuation” area) on a permanent basis. M+C organizations that choose to offer a continuation of enrollment option must explain the option in marketing materials, and make it available to all enrollees in the service area of the plan. Enrollees may choose to exercise the option of continued enrollment when they move out of the plan's service area, or they may choose to disenroll.
An M+C organization must obtain our approval of the continuation area and related marketing materials, and meet the access requirements under section 1851(b)(1)(B) of the Act, before it may offer a continuation of enrollment option to Medicare beneficiaries.
The payment rate for the M+C organization is based on the rate and adjustment factors that correspond to the beneficiary's permanent residence. Under section 1851(b)(1)(B) of the Act, the M+C organization must, at a minimum, provide or arrange for the provision of Medicare-covered benefits under section 1852(a)(1)(A) of the Act in the continuation area. This does not include any additional benefits the organization is required to provide to noncontinuation area members under section 1852(a)(1)(B) of the Act.
Section 1851(b)(1)(B) of the Act requires that “reasonable access” be provided in the continuation area, and that enrollees be subject to “reasonable cost sharing.” In the interim final rule, we required that M+C organizations satisfy the access requirements in § 422.112, and provide services either through written agreements with providers or by making payments that satisfy the requirements in § 422.100(b)(2).
We are defining “reasonable cost sharing” in the continuation area as limited to the cost-sharing amounts required in the M+C plan's service area (in which the enrollee no longer resides).
The interim final rule also provides that appeals and grievances of enrollees in the continuation area must be handled in the same timely fashion as for other enrollees. The ultimate responsibility for the handling of appeals and grievances is with the organization that is receiving payment from us.
We received 11 comments requesting further guidance regarding the continuation of enrollment option. Generally, commenters endorsed the continuation of enrollment concept and urged us to define continuation areas broadly in order to enhance coverage options for enrollees.
The general rule for acceptance of enrollees is that, except for the limitations on enrollment in an M+C MSA plan (§ 422.62(d)(1)), and for cases in which a plan has reached its enrollment capacity, each M+C organization must accept without restriction eligible individuals who elect an M+C plan during initial coverage election periods, annual election periods, and special election periods specified in §§ 422.62(a)(1), (a)(2), and (b).
Additionally, M+C organizations must accept elections during the open enrollment periods specified in
We stated in the interim final rule that the election form must comply with our instructions regarding content and format and have been approved by us as described in § 422.80. The form must be completed and signed by the M+C eligible individual (or the individual who will soon become entitled to Medicare benefits) and include authorization for disclosure and exchange of necessary information between the DHHS and its designees and the M+C organization. Persons who assist beneficiaries in completing forms must sign the form and indicate their relationship to the beneficiary.
We further stated that the M+C organization must file and retain election forms for the period specified in our instructions. An election in an M+C plan is considered to have been made on the date the election form is received by the M+C organization. Also, the M+C organization must have an effective system for receiving, controlling, and processing election forms that requires that each election form is dated as of the day it is received and election forms are processed in chronological order, by date of receipt. Additionally, the M+C organization must give the beneficiary prompt written notice of acceptance or denial in a format specified by us. We also provided that a notice of acceptance, in a format specified by us, informs the beneficiary of the date on which enrollment will be effective under § 422.68; and if the M+C plan is enrolled to capacity, explains the procedures that will be followed when vacancies occur. Also, a notice of denial explains the reasons for denial in a format specified by us. Within 30 days from receipt of the election form (or from the date a vacancy occurs for an individual who was accepted for future enrollment), the M+C organization transmits the information necessary for us to add the beneficiary to our records as an enrollee of the M+C organization.
We agree that the M+C organization should be allowed to assist beneficiaries in completing the election form only under limited circumstances. For this reason, representatives should be assisting the beneficiary in completing the election forms only when assistance is needed, such as for a person who is disabled, illiterate, or otherwise impaired by age or health. In fact, in some circumstances assistance may be required to comply with civil rights requirements, for example, to ensure that individuals with disabilities or limited English proficiency have an equal opportunity to participate. Any M+C organization that unduly influences beneficiaries through this assistance should be identified by our monitoring procedures and subject to sanctions as specified in § 422.750.
We believe requiring the signature and identifying their relationship to the individual who is enrolling in the M+C plan is a sufficient beneficiary protection. It provides adequate information to monitor a beneficiary's understanding that the form is for enrollment. The reason why an individual needs assistance should not be included on the enrollment form because it could undermine a Medicare beneficiary's right to privacy by disclosing health related information without his or her consent.
Sections 422.60(b) and 422.306(a) of the original M+C regulations required M+C organizations to submit information on the enrollment capacity of plans they offer by May 1 of each year. As noted in section I.C.8 of this preamble, section 516 of the BBRA amended section 1854(a)(1) of the Act to move the annual deadline for submission of ACR proposals and enrollment capacity data (if any) from May 1 to July 1, effective in 1999. If a plan reaches its HCFA-approved capacity limit, the M+C organization offering the plan generally is not obligated to accept new enrollees.
As the commenter suggested, however, we recognize that under certain circumstances, there may be a legitimate need for an M+C organization to request a capacity limit or a revision of a capacity limit for an M+C plan during the contract year. The circumstances under which a capacity limit will be approved after the ACRP date would likely occur when a portion of a provider network that furnishes services under an M+C plan becomes unavailable during the course of a contract year. We have provided for HCFA to consider enrollment capacity requests outside of the ACR process under new § 422.60(b)(3), which permits consideration of such requests only if the health and safety of beneficiaries is at risk, such as if the provider network is no longer available to serve enrollees in all or a portion of the service area. The requirements for a midyear capacity limit request are also described in OPL99.095.
All M+C plans must be open to M+C-eligible enrollees residing in the service area served by the plan during initial coverage election periods, annual election periods, and special election periods, unless such enrollment in the plan is limited based upon a limit on enrollment capacity.
The initial coverage election period is the period during which a newly M+C-eligible individual may make an initial election. This period begins 3 months prior to the month the individual is first entitled to both Part A and Part B and ends the last day of the month preceding the month of entitlement. An election made during this period is effective when entitlement to Part A and Part B coverage begins.
The month of November is the annual election period for the following calendar year. During the annual election period, an individual eligible to enroll in an M+C plan may change his or her election from an M+C plan to original Medicare or to a different M+C plan, or from original Medicare to an M+C plan. This election is effective on January 1.
Special election periods are periods during which enrollment must be made open to certain beneficiaries, for various reasons specified in the statute, or by us. We specify the effective date of elections made during special election periods.
M+C plans may be open to new enrollees at other times of the year (that is, during open enrollment periods) at the discretion of the M+C organization offering the plan.
From 1998 through 2001, the number of elections or changes that an M+C-eligible individual may make is not limited (except for M+C MSA plans).
• When the individual is no longer eligible to be enrolled in a certain plan due to a change of residence,
• When HCFA terminates the organization's contract for the plan, or the organization terminates the plan or discontinues offering the plan in the service or continuation area in which the individual resides,
• When the M+C organization has violated a material provision of its contract or materially misrepresented the plan's provisions in marketing the plan to the individual, or
• When the individual meets such other exceptional conditions as we may provide.
Through 2001, open enrollment periods are continuous, that is, every month through 2001. Beginning in 2002, the open enrollment periods are the first 6 months of the year, or the first 6 months of Medicare Part A and Part B entitlement (or December 31, 2002, whichever is earlier). In 2003 and in subsequent years, the open enrollment periods are the first 3 months of the year, or the first 3 months of Medicare Part A and Part B entitlement (or December 31, 2003, whichever is earlier). Again, open enrollment periods remain continuous for institutionalized individuals during and after 2002.
The election rules for M+C MSA plans (see § 422.62(d)) include some exceptions to the election periods described above. M+C-eligible individuals may only enroll in an MSA plan during an initial coverage election period or an annual election period. They may not make an election of an MSA plan during open enrollment periods or special election periods. M+C-eligible individuals may only disenroll from an MSA plan during annual election periods and special election periods, excluding special election periods for individuals age 65. In addition, if an individual elects an M+C MSA plan for the first time during the annual November election period, he/she may revoke that election by December 15 of that same year.
Section 422.64 contains requirements related to information about M+C plans. Paragraph (a) applies to M+C organizations, and requires that organizations annually provide to us, using a prescribed format and terminology, the information we need to carry out our annual information campaign for all Medicare beneficiaries. However, the remaining paragraphs of existing § 422.64 essentially reflect statutory provisions governing our information distribution activities.
• Internet at www.Medicare.gov. Local libraries or senior centers may be able to help the person find the information on their computers.
• Medicare Choices Help line at 1-800-MEDICAR(E) and TTY for the speech and hearing impaired at 1-877-486-2048.
• State Health Insurance Assistance Program (SHIP) in the beneficiary's area.
• Local outreach events.
• Obtaining public input through currently established communication activities (for example, committees, consultation avenues, public meetings, training seminars). Limited resources and time demands do not permit the establishment of separate or overlapping processes with those already established and working (such as industry council meetings). It may not always be possible to hold public meetings to invite interested individuals to comment and provide input on the process of determining data specifications.
• Obtaining public input through normal data collection clearance channels when we are the lead for the data collection activity. The OMB clearance process is a very effective and efficient way to obtain broad public comment on the content and format specifications for data collection (for example, the Plan Benefit Package). However, it may not always be possible to publish a notice or a summary of public processes regarding data elements to be collected.
• Obtaining public input through collaborative efforts with private industry, health care providers, researchers, and other interested parties. This approach allows the Federal government to be a partner with other experts (private and public) in the field of managed care and thereby not duplicate already successful and useful collaborative efforts (such as HEDIS).
Thus, our strategy strongly supports the use of efficient and effective methods of public input into the determination of information and specifications for beneficiary information campaign material. We also recognize the need to collaborate with organizations and individuals involved in the development of quality and performance measurements that support beneficiaries' increased understanding of managed care.
An individual who wishes to elect an M+C plan offered by an M+C organization may make or change his or her election during the election periods specified in § 422.62 by filing the appropriate election form with the organization or through other mechanisms as determined by us.
Additionally, an individual who wishes to disenroll from an M+C plan may change his or her election during the election periods specified in § 422.62 by either electing a different M+C plan by filing the appropriate election form with the M+C organization or through other mechanisms as determined by us. Individuals may also disenroll by submitting a signed and dated request for disenrollment to the M+C organization in the form and manner prescribed by us or by filing the appropriate disenrollment form through other mechanisms as determined by us.
Under existing § 422.66(d)(1), an M+C plan offered by an M+C organization must accept any individual (residing in the service area or continuation area of the M+C plan) who is enrolled in a health plan offered by the M+C organization (regardless of whether the individual has end-stage renal disease—see §§ 422.50(a)(2) and (a)(3)) during the month immediately preceding the month in which he or she is entitled to both Part A and Part B. This is generally known as a “conversion” of enrollment for the enrollee (from commercial status to M+C enrollee status).
Subject to our approval, under § 422.66(d)(2), an M+C organization may set aside a reasonable number of vacancies in order to accommodate conversions. Any set aside vacancies that are not filled within a reasonable time must be made available to other M+C-eligible individuals.
If the individual enrolled in a health plan offered by an M+C organization chooses to remain enrolled with the organization as an M+C enrollee, the individual must complete and sign an election form as described in § 422.60(c)(1). In that case, the individual's conversion to an M+C enrollee is effective the month in which he or she is entitled to both Part A and Part B. The M+C organization may disenroll an individual who is converting from its commercial plan to M+C status only under the conditions specified in § 422.74. The M+C organization must transmit the information necessary for us to add the individual to our records as specified in § 422.60(e)(6).
An individual who has made an election under this section is considered to have continued to have made that election until the individual changes the election under this section or the elected M+C plan is discontinued or no longer serves the service area in which the individual resides, and the organization does not offer, or the individual does not elect, the option of continuing enrollment, as provided in § 422.54, whichever occurs first.
The expansion of the managed care provisions under the BBA has presented an extraordinary challenge to us and to the Medicare managed care data system that supports our information system business requirements. We anticipate that in the future, we will develop strategies to incorporate information collection activities in our managed care systems that will allow this kind of mechanism to be put in place. As we develop strategies that will incorporate additional information collection activities under our authority under section 1851(c)(2) of the Act, we will consider procedures necessary to identify in which plan a beneficiary wants to enroll if the M+C organization offers more than one M+C plan and also whether Medicare Secondary Payer rules apply. Until that time, and in accordance with § 422.66(d), an M+C plan offered by an M+C organization must accept enrollments from any eligible individual residing in the service area or continuation area of the M+C plan, who is enrolled in a commercial health plan offered by that same M+C organization during the month immediately preceding the month in which he/she is entitled to Medicare Part A and Part B.
An election made during an initial coverage election period as described in § 422.62(a)(1) is effective as of the first day of the month of entitlement to both Part A and Part B. Also, for an election or change of election made during an annual election period as described in § 422.62(a)(2), coverage is effective as of the first day of the following calendar year. For an election or change of election made during the open
For an election or change of election made during a special election period as described in § 422.62(b), we determine the effective date of coverage, to the extent practicable, in a manner consistent with protecting the continuity of health benefits coverage. For an election of coverage under original Medicare made during a special election period for an individual age 65 as described in § 422.62(c), coverage is effective as of the first day of the first calendar month following the month in which the election is made.
The general rule for disenrollment by the M+C organization is that an M+C organization may not disenroll an individual from any M+C plan it offers; or request or encourage (orally or in writing, or by any action or inaction) an individual to disenroll. However, § 422.74(b) describes the conditions under which the M+C organization may either be permitted or required to disenroll an individual. Under § 422.74(b)(1), the M+C organization may choose to disenroll an individual based on that individual's (1) failure to pay premiums, (2) disruptive behavior, (3) provision of fraudulent information on his or her election form, or (4) having permitted his or her enrollment card to be abused. Section 422.74(b)(2) requires the M+C organization to disenroll the individual if the individual no longer resides in the M+C plan's service area, the individual loses entitlement to Medicare Part A or Part B benefits, or the individual dies. The M+C organization must follow the procedures specified at § 422.74(c) and (d) when disenrolling an individual. The procedures to be followed and the consequences of the disenrollment vary depending upon the cause of the disenrollment.
Such an action would not affect the beneficiary's status as a member of the M+C plan, and would not constitute a new election. Therefore, the M+C organization does not have to formally disenroll and re-enroll the individual when downgrading the member's enrollment to the standard benefit package because the beneficiary fails to pay the plan premiums.
The M+C organization must continue to provide benefits and we will continue to pay capitation until the disenrollment is effective. We clarified this policy in OPL 99.100, issued on August 9, 1999. We note that § 422.74(d)(1) erroneously refers to the possibility of disenrollment for an individual who fails to pay any “basic
The 12-month rule set forth under existing § 422.74(d)(4) establishes the time limit for how long an individual who has left the service area on a temporary basis may remain a member of the M+C plan. That is, an M+C organization must disenroll an individual who has not permanently changed his or her address but has been out of the service area for over 12 months.
After considering the comments on this provision, we agree that 12 months is too long for a beneficiary to have access only to emergency and urgently needed care (based on our operational policy that when a member is out of the service area, the M+C organization is required to cover only emergency and urgently needed care). Therefore, we are further revising § 422.74(d)(4) to state that the M+C organization must disenroll an individual, unless he or she chooses the continuation option, if the individual leaves the plan's service area on a nonpermanent basis for over 6 months. This change is within the parameters of the previous requirement under section 1876 of the Act which, as provided in § 417.460(f)(2), allowed an uninterrupted absence from the geographic area for more than 90 days but less than 1 year. However, we believe it is appropriate to extend the time frame from 90 days to 6 months to accommodate the many beneficiaries who leave the service area for seasonal periods each year, which often last more than 90 days, but rarely more than 6 months.
We note that on August 9, 1999, we issued OPL 99.100, specifying that: (1) If an M+C organization receives notice of a permanent change of address from the member (or member's legal representative) at any time, then it must disenroll that individual from the plan if that change of address is outside the M+C plan's service area unless the member chooses the continuation of enrollment option; and (2) if a member
Section 1851(h) of the Act outlines the requirements related to marketing by M+C organizations. These provisions are implemented in § 422.80 of the interim final rule. Section 422.80(a) implements the requirements in section 1851(h)(1) that all marketing material and application forms be submitted to us for approval 45 days before distribution, and that such materials may be used only if we do not disapprove such use by the end of the 45-day period. Section 422.80(b) defines the “marketing materials” that must be submitted for approval. We note that we have made a minor revision to this regulation to reflect the fact that HCFA does not review newsletters as marketing material. The reference to newsletters was included in the interim final rule because it appeared in the part 417 regulations governing marketing by section 1876 contractors. In fact, HCFA did not treat newsletters as marketing materials in the case of section 1876 contractors, and there was no intent in the interim final rule to change HCFA's practice on this point. The interim final rule thus should not have included the reference to newsletters, and we are correcting our error in doing so.
Section 1851(h)(2) of the Act requires that the M+C standards include guidelines for review of marketing materials and requires that the guidelines provide that the Secretary will not approve materials that are inaccurate or misleading. Section 422.80(c) establishes the guidelines for our review of marketing materials. Consistent with the provision in section 1856(b)(2) of the Act for use of existing section 1876 standards, the guidelines in § 422.80(c) include existing marketing guidelines for HMOs and CMPs (from § 417.428), which have been in effect since the inception of the Medicare risk contract program.
Section 1851(h)(3) of the Act provides that if we have not disapproved the dissemination of marketing materials or forms with respect to an M+C plan in an area, we are deemed not to have disapproved the distribution in all other areas covered by the M+C plan and M+C organization except with regard to any portion of the material or form that is specific to the particular area. This “deemed approval” or “one-stop shopping” provision is implemented in § 422.80(d).
Section 1851(h)(4) of the Act provides that M+C organizations shall conform to “fair marketing standards” and requires that the fair marketing standards prohibit organizations from providing cash or other monetary inducements for enrollment. Section 422.80(e) outlines the fair marketing standards provided for under section 1851(h)(4) of the Act, and includes existing section 1876 standards as provided for in section 1856(b)(2) of the Act.
Finally, § 422.80(f) specifies that we may permit M+C organizations to develop and distribute marketing materials specifically designed for members of an employer group who are eligible for employer-sponsored benefits through the M+C organization. Although these materials must be submitted for approval under § 422.80(a), we do not review portions of these materials that relate only to employer group benefits, rather than to M+C plan benefits.
The public comments that addressed marketing issues governed by § 422.80 are discussed below.
We do not review materials that are directed solely at an HMO's commercial population. However, we believe that any materials targeted at the Medicare population, and designed to inform beneficiaries about benefits, or encourage beneficiaries to enroll or remain enrolled, should be subject to our review on their behalf. Thus, we are retaining the provision under § 422.80(b)(1) that calls for review of materials that “promote the M+C organization.”
Because VAIS do not constitute a benefit under the M+C program, neither the actual costs of the VAIS nor associated administrative costs may appear in the ACR, nor are they subject to the Medicare appeals process. Nonetheless, VAIS may be of value to some enrollees, and we do not wish to deprive M+C enrollees of access to items and services commonly available to commercial enrollees. Therefore, M+C organizations may offer VAIS to Medicare enrollees, but materials describing VAIS must clearly distinguish between VAIS and M+C benefits, including clarifying that VAIS are not subject to the M+C appeal procedures. VAIS may not appear in the Beneficiary Information Form or the Plan Benefit Package. Further, VAIS may not be described in Medicare Compare, the Medicare and You handbook, or the Standardized Summary of Benefits. We will provide further guidance regarding VAIS in a forthcoming OPL.
We recognize that independent insurance agents may be able to provide a necessary service to Medicare beneficiaries who are considering enrolling in the M+C program. In the past, our position has been to strongly discourage, but not prohibit, Medicare managed care organizations from employing independent insurance agents to sell their products. Recently, we have engaged in extensive consultations on this issue with the DHHS Office of the Inspector General, and we intend to issue guidance to M+C organizations in the near future regarding the parameters for the participation of independent agents in marketing M+C plans.
Subpart C of these regulations details the scope of benefits a Medicare beneficiary is entitled to receive when electing coverage through an M+C plan, as well as establishing a number of beneficiary protections in areas related to access rules, enrollee notification requirements, confidentiality and others. The statutory authority for most of the provisions of subpart C is found in section 1852 of the Act, which outlines benefit requirements and provides authority for beneficiary protections under Medicare Part C. Many of the statutory provisions are the same as, or similar to, benefit provisions of section 1876 of the Act. Therefore, much of the regulatory language of part 417 is retained for purposes of establishing M+C standards, as provided for in section 1856(b)(2) of the Act (which provides for basing M+C standards on section 1876 standards implementing analogous provisions, where consistent with Part C).
All M+C organizations are required to cover the full range of Medicare benefits that are available under original Medicare to beneficiaries in the area who are not enrolled in an M+C plan, subject to certain rules regarding an accessible network of providers. M+C organizations are further required to cover Medicare preventive benefits with the same frequency that they are covered under original Medicare (for example, annual screening mammography examinations). Beneficiaries may be required to contribute to the cost of covered services in the form of cost sharing provided for under the M+C plan. Beneficiaries may have to cover all costs until a deductible is met (including the high deductible provided for under an MSA plan—see section III of this preamble), a percentage of costs in the form of coinsurance, or a fixed amount for services, in the form of a copayment. As discussed in section II.G below, there are limits that apply to the cost sharing that can be imposed on beneficiaries under M+C plans. For benefits that are covered under original Medicare, the benefits must be obtained through providers meeting the conditions of participation of the Medicare program.
This section of the preamble mainly discusses the requirements for network plans. Sections III and IV of the preamble provide more extensive information about benefit requirements applicable to non-network M+C MSA plans and to private fee-for-service plans, respectively. Organizations with network plans, which include coordinated care plans and network M+C MSA plans, are permitted to restrict enrollees to a specified network of providers in the case of non-emergency/urgent services if they have a network in place to provide these services directly or through arrangements (that is, written agreements with providers) that meet the availability and accessibility requirements of section 1852(d)(1) of the Act and § 422.112, discussed below.
In some situations, an M+C organization is required to assume liability for services provided to Medicare enrollees through noncontracting providers. In particular, under § 422.100(b), the organization is required to assume financial responsibility for the following items and services obtained from a provider that does not contract with the M+C organization:
• Emergency services;
• Urgently needed services;
• Renal dialysis services provided while the enrollee was temporarily outside the M+C plan's service area;
• Post-stabilization care services; and
• For both network and non-network plans, services denied by the M+C organization and found upon appeal (under subpart M of this part) to be services the enrollee was entitled to have furnished or paid for by the M+C organization.
The requirements that the M+C organization assume financial liability for renal dialysis services and post-stabilization care are new requirements introduced by the BBA that were not included in the requirements of section 1876 of the Act. The definitions of emergency services and urgently needed services in the M+C regulations are based on section 1852(d) of the Act, and thus differ from those used under the previous Medicare managed care program (see § 417.401). In accordance with section 1852(d)(3) of the statute, an “emergency medical condition” exists if a “prudent layperson” could reasonably expect the absence of immediate medical attention to result in serious jeopardy or harm to the individual. In addition, the new definition of “emergency services” includes emergency services provided both within and outside of the plan, while the definition of “urgently needed services” continues to encompass only services provided outside of the plan's service area (or continuation area, if applicable), except in extraordinary circumstances (as discussed below). Under section 1852(d)(1)(C)(i) of the Act, M+C organizations are required to pay for nonemergency services provided other than through the organization where the services are immediately required because of unforeseen illness, injury or condition, and it is not reasonable given the circumstances to obtain the services through the organization.
In the June 26, 1998 interim final rule, definitions of emergency services and
With regard to the request that the in-area exception in the definition of urgently needed services be interpreted to mean that beneficiaries could seek care out-of-plan if the particular services are not provided by an M+C organization, we believe that the commenter is asking about situations where an M+C organization has made a judgment that services are not necessary or not covered, rather than one in which the network is unavailable. There are other mechanisms in place to handle such situations. We may require a plan to take corrective action, where necessary, if a plan fails to provide services. In addition, services that the beneficiary believes he or she was entitled to receive from the M+C organization, but that the organization denied or otherwise did not provide, may be appealed under the regulations in subpart M of part 422. Whether situations involving equipment failures would be considered urgently needed services depends upon the clinical condition of the patient, and the M+C organization's ability to make services available notwithstanding the equipment failure.
We note that, inherent to the various requirements under § 422.112 relating to an M+C organization's responsibility to provide adequate access to covered services, is the obligation of an M+C organization to provide access to necessary care through out-of-network specialists when its network is inadequate or unavailable. That is, if in an individual case a plan's provider network is not adequate to meet an enrollee's health care needs (for example, the plan includes no specialist qualified to treat an enrollee's rare condition), the organization shall authorize the individual to go out of network to obtain the necessary care. We are revising § 422.112(a)(3) to make this requirement explicit. As discussed in detail in section II.M.9 of this preamble, failure to authorize such care constitutes an adverse organization determination, with concomitant appeal rights.
Also in response to this comment, we have decided to specify at § 422.100(b)(1)(i) that M+C organizations are required to cover ambulance services provided other than through the organization that are dispatched through 911 or its local equivalent. Section 422.113 specifies that the M+C organization bears financial responsibility for ambulance services where other means of transportation would endanger the beneficiary's health. This policy is consistent with original Medicare's coverage of ambulance services where other means of transportation would endanger the health of the beneficiary as provided by section 1861(s)(7) of the Act, as well as with the emergency coverage provisions of section 1852(c)(1)(E) of part C of the Act. In particular, we believe that the law's reference to use of the 911 telephone system indicates statutory intent for coverage of ambulance services whether provided through the organization or other than through the organization. Ambulance services provided through the organization would also be considered part of basic benefits under §§ 422.100(a) and 422.101. We note that nonemergency ambulance services generally would be covered only when provided through the organization, to the same extent the services are covered under the general Medicare principles set forth in section 1861(s)(7) of the Act (that is, when use of other forms of transportation would endanger the health of the beneficiary.) Regulations on original Medicare coverage of ambulance services may be found at § 410.40.
We believe that these clarifications will promote compliance with the prohibition in section 1852(d)(1)(E) of the Act on prior authorization requirements for emergency services.
Section 1852 (d)(2) of the Act gives the Secretary express authority to establish requirements needed to promote the “efficient and timely coordination of appropriate maintenance and post-stabilization care” (hereafter together referred to as “post-stabilization care”). Section 1852(d)(1)(C)(iii) of the Act establishes an M+C organization's responsibility to provide reimbursement for these services. Implementing regulations at §§ 422.100(b)(1)(iii) and 422.113(c) specify that an M+C organization is financially responsible for post-stabilization care services obtained within or outside of the M+C organization. This requirement applies both to services pre-approved by the organization and services that were not pre-approved, under certain circumstances, including situations where an M+C organization fails to respond within 1 hour to a request for pre-approval from a provider of post-stabilization care services (as discussed in detail below). We received a number of comments regarding this section.
In this final rule, the special rules for post-stabilization care services are included under new § 422.113. The requirement for financial responsibility for post-stabilization care services provided outside the organization remains at § 422.100.
By post-stabilization care services, we generally mean covered services, related to an emergency episode, provided after the enrollee is considered to be stable (see new § 422.113(c)). Under the post-stabilization provisions set forth in the interim final rule, “post-stabilization” services were limited to services authorized by the M+C organization or services furnished when the organization cannot be reached, or fails to respond to a request for authorization within an hour. This definition did not address services that may be required during that hour to keep the patient stabilized. We believe that it is necessary to ensure that the patient continues to receive necessary treatment during the 1-hour time frame when the provider waits for the organization to respond. These services consist of those necessary to maintain the stable condition achieved through previously administered emergency services. Any period of instability that rises to the level of an emergency medical condition that occurs during this time would be covered under § 422.113(b).
Section 422.113(c) also establishes that if the M+C organization does not respond within the 1-hour time frame, the M+C organization cannot be reached, the treating physician can proceed with post-stabilization services that are administered not only to ensure stability, but also to improve or resolve the patient's condition. When an M+C organization representative who is a non-physician and the treating physician cannot reach agreement on a course of treatment, the M+C organization must allow the treating physician to speak with a plan physician. By allowing the treating physician to proceed with care of the patient in these cases, we are ensuring that M+C enrollees receive the same standard of timely care as beneficiaries under original Medicare.
Accordingly, the revised definition of post-stabilization care services at § 422.113(c)(1) reads as follows:
“(c) Post-stabilization care services means covered services, related to an emergency medical condition, that are provided after the enrollee is stabilized in order to maintain the stabilized condition, or, under the circumstances described in paragraph (2)(iii) below, to improve or resolve the enrollee's condition.”
Section 422.113(c)(2) then describes the M+C organization's financial responsibility for post-stabilization care services. Specifically, “the M+C organization is financially responsible (consistent with § 422.214) for post-stabilization care services obtained within or outside of the M+C organization that are— (i) Pre-approved by a plan provider or other M+C organization representative; (ii) Not pre-approved by a plan provider or other M+C organization representative, but administered to maintain the stabilized condition, within 1 hour of a request to the M+C organization for pre-approval of further post-stabilization services; or (iii) Not pre-approved by a plan provider or other M+C organization representative, but administered to maintain, improve, or resolve the enrollee's stabilized condition if—
(A) The M+C organization does not respond to a request for pre-approval within 1 hour;
(B) The M+C organization cannot be contacted; or
(C) The M+C organization representative and the treating physician cannot reach an agreement concerning the enrollee's care and a plan physician is not available for consultation. In this situation, the treating physician may continue with the care of the patient until a M+C organization physician is reached or one of the criteria in § 422.113 (c)(3) is met.”
To further clarify the above requirements, consider the following example: A patient is brought to the emergency department with the preliminary diagnosis of a seizure. The patient is screened and receives services to stabilize his condition. Thus far, the services that the patient has received are emergency services under § 422.113(b). Once the emergency room physician considers the patient stabilized, the M+C organization is notified of the need to consult a neurologist in order to proceed with relevant diagnostic tests to determine the cause of the seizure, and to treat the cause of the seizure definitively. While the emergency provider waits 1 hour for a response from the organization, post-stabilization services necessary to maintain the stable condition achieved through previously administered emergency services are administered.
If the M+C organization responds within 1 hour, it can approve the request for additional post-stabilization services under § 422.113(c)(2)(i) or make other arrangements for additional services. If the organization did not respond within the 1-hour time frame, if the organization could not be contacted, or if the organization representative and the treating physician could not reach an agreement and a plan physician was not available for consultation during the hour, the treating physician can proceed with post-stabilization services administered not only to maintain the stabilized condition, but to improve or resolve the patient's condition. Again, if the organization representative and the treating physician cannot reach an agreement, the M+C organization must give the treating physician the opportunity to speak with a plan physician concerning the care of the patient. If a plan physician responds to a request for consultation outside the one hour time frame, the plan physician and the treating physician are expected to execute a plan for safe transfer of responsibility of the patient.
We do not agree that the M+C organization should have the absolute right to control the care that is given to the member when it does eventually respond and the one hour time period has elapsed. For example, a late response could result in a scenario where post-stabilization care services may have already started, and in such a situation, we believe that interruption of a procedure in progress in order to transfer the enrollee to another facility could be harmful to the member. The M+C organization is financially responsible for post-stabilization services until the M+C organization and the treating physician execute a plan for safe transfer of responsibility. Safe transfer of responsibility should occur with the needs and the condition of the patient as the primary concern, so that the quality of care the patient receives is not compromised.
With respect to the comment concerning denials, if the organization representative and the treating physician cannot reach an agreement concerning the enrollee's care, the M+C organization must give the emergency physician an opportunity to consult with an M+C organization physician.
With respect to the request for further patient protections, as noted above, the enrollee (or, the provider, if the provider agrees not to charge the enrollee) has the right to appeal any decision by an M+C organization to deny payment for post-stabilization services.
In the June 26, 1998 interim final rule, we defined the term “service area” as a geographic area approved by us within which an M+C eligible individual may enroll in a particular M+C plan offered by an M+C organization. We specified that for coordinated care plans and network medical savings account (MSA) plans only, the service area also is the area within which a network of providers exists that meets the access standards in § 422.112. Existing regulations also require that an M+C plan's uniform benefit package must be available throughout a plan's service area (see the discussion below of modifications to this policy made by the BBRA). In deciding whether to approve a service area proposed by an M+C organization for an M+C plan, we consider the M+C organization's commercial service area for the type of plan in question (if applicable), community practices generally, whether the boundaries of the service area are discriminatory in effect, and, in the case of coordinated care and network MSA plans, the adequacy of the provider network in the proposed service area. As discussed in the interim final rule preamble, because of unique rules pertaining to the amount deposited in MSA plan accounts, we may approve single county M+C non-network MSA plans even if the M+C organization has a different commercial service area (63 FR 34971).
We note that since the publication of the interim final rule, we have issued further guidance implementing the definition of service area set forth in § 422.2, including an affirmation of our longstanding policy of not approving less than full county service areas unless circumstances justify an exception to this rule. This policy, which we refer to as the “county integrity policy,” is explained in detail in OPL 99.090 released April 23, 1999. The county integrity rule, which implements the reference in the service area definition to consideration of whether boundaries are discriminatory in effect, prevents the establishment of boundaries that could “game” the county-wide M+C payment system by excluding high cost areas of a county. (Note that M+C organizations are paid based on Medicare expenditures at the county level.) Under limited circumstances, as described in OPL 99.090, we will allow an M+C organization to establish a service area that includes a partial county. However, it is never acceptable for an M+C organization to devise an M+C plan service area that excludes portions of a county because it anticipates enrollees with higher health care needs.
Under § 422.100(f), an M+C organization may offer more than one M+C plan in the same service area subject to the conditions and limitations for each M+C plan set forth in subpart C of the M+C regulations. For example, § 422.100(g) provides that we review and approve each M+C plan to ensure that the service area boundaries do not promote discrimination (for example, that they do not include partial counties unless justified), discourage enrollment, steer specific subsets of Medicare beneficiaries to particular M+C plans, or inhibit access to services.
We received about 20 letters commenting on various aspects of M+C service area policy and an M+C organization's ability to offer multiple M+C plans.
As noted in section I.C of this preamble, section 515 of the BBRA amended section 1854 of the Act by adding a new paragraph (h) to permit, effective for contract years beginning on or after January 1, 2001, the application of the uniformity rule to individual “segments” of an M+C plan service area, provided that each segment is composed of one or more M+C payment areas (that is, one or more counties), and a separate complete ACR is submitted for each such segment. The practical implications of this option are similar to our existing administrative policy, under which M+C organizations have the flexibility, by offering multiple plans in a given area or areas, to tailor the benefits offered under their M+C plans to the areas where the plans are offered. In practice, we anticipate that organizations will likely continue to offer multiple M+C plans, since they have already established such separate
(1) Whether the area meets the “county integrity rule” that a service area generally consists of a full county or counties. However, we may approve a service area that includes a portion of a county if we determine that the “partial county” area is necessary, nondiscriminatory, and in the best interests of the beneficiaries.
(2) The extent to which the proposed service area mirrors service areas of existing commercial health care plans or M+C plans offered by the organization.
(3) For M+C coordinated care plans and network M+C MSA plans, whether the contracting provider network meets the access and availability standards set forth in § 422.112. Although not all contracting providers must be located within the plan's service area, HCFA must determine that all services covered under the plan are accessible from the service area.
(4) For non-network M+C MSA plans, we may approve single county non-network M+C MSA plans even if the M+C organization's commercial plans have multiple county service areas.
We believe that these revisions to the service area definition, although they do not constitute policy changes, should help to clarify for M+C organizations our method for determining whether a service area is acceptable.
Under both the former risk contracting program and the M+C program, we generally have required that M+C organizations make health care services available through a network of contracting providers located within the boundaries of the M+C plan service area. Under certain circumstances, however, we have always allowed exceptions to this policy, such as in rural areas when providers were not available in a plan's service area, when traveling outside the service area to obtain health care is not uncommon, and also when the services are still reasonably accessible and available. We have also allowed plans to provide certain specialist services outside of a plan's service area if the specialist services were not available in the plan's service area and if the specialist was reasonably accessible.
Another reason that we do not require an M+C plan's provider network to be located entirely within the plan's service area is to allow for multiple M+C plans in the same or close geographic areas that share the same provider network, as discussed in the next comment and response. However, we will continue to employ the same criteria in evaluating whether beneficiaries enrolling in an M+C plan are provided with the required access and availability to health care services. Generally, we will evaluate the provider
The regulations contained in subpart C describe the requirements for M+C organizations' benefit offerings. The statutory basis for these provisions generally can be found in section 1852 of the Act. The basic categories of benefits parallel those that applied under the section 1876 risk contracting program with the exception of the use of the term “basic benefits,” which we now define as both original Medicare benefits and additional benefits. Despite the limited changes, we believe it is important to carefully define the different benefit categories, because, historically, organizations participating in the risk-contracting program often used different terminology in describing their benefit packages to beneficiaries and in structuring benefits under Medicare risk contracts.
Thus, in order to promote consistency, M+C organizations must use the benefit terminology specified in the M+C regulations and in instructions and operational policy letters. We intend to provide further instructions over the next several years to assist organizations in standardizing the structure and terminology used in describing their benefit offerings. In addition to issuing instructions, we will be reviewing benefit design closely to provide feedback to M+C organizations on ways they can improve their benefit descriptions and ensure that the benefits comply with our requirements. The use of consistent terminology in describing benefit categories will result in better information for Medicare beneficiaries to compare their Medicare options as well as help us to review both benefits paid for with Medicare capitation payments and benefits for which Medicare beneficiaries are charged a premium.
Mandatory supplemental benefits are M+C plan benefits not otherwise covered under original Medicare for which anyone who enrolls in an M+C plan is charged a premium. Thus, additional benefits (included in the basic benefit package) and mandatory supplemental benefits are similar in that they are not covered by original Medicare, and
Like additional benefits and mandatory supplemental benefits, optional supplemental benefits are not covered by original Medicare. However, plan enrollees may choose whether to elect and pay for optional supplemental benefits. M+C organizations may offer M+C plans that have individual items or groups of items and services as optional supplemental benefits.
We are making several minor technical changes to improve the accuracy and consistency of the benefit-related definitions set forth in § 422.2. For example, we are clarifying under the definitions of “mandatory supplemental benefits” and “optional supplemental benefits” that these categories of benefits consist of “health care services” that may be paid through premiums “and/or” cost sharing. Also, we are clarifying in the definition of “benefits” that the costs an M+C organization incurs in providing benefits may not be solely an administrative processing cost and that benefits must be “submitted and approved through the ACR process.”
When we assess the capability of any proposed plan to serve an M+C service area, we consider the numbers, types, and locations of all providers needed to provide all Medicare-covered services or, in regulation terms, the access and availability of Medicare-covered services. We continue to believe that it is in the best interest of the Medicare program and Medicare beneficiaries to evaluate proposed M+C plan networks on a case-by-case basis taking into account the patterns of care and access to care in particular geographic areas. It is not unusual for services such as a dialysis center or transplant center not to be available in a county. If, for example, a Medicare beneficiary would normally have to travel to a different county for renal dialysis or a transplant, we believe it would not be unreasonable for an M+C plan enrollee to be required similarly to travel outside of a service area for access to such services. Such exceptions to in-area care access should, however, be limited in order to have a viable M+C plan.
The fundamental requirement under § 422.101(a) that an M+C organization provide coverage for all Medicare-covered services is not intended to dictate care delivery approaches for a particular service. For example, M+C organizations may furnish a given service using a defined network of providers, some of whom may not see patients in original Medicare. M+C organizations may also encourage patients to see more cost-effective provider types than would be the typical pattern in original Medicare (as long as those providers are working within the scope of care they are licensed to provide, and the M+C organization complies with the provider antidiscrimination rules now set forth under new § 422.205).
M+C organizations' flexibility to deliver care using cost-effective approaches should not be construed to mean that Medicare coverage policies do not apply to the M+C program. If original Medicare covers a service only when certain conditions are met, these conditions must be met in order for the service to be considered part of the Medicare benefits component of an M+C plan. M+C plans may cover the same service when the conditions are not met, but these benefits would then be defined as additional or supplemental.
In summary, each M+C plan must include all Medicare-covered services available in the service area served by the M+C plan, with the exception of hospice services. Our longstanding policy of allowing organizations flexibility in the provision of services (for example, in terms of who provides the service, what equipment is used, where the service is provided, and what procedure is used) has not been affected by the BBA. Organizations are required to provide services within the guidelines of Medicare national coverage policy and other Medicare rules and requirements that apply to the traditional Medicare fee-for-service system. When a health care service can be Medicare-covered and delivered in more than one way, or by more than one type of practitioner, we continue to recognize a managed care organization's right to choose how services will be provided. These decisions have been left to managed care organizations to allow them to maximize their value purchasing power, and use resulting savings to provide services not covered by the Medicare program.
• The national requirements which must be followed, and the meaning of “HCFA's national coverage decisions”.
• General confusion about the relationship between national coverage decisions and local medical review policy.
• Need for additional guidance in situations when plan service areas extend over a geographic area involving multiple carriers or intermediaries, and thus potentially conflicting medical review policies.
• Difficulties in obtaining coverage decisions by local carriers and intermediaries, and the unwillingness of some carriers to permit M+C organizations to be represented on carrier advisory boards.
It is important to note, that all M+C organization determinations must be made based on the individual circumstances of a given case, using the best and most relevant information available. All organization determinations are subject to enrollee appeals to the M+C organization and subsequently to an independent review entity. The fact that an M+C organization determination was applying a local medical review policy does not in itself ensure that an appeal to the independent review entity might not result in a determination that the service in question was medically necessary for the individual enrollee and therefore should be covered.
In this final rule, we are revising § 422.101(b)(1) to clarify that the requirement that M+C organizations comply with national coverage decisions includes following the general coverage guidelines included in original Medicare's manuals and instructions to contractors, unless superseded by the M+C regulations or operational policy letters. The Coverage Issues Manual is the primary resource for national coverage decisions. Additional guidance on coverage of hospital and skilled nursing services, home health services, physician services, and other Medicare services can be found in the instructions in the Carriers, Intermediaries, and other HCFA manuals. In the absence of a national standard, M+C organizations should follow local medical review policies in making medical necessity decisions.
We recognize the potential for conflicting local medical review policies when an M+C plan's service area extends across the jurisdictions of more than one carrier, for example. Our general rule under OPL 46 continues to be that the M+C organization should apply the medical review policy of the Medicare carrier in the area where the services are furnished, since that is the policy that would apply to those services under original Medicare. However, as one commenter pointed out, an M+C organization is not precluded from covering services that a local carrier may have determined are not covered, if the organization's own utilization and quality management standards support the medical necessity of the service. Similarly, an organization may occasionally need to make a coverage determination in a situation when there is neither national coverage policy or relevant local review guidelines. In all such cases, an M+C organization's fundamental responsibility is to use the best information available to make an informed decision on the medical necessity of a given service, and then to provide the medically necessary service, even if doing so may conflict with local medical review policies.
One way for an M+C organization to attempt to pursue consistency in medical review policies is to participate on the review boards of local carriers or intermediaries. We are aware of the difficulties M+C organizations are encountering in some areas of the country in participating on these boards, and are actively working to address this issue. We remain committed to establishing more standardized procedures for developing medical review policies, and for increasing M+C representation in formulating these policies.
We recognize that the existing regulations describing these situations are somewhat unclear. Therefore, we are revising the language at § 422.106 by reorganizing its requirements for clarity. Revised § 422.106(a)(1) clarifies that if an M+C organization contracts with an EGHP that covers enrollees in an M+C plan, or contracts with a State Medicaid agency to provide Medicaid benefits to individuals who are eligible for both Medicare and Medicaid, and who are enrolled in an M+C plan, the enrollees must be provided the same benefits as all other enrollees in the M+C plan, with the EGHP or Medicaid benefits supplementing the M+C plan benefits. Section 422.106(a)(1) states that all M+C program requirements apply to the M+C plan coverage provided to enrollees eligible for benefits under an EGHP or Medicaid contract. We also are revising § 422.106 to delineate clearly that our review authority extends only to the M+C plan benefits provided to members of the EGHP, and the associated marketing materials, rather than to any other complementary benefits provided only under the EGHP. The rules contained in this regulation and the corresponding instructions and operational policy letters take precedence for benefits included in the M+C plan.
We are also adopting the commenter's suggestion that § 422.106 incorporate our requirements concerning the coordination of M+C and Medicaid benefits. These rules are conceptually identical to those governing EGHPs. Thus, for individuals dually eligible under Medicare and Medicaid who are enrolled in an M+C plan, the enrollees must be provided the same benefits as all other enrollees in the M+C plan, with the Medicaid benefits supplementing the M+C plan benefits.
We note, however, that in the case of abortion-related services, Congress has provided M+C organizations with conscience protections independent of that in section 1852(j)(3)(B) of the Act. Specifically, under section 211 of the fiscal year 2000 Department of Health and Human Services Appropriations Act, Pub. L. 106-113, we are prohibited from denying a M+C contract to an entity on the grounds that it refuses on conscience grounds to cover abortions. We are required, however, to make appropriate adjustments to such an entity's M+C capitation payments to cover our costs in providing Medicare-covered abortion services outside the M+C contract.
Section 422.100(h) establishes special rules for screening mammography, influenza vaccine, and pneumococcal vaccine. Enrollees of M+C organizations may directly access, through self-referral, screening mammography and influenza vaccine. In addition, M+C organizations may not impose cost sharing for influenza vaccine and pneumococcal vaccine.
A POS benefit is an option that an M+C organization may offer under an M+C coordinated care plan, or network M+C MSA plan, to provide enrollees in
Under a POS option, the M+C organization generally permits enrollees to obtain specified items and services outside of the M+C plan's normal prior authorization rules, but provides that enrollees will incur higher financial liability for such services. The enrollee may be required to pay a premium for the benefit unless the benefit is offered as an additional benefit. M+C organizations can establish what services are available under a POS benefit and the amount of member cost sharing subject to ACR limits. M+C organizations may also place other limits on the benefit; for example, a plan could offer a POS benefit as a travel benefit allowing members to access specified services when the member is traveling outside of the plan's service area.
We remain concerned about the potential for inappropriate cost-shifting to beneficiaries. To help guard against this possibility, we have revised § 422.105 to require that M+C organizations offering a POS benefit must track, and report to us upon request, POS utilization at the M+C plan level by both contracting providers and noncontracting providers. In monitoring use of the POS benefit, we will pay particular attention to potential over-utilization of the POS benefit by plan enrollees in obtaining services from the plan contracting provider network. We will attempt to verify that it is a matter of choice when a plan member uses a POS benefit to obtain services, rather than due to the member being inappropriately denied prompt access to the service by the plan. We note that an M+C organization still has the option of offering a POS benefit through an M+C plan that can be used by plan members only to obtain health care services from providers who do not contract with the plan.
In general, we expect that organizations offering a POS benefit will be able to provide enrollees with timely information on the POS financial limits, coverage rules, and enrollee cost-sharing for a given service, including the capacity to provide enrollees with advance coverage information over the phone. For example, if the POS benefit has an annual dollar cap, enrollees should be able to phone the organization offering the POS benefit and be informed of how close they are to reaching the financial cap on the benefit. In addition, the plan should be able to advise an enrollee whether a particular service will be paid for under a POS benefit, how much the member will pay out-of-pocket, and how much the plan will contribute under the POS benefit.
As stated in the June 26, 1998 interim final rule, Medicare does not pay for services to the extent that there is a third party that is to be the primary payer under the provisions in section 1862(b) of the Act and 42 CFR Part 411. The M+C organization must, for each M+C plan, identify payers that are primary to Medicare under section 1862(b) of the Act and part 411; determine the amounts payable by those payers; and coordinate its benefits to Medicare enrollees with the benefits of the primary payers.
The M+C organization may charge, or authorize a provider to charge, other individuals or entities for covered Medicare services for which Medicare is not the primary payer. If an enrollee receives from an M+C organization covered services that are also covered under State or Federal workers' compensation, any no-fault insurance, or any liability insurance policy or plan, including a self-insured plan, the M+C organization may charge, or authorize a provider to charge the insurance carrier, the employer, or any other entity that is liable for payment for the services under section 1862(b) of the Act and part 411 of this chapter, or the M+C enrollee, to the extent that he or she has been paid by the carrier, employer, or entity for covered medical expenses.
Where Medicare is a secondary payer to employer coverage in the case of certain working Medicare beneficiaries, an M+C organization may charge a group health plan (GHP) or large group health plan (LGHP) for services it furnishes to a Medicare enrollee who is also covered under the GHP/LGHP, and may charge the Medicare enrollee to the extent that he or she has been paid by the GHP/LGHP.
Since section 1852(a)(4) of the Act and § 422.108 are the only MSP provisions that apply in the M+C context, M+C organizations would pursue their Federally authorized claims under State law. Federal preemption of State laws in the MSP context would occur only to the extent a State law would prohibit an M+C organization from complying with what the Federal rules authorize (that is, from billing and recovering from specified third parties, and from beneficiaries to the extent they have received third party payments that are primary to Medicare under MSP rules). These recoveries are not made on behalf of the United States and, therefore, the Federal overpayment rules cited by the commenter do not apply.
Section 422.109 addresses how M+C organizations are paid when a new Medicare benefit is required under a national coverage determination, but payment for this benefit is not yet included in the organization's capitation rate. Frequently, we develop coverage policy on new procedures or technology during the year. M+C organizations must provide these benefits as soon as they are covered by Medicare, even if this occurs during the middle of a contract year. If the cost of such new benefits exceeds a specified threshold, we pay the M+C organization on a fee-for-service basis under original Medicare payment rules to cover the services in question.
Under these payment rules, a beneficiary is liable for deductible and cost-sharing amounts, which is why § 422.109(b)(5) provides that enrollees would pay these amounts. Although the enrollee has in most cases paid a premium and other cost sharing based on the actuarial value of Part A and Part B deductibles and cost sharing, this amount is for services covered under the contract. These services are covered outside the contract under original Medicare payment rules. However, since the general Part A deductible arguably would already have been satisfied for the beneficiary through M+C plan premiums and cost sharing, we are revising § 422.109(b)(5) in response to this comment to provide that M+C enrollees are responsible only for coinsurance amounts. Medicare payments will thus be made without regard to satisfaction of the Part A deductible.
Consistent with section 1852(b)(1) of the Act, § 422.110 establishes that an M+C organization may not discriminate among Medicare beneficiaries based on any factor that is related to health status, including, but not limited to the following factors: medical condition (including mental as well as physical illness), claims experience, receipt of health care, medical history, genetic information, evidence of insurability (including conditions arising out of acts of domestic violence), or disability. The only exception to this rule is that an M+C organization may not enroll an individual who has been medically determined to have end-stage renal disease (unless the individual is already enrolled with the organization under a different plan). M+C organizations are required to observe the provisions of the Civil Rights Act, Age Discrimination Act, Rehabilitation Act of 1973, and Americans with Disabilities Act.
Section 1852(c) of the Act lists several areas where an M+C organization must disclose specific information to each M+C plan enrollee. These disclosure requirements are set forth in § 422.111 of the regulation. M+C organizations are required to provide to each M+C plan enrollee, at the time of enrollment and at least annually thereafter, in a clear, accurate, and standardized form (that is, through the Evidence of Coverage), the following information regarding the enrollee's M+C plan: Service area, benefits offered under the plan and under original Medicare, access to providers, out-of-area coverage, emergency coverage, supplemental benefits, prior authorization rules, grievance and appeals rights and procedures, quality assurance programs, and disenrollment rights and responsibilities.
M+C organizations are also required to provide additional information upon request of a beneficiary, including: General coverage and comparative plan information, information on the number and disposition of grievances and appeals, information on the financial condition of the M+C organization, the procedures the organization uses to control utilization of services and expenditures, and a summary of physician compensation arrangements. Section 422.111 also includes procedures for an M+C organization to follow when it intends to change its rules for an M+C plan, and describes the enrollee notification requirements when there are changes in a plan's provider network.
Finally, as discussed in section II.B of this preamble, § 422.64 no longer lists the information that we must provide to beneficiaries. However, because § 422.111 referred to this material in several places, we are revising § 422.111 to incorporate the necessary specifications into a new paragraph (f).
Our plans for standardizing beneficiary enrollment and appeals notices, including the Evidence of Coverage (EOC), involve consulting with interested parties, including beneficiary advocacy groups. We are now in the process of consumer testing the enrollment and appeals notices to ensure that the message of each notice is clearly understood by beneficiaries. (For a further discussion of cultural competency issues as they pertain to the delivery of services, see section II.C.11 below.)
We have initiated a two-phase Marketing Material Standardization Project that includes input from the managed care industry and beneficiary advocacy groups. In Phase I, we have implemented, beginning October 15, 1999, a standardized Summary of Benefits (SB), the key pre-enrollment marketing document provided to beneficiaries, so that they can compare the same benefits and costs across several M+C plans and original Medicare. Phase II will involve standardizing beneficiary enrollment and appeals notices. We are conducting consumer testing of these notices in preparation for the final phase of the standardization initiative.
Phase II of our standardization project includes the EOC, also known as the Subscriber Agreement and Member Contract. The EOC contains an explanation of plan benefits (covered services), member rights, and member/M+C plan contractual responsibilities and obligations. The EOC is provided to beneficiaries when they join the M+C plan and annually thereafter. As part of the standardization process for the EOC, we released a model EOC on December 1, 1999, for use in contract year 2000, that M+C organizations are required to distribute to all enrolled members by May 15, 2000. In developing the model EOC, we consulted with managed care industry representatives and beneficiary advocacy groups, and we intend to use this model as a baseline for developing the standardized EOC. The process for standardizing a document as important and comprehensive as the EOC requires adequate time for input from the industry and beneficiary advocacy groups, for public review and comment, and for implementation of the standardized document. We plan to begin standardization of the EOC in the Spring of 2000 and to complete the process in time for the November 2001 annual election period for contract year 2002.
We also have provided guidance to M+C organizations on the manner and form for disclosing the information required under § 422.111(c) upon a beneficiary's request. For example, OPL 099.081, issued on February 10, 1999, addresses appeal and grievance data disclosure requirements, and further clarifying instructions were issued in OPL 2000.114. These disclosure requirements are consistent with the reporting units for the Health Plan Employer Data and Information Set (HEDIS), the Medicare Consumer Assessment of Health Plans Study (CAHPS), and the Medicare Health Outcomes Survey (HOS). We have also issued guidance on how M+C organizations can best provide information relating to compensation for physicians, specifically incentive arrangements. The guidance includes suggested language for marketing materials as well as suggested responses for requests from beneficiaries. Again, our ROs will review these materials as part of their usual responsibilities for pre-approving beneficiary materials.
Section 422.112 establishes a series of requirements aimed at ensuring that enrollees in M+C plans have adequate access to services. As discussed in our June 26, 1998 interim final rule (63 FR 34989), these requirements stem from section 1852(d) of the Act and existing regulations and policies under part 417, as well as addressing recommendations from the Consumer Bill of Rights and Responsibilities, and reflecting standards from the Quality Improvement System for Managed Care (QISMC).
On February 17, 1999, we published a final rule (64 FR 7968) that set forth limited changes to the M+C regulations published in the June 26, 1998 interim final rule. In the February 17, 1999 final rule, we made changes to several of the access provisions of this section. These changes involved the coordination of care requirements, provisions related to complex or serious medical conditions, notification requirements when specialists are terminated from an M+C plan, and initial care assessment requirements.
More specifically, for serious and complex conditions, the treatment plan may be updated by a health care professional other than the primary care provider. Furthermore, this section now requires that the M+C organization ensure adequate coordination of providers for persons with serious or complex medical conditions. Under the general coordination of care requirements, the responsibility for ensuring coordination of care is not limited to an individual provider. Instead, the organization must: (1) Establish policies to ensure coordination; and (2) offer each enrollee a primary source of care. Further, as to the initial assessment, each organization will be expected only to demonstrate a “best effort” attempt to complete the assessment of health care needs within 90 days of enrollment. Finally, we no longer require, when a specialist is involuntarily terminated from an M+C plan, that the M+C organization offer to provide enrollees with the names of other plans in the area that contract with the specialist. However, as discussed above, the general requirements regarding notification of affected patients upon provider
Section 422.112(a)(1) requires M+C organizations that wish to limit an enrollee's choice of providers to maintain and monitor a network of appropriate providers that is supported by written agreements and is sufficient to provide adequate access to covered services to meet the needs of the population served. We received several comments regarding access standards and one comment regarding contracting with community pharmacies.
Section 422.112(a)(2) requires an M+C organization that wishes to limit an enrollee's choice of providers to establish a panel of PCPs from which an enrollee may choose. We received two comments regarding the PCP panel.
An organization may permit licensed practitioners other than physicians to serve as primary care providers, consistent with requirements of applicable State laws. (Qualifications of such practitioners, and the degree of supervision required, are generally established under State law). If an organization designates nonphysician practitioners as primary care providers, it must still ensure that each enrollee has a right to direct access to a physician for primary medical care. This right may be ensured in either of two ways: (a) the enrollee may choose between a physician and nonphysician primary care provider, and may change this choice at any time; or (b) when the enrollee is not allowed such a choice, an enrollee with a nonphysician primary care provider may have timely access to a physician upon request.
The guideline further states: “An organization may allow an enrollee to select a physician group, clinic, federally qualified health center, or other facility with multiple practitioners as his or her primary source of care. To the extent feasible, the enrollee must be allowed to choose an individual primary care provider within the group or facility.”
Thus, the QISMC guidelines do not limit enrollees to the use of physicians or Doctors of Osteopathy as PCPs. However, as indicated, an M+C organization must provide enrollees with access to physicians or Doctors of Osteopathy upon request. Furthermore, § 422.112(a)(1) requires that the M+C organization have an adequate network of providers and § 422.112(b)(2) requires the organization to offer each enrollee a source of primary care. In addition, consistent with the BBA provisions regarding antidiscrimination, and the Consumer Bill of Rights and Responsibilities, we intend to provide enrollees with freedom of choice in the selection of providers subject to the above constraints. Therefore, we are not adopting the commenter's suggestion. We note that an M+C organization's use of nonphysicians to deliver Medicare benefits must be consistent with Medicare coverage requirements, such as “incident to” supervision requirements. To the extent nonphysicians are providing non-Medicare covered services as an additional or supplemental benefit, these requirements do not apply.
This section requires an M+C organization to provide or arrange for necessary specialty care, and gives women enrollees the option of direct access to a women's health specialist within the network for women's routine and preventive health care services, notwithstanding that the M+C organization maintains a PCP or some other means for continuity of care.
In the setting of such an exam, abnormalities may be found, such as incidental vaginitis or UTI, or abnormal Pap smear. We would consider routine services to follow up on such gynecologic abnormalities to be included under this definition.
We agree that the provision is unclear about the role of PCPs, and have deleted from § 422.112(a)(3) the reference to “while the plan maintains a PCP or some other means for continuity of care.”
Although the regulations require that M+C organizations allow women direct access (that is, without referrals or preauthorization) to a women's health care specialist within the network for women's routine and preventive services, if there is a PCP, he or she needs to be kept informed of the health care provided by such specialists. It is up to the M+C organization to develop appropriate strategies for assuring such an outcome.
We note that an M+C organization may place restrictions on enrollees as to the eligible universe of providers to whom they may “self-refer” for women's health services. Thus, QISMC guideline 2.2.3.2 provides for M+C organizations to create formal subnetworks. In these cases, an organization can require an enrollee at the time of initial selection of a PCP, to choose an entire subnetwork that may also include specialists, hospitals, or other providers. The enrollee may be required to obtain covered services, including routine and preventive women's health services through providers affiliated with the system. Under the QISMC guideline, an enrollee could change his or her choice of subnetwork at any time. (See the guidelines for further details, including an M+C organization's responsibilities to ensure that enrollees are aware of the implications of their choice of a PCP in terms of the available subnetworks associated with a given PCP.)
Under § 422.112(a)(4), M+C organizations must have procedures that enable the organization to identify individuals with serious or complex medical conditions, assess and monitor those conditions, and establish and implement treatment plans.
A key recommendation made in the report is: “The committee recommends that the Health Care Financing Administration should provide guidance [emphasis added] to health plans to assist their efforts to identify patients with serious and complex medical conditions. Specifically, the committee recommends the following language be used to facilitate efforts of plans to identify their enrollees with “serious and complex conditions”: A serious and complex condition is one that is persistent and substantially disabling or life-threatening that requires treatments and services across a variety of domains of care to ensure the best possible outcomes for each unique patient or member.”
In view of the committee's recommendation that it is premature to establish an administrative definition of these terms, we have decided not to make any changes at this time to the regulations regarding serious medical conditions. We will provide further policy guidance on the meaning of this definition through a future OPL. For now, M+C organizations have the option of adopting the IOM definition or developing an alternative definition.
The committee also recommended that rather than focus on access to specialists, the treatment plans that M+C organizations develop should address access to specialty care. Furthermore, the committee recommended that M+C organizations develop a care management strategy that integrates the participation of all those involved in the care of the patient, including primary care physicians; medical and surgical specialists; nurses and nurse specialists; behavioral and mental health specialists; physical, occupational, and speech therapists; social workers; allied health professionals; and community-based service providers. The forthcoming OPL will address these strategies, as well as provide guidance on implementation and monitoring procedures.
Section 422.112(a)(7) (as recodified in the February 17, 1999 final rule) requires the establishment of written standards for specified areas of policy and procedures (coverage rules, practice guidelines, payment policies, and utilization management). This section is based on existing regulations and policies under part 417. We received two comments regarding this requirement.
Section 422.112(a)(9) (as recodified in the February 17, 1999 final rule) requires that services be provided in a culturally competent manner to all enrollees, including those with limited English proficiency or reading skills, diverse cultural and ethnic backgrounds, and physical or mental disabilities. We received many comments regarding this section.
We do not believe that changes to the regulation text regarding the definition of cultural competence are needed, other than to delete the reference in the regulations to mental and physical disabilities (as discussed below). However, in this preamble, we will attempt to provide further guidance on this issue. We also intend to incorporate the principles discussed here into the QISMC guidelines as we revise the QISMC cultural competence standards.
We believe that the delivery of culturally competent health care and services requires health care providers and administrative staff to possess a set of attitudes, skills, behaviors, and policies that enables the organization to function effectively in cross-cultural situations. Appropriate care delivery should reflect an understanding of the importance of acquiring and using knowledge of the unique health-related beliefs, attitudes, practices and communication patterns of beneficiaries and their families to improve services, strengthen programs, increase community participation and eliminate disparities in health status among diverse population groups.
Activities to promote achievement of this objective fall under a variety of categories, including but not limited what we refer to as “Organizational Readiness,” “Community Assessment,” “Program Development,” and “Performance Improvement,” for example. Under Organizational Readiness, M+C organizations would conduct educational programs to increase the knowledge of their staff about the unique health care beliefs, attitudes, practices, and communication patterns of the populations served by their plan. Title VI of the Civil Rights Act (see 28 CFR § 42.405(d)(1)) specifically requires that M+C organizations provide assistance to persons with limited English proficiency, where a significant number or percentage of the eligible population is likely to be affected. These requirements may require the organization to take some of the following steps: assess the language needs of beneficiaries in their service area, provide sufficient access to proficient interpreters, and disseminate written policies on the use of interpreters. In addition, the M+C organization provider network should be capable of meeting the cultural, linguistic, and informational needs of the beneficiaries residing in the service area. Ideally, the racial and ethnic diversity of the service area would be reflected in the provider network and staff of the M+C organization. The literature has demonstrated that enrollees are more likely to seek and accept health care services when delivered by one of their own racial or ethnic group. The M+C organization must ensure that all employees have received education regarding the importance of providing clinically competent and culturally appropriate services.
Community Assessment entails conduct of a market assessment to identify the specific health care needs of the beneficiary population as they relate to enrollee groups' health problems (for example, some diseases are ethnically and genetically linked). Using existing and secondary data resources, organizations would collect data to the extent necessary to identify any special culturally-based health care needs among their beneficiaries. Program Development would entail implementation of formal programs and culturally sensitive patient education projects that reduce and eventually eliminate cultural, linguistic, and informational barriers known to deter or discourage health-seeking behavior.
Finally, Performance Improvement would entail addressing an identified need or opportunity for improvement, either through a quality improvement project or other formal program that seeks to resolve undesirable differences in utilization of services and outcomes of care across all relevant racial, ethnic and cultural groups served by the managed care organization.
The goal is to promote quality health care services, ensure effective dissemination of information, and enhance consumer rights and protections by fostering a demonstrated commitment to and establishing a coordinated and integrated system for, cultural competence. This approach is consistent with other Federal initiatives and recommendations from the President's Race Initiative and from the President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry.
As achieving this objective is a M+C program requirement, M+C organizations will be monitored for compliance in this regard. We have developed additional implementation tools to assist M+C organizations in meeting the cultural competency requirement, such as operational specifications for five initial test measures and further steps which could be taken to improve, test, and expand on enrollee, disparity and standard-based inventories. The specifications for the five initial measures were developed based upon the recommendations of an expert panel and would require no new data collection on the part of the M+C
Finally, ensuring culturally competent care is congruent with our commitment to being a prudent purchaser of health care services. A growing body of knowledge demonstrates that when care is provided in a clinically competent and culturally appropriate fashion, it is more readily understood and accepted by the patient. As a result, patient compliance with treatment is enhanced, outcomes are improved, and health care costs and expenses are reduced as a result of diminished morbidity and mortality.
Consistent with section 1852(h) of the Act, § 422.118 requires M+C organizations to establish procedures that safeguard the confidentiality and accuracy of enrollee records that identify a particular enrollee, including medical documents, administrative documents, and enrollment information. The regulations specify that information from these records may be released only to authorized individuals. Each M+C organization must establish procedures for complying with the confidentiality standards, including policies governing access to information within the organization as well as when and how information may be disclosed outside the organization without enrollee authorization. Additionally, the M+C organization must maintain accurate records and ensure timely access for enrollees who wish to examine their own records.
The M+C organization must abide by all applicable State and Federal laws regarding confidentiality and disclosure of health information and any other information about enrollees. In the existing regulations, “mental health records” are mentioned separately as subject to this requirement. However, because mental health records clearly constitute a subset of the other health records specified at § 422.118 (that is, “medical records, health information, and any other enrollee information”), we are revising the regulations via this final rule to eliminate the redundant separate reference. This has no effect on the substance of the requirement.
Pursuant to Section 264 of the Health Insurance Portability and Accountability Act (HIPAA) (Pub. L. 104-191), the Secretary of Health and Human Services was directed to promulgate regulations on the confidentiality and privacy of individually identifiable health information if confidentiality legislation governing electronic health information was not enacted by August 20, 1999. Such legislation was not enacted, and the Secretary published a notice of proposed rulemaking, Standards for Privacy of Individually Identifiable Health Information, in the
Advance directives are documents recognized under State law, signed by a patient or his/her authorized representative that explain the patient's wishes concerning a given course of medical care should a situation arise when he or she is unable to make these wishes known. The M+C organization is legally responsible for providing enrollees with information on their rights under State law to establish advance directives, and ensuring that advance directives are documented in a prominent part of the beneficiary's medical record. The M+C organization is permitted to contract with other entities to furnish information concerning advance directives requirements. The M+C regulations retain for M+C organizations the requirements that applied to HMOs and CMPs under part 417, which state an HMO must maintain written policies and procedures concerning advance directives as defined in § 489.100 with respect to all adult individuals receiving medical services by or through HMOs.
Regarding the commenter's concerns about possible encouragement of inappropriate underutilization as the result of advance directives, we believe that the monitoring process will prevent and/or identify abuses of advance directives. For example, the M+C contractor interim monitoring guide states that an organization's policies must promote enrollee understanding of their conditions and facilitate the development of mutually agreed upon treatment goals. We have stated in QISMC and OPL 98-72, that with respect to advance directives, the M+C organization must meet several criteria, including that it may not make treatment conditional or otherwise discriminate on the basis of whether an individual has executed an advance directive. Underutilization patterns should be revealed by other aspects of the monitoring process, and, with regard to advance directives specifically, we are exploring the possibility of developing further monitoring criteria.
The quality assurance requirements for M+C organizations were addressed in subpart D of the June 26, 1998 interim final rule. These requirements implement and are based on the provisions of section 1852(e) of the Act. Further, they incorporate the requirements of section 1851(d)(4)(D) of the Act, which provides that the information made available to Medicare beneficiaries for plan comparison purposes must include plan quality and performance indicators, to the extent available. Section 1852(e)(1) of the Act sets forth the general rule that each M+C organization must establish an ongoing quality assurance program, consistent with implementing regulations, for the health care services it provides to enrollees in the organization's M+C plan or plans. The remaining portions of section 1852(e) of the Act contain the required elements of the quality assurance program, requirements for external review, and provisions concerning the use of accreditation organizations to determine compliance with the quality assurance requirements.
Section 422.152 incorporates each of the explicit statutory requirements of
Section 422.152(c) requires that the organization: (1) measure and report its performance to HCFA using measures required by HCFA; and (2) for M+C coordinated care plans, achieve any minimum performance levels that may be established locally, regionally, or nationally by HCFA.
Section 422.152(d) establishes the requirements for performance improvement projects, beginning with the requirement that performance improvement projects focus on specified areas of clinical and nonclinical services. It also explains that we will set M+C organizational and plan-specific requirements for the number and distribution of these projects among the required areas. In addition, it authorizes us to direct an M+C organization to undertake specific performance improvement projects and participate in national and state-wide performance improvement projects. Section 422.152(d) reflects many of the provisions of section 1852(e)(2) of the Act.
In enacting the quality assurance provisions of the BBA, Congress recognized that not all of the quality assessment and performance improvement activities that are appropriate for a plan with a defined provider network would be appropriate for an M+C non-network MSA plan or an M+C PFFS plan. The requirements specific to these types of plans are addressed in § 422.152(e). (Note that, as discussed below and in section I.C of the preamble, section 520 of the BBRA amended section 1852(e) of the Act to apply the non-network plan requirements to PPO plans as well.)
In order to support the measurement of performance levels and the conduct of performance improvement projects, if applicable, M+C organizations offering all types of M+C plans must maintain a health information system that collects, analyzes, integrates, and reports data. This requirement is covered at § 422.152(f)(1). Section 422.152(f)(2) requires that for each M+C plan an M+C organization offers, it has a process for formal evaluation, at a minimum annually, of the impact and effectiveness of the quality assessment and performance improvement program strategy with respect to services under that plan.
Section 520(a)(3) of the BBRA defined a PPO plan as an M+C plan that (1) has a network of providers that have agreed to a contractually specified reimbursement for covered benefits with the organization offering the plan; (2) provides for reimbursement for all covered benefits regardless of whether such benefits are provided within such network of providers; and (3) is offered by an organization that is not licensed or organized under State law as a health maintenance organization. This definition is being added to the regulation at § 422.4.
With respect to the issue of whether hospitals will be asked to bear costs associated with data collection, we do not expect these costs to be unreasonable, and we note that they are voluntarily assumed when the hospital decides to participate in the M+C organization's network.
As we stated in the preamble to the interim final rule, we are sensitive to the different structures of plans. We will consider the impact plan structure has upon the ability of an M+C organization to affect provider behavior. We will consider these issues when making our decisions regarding the standard measures for which it is appropriate to establish minimum levels of performance.
We are aware that a number of technical issues relating to improvement project design remain to be resolved. For instance, we must decide what to do when a project population is so small that measurement of the results of the project is not meaningful or what to do if the baseline performance is so high that the sample size required for statistical significance is very large. We intend to resolve these issues in an updated version of QISMC.
Two other commenters suggested that we take a different approach. They recommended that in lieu of requiring a 10 percent reduction in the performance gap, we follow NCQA's approach and require that managed care organizations provide meaningful evidence that they are making improvements in clinical care and service. One of these commenters suggested that to define “meaningful,” we consider whether the improvement resulted in a better outcome for the enrolled population, whether it is attributable to the organization's actions, and whether it affects high-volume, high-risk, and/or high-cost conditions or services. The commenter added that this would be more effective in encouraging complex or innovative projects that have a high risk of failure but that offer significant potential, a comment that was echoed by other commenters who were concerned that a rigid numerical significant improvement standard would encourage organizations to pursue performance goals that are easily attainable.
A third alternative to the 10 percent standard was submitted by a commenter concerned that certain characteristics of the Medicare population will complicate the achievement of significant improvement. This commenter pointed out that the elderly population is at a higher risk of illness and disease, and that a greater percentage of Medicare beneficiaries have multiple disabilities and comorbidities, which results in greater instability in their health status. This commenter recommended that we require only that organizations establish measurable goals for their interventions, and that we evaluate organizations on their ability to demonstrate the strength of their interventions and performance gains over time. Further support of this approach was offered by an additional commenter who was concerned that the 10 percent standard would encourage risk selection and discourage the enrollment of sicker beneficiaries with more complex health issues.
The 10 percent improvement standard is the best way we have at present to ensure that projects are meaningful, and that they translate into positive changes in enrollees' lives. In the long run, in order to mitigate the incentive to choose trivial projects, we will attempt to devise a way to measure and report the relative contribution of each performance improvement project, taking into account such factors as the number of enrollees affected by the improvement and the impact the improvement actually has upon enrollee health and satisfaction. Such a system is years away, but we have taken a first step towards it by starting to develop a common vocabulary for performance improvement projects.
As for the comment that requiring a 10 percent reduction in the performance gap will encourage risk selection, we believe that there exist numerous opportunities for M+C organizations to improve performance on measures relating to the care of sicker enrollees with complex health care needs. In fact, we believe the improvement potential associated with the care of sicker enrollees exceeds that associated with the care of healthier enrollees. In addition, the introduction of risk-adjusted payments to M+C organizations should further discourage risk selection.
One of the commenters opposed to national or statewide performance improvement projects complained that mandated projects will detract from the flexibility organizations need to best care for their enrollees. This commenter pointed out that many organizations have already conducted projects addressing flu and pneumonia; consequently, it would be a poor use of resources for them to be required to conduct another such project. Another opponent argued that national or statewide performance improvement projects may prove to be inconsistent with local market considerations.
With respect to the concern that organizations may have already conducted projects addressing influenza and pneumonia, which have been selected as the national project topics for 2000, there are many aspects to the care and prevention of these diseases that organizations may not have fully addressed in previous projects that would lend themselves very well to further projects.
At this point, we have not selected national project topics beyond year 2000, but we will consider the care of enrollees with Alzheimer's and with disabilities when making future selections.
Since M+C organizations will be monitored on whether they conduct QAPI projects addressing these focus areas, and to respond to the request for further information, we suggest that organizations consult the QISMC Interim Standards and Guidelines (specifically, Standards 1.3.4.5 and 1.3.4.6) for further guidance as to our expectations. In selecting a quality improvement project focusing on high-risk or high-volume services, we note that the focus does not necessarily have to be on a clinical condition per se, but on a service and how it may be improved. In HEDIS 99, Volume 2, Technical Specifications, there are several clinical conditions for which suggested indicators are provided in assessing “High-Occurrence/High-Cost” DRGs. Congestive heart failure, angina pectoris, chronic obstructive pulmonary disease and other conditions which place the enrollee at risk of increased morbidity or mortality would certainly constitute appropriate conditions under the “high-risk” category. An organization may assess experiences of care received from specialized centers inside or outside of its network, such as burn centers, transplant centers, or cardiac surgery centers. With respect to “high-volume” services, an M+C organization may target quality improvement in a frequently performed surgical procedure, or across different surgical or invasive procedures.
As for oversight of the health information system, the organization is ultimately responsible for determining at what level within its structure there will be oversight which ensures the reliability and completeness of information received from providers.
We agree with the commenter that in processing requests for authorization of services, the organization should follow policies and procedures that are based on scientifically sound and evidence-based guidelines. Nevertheless, we recognize that in instances where such guidelines do not exist, individuals making authorization determinations may need to refer to current standards of medical practice. In those cases, an M+C organization must have in place written policies and procedures to ensure that all coverage decisions are designed to provide care in the safest, most beneficial and cost-effective fashion.
Finally, in response to concerns raised by managed care organizations regarding the potential burden imposed by the QISMC performance improvement project requirements, we significantly scaled back the number of required projects per year from nine required projects to only two per year. To assist M+C organizations further in this effort, we are currently developing model performance improvement projects and other implementation tools.
One commenter praised the policy we put forth in the preamble, explaining that providing the results of performance improvement projects to Medicare beneficiaries could undermine the legal confidentiality of peer review activities and could make such information reported outside the organization discoverable in legal proceedings. Another commenter also expressed support for our disclosure policy, noting that performance improvement requirements are new and that a non-punitive atmosphere is most conducive to improvement. However, this commenter recommended that we reexamine our disclosure policy in the future, and make it our goal to provide public access to performance information that will not violate patient confidentiality.
We note that we do make a substantial amount of information available to the public for research purposes, such as the HEDIS public use file on our website; moreover, there is nothing to preclude researchers from attempting to obtain information directly from the M+C organizations themselves as long as enrollee confidentiality is protected.
The same is true for the results of performance improvement projects. We again believe it preferable that performance improvement project data not go directly to the PRO. The data will be reported either to HCFA or to the specialized quality review organizations with which we have contracted to evaluate the success of performance improvement projects (the M+C/QROs). HCFA or the M+C/QROs will then present and interpret the results for the PROs.
Section 422.154 implements section 1852(e)(3) of the Act. Section 1852(e)(3) requires, subject to certain exceptions, that each M+C organization, for each M+C plan it operates, have an agreement with an independent quality review and improvement organization approved by us to perform functions of the type described in part 466 of chapter 42, which establishes review responsibilities for utilization and quality control Peer Review Organizations (PROs). This general requirement appears in § 422.154(a) of the interim final rule. The terms of the agreement are described in § 422.154(b), and the exceptions to the general requirement are stated in § 422.154(c).
With respect to the comment that our application of the “anti-duplication” policy in section 1852(e)(3)(B) of the Act be subjected to notice and comment, we believe that the process of determining whether review activities are duplicative in a given case represents “operational” implementation of the substantive standard set forth in the regulations. We believe it would be neither workable nor appropriate to subject such operational judgments to notice and comment rulemaking.
With respect to the commenter's advocating that we require “disclosure” by accreditation bodies of their protocols, and disclosure to beneficiaries of decisions on duplication (with an opportunity to comment), we do not believe these steps are warranted. The quality standards that apply to M+C organizations apply without regard to whether duplication has been found. A beneficiary has access to detailed information on these standards, which are all public. We believe that it should not make a difference to the beneficiary whether our judgment that these standards are being satisfied is based on the findings of an accreditation body, HCFA, or an external review entity, as long as HCFA is responsible for ensuring that they are met.
We do not see the point in limiting exemptions to a year, if there is no reason to believe that the factors we will consider in making a decision on duplication will be changing.
On the issue of “nonpublic reports,” we expect that the public will have access to the same quality information for all M+C organizations, without regard to whether specific review activities were found to be duplicative.
Section 1852(e)(4) of the Act gives the Secretary the authority to deem that an M+C organization meets certain requirements if the M+C organization is accredited and periodically reaccredited by a private organization under a process that we have determined ensures that the M+C organization, as a condition of accreditation, meets standards that are no less stringent than the applicable HCFA requirements.
Section 422.156(a) of the M+C regulations specifies the conditions under which an M+C organization may be deemed to meet the HCFA requirements permitted to be deemed under section 1852(e)(4) of the Act.
The current version of § 422.156(b) specifies the requirements that could be deemed under the original BBA deeming provisions. In accordance with those BBA provisions, these included only the quality assessment and performance improvement requirements of § 422.152, and the requirements of § 422.118 related to confidentiality and accuracy of enrollee records. As discussed in section I.C. of this preamble, the BBRA amended section 1852(e)(4) of the Act to provide for deeming of additional requirements. An M+C organization accredited by an approved accreditation organization could be deemed to meet any or all of the requirements specified in section 1852(e)(4) of the Act, depending on the specific requirements for which its accreditation organization's request for approval was granted.
Section 422.156(c) establishes when deemed status is effective. Deemed status is effective on the later of the following dates: The date on which the accreditation organization is approved by us, or the date that the M+C organization is accredited by the accreditation organization.
Section 422.156(d) establishes the obligations of deemed M+C organizations. An M+C organization deemed to meet Medicare requirements must submit to surveys to validate its accreditation organization's accreditation process, and authorize its accreditation organization to release to us a copy of its most current accreditation survey, together with any information related to the survey that we may require (including corrective action plans and summaries of unmet HCFA requirements.)
Section 422.156(e) addresses removal of deemed status. We will remove part or all of an M+C organization's deemed status if: (1) We determine, on the basis of our own survey or the results of the accreditation survey, that the M+C organization does not meet the Medicare requirements for which deemed status was granted; (2) we withdraw our approval of the accreditation organization that accredited the M+C organization; or (3) the M+C fails to meet the requirements of paragraph (d) of this section.
Finally, § 422.156(f) explains that we retain the authority to initiate enforcement action against any M+C organization that we determine, on the basis of our own survey or the results of the accreditation survey, no longer meets the Medicare requirements for which deemed status was granted.
In addition to expanding the types of requirements that are deemable, section 518 of the BBRA also specified procedural changes to the accreditation process which are also discussed in section I.C above and in several responses below. As noted above, these changes have been reflected in a revised version of § 422.156.
The comments and responses regarding § 422.156 are discussed below.
We note that HCFA's oversight of managed care accreditors will be different from that of hospital accreditors,
When we withdraw an accreditation organization's approval, we also remove the deemed status of all M+C organizations accredited by the organization. Upon removal of an M+C organization's deemed status, HCFA immediately assumes responsibility for ensuring that the organization meets our standards. Because beneficiaries are not at risk, and because notifying them of the loss of their M+C organization's deemed status could cause them to be concerned that they are at risk, we do not believe it is necessary or appropriate to so notify beneficiaries.
In § 422.157(a), we discuss three conditions for our approval of an accreditation organization. We may approve an accreditation organization if the organization applies and enforces standards for M+C organizations that are at least as stringent as Medicare requirements (as discussed above); the organization complies with the application and reapplication procedures set forth in § 422.158, “Procedures for approval of accreditation as a basis for deeming compliance;” and, the organization is not controlled by the managed care organizations it accredits, as defined at § 413.17.
Section 422.157(b) of the interim final rule describes notice and comment procedures. Because the approval of an accreditation organization could have broad impact upon large numbers of organizations, providers, and consumers, we are providing notice and comment opportunities similar to those provided in the fee-for-service arena.
Section 422.157(c) establishes ongoing accreditation organization responsibilities. These responsibilities largely parallel those currently imposed upon accreditors under original Medicare. One exception is the requirement at § 422.157(c)(4) that an accreditation organization notify us in writing within 3 days of identifying, with respect to an accredited M+C organization, a deficiency that poses immediate jeopardy to the M+C organization's enrollees or to the general public.
Section 422.157(d) establishes specific criteria and procedures for continuing oversight and for withdrawing approval of an accreditation organization. Oversight consists of equivalency review, validation review, and onsite observation.
Section 422.157(d) states that an accreditation organization dissatisfied with a determination to withdraw our approval may request a reconsideration of that determination in accordance with subpart D of part 488 of this chapter. The comments and responses regarding § 422.157 are discussed below.
In addition, because we are now required to make our decision on an accreditation organization's application within 210 days, we are revising § 422.157(b)(1) to restructure the provisions concerning timing and content of the
In the interim final rule, we modeled § 422.157(b)(1) on the original Medicare deeming regulation at § 488.8(b)(1). However, § 488.8(b)(1) was written before section 1865(b)(3)(A) of the Act was amended to require 210-day turnaround on accreditation organization applications, and we are now in the process of revising § 488.8 to conform with the Act. If we do not revise § 422.157(b)(1) to follow original Medicare's model, we are concerned that our review of the accreditation organization's standards will be so time consuming, there will be little time left within the 210 days for the public comment period. Therefore, revised § 422.157(b)(1) specifies that the
In response to the commenter's concern, we are requiring that accreditation organizations provide us annually with summary data relating to their accreditation activities and observed trends. These data will assist us in making a comprehensive assessment of accreditation organization performance, and will help ensure that our oversight decisions are well-informed and appropriate. This change appears at § 422.157(c)(6).
The requirements of § 422.158, which pertain to required application materials, the mechanics of the approval process, and the reconsideration of an adverse determination, are essentially restatements of the original Medicare requirements under § 488.4.
Part 422, subpart E of the M+C regulations focuses on requirements for relationships between M+C organizations and health care professionals with whom they contract to provide services to beneficiaries enrolled in an M+C plan. Many of these requirements stem from the rules regarding provider participation that are set forth in section 1852(j) of the Act. In our February 17, 1999 final rule, we addressed comments and made changes concerning several aspects of the provider participation requirements contained in subpart E, including the scope and applicability of the provider participation procedures. This final rule addresses comments on all other requirements in subpart E.
For the most part, we responded to comments on issues related to §§ 422.202(a) and 422.204(c) of the regulations in our February 17, 1999 final rule (64 FR 7975). In reviewing the comments on the interim final rule, however, we believe that additional clarification may be necessary on the applicability of the provider appeals procedures now set forth under § 422.204(c).
With regard to the membership of appeals panels, an M+C organization is free to enlist non-contracting physicians on these panels if it chooses to do so. However, section 1852(j)(1)(C) of the Act refers to an appeals process “within the organization,” and we do not believe it would be reasonable to require the participation of non-contracting physicians.
In accordance with section 1852(j)(2) of the Act, § 422.202(b) specifies that an M+C organization must consult with physicians participating in its M+C plans regarding the organization's medical policies, quality assurance programs, and medical management procedures. Under the regulations set forth in our June 26, 1998 interim final rule, these provisions were applied to other health care professionals as well as physicians. However, in response to comments on the interim rule, we revised this section in our February 1999 final rule to limit the applicability of these requirements to physicians. We also received a number of comments on other aspects of the consultation provisions, which are discussed below.
Other commenters representing M+C organizations asked for confirmation that the use of physician committees to obtain consultation was an acceptable means of satisfying the consultation requirements. Two M+C organizations suggested that we define “consultation” as “soliciting and considering advice from participating professionals through committees established by the M+C organization.” Another commenter noted that local medical review procedures (LMRP) should be part of the consultation process, and could in some instances substitute for the consultative process. One commenter indicated that the consultative requirements could be read to require consultation with hundreds of individual physicians and expressed concern that the consultative requirements would interfere with an individual physician's judgement in treating patients.
Similarly, although we agree with the definition of consultation offered by the commenters, we believe that the term is sufficiently self-explanatory and that inserting a formal definition of the term into the regulations is unnecessary. We also agree that M+C organizations should take local medical review policies into consideration in establishing and updating their medical review policies. However, we believe that the regulations need not include that degree of specificity concerning the evidence-based guidelines an M+C organization must consider in adopting practice guidelines. We will consider adding such policies to the list of guidelines now described in the QISMC standards on this subject (QISMC Guideline 3.4.1.1).
Finally, we do not agree that the consultation requirement infringes on the ability of an individual physician's judgement in the practice of medicine. As their name implies, practice “guidelines” are intended for general application rather than as procedures to be followed in every case independent of physician judgment.
Under § 422.202(c), an M+C organization that uses subcontracted physician groups or other networks of health care professionals must provide M+C participation procedures that apply equally to these subcontracting groups.
As spelled out under § 422.502(i), under any type of subcontracting arrangement, the M+C organization retains ultimate responsibility for ensuring that its subcontractors achieve full compliance with all terms and conditions of the organization's contract with us. This includes ensuring that activities performed by its subcontractors are consistent and comply with the M+C organization's contractual obligations. For activities that are delegated to contractors (such as provider appeals), the contract must specify that the subcontractor must comply with all Medicare laws, regulations, and instructions. Thus, a physician who is employed by a group practice that contracts with an M+C organization would have the same fundamental consultation and appeal rights as a physician who contracts directly with the M+C organization. Whether that physician exercises those rights at the subcontractor level, or directly through the M+C organization, would be left to the discretion of the M+C organization and its subcontractors. For example, an M+C organization could enter into a contract with a physician group under which all individual appeals of adverse participation decisions were adjudicated at the subcontractor level. However, the subcontractor's appeals process would need to meet the requirements established under redesignated § 422.202(d), as discussed above: all procedural rights established there would apply equally for the subcontracting physicians. For situations in which a subcontract with an entire group practice was terminated by an M+C organization, we would expect that the appeal rights would fall to the subcontracting group practice to exercise on its physicians' behalf.
Similarly, with respect to the consultation requirements, we can envision various ways in which the requirements could be met under subcontracting arrangements, such as through direct representation for the subcontractor's providers on M+C organization committees, or through committees convened by the subcontractor, with its consultative input channeled to the M+C organization. In either case, though, the underlying requirement must be met that practice and utilization management guidelines be developed in consultation with contracting physicians.
In general, our policy to date has been to afford extensive flexibility to M+C organizations in meeting subcontracting requirements. In 1999, for example, we required risk contractors that became M+C organizations to submit a plan demonstrating how they would work toward executing new or revised provider or administrative service contracts, with full compliance required by January 1, 2000. Again, for further information on the ways in which an organization can demonstrate compliance with provider contracting requirements, please see OPL 77.
Sections 422.100(j) and 422.204(b) both relate to the provision set forth in section 1852(b)(2) of the Act that precludes M+C organizations from discriminating against providers based on their licensure or certification. Section 422.204(b), for the most part, simply incorporates the statutory prohibitions on discrimination based on provider licensure or certification, but also provides that these prohibitions do not preclude the “use of different reimbursement amounts for different specialties.” Section 422.100(j) states that if more than one type of practitioner is qualified to furnish a particular service, the M+C organization may select the type of practitioner to be used.
In general, commenters representing M+C organizations supported the inclusion of the choice-of-practitioners provision (§ 422.100(j)); they believe that this provision establishes that M+C organizations are not required to adopt an “any willing provider” policy, but rather have the flexibility to choose the practitioners that participate in an organization's provider network. In contrast, commenters representing physicians and other health care professionals believe that the choice-of-practitioners provision is unnecessary and confusing; they see the provision as undermining the antidiscrimination provisions of the statute and the M+C regulations. These commenters particularly objected to the wording in § 422.100(j) that allows an M+C organization to select the “type of practitioner” to be used. These commenters offered various recommendations, including: (1) delete the provision in its entirety; (2) add a requirement that an M+C organization employ a “representative range of providers” (comparable with the available range of providers under original Medicare); (3) amend the provision so that it would focus on the availability of all Medicare-covered “benefits” (many of which can be furnished only by qualified practitioners), rather than “services”.
Commenters displayed similar perspectives with regard to the antidiscrimination prohibitions set forth under § 422.204(b). As noted above, the only portion of this section that is not taken directly from the statute is the provision under existing § 422.204(b)(2)(ii) that indicates that an M+C organization is not precluded from use of different reimbursement amounts for different specialties. Commenters representing M+C organizations generally supported the addition of this language, although one commenter believed that it unnecessarily restricted an M+C organization's ability to negotiate with physicians or other practitioners. This commenter stated that the regulations do not give an organization sufficient leeway to take into consideration the reputation, volume, or experience of a practitioner, or alternative payment methods, in establishing compensation.
Other commenters representing various types of physicians and other health care professionals objected to this
To assist in clarifying the relevant requirements, we believe it is appropriate to consolidate the regulations concerning antidiscrimination and choice of providers into a new, separate § 422.205, Provider antidiscrimination. This section will begin with the general rule prohibiting discrimination based solely on licensure or certification, consistent with the law. We then will specify that in choosing its practitioners, an M+C organization must ensure that all Medicare-covered services must be available to a plan's enrollees. We are also incorporating under § 422.205(a) a revised version of the existing provision regarding choice of practitioners that eliminates any reference to “type of practitioners.” Thus, the general rule will continue to permit M+C organizations the flexibility to choose their practitioners, consistent with the statute's antidiscrimination constraints, which are set forth under § 422.205(b). At the same time, this provision will emphasize the mandatory availability of all Medicare-covered services (such as physical therapy or manual manipulation of the spine to correct a subluxation).
Finally, we are adding at, § 422.205, a requirement that when an M+C organization declines to include a given provider or group of providers in its network, it must notify the provider(s) of the reason for its decision. Although this provision does not impart any appeal rights, we believe it is both a reasonable business practice and a means of ensuring that such decisions are subject to our monitoring efforts.
Our goal in implementing these changes is to strike a balance between our responsibility to ensure that M+C organizations are employing all the types of health care professionals needed to ensure that required Medicare-covered services are available to their enrollees, and our aversion to limiting organizations' flexibility in providing these services. Over the next few years, we intend to closely monitor organization compliance with the antidiscrimination provisions, including examining encounter data as it becomes available and tracking organizational participation decisions, to determine the degree to which all Medicare-covered services are made available under different plans.
We believe that the statute is not intended to preclude an M+C organization from negotiating appropriate, market-based, payment rates with its providers. It is quite possible, for example, that the “market rate” that must be paid to get a particular type of specialist to participate in an M+C organization's network may be higher or lower than that dictated by the market with respect to another type of practitioner. Section 1852(b)(2) of the Act expressly provides that its antidiscrimination rule “shall not be construed to prohibit a plan from * * * measure[s] designed to * * * control costs. * * *” Paying no more than the market rate for a given provider is clearly a component of cost control. We believe that establishing requirements concerning the comparative rates M+C organizations pay for contracting provider services would be inconsistent with the overall design of the M+C program, under which we pay a fixed amount to ensure that Medicare beneficiaries receive the services to which they are entitled, but M+C organizations have wide discretion in managing enrollee care and establishing provider networks. Inherent to this design is the premise that payment rates should be established through negotiated contracts rather than micro-managed by the Federal government. Thus, new § 422.205(b) specifies that an organization may use different reimbursement amounts for different specialties, or different practitioners within the same specialty.
Further, we do not agree with the commenter that the payment rules established under original Medicare's fee schedules necessarily represent the appropriate model for payment under the M+C program, or that it would be appropriate or feasible to establish a requirement that an M+C organization's provider network reflect the identical mix of providers participating in Medicare generally. Beneficiaries have the option of returning to original Medicare if they place a premium on being able to receive services from any provider they wish, or are not satisfied with being limited to a defined network established by an M+C organization.
In addition to addressing measures designed to control costs, section 1852(b)(2) of the Act also makes clear that the antidiscrimination rule therein shall not be construed to prevent an M+C organization from taking measures to “maintain quality” of services. For example, we would not want to preclude higher payments to providers for demonstrating quality improvement, or preclude an M+C organization from imposing quality-related requirements, such as using only board-certified physicians.
Finally, section 1852(b)(2) of the Act makes clear that its antidiscrimination provision “shall not be construed to prohibit a plan from including providers only to the extent necessary to meet the needs of the plan's enrollees.” If an M+C organization can provide all physicians' services through a doctor of medicine, it may not “need” to contract with another practitioner who can provide only a discrete subset of physicians' services (such as a podiatrist or a chiropractor who under section 1861(r) of the Act are considered physicians under Medicare only for specified purposes). As long as all Medicare-covered services are available in the plan, there may be no “need” to assume the additional administrative costs of contracting with another practitioner when an existing contractor is able to perform the services the additional practitioner would be providing. This would not constitute discrimination based “solely” on the basis of license or certification, but rather, not contracting with practitioners not “needed” to provide the full Medicare range of benefits.
With respect to the choice-of-practitioners provision, this right has always been inherent in the managed care model of health care delivery. While a practitioner is not to be discriminated against
We do not understand the commenter's reference to the Supreme Court's
In addition, as noted above, § 422.205 will now incorporate the requirement that an M+C organization must state in writing its reasons for declining to include any given provider or group of providers in its provider network. This should enhance our ability to identify violations of the antidiscrimination requirements, for example, by detecting situations in which organizations exhibit a pattern of repeated refusal to contract with certain types of practitioners. If a prospective provider has evidence of discrimination on the basis of licensure, the appropriate avenue to raise this concern is the HCFA regional office in the relevant area.
Ensuring that providers have the proper credentials for the services they are providing is a key component of an overall “ongoing quality assurance program for health care services,” as required under section 1852(e)(1) of the Act. Section 422.204(a) accordingly sets forth basic requirements that an M+C organization must follow with respect to the credentialing and recredentialing of the providers and suppliers with whom it enters into participation agreements. The M+C organization must ensure that providers and suppliers meet applicable State and Federal requirements. Basic benefits must be provided through, or payments must be made to, providers that meet applicable requirements of title XVIII and part A of title XI of the Act. Also, in the case of providers meeting the definition of “provider of services” in section 1861(u) of the Act, § 422.204(a)(3)(i) specifies that basic benefits may only be provided through such providers if they have a provider agreement with us permitting them to provide services under original Medicare. An M+C organization may not employ or contract with providers excluded from participation in Medicare.
This change in no way obviates our awareness that an organization's selection criteria, and thus its credentialing policies and procedures, should be tailored to take into account the individual characteristics of each M+C organization. The process of provider selection also should be integrated with the process of establishing and maintaining an adequate provider network to assure enrollee access to plan services. Thus, we do not intend to add to the regulations greater specificity concerning the procedures an M+C organization must follow for credentialing and recredentialing purposes, or establish detailed criteria as to what constitute adequate credentials. Instead, the regulations will continue to require that M+C organizations follow a “documented process” for these activities that meets the relatively flexible existing standards.
With respect to the question about whether meeting NCQA standards would constitute compliance with M+C requirements, we are currently evaluating this question in the context of the “deeming” provisions discussed in section II.D above. If we find that NCQA, or any other private accreditation organization, applies and enforces standards that are at least as stringent as those set forth in § 422.204, then satisfying NCQA standards would constitute compliance with M+C requirements. Until we make such a determination, however, meeting NCQA credentialing standards does not necessarily achieve compliance with the M+C requirements. We note that we agree with NCQA that credentialing is not required for health care professionals who are permitted to furnish services only under the direct supervision of a physician or other provider, or for hospital-based health care professionals (such as an emergency room physician, anesthesiologist, or certified registered nurse anesthetist (CRNA)) who provide services to enrollees only incident to hospital services. (This exception does not apply if the practitioner contracts independently with the M+C organization or is promoted by the organization as being part of its provider network.)
Finally, we agree that the requirement that an M+C organization's process include “receiving advice” from contracting health care professionals could be misconstrued. We are changing this requirement to indicate that the organization must have a process for consulting with its contracting health care professionals on its credentialing and recredentialing criteria.
Existing § 422.204(a)(3)(i) requires that in the case of providers of services that meet the original Medicare definition of “providers” under section 1861(u) of the Act (such as HHAs or SNFs), that provider must have a provider agreement with us in order to be permitted to furnish basic benefits under an M+C plan. Under this requirement, neither accreditation nor approval under the Medicaid program is necessarily sufficient to enable an HHA to furnish services under an M+C plan, unless the HHA is Medicare-certified. The objective of this policy is to ensure that M+C enrollees are guaranteed services of a quality level at least equal to that available to other Medicare beneficiaries. We continue to believe that the existence of a provider agreement with us is the best way to ensure that HHAs providing services to M+C enrollees meet uniform standards in all States and are subject to Federal enforcement authority. Thus, we believe it would be inappropriate to create an exception for HHAs to the general rule that “providers of services” as defined under section 1861(u) of the Act must have a provider agreement that permits them to furnish services under original Medicare.
Consistent with section 1852(j)(3)(A) of the Act, § 422.206(a) prohibits an M+C organization from interfering with the advice of a health care professional to an enrollee who is his or her patient. Thus the health professional may act within his or her scope of practice in advising the enrollee about his or her health status, all relevant medical or treatment options available regardless of whether care or treatment is provided under the plan. Section 422.206(b) incorporates the requirements of section 1852(j)(3)(B) of the Act. The regulations state that the prohibition against interference with the content of advice a health care provider has given to enrollees regarding medical treatment should not be construed as requiring counseling by a professional, if the M+C organization objects, based on moral or religious grounds, and fulfills certain notification requirements to prospective and current enrollees. The regulations incorporate the notification process and time frames included in the law and clarify that the plan must also notify us at the time of application and within 10 days of submitting its ACR proposal. We received 12 comments addressing the provisions set forth under § 422.206.
Another commenter asserted that there was a potential conflict between the conscience protection provisions and the information disclosure rules in § 422.111 and recommended that we establish an exception to the advance disclosure rules for “duly adopted religious policies.” The commenter noted that the conference agreement to the BBA indicates the Congress' intent that the Secretary not “impose burdensome regulatory, legal, or stylistic requirements with respect to this notice requirement.” (House Report, 105-217, pg. 607.)
We agree that the disclosure provisions under § 422.206(b) should be read consistently with other disclosure provisions in the regulations, and thus M+C organizations must take into account the special needs of individuals who are blind, disabled, or cannot read or understand English. The notification requirements set forth in § 422.206(b)(2) are not intended to result in an M+C organization being put in the position of being required to furnish counseling or referral services that violate a duly adopted religious policy. Experience indicates that neither changes in Medicare coverage policies nor in “duly adopted” religious policies take place so quickly as to preclude an M+C organization from providing advance notice to us, and then to enrollees, concerning service restrictions based on such policy changes. Thus, we believe that only very rarely, if ever, would a conflict exist between the advance disclosure requirement of § 422.111(d) and the provision that permits an organization to implement a conscience exception, provided that it notifies its enrollees of such changes within 90 days after adopting the change. Consequently, we do not view the advance disclosure procedure as a burdensome requirement.
Sections 422.208 and 422.210 outline the limitations and disclosure rules for physician incentive plans. Specifically, § 422.208 applies to an M+C organization and any of its subcontracting arrangements that use a physician incentive plan in their payment arrangements with individual physicians or physician groups. With the exception of the deletion of a requirement that information on expenditures of capitation payments be reported to us, the provisions in these sections are essentially the same as those that previously applied to Medicare risk plans under § 417.479. We received several comments regarding physician incentive rules.
The majority of arrangements that exceed the threshold are capitation arrangements, where 100 percent of the income is put at risk. For these arrangements, the precise amount at which we set the threshold will not make a difference, they will exceed any reasonable risk threshold.
As we indicated in guidance provided in December 1996 to section 1876 contractors, M+C organizations do not have to disclose to beneficiaries the precise formula and payment amounts involved, nor do they have to provide incentive plan information for individual physicians or physician groups. Only summary information needs to be reported. However, the M+C organizations are required to report more detailed information to us or the State Medicaid Agencies.
Consistent with sections 1852(k)(1) and 1866(a)(1)(O) of the Act, § 422.214 requires that any health care provider that does not have in effect a contract establishing payment amounts for services furnished to a beneficiary enrolled in an M+C coordinated care plan must accept, as payment in full, the amounts that they could collect if the beneficiary were enrolled in original Medicare (less the amounts specified in §§ 412.105(g) and 413.86(d) of the regulations on hospital graduate medical education payments, when applicable). Any statutory provisions (including penalty provisions) that apply to payment for services furnished to a beneficiary not enrolled in an M+C plan also apply to the payment described in § 422.214(a)(1) of our regulations. We received three comments regarding this section.
We note, however, that a provision in the BBA does give providers furnishing services to coordinated care plan enrollees the right to be paid the Medicare payment amount under certain circumstances. Section 1852(a)(2) provides that where an M+C organization chooses to furnish services through providers that do not have contracts with the organization in order to meet its obligation under section 1852(a)(1) to make Medicare services available, it must provide for payment “equal to at
To summarize our position, in the case of services arranged by an M+C organization to be furnished by a noncontracting provider to a coordinated care plan enrollee, or any services furnished by a noncontracting provider to a private fee-for-service plan enrollee, section 1852(a)(2) applies, and the M+C organization must pay the Medicare payment amount. In the case of emergency services (referred to in section 1852(d)(1)(E)), urgently needed services (referred to in section 1852(d)(1)(C)(i)), renal dialysis services provided out of the M+C plan's service area (referred to in section 1852(d)(1)(C)(ii)), and maintenance care or poststabilization services (referred to in section 1852(d)(1)(C)(iii)) furnished to a coordinated care enrollee by a noncontracting provider, the provider is required to accept the Medicare
As discussed in further detail in section II.Q of this preamble, we anticipate that the organizations offering M+C private fee-for-service (PFFS) plans may have a particular need for such a process, both to pay non-contracting providers who must be paid at least the amount they could collect under original Medicare, and to pay contracting and deemed contracting providers, assuming that the M+C organization offering the PFFS plan has chosen to meet access requirements by paying contracting providers “no less than” the amount paid under original Medicare. Therefore, we have decided to permit M+C organizations offering PFFS plans to establish “proxies” for use in paying services for which no Medicare prospective payment system or fee schedule exists, provided that the proxy methodology has been approved by us as not being less than the expected Medicare payment amount.
We emphasize that the proxy methodologies will be designed to provide an accurate estimate of the Medicare payment amount, including possible beneficiary cost-sharing under original Medicare. In some cases (for example, for Medicare-certified hospitals, SNFs, or HHAs, or for Medicare-participating physicians), this is the amount that a noncontracting provider is required to accept as payment in full from the M+C organization. In other cases, the amount that a noncontracting provider may collect is not limited to the Medicare payment amount but could include allowable balance billing amounts under original Medicare. In such a case, the provider has a right to collect more from the M+C organization than the Medicare payment amount reflected in the proxy (and in the case of a non-contracting provider furnishing services to a PFFS plan enrollee, the M+C organization may have an obligation to pay more than the proxy amount).
An M+C organization may not pay, directly or indirectly, on any basis, for services (other than emergency or urgently needed services as defined in § 422.2) furnished to a Medicare enrollee by a physician (as defined in section 1861(r)(1) of the Act) or other practitioner (as defined in section 1842(b)(18)(C) of the Act) who has filed with the Medicare carrier an affidavit promising to furnish Medicare-covered services to Medicare beneficiaries only through private contracts with the beneficiary under section 1802(b) of the Act. An M+C organization must pay for emergency or urgently needed services furnished by a physician or practitioner who has not signed a private contract with the beneficiary.
As part of our effort to streamline the flow of information on opt-out physicians and practitioners, we are also considering what information can be placed on a list or made available through a website. Some information such as the SSN cannot be disclosed under the Privacy Act.
Currently, M+C plans should contact the Medicare carrier with jurisdiction over the payment of claims under original Medicare in their service area to work out a mutually agreeable means of receiving this information on a timely basis. Disputes should be referred to the HCFA regional office for resolution.
With respect to contracting physicians, M+C organizations may, through their contracts, require contract providers to notify them immediately when they enter into private contracts under section 1802(b). This will provide the information more timely than any process that might be arranged with Medicare carriers or through a listing prepared by us, and will permit the M+C organization to cease payment immediately to the contracting physician or practitioner who has opted out of Medicare.
The physician referral prohibition in section 1877 of the Act concerns M+C organizations, although the implementing regulations are located in subpart J of part 411 rather than in part 422. Under section 1877, if a physician or a member of a physician's immediate family has a financial relationship with a health care entity (through an ownership interest or a compensation relationship), the physician may not refer Medicare patients to that entity for any of 11 designated health services, unless an exception applies. Under section 1877(b)(3) of the Act and § 411.355(c) of the regulations, services furnished by section 1876 contractors to their enrollees were exempted from the physician referral prohibition. In the June 1998 interim final rule, we revised § 411.355(c) to similarly exclude from the physician referral prohibition services furnished under an M+C coordinated care plan to an enrollee. We did not exclude services furnished by private fee-for-service plans or MSA plans from the physician referral prohibition. Subsequently, section 524 of the BBRA amended section 1877(b)(3) of the Act by adding a new subparagraph (E) to exempt an M+C organization offering an M+C coordinated care plan from the physician referral prohibition. The comments and responses regarding this subject are discussed below.
We do not understand why a beneficiary's knowledge of the differences between coordinated care plans and private fee-for-service/MSA plans addresses the concerns behind our decision not to exempt services furnished under the latter plans from the prohibition in section 1877. Under section 1877, we can create a new exception only if the Secretary determines, and specifies in regulations, that a financial relationship between a physician and an entity to which the physician refers does not pose a risk of program or patient abuse. Pursuant to this authority, we exempted services furnished under coordinated care plans because the Congress had already exempted the identical type of arrangement when it exempted services furnished under section 1876 contracts, (and likely inadvertently failed to make a conforming change to this exception when M+C contracts replaced section 1876 contracts), and because we did not see a potential for program or patient abuse in the case of coordinated care plans. This latter conclusion was based on the facts that, as in the case of a section 1876 risk contractor: (1) A physician working with an M+C organization offering a coordinated care plan has no incentive to order unnecessary care, since physicians are not paid for ordering additional services; (2) the organization has control over its network of providers, and provides incentives for its network providers to avoid unnecessary care; and (3) incentives to deny necessary care are addressed by physician incentive plan requirements limiting the risk that can be imposed on physicians. These are the same physician incentive plan requirements that are incorporated in a section 1877 provision permitting certain risk arrangements that would otherwise be subject to the referral prohibition. (See section 1877(e)(3)(B) of the Act.)
In contrast, under M+C MSA plans or private fee-for-service plans, individual providers, including physicians, are paid on a fee-for-service basis for services provided, and thus have the same kind of incentives to provide unnecessary services that gave rise to the enactment of section 1877. Although this would not result in more Medicare funds being expended during the year in question, it could harm beneficiaries in two ways. First, it could result in higher cost-sharing paid by beneficiaries in the current year. Second, it could result in the M+C organization offering less in benefits the following year than it would otherwise be able to offer if its expenses were not as high. For these reasons, we do not believe that the exception from the physician referral prohibition that we have created for services furnished under coordinated care plans should apply to services under M+C private fee-for-service plans or MSA plans. We note that the Congress implicitly endorsed our position through the amendments to section 1877 included in section 524 of the BBRA. This section explicitly exempted M+C coordinated care plans from the physician referral prohibitions, but did not include any changes related to other types of plans.
Part 422 Subpart F sets forth rules that govern payment to M+C organizations, including the methodology used to calculate M+C capitation rates. These rules are based primarily on section 1853 of the Act. (For a complete discussion of these requirements, see the June 26, 1998 interim final rule at 62 FR 35004.)
One of the more significant payment changes in section 1853 of the Act is a gradual transition from rates based on local Medicare costs to “blended” rates based on a 50/50 mix of local and national costs. Under the Adjusted Average Per Capita Cost (AAPCC) payment methodology that applied to section 1876 risk contracts, payment was based on Medicare fee-for-service expenditures in the county in which the enrollee resided. These fee-for-service expenditures were adjusted for demographic factors (that is, age; sex; institutional, welfare, and employment status).
The AAPCC was criticized for its wide range of payment rates among geographic regions: in some cases payment rates varied by over 20 percent between adjacent counties. It was also criticized for its poor risk adjustment capabilities and inappropriate provision of graduate medical education funds to some Medicare risk plans. Moreover, the AAPCC was criticized for setting erratic annual payment updates, which often made it difficult for contracting health plans to engage in long-term business planning. The BBA introduced a new payment methodology that addressed these and other concerns.
• The blended capitation rate is a blend of the area-specific (local) rate and the national rate, with the latter adjusted for input prices. The blended capitation rate is then adjusted by a budget neutrality factor designed to ensure that payment is not higher than it would be under purely local rates.
• The minimum amount rate was $367 per month per enrollee in 1998 for all areas in the 50 States and the District of Columbia. Outside the 50 States and the District of Columbia, the rate was limited to 150 percent of the 1997 AAPCC for the area in question, if this amount was lower than $367. The minimum amount rate is adjusted each year using the update factors described in § 422.254(b).
• The minimum percentage increase is 2 percent. The minimum percentage increase rate for 1998 was 102 percent of the 1997 AAPCC. Thereafter, it is 102 percent of the prior year's capitation rate.
With the exception of payments under M+C MSA plans, we pay M+C organizations monthly payments for each enrollee in an M+C plan they offer
However, passage of the BBRA may alleviate some concerns of the commenters. The BBRA requires several modifications to the payment calculations set forth in the BBA, including: lowering the reduction of the national per capita growth percentage defined in § 422.254(b), offering bonus payments to eligible M+C organizations as described in § 422.250(g), and revising our original schedule for transitioning to risk-adjusted payments to providing for an even more gradual introduction of risk adjustment. (See Section I.C for a full discussion of the BBRA provisions.)
Section 1853(a)(3) of the Act required implementation of risk adjustment for payment periods beginning on or after January 1, 2000. In the June 26, 1998 rule, we provided for such risk adjustment in § 422.256(d). We also provided that, in the period prior to the implementation of risk adjustment, we would continue to apply the demographic adjustments used under the old AAPCC methodology.
On September 8, 1998, we published a
(1) Based on inpatient data;
(2) Applied individual enrollee risk scores in determining fully capitated payments;
(3) Utilized a prospective PIP-DCG risk adjuster to estimate relative beneficiary risk scores;
(4) Applied separate demographic-only factors to new Medicare enrollees for whom no diagnostic history is available;
(5) Applied a rescaling factor to address inconsistencies between demographic factors in the rate book and the new risk adjusters;
(6) Used 6-month-old diagnostic data to assign PIP-DCG categories (the “time shift” model, as opposed to using the most recent data and making retroactive adjustments of payment rates part way through the year);
(7) Allowed for a reconciliation after the payment year to account for late submissions of encounter data;
(8) Phased-in the effects of risk adjustment, beginning with a blend of 90 percent of the demographically-adjusted payment rate, and 10 percent of the risk-adjusted payment rate in the first year (CY 2000); and
(9) Implemented processes to collect encounter data on additional services, and move to a full risk adjustment model as soon as is feasible.
On March 1, 1999, we published the annual Announcement of Calendar Year (CY) 2000 Medicare+Choice Payment Rates, as provided under § 422.266(a) of the regulations. In this announcement, we informed Medicare+Choice organizations of the county rates and factors that were employed for payment in calendar year 2000, including the rescaling factors for use with the risk adjusted portion of payment, and tables of risk and demographic adjustment factors. We also responded to questions and comments on the January 15 notice. (These notices are available on the HCFA Web site, at http://www.hcfa.gov/stats/hmorates/aapccpg.htm.)
Section 1853(a)(3)(B) of the Act provided for the collection from M+C organizations, of encounter data needed to implement the risk adjustment methodology. The BBA required the collection of inpatient hospital data for discharges beginning on or after July 1, 1997, and allowed the collection of other data for periods beginning on or after July 1, 1998. We were prohibited from requiring the actual submission of data before January 1, 1998. This data submission requirement appeared in section 1853(a)(3) of the Act, which was titled “Establishment of Risk Adjustment Factors.” (See § 422.256(d).)
Requirements concerning collection of encounter data apply to M+C organizations with respect to all M+C plans, including private fee-for-service plans. Instructions for the collection of hospital encounter data were sent to M+C organizations in December 1997 (OPL 97.064) and May 1998 (OPL 98.71). Hospital discharges for the period July 1, 1997 through June 30, 1998 have been collected and used for estimating the impact of risk adjustment at the contract level and in the aggregate. We announced in the January 15, 1999 notice of methodological changes that comprehensive risk adjustment would be implemented for
There are two different ways encounter data are used for risk-adjustment purposes. To calculate payment rates, encounter data are necessary to tie payment to expected patient resource use using diagnosis codes. (The initial risk-adjusted payment will be based on inpatient hospital encounter data. However, we are developing a more comprehensive risk-adjustment methodology that uses diagnosis data from physician services and hospital outpatient department encounters.) Encounter data are also necessary to “recalibrate” any risk-adjusted payment model. Recalibration adjusts payment models for changes in resource requirements that derive from such factors as technological change and improved coding.
While these are the primary purposes collecting the encounter data, we discussed other possible uses of these data in the June 1998 interim final rule. These other uses include identification of quality improvement targets and monitoring the care received by M+C enrollees through targeted special studies (such as an examination of post-acute care utilization patterns). Encounter data will also be useful for program integrity functions, both by providing additional utilization norms for original Medicare billing and by providing additional information regarding M+C organizations' behavior.
As noted above, the notices of January 15, 1999, and March 1, 1999, contained detailed discussions of the risk adjustment methodology and responses to comments. Similar notices, reflecting BBRA changes, and our methodology and rates for 2001, were published in January and March of 2000. Here we respond formally to comments submitted on the June 26, 1998 rule.
Even if we believed that delaying risk adjustment were desirable, we do not have the authority to do so. The Balanced Budget Act specifically required “implementation of a risk adjustment methodology * * * no later than January 1, 2000.” In order to meet that deadline, we were constrained to employ a model based on hospital encounter data alone in the interim until the data to implement a comprehensive risk adjustment methodology can be provided by all plans and processed by us. The Medicare+Choice legislation (section 1853(a)(3)(B) of the Act) provided for the collection of non-inpatient data for periods beginning on or after July 1, 1998, a full year later than the date for which inpatient data would be collected. This provision envisioned that a hospital-only system would be implemented initially, both because it seemed more feasible for M+C organizations to produce inpatient data only in the short term, and because the effect of a hospital-only system on payments would be smaller than a system based on comprehensive encounter data. (The Medicare+Choice regulations further provided that we would collect physician, outpatient hospital, SNF, or HHA data no earlier than October 1, 1999. See § 422.257(b)(2)(i).) However, the statute grants us broad authority to develop a risk adjustment methodology, and does not prohibit us from including a transition or “phase-in” period as a component of the methodology we develop.
We therefore included a transition period as a component of our risk adjustment methodology, initially using a blend of payment amounts under the current demographic system and the PIP-DCG risk adjustment methodology. Under a blend, payment amounts for each enrollee would be separately determined using the demographic and risk methodologies (that is, taking the separate demographic and risk rate books and applying the demographic and risk adjustments, respectively). Those payment amounts would then be blended according to the percentages for the transition year.
In order to provide adequate safeguards against abrupt changes in payment, our transition mechanism initially provided for a low blend percentage of the risk-adjusted payment rate. Specifically, first year blend percentages will be 90 percent of the demographically adjusted rates, and 10 percent of the risk-adjusted payment rate. We are also contemplating a five-year transition, which would culminate in full implementation of comprehensive risk adjustment, using all encounter data, in the fifth year. Our initial transition schedule, announced in the January 5, 1999, Advance Notice of Methodological Changes for the CY 2000 Medicare+Choice Payment Rates was:
In order to implement comprehensive risk adjustment in CY 2004, we will soon be providing M+C organizations with guidance concerning requirements for submission of outpatient, physician, and other non-inpatient encounter data.
In providing for payment under a comprehensive risk adjustment system in 2004, we have taken into account the costs and burdens necessary for organizations to develop the capacity for collecting and submitting physician, outpatient hospital, skilled nursing facility, and home health agency encounter data. This is the most ambitious schedule that we believe we can adopt consistent with allowing sufficient time for organizations and the agency to prepare.
The legislation mandating risk adjustment also provides for the collection of inpatient and other encounter data. The legislation therefore contemplates a risk adjustment system based on encounter data rather than surveys. We believe that the greater accuracy of a system based on full submission of encounter data justifies the additional burdens that this requirement entails.
A range of problems in the submission of encounter data have arisen. These problems have included: not following the required UB-92 format, difficulties in accurately tracking counts of discharges, failure to arrange hospital submission of encounter data, difficulties in understanding Fiscal Intermediary reports, and HCFA/FI and FSS processing problems. Plans themselves may have problematic data processing systems in-house. We have worked with Medicare+Choice organizations, managed care associations, and other parties to address many specific issues that have arisen concerning data transmission and processing, and we will continue to do so. We have taken a number of specific steps to facilitate and improve the encounter data submission process. These activities have included the following:
• Encounter Data Reconciliation Analyses—We have shared with M+C organizations analyses of their individual M+C plan level data. The data have been successfully posted at our offices. We have further conducted analyses upon request at the provider level and by the different methods of submission to help explain discrepancies. We are in the process of sharing these analyses with the plans. The detailed provider level analyses are requiring additional time to conduct, and the results of these analyses will be shared with plans over the coming weeks.
• Onsite Consultations—Our contractor conducted a series of onsite consultation visits to 20 M+C organizations in order to learn more about the process of data submission. The majority of the 20 organizations selected for the visits were those that experienced problems with encounter data submission. The information gained during these visits will be used to assist plans to identify and resolve problems.
• HCFA Data System Fixes—Processing problems have been identified that relate to beneficiaries who change from one M+C plan to another. The estimated number of affected encounters from all plans is less than 3,000. These problems will be fixed over the next 2 months, and they are not expected to impact the March 1 rate estimates, which, in any case, will not be used to make direct enrollee payments.
• Communication with the FIs—We have shared data problems raised by M+C organizations with the FIs. Furthermore, discussions between us, FI's, and plans have been encouraged in order to address problems.
However, M+C organizations have informed us that some providers are either failing to submit encounter data at all, or submitting data that do not conform to quality standards for submission to our systems (for example, that the coding often fails to meet standards required to pass the coding edits). To the extent usable data are not submitted, M+C organizations are denied the benefit of any risk adjustment that might be justified based on the costs in question. We are therefore proposing to make several changes to the rules that are designed to give M+C organizations greater leverage in obtaining adequate cooperation from providers to submit complete and accurate data.
First, we will make explicit in § 422.257 that M+C organizations are required to obtain from providers,
Second, we will specifically state in the rules that M+C organizations may include a requirement for submission of complete and accurate encounter data, conforming to the format used under original Medicare, in their contracts with providers, suppliers, physicians, and other practitioners. Contracts with providers and others may impose financial penalties, including withholding payment, for failure to submit complete and accurate data conforming to all requirements for submission. We have revised § 422.257 of the regulations to reflect these two changes.
Third, as discussed below in section K, we have modified the definition of “clean claim” in § 422.500 to specify that a claim must include information necessary for purposes of encounter data requirements, and must conform to the requirements for a clean claim under original Medicare. This will exempt claims that do not, for example, meet accurate coding requirements from the application of the “prompt payment” standard that applies to claims submitted by non-contracting providers. This standard requires that “clean claims” submitted by non-contracting providers be paid within 30 days, or interest will be owed. M+C organizations will therefore be able to withhold payment in cases in which non-contracting providers submit claims with inadequate coding or other deficiencies that make the claims impossible to use for encounter data purposes.
Fourth, we are providing a reconciliation process which will give M+C organizations additional time to submit encounter data before final payment determinations are made. M+C organizations have approximately 3 months after the end of a data collection year to submit the encounter data that will be used to develop beneficiary risk scores to their fiscal intermediary. For example, M+C organizations must submit encounter data for the period July 1, 1998 through June 30, 1999 to their fiscal intermediary by September 17, 1999. If organizations submit encounters after this date, they will not be incorporated into payments for CY 2000. However, in response to concerns expressed by M+C organizations over this short time frame, we expect to institute a reconciliation process that will take into account late data submissions. M+C organizations should attempt to have all data in by the annual deadline of September 10. However, if organizations receive UB-92s from hospitals after this date, they may submit the encounter to their fiscal intermediary and the data will be processed. M+C organizations should note that the deadline for submission of all data from a payment year will be June 30 of the payment year for the period ending the previous June 30 (for example, the final deadline for the period of July 1, 1998 to June 30, 1999, which is used for payment in 2000, will be June 30, 2000). After that date, the fiscal intermediary will no longer accept these data. After the payment year is completed, we will recalculate risk factors for individuals who have late encounters submitted. Then, we will determine any payment adjustments that are required. This reconciliation will be undertaken after the close of a payment year and will be a one-time only reconciliation for each payment year. We are adding § 422.256(g) to provide for this reconciliation process.
Part 422, subpart G is based on the provisions found in section 1854 of the Act. These provisions were discussed in detail in the June 26, 1998 interim final rule (63 FR 35007). This subpart addresses how limits on M+C plan enrollee premiums and other cost-sharing are established through the Adjusted Community Rate (ACR) approval process. The ACR process is applicable to all M+C plans except M+C MSA plans. M+C organizations offering an M+C MSA plan are not required to submit an ACR for that plan, but they are required to submit other information for our review using the ACR process.
Section 422.300(b) provides that for contract periods beginning before January 1, 2002, M+C organizations may modify an M+C plan by adding benefits at no additional cost to the M+C plan enrollee; lowering the premiums approved through the ACR process; or lowering other cost-sharing amounts. Also prior to January 1, 2002, under § 422.504(d), contracts may be for a longer period than 12 months, and may begin on a date other than January 1. In the case of such contracts, under § 422.300(b)(2), ACRs must be submitted on the date specified by us. The transition rules for this period are found in § 422.300(b).
We accordingly believe that beginning in 2002, (when beneficiaries will be locked in for the last 6 months of the year), benefits for a given calendar year should be established in advance of the November open season. This will allow beneficiaries to make informed decisions about which M+C plan they will choose for the following calendar year. In order for this to happen, the benefits that will apply throughout the following calendar year must be included in the ACR submission filed with us, so that these benefits can be approved by us in time to provide reliable information to beneficiaries.
Our decision to require uniform benefits throughout the calendar year after a transition period is further supported by the nature of the ACR process under M+C. As under the section 1876 risk program, the ACR process under the M+C program serves three important purposes. First, we are required to examine an M+C organization's ACR proposal for each M+C plan to determine if Medicare beneficiaries are entitled to receive additional benefits as a result of Medicare payments that are higher than the organization's charge (adjusted for differences in utilization characteristics of the Medicare population) to a non-Medicare enrollee for a Medicare-covered benefit. Second, we are required to review ACR proposals to determine whether the pricing structure (premiums and cost-sharing charged to beneficiaries) is within the limits established by law as required under section 1854(b)(1) of the Act, and is applied uniformly to all Medicare enrollees as required under section 1854(c) of the Act. Third, we review benefit package information to determine if the benefit package is in compliance with the requirements contained in subpart C. Once this process is complete, M+C organizations are allowed to market the M+C plan as approved.
Under the M+C program, we focus on an entire calendar year in performing the above tasks. Our approval of the pricing structure of an M+C plan is based on the appropriate actuarial value of furnishing the items and services for the entire calendar year. Limits on the amount of premiums (section 1854(b) of the Act), and on the liability of the Medicare beneficiary (section 1854(e) of the Act), are based on a 12 month period. In addition, the capitation payments that will be made to the M+C organization under section 1853(a) of the Act for the M+C plan is an integral part of establishing the value of additional benefits that must be offered under section 1854(f) of the Act. Capitation payments are based on the annual M+C capitation rate for the county (that is, the amount for the full calendar year), adjusted for various demographic and other risk factors. Section 1853(c)(1) of the Act clearly states that capitation rates are based on a contract year consisting of a calendar year. We believe that this entire scheme assumes that benefits will be the same over the 12 month period at issue. This is another reason why we believe our decision to eliminate mid-year changes after a transition period is appropriate.
This section implements provisions of the BBA relating to premiums paid by or on behalf of beneficiaries. The beneficiary in an M+C plan, other than an M+C MSA plan offered by an M+C organization, pays the monthly basic premium plus the monthly supplemental premium, if any. In the case of an M+C MSA plan, the beneficiary must pay the monthly supplemental premium, if any. The M+C monthly basic beneficiary premium, the M+C monthly supplemental premium, and the monthly MSA premium may not vary among individuals in the M+C plan, unless the M+C organization offering the plan has elected to apply this rule to individual segments of a plan service area, as provided in section 515 of the BBRA (See section I.C of this preamble). Also, the M+C organization cannot vary the level of cost-sharing (copayments, coinsurance, or deductibles) charged for the basic benefits or supplemental benefits, if any, among the individuals enrolled in the M+C plan, again unless the M+C organization has elected to apply this rule to segments of the plan service area, as provided in section 515 of the BBRA.
As discussed in section I.C above, under section 515, the premium and cost-sharing uniformity requirements may be applied only within segments of an M+C plan's service area, with premiums or cost-sharing varying between such segments, provided: (1) a separate, and complete ACR is filed for each such segment; and (2) each segment is composed of one or more M+C payment areas. We have revised § 422.304(b) to add a new paragraph (b)(2) that provides for this option.
This section reflects the original BBA version of section 1854(a)(1) of the Act, which prior to the BBRA provided that each M+C organization, and any organization intending to contract as an M+C organization in the subsequent year, submit specified data for every plan it intends to offer no later than May 1 of each year.
Section 422.308(a) imposes a limit on the amount that an M+C organization can charge as a basic beneficiary premium for a coordinated care plan, or impose as cost-sharing under such a plan. Specifically, the basic premium (multiplied by 12), the actuarial value of any cost-sharing, or a combination of these two forms of beneficiary liability, may not exceed the annual actuarial value of the deductibles and coinsurance that would be applicable on average to beneficiaries entitled to Medicare Part A and enrolled in Part B if they were not enrollees of an M+C organization. For those M+C enrollees who are enrolled in Medicare Part B only, the monthly basic premium (multiplied by 12), plus the actuarial value of cost-sharing, may not exceed the annual actuarial value of the deductibles and coinsurance that would be applicable to beneficiaries enrolled in Medicare Part B if they were not enrollees of an M+C organization. With respect to supplemental benefits under coordinated care plans, the monthly supplemental beneficiary premium (multiplied by 12) charged, plus the actuarial value of its cost-sharing, cannot exceed the ACR for such services.
In the case of a private fee-for-service plan, there is no limit on premium charges. However, under § 422.308(b), the actuarial value of any cost-sharing imposed under the plan may not exceed the actuarial value that would apply to beneficiaries entitled to Medicare Part A and enrolled in Part B if they were not enrolled in an M+C plan as determined in the ACR. In the case of supplemental benefits, the actuarial value of cost-sharing may not exceed the ACR amounts for the benefits. Additionally, if inadequate data is available to determine actuarial value, we can make the determination with respect to all M+C eligible individuals in the same geographic area or State or in the United States on the basis of other appropriate data.
Once we have approved cost-sharing amounts specified in an ACR, however, an M+C organization is permitted to collect those amounts, even if the actual amount collected turns out to exceed the amount projected in the original estimate of the cost-sharing's actuarial value. While some of our guidance has indicated that a “cap” would be imposed on the aggregate cost-sharing amount actually collected, we have determined, in examining the language in section 1854(e)(1) of the Act in response to this comment, that the limit on cost-sharing was intended to limit the amount of cost-sharing that can be provided for under an M+C plan, not on the amount that is actually collected. The statute provides that the “actuarial value” of M+C plan cost-sharing (and any premium charged) cannot exceed the “actuarial value” of cost-sharing under original Medicare. Since we do not keep track of cost-sharing actually collected under original Medicare, but instead rely only on the “actuarial value” projected up front, we believe that the same approach should apply to the M+C plan side of the equation.
We note that, as discussed above, in the case of private fee-for-service plans, the limit on beneficiary liability applies only to cost-sharing. The actuarial value of cost-sharing for Medicare services may not exceed the actuarial value of the deductible and coinsurance imposed under original Medicare.
Section 422.309 requires an M+C organization to refund all amounts incorrectly collected from its Medicare enrollees, or from others on behalf of the enrollees, and to pay any other amounts due the enrollees or others on their behalf. We further stated that amounts incorrectly collected include: (1) Exceeding the limits imposed by § 422.308 (that is, exceeding the amounts approved in the ACR as falling within these limits); (2) in the case of an M+C private fee-for-service plan, exceeding the M+C monthly basic premium or monthly supplemental premium; (3) in the case of an M+C MSA plan, exceeding the M+C monthly supplemental premium, or the deductible for basic benefits; and (4) amounts collected from an enrollee who was believed ineligible for Medicare benefits but was later found to be entitled. In addition, “other amounts due” include amounts due for services that were considered an emergency, urgently needed, or other services obtained outside the M+C plan; or initially denied, but upon appeal, found to be services that the enrollee was entitled to have furnished by the M+C organization.
The June 1998 interim final rule requires that, except M+C MSA plans, each M+C organization must compute a separate ACR for each coordinated care or private fee-for-service plan offered to Medicare beneficiaries. If an M+C organization opts to apply uniformity requirements to segments of an M+C plan service area, a separate ACR must also be submitted for each such segment. We also stated in the June 1998 interim final rule that, in computing the ACR for years beginning in 2000, the M+C organization calculates an initial rate according to the specifications in § 422.310(b), that represents the “commercial premium” that the M+C organization would charge its general non-Medicare enrollees for Medicare-covered benefits and any supplemental benefits covered by the M+C plan. The M+C organization would also calculate a separate ACR value for each optional supplemental benefit it offers under the plan. Then, the organization either adjusts the initial rate by the factors specified in § 422.310(c), or requests that we adjust the rate.
Section 422.310(b) dictates that the initial rate for each M+C plan is calculated on a 12-month basis for non-Medicare enrollees, using either a community rating system or a system approved by us, under which the M+C organization develops an aggregate premium for each M+C plan for all non-Medicare enrollees of that M+C plan that is weighted by the size of the various enrolled groups and individuals that compose the M+C's enrollment in that plan. Regardless of the method the M+C organization uses to calculate its initial rate, the rate must equal the premium that the M+C organization would charge its non-Medicare enrollees on a yearly basis for services included in the M+C plan.
The June 1998 interim final rule also established special rules in § 422.310(d) for M+C organizations that do not have non-Medicare enrollees or sufficient Medicare enrollment experience to sufficiently calculate ACR values. We have amended § 422.310(d) because the interim final rule used incorrect citations in describing how such an M+C organization may estimate ACR values.
While we do not agree with the commenter's specific proposal, in light of this comment, we have reconsidered the relative cost ratio formula contained in the regulations at § 422.310(c)(3). Since additional revenues are produced when revenues exceed expenses, we believe the best way to project additional revenues for a benefit or group of benefits is to first project total revenues of that benefit or group of benefits and, then, subtract projected total expenses of that benefit or group of benefits. Therefore, we have modified the formula in § 422.310(c)(3) to project total revenues using a relative cost ratio of revenues charged in a base period for Medicare enrollees compared to revenues charges to non-Medicare enrollees of the same period and, then, subtracting projected expenses. We have used the calendar year prior to the calendar year the ACR is submitted as the “base year” for this purpose. If an M+C organization believes the computation produced under this formula does not adequately reflect the future period for an M+C plan, the organization may, with adequate justifying documentation, make an expected variation adjustment to the amount calculated.
Some organizations have argued that their accounting systems cannot segregate the revenues and cost of providing services to Medicare enrollees between different service areas and among various products sold. These organizations should discuss these matters with their HCFA-assigned plan manager. Since the M+C ACR process is still relatively new, we expect to grant some flexibility to M+C organizations. M+C organizations unable to comply with ACR requirements would be required to submit a plan of action designed to bring the organization in compliance with the regulations.
Section 422.312(b) requires that the M+C organization provide additional benefits if there is an adjusted excess amount for the plan it offers. The actuarial value of these additional benefits, less the actuarial value of any cost-sharing associated with the benefit, must at least equal the adjusted excess amounts. We received no comments on this provision, but are making a technical change to § 422.312(b) to use the term “cost-sharing” rather than copayment or coinsurance because the term cost-sharing has been previously defined in § 422.2 to include copayments and coinsurance.
Among the new options available to Medicare beneficiaries is enrollment in a provider-sponsored organization (PSO). A PSO is described in section 1855(d) of the Act as a public or private entity—
• That is established or organized, and operated, by a health care provider or group of affiliated health care providers;
• That provides a substantial portion of the health care items and services directly through the provider or affiliated group of providers; and
• With respect to which the affiliated providers share, directly or indirectly, substantial financial risk for the provision of these items and services, and have at least a majority financial interest in the entity.
The PSO regulations at §§ 422.350 through 422.390 include definitions, solvency standards (developed through negotiated rule making), and waiver requirements that have been established through three previous
The M+C regulations at § 422.352(b) specify that a PSO must deliver a substantial proportion of the health care items and services through the provider or affiliated group of providers responsible for operating the PSO. We have concluded that setting the substantial proportion requirement at 70 percent for a non-rural PSOs and 60 percent for rural PSOs balances two key interests. These interests are, specifically: (1) That we not set the proportion of services so high as to prevent participation by all but the most sophisticated provider organizations; and (2) that the substantial proportion threshold be sufficient to ensure that a PSO have a well-developed capacity to deliver services, thus meeting the financial stability objective explicit in the statute, and increasing the prospects for successful development and solvent operation of a PSO. There is no indication in the PSO provisions in Part C that the Congress intended that a different standard be applied to community health centers, or any other entity. We see no basis for doing so.
Section 1855 of the Act requires that a potential M+C organization be organized and licensed under State law as a risk-bearing entity eligible to offer health insurance or health benefits in every State in which it wishes to offer an M+C plan. (An exception to the licensure requirement is made for PSOs, as provided for in part 422, subpart H.) Section 1855(b) of the Act specifies that, with limited exceptions, an M+C organization must assume full financial risk for the cost of the health services it provides under its contract. Thus, the licensure requirement is a two-pronged requirement, and any potential M+C organization must meet both prongs, such that it is licensed, and is assuming the appropriate risk level for its license.
To establish the licensure status of potential M+C organizations, and in particular to determine compliance with the requirement that the organization's M+C contract falls within the scope of its licensure, we require that new M+C applicants supply documentation from the appropriate State regulatory authorities that the organization meets both the licensure and scope of licensure requirements. In the case of noncommercially licensed entities, § 422.400(b) requires that they obtain a certification from the State that they meet appropriate solvency standards.
With regard to State monitoring of M+C organizations that they license, we do not have the authority to second guess a State's judgment concerning the sufficiency of its resources to monitor M+C plans for which it has given authorization. The States have the sole authority for licensure of M+C organizations, and can set their own standards for monitoring conditions of licensure.
The question of availability of MSA plans in States that do not approve high-deductible plans again goes back to the question of licensure. An organization wishing to offer an MSA plan must be licensed as a risk-bearing entity eligible to offer health insurance or health benefits in the State in question. If the organization wishes to offer a high-deductible policy as part of an MSA plan, the organization must be authorized by the State to assume risk, and under § 422.400(c)(1), must demonstrate that it is authorized to offer a high-deductible policy to Medicare beneficiaries under an M+C contract. This does not mean that it must be authorized by the State to offer such a policy commercially in the State.
With regard to the availability of PPOs in States that do not have a category of licensure into which PPOs would fit, the organization again would have to demonstrate that it was licensed as a risk-bearing entity or otherwise authorized to assume risk, and that it was authorized by the State to offer a PPO product to Medicare enrollees. (We note that under new section 1852(e)(2)(D), for purposes of the applicability of certain quality assurance requirements, a PPO is defined as an entity that is not licensed as an HMO.) If a State does not have a category for a PPO product, an organization may not offer a PPO product in that State unless it is able to demonstrate that the State has authorized it to do so in the context of an M+C contract. This same analysis applies to the question of whether a State may only allow products with “gatekeepers.” If the State only has licensure categories for “gatekeeper” products, then only those products may be offered in the State, absent State authorization of an alternative product in the M+C context.
The only exception to the above requirements that the State authorize the M+C organization to offer the type of plan at issue is the exception provided by Congress for PSOs that are unable to obtain a State license.
Section 1856(b)(3)(A) of the Act reflects the general principle that under the supremacy clause of the constitution, State laws are “preempted” when they conflict with applicable Federal laws. Specifically, section 1856(b)(3)(A) of the Act provides that “any State law or regulation” with respect to M+C plans is superseded “to the extent such law or regulation is inconsistent” with M+C standards. This general preemption authority does not extend to non-M+C enrollees or non-M+C lines of business or activities. We apply this provision in the same manner that Executive Order 12612 on Federalism was applied to managed care organizations with contracts under section 1876 of the Act prior to the BBA. Under that Executive Order (recently superseded by Executive Order 13132; see section VI.1 below), the requirements of section 1876 of the Act did not preempt a State law or standard unless the law or standard was in direct conflict with Federal law. Put another way, if a State law required a managed care organization to do something that it would be permitted to do under section 1876 of the Act, there was no preemption. As discussed below, new Executive Order 13132 (64 FR 43255) contains this same standard for general preemption. The general preemption rule in section 1856(b)(3)(A) of the Act is implemented in § 422.402(a).
There are three areas in which section 1856(b)(3) of the Act provides for specific (rather than general) Federal preemption of State law: benefit requirements; requirements relating to treatment and inclusion of providers; and coverage determinations (including related appeals and grievance processes.) In the BBA Conference Report (H. Rept. 105-217, page 638), the conferees noted that benefit requirements, provider participation requirements, and coverage determinations (and related appeals mechanisms) are governed exclusively by Medicare standards under original Medicare, and expressed their view that this should be the case under the M+C program as well. That is, under original Medicare, States cannot specify what must be included as a Medicare benefit; States do not specify the conditions of participation for Medicare providers (though they license providers and practitioners and determine their scope of practice); States may not specify how a coverage determination is made with respect to whether or not the Medicare program covers a benefit; and States do not determine the type of appeal mechanism that is used to appeal a coverage decision made by a Medicare carrier or intermediary with respect to a Medicare benefit. In the specific preemption provisions in section 1856(b)(3)(B) of the Act, Congress provided that States similarly cannot regulate M+C plans in these areas. As in the case of general preemption, these specific preemption provisions do not extend to non-M+C enrollees, activities, or lines of business of the managed care organization.
In the interim final rule (63 FR 35012), we stated our intention to adopt a narrow interpretation of the
• Benefit mandates (note that we did not interpret a limit on cost-sharing to be a “benefit”).
• Appeals and grievances with respect to M+C coverage determinations.
• Requirements relating to the inclusion of providers (such as “any willing provider” laws or requirements to included specific types of providers within a plan's provider network). We note that State laws providing enrollees with a right to directly access providers are considered to provide a “benefit” to enrollees, and to affect the “inclusion” and the “treatment of” providers, and thus also are specifically preempted.
In contrast, commenters representing the States and beneficiary advocacy groups recommended that we continue to construe the benefit preemption as narrowly as possible, and thus not change our policy to consider cost-sharing a part of a benefit for preemption purposes. They supported our existing policy of generally not preempting State cost-sharing requirements. One commenter believed that even benefit requirements should not be preempted, however, arguing that if States cannot mandate certain benefits, then beneficiaries in M+C plans might have different, lesser benefits than beneficiaries with original Medicare and a Medigap policy.
As a matter of policy, we believe that return home laws have value for beneficiaries, families, and communities, and we encourage M+C organizations to offer a return home option where it would not adversely affect quality or continuity of care, and does not pose an unreasonable administrative burden. However, absent legislative change, we do not believe that the statutory preemption provisions permit any alternative interpretation that would allow enforcement of these State laws for M+C enrollees. We are exploring developing a legislative proposal to establish a limited exception to the M+C preemption provisions to accommodate State return home laws.
Another commenter asserted that “any willing provider laws,” specific benefit requirements, and requirements for the inclusion of specific types of providers should not be preempted. This commenter believes that if State standards are more stringent than Federal standards and not inconsistent with them, they should not be preempted, regardless of whether these standards relate to the areas specifically preempted by Congress.
Since enrollees may have complaints that involve matters unrelated to coverage determinations, there needs to be a mechanism in place to address other types of complaints involving the manner in which enrollees receive care. Therefore, M+C organizations are required to have a grievance process in place to handle complaints unrelated to coverage determinations.
The preamble to the interim final rule alerted the public that we would establish a grievance procedure through proposed rulemaking, and sought comments on ways to make it meaningful. Until publication of that proposed rule, M+C organizations should look to State requirements for resolving complaints unrelated to coverage determinations.
Section 1854(g) of the Act provides that “no State may impose a premium tax or similar tax with respect to payments to M+C organizations under section 1853.” This prohibition does not apply to enrollee premium payments made to M+C plans, which are authorized under section 1854 of the Act. Section 402.404(a) sets forth the statutory provision, and specifies that the term “State” includes any political subdivision or other governmental authority within a State.
Section 422.404(b) clarifies the scope of what constitutes a prohibited premium tax, establishing that the prohibition generally does not apply to a generally applicable tax on the net income or profits of any business. As noted in the preamble to the interim final rule, if the tax applies to premium revenue specifically, there is no exception to the prohibition of such a tax, based on the purpose of the tax.
Section 1882 of the Act governs the sale of Medicare supplemental (“Medigap”) policies, private health insurance policies that are designed to cover certain out-of-pocket costs incurred by Medicare beneficiaries. With minor exceptions, a Medigap policy cannot be sold in any State unless it conforms to one of ten standardized benefit packages, labeled plans “A” through “J”.
Before enactment of the BBA, Federal law provided for only one opportunity for a Medicare beneficiary to purchase a Medicare supplemental (“Medigap”) policy on a “guaranteed issue” basis. (Generally, this term means that the Medigap insurer cannot deny the application, delay the issuance or effective date of the policy, or charge an additional amount based on the individual's health status.) This opportunity occurs only during the 6-month period beginning with the date the beneficiary is both age 65 or older and enrolled in Medicare Part B.
Section 4031 of the BBA amended section 1882(s) of the Social Security Act to specify additional situations in which beneficiaries are able, as of July 1, 1998, to buy specific types of Medigap policies on a guaranteed issue basis, if they apply within 63 days of losing certain other types of health coverage, and if they submit evidence of the date that the prior coverage terminated. The law also requires that the entity that provided the prior coverage advise the beneficiary of these rights. While the M+C regulations do not implement the Medigap provisions of the BBA or the BBRA, it is important to understand the implications for M+C organizations, since some situations addressed by the Medigap provisions involve beneficiaries who leave M+C plans and return to original Medicare.
The situations that give rise to the obligation to notify the beneficiary include, for example, termination of
With regard to availability, we note that not all 10 standardized Medigap plans may be available in all States, and all plans available in a State might not be offered by every insurer. Wisconsin, Minnesota, and Massachusetts have alternative forms of standardized policies under a waiver granted them by the Omnibus Budget Reconciliation Act of 1990 (OBRA). Federal law does not generally require sale of Medigap policies to beneficiaries under age 65 (eligible for Medicare by reason of disability or ESRD). However, State law may require insurers to sell to these populations under certain circumstances. Also, some insurers voluntarily sell policies to the disabled, usually on an underwritten basis. Where an insurer has filed in a State to sell to the under 65 population, these policies are subject to the BBA guaranteed issue protections.
The beneficiary may also have the right to guaranteed issue of a broader selection of Medigap policies if he or she either: (1) Directly enrolls in an M+C plan upon first becoming entitled to Medicare at age 65; or (2) enrolls for the first time in an M+C plan after previously having been covered under a Medigap policy, and, in both instances, later disenrolls from the M+C plan within 12 months of the effective date of the M+C enrollment. Beneficiaries who were previously enrolled in original Medicare and who purchased a Medigap policy, who disenroll from the M+C plan before the 12-month “trial” period has expired, are guaranteed the right to return to their old Medigap policy, if it is still available from their former insurer; (otherwise they have the choice of plans A, B, C, or F from any insurer). Alternatively, if an M+C plan was their first choice as newly entitled Medicare beneficiaries at age 65, and they disenroll during the first 12 months after enrolling, they have their choice of all 10 Medigap plans, including plans H, I, and J, which provide some outpatient prescription drug coverage. This broader array of choices for beneficiaries who elected an M+C plan when they first became entitled to Medicare at 65, in effect, compensates them for having forgone their 6-month Medigap open enrollment opportunity, which began when they reached age 65.
In all these cases of voluntary or involuntary terminations from an M+C plan, beneficiaries must apply for the Medigap policy of their choice, from among the options available to them, within 63 days. If they fail to act within this time period, they lose both their guaranteed issue right to purchase the policy of their choice at the standard premium rate, and their protection from pre-existing exclusion periods. Outside of this guaranty issue period, they may be able to find some Medigap insurers who are willing to sell to them, but they may not be able to purchase the policy they want. Additionally, the insurer can apply a pre-existing condition exclusion period of up to 6 months and/or charge them an additional amount based on their health status.
Because the Medigap provisions establish specific deadlines for beneficiaries who wish to take advantage of these new rights, prompt action by the M+C organizations to notify beneficiaries of their rights, or by us to provide accurate evidence of recently terminated coverage, is essential. We are committed to providing beneficiaries whose M+C coverage is terminated with timely and accurate evidence of the recently terminated coverage. To this end, we will provide M+C plans with, among other things, a model final termination letter that must be sent 90 days prior to termination of a contract. This letter will contain detailed information about beneficiaries' rights to Medigap under BBA and the BBRA.
We urge M+C organizations to keep in mind that they are obligated to notify beneficiaries whose coverage terminates of their rights under the Medigap provisions. Those provisions are complex, and beneficiaries will be entitled to guaranteed issue of Medigap policies at standard premium rates and with no preexisting condition exclusion periods only under certain circumstances. As noted above, their choice of Medigap policies will depend on the precise reason for, and timing of, the termination of their coverage under the M+C plan. It also matters whether they disenroll voluntarily or wait to be involuntarily disenrolled. However, if their initial 12-month trial period will expire before the M+C plan's contract will terminate, they have the option of disenrolling before the 12-month period has expired if they wish to obtain the broader selection of Medigap policies that may be available to them.
Further guidance is available to beneficiaries from their State Health Insurance Assistance Program (SHIP) or State insurance department.
The policy may, however, be required to make payment with respect to the types of costs that are not otherwise covered by Medicare.
In addition, we are working with the NAIC and the States to develop the Medigap Compare database, which will identify available Medigap policies and allow beneficiaries to compare costs and benefits. Beneficiaries and M+C plans will be able to access this database to gain the appropriate information a beneficiary needs when seeking Medigap insurance.
Subpart J of part 422 has been reserved for future use.
Subpart K sets forth provisions relating to the contracts that are entered into by M+C organizations, including a description of terms that must be included in the contract, the duration of contracts, provisions regarding the nonrenewal or termination of a contract, and minimum enrollment, reporting, and prompt payment requirements.
The BBA does not specifically define or directly address the issue of national contracting. It facilitated such contracting, however, when it provided in section 1857(a) of the Act that an M+C contract “may cover more than 1 Medicare+Choice plan,” and, in section 1851(h)(3) of the Act, provided that marketing material need only be approved once to the extent it is consistent from area to area. While we are interested in national contracting, we similarly have not expressly provided for it in the regulations. One national contracting approach we would be willing to consider would permit an M+C applicant to request that we enter into a national contract with the applicant if the applicant holds license as a risk-bearing entity in each State where it intends to operate. The applicant would have the option of adopting a single M+C plan across the country, with one service area and a national ACR proposal, or offering different M+C plans in different areas under the same national contract.
While we have not at this time entered into a national contract with any M+C organization, HCFA has entered into national “agreements” with national chain organizations that hold M+C contracts. These arrangements apply to those chain organizations that enter into separate contracts in multiple States. These agreements allow a chain organization to establish a uniform policy across all of its States as to marketing, quality assurance, utilization review, claims processing, etc. HCFA pre-approves these national policy procedures. We continue to contract separately with individual, albeit related, M+C organizations affiliated through common ownership or control. We likewise continue to monitor operational activities for each organization in each State, but, having approved national policy, the need for
Nine commenters addressed national contracting for M+C organizations. While most of the public comments favored extending the option of national contracting to M+C organizations and applicant organizations, commenters generally linked their support for the concept to a request that we provide additional information on the specifics of any national contracting policy.
As a condition for entering into an M+C contract with HCFA, applicant organizations must demonstrate that they have certain administrative and management arrangements in place. There are six specific administration and management requirements at § 422.501(b)(3). One of these requirements is that M+C organizations have in place a compliance plan for meeting all applicable Federal and State standards. The regulations list the required elements of the compliance plan, which generally follow the standards applied under the U.S. Sentencing Commission's Federal Sentencing Guidelines in determining whether the existence of a compliance plan should mitigate penalties. We received nine public comments on the M+C compliance plan requirement.
While HCFA and the OIG conduct ongoing M+C program monitoring and enforcement activities, the number and variety of M+C operational requirements presents a significant regulatory challenge to both of these agencies. As a result, we believe that the additional level of scrutiny imposed by a compliance plan is a reasonable requirement.
While the OIG stated in its November 1999 guidance that the document was intended only to provide assistance for M+C organizations, the OIG did note that it “believes an effective compliance program provides a mechanism that brings the public and private sectors together to reach mutual goals of reducing fraud and abuse, improving operational quality, and ensuring the provision of high-quality cost-effective care.” The OIG also stated that a compliance plan is a tool for an M+C organization “to ensure that it is not submitting false or inaccurate information to the Government or providing substandard care to Medicare beneficiaries * * *.” We agree with the OIG's judgement with respect to the utility of the compliance plan tool and have adopted this requirement to protect the integrity of the M+C program.
Nevertheless, we believe that the existence of voluntary self-reporting procedures of potential misconduct is an appropriate part of an M+C organization's compliance program. While this rule does not make any type of self-reporting mandatory, M+C organizations may wish to consider the following suggestions, as a matter of voluntary good business practice. These suggestions are not mandatory. Where the M+C organization discovers evidence of misconduct related to payment or delivery of health care items or services under the M+C contract, the M+C organization may conduct a timely, reasonable inquiry into the misconduct. After the reasonable inquiry, if the organization has determined that the misconduct resulted in an overpayment, the M+C organization is encouraged voluntarily to report the overpayment to HCFA. If the M+C organization has determined that the misconduct may violate the statutes of direct concern to the HHS Office of Inspector General, it is encouraged voluntarily to report the existence of the misconduct to that office. Finally, the M+C organization is encouraged voluntarily to initiate and implement appropriate corrective actions to ensure the problem does not recur.
While we are withdrawing all requirements for self-reporting in this rule, we believe that the required reporting of overpayments is an effective tool for promoting Medicare program integrity generally. Accordingly, HCFA intends to develop policies through separate notice and comment rulemaking in cooperation with the HHS Office of Inspector General that would require all Medicare providers, suppliers and contractors to report overpayments to HCFA.
M+C organizations and contract applicants have broad discretion under § 422.501(b)(3)(vi) to design their compliance plan structure to meet the unique aspects of each organization. We recognize that there is no one best way for an organization to take steps to ensure that it is operating in compliance with all applicable regulations and requirements. Thus, we intend to work with M+C organizations and contract applicants to apply a flexible standard in reviewing M+C compliance plans, while still ensuring that these compliance plans serve their intended purpose: to detect and prevent compliance problems, in addition to identifying aspects of the organization that may be vulnerable to such problems.
We believe that one way for us to determine if an organization's corporate compliance plan is effective is to evaluate and audit the performance of the organization according to the M+C requirements articulated in the M+C contract and regulations. Since we have an established monitoring process for M+C organizations, we believe that the infrastructure is already established that may assist HCFA in its efforts to assess the effectiveness of organizations' compliance plans based in part on the results of our monitoring efforts.
Under § 422.502(e) of the regulations, an M+C organization must agree to allow access to HHS or the Comptroller General to evaluate the quality, appropriateness, and timeliness of services furnished to Medicare enrollees under the contract; the facilities of the M+C organization; and the enrollment and disenrollment records for the current contract period, and 6 prior contract years. We received two comments regarding access to M+C organization records.
We would add, however, that as a general principle, if Federal funds are going to a provider of Medicare or Medicaid services, appropriate Federal officials have a right to review that provider's facility or books as a condition of receipt of those Federal funds.
For purposes of clarity, we also point out that the 6-year record retention requirement requires M+C organizations to keep a specific year's records for 6 years, after which the organization is free to dispose of any records they deem appropriate. This is to clarify one misconception that M+C organizations must maintain 6 years of records for an additional 6-year period. We instead
Pursuant to authority at section 1851(d) of the Act, § 422.502(f)(2) describes the information that M+C organizations must submit to HCFA. We specify that this information is necessary for us to fulfill our responsibilities in evaluating and administering the program. Our dissemination of some of this information to current and prospective Medicare beneficiaries enables them to exercise informed choice in obtaining Medicare services. We received one comment on this section of the interim final rule.
Also, pursuant to both sections 1851(d)(3) and 1852(c)(2)(C) of the Act, § 422.502(f) requires that M+C organizations disclose to us the appeal data that they are required to disclose upon request to beneficiaries. We believe that this is necessary so that we can begin to capture important baseline data on the appeals process. Our contractor (the Center for Health Disputes Resolution) is responsible for making reconsideration decisions when an enrollee files an appeal, and these decisions are appealed to HHS administrative law judges and the Departmental Appeals Board. In addition, HCFA enforces decisions made by these entities, which necessarily involve the critical question of whether services will be covered by the M+C organization.
While the regulations provide for beneficiary access to information on an M+C organization's grievance process, we do not at this time believe that it is necessary for HCFA to collect this information for administrative purposes. We would advise M+C organizations, however, that while we are not requiring that M+C organizations disclose grievance data to us at this time, we intend to propose additional requirements pertaining to M+C grievances, including quality of care grievances, in a notice of proposed rulemaking to be published later this year. Thus, we anticipate that M+C organizations may be required to report grievance data in the future.
In the interim final rule, we addressed enrollee financial protection provisions at § 422.502(g). These provisions are designed to protect enrollees from incurring liability for payment of any fee for which M+C organizations are legally obligated. Section 422.502(g) incorporates enrollee financial protections that were in place before the BBA in § 417.122(a)(1), which applies to all section 1876 contractors under § 417.407(f). Section 422.502(g)(1) is intended to protect enrollees from being held financially responsible for fees for which the M+C organization is legally liable; § 422.502(g)(2) addresses M+C organizations' obligation to provide for continued coverage of health care benefits, and § 422.502(g)(3) sets forth the mechanisms M+C organizations can employ to provide the required enrollee protections. We received three comments regarding § 422.502(g).
In instances where providers do bill M+C enrollees for amounts beyond those approved in an M+C plan, we believe that it is the responsibility of the M+C organization to take appropriate steps, such as recovering these amounts from the providers, to see that beneficiary enrollees are made financially whole. If they fail to do so, we would take appropriate action against the M+C organization. We believe it would be inappropriate for us to engage in activities directed at individual providers.
We note, however, that even in situations, (such as insolvency or other financial difficulties), where an M+C organization fails to satisfy its responsibility to pay a provider for services furnished to an M+C enrollee, the principle that the beneficiary is protected still applies. Although we believe this principle is inherent in the existing regulations, to clarify this point, we are revising § 422.502(g)(1) to indicate that the applicable beneficiary financial protections apply in situations such as insolvency or other financial difficulties.
We believe that the term “fee” is commonly understood, and does not need a special definition. In this context, the term refers to the fees charged by a provider (for example, a physician's fee for services provided). M+C organizations are responsible for payment of such fees, except for applicable enrollee cost-sharing amounts specified under the M+C plan, which are the obligation of the Medicare enrollee.
Section 422.502(h) requires that contracts reflect the M+C organization's obligations under other laws, specifically, the Civil Rights Act of 1964, the Age Discrimination Act of 1975, the Americans with Disabilities Act, other laws applicable to recipients of Federal funds, and all other applicable laws and rules.
The requirements found at § 422.502(i)(3) pertaining to M+C contracting requirements with providers, suppliers, and administrative service entities were developed pursuant to our authority under section 1856(b)(1) of the Act to “establish” M+C “standards.” We developed these rules in recognition of the fact that managed care organizations commonly enter business relationships with entities that they place under contract to perform certain functions that would otherwise be the responsibility of the M+C organization. Section 422.502(i)(3) establishes these requirements in three broad categories: enrollee protection provisions, accountability provisions, and a provision that assures that services performed by other entities are carried out in a manner that complies with the M+C organization's contractual obligations to us. We received three comments concerning the subcontracting issues addressed in § 422.502(i)(3).
Regarding the question on Y2K requirements, this issue is moot, since all contracting M+C organizations appear to have succeeded in avoiding related problems. We would note, however, that to the extent an M+C organization provided services through subcontractors, it was responsible for ensuring the Y2K compliance of those subcontractors to the extent necessary to ensure overall Y2K compliance.
As a result, and in response to the comment, we have added two terms—“first tier” and “downstream”—to the list of definitions at § 422.500. We believe these definitions will clarify the types of entities to which the M+C contracting requirements described at § 422.502(i) apply. We began using the terms “first tier” and “downstream” in OPL 98.077, and believe that both terms satisfactorily enhance the description of entities or individuals that are the intended audience for satisfying the requirements found at § 422.502(i).
Under § 422.502(l), M+C organizations must certify to the accuracy, completeness, and truthfulness of the data used to calculate payments to the organizations. These data include enrollment information, encounter data, and the information included in an M+C organization's ACR proposal. In the preamble to the interim final rule, we noted that in submitting these data, M+C organizations are making a “claim” for payment from HCFA, since this information directly affects the calculation of payment rates and amounts. We stated that the certifications would help ensure accurate data submissions and assist us in maintaining the integrity of the Medicare program.
In presentations to industry, HHS representatives have emphasized that simple mistakes will not result in sanctions. Generally, the Federal government can bring an action only when one of three states of mind exists: (1) Actual knowledge of falsity of a claim or information; (2) reckless disregard; or (3) deliberate ignorance of information supporting the truth or falsity of a claim or other information (42 CFR 1003.101). However, no specific intent to defraud is required. The “best knowledge, information, and belief” standard of the M+C contract certification forms is consistent with these standards.
It is appropriate that the M+C regulations be consistent with the standard of knowledge reflected in Federal fraud statutes. Therefore, we are modifying § 422.502(l) as needed to reflect the “best knowledge, information, and belief” certification standard.
We acknowledge that encounter data come into M+C organizations in great volume and from a number of sources, presenting significant verification challenges for the organizations. However, we believe that M+C organizations have an obligation to undertake “due diligence” to ensure the accuracy, completeness, and truthfulness of encounter data submitted to HCFA. Therefore, they will be held to a “best knowledge, information, and belief” standard. Therefore, M+C organizations will be held responsible for making good faith efforts to certify the accuracy, completeness, and truthfulness of encounter data submitted.
Section 1857(c)(3) of the Act provides that the effective date of an M+C contract is to be specified in the M+C contract, and section 1857(c)(1) requires that contracts be for a term of at least one year. The Secretary was provided the discretion under section 1857(c)(1) to provide for contracts to be “automatically” renewable in the absence of notice.
Section 1857(c)(2) of the Act authorizes us to terminate an M+C contract if we determine that an M+C organization substantially fails to carry out its M+C contract, carries out the contract in a manner that is inconsistent with the effective and efficient administration of the M+C program, or fails to continue to meet the M+C requirements.
Section 422.504 of the June 1998 interim final rule implements section 1857(c)(1) and (3) of the Act. Section 422.504(b) provides that contracts generally are for a 12-month period beginning January 1 and ending December 31. Section 422.504(d) provides for a limited exception to this rule, permitting HCFA the discretion, prior to January 1, 2002, to approve a contract for longer than 12 months beginning on a date other than January 1. This decision permits us to accept M+C applications on a continuous “flow” basis until the beginning of the lock-in periods contemplated under the BBA starting in 2002. We received one comment pertaining to the effective date and term of the M+C contract.
Section 422.506 specifies the process that M+C organizations and HCFA must use should HCFA decide not to renew the organization's contract, or should the organization give HCFA notice that it does not want its contract to be renewed. We received four comments addressing our M+C contract renewal policy.
However, in response to the commenter's concern, we have determined that the standard outlined at § 422.506(b)(1)(ii) for declining to renew an M+C contract may be too vague to enforce; therefore, we are deleting § 422.506(b)(1)(ii).
We address M+C contract determinations in several sections throughout subparts K and N of the M+C regulations. As noted above, § 422.506 contains provisions governing our decisions and M+C organization decisions concerning whether to renew an M+C contract. Section 422.508 specifies that HCFA and an M+C organization may together elect, upon mutual consent, to modify an M+C contract. Sections 422.510 and 422.512 describe M+C contract termination procedures when initiated by either HCFA or an M+C organization. When M+C contract determinations occur, either the organization initiating the determination, or the organization impacted by the determination, must meet certain notification requirements described in §§ 422.506, 422.508, 422.510, and 422.512. The notice requirements compel either HCFA or the M+C organization to notify: (1) The party affected by the contract determination (for example, if HCFA elects to terminate a contract, HCFA must notify the M+C organization of our determination); (2) the Medicare beneficiaries from the affected M+C organization's M+C plans; and (3) the general public.
In any event, since M+C organizations and/or HCFA are already required to disclose specified information to the general public, a subset of which are the M+C organization's providers, pursuant to an M+C contract determination, we believe that any additional notification requirements may be duplicative and unnecessary.
Section 422.508 provides that M+C organizations and HCFA may mutually agree to modify or terminate an M+C contract. When a contract is terminated by mutual consent, M+C organizations must provide notice to affected Medicare enrollees and the general public. If the contract terminated by mutual consent is replaced on the following day by a new M+C contract, the notice requirements do not apply.
We agree with the commenter that a termination (and not modification) of an M+C contract by mutual consent should trigger a special election period as described at § 422.62(b), and we believe that the existing language at § 422.62(b)(1) supports this position. In stating “HCFA has terminated * * * or the organization has terminated * * * the [M+C] plan in the service area or continuation area in which the [Medicare eligible] individual resides * * *,” we believe that termination of a contract by mutual consent of the two aforementioned parties is consistent with the intent of the provision at § 422.62(b)(1). Thus, we believe that any change to the regulation language at § 422.508 or § 422.62(b)(1) is unnecessary.
Section 422.510 implements the provisions in section 1857(c)(2) of the Act pertaining to our authority to terminate an M+C organization's contract if we determine that the organization: (1) Fails to substantially carry out the contract; (2) is carrying out the contract in a manner inconsistent with the efficient and effective administration of Medicare Part C; and/or (3) no longer substantially meets the applicable conditions of Part C. In § 422.510(a), we set forth the above standards, as well as several specific circumstances that we believe constitute a substantial failure to carry out the contract, justifying termination. The procedures under which we would take action to terminate an M+C contract are described in section 1857(h) of the Act. In general, we may terminate an M+C contract after: (1) We provide the M+C organization with an opportunity to correct identified deficiencies; and (2) we provide the organization with notice and opportunity for a hearing, including the right to an appeal of an initial decision.
We received three comments on § 422.510. One commenter requested further explanation regarding the termination process, for which we refer the commenter to subpart N of the regulations. The other comments are addressed below.
We have longstanding compliance standards for Medicare managed care contractors. In addition to those set forth in the statute and regulations, compliance standards are set forth in our Medicare Managed Care Performance and Monitoring protocol. We use this document when conducting performance/monitoring evaluations of contracting Medicare managed care organizations, including M+C organizations. Pursuant to these reviews, each contracting organization must demonstrate that it again complies with all applicable statutory, regulatory and contract requirements that apply to M+C organizations. These reviews result in findings as to whether a failure to comply with requirements constitutes a “substantial failure” for purposes of § 422.510(a). In determining whether a failure is “substantial,” we consider both the frequency and the seriousness of the noncompliance. In the case of a serious violation that could put the health of an enrollee at risk, even a single violation might be considered substantial. In the case of a less serious violation, the noncompliance would have to be more pervasive or systematic in order to be considered substantial.
Section 1857(b) of the Act specifies that we may not enter into a contract with an M+C organization unless the organization has at least 5,000 enrollees (or 1,500 if it is a PSO), or at least 1,500 enrollees (or 500 if it is a PSO) if the organization primarily serves individuals residing outside of urbanized areas. Section 1857(b)(3) creates a transition standard for meeting this requirement by allowing us to waive the minimum enrollment requirement during the M+C organization's first 3 years.
The M+C regulations contain various provisions that specify information disclosure requirements. The requirements address both information to be provided by M+C organizations to HCFA (see §§ 422.64, 422.502, and 422.512), by M+C organizations to beneficiaries (see §§ 422.80 and 422.111), and by HCFA to beneficiaries (under existing § 422.64). Section 422.516 specifies requirements that M+C organizations must meet regarding disclosure of statistics and information to HCFA, M+C enrollees, and the general public.
Section 422.520 indicates that contracts between M+C organizations and HCFA must specify that the M+C organization agrees to provide prompt payment of claims that have been submitted by providers for services and supplies furnished to Medicare enrollees when these services and supplies are not furnished by an organization-contracted provider. Specifically, 95 percent of “clean claims” must be paid within 30 days of receipt. While this provision closely follows requirements already in place for section 1876 contractors, (including provisions pertaining to interest to be paid if timely payment is not made), section 1857(f) of the Act extends similar prompt payment requirements to claims submitted by Medicare beneficiaries enrolled in M+C private fee-for-service plans. Section 422.520(a) incorporates this requirement of new section 1857(f), as well as the general 30-day requirement that applied to noncontracting providers under section 1876. In the preamble to the June 1998 interim final rule, we indicated that pursuant to our authority under section 1856(b)(1) to establish standards under Part C, M+C organizations would be required to act upon (either approve or deny, not necessarily pay) all claims not subject to the 30-day standard within 60 calendar days from the date of request.
The provisions set forth in subpart L of part 422 by the June 1998 interim final rule merely constituted a redesignation of the provisions in part 417 on change of ownership or leasing of facilities. However, since the June 1998 interim final rule was published, it has come to our attention that M+C organizations have serious concerns about language in the italicized title to § 422.550(a)(2) which has been construed to present an impediment to an asset sale by one corporation to another. Section 422.550(a) sets forth what constitutes a “change of ownership” for purposes of provisions in § 422.552 which permit an M+C contract to be transferred to a new owner under certain circumstances (for example, the new owner must meet the requirements to qualify as an M+C organization). Because this italicized title refers to an “unincorporated sole proprietor,” it suggests that a “[t]ransfer of title and property to another party” does not constitute a change of ownership if the assets are transferred by a corporation, rather than a sole proprietor. This has presented problems in cases in which transactions that would benefit Medicare beneficiaries by keeping a M+C plan option available do not appear to fall within the definition of change of ownership. If an M+C contract accordingly could not be transferred as part of an asset sale, this could prevent the sale from going forward, or limit the sale to commercial or Medicaid lines of business, in either case, potentially depriving Medicare beneficiaries of an M+C plan option they would otherwise have.
The italicized language in question was adopted from rules in section 1876 of the Act, which in turn were adopted from longstanding original fee-for-service Medicare change of ownership regulations containing identical language (see § 489.18(a)). These original Medicare change of ownership regulations apply to a change of ownership in the case of a Medicare provider, and address the assumption of a Medicare provider agreement, rather than an M+C contract. However, the language in § 489.18(a)(2) is identical to that in § 422.550(a)(2). In the original Medicare context, this language has consistently been interpreted to encompass an asset sale from one corporation to another. This interpretation was applied by the U.S. Court of Appeals for the Fifth Circuit in
Subpart M of part 422 implements sections 1852(f) and (g) of the Act, which set forth the procedures M+C organizations must follow with regard to grievances, organization determinations, and reconsiderations and other appeals. Under section 1852(f) of the Act, an M+C organization must provide meaningful procedures for hearing and resolving grievances between the organization (including any other entity or individual through which the organization provides health care services) and enrollees in its M+C plans. Section 1852(g) of the Act addresses the procedural requirements concerning coverage (“organization”) determinations and reconsiderations and other appeals. Only disputes concerning “organization determinations” are subject to the reconsideration and other appeal requirements under section 1852(g). In general, organization determinations involve whether an enrollee is entitled to receive a health service or the amount the enrollee is expected to pay for that service. All other disputes are subject to the grievance requirements under section 1852(f) of the Act. For purposes of this regulation, a reconsideration consists of a review of an adverse organization determination (a decision that is unfavorable to the M+C enrollee, in whole or in part) by either the M+C organization itself or an independent review entity. We use the term “appeal” to denote any of the procedures that deal with the review of organization determinations, including reconsiderations, hearings before administrative law judges (ALJs), reviews by the Departmental Appeals Board (DAB) and judicial review.
For the grievance, organization determination, and appeal requirements, an M+C organization must establish procedures that satisfy these requirements with respect to each M+C plan that it offers. These requirements generally are the same for each type of M+C plan—including M+C non-network MSA plans and M+C PFFS plans. (Please refer to the preamble material on M+C appeals and grievances in the June 26, 1998 interim final rule (63 FR 35021) for a detailed discussion of the specific requirements under Subpart M.)
Additional regulatory improvements to the M+C appeal and grievance processes are currently under development. We included in the M+C interim final rule those improvements that were practical within the short time frame allotted for completing that interim final rule. As we indicated in the preamble to the M+C interim final rule (63 FR 35030), we intend in the near future to publish a proposed rule implementing a variety of other improvements to the M+C dispute resolution process, including both appeals and grievances.
Sections 422.560 and 422.561 contain the basis and scope and the relevant definitions for subpart M. Section 422.562, General Provisions, provides an overview of the rights and responsibilities of M+C organizations and M+C enrollees with respect to grievances, organization determinations, and appeals. The responsibilities of M+C organizations, under § 422.562(a), essentially parallel those applicable to
Section 422.562(b) explains the basic rights of M+C enrollees under subpart M, and provides regulatory references to the sections that fully explain the relevant rights. This section does not establish any rights beyond those previously provided for HMO enrollees under part 417, but consolidates general information about enrollees' rights into a central location in the regulations.
Like the part 417 regulations, § 422.562(b) contains provisions addressing the applicability of other regulations that implement Social Security appeals procedures under title II of the Act.
Section 1852(f) of the Act requires that each M+C organization provide “meaningful procedures for hearing and resolving grievances.” We have defined this term in § 422.561 as any complaint or dispute other than one that involves an “organization determination” (as described under § 422.566(b)). (This definition retains the meaning of grievance used in part 417.) An enrollee might file a grievance if, for example, the enrollee received a service but believed that the demeanor of the person providing the service was insulting or otherwise inappropriate. Also, as specified under §§ 422.570(d)(2)(ii) and 422.584(d)(2)(ii), grievance procedures would apply when an enrollee disagrees with an M+C organization's decision not to grant an enrollee's request to expedite an organization determination or a reconsideration.
Under § 422.564(a), an M+C organization must resolve grievances in a timely manner using procedures that comply with any guidelines which we establish. Section 422.564(c) clarifies that the PRO complaint process under section 1154(a)(14) of the Act addresses quality issues, but is separate and distinct from the M+C organization's grievance procedures. Thus, there are three different complaint processes (grievance, appeals and PRO processes) available to an enrollee in an M+C organization.
Section 1852(g) of the Act requires an M+C organization to establish procedures for hearing and resolving disputes between the organization and its Medicare enrollees concerning organization determinations. In accordance with section 1852(g)(1) of the Act, § 422.566 specifies that an M+C organization must have a procedure for making timely organization determinations regarding the benefits an enrollee is entitled to receive and the amount, if any, that an enrollee must pay for a health service. Also, an M+C organization's refusal to provide services that the enrollee believes should be furnished or arranged for by the M+C organization is an action that constitutes an organization determination. Disputes involving additional benefits, as well as mandatory and optional supplemental benefits, also constitute organization determinations and are subject to the appeals process.
Section 422.566(b) lists actions that are organization determinations, and with two exceptions, follows the previous HMO regulation at § 417.606(a). The exceptions involve the inclusion as organization determinations of decisions involving—(1) optional supplemental benefits, and (2) payment for post-stabilization services.
Section 422.568 includes the standard time frame and notice requirements for organization determinations. Under § 422.568(a), an M+C organization must make a determination with respect to an enrollee's request for service as expeditiously as the enrollee's health status requires, and in no case later than 14 calendar days after the organization receives the request. An M+C organization may extend the time frame by up to 14 calendar days if the enrollee requests the extension, or if the organization justifies a need for additional information and how the delay is in the interest of the enrollee; (for example, the receipt of additional medical evidence from noncontract providers may change an M+C organization's decision to deny). The M+C organization must include a written justification for the extension in the case file.
Section 422.568(b) specifies that time frames for requests for organization determinations on payment issues are identical to the “prompt payment” requirements set forth under § 422.520. Thus, for issues relating to payment, the requirements are as follows: (1) For “clean claims,” an M+C organization must make a determination regarding the claim within our current “clean claim” rules, that is, 95 percent of clean claims must be paid within 30 calendar days after receipt of the request for payment; (2) for all other claims, an M+C organization must make a determination regarding the claim within 60 calendar days after receipt of the request for payment. (Under existing § 422.500, “clean claims” are claims that have no defect, impropriety, lack of any required substantiating documentation, or particular circumstances requiring special treatment that prevents timely payment. See section II.K of this preamble for a further discussion of rules regarding clean claims and prompt payment.)
Consistent with section 1852(g)(1)(B) of the Act, § 422.568(c) and (d) require that an M+C organization issue written notification for all denials of a request for services, including the specific reasons for the denial in understandable language, information regarding the enrollee's right to either an expedited or standard reconsideration, and a description of both the expedited and standard review processes, as well as the rest of the appeals process.
Sections 422.570 and 422.572 set forth the requirements for M+C organizations with respect to expedited determinations. Sections 422.570(a) (for expedited organization determinations) and 422.584(a) (for expedited reconsiderations) allow either an enrollee or a physician to request an expedited organization determination or reconsideration, regardless of whether the physician is affiliated with the M+C organization. Under § 422.570(a), any physician can request an expedited organization determination. Section 422.584(a) provides that a physician who requests an expedited reconsideration must be acting on behalf of the enrollee as an authorized representative.
Section 422.570(b)(2) specifies that a physician may provide written or oral support for a request for expedition, and under § 422.570(c)(2)(ii), requests for expedited organization determinations that are made or supported by a physician must be granted by the M+C organization if the physician indicates that the enrollee's health could be jeopardized.
Under § 422.568(d)(1), an M+C organization must automatically transfer a denied request for an expedited organization determination to the standard 14-day time frame described in § 422.568(a), and § 422.570(d)(2)(ii) requires an M+C organization to inform the enrollee of the right to file a grievance if he or she disagrees with the
Section 422.572(a) requires an M+C organization to notify the enrollee (and the physician involved, as appropriate) of an expedited determination as expeditiously as the enrollee's health condition requires but no later than 72 hours after receiving the request. Under § 422.572(b), an M+C organization may extend the 72-hour deadline for expedited review by up to 14 calendar days if the enrollee requests the extension or if the organization finds that additional information is needed and the delay is in the interest of the enrollee. Also under this section, an M+C organization must notify an enrollee of a determination as expeditiously as the enrollee's health care needs require but no later than upon expiration of the extension.
Provisions in both §§ 422.570(f) and 422.584(f) prohibit an M+C organization from taking or threatening to take any punitive action against a physician acting on behalf or in support of an enrollee in requesting an expedited organization determination or reconsideration.
Section 422.574 identifies the parties to an organization determination, which include the enrollee, certain physicians and other providers who are assignees of the enrollee, legal representatives of a deceased enrollee's estate, and any other entity (other than the M+C organization) determined to have an appealable interest in the proceeding.
If a decision regarding a request for payment or service is unfavorable (in whole or in part) to the enrollee, the enrollee or any other party to an organization determination as listed in § 422.574 who is dissatisfied with the organization determination may request that the M+C organization reconsider the decision. Reconsiderations represent the first step in the appeals process. The reconsideration process encompasses both standard and expedited reconsiderations, as described under §§ 422.582 and 422.584. The time frame and notice requirements for reconsiderations are set forth under § 422.590.
Section 422.590(a)(1) requires that, with respect to standard reconsiderations concerning requests for service, an M+C organization must issue any determination that is entirely favorable to the enrollee as expeditiously as the enrollee's health condition requires but no later than 30 calendar days after it receives the request for reconsideration. As with organization determinations, § 422.590(a) also provides that the M+C organization may extend the time frame by up to 14 calendar days if the enrollee requests the extension, or if the organization justifies a need for additional information, and how the delay is in the interest of the enrollee. Under § 422.590(b)(1), for standard reconsiderations involving requests for payment, the M+C organization must issue any fully favorable determination no later than 60 calendar days from the date it receives the request for the reconsideration.
In the case of expedited reconsiderations (which involve only requests for services), § 422.590(d)(1) requires that an M+C organization issue any determination that is entirely favorable to the enrollee as expeditiously as the enrollee's health condition requires but no later than 72 hours after it receives the request for expedited reconsideration, again with the possibility of a 14-day extension as described in § 422.590(d)(2). If, however, the M+C organization's reconsideration results in an affirmation, in whole or in part, of its original adverse organization determination, this decision is automatically subject to further review by an independent entity contracted by us. (Again, the time frame within which an M+C organization must reconsider a standard or expedited case has been tied to the enrollee's health needs for service requests, subject to either a 30-day or 72-hour maximum (with a possible 14-day extension), while the time frame remains at 60 days for reconsideration requests involving payment.)
Section 1852(g)(4) of the Act requires us to contract with an independent, outside entity to review and resolve in a timely manner reconsiderations that affirm, in whole or in part, an M+C organization's denial of coverage. Thus, unless an M+C organization completely reverses its coverage denial, it must prepare a written explanation, and refer the case to the independent review entity for a new and impartial determination concerning the payment or service at issue.
Section 422.590(a)(2) provides that for standard requests for services, an M+C organization that makes a reconsidered determination affirming, in whole or in part, its adverse organization determination, must send the case file to the independent review entity as expeditiously as the enrollee's health requires, but no later than 30 calendar days from the date the M+C organization receives the request for a standard reconsideration (or the date of an expiration of an extension). For standard requests for payment, § 422.590(b)(2) allows the M+C organization 60 calendar days from the date it receives the request to send the case to the independent review entity. In instances involving expedited requests for reconsideration, § 422.590(d)(5) requires that the M+C organization forward its decision to the independent entity as expeditiously as the enrollee's health condition requires, but not later than within 24 hours of its affirmation of the adverse expedited organization determination.
Section 422.590(g)(2) requires that any reconsideration that relates to a determination to deny coverage based on a lack of medical necessity must be made only by a physician with expertise in the field of medicine that is appropriate for the services at issue.
For the most part, the procedures outlined above were carried over into the M+C requirements from the existing part 417 standards. We also implemented several changes in the reconsideration requirements that are analogous to those described for organization determinations, such as the requirement under § 422.584(d)(1) that an M+C organization automatically transfer a denied request for an expedited reconsideration to the standard 30-day time frame described in § 422.590(a). In addition, § 422.590(e) requires that if an M+C organization refers a case to the independent entity, it must concurrently notify the enrollee of that action.
Consistent with section 1852(g)(4) of the Act, §§ 422.592 and 422.594 address reconsiderations by an independent entity. If the independent review entity's reconsidered determination is not fully favorable to the enrollee, subsequent review possibilities include ALJ and Departmental Appeals Board (DAB) hearings, as well as judicial review. Provisions addressing these forms of review are set forth in §§ 422.600 through 422.616.
Section 422.618 established effectuation requirements for payments
Sections 422.620 and 422.622 pertain to M+C organizations' responsibilities in connection with inpatient hospital care. The existing provisions clarify that inpatient services continue to be covered only until written notice of noncoverage in situations in which the hospital admission was authorized in the first instance by the M+C organization, or in which the admission constituted urgent or emergent care. This notice now is issued to enrollees by the M+C organization, either directly or through the hospital, with the concurrence of the attending physician responsible for the enrollee's hospital care. Section 422.622 provides enrollees with the right to seek PRO review by noon on the day after the receipt of the notice if the enrollee believes that he or she is being discharged too soon. The enrollee bears no additional financial liability for care furnished during the period of PRO review, regardless of the proposed date of discharge. If the enrollee misses the noon deadline for requesting PRO review, the enrollee may file an expedited appeal with the M+C organization. Unlike the PRO review process, there is no financial protection afforded to the beneficiary while the M+C organization conducts its review.
• Paragraph (b)(1), which concerns payment for out-of-plan services, is revised by adding payment for out-of-area renal dialysis to the existing list of such services (which already included emergency, urgently needed, and post-stabilization services);
• Paragraph (b)(3) includes additional language to clarify that an organization's refusal to pay for or provide services “in whole or in part, including the type or level of services” can constitute an organization determination if the enrollee believes they should be furnished or arranged for;
• Paragraph (b)(4) is restructured to indicate that a discontinuation of services when an enrollee believes that the services continue to be medically necessary constitutes an organization determination (thus eliminating any implication that an organization must make a formal determination as to medical necessity to give rise to appeal rights); and
• New paragraph (b)(5) is added to specify that another situation that constitutes an organization determination is an MC organization's failure to approve, furnish, arrange for, or provide payment for health care services in a timely manner, or failure to provide the enrollee with timely notice of a determination, if such a delay would adversely affect the health of the enrollee.
Thus, we agree that a reduction in services can be considered an
Examples of other situations that are intended to fall within the clarified definition of an organization determination include:
• A physician requests approval of 10 home health visits, but the organization approves only five visits (even though Medicare allows more than five visits);
• An organization approves a referral to a specialist, but the specialist it designates does not have experience in treating the enrollee's rare condition;
• A physician requests inpatient surgery for a patient because of the patient's history of complications with anesthesiology, but the organization will approve only outpatient surgery; or
• Although an organization agrees to pay for an in-network service, it imposes greater cost-sharing than the enrollee believes is permissible.
We believe that each of these examples fit within the statutory language at section 1852(g)(1)(A) and (B) of the Act that establishes that an M+C organization must have an appeals procedure for determinations as to whether an enrollee “is entitled to receive a health service under this section and the amount (if any) that the individual is required to pay with respect to such service.” Thus, the purpose of the revisions to § 422.566(b) is not to expand on our interpretation of what types of situations constitute organization determinations but rather to provide additional insight into how we continue to interpret the intent of the applicable statutory provisions.
As we explained above, we are developing a proposed regulation that would provide additional specific guidance as to when a reduction in services gives rise to the obligation to provide a written notice. This has been an extremely difficult issue to resolve, and despite extensive consultations with beneficiary advocates, industry representatives, and State officials, we still have not been able to reach conclusions as to standards beyond those already in the statute and regulations and quoted above. Again, we will address the issue in connection with a separate rulemaking that is being developed in close consultation with all affected groups. Finally, as commenters suggested, if in the future we believe that it is necessary to require notices of appeal or other rights for situations other than organization determinations, we would do so through notice and comment rulemaking.
Other commenters supported the current requirement that the M+C organization provide notice when the enrollee disagrees that the services are no longer medically necessary. One commenter stated that where there is no disagreement, it is wholly inappropriate to provide notice and appeal rights. Instead, it is more appropriate to provide notice at the beginning of a course of treatment. One commenter recommended that we provide advance notice for reductions and terminations in writing, describing the basis for the decision and appeal rights. Some
To eliminate confusion, we want to point out that written notice is always required for inpatient hospital discharges regardless of whether the enrollee agrees with the discharge decision. The issuance of a notice to an enrollee prior to an inpatient hospital discharge required under § 422.620 is a separate requirement that should not be confused with the provisions at §§ 422.566(b)(4) and 422.568(c). We will address the SNF issue in the forthcoming proposed rule.
Finally, as the commenters suggested, we recognize the potential compliance difficulties and burden associated with existing § 422.568(c), which requires that if an M+C organization denies services or payment, in whole or in part, it must give the enrollee a detailed written notice that meets the content requirements of § 422.568(d) (such as stating the specific reason for the denial and describing the available appeals procedures). We understand that in practice, plan practitioners generally are responsible on behalf of M+C organizations for issuing these detailed notices to their patients, given that most care decisions about future care are made at the practitioner level; and we agree that this practice may be unnecessarily burdensome and intrusive on the practitioner/patient relationship. Moreover, we can understand that requiring M+C organizations to ensure that appropriately detailed notices are given to enrollees in practitioners' offices may be difficult to monitor and enforce in all circumstances.
Therefore, we have revised the provisions at §§ 422.568(c) through (e) to establish a process under which—(1) practitioners routinely notify enrollees at each patient encounter of their right to receive a
The practitioner's notification must inform enrollees of their right to receive a detailed notice from the M+C organization and provide enrollees with all information necessary in order to contact the M+C organization. Consistent with other notification requirements set forth in subpart M (for example, under existing § 422.568(d)(4) or under § 422.572(e)(2)(ii)), we also specify that the content of the practitioner's notification must comply with any other requirements established by HCFA. We are now developing standardized language for use by affected practitioners, and will provide an opportunity for public comment through OMB's Paperwork Reduction Act process. Once that process is completed, we intend to provide further guidance on the content and form of the required practitioner notice. We believe that this requirement will serve to improve M+C organizations' ability to assure implementation of the requirement for detailed written notices while at the same time reducing the administrative burden on practitioners by freeing them from the obligation to routinely provide such detailed notices to their patients.
In view of the range of opinions contained in the comments on the M+C interim final rule, we believe that we succeeded in establishing an appropriate middle ground for the maximum time frames. It has also been reported to us that the majority of organizations make decisions within our reduced time frames. Only one commenter contended that the 14-day time frame could not be met as a general rule. We believe that the opportunity for up to a 14-day extension to the time frames for service-related requests allows the M+C organization adequate time in which to render a determination. We also believe that the new 14 and 30 calendar day time frames are appropriate from both consumer protection and industry feasibility standpoints. The medical exigency standard, which requires that decisions be rendered as expeditiously as an enrollee's health requires, provides for a quicker response where appropriate. Likewise, the opportunity for up to a 14-day extension for both organization determinations and reconsiderations
Moreover, to further clarify the grounds on which an M+C organization may seek an extension, and to ensure an enrollee is adequately advised of the M+C organization's use of an extension, we are adding language to both §§ 422.568(a) and 422.572(b) that requires an M+C organization to notify the enrollee in writing of the reasons for the extension, and to inform the enrollee of the right to file a grievance if he or she disagrees with the M+C organization's decision. Relatively few enrollees utilize the appeals process, and most organizations are able to make determinations on requests for services within 30 days. Therefore, we do not foresee that requiring M+C organizations to notify enrollees upon initiating an extension will create an undue burden on M+C organizations.
In our consultations with the public before publishing the M+C interim final rule, industry representatives advised us that each request is different; where some organization determinations are likely to require a 14-day time frame, and possibly 14 additional days, other decisions require less resolution time. Likewise, resolution of some reconsiderations will take up to 30 calendar days, and may require more time to gather additional information. The medical exigency standard requires M+C organizations to prioritize those cases where waiting for a decision is more likely to affect an enrollee adversely. We interpret this standard as requiring that the M+C organization or the independent entity apply, at a minimum, established, accepted standards of medical practice in assessing an individual's medical condition. Evidence of the individual's condition can be demonstrated by indications from the treating provider or from the individual's medical record (including such information as the individual's diagnosis, symptoms, or test results). We established the medical exigency standard by regulation to ensure that M+C organizations would develop a system for determining the urgency of both standard and expedited requests for services, and give each request priority according to that system. That is, we intend that M+C organizations treat every case in a manner that is appropriate to its medical particulars or urgency, rather than systematically use the maximum time permitted for service-related decisions.
Also, as indicated in the preamble to the interim final rule (63 FR 35028), we continue to believe that the emphasis on the health needs of the individual enrollee is consistent with the statutory requirement that determinations be made on a timely basis. Thus, the fact that an organization makes a determination on a service-related issue within 14 days does not necessarily constitute compliance with the law or regulations if there is evidence that an earlier determination was necessary to prevent harm to the enrollee's health.
We intend to issue additional guidance on the medical exigency standards in a future operational policy letter.
We also agree with the comments that expedited effectuation requirements should be incorporated into the regulations. To promote consistency in implementation, and to ensure enrollees receive the services they need as quickly as possible, we are establishing a new § 422.619 to require M+C organizations to effectuate overturned, expedited determinations as quickly as necessary, but no later than within 72 hours. Under the new provision, if the M+C organization reverses its original adverse organization determination, in whole or in part, the M+C organization must authorize or provide the service under dispute as expeditiously as the enrollee's health condition requires, but no later than 72 hours from the date it receives the request for the determination.
Where the independent entity reverses, in whole or in part, the M+C organization's initial expedited determination, the M+C organization must authorize or provide the service under dispute as expeditiously as the enrollee's health condition requires, but no later than 72 hours from the date it receives notice reversing the determination. In instances where the independent review entity expedites certain cases on its own accord (for example, where an enrollee or physician did not originally request an expedited appeal at the M+C organization level, but the independent review entity determines an expedited appeal is warranted), the expedited effectuation requirements of § 422.619 still apply.
If the ALJ or higher level reviewer reverses the independent review entity's expedited reconsidered determination, the M+C organization must authorize or provide the service under dispute as expeditiously as the enrollee's health requires, but no later than 60 calendar days from the date of the decision.
Additionally, we agree with one of the recommended changes to the independent entity's reconsideration notice, and are amending § 422.568 to require that the notice be written in “understandable language.” We also will consider issuing instructions to require the independent entity to advise an enrollee of his or her right to review by the PRO for quality of care concerns; (the same requirement on M+C organizations is set forth via model notice instructions).
We want to make clear, however, the distinction between a physician acting on behalf of the enrollee, and a physician who meets the conditions for being a party in his or her own right. When a physician seeks either a standard or expedited organization determination for services on behalf of the enrollee, the physician does not need to be an authorized representative. But, if the physician seeks a standard reconsidered determination for purposes of obtaining payment, then the physician must sign a waiver of liability, consistent with § 422.574(b).
As noted above, upon denial of an enrollee's request for expedited review, existing regulations require an M+C organization to provide the enrollee with “prompt oral notice” of the denial, and follow up with a written letter within 2 working days. We believe that this is a reasonable requirement which indicates that an M+C organization must contact and advise the enrollee of the denial without delay. As suggested by the commenter, we are clarifying the regulations to indicate that subsequent to providing oral notice of the denial, M+C organizations must “deliver” to the enrollee, within 3 calendar days, a written letter that includes the information listed in the regulation at §§ 422.570(d)(2) and 422.584(d)(2). We interpret this provision as requiring an M+C organization to first orally notify an enrollee of a denial, and subsequently deliver written notice to the enrollee within 3 days after the decision. Note that we have revised the regulations at §§ 422.570(d)(2), 422.572(c), 422.584(d)(2), and 422.590(d)(3) to establish a requirement of 3 calendar days, rather than 2 working days. We believe this is a reasonable amount of time within which to require M+C organizations to deliver written notice enrollees (following the oral notice) of a denied expedited request, and that the change to calendar days will eliminate confusion over what constitutes a working day. This change is consistent with the general replacement of standards related to “working days” with “calendar day” standards throughout the M+C regulations.
We also wish to clarify that if an enrollee's request for an expedited organization determination is denied, the M+C organization will automatically transfer and process the enrollee's request under the standard process. If the M+C organization denies the request in whole or in part, the enrollee (or a physician on the enrollee's behalf) then has a right to orally request expedited reconsideration. The M+C organization continues to be responsible for documenting all oral requests in writing and maintaining the documentation in the case file.
We disagree with the commenters who requested that the definition of “enrollee” exclude an authorized representative. Although we recognize that an authorized representative is not an enrollee in the literal sense of being entitled to health services, we believe that to ensure authorized representatives are always permitted to act on behalf of an enrollee, the regulations should include an authorized representative in the definition of “enrollee” under subpart M. We note that § 422.561, which sets forth the definitions used in the appeals regulations contained in subpart M, specifies that the definitions are only “as used in this subpart, unless the context indicates otherwise.”). An authorized representative thus would not be considered an enrollee for general M+C program purposes, such as under enrollment or financial liability provisions, but would be able to exercise the rights available to an enrollee for appeal and grievance purposes, such as the right to act on behalf of an enrollee in requesting an appeal or to receive applicable notifications.
The policy limiting ALJ appeal rights to Medicare enrollees has been in place since the inception of the Medicare risk contracting program under section 1876 of the Act. As noted above, under section 1856(b)(2) of the Act, M+C standards are to be based on standards established under section 1876 of the Act to the extent consistent with M+C rules. More importantly, the M+C statute expressly grants a right to a hearing only to an enrollee, with the M+C organization given the right to: (1) Be made a party to such a hearing; and (2) appeal from an ALJ. Section 1852(g) of the Act sets forth a three step process for appeals of coverage determinations. Section 1852(g)(1) of the Act establishes the process for making initial organization determinations and providing notice of appeal rights. Section 1852(g)(2) of the Act provides for the reconsideration process, which is conducted initially by the M+C organization. (Section 1852(g)(3) of the Act provides for M+C organizations to
We believe that the commenter's confusion about what constitutes a “final decision of HCFA” may be due to some confusing regulatory text in § 422.612(b). Section 422.612(b) provides that a decision of the DAB may be appealed to Federal court if “(1) It is the final decision of HCFA; and (2) The amount in controversy is $1,000 or more.” This implies that there is a distinction between a DAB decision and a “final HCFA decision.” In fact, a DAB decision constitutes a “final decision” on our behalf, since it is not subject to any further administrative review. We therefore are revising § 422.612(b) to provide that a DAB decision may be appealed to district court if the amount in controversy is $1,000 or more.
We began consulting with industry groups, beneficiary advocacy groups, and peer review organizations in support of drafting a notice that would serve the intended purpose. On February 11, 1999, we issued OPL 99.082. This OPL conveyed: (1) Our new notice, the NODMAR; (2) our intent to consumer test and standardize the model language; and (3) our continued effort to find the best balance of beneficiary protections with administrative burden. The model language conveyed in the OPL contains language that is in 12 and 14-point fonts, is written in understandable language, and is only three pages in length.
The Important Message from Medicare (IMM) and the NODMAR are two documents that contain similar information. The IMM is currently given to the Medicare beneficiary at or about the time of admission, while the NODMAR is given in advance of the patient's discharge. We recognized the burden associated with issuing two notices with similar information. Therefore, we have developed a single document and process that allows patients to be informed about their inpatient hospital rights at a time and in a form that will be most beneficial to them and in a manner that reduces administrative burden. This single document is a revision to the existing Important Message from Medicare.
Accordingly, we have revised the IMM to provide for the inclusion of information on patients' inpatient hospital discharge rights. All Medicare beneficiaries will receive a revised notice, the “Important Message About Medicare Rights: Admission, Discharge, & Appeals,” as required under section 1866(a)(1)(M) of the Act.
This revised standardized form will be issued to all Medicare beneficiaries who are inpatients of a hospital at or about the time of their admission. Once a Medicare beneficiary's time of discharge is determined, an amended notice that includes the reasons for the discharge would again be provided to the beneficiary prior to his or her actual discharge. The revised Important Message About Medicare Rights: Admission, Discharge, & Appeals has been consumer-tested, and has received favorable feedback. (Pursuant to the Paperwork Reduction Act of 1995 (PRA), a notice outlining this document was published in the
Therefore, when the model language, NODMAR, was drafted, we included language that would allow the enrollee to understand the significance of meeting the immediate PRO review deadline. Likewise, the revised Important Message stipulates that if the enrollee meets the deadline for filing for immediate PRO review, the enrollee's M+C organization continues to be responsible for paying the costs of the enrollee's hospital stay until noon of the day after the PRO notifies the enrollee of its official decision.
In addition to stating that the enrollee has financial protection if he/she meets the immediate PRO review deadline, we have included a section that explains what happens to the enrollee if he/she misses the deadline and has to appeal to the M+C organization.
With respect to the commenter's suggestion that the enrollee not be financially liable until an appeal is resolved, as noted above, if the enrollee disagrees with a discharge decision, the enrollee may file for immediate PRO review by noon the day after a discharge notice is received. If such a timely request for review is filed, the enrollee is protected from financial liability until at least noon on the day after notice of the PRO's decision, if the PRO upholds the decision to discharge the enrollee. If the PRO decides that hospital services are still necessary, coverage would continue until a new discharge notice is issued.
Lastly, we note that it is the responsibility of the entity that made the discharge decision to ensure that an enrollee's questions about the discharge decision be directed to someone within that entity who can provide assistance. Thus, where a discharge decision is made by an M+C organization, that organization should be available to answer questions, even though the notice is issued on the organization's behalf by a hospital.
Again, the revised Important Message has undergone extensive consumer testing. This has helped us to improve the content of the notice to make it less confusing to the beneficiary. Since the revised notice will be used to satisfy the requirement for notice of discharge/termination of coverage, beneficiaries will have the benefit of the consumer testing in this context as well.
We do not agree that we should add the requirement that an M+C organization's failure to give timely and proper notice shall result in an automatic authorization/approval, or that failure to give timely and proper notice shall result in
With respect to the commenter who specified training that the commenter believes reviewing physicians should have, we believe that our standard of “appropriate” expertise addresses this comment. Nor do we believe that it would be appropriate for the reviewing physician's identity to be provided to the treating physician being reviewed. The treating physician has the right to challenge the M+C organization's decision on the merits through several levels of an appeals process. We believe that sufficient accountability exists for reviewing physicians through the appeals process, since a physician whose decisions are reversed on appeal would be accountable to his or her M+C organization. Providing the name of the physician making the initial decision for the M+C organization could result in needless personal harassment of that physician by the physicians he or she reviews.
Finally, we do not agree with the comment that organization determinations should be made or approved by a physician. We do not believe that it is necessary to require physician involvement in all organization determinations that are adverse. Nevertheless, we expect that where adverse determinations are based on a lack of medical necessity, M+C organizations will ensure that appropriate health care professionals will be involved in the decision-making. For example, a nurse practitioner could render an adverse organization determination without the need to involve a physician. Furthermore, if an enrollee believes that the lack of physician involvement was a central factor in an adverse organization determination, then the enrollee need only request a reconsideration since the reconsideration requirements (§ 422.590(g)(2)) specify that a denial of coverage based on a lack of medical necessity must be made by a physician with expertise in the field of medicine that is appropriate for the services at issue. (We note that we have made a minor technical change to § 422.590(d) to clarify that the term “medical necessity” includes any substantively equivalent term used by an M+C organization to describe the concept of medical necessity.)
Subpart N of Part 422 addresses M+C contract determinations. There are three types of contract determinations addressed under Subpart N: (1) A determination that a contract applicant is not qualified to enter into a contract with us under Part C of title XVIII of the Act; (2) a determination to terminate a contract with an M+C organization; and (3) a determination not to authorize a renewal of a contract with an M+C organization. Regarding item (1), above, this type of contract determination likewise applies to service area expansion applications.
As indicated in the June 1998 interim final rule, pursuant to section 1856(b)(2) of the Act, most of what comprises subpart N was drawn from regulations in part 417 governing similar contract determinations involving contracts under section 1876 of the Act. We received nine public comments concerning subpart N of the interim final rule.
A similar issue exists at § 422.656 of the interim final rule. Paragraph (a) discusses giving both the M+C organization and the contract applicant written notice of the reconsidered determination, while paragraph (b)(1) refers only to the M+C organization. Paragraph (b)(3) returns to using both M+C organizations and contract applicants.
We believe that § 422.668 provides an adequate remedy to situations where bias of the hearing officer is questioned. This section states that the objecting party may, at the close of the hearing, present objections, request that the decision of the hearing officer be revised, or request a new hearing before a different hearing officer.
As stated in the interim final rule, M+C organization actions that are subject to intermediate sanctions include those specified at § 417.500 for contracts under section 1876 of the Act. The BBA also contained additional sanction authority not found in § 417.500, which we have implemented in subpart O. Specifically, section 1857(g)(3) of the Act provides that the Secretary can impose intermediate sanctions and civil money penalties based on a finding that the grounds in section 1857(c)(2) of the Act for terminating a contract are met. These grounds for termination are reflected in § 422.510(a), and are discussed in section II.K and II.N above. While intermediate sanctions based on the grounds for termination at § 422.510 generally are imposed on the same terms as sanctions for the violations specified in § 422.750(a), in the case of all grounds except a finding of fraud or abuse under § 422.510(a)(4), HCFA, rather than the OIG, imposes civil money penalties.
We received 3 comments on subpart O.
Among the types of M+C options authorized under section 1851(a)(2) of the Act is an M+C medical savings account (MSA) option, that is, a combination of a high deductible M+C insurance plan (an M+C plan) and a contribution to an M+C MSA. Section 1859(b)(3)(A) of the Act defines an MSA plan as an M+C plan that:
• Provides reimbursement for at least all Medicare-covered items and services (except hospice services) after an enrollee incurs countable expenses equal to the amount of the plan's annual deductible.
• Counts for purposes of the annual deductible at least all amounts that would have been payable under original Medicare if the individual receiving the services in question was a Medicare beneficiary not enrolled in an M+C plan, including amounts that would be paid by the beneficiary in the form of deductibles or coinsurance.
• After the annual deductible is reached, provides a level of reimbursement equal to at least the lesser of actual expenses or the amount that would have been paid under original Medicare, if the individual receiving the services in question was a Medicare beneficiary not enrolled in an M+C plan, including amounts that would be paid by the beneficiary in the form of deductibles or coinsurance.
Sections 422.2 and 422.4 set forth several definitions for terms connected with M+C MSA plans, including “M+C MSA,” “M+C MSA plan,” and “MSA trustee.” We also distinguish between a “network” and a “non-network” M+C MSA plan. These definitions consist of general meanings for these terms as used in the BBA, and do not include specific requirements in the definitions themselves. The definition for an MSA does, however, reference the applicable requirements of sections 138 and 220 of the Internal Revenue Code, while the M+C MSA plan definition references the applicable requirements of part 422.
Any individual who is entitled to Medicare under Part A, is enrolled under Part B, and is not otherwise prohibited (such as an ESRD patient), is eligible to enroll in an M+C plan. However, the statute places several limitations on eligibility to enroll in an M+C MSA plan, and these limitations are set forth at § 422.56 of the regulations. Section 422.56(a) indicates that M+C MSA plans are authorized on a limited “demonstration” basis, and incorporates the statutory provisions of section 1851(b)(4), that is:
• No more than 390,000 individuals may enroll in M+C MSA plans.
• No individual may enroll on or after January 1, 2003, unless the enrollment is a continuation of an enrollment already in effect as of that date.
• No individual may enroll or continue enrollment for any year unless he or she can provide assurances of residing in the United States for at least 183 days during that year.
Section 1851(e) of the Act establishes general rules concerning the time periods when a beneficiary could elect to enroll in an M+C plan (if one is offered in the beneficiary's area), with special rules for M+C MSA plans set forth at section 1851(e)(5) of the Act. Based on these provisions, § 422.62(d) specifies that an individual may elect an MSA plan only during one of the following periods:
• An initial election period, that is, the 7-month period beginning 3 months before the individual is first entitled to parts A and B of Medicare.
• The annual coordinated election period in November of each year.
Section 422.103 incorporates the statutory requirements for M+C MSA plans defined under section 1859(b)(3) of the Act, as outlined above. Thus, § 422.103(a) specifies that an MSA organization offering an MSA plan must make available to an enrollee, or provide reimbursement for, at least all Medicare-covered services (except for hospice services) after the enrollee's countable expenses reach the plan's annual deductible. Further, § 422.103(b) then indicates that countable expenses must include the lesser of actual costs or all the amounts that would have been paid under original Medicare if the services were received by a Medicare beneficiary not enrolled in an M+C plan, including the amount that would have been paid by the beneficiary under his or her deductible and coinsurance obligation.
Section 422.103(c) provides that after the deductible is met, an M+C MSA plan pays the lesser of 100 percent of either the actual expense of the services, or of the amounts that would have been paid under original Medicare if the services were received by a Medicare beneficiary not enrolled in an M+C plan, including the amount that would have been paid by the beneficiary under his or her deductible and coinsurance obligation.
Section 422.103(d), concerning the annual deductible, is based on section 1859(b)(3)(B) of the Act. As the statute specifies, the maximum annual deductible for an MSA plan for contract year 1999 was $6,000. In subsequent contract years, the maximum deductible may not exceed the maximum deductible for the previous contract year increased by the national per capita M+C growth percentage for the year. Thus, based on a national per capita growth percentage of 5 percent, the maximum deductible for 2000 is $6,300. In calculating the maximum deductible for future years, HCFA will round the amount to the nearest multiple of $50.
Section 422.102 addresses the general M+C rules on supplemental benefits.
Consistent with section 1852(e)(2) of the Act, a network model M+C MSA plan must meet requirements similar to those that apply to all other M+C coordinated care plans (with the exception of the achievement of minimum performance levels); the statute and regulations establish different requirements for non-network M+C MSA plans. These requirements are discussed in detail in section II.D of this preamble.
For the most part, subpart E of new part 422 does not establish any requirements that are specific to MSA plans. However, § 422.214, “Special rules for services furnished by noncontract providers,” does not apply to enrollees in MSA plans. Section 422.214 implements section 1852(k) of the Act, which contains limits on amounts providers can collect in the case of coordinated care plan enrollees (section 1852(k)(1) of the Act), and private fee-for-service plan enrollees (section 1852(k)(2) of the Act). As explained in the June 1998 interim final rule preamble, it is clear that Congress intended no such limits to apply to services provided to MSA plan enrollees.
Section 1853 of the Act describes the method to be used to calculate the annual M+C capitation rate for a given payment area. We apply the same methodology in determining the annual capitation rate associated with each M+C MSA plan enrollee, though the actual amount paid to an M+C organization offering an M+C plan is not the amount determined under section 1853 of the Act.
The special rules concerning the allocation of the M+C capitated amount for individuals enrolled in M+C MSA plans are set forth at section 1853. In general, HCFA will allocate the capitated amount associated with each M+C MSA enrollee as follows:
• On a lump-sum basis at the beginning of the calendar year, pay into a beneficiary's M+C MSA an amount equal to the difference between the annual M+C capitation rate calculated under section 1853(c) of the Act for the county in which the beneficiary resides and the M+C MSA premium filed by the organization offering the MSA plan (this premium is uniform for all enrollees under a single M+C MSA plan, or segment of a plan service area, if authorized under section 1854(h). (See section I.C.7 for a discussion of the BBRA changes in this regard). This results in a uniform amount being deposited in an M+C MSA plan enrollee's M+C medical savings account(s) in a given county, since the uniform premium amount will be subtracted from the uniform county-wide capitation rate for every enrollee in that county.
• On a monthly basis, pay to the M+C organization an amount equal to one-twelfth of the difference, either positive or negative, between the risk adjusted annual M+C capitation payment for the individual and the amount deposited in the individual's M+C MSA.
Section 422.262 contains the regulations concerning the allocation of Medicare trust funds for enrollees in M+C MSA plans.
Section 1854 of the Act establishes the requirements for determination of the premiums charged to enrollees by M+C organizations. Like other M+C organizations, organizations offering M+C MSA plans in general must submit by July 1 of each year information concerning enrollment capacity and premiums. For M+C MSA plans, the information to be submitted includes the monthly M+C MSA plan premium for basic benefits and the amount of any beneficiary premium for supplementary benefits. These requirements are set forth under section 1854(a)(3) of the Act and § 422.306(c) of the regulations.
The remaining requirements under subpart 422 have few, if any, implications specific to M+C MSA plans. One issue that we discussed in the interim final rule, however, involves the provision of section 1856(b)(3)(B)(i) of the Act (and § 422.402(b)) that any State standards relating to benefit requirements are superseded. We recognize that this provision means that State benefit rules will not apply (for example, State laws that mandate first dollar coverage for particular benefits such as mammograms or other preventative services). Some States may not license entities to offer catastrophic coverage, and it is possible that M+C MSA plans could not be offered in that State. We invited public comment on this issue.
As noted above, one type of M+C option available under section 1851(a)(2) of the Act is an M+C private fee-for-service (PFFS) plan. Consistent with the statutory definition of an M+C private fee-for-service plan at 1859(b)(2)(A) of the Act, the regulations state that an M+C PFFS plan is an M+C plan that: Pays providers at a rate determined by the M+C organization offering the PFFS plan on a fee-for-service basis without placing the provider at financial risk; does not vary the rates for a provider based on the utilization of that provider's services; and does not restrict enrollees' choice among providers who are lawfully authorized to provide the services, and agree to accept the plan's terms and conditions of payment. The requirements M+C organizations must meet to contract with HCFA to offer an M+C PFFS plan generally are incorporated into the relevant sections of the M+C regulations. An M+C organization wishing to offer a PFFS plan must meet all of the requirements that apply with respect to offering any other type of M+C plan, except to the extent that there are special rules that apply to M+C PFFS plans.
With respect to the notice of anticipated cost sharing, the law requires such a notice for hospital services, but not for other services. The M+C organization could, however require that contracting and deemed contracting providers of other types furnish such a notice in advance of providing care as a term and condition of payment, and could set whatever tolerance they chose for such a notice.
We chose the $500 threshold for a notice of out-of-pocket expenses that a hospital may collect from the enrollee because it mirrors the $500 threshold long established by law at section 1842(m)(1) of the Act. Section 1842(m)(1) of the Act requires that a nonparticipating physician who does not accept assignment on the Medicare claim must give the beneficiary advance notice if the actual charges that will be collected from the beneficiary equal or exceed $500. While the benefit to which the threshold applies is different, the concept of advance notice of amounts to be collected from the enrollee is the same, and therefore use of the same threshold is justified.
In the case of noncontracting providers (that is, providers that neither have a written contract with the M+C organization offering the PFFS plan nor meet the criteria for a deemed contract), there is no balance billing permitted; by law, the provider may collect no more than the plan's cost sharing. Under section 1852(k)(2)(B) of the Act, the beneficiary liability limits governing payment to noncontracting providers are the same for M+C PFFS plans as for M+C coordinated care plans. We have clarified this by indicating in § 422.214 that the special rules for payment to noncontracting providers that apply for M+C coordinated care plans also apply for M+C PFFS plans. Specifically, the provider must accept as payment in full the amount that it would be entitled to receive under original Medicare, and the plan must pay the provider the amount that the provider would collect if the beneficiary were enrolled in original Medicare, less the enrollee's cost-sharing. For example, if the physician participates in Medicare, the plan would pay the noncontracting physician the Medicare allowed amount less the plan's cost-sharing. In the case of a nonparticipating physician, the plan would pay the Medicare limiting charge less the enrollee's cost-sharing. In the case of an acute care hospital, the plan would pay the diagnosis-related group (DRG) payment less the enrollee's cost-sharing. In the case of a nonparticipating durable medical equipment, prosthetic and orthotics (DMEPOS) supplier, the plan would pay actual charges less the enrollee's cost-sharing.
While the law addresses the payments to providers and the payment liabilities of beneficiaries, it does not specify whether the M+C organization must pay the provider, or whether it may function as an indemnity plan and pay the enrollee, for services for which the enrollee has paid the provider. Moreover, the discussion of prompt payment by M+C plans at section 1857(f) of the Act contemplates that the M+C organization may make payment to the beneficiary. Hence, the M+C organization may determine to whom (provider or beneficiary) it will make payment for covered services. However, we anticipate that M+C organizations will want to make payment to providers of services, rather than to beneficiaries since we believe that minimizing beneficiary paperwork and confusion is necessary to attract and keep enrollees in the plan.
As discussed in section II.D of this preamble concerning quality assurance requirements, M+C PFFS plans and non-network MSA plans (and now PPO plans) are exempt from some of the quality assurance requirements that apply to network model M+C plans. The statute also exempts these plans from external quality review if they do not have written utilization review protocols. As with all other requirements for M+C organizations and M+C plans, those provisions of regulations that are not identified as
Like other M+C plans, an M+C private fee-for-service plan must offer sufficient access to health care. Section 422.114(a) specifies that an M+C organization that offers an M+C PFFS plan must demonstrate to HCFA that it has sufficient number and range of health care providers willing to furnish services under the plan. Pursuant to the specific instructions of the law, under § 422.114(a), HCFA will find that an M+C organization meets this requirement if, with respect to a particular category of provider, the plan has: Payment rates that are not less than the rates that apply under original Medicare for the provider in question; contracts or agreements with a sufficient number and range of providers to furnish the services covered under the plan; or a combination of the above. These access tests must be met for each category of service established by HCFA on the M+C organization application. Thus, if an M+C PFFS plan has payment rates that are no lower than Medicare, it need not address if it has a sufficient number of providers of services under written contract. However, where the plan's payment rates are less than the Medicare payment for that type of provider, the M+C organization must demonstrate that the plan has a sufficient number of providers of that type under written contract.
Medicare payment amounts are established in a variety of different ways. For many of the key services for which Medicare pays, Medicare has prospectively set payment amounts or fee schedules that are established by HCFA and published in the
However, for some services, Medicare payments are set retrospectively or concurrently by Medicare carriers and intermediaries. For example, until the prospective payment systems or fee schedules are implemented, home health care, outpatient hospital care, and ambulance services will be paid by carriers and intermediaries based upon a HCFA-specified national methodology that they apply either upon receipt of the claim (for example, ambulance services paid on a reasonable charge basis) or long after the service is furnished (for example, retroactive cost report settlement). Moreover, there are some services for which reasonable cost and reasonable charge payment will continue indefinitely. Examples of these services are critical access hospital care (which by law must be paid actual cost without limits) and carrier priced physician services (for which the service is too new or too rare to support a national fee schedule value).
Clearly, where there are national prospective payment systems and fee schedules, M+C organizations offering PFFS plans should have no problem in paying amounts no less than the Medicare payment amount for covered services since those amounts are clearly and prospectively published by HCFA. However, the question arises as to how the access test based on Medicare payment levels can be met with regard to services that are paid by Medicare intermediaries or carriers on a reasonable cost or reasonable charge basis. Moreover, consistent with section 1852(d)(4) of the Act and § 422.214(b), M+C organizations offering PFFS plans cannot restrict providers from whom the beneficiary can acquire care. Therefore, the M+C organization must have the capacity to pay no less than the Medicare-allowed amounts for any Medicare-covered service furnished by any provider in any area of the nation. Acquiring the payment amounts from individual Medicare intermediaries and carriers would be a cumbersome and difficult task, and would be likely to result in unwanted payment delays. Therefore, we have decided to permit M+C organizations offering PFFS plans to establish proxies for use in paying services for which no Medicare prospective payment system or fee schedule exists.
The law and regulations permit the use of HCFA-approved proxies as long as those proxies result in payment amounts that are “not less than” Medicare payment rates. If the payment amounts to be paid by the M+C organization are equal to or more than the Medicare payment amounts for those services, the requirement of the law and regulations are met and HCFA must find that the PFFS plan provides for adequate access to care for those categories of services. Therefore, in cases of services for which there is no prospective payment system or fee schedule amount, we will permit M+C organizations to pay proxy amounts under certain circumstances. These proxy amounts must be approved by HCFA as approximating as closely as possible what providers as a whole receive for certain services. Because we expect these payment proxies would be estimates, the M+C organization must also have a process for reviewing these amounts, if necessary, on a provider-by-provider basis. If a provider is able to demonstrate that the proxy amount is less than the amount Medicare would actually pay, the M+C organization must pay the latter amount.
Proxies will take different forms, depending upon what makes the most sense for the type of service being paid. For example, a hospital that is paid on reasonable costs subject to a limit may be paid a percent of charges that is taken from the provider's last settled Medicare cost report. Similarly, an ambulance supplier may be paid the prevailing charge adjusted for the IC that applies in the year in which the service is furnished. Where proxies are used, HCFA will require that a description of the proxy methodology must be included in the terms and conditions of plan payment for deemed contractors that must be made available to providers of services before they treat an PFFS enrollee (see § 422.216(h)(2)(iii)(B)). As nationally established prospective payment systems and fee schedules are developed and implemented by HCFA, the use of proxies should diminish. However, at this time, and for the foreseeable future, for a limited subset of Medicare-covered services, proxies will be necessary for organizations offering M+C PFFS plans that choose not to contract directly with providers. For the reasons discussed above, we believe that their use comports with both the spirit and intent of the law and regulations.
In § 422.208(e), we specify that an M+C PFFS plan may not use capitated payment, bonuses, or withholds in the establishment of the terms and conditions of payment. This is necessary to implement that part of the definition of an M+C plan that specifies that the plan must pay without placing the provider at financial risk.
As discussed in detail in our June 1998 interim final rule (63 FR 35040), § 422.216(a) addresses payment to providers. Specifically § 422.216(a)(1) provides that the M+C organization offering a PFFS plan must pay all contract providers (including those that are deemed to have contract under § 422.216(f)) on a fee-for-service basis at a rate, determined under the plan, that does not place the provider at financial risk. This reflects the statutory definition of an M+C PFFS plan. We also specify in § 422.216(a)(1) that the payment rate includes any deductibles, coinsurance, and copayment imposed under the plan, and must be the same for all providers paid pursuant to a contract whether or not the contract is signed or deemed to be in place. Section 422.216(a)(3) establishes the payment rate for noncontracting providers.
Section 422.216(b) addresses permissible provider charges to enrollees. Under § 422.216(b)(1), contracting providers (including deemed providers) may charge the enrollee no more than the deductible, coinsurance, copayment, and balance billing amounts permitted under the plan. Like payment rates, the plan deductible, coinsurance or copayments and other beneficiary liability must be uniform for services furnished by all contracting providers, whether contracts are signed or deemed to be in place. These two requirements are closely related, since permissible enrollee liability is linked by statute to the plan's payment rate. These cost-sharing amounts must be specified in the plan contract. The plan must have the same cost-sharing for deemed contract providers as for contract providers, and it may permit balance billing no greater than 15 percent of the payment rate for the service.
Other significant requirements set forth in § 422.216 address monitoring and enforcement of the payment and charge provisions (§ 422.216(c)), notifications to plan members concerning payment liability, including balance billing rules (§ 422.216(d)), and rules covering deemed contract providers, including enrollee and provider notification requirements associated with these providers regarding payment terms and conditions (§§ 422.216(f), (g), and (h)).
Specifically, a commenter indicated that M+C organizations offering PFFS plans will not be able to get providers to sign contracts because there is no incentive for a provider to bind itself to a contract when it is not promised a share of the market in the area, and when it will be paid like a contracting provider, whether it signs a contract or not, under the deemed contracting provisions. Commenters indicated that there will be problems determining the “deemed contract” vs. the noncontract status of providers, since it depends on what they knew at the time of service. A commenter said that HCFA should tighten the rules under which deeming can be presumed, and seek statutory modifications to limit the use of deeming.
Some commenters indicated that emergency department physicians should not be deemed contractors because the M+C organization could blanket an area with terms and conditions of plan payment, and thereby force them to accept terms and conditions with which they did not agree, since they must treat all patients who present in the emergency department. They commented that HCFA should stipulate that deeming is never presumed to have occurred when emergency services or urgent care are required, particularly when they are required under the Emergency Medical Treatment and Labor Act. Other commenters recommended that the deemed contract language should be amended to explicitly not apply to out of network service provided in an emergency department, and to require that all physicians who provide services in the emergency department be paid as noncontracting providers. Commenters believe that this is needed because, under the Medicare provider agreement anti-dumping rules, the hospital must ensure that all patients who present in the emergency room are seen and that, therefore, the physicians on duty have no ability to choose not to provide care to the enrollee. Under the deemed contracting provisions of the law, they are forced to accept the terms and conditions of plan payment when they treat the patient.
The statute specifies that the M+C organization must treat providers that do not have a contract with the plan as if they had such a contract, if the provider knew that the beneficiary was enrolled in the plan, and either knew the terms and conditions of plan payment, or had reasonable access to those terms and conditions.
In general, if the beneficiary has advised the provider of his or her plan enrollment (as is often requested by the provider before providing care), and the provider knows the terms and conditions of plan payment (for example, because the physician or the party to whom the physician has reassigned benefits has received the plan terms and conditions in writing), or has a reasonable opportunity to learn the terms and conditions of plan payment (for example, through a toll free phone number, a website, or by having been sent a copy of the terms and conditions of plan payment), in a manner reasonably designed to effect informed agreement by a provider, then the provider meets the statutory test of being a deemed contracting provider, and the law requires that he or she must be treated as such. The law and regulations presume that, if the provider meets the criteria as a deemed contracting provider and subsequently treats the enrollee, then the provider has implicitly demonstrated agreement to the terms and conditions of payment by treating the enrollee.
While the law does not provide an explicit exception to the deemed provider provisions for emergency or urgent care services, we acknowledge that there are special circumstances that surround services in an emergency department of a hospital that justify considering providers who have not signed a contract with the PFFS plan to be noncontracting providers when they furnish services in an emergency
When a physician or hospital has not signed a contract with a PFFS plan but treats a plan enrollee in an emergency department of a hospital, the physician or hospital has no opportunity to refuse to treat the patient as the deemed contracting provisions of the law anticipate. Hence, we believe that it is appropriate to specify that a physician or hospital that furnishes services in the emergency department of a hospital on behalf of the hospital's obligations under the Emergency Medical Treatment and Active Labor Act (EMTALA) cannot be deemed to be a contracting provider. Of course, if the physician or hospital has previously signed a contract with the PFFS plan, the physician or hospital is a contracting provider, and is bound by the terms and conditions of that contract. Moreover, once the services furnished in the emergency department of a hospital cease to be required under § 489.24, the criteria that determine whether the providers are deemed contracting providers or noncontracting providers would then apply.
For the convenience of the reader, listed below are all significant changes to the M+C regulations that are set forth in this final rule. Please note that changes stemming from the BBRA, which—unlike those changes listed below—are subject to public comment, are all discussed in a discrete section of this preamble (section I.C) and thus are not listed here. In addition, we caution the reader that the list below is intended solely as a reference aid, rather than as a policy summary.
• In § 422.2, we are revising the definition of “service area”, as well as making minor technical changes to several other definitions.
• We are revising § 422.50(a) to allow individuals and employer group members who become entitled to Medicare and live outside of the service area to convert to an M+C plan if they were previously enrolled in a commercial plan offered by the M+C organization, provided these individuals receive full plan benefits and M+C access and availability standards are met.
• To allow us the flexibility to vary the timeframes for the enrollment transmission schedule in the future, we are amending § 422.60(e)(6) to state “upon receipt of the election form or from the date a vacancy occurs for an individual who was accepted for future enrollment, the M+C organization transmits within time frames specified by HCFA, the information necessary for HCFA to add the beneficiary to its records as an enrollee of the M+C organization.”
• We are revising § 422.60(f)(3) to state that “upon receipt of the election form from the employer, the M+C organization must submit the enrollment within time frames specified by HCFA.”
• In order to avoid introducing confusion between responsibilities of M+C organizations and HCFA, we have eliminated material in § 422.64 concerning HCFA's information responsibilities and moved necessary material to § 422.111.
• We have modified § 422.66(b)(3)(i) to state that the timeframe to submit disenrollment transactions will be “specified by HCFA,” and have made a conforming change at § 422.66(f)(2), as opposed to within 15 days.
• At § 422.66(d) we are clarifying that an M+C organization must accept any eligible individual who is enrolled in a health plan offered by “an” M+C organization to apply to a specific M+C organization, namely the organization that offers both the commercial health plan in which the individual is enrolled and the M+C plan in which the individual will be enrolling.
• At § 422.74(b)(3)(ii) we are permitting an M+C organization that has reduced an M+C plan's service area to offer continued enrollment in one of its M+C plans to enrollees in all or a portion of the reduced area if enrollees agree to receive “basic benefits” exclusively at designated facilities within the plan's new service area.
• We are adding a provision to § 422.74(d)(1)(iv) that expressly provides an M+C organization the option to discontinue an optional supplemental benefit for which premiums are not paid, while retaining the beneficiary as an M+C enrollee.
• We are changing the requirement at § 422.74(d)(4) to state that the M+C must disenroll an individual, unless he or she chooses the continuation option, if the individual moves out of the plan's service area for over 6 months, rather than 12 months.
• We are adding wallet card instructions to the list of examples of marketing materials at § 422.80(b)(5)(v), to ensure that wallet card instructions to enrollees are consistent with the statute and regulations, particularly requirements that apply to emergency and urgently needed services.
• We are revising § 422.80(e) to permit more flexibility for providers in distributing materials to M+C enrollees.
• We are adding a new § 422.80(e)(1)(viii) that prohibits new M+C plan names that exclude the disabled population.
• We are removing the definition of post-stabilization services in § 422.100(b)(1)(iv) and instead including all post-stabilization requirements in new § 422.113. See section II.C of this preamble for a full discussion of changes in the post-stabilization requirements.
• We are specifying at § 422.100(b)(1)(vi) and § 422.113 that M+C organizations are required to cover ambulance services dispatched through 911 or its local equivalent when use of other forms of transportation would endanger the health of the beneficiary.
• We are adding a provision at § 422.101(a) to state explicitly that services may be provided outside of the service area of the plan if the services are accessible and available to enrollees.
• To promote beneficiary freedom of choice among providers, § 422.105 is revised to permit use of the POS option for in-network providers, rather than only for providers outside the plan network.
• To clarify our existing policy, we are clearly delineating HCFA's review authority in § 422.106 for employer group health plans and Medicaid plans.
• We are adding a new § 422.108(f) to clarify that a State cannot take away an M+C organization's Federal rights to bill or authorize providers to bill for services for which Medicare is not the primary payer.
• We are revising § 422.109(b)(5) to provide that M+C enrollees are responsible only for coinsurance amounts.
• We are revising § 422.111(e) to decouple the enrollee notice time frame from the “issuance or receipt” of a notice of termination and instead require that an M+C organization make a good faith effort to provide written notice at least 30 calendar days before the termination effective date.
• We are revising § 422.112(a)(3) to clarify that an M+C organization shall authorize out-of-network specialty care when its plan network is unavailable or inadequate to meet an enrollee's medical needs.
• At new § 422.113(b) we are specifying that “urgently needed services” are not “emergency services.”
• We are clarifying at § 422.113(b)(2)(ii) that prior authorization may not be required from the beneficiary in wallet card instructions or in other enrollee materials . We are also specifying that instructions on what to do in an emergency should include a statement
• We are revising § 422.113(b)(2)(iii) to expressly set forth the requirement that M+C organizations assume financial responsibility for services meeting the prudent layperson definition of emergency at § 422.2 regardless of final diagnosis.
• In order to clarify the distinction between a removal of deemed status by HCFA based on HCFA's own survey and a removal based on a determination by an accreditation organization based on its accreditation survey, we are revising § 422.156(a) to separate these two situations.
• We are revising § 422.157(a)(3) to relax the prohibition on the participation of managed care organization representatives in private accreditation organization activities.
• We are revising § 422.158(e) to provide that we will act within the same timeframes that apply to fee-for-service deeming.
• To help clarify that the appeals procedures apply only for adverse participation decisions, we are redesignating the provider appeals procedures from § 422.204(c) to new § 422.202(d).
• Section 422.204 has been re-titled “Provider selection and credentialing” and contains the general rule that an organization must have written policies and procedures for the selection and evaluation of providers.
• We are consolidating the regulations concerning antidiscrimination and choice of providers into new § 422.205. We reaffirm that M+C organizations are prohibited from discriminating against providers based solely on their licensure or certification, and specify that when an M+C organization declines to include a provider in its network, it must notify the provider of the reason for its decision.
• We have revised § 422.214 to clarify the rules concerning payments to noncontracting providers.
• We have revised § 422.216(f) to indicate that, for PFFS purposes, “deemed contract” providers are considered to be noncontracting providers when they furnish services in an emergency department of a hospital.
• We are revising § 422.257 to permit M+C organizations to require that their contractors provide them with complete and accurate encounter data.
• We are adding two terms—“first tier” and “downstream”—to the list of definitions at § 422.500 that we believe clarify the types of entities to which the M+C contracting requirements described at § 422.502(i) apply.
• We are revising the definition of “clean claim” in § 422.500 to require that claims include data for encounter data submission, and meet the original Medicare “clean claim” requirements in order to be considered a clean claim.
• In consultation with the Office of Inspector General, we are revising the compliance plan requirements under § 422.501 to eliminate mandatory self-reporting.
• In order to ensure that M+C enrollees are not put at financial risk in situations where provider groups or other entities “downstream” from an M+C organization become insolvent, we are revising § 422.502 to strengthen the protections for Medicare enrollees in situations where an M+C organization or its contractors encounter financial difficulties.
• Section 422.502(l), concerning certifications of the accuracy of payment data, has been modified to be consistent with the OIG's “good faith” standard, under which M+C organizations certify the accuracy of payment information to their “best knowledge, information, and belief.” We are also permitting the delegation of this responsibility to individuals other than the CEO or CFO of the M+C organization.
• We are revising § 422.506(a)(2)(i) to permit an M+C organization until July 1 to notify us of its intent not to renew its M+C contract for the upcoming contract year.
• We are deleting § 422.506(b)(ii) in response to a concern that the standard for declining to renew an M+C contract was too vague to enforce.
• We are adding a new § 422.510(a)(12) that would specify that a substantial failure to comply with marketing guidelines is grounds for termination, non-renewal, or intermediate sanction.
• We are changing the language at section § 422.520(a)(3) to indicate that non-clean claims and the remaining 5 percent of clean claims not paid within 30 days must be either paid or denied within 60 calendar days from the date of the request.
• We are revising the definition of an organization determination under § 422.566 to provide additional clarity as to the types of situations that constitute an organization determination and thus give rise to the pursuant appeal rights.
• To further clarify the grounds on which an M+C organization may seek an extension, and to ensure an enrollee is adequately advised of the M+C organization's use of an extension, we are adding language to both §§ 422.568(a) and 422.572(b) that requires an M+C organization to notify the enrollee in writing of the reasons for the extension, and to inform the enrollee of the right to file a grievance if he or she disagrees with the M+C organization's decision.
• We are revising § 422.568(c) and (d) to modify the requirement concerning written notification of M+C enrollees when a service is denied in whole in or part.
• We have added new § 422.619 concerning effectuation of expedited reconsideration determinations.
• We have revised § 422.620 to eliminate the requirement that M+C organizations distribute to enrollees the notification of noncoverage of inpatient hospital care.
We have also made many minor technical and conforming changes to the M+C regulations to ensure that citation references are accurate, use more consistent terminology, and correct typographical errors in the current regulations.
Under the PRA, we are required to provide 30-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.
We are soliciting public comment on each of these issues for the sections that contain information collection requirements.
Unless otherwise noted below, all information collection requirements in this rule are currently approved under OMB approval #0938-0753, which currently expires August 31, 2000.
Paragraph (b) of this section states that M+C organizations may submit information on enrollment capacity of plans they offer by July 1 of each year as provided by § 422.306(a)(1). The
Paragraph (c) of this section requires that if the disenrollment is for any reason other than death or loss of entitlement to Part A or Part B, the M+C organization must give the individual a written notice of the disenrollment with an explanation of why the M+C organization is planning to disenroll the individual. Notices for reasons specified in paragraphs (b)(1) through (b)(2)(i) must include an explanation of the individual's right to a hearing under the M+C organization's grievance procedures. This requirement is currently approved under 0938-0763, which expires March 31, 2003.
Paragraph (e) requires the M+C organization to make a good faith effort to provide written notice of a termination of a contracted provider at least 30 calendar days (revised from 15 days) before the termination effective date to all enrollees who are patients seen on a regular basis by the provider whose contract is terminating. The burden associated with this requirement has not changed.
Paragraph (b)(2) of this section requires that enrollees be informed of their right to call 911.
The burden associated with this disclosure provision is the time it takes an M+C organization to inform each beneficiary of his or her right. In addition, instructions to seek prior authorization for emergency services and/or before the enrollee has been stabilized may not be included in any materials furnished to the enrollee. We anticipate that these requirements will be provided as part of standard enrollment disclosures. Therefore, the burden associated with this requirement is contained in section 422.64.
Paragraph (e) of this section requires that an organization offering an M+C plan, non-network MSA plan, or private fee-for-service plan to measure performance under the plan using standard measures required by HCFA and report its performance to HCFA. The standard measures may be specified in uniform data collection and reporting instruments required by HCFA and will relate to clinical areas including effectiveness of care, enrollee perception of care, and use of services and to nonclinical areas including access to and availability of services, appeals and grievances, and organizational characteristics.
The burden associated with this reporting provision is the time it takes an M+C organization to gather and submit the information. “All Medicare+Choice organizations and an organization offering an M+C non-network MSA plan or an M+C private fee-for-service plan will be required to measure performance under their plans, using standard measures required by HCFA, and report their performance to HCFA. Reporting will be required annually. Currently the standard measures that will be required will most likely be those already captured in HEDIS and CAHPS, approved under OMB #0938-0701. The currently approved annual per plan burden is estimated to be 400.53 hours. Therefore, the total burden associated with this requirement is 180,239 hours (400.53 hours × 450 plans (100 new/350 current)).
Paragraph (d) of this section requires that an M+C organization that suspends or terminates an agreement under which the physician provides services to M+C plan enrollees give the affected individual written notice as required by this section.
This section also requires that an M+C organization that suspends or terminates a contract with a physician because of deficiencies in the quality of care give written notice of that action to licensing or disciplinary bodies or to other appropriate authorities.
The burden associated with these reporting provisions is the time it takes an M+C organization to write the notice and give it to the practitioner and the appropriate licensing, or disciplinary bodies or to other appropriate authorities. We estimate that it will take 450 plans, 10 hours to produce and disclose 10 notices on an annual basis, for a national annual burden of 4,500 hours.
In addition this paragraph requires that an M+C organization and a contracting provider must provide at least 60 days written notice to each other before terminating the contract without cause.
The burden associated with this reporting provision is the time it takes an M+C organization and provider to write the notice and furnish it to the other party. We estimate that 450 entities will be required to write 10 notices, at 1 hour per notice, for a national annual burden of 4,500 hours.
The reporting requirement of this section requires that, if an M+C organization declines to include a given provider or group of providers in its network, it furnish written notice to the affected provider(s) of the reason for the decision.
The burden associated with this reporting provision is the time it takes an M+C organization to write and provide the required notice. We estimate that it will take 450 plans, 30 minutes to produce and disclose 20 notices on an annual basis, for a national annual burden of 4,500 hours.
The reporting requirement in paragraph (b)(2) requires that, through appropriate written means, an M+C organization make available information on any conscience protected policies to HCFA, with its application for a Medicare contract, within 10 days of submitting its ACR proposal or, for policy changes, in accordance with § 422.80 (concerning approval of marketing materials and election forms) and with § 422.111. With respect to current enrollees, the organization is eligible for the exception provided in paragraph (b)(1) of this section if it provides notice within 90 days after adopting the policy at issue.
The revision to the information collection provisions requires the M+C organization to make available policy changes. We estimate that it will take 30 minutes for each of the 450 M+C organizations to comply, for a total of 2,225 hours nationally on an annual basis.
Paragraph (d)(1) of this section requires that M+C organizations must submit data that conform to the requirements for equivalent data for Medicare fee-for-service, when appropriate, and to all relevant national standards. M+C organizations must obtain the encounter data required by HCFA from the provider, supplier, physician, or other practitioner that rendered the services. In addition, M+C organizations may include in their contracts with providers, suppliers, physicians, and other practitioners, provisions that require submission of
The burden associated with this paragraph is currently approved under OMB approval #0938-0753.
Under paragraph (a) of this section, when a party has made a request for a service, the M+C organization must notify the enrollee of its determination as expeditiously as the enrollee's health condition requires, but no later than 14 calendar days after the date the organization receives the request for a standard organization determination. The M+C organization may extend the timeframe by up to 14 calendar days if the enrollee requests the extension or if the organization justifies a need for additional information and how the delay is in the interest of the enrollee. When the M+C organization extends the timeframe, it must notify the enrollee in writing of the reasons for the delay and inform the enrollee of the right to file a grievance if he or she disagrees with the M+C organization's decision to grant an extension. The M+C organization must notify the enrollee of its determination as expeditiously as the enrollee's health condition requires, but no later than upon expiration of the extension.
The revision to this provision is that requiring the M+C organization to notify the beneficiary of its reasons for delay and of the right to file a grievance.
We estimate that this requirement will add 40 hours for each of the 450 M+C organizations to the burden currently captured under 0938-0753, for an annual addition of 18,000 hours.
Under paragraph (c), at each patient encounter with an M+C enrollee, a practitioner must notify the enrollee of his or her right to receive, upon request, a detailed notice from the M+C organization regarding the enrollee's services. The practitioner must provide the enrollee with complete information, using approved notice language in a readable and understandable form, necessary to contact the M+C organization.
The burden associated with this reporting provision is the time it takes a practitioner to notify the beneficiary. We estimate that there will be 160 encounters per entity (450) and that each notification will take an average of 15 minutes to do so, for a national annual burden of 4,500 hours.
Under paragraph (d), if an enrollee requests an M+C organization to provide a detailed notice of a practitioner's decision to deny a service in whole or in part, or if an M+C organization decides to deny service or payment in whole or in part, it must give the enrollee written notice of the determination.
In addition to the currently approved burden under 0938-0753, the burden associated with this reporting provision is the time it takes to write the detailed decision and provide it to the beneficiary. We estimate that there will be 160 occasions per entity (450) for which a detailed decision must be provided and that each notification will take an average of 15 minutes for a national annual burden of 4,500 hours.
Under paragraph (e), the notice of any denial under paragraph (d) of this section must, in addition to currently approved requirements, (1) for service denials, describe both the standard and expedited reconsideration processes, including the enrollee's right to, and conditions for, obtaining an expedited reconsideration and the rest of the appeal process; and (2) for payment denials, describe the standard reconsideration process and the rest of the appeal process.
The burden associated with this reporting provision is the time it takes an M+C organization to add the required information to a notice. We estimate that it will take 450 plans 1 hour to produce and disclose the necessary language on an annual basis, for a national annual burden of 450 hours.
The information collection requirement in this section ((d)(2)(iii)) that is not currently approved under 0938-0753 requires that, if an M+C organization denies a request for expedited determination, it must take give the enrollee prompt oral notice of the denial and subsequently deliver, within 2 calendar days (proposed as 2 working days), a written letter that informs the enrollee of the right to resubmit a request for an expedited determination with a physician's support. The currently approved burden, associated with this requirement has not changed.
The information collection requirement change to paragraph (b) requires that, when the M+C organization extends the deadline, it notify the enrollee in writing of the reasons for the delay and inform the enrollee of the right to file a grievance if he or she disagrees with the M+C organization's decision to grant an extension.
The additional burden associated with this requirements set forth in this section is the time it takes an M+C organization to notify the beneficiary of the delay and the reasons for it. We estimate that 450 plans will provide extension notices to approximately 100 of their M+C enrollees on an annual basis and it will take an average of 5 minutes per notification. Therefore, the annual national burden is estimated to be 3,750 hours.
The information collection change to this section requires that, if an M+C organization denies a request for expedited reconsideration, it must give the enrollee prompt oral notice, and subsequently deliver, within 2 calendar days, a written letter that (in addition to currently approved disclosure requirements) informs the enrollee of the right to resubmit a request for an expedited reconsideration with a physician's support.
The one time burden associated with this disclosure requirement is the time it takes an M+C organization to add the requisite language to the letter it furnishes to the beneficiary. We estimate that it will take each M+C organization (450) an average of 30 minutes to add the language to its current letter for notifying beneficiaries, for a national annual burden of 2,250 hours.
The information collection change to this section the clarification that in
We have submitted a copy of this final rule to OMB for its review of the revised information collection requirements in §§ 422.60, 422.74, 422.111, 422.113, 422.152, 422.205, 422.206, 422.257, 422.568, 422.570, 422.572, 422.584, and 422.620. These revised requirements are not effective until they have been approved by OMB.
If you have any comments on any of these information collection and record keeping requirements, please mail the original and 3 copies within 30 days of
We have examined the impact of this rule as required by Executive Order 12866 and the Regulatory Flexibility Act (RFA) (Pub. L. 96-354). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, non-profit organizations and governmental agencies. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $5 million or less annually.
Section 1102(b) of the Act requires us to prepare a regulatory impact analysis for any rule that 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 603 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 a Metropolitan Statistical Area and has fewer than 50 beds.
As a result of changes to the M+C regulations to reflect provisions of the BBRA, this rule has been determined to be a major rule as defined in Title 5, United States Code, section 804(2). We consider a major rule to be one with economic effects of $100 million or more in a given year, and as noted below in section V.B.8 of this regulatory impact analysis, the effects of the BBRA changes reach this threshold. Generally, a major rule takes effect 60 days after the date the rule is published in the
The Unfunded Mandates Reform Act of 1995 also requires (in section 202) that agencies prepare an assessment of anticipated costs and benefits before enacting any rule that may result in an expenditure in any one year by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more. This final rule with comment period will have no consequential effect on State, local, or tribal governments. We believe the private sector cost of this rule falls below these thresholds as well.
As discussed in detail above, this rule implements only limited changes in the M+C regulations published June 26, 1998 (and further amended February 17, 1999). While we do not expect the changes contained in this final rule to have a significant economic impact, we believe that we have a responsibility to keep the public informed of the impact of inherent features of the M+C program, such as payment changes and the implementation of risk-adjusted payments. We attempted to describe the impacts of these payment changes in the interim final rule. However, after a year of experience administering the program, we now have a better understanding of the impact of the payment changes. This impact analysis will examine payment effects associated with these two items, and respond to public comments concerning the economic impact of M+C policies.
Although commenters on the interim final rule generally recognized that the payment methodology and rates associated with the M+C program were implemented as directed by the BBA, several commenters still expressed concern that resulting payments to M+C organizations were insufficient to keep pace with the costs of providing medical care. These commenters suggested that the new payment methodology, particularly when combined with the implementation of a risk adjustment mechanism in 2000, could have the unintended consequence of limiting, rather than expanding, the health plan choices available to Medicare beneficiaries. M+C organizations have withdrawn from some areas, and many beneficiaries have experienced growing premium increases or benefit reductions. Commenters also asserted that the M+C regulations contained discretionary provisions that added unnecessarily to the administrative burden on M+C organizations. In particular, commenters identified quality standards, provider participation requirements, and attestation procedures as examples of what they considered overly proscriptive rules that had the potential to raise health plan costs. In general, commenters urged us to evaluate more carefully the cumulative impact of the changes introduced by the M+C program.
We noted in our February 17, 1999 limited M+C final rule that we needed a statistically-based model to evaluate the total impact of payment changes for M+C organizations. We have subsequently developed a model that estimates the impact of risk-adjusted payments on M+C organizations. This impact analysis focuses on results from this model. When possible, we provide detail on impacts by geographic area and by organization size.
We then discuss some of the concerns raised by commenters about likely withdrawals from the M+C program. Finally, our analysis examines available information concerning the administrative burden associated with selected M+C requirements.
Prior to the BBA, Medicare's capitation rates for managed care plans had been set at 95 percent of expected costs based on actual fee-for-service costs. Because of the variation in fee-for-service expenditures for different counties due to different utilization patterns and cost structures, the Medicare managed care rates for different counties were also quite divergent. In addition, there was significant evidence that Medicare had paid more for enrollees in the Medicare managed care programs than it would have paid in the fee-for-service program. This was due primarily to the favorable selection that these plans have experienced.
The BBA made a number of changes in Medicare payments to managed care plans including:
• Increasing payments in counties that historically had the lowest payment rates (and generally have not had risk-based Medicare managed care plans) through the use of a payment floor and by introducing a blended payment rate.
• Reducing the rate increases in counties that historically had higher payment rates.
• Reducing M+C capitation rates by phasing in the removal of direct and indirect medical education payments from M+C capitation rates beginning in 1998 (and phasing in direct payment of these “carved out” amounts to the institutions providing care to M+C enrollees).
Payment increases from year to year after 1997 are based on an update factor that is the rate of increase in projected Medicare expenditures each year, less a statutorily specified reduction (reducing the rate to .8 percent less in 1998 and .5 percent less each year thereafter through 2002). However, all counties are guaranteed a minimum payment increase of 2 percent over the preceding year's base rates.
The BBA also mandated the introduction, by the year 2000, of risk-adjusted payments in the M+C program. Risk adjustment will have the effect of reducing payments to plans because, as a number of studies have shown, relatively healthier Medicare beneficiaries enroll in M+C plans. Projections on reduced payments assume a stable mix of enrollees. However, we assume that organizations will respond appropriately to the incentives to attract more seriously ill beneficiaries. As a result, organizations can do better under risk adjustment than they would if case mix stayed the same.
These M+C payment changes were intended to promote the three objectives which we discuss below in V.B.2, 3 and 4.
The introduction of a “floor” on the payment rates for M+C organizations was intended to make the program financially viable in areas where the AAPCC appeared to be too low for any organization to recoup its costs. Beginning in 1998, the floor was set at $367 and was adjusted annually by the rate of growth of the overall Medicare program. By providing this floor payment level, M+C organizations are paid more than would otherwise be spent on the same beneficiaries in original Medicare.
Some county payment rates are raised through implementation of blended payments. These rates are calculated as a blend of national average rates adjusted for local input prices and area-specific rates. Area-specific rates are 1997 payment rates, adjusted for spending for graduate medical education, and updated using the national M+C update factor.
By raising the M+C payment levels higher than the spending amounts in original Medicare, it was hoped that M+C organizations would be attracted to these lower payment areas. In the chart below, we have compared the M+C county payment rates for 2001 to the area-specific rate in each county. In 2001, 3,020 counties will receive a payment rate higher than their area-specific rate. The payment rate for Arthur, Nebraska, will be 77 percent or $175 higher, the greatest improvement for any county.
The payment floor and the phased in blended payments were also designed to raise the payment level for more than just the lowest payment counties. Raising payments above the levels determined by the pre-BBA methodology was intended to give organizations that have operated in lower payment counties the opportunity to enhance their benefit packages, thereby increasing enrollment.
The largest improvements in payments are for areas with relatively small numbers of beneficiaries, and are largely achieved in most cases by applying the payment floor. Many more beneficiaries live in counties where the improvements are more modest (up to a 5 percent difference). These counties were primarily those paid under the blend mechanism in 2000, whose payment improvements were safeguarded by the minimum increase component of the formula for 2001.
Following is a breakout of the 3,147 U.S. counties by percentage improvement over their area specific rate:
Counties where M+C payment rates are lower than their area-specific payment rate tend to be those that have received the minimum increase for each of the four years that the M+C payment formula has been in place, and also had relatively little medical education spending. The cumulative four-year increase of the national update was approximately 9.3 percent, only a percentage point higher than the cumulative four-year increase of 8.2 percent for those counties receiving the minimum update each year. The area-specific payment rate in 2001 reflects a reduction to the 1997 rate of 80 percent of spending attributable to medical education. Thus, a county with relatively high medical education spending will have a higher M+C payment rate than area-specific payment rate even if it also had received the minimum update each year.
By changing how payment rates are calculated, the BBA also sought to even out the wide disparity in Medicare managed care payment rates across
There were only limited payment increases for 1998 and 1999, with counties receiving either the floor payment or the minimum 2 percent update. This was due primarily to the combined effects of the amount of the national update and the budget neutrality provision affecting calculation of the blended rate. In 2000, however, well over half the counties are receiving the blended rate. The enrollment-weighted average increases in M+C payments nationwide in the year 2000 over 1999 is slightly more than 5 percent. For 2001, all counties will receive the floor payment or the minimum 2 percent update, again because of the budget neutrality provision and a national update that reflects the extremely low rate of spending in original Medicare in 1999. Although most counties will receive the minimum increase in 2001, many of these had enjoyed relatively large increases due to the blended rates in 2000, which the minimum increase essentially will preserve.
As illustrated in the graph below (1997 Medicare+Choice Payment Rates Compared with 2001 Payment Rates), the new payment formulas have changed the distribution of payment rates across counties, although perhaps not as quickly as the Congress envisioned because of the unusually low national increases in spending. In 1997, county payment rates for aged beneficiaries ranged from $221 to $767. Through the implementation of the payment floor, blended payment rates, and minimum update, payments have increased substantially at the low end of the distribution, and increases at the high end have slowed. The range of payment rates in 2001 is only somewhat smaller: between $415 and $831, but the 2001 payment curve is straighter than the 1997 curve, indicating a narrower distribution.
While national numbers show the overall pattern, the impact is highlighted when examining the effect of the BBA on the payment rates at the State level. Table 3 shows the effect of the payment changes in two States: Oregon and Florida. Both States have significant M+C enrollment penetration, but Oregon's rates are low, and Florida's are high.
The BBA payment changes have narrowed the regional difference. In 1997, prior to the BBA payment changes, Florida's weighted average payment rates were 149 percent higher than those of Oregon. (Florida's statewide average payments were at 114 percent of the national average, while Oregon's were at 76 percent.) In 2001, Florida's rates will be 136 percent of Oregon's, because many Oregon counties had benefited from blended payment rates in 2000, while many large Florida counties received the minimum update that year.
Lower-paid States such as Oregon receive relatively higher rates of payment increases than higher-paid States such as Florida. These differential payment increases will bring both States' average payments closer to the national average payment rate.
Despite the BBA changes, the levels of benefits and premiums between higher and lower payment counties continue to vary in 2000. In Oregon, for example, premiums range from $35 to $83 for benefit packages that do not include outpatient drug coverage, and between $81 and $123 for packages including drug coverage. In Florida the enrollment-weighted average monthly premium is $84 per month, and all enrollees in Florida M+C plans have drug coverage in their basic package. Over time, the BBA payment changes may narrow this difference.
The BBA mandated that we “implement a risk adjustment methodology that accounts for variations in per capita costs based on health status and other demographic factors for payment [to M+C organizations] starting no later than January 1, 2000.” The BBA also gives us the authority to collect inpatient hospital data for discharges occurring on or after July 1, 1997, and allows us to require additional data from M+C organizations for services occurring on or after July 1, 1998.
We decided to include a transition period as a component of our risk adjustment methodology, initially using a blend of payment amounts under the current demographic system and the PIP-DCG risk adjustment methodology. Under a blend, payment amounts for each enrollee will be separately determined using the demographic and risk methodologies (that is, taking the separate demographic and risk rate books and applying the demographic and risk adjustments, respectively). These payment amounts would then be blended according to the percentages for the transition year. This transition to full risk adjusted payment will be phased in over 5 years. Following is the transition schedule to comprehensive risk adjusted payment as mandated by the BBRA:
This analysis uses the best data available at this time. The data to be used for actual payments (beginning January 1, 2000) will be based on hospital discharge data for the calendar year beginning on July 1, 1998 and ending June 30, 1999. The actual impact of the risk adjustment system relative to the current demographic system at the time of implementation may differ, due primarily to potential changes in M+C organization enrollment profiles and possible improvement in the quality and completeness of M+C organization data.
The impacts presented here show estimated figures for both the full effects of the PIP-DCG based payment system (that is, with no transition period), and for the first implementation year during which a 10 percent phase-in was included as part of the methodology. To estimate impacts under phase-in years, full impact results can be multiplied by the appropriate proportion of the risk adjustment payments. For example, the first year risk adjusted payment phase-in level is 10 percent. Therefore, to estimate the impact under a 10 percent risk adjusted phase-in, the impacts can be multiplied by .10.
If our methodology did not include a transition period, payments to M+C organizations would decrease by approximately 5.7 percent. This is a revision over preliminary estimates of 7.6 percent, which were prepared using an earlier, more limited data set. The majority of M+C organizations would face payment decreases of between five and eight percent.
The table below presents the simulated impacts aggregated to our administrative regions. None of our regions will experience increased payments under the proposed system. The variation between regions is not considerable. Organizations in the Atlanta region will see an average .7 percent reduction, and organizations in the Seattle region will see less than a .4 percent reduction.
In addition, we simulated impacts by M+C organization enrollment size. Table 5 reveals that the variation in impact between the small M+C organizations and the large M+C organizations does not appear to be systematic. M+C organizations of all sizes are very close to the national average, although smaller organizations will experience a slightly higher reduction.
At the end of 1998, approximately 100 organizations dropped Medicare managed care contracts or reduced the number of counties in which a plan was offered. The result of these withdrawals was that nearly 50,000 beneficiaries were left with no remaining M+C plan in their county. Likewise, the analysis of 1999 health plan departures shows that approximately 79,000 additional M+C beneficiaries were forced to leave the program because there was no plan offered in their area.
Table 6 below shows the decline in beneficiaries' access to a M+C plan in their area (declining about 2 percentage points from the 1999 level of almost 70 percent).
Of the 71 counties that had an M+C plan in 1999 but will no longer have an M+C option in 2000, 11 were considered high payment counties. In fact, the average increase in 2000 for these 71 counties is 6.2 percent. The county in this situation with the greatest increase was Clallum County, in Washington State, which received a blended rate increase of 12.8 percent over their 1999 rate.
Plan decisions to withdraw from M+C do not appear to be caused only by changes in payment amounts. Payment is rising in all counties this coming year by an average of 5 percent, and will rise by as much as 18 percent in some areas. BBA payment reforms were designed to increase payment in counties that had the lowest rates, and therefore the fewest number of plans. Yet counties receiving the largest increases under the BBA payment system are experiencing the most disruption. Plan withdrawals are affecting 11.1 percent of enrollees in counties where rates are rising by 10 percent, but affecting only 2.3 percent of enrollees where rates are rising by just 2 percent.
Table 7 shows the States with the largest percentage decrease since 1997 (the start of the M+C program) of Medicare beneficiaries with access to an M+C plan.
While several States have experienced a significant loss of access to M+C plans, other States have seen access to M+C organizations increase. In addition, the M+C program continues to grow despite challenges that parallel those in the larger managed care market in the United States. As of January 2000, there were 6.2 million M+C enrollees representing over 16 percent of the more than 39 million seniors and disabled Americans in Medicare. Total Medicare managed care enrollment has more than doubled in the past four years from 3.1 million enrollees at the end of 1995 to 6.9 million enrollees as of April 1, 2000. (Total managed care enrollees consist of M+C enrollees and enrollees in Medicare Managed Care Cost Plans, Health Care Prepayment Plans, and managed care demonstrations.) However, the rate of growth has dropped significantly from earlier periods, and has grown by only 1 percent per month the last several months.
Table 8 below shows the States with the largest percentage increase since 1997 (the start of the M+C program) of Medicare beneficiaries with access to an M+C plan.
In our Impact Analysis that accompanied the Interim Final Rule we stated that “Reductions in capitated payment amounts in what are now relatively higher payment areas may result in reduced benefits for beneficiaries.” While higher premiums and reduced benefits were not intended effects of the BBA, they are also not surprising given the reduced payment increases in higher cost areas. While benefits, premiums, and cost sharing remained relatively stable in 1999, year 2000 has been different.
Analysis of the Adjusted Community Rate proposals submitted in July show that premiums for 2000 have increased, especially in rural areas. For example, in 1999, the enrollment-weighted average premium for a basic plan was $5.35. For 2000, this amount will almost triple to $15.84.
Table 9 shows the percent of M+C beneficiaries living in the designated areas that have access to a plan with the associated premium. While the percent of beneficiaries with access to zero dollar premium plans is expected to be reduced by more than 3 percentage points, the percent of beneficiaries that must pay a $40-$100 premium has more than doubled. In 1999, only 50,000 Medicare beneficiaries lived in an area where the minimum premium is in the $80 to $100 range; however, in 2000, the number will rise to 207,000. The majority of these individuals (60 percent) are residents of rural counties.
In addition, access to a zero premium plan for rural beneficiaries will be reduced by almost 50 percent. In 1999, 1.3 million rural beneficiaries (63 percent of those with any plan available) live in an area with at least one zero premium plan; in 2000, only 784,000 rural beneficiaries, (40 percent of those with any plan available), will have such an option. One-half million fewer rural beneficiaries will have access to a zero premium plan.
Medicare beneficiaries who live in areas with only one plan will be particularly affected by premium increases. Approximately 8 percent of M+C beneficiaries (just over three million) live in areas with only one plan. Note also in Table 10 that of the 207,000 beneficiaries who live in areas where the minimum monthly premium available is over $80, 94 percent (over 195,000) live in areas with only one plan available. There will be a nearly six-fold increase from 1.6 percent to 9.3 percent in the percentage of beneficiaries who live in an area where the sole M+C plan available has a monthly premium in the $80 to $100 range.
Premium increases in areas with only one plan will have the most pronounced impact in rural areas. From 1999 to 2000, roughly the same percentage of beneficiaries who live in rural areas will have only one plan available—28.4 percent and 29.6 percent in each year, respectively. However, Table 11 shows that zero premium plans are becoming less widely available in rural areas. It also shows that there will be a significant increase in the number of rural Medicare beneficiaries whose only M+C option is a relatively high cost plan.
The Balanced Budget Refinement Act (BBRA) made two changes to the payment methodology established by the BBA. First, Section 512 of the BBRA introduced bonus payments for M+C organizations that enter previously unserved counties. These organizations will receive an additional 5 percent payment for the first 12 months and an additional 3 percent for the subsequent 12 months. The second change in section 517 of the BBRA was to lower the reduction in the National per Capita Medicare +Choice Growth percentage
The Congressional Budget Office (CBO) estimated that the bonus payments would amount to additional payments of $.1 billion over three years. Our experience to date suggests that this figure may be high, as currently there are only five M+C organizations receiving bonus payments and very few pending applications from prospective M+C organizations that would be eligible for the bonus. However, there is an application on file from a prospective M+C organization that envisions expanding into a large number of previously unserved counties. If this organization is extremely successful in enrolling beneficiaries, the CBO estimate could in fact be a low estimate.
We estimate that lowering the reduction of the National per Capita Medicare+Choice Growth percentage in the year 2002 will provide an additional $80 million in payments to plans in 2002, and an additional $560 million over 5 years. Payments to plans in all subsequent years will be higher because of the effect of lowering the reduction on the baseline.
Since the publication of our June 26, 1998 interim final rule, we have implemented several significant changes aimed at alleviating unnecessary administrative burdens. Examples of these changes include the less expansive provider participation requirements adopted in our February 17, 1999 rule, our December 1998 revisions to the QISMC standards as discussed below, and clarification of the attestation requirements through this final rule. Clearly the cumulative effect of these changes will be to reduce the administrative costs associated with these requirements. Although we continue to solicit quantifiable data that can help us to assess the costs of complying with particular provisions, we have not received any data in this regard. We remain particularly interested in detailed estimates of the administrative costs associated with the QISMC and HEDIS standards. Research of available literature/studies related to these administrative costs is presented below.
The BBA codified many existing quality assurance requirements that had been established through operational policy letters and other guidance issued under the Medicare risk and cost contracting programs.
On September 28, 1998, we issued interim Quality Improvement Systems for Managed Care (QISMC) standards and guidance. QISMC is a system for ensuring that managed care organizations contracting with Medicare and Medicaid protect and improve the health and satisfaction of enrolled beneficiaries. It consists of a set of standards and guidelines developed around four domains—quality assessment and performance improvement, enrollee rights, health services management, and delegation.
QISMC was developed in conjunction with federal and state officials, beneficiary advocates and the managed care industry to develop a coordinated quality oversight system to reduce duplicative or conflicting efforts, emphasize demonstrable and measurable improvement, and avoid reinventing the wheel. QISMC standards represent the evolution of existing quality standards being used by commercial, Medicare and Medicaid health plans or managed care organizations. We believe QISMC incorporates the currently accepted quality assurance elements and provides safeguards for vulnerable Medicare and Medicaid populations enrolled in managed care.
We reviewed NCQA accreditation 1999 standards for their consistency with QISMC standards. This is an appropriate comparison because the National Committee for Quality Assurance has been recognized as a forerunner in assuring quality assurance in health plans through its accreditation processes, and development and implementation of HEDIS performance data reporting. Also, many Medicare+Choice organizations are NCQA accredited.
Our findings are provided in the table below, which was reviewed by NCQA representatives in order to assure the highest level of technical accuracy. In general, almost two-thirds of NCQA accreditation 1999 standards were determined to be either consistent with variation or highly consistent or identical to QISMC standards.
Beneficiaries will benefit significantly from information available to them about the performance of their health plans as well as through improvements in the delivery of care and services that evolve out of on-going quality improvement projects under QISMC. Beneficiaries already have access to health plan performance and consumer satisfaction measures about the M+C organizations available in their area through our beneficiary education campaign and individual plan marketing.
We expect that as consumers become increasingly familiar with health plan performance and consumer satisfaction information, it will become an integral part of their decision-making process, in addition to cost and benefits, for selecting their M+C organization. It is our intent that as consumers become better informed and decide not to select plans of lower quality, such plans will be motivated to initiate improvements in the quality of care they provide.
At the same time, we expect that plan's focus on one national and one plan-specific quality assessment and performance improvement project each year will improve the delivery of services to Medicare beneficiaries, especially beneficiaries suffering from chronic conditions. M+C organizations will need to be proactive in identifying and treating beneficiaries who suffer
We do not believe that QISMC will present significant additional fixed costs for M+C organizations that have already received accreditation from the National Committee for Quality Assurance. While QISMC presents some subtle and significant differences from NCQA accreditation, we do not expect that organizations that have prepared for NCQA accreditation will incur significant additional costs to comply with QISMC. We recognize that there will be incremental costs associated with QISMC, such as costs associated with additional quality assessment and performance improvement projects, internal staff training expenses, and oversight and compliance.
In addition, we expect that some M+C organizations that are not NCQA accredited may incur higher costs to comply with QISMC than organizations in other parts of the country.
We do not expect that requirements for reporting HEDIS and consumer satisfaction measures are inconsistent with expectations that private purchasers have access to health plan performance data (GAO, June 1998). As a result, we do not expect that organizations will incur significant new fixed costs as a result of requirements to report performance measurement and consumer satisfaction data, since we expect that M+C organizations will use audited HEDIS data. However, we do recognize that there may be incremental costs to reporting audited HEDIS data in terms of additional processes, audit fees, etc.
In addition, requirements for M+C organizations to report audit HEDIS data will likely yield improved processes for collecting and reporting complete, accurate and timely data as a result of an independent third party review of their data collection, warehousing and production/reporting processes.
At the same time, specifying beginning and ending dates for QAPIs will ensure that plans do not become mired in projects that do not end. We expect that plans will focus their efforts on achieving results and institutionalizing improvements in the delivery of care, data collection and reporting and information system improvements gained from successful QAPI projects. Even in instances where demonstrable improvements were not obtained, we expect that, in many cases, some improvement will result.
In addition, plans will have added incentives to initiate performance improvement projects that will lead to more cost-effective delivery of health care services, such as influenza immunization. For example, one national managed care organization increased the percentage of Medicare enrollees receiving flu shots from 27 percent to 55 percent in one year. The organization reported a reduction of about 30 percent in hospital admissions for pneumonia, savings of about $700,000, and fewer lives lost. (GAO, May 1996) We expect that investments in QAPI activities will lead to cost-savings over and above the initial investment.
We recognize that some high-performing managed care organizations will have less ability to achieve additional improvements in some areas. Some organizations will respond to incentives to select projects where results may be more easily obtainable. We continue to believe, however, that there are significant gains that remain to be made in the delivery of quality services.
We concur with industry comments that small plans may have difficulty in complying, since they may not have a statistically credible population for producing reliable and/or comparable measures. For example, a small plan with a healthier population than average may not have sufficient instances of myocardial infarction for which beta-blocker treatment would be appropriate. We will work with these organizations to address these and other unique issues that may arise.
We believe that requiring plans to participate in at least one national and one plan-specific QAPI project annually and to demonstrate a 10 percent improvement in their QAPI is in the best interest of beneficiaries. These requirements will improve the quality of care and services delivered to Medicare and other populations served by the M+C organization, as performance improvement practices become routine.
Much less information is available about other requirements cited by some commenters as entailing significant administrative burdens. For example, we received many public comments regarding provider participation requirements. We responded to many of those comments in our February 17, 1999, final rule (64 FR 7968), under which we narrowed many of the requirements set forth in our June 26, 1998 interim final rule (63 FR 34968). Modifications to the interim final rule included:
• Applying the applicable notice and appeal rights and consultation requirements only to physicians, as defined under section 1861 of the Act;
• Adopting a narrower interpretation of what constitute “rules regarding participation” to focus on whether a physician can participate under a given M+C plan;
• Clarifying that an M+C organization need only have reasonable procedures for notifying potential participating physicians of participation rules, which may include providing the information upon request;
• Clarifying that an M+C organization is not required to release information that an organization considers proprietary information;
• Clarifying that in the event that immediate changes are mandated
• Clarifying that there is no requirement that an organization obtain signatures acknowledging receipt of a notice of changes;
• Limiting the applicability of the appeals process to appealing adverse participation decisions;
• Clarifying that the availability of the provider appeals process applies only to cases involving suspension or termination of participation privileges, rather than including initial denials of an application to participate; and
• Clarifying that the information to be included in a notification of a decision to suspend or terminate an agreement with a physician is limited to information relevant to the decision.
Since publication of our February 17, 1999 final rule, we have subsequently communicated with several M+C organizations about the costs and benefits associated with the requirements included in this final rule. We believe that the steps taken in our February 17, 1999 final rule significantly reduced the burden on M+C organizations and also ensured that providers and beneficiaries receive the protections intended by Congress under the Act. For example, by narrowing the scope of the requirement for advance notice of changes in participation rules, an M+C organization need not prepare an advance notice for administrative and other changes that do not affect whether a physician can participate in a plan. Notification of most changes made by a M+C organization can be made via usual communication methods, such as regular newsletters, rather than through the preparation of special mailings or other more burdensome methods.
In addition, the M+C organization must consult with the physicians who have agreed to provide services under the M+C plan offered by the organization, regarding the organization's medical policy, quality assurance program, and medical management procedures, and ensure that the following standards are met. We understand that these requirements are consistent with current operational practices by M+C organizations and pose little additional burden, and that the costs associated with incremental changes would be marginal.
We also understand that our requirements concerning credentialing processes and prohibitions on discrimination reflect current practices and similar requirements from other entities (for example, accrediting bodies) and do not impose additional burden.
Similarly, commenters objected to attestation requirements as discussed in detail above (See Subpart K). To receive a monthly payment under subpart F, the chief executive officer (CEO) or chief financial officer (CFO) of a M+C organization must request payment under the contract on a document that certifies the accuracy, completeness, and truthfulness of relevant data that we request. Such data include specified enrollment information, encounter data, and other information that we may specify. The CEO or CFO must certify that each enrollee for whom the organization is requesting payment is validly enrolled in an M+C plan offered by the organization, and the information relied upon by us in determining payment is accurate. The CEO or CFO must certify that the encounter data it submits under § 422.257 are accurate, complete, and truthful. If such encounter data are generated by a related entity, contractor, or subcontractor of an M+C organization, such entity, contractor, or subcontractor must similarly certify the accuracy, completeness, and truthfulness of the data. In addition, the M+C organization must certify that the information in its ACR submission is accurate and fully conforms to the requirements in § 422.310 in order to retain payment amounts below the amount of its ACR.
We understand that the collection and dissemination of this information by M+C organizations is undertaken in a manner that reflects an M+C organization's best efforts to ensure its accuracy, completeness, and truthfulness. Accordingly, we do not believe that this requirement imposes significant new burdens on an M+C organization that operates in good faith to comply with requirements under the M+C program. We realize that mistakes and errors may occur even under an organization's best efforts, and these attestation requirements are not intended to penalize an M+C organization that operates in good faith. We believe these requirements are important to safeguard the integrity of the M+C program against those few M+C organizations that do not utilize the kind of business and operational practices of most M+C organizations. We also believe the requirements will provide an important tool for seeking out the few bad actors that could harm the M+C program, beneficiaries, providers, and other M+C organizations. As suggested by many commenters, we have revised the requirements to establish a “good faith” compliance standard as opposed to requiring an attestation of 100 percent accuracy for encounters and enrollment (payment related) data. We believe this change should alleviate commenters concerns over the undue financial burdens associated with attestation requirements.
On August 4, 1999, the president signed Executive Order 13132 (effective November 2, 1999) establishing certain requirements that an agency must meet when it promulgates regulations that impose substantial direct compliance costs on State and local governments, preempt State law, or otherwise have federalism implications. Any such regulations must include a federalism summary impact statement that describes the agency's consultation with State and local officials and summarizes the nature of their concerns, the extent to which these concerns have been met, and the agency's position supporting the need to issue the regulation.
In this final rule, we are not promulgating any changes to the existing M+C regulations that meet any of the criteria mentioned above that would require the inclusion of a federalism impact statement under Executive Order 13132. However, the M+C interim final rule published on June 26, 1998 (63 FR 34968) did contain provisions that have a federalism impact, and we respond to comments on these provisions from States and other interested parties in this rule. Thus, in keeping with the intent of the Executive Order that we closely examine any policies that have federalism implications or would limit the policy making discretion of the States, we have prepared the following voluntary federalism impact statement.
In establishing the M+C program, the BBA included two provisions that have significant implications for States. First, under section 1855(a)(1) of the Act, an organization that wishes to participate in the M+C program generally is required to be organized and licensed under State law as a risk-bearing entity eligible to offer health benefits coverage in each State in which it offers an M+C plan. This statutory requirement is codified at § 422.400(a) and § 422.501(b)(1) of the M+C regulations, and we do not believe it interferes with State functions or limits their policy making discretion. The requirement does not imposes any significant
The other aspect of the M+C statute and regulations that has significant federalism implications involves the Federal preemption provisions set forth under section 1856(b) of the Act and § 422.402. Section 1856(b)(3)(A) provides for Federal preemption of State laws, regulations, and standards affecting any M+C standard if the state provisions are inconsistent with Federal standards. As discussed in the preamble to the interim final rule (63 FR 35012), and in section II.I of this preamble, we are applying this “general preemption” in much the same way that we previously applied Executive Order 12612 on Federalism. That is, State laws or standards that are more strict than the M+C standards would not be preempted unless they prevented compliance with the M+C requirements.
In addition to this general preemption, the Congress also provided (under section 1856(b)(3)(B) for a “specific preemption” whereby M+C standards supersede any State laws and standards in the following three areas:
• Benefit requirements;
• Requirements relating to the inclusion or treatment of providers; and
• Coverage determinations (including related appeals and grievance processes).
During the development of the June 26, 1998 interim final rule, we consulted with the National Association of Insurance Commissioners (NAIC) regarding the proper interpretation of these provisions. (The NAIC is the organization of the chief insurance regulators from the 50 states, the District of Columbia, and four U.S. territories.) The interim final rule contained an extensive discussion of this subject, including providing examples both of State laws that would be preempted under the M+C statue (such as “any willing provider laws” that would mandate the inclusion of specific types of providers or practitioners) and of State requirements that would continue to apply (such as a requirement that all providers and practitioners be licensed by the State and comply with scope of practice laws). We asserted our intention to adopt a narrow interpretation of the applicability of the three areas of specific preemption in order to ensure that any regulatory preemption of State law would be restricted to the minimum level necessary consistent with the BBA. State and local officials then had an opportunity to participate in the rulemaking process through their public comments on the M+C interim final rule.
For the most part, commenters representing State governments supported HCFA's narrow interpretation of the BBA's specific preemption provisions. (See section II.I of this final rule for a full discussion of comments on these provisions.) The most notable exception to this general support was the contention by one State that its mandatory drug benefit laws should not be preempted by the M+C benefit provisions; but we continue to believe that the specific preemption of “benefit requirements” under section 1856(b)(3)(B) of the Act clearly contradicts the State's contention. Moreover, we believe that our general approach is fully consistent with the “Special Requirements for Preemption” set forth in section 4 of Executive Order 13132. This section directs that an agency take action to preempt State law only where the exercise of State authority directly conflicts with the exercise of Federal authority under Federal law or there is other clear evidence (such as an express statutory preemption provision) to conclude that Congress intended the agency to have the authority to preempt State law. It also provides that any regulatory preemption of State law be restricted to the minimum level necessary to achieve the objectives of the relevant statute. In conclusion, we believe that the concerns of State and local officials have been met to the greatest possible extent, consistent with the BBA's preemption provisions.
We ordinarily publish a notice of proposed rulemaking in the
For the most part, the changes to the M+C regulations set forth in this final rule with comment period result from our review of the public comments on the June 26, 1998 interim final rule that established the M+C program. Congress expressly authorized the publication of that final rule without prior notice and comment in section 1856(b)(1) of the Act. To the extent the provisions of this final rule respond to comments on that rule, they will have been subjected to prior notice and comment. However, as discussed in detail in section I.C of this preamble, this rule also makes conforming revisions to the regulations that are necessary to reflect changes to the M+C statute resulting from the BBRA (Pub. L. 106-113) which was enacted on November 29, 1999. These changes in requirements and new requirements or provisions were enacted by Congress, and would be in effect without regard to whether they are reflected in conforming changes to the regulations text, since a statute controls over a regulation. In this final rule, we merely have revised the regulations text to reflect these new statutory provisions, as we interpret them. In most cases, the BBRA provisions have merely been incorporated virtually verbatim, with no interpretation necessary. Examples of such provisions include: the earlier availability of alternative Medicare enrollment options and the elimination of the lock-in rules for institutionalized individuals under section 501 of the BBRA, changes in the effective date of elections under section 502, the extension of Medicare cost contracts under section 503, the modification of the 5-year re-entry rule after contract terminations under section 513, flexibility to tailor benefits under an M+C plan under section 515, the delay until July 1 in the deadline for ACR submissions under section 516, the reduction in the adjustment in the national per capita M+C growth percentage under section 517, the new deeming provisions in section 518, the revised quality assurance requirements for PPOs under section 520, and the user fee provisions in section 522. For these types of provisions, we do not believe that publishing a notice a proposed rulemaking is necessary, nor would it be practical given that a number of the provisions have already taken effect consistent with effective dates established under the BBRA. (For example, the changes in the effective date of elections and the new quality assurance requirements for PPOs took effect on January 1, 2000, and several other provisions were effective upon enactment of the BBRA.) In addition, we believe that it would be contrary to the public interest to delay implementation of these provisions until the process of publishing both a proposed and a final
In the case of two BBRA provisions, we have reflected our interpretation of the provisions in the regulations text. This interpretation is already in effect, and has been applied, as the provisions in question are already in effect. These provisions are section 501(c) of the BBRA, which permits an M+C organization that has reduced a plan service area to offer continued enrollment to current enrollees in all or a portion of the reduced areas, and section 512 that introduces “bonus payments” to encourage organizations to offer M+C plans in areas without such plans. Both of these provisions are discussed in detail in section I.C of this preamble, and both required a limited amount of interpretation of the statute in order to implement the provisions on a timely basis. For example, with regard to the continuation of enrollment option (which was effective upon enactment of the BBRA), we have clarified that an M+C organization may offer enrollment in any plan it offers in the affected area, rather than solely the plan in which an individual was previously enrolled. This clarification results in greater flexibility for M+C enrollees and is consistent with our interpretation of a similar statutory provision affecting individuals with ESRD. Similarly, with regard to the bonus payment provisions (which took effect as of January 1, 2000), we have indicated that if an M+C organization or organizations offers two or more new plans simultaneously in a given area, the organization could receive the bonus payments for each new plan. We believe this interpretation of the statute clearly is consistent with legislative intent to promote the availability of more M+C alternatives for Medicare beneficiaries.
Policy clarifications of this limited nature were essential to implement these BBRA provisions in a clear and timely manner. Again, it would have been impractical and contrary to the public interest to proceed with proposed rulemaking before implementing the interpretive policies linked with these provisions, nor is such rulemaking required under section 1871(b) of the Act. Thus, we believe that the “good cause” exemption to notice and comment rulemaking is equally applicable for these BBRA provisions as for the others discussed above, and the same 60-day period for public comment applies.
As discussed above, a limited number of the provisions set forth in this final rule are subject to a 60-day comment period. Because of the large number of items of correspondence we normally receive on a rule, we are not able to acknowledge or respond to them individually. We will, however, consider all comments that we receive by the date specified in the
Administrative practice and procedure, Grant programs-health, Health care, health facilities, Health insurance, Health maintenance organizations (HMO), Loan programs-health, Medicare, Reporting and recordkeeping requirements.
Administrative practice and procedure, Health facilities, Health maintenance organizations (HMO), Medicare+Choice, Penalties, Privacy, Provider-sponsored organizations (PSO), Reporting and recordkeeping requirements.
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh), secs. 1301, 1306, and 1310 of the Public Health Service Act (2 U.S.C. 300e, 300e-5, 300e-9), and 31 U.S.C. 9701.
(b) The changes made to section 1876 of the Act by section 4002 of the Balanced Budget Act (BBA) of 1997 are incorporated in section 422 except for 1876 cost contracts. Upon enactment of the BBA (August 5, 1997) no new cost contracts or service area expansions are accepted by HCFA except for current Health Care Prepayment Plans that may convert to 1876 cost contracts. Also, 1876 cost contracts may not be extended or renewed beyond December 31, 2004.
Secs. 1102, 1851 through 1857, 1859, and 1871 of the Social Security Act (42 U.S.C. 1302, 1395w-21 through 1395w-27, and 1395hh ).
(1) Is described in section 501(c)(8) of the Internal Revenue Code of 1986 and is exempt from taxation under section 501(a) of that Act; and
(2) Is affiliated with, carries out the tenets of, and shares a religious bond with, a church or convention or association of churches or an affiliated group of churches.
(1) Whether the area meets the “county integrity rule” that a service area generally consists of a full county or counties. However, HCFA may approve a service area that includes a portion of a county if it determines that the “partial county” area is necessary, nondiscriminatory, and in the best interests of the beneficiaries.
(2) The extent to which the proposed services area mirrors service areas of existing commercial health care plans or M+C plans offered by the organization.
(3) For M+C coordinated care plans and network M+C MSA plans, whether the contracting provider network meets the access and availability standards set forth in § 422.112. Although not all contracting providers must be located within the plan's service area, HCFA must determine that all services covered under the plan are accessible from the service area.
(4) For non-network M+C MSA plans, HCFA may approve single county non-network M+C MSA plans even if the M+C organization's commercial plans have multiple county service areas.
(a) * * *
(1) * * *
(iii) Coordinated care plans include plans offered by health maintenance organizations (HMOs), provider-sponsored organizations (PSOs), preferred provider organizations (PPOs) as specified in paragraph (a)(1)(iv) of this section, RFBs, and other network plans (except network MSA plans).
(iv) A PPO plan is a plan that has a network of providers that have agreed to a contractually specified reimbursement for covered benefits with the organization offering the plan; provides for reimbursement for all covered benefits regardless of whether the benefits are provided within the network of providers; and is offered by an organization that is not licensed or organized under State law as an HMO.
(a)
(2) If the application is incomplete, HCFA notifies the contract applicant and allows 60 days from the date of the notice for the contract applicant to furnish the missing information.
(3) After evaluating all relevant information, HCFA determines whether the contract applicant's application meets the applicable requirements of § 422.6.
(b)
(c)
(d)
(e)
(2) Within 60 days from the date of the notice, the contract applicant may respond in writing to the issues or other matters that were the basis for HCFA's preliminary finding and may revise its application to remedy any defects HCFA identified.
(f)
(1) That the contract applicant does not meet the contract requirements under part C of title XVIII of the Act;
(2) The reasons why the contract applicant does not meet the contract requirements; and
(3) The contract applicant's right to request reconsideration in accordance with the procedures specified in subpart N of this part.
(g)
(2) If an M+C organization no longer meets those requirements, HCFA terminates the contract in accordance with § 422.510.
(a)
(b)
(c)
(d)
(2)
(i) The estimated costs to be incurred by HCFA in that fiscal year to carry out the activities described in paragraph (b) of this section; or
(ii) For fiscal year 2000, $100 million and for fiscal year 2001 and each succeeding year, the M+C portion (as defined in paragraph (e) of this section) of $100 million.
(e)
(f)
A times B divided by C where—
A is the total estimated January payments to all organizations subject to the assessment;
B is the 9-month (January through September) assessment period; and
C is the total fiscal year M+C user fee assessment amount determined in accordance with paragraph (d)(2) of this section.
(2) HCFA determines each organization's pro rata share of the annual fee on the basis of the organization's calculated monthly payment amount during the 9 consecutive months beginning with January. HCFA calculates each organization's monthly pro rata share by multiplying the established percentage rate by the total monthly calculated Medicare payment amount to the organization as recorded in HCFA's payment system on the first day of the month.
(3) HCFA deducts the organization's fee from the amount of Federal funds otherwise payable to the organization for that month under the M+C program.
(4) If assessments reach the amount authorized for the year before the end of September, HCFA discontinues assessment.
(5) If there are delays in determining the amount of the annual aggregate fees specified in paragraph (d)(2) of this section, or the fee percentage rate specified in paragraph (f)(2), HCFA may adjust the assessment time period and the fee percentage amount.
6. Revise § 422.50(a) to read as follows:
(a) An individual is eligible to elect an M+C plan if he or she—
(1) Is entitled to Medicare under Part A and enrolled in Part B (except that an individual entitled only to Part B and who was enrolled in an HMO or CMP with a risk contract under part 417 of this chapter on December 31, 1998 may continue to be enrolled in the M+C organization as an M+C plan enrollee);
(2) Has not been medically determined to have end-stage renal disease, except that an individual who develops end-stage renal disease while enrolled in an M+C plan or in a health plan offered by the M+C organization is eligible to elect an M+C plan offered by that organization;
(3) Meets either of the following residency requirements:
(i) Resides in the service area of the M+C plan.
(ii) Resides outside of the service area of the M+C plan and is enrolled in a health plan offered by the M+C organization during the month immediately preceding the month in which the individual is entitled to both Medicare Part A and Part B, provided that an M+C organization chooses to offer this option and that HCFA determines that all applicable M+C access requirements of § 422.112 are met for that individual through the M+C plan's established provider network. The M+C organization must furnish the same benefits to these enrollees as to enrollees who reside in the service area;
(4) Has been a member of an Employer Group Health Plan (EGHP) that includes the elected M+C plan, even if the individual lives outside of the M+C plan service area, provided that an M+C organization chooses to offer this option and that HCFA determines that all applicable M+C access requirements at § 422.12 are met for that individual through the M+C plan's established provider network. The M+C organization must furnish the same benefits to all enrollees, regardless of whether they reside in the service area;
(5) Completes and signs an election form and gives information required for enrollment; and
(6) Agrees to abide by the rules of the M+C organization after they are disclosed to him or her in connection with the election process.
(b)
(c) * * *
(2) An enrollee who moves out of the service area into the geographic area designated as the continuation area has the choice of continuing enrollment or disenrolling from the plan. The enrollee must make the choice of continuing enrollment in a manner specified by HCFA. If no choice is made, the enrollee must be disenrolled from the plan.
(d) * * *
(1)
(3)
(b)
(3) HCFA considers enrollment limit requests for an M+C plan service area, other than those submitted with the adjusted community rate proposal, or for a portion of the plan service area, only if the health and safety of beneficiaries is at risk, such as if the provider network is not available to serve the enrollees in all or a portion of the service area.
(e) * * *
(6) Upon receipt of the election form or from the date a vacancy occurs for an individual who was accepted for future enrollment, the M+C organization transmits, within the timeframes
(f) * * *
(1) In cases in which an M+C organization has both a Medicare contract and a contract with an employer group health plan, and in which the M+C organization arranges for the employer to process election forms for Medicare-entitled group members, who wish to enroll under the Medicare contract, the effective date of the election may be retroactive. Consistent with § 422.250(b), payment adjustments based on a retroactive effective date may be made for up to a 90-day period.
(3) Upon receipt of the election form from the employer, the M+C organization must submit the enrollment within timeframes specified by HCFA.
(a) * * *
(4) * * *
(i) Except as provided in paragraphs (a)(4)(ii), (a)(4)(iii), and (a)(6) of this section, an individual who is eligible to elect an M+C plan in 2002 may elect an M+C plan or change his or her election from an M+C plan to original Medicare or to a different M+C plan, or from original Medicare to an M+C plan, but only once during the first 6 months of the year.
(5) * * *
(i) For 2003 and subsequent years, except as provided in paragraphs (a)(5)(ii), (a)(5)(iii), and (a)(6) of this section, an individual who is eligible to elect an M+C plan may elect an M+C plan, change his or her election from an M+C plan to original Medicare or to a different M+C plan, or from original Medicare to an M+C plan, but only once during the first 3 months of the year.
(6)
(b) * * *
(1) HCFA or the organization has terminated the organization's contract for the plan, discontinued the plan in the area in which the individual resides, or the organization has notified the individual of the impending termination of the plan, or the impending discontinuation of the plan in the area in which the individual resides.
Each M+C organization must provide, on an annual basis, and in a format and using standard terminology that may be specified by HCFA, the information necessary to enable HCFA to provide to current and potential beneficiaries the information they need to make informed decisions with respect to the available choices for Medicare coverage.
(b)
(3)
(i) Submit a disenrollment notice to HCFA within timeframes specified by HCFA;
(d) * * *
(1)
(3)
(e)
(2) The elected M+C plan is discontinued or no longer serves the area in which the individual resides, the organization does not offer, or the individual does not elect, the option of continuing enrollment, as provided under either § 422.54 or § 422.74(b)(3)(ii).
(f)
(2) Upon receipt of the election form from the employer, the M+C organization must submit a disenrollment notice to HCFA within timeframes specified by HCFA.
(c)
(b) * * *
(2) * * *
(i) The individual no longer resides in the M+C plan's service area as specified under paragraph (d)(4) of this section, is no longer eligible under § 422.50(a)(3)(ii), and optional continued enrollment has not been offered or elected under § 422.54.
(3)
(ii)
(c)
(1) Be mailed to the individual before submission of the disenrollment notice to HCFA; and
(2) Include an explanation of the individual's right to a hearing under the M+C organization's grievance procedures.
(d) * * *
(1)
(i) The M+C organization makes a reasonable effort to collect unpaid premium amounts by sending a written notice of nonpayment to the enrollee within 20 days after the date the delinquent charges were due—
(A) Alerting the individual that the premiums are delinquent;
(B) Providing the individual with an explanation of the disenrollment procedures and any lock-in requirements of the M+C plan; and
(C) Advising that failure to pay the premiums within the 90-day grace period will result in termination of M+C coverage;
(ii) The M+C organization only disenrolls a Medicare enrollee when the organization has not received payment within 90 days after the date it has sent the notice of nonpayment to the enrollee.
(iii) The M+C organization gives the individual a written notice of disenrollment that meets the requirement set forth in paragraph (c) of this section.
(iv) If the enrollee fails to pay the premium for optional supplemental benefits (that is, a package of benefits that an enrollee is not required to accept), but pays the basic premium and any mandatory supplemental premium, the M+C organization has the option to discontinue the optional supplemental benefits and retain the individual as an M+C enrollee.
(3)
(4)
(ii)
(iii)
(7)
(ii) The notice must be sent before the effective date of the plan termination or area reduction, and in the timeframes specified in § 422.506(a)(2).
F. Revising paragraph (f).
(b) * * *
(5) Examples of marketing materials include, but are not limited to:
(v) Membership communication materials such as membership rules, subscriber agreements (evidence of coverage), member handbooks and wallet card instructions to enrollees.
(c)
(4) Are not materially inaccurate or misleading or otherwise make material misrepresentations.
(e) * * *
(1) * * *
(vi) Use providers or provider groups to distribute printed information comparing the benefits of different health plans unless the materials have the concurrence of all M+C organizations involved and have received prior approval by HCFA. Physicians or providers may distribute health plan brochures (exclusive of application forms) at a health fair or in their offices. Physicians may discuss, in response to an individual patient's inquiry, the various benefits in different health plans.
(vii) Accept plan applications in provider offices or other places where health care is delivered.
(viii) Employ M+C plan names that suggest that a plan is not available to all Medicare beneficiaries. This prohibition shall not apply to M+C plan names in effect on July 31, 2000.
(f)
(a)
(b)
(i) Ambulance services dispatched through 911 or its local equivalent as provided in § 422.113.
(ii) Emergency and urgently needed services as provided in § 422.113.
(iii) Maintenance and post-stabilization care services as provided in § 422.113.
(iv) Renal dialysis services provided while the enrollee was temporarily outside the plan's service area.
(v) Services for which coverage has been denied by the M+C organization and found (upon appeal under subpart M of this part) to be services the enrollee was entitled to have furnished, or paid for, by the M+C organization.
(2) An M+C plan (other than an M+C MSA plan) offered by an M+C organization satisfies paragraph (a) of this section with respect to benefits for services furnished by a noncontracting provider if that M+C plan provides payment in an amount the provider would have received under original Medicare (including balance billing permitted under Medicare Part A and Part B).
(c)
(1) Basic benefits are all Medicare-covered services, except hospice services, and additional benefits as defined in § 422.2 and meeting all requirements in § 422.312.
(2) Supplemental benefits, which consist of—
(i) Mandatory supplemental benefits are services not covered by Medicare that an M+C enrollee must purchase as part of an M+C plan that are paid for in full, directly by (or on behalf of) Medicare enrollees, in the form of premiums or cost-sharing.
(ii) Optional supplemental benefits are health services not covered by Medicare that are purchased at the option of the M+C enrollee and paid for in full, directly by (or on behalf of) the Medicare enrollee, in the form of premiums or cost-sharing. These services may be grouped or offered individually.
(d)
(1) To all Medicare beneficiaries residing in the service area of the M+C plan;
(2) At a uniform premium, with uniform benefits and cost-sharing throughout the plan's service area, or segment of service area as provided in § 422.304(b)(2).
(e)
(f)
(g)
(1) Medicare-covered services meet HCFA fee-for-service guidelines;
(2) M+C organizations are not designing benefits to discriminate against beneficiaries; and
(3) Benefit design meets other M+C program requirements.
(h)
(2) M+C organizations may not impose cost-sharing for influenza vaccine and pneumococcal vaccine on their M+C plan enrollees.
(i)
(j)
Except as specified in § 422.264 (for entitlement that begins or ends during a hospital stay) and § 422.266 (with respect to hospice care), each M+C organization must meet the following requirements:
(a) Provide coverage of, by furnishing, arranging for, or making payment for, all services that are covered by Part A and Part B of Medicare (if the enrollee is entitled to benefits under both parts) or by Medicare Part B (if entitled only under Part B) and that are available to beneficiaries residing in the plan's
(b) Comply with—
(1) HCFA's national coverage determinations;
(2) General coverage guidelines included in original Medicare manuals and instructions unless superseded by operational policy letters or regulations in this part; and
(3) Written coverage decisions of local carriers and intermediaries with jurisdiction for claims in the geographic area in which services are covered under the M+C plan.
(a)
(2) If the M+C organization imposes mandatory supplemental benefits, it must impose them on all Medicare beneficiaries enrolled in the M+C plan.
(3) HCFA approves mandatory supplemental benefits if the benefits are designed in accordance with HCFA's guidelines and requirements as stated in this part and instructions and operational policy letters.
(b)
(c)
(d)
A. Revising the introductory text for paragraph (a).
B. Revising paragraph (f).
(a)
(f)
(a)
(1) All requirements of this part that apply to the M+C program apply to the M+C plan coverage provided to enrollees eligible for benefits under an EGHP or Medicaid contract.
(2) Employer benefits that complement an M+C plan, and the marketing materials associated with the benefits, are not subject to review or approval by HCFA. M+C plan benefits provided to members of the EGHP, and the associated marketing materials, are subject to HCFA review and approval.
(3) Medicaid benefits are not reviewed under this part, but are subject to appropriate HCFA review under the Medicaid program. M+C plan benefits provided to individuals entitled to Medicaid benefits provided by the M+C organization under a contract with the State Medicaid agency are subject to M+C rules and requirements.
(b)
(1) Payment of a portion or all of the M+C basic and supplemental premiums.
(2) Payment of a portion or all of other cost-sharing amounts approved for the M+C plan.
(3) Other employer-sponsored benefits that may require additional premium and cost-sharing, or other benefits provided by the organization under a contract with the State Medicaid agency.
A. Republishing the introductory text for paragraph (b).
B. Revising paragraphs (b)(2), (c), the introductory text in paragraph (d), and paragraph (e).
C. Adding a new paragraph (f).
(b) Responsibilities of the M+C organization. The M+C organization must, for each M+C plan—
(2) Identify the amounts payable by those payers; and * * * * *
(c)
(d)
(e)
(f)
(b) The M+C organization must furnish, arrange or pay for an NCD “significant cost” service before the adjustment of the annual M+C capitation rate. The following rules apply to these services:
(5) Beneficiaries are liable for any applicable coinsurance amounts, but are not responsible for the Part A deductible.
(c)
A. Revising the introductory text in paragraph (a).
B. Revising paragraphs (b)(2)(i), (b)(4), and (b)(5)(i).
C. Republishing the introductory text in paragraph (c) and revising paragraph (c)(1).
D. Revising paragraph (e).
E. Adding new paragraph (f).
(a)
(b) * * *
(2) * * *
(i) The benefits offered under original Medicare, including the content specified in paragraph (f)(1) of this section;
(4) Out-of-area coverage provided under the plan, including coverage provided to individuals eligible to enroll in the plan under § 422.50(a)(3)(ii).
(5) * * *
(i) Explanation of what constitutes an emergency, referencing the definitions of emergency services and emergency medical condition at § 422.113;
(c)
(1) The information required paragraph (f) of this section.
(e)
(f)
(ii) Beneficiary cost-sharing, such as deductibles, coinsurance, and copayment amounts.
(iii) Any beneficiary liability for balance billing.
(2)
(3)
(4)
(5)
(6)
(7)
(ii) Any beneficiary cost-sharing.
(iii) Any maximum limitations on out-of-pocket expenses.
(iv) In the case of an M+C MSA plan, the amount of the annual MSA deposit and the differences in cost-sharing, enrollee premiums, and balance billing, as compared to M+C plans.
(v) In the case of an M+C private fee-for-service plan, differences in cost-sharing, enrollee premiums, and balance billing, as compared to M+C plans.
(vi) The extent to which an enrollee may obtain benefits through out-of-network health care providers.
(vii) The types of providers that participate in the plan's network and the extent to which an enrollee may select among those providers.
(viii) The coverage of emergency and urgently needed services.
(8)
(ii) The M+C monthly supplemental beneficiary premium.
(9)
(10)
(i) Disenrollment rates for Medicare enrollees for the 2 previous years, excluding disenrollment due to death or moving outside the plan's service area, calculated according to HCFA guidelines.
(ii) Medicare enrollee satisfaction.
(iii) Health outcomes.
(iv) Plan-level appeal data.
(v) The recent record of plan compliance with the requirements of this part, as determined by the Secretary.
(vi) Other performance indicators.
(11)
A. Republishing the introductory text to paragraph (a).
B. Revising paragraphs (a)(2), (a)(3) and (a)(9).
C. Adding new paragraph (a)(10).
D. Removing paragraph (c).
(a)
(2)
(3)
(9)
(10)
(a)
(b)
(i)
(A) Serious jeopardy to the health of the individual or, in the case of a pregnant woman, the health of the woman or her unborn child;
(B) Serious impairment to bodily functions; or
(C) Serious dysfunction of any bodily organ or part.
(ii)
(A) Furnished by a provider qualified to furnish emergency services; and
(B) Needed to evaluate or stabilize an emergency medical condition.
(iii)
(A) As a result of an unforeseen illness, injury, or condition; and
(B) It was not reasonable given the circumstances to obtain the services through the organization offering the M+C plan.
(2)
(i) Regardless of whether the services are obtained within or outside the M+C organization;
(ii) Regardless of whether there is prior authorization for the services.
(A) Instructions to seek prior authorization for emergency or urgently needed services may not be included in any materials furnished to enrollees (including wallet card instructions), and enrollees must be informed of their right to call 911.
(B) Instruction to seek prior authorization before the enrollee has been stabilized may not be included in any materials furnished to providers (including contracts with providers);
(iii) In accordance with the prudent layperson definition of
(iv) For which a plan provider or other M+C organization representative instructs an enrollee to seek emergency services within or outside the plan; and
(v) With a limit on charges to enrollees for emergency services of $50 or what it would charge the enrollee if he or she obtained the services through the M+C organization, whichever is less.
(3)
(c)
(1)
(2)
(i) Is financially responsible (consistent with § 422.214) for post-stabilization care services obtained within or outside the M+C organization that are pre-approved by a plan provider or other M+C organization representative;
(ii) Is financially responsible for post-stabilization care services obtained within or outside the M+C organization that are not pre-approved by a plan provider or other M+C organization representative, but administered to maintain the enrollee's stabilized condition within 1 hour of a request to the M+C organization for pre-approval of further post-stabilization care services;
(iii) Is financially responsible for post-stabilization care services obtained within or outside the M+C organization that are not pre-approved by a plan provider or other M+C organization representative, but administered to maintain, improve, or resolve the enrollee's stabilized condition if—
(A) The M+C organization does not respond to a request for pre-approval within 1 hour;
(B) The M+C organization cannot be contacted; or
(C) The M+C organization representative and the treating physician cannot reach an agreement concerning the enrollee's care and a plan physician is not available for consultation. In this situation, the M+C
(iv) Must limit charges to enrollees for post-stabilization care services to an amount no greater than what the organization would charge the enrollee if he or she had obtained the services through the M+C organization.
(3)
(i) A plan physician with privileges at the treating hospital assumes responsibility for the enrollee's care;
(ii) A plan physician assumes responsibility for the enrollee's care through transfer;
(iii) An M+C organization representative and the treating physician reach an agreement concerning the enrollee's care; or
(iv) The enrollee is discharged.
For any medical records or other health and enrollment information it maintains with respect to enrollees, an M+C organization must establish procedures to do the following:
(a) Abide by all Federal and State laws regarding confidentiality and disclosure of medical records, or other health and enrollment information. The M+C organization must safeguard the privacy of any information that identifies a particular enrollee and have procedures that specify—
(1) For what purposes the information will be used within the organization; and
(2) To whom and for what purposes it will disclose the information outside the organization.
(b) Ensure that medical information is released only in accordance with applicable Federal or State law, or pursuant to court orders or subpoenas.
(c) Maintain the records and information in an accurate and timely manner.
(d) Ensure timely access by enrollees to the records and information that pertain to them.
A. Revising the heading and introductory text for paragraph (b).
B. Revising the heading and introductory text for paragraph (e).
C. Revising paragraph (e)(1).
D. Republishing the heading of paragraph (f).
E. Adding new paragraph (f)(3).
(b)
(e)
(1) Measure performance under the plan using standard measures required by HCFA and report its performance to HCFA. The standard measures may be specified in uniform data collection and reporting instruments required by HCFA and will relate to—
(i) Clinical areas including effectiveness of care, enrollee perception of care, and use of services; and
(ii) Nonclinical areas including access to and availability of services, appeals and grievances, and organizational characteristics.
(f)
(3)
(b)
(2) Except in the case of complaints about quality, exclude review activities that HCFA determines would duplicate review activities conducted as part of an approved accreditation process or as part of HCFA monitoring.
(a)
(1) The M+C organization is fully accredited (and periodically reaccredited) for the standards related to the applicable area under paragraph (b) of this section by a private, national accreditation organization approved by HCFA; and
(2) The accreditation organization used the standards approved by HCFA for the purposes of assessing the M+C organization's compliance with Medicare requirements.
(b)
(1) Quality assurance.
(2) Antidiscrimination.
(3) Access to services.
(4) Confidentiality and accuracy of enrollee records.
(5) Information on advance directives.
(6) Provider participation rules.
(a)
(3) It ensures that:
(i) Any individual associated with it, who is also associated with an entity it accredits, does not influence the accreditation decision concerning that entity.
(ii) The majority of the membership of its governing body is not comprised of managed care organizations or their representatives.
(iii) Its governing body has a broad and balanced representation of interests and acts without bias.
(b)
(i) Announces HCFA's receipt of the accreditation organization's application for approval;
(ii) Describes the criteria HCFA will use in evaluating the application; and
(iii) Provides at least a 30-day comment period.
(e)
A. Revising the introductory text of paragraph (b).
B. Adding a heading to paragraph (c).
C. Adding a new paragraph (d)
(b)
(c)
(d)
(1)
(i) The reasons for the action, including, if relevant, the standards and profiling data used to evaluate the physician and the numbers and mix of physicians needed by the M+C organization.
(ii) The affected physician's right to appeal the action and the process and timing for requesting a hearing.
(2)
(3)
(4)
(a)
(b)
(1) For providers (other than physicians and other health care professionals) requires determination, and redetermination at specified intervals, that each provider is—
(i) Licensed to operate in the State, and in compliance with any other applicable State or Federal requirements; and
(ii) Reviewed and approved by an accrediting body, or meets the standards established by the organization itself;
(2) For physicians and other health care professionals, including members of physician groups, covers—
(i) Initial credentialing that includes written application, verification of licensure or certification from primary sources, disciplinary status, eligibility for payment under Medicare, and site visits as appropriate. The application must be signed and dated and include an attestation by the applicant of the correctness and completeness of the application and other information submitted in support of the application;
(ii) Recredentialing at least every 2 years that updates information obtained during initial credentialing and considers performance indicators such as those collected through quality assurance programs, utilization management systems, handling of grievances and appeals, enrollee satisfaction surveys, and other plan activities, and that includes an attestation of the correctness and completeness of the new information; and
(iii) A process for consulting with contracting health care professionals with respect to criteria for credentialing and recredentialing.
(3) Specifies that basic benefits must be provided through, or payments must be made to, providers and suppliers that meet applicable requirements of title XVIII and part A of title XI of the Act. In the case of providers meeting the definition of “provider of services” in section 1861(u) of the Act, basic benefits may only be provided through these providers if they have a provider agreement with HCFA permitting them to provide services under original Medicare.
(4) Ensures compliance with the requirements at § 422.752(a)(8) that prohibit employment or contracts with individuals (or with an entity that employs or contracts with such an individual) excluded from participation under Medicare and with the requirements at § 422.220 regarding physicians and practitioners who opt out of Medicare.
(a)
(b)
(1) Refusal to grant participation to health care professionals in excess of the number necessary to meet the needs of the plan's enrollees (except for M+C private-fee-for-service plans, which may not refuse to contract on this basis).
(2) Use of different reimbursement amounts for different specialties or for different practitioners in the same specialty.
(3) Implementation of measures designed to maintain quality and
(b)
(2) Through appropriate written means, makes available information on these policies as follows:
(i) To HCFA, with its application for a Medicare contract, within 10 days of submitting its ACR proposal or, for policy changes, in accordance with § 422.80 (concerning approval of marketing materials and election forms) and with § 422.111.
(ii) To prospective enrollees, before or during enrollment.
(iii) With respect to current enrollees, the organization is eligible for the exception provided in paragraph (b)(1) of this section if it provides notice of such change within 90 days after adopting the policy at issue; however, under § 422.111(d), notice of such a change must be given in advance.
A. Republishing the introductory text for paragraph (c).
B. Revising paragraph (c)(2).
C. Adding a heading to paragraph (e).
(c)
(2) If the physician incentive plan places a physician or physician group at substantial financial risk (as determined under paragraph (d) of this section) for services that the physician or physician group does not furnish itself, the M+C organization must assure that all physicians and physician groups at substantial financial risk have either aggregate or per-patient stop-loss protection in accordance with paragraph (f) of this section, and conduct periodic surveys in accordance with paragraph (h) of this section.
(e)
(a)
(b)
(a) * * *
(4)
(b) * * *
(2) Noncontract providers. A noncontract provider may not collect from an enrollee more than the cost-sharing established by the M+C private fee-for-service plan as specified in § 422.308(b), unless the provider has opted out of Medicare as described in part 405, subpart D of this chapter.
(c) * * *
(2)
(f)
A. In paragraph (a)(1), removing the phrase “in paragraph (a)(2)” and adding in its place the phrase “in paragraphs (a)(2) or (f)”.
B. Revising paragraph (a)(2)(i)(B).
C. Adding new paragraph (g).
(a) * * *
(2) * * *
(i) * * *
(B) HCFA reduces the payment rate for each renal dialysis treatment by the same amount that the Secretary is authorized to reduce the amount of each composite rate payment for each treatment as set forth in section 1881(b)(7) of the Act. These funds are to be used to help pay for the ESRD network program in the same manner as similar reductions are used in original Medicare.
(g)
(i) For the first 12 months after a plan is offered in a previously unserved county, 5 percent of the monthly capitation rate otherwise payable under this section; and
(ii) For the subsequent 12 months, 3 percent of the monthly capitation rate otherwise payable under this section.
(2) A previously unserved county is defined as—
(i) A county in which no M+C plan has been offered; or
(ii) A county in which an M+C plan or plans has been offered, but where any M+C organization offering an M+C plan notified HCFA by October 13, 1999, that it will no longer offer plans in the county as of January 1, 2000.
(3) A plan is considered to be offered when—
(i) The M+C organization sponsoring the plan has a contract in effect to serve beneficiaries in the previously unserved area; and
(ii) The M+C plan is open for enrollment.
(b) * * *
(2) The percentage points that HCFA uses to reduce its estimates are as follows:
(i) For 1998, 0.8 percentage points.
(ii) For years 1999 through 2001, 0.5 percentage points.
(iii) For 2002, 0.3 percentage points.
(iv) For years after 2002, 0 percentage points.
(d)
(2) The data must be submitted electronically to the appropriate HCFA contractor.
(3) M+C organizations must obtain the encounter data required by HCFA from the provider, supplier, physician, or other practitioner that rendered the services.
(4) M+C organizations may include in their contracts with providers, suppliers, physicians, and other practitioners, provisions that require submission of complete and accurate encounter data as required by HCFA. These provisions may include financial penalties for failure to submit complete data, or for failure to submit data that conform to the requirements for equivalent data for Medicare fee-for-service.
(g)
(1) The annual deadline for encounter data submission is September 10 for encounter data reflecting services furnished during the 12 month period ending the prior June 30 (for example, the deadline for submission of data for the period July 1, 1998 through June 30, 1999 is September 10, 1999).
(2) HCFA allows a reconciliation process to account for late data submissions. HCFA continues to accept encounter data submitted after the September 10 deadline until June 30 of the payment year (for example, until June 30, 2000 for data from the period July 1, 1998 through June 30, 1999). After the payment year is completed, HCFA recalculates the risk factors for affected individuals to determine if adjustments to payments are necessary.
(b) * * *
(2) For contracts beginning on a date other than January 1 (according to § 422.504(d)), M+C organizations may submit ACRs on a date other than July 1 approved by HCFA.
(b)
(2)
(a)
A. In the introductory text for paragraph (d), removing the phrase “paragraphs (a)(1) and (a)(2) of this section” and adding in its place the phrase “paragraphs (d)(1) and (d)(2) of this section”.
B. Revising paragraph (c)(3).
(c) * * *
(3)
(b)
(1) Provide additional benefits with an actuarial value (less the actuarial value of any cost-sharing associated with the benefit) which HCFA determines is at least equal to the adjusted excess amount; and
(a)
(1) Has obtained a waiver of State licensure as provided for under § 422.370;
A. Revising the definition of “clean claim.”
B. Adding definitions for “downstream entity” and “first tier entity.”
(1) A claim that has no defect, impropriety, lack of any required substantiating documentation (consistent with § 422.257(d)) or particular circumstance requiring special treatment that prevents timely payment; and
(2) A claim that otherwise conforms to the clean claim requirements for equivalent claims under original Medicare.
A. Republishing the introductory text in paragraphs (b), (b)(3), and (b)(3)(vi).
B. Revising paragraphs (b)(3)(vi)(G) and (b)(5).
C. Removing paragraph (b)(3)(vi)(H).
D. Republishing the introductory text in (d)(2) and (d)(2)(iii).
E. Revising paragraph (d)(2)(iii)(A).
(b)
(3) Have administrative and management arrangements satisfactory to HCFA, as demonstrated by at least the following:
(vi) A compliance plan that consists of the following:
(G) Procedures for ensuring prompt response to detected offenses and development of corrective action initiatives relating to the organization's M+C contract.
(5) The M+C organization's contract must not have been terminated by HCFA under § 422.510 within the past 2 years unless—
(i) During the 6-month period beginning on the date the organization notified HCFA of the intention to terminate the most recent previous contract, there was a change in the statute or regulations that had the effect of increasing M+C payments in the payment area or areas at issue; or
(ii) HCFA has otherwise determined that circumstances warrant special consideration.
(d) * * *
(2) Each contract under this section must provide that HCFA, or any person or organization designated by HCFA has the right to:
(iii) Audit and inspect any books, contracts, and records of the M+C organization that pertain to—
(A) The ability of the organization or its first tier or downstream providers to bear the risk of potential financial losses; or
A. In paragraph (a)(12), removing the phrase “To comply will all requirements” and adding in its place the phrase “To comply with all requirements”.
B. Republishing the introductory text for paragraph (g).
C. Revising the introductory text for paragraph (g)(1) and the introductory text for paragraph (g)(3).
D. Revising paragraph (i)(3).
E. Revising paragraph (l).
(g)
(1) Each M+C organization must adopt and maintain arrangements satisfactory to HCFA to protect its enrollees from incurring liability (for example, as a result of an organization's insolvency or other financial difficulties) for payment of any fees that are the legal obligation of the M+C organization. To meet this requirement, the M+C organization must—
(3) In meeting the requirements of this paragraph, other than the provider contract requirements specified in paragraph (g)(1)(i) of this section, the M+C organization may use—
(i) * * *
(3) All contracts or written arrangements between M+C organizations and providers, related entities, contractors, subcontractors, first tier and downstream entities must contain the following:
(i) Enrollee protection provisions that provide, consistent with paragraph (g)(1) of this section, arrangements that prohibit providers from holding an enrollee liable for payment of any fees that are the obligation of the M+C organization.
(ii) Accountability provisions that indicate that—
(A) The M+C organization oversees and is accountable to HCFA for any functions or responsibilities that are described in these standards; and
(B) The M+C organization may only delegate activities or functions to a provider, related entity, contractor, or subcontractor in a manner consistent with requirements set forth at paragraph (i)(4) of this section.
(iii) A provision requiring that any services or other activity performed by a related entity, contractor, subcontractor, or first-tier or downstream entity in accordance with a contract or written agreement are consistent and comply with the M+C organization's contractual obligations.
(1)
(1) The CEO, CFO, or an individual delegated the authority to sign on behalf of one of these officers, and who reports directly to such officer, must certify that each enrollee for whom the organization is requesting payment is validly enrolled in an M+C plan offered by the organization and the information relied upon by HCFA in determining payment (based on best knowledge, information, and belief) is accurate, complete, and truthful.
(2) The CEO, CFO, or an individual delegated with the authority to sign on behalf of one of these officers, and who reports directly to such officer, must certify (based on best knowledge, information, and belief) that the encounter data it submits under § 422.257 are accurate, complete, and truthful.
(3) If such encounter data are generated by a related entity, contractor, or subcontractor of an M+C organization, such entity, contractor, or subcontractor must similarly certify (based on best knowledge, information, and belief) the accuracy, completeness, and truthfulness of the data.
(4) The CEO, CFO, or an individual delegated the authority to sign on behalf of one of these officers, and who reports directly to such officer, must certify (based on best knowledge, information, and belief) that the information in its ACR submission is accurate, complete, and truthful and fully conforms to the requirements in § 422.310.
(b)
A. Republishing the introductory text of paragraph (a)(2).
B. Revising paragraph (a)(2)(i) and the introductory text of paragraph (a)(3).
C. Removing paragraph (b)(1)(ii).
D. Redesignating paragraphs (b)(1)(iii) and (b)(1)(iv) as (b)(1)(ii) and (b)(1)(iii), respectively.
(a) * * *
(2) If an M+C organization does not intend to renew its contract, it must notify—
(i) HCFA in writing, by July 1 of the year in which the contract would end;
(3) HCFA may accept a nonrenewal notice submitted after July 1 if—
(a) * * *
(12) The M+C organization substantially fails to comply with the marketing requirements in § 422.80.
(c) * * *
(1)
(b) * * *
(1) For a contract applicant or M+C organization that does not meet the applicable requirement of paragraph (a) of this section at application for an M+C contract or during the first 3 years of the contract, HCFA may waive the minimum enrollment requirement as provided for below. To receive a waiver, a contract applicant or M+C organization must demonstrate to HCFA's satisfaction that it is capable of administering and managing an M+C contract and is able to manage the level of risk required under the contract. Factors that HCFA takes into consideration in making this evaluation include the extent to which—
(i) The contract applicant or M+C organization's management and providers have previous experience in managing and providing health care services under a risk-based payment arrangement to at least as many individuals as the applicable minimum enrollment for the entity as described in paragraph (a) of this section, or
(ii) The contract applicant or M+C organization has the financial ability to bear financial risk under an M+C contract. In determining whether an organization is capable of bearing risk, HCFA considers factors such as the organization's management experience as described in paragraph (b)(1)(i) of this section and stop-loss insurance that is adequate and acceptable to HCFA; and
(iii) The contract applicant or M+C organization is able to establish a marketing and enrollment process that allows it to meet the applicable enrollment requirement specified in paragraph (a) of this section before completion of the third contract year.
(a) * * *
(3) All other claims must be paid or denied within 60 calendar days from the date of the request.
As used in this subpart, unless the context indicates otherwise—
(a)
(ii) A procedure for making timely organization determinations;
(b)
(1) Payment for temporarily out of the area renal dialysis services, emergency services, post-stabilization care, or urgently needed services.
(2) Payment for any other health services furnished by a provider other than the M+C organization that the enrollee believes—
(i) Are covered under Medicare; or
(ii) If not covered under Medicare, should have been furnished, arranged for, or reimbursed by the M+C organization.
(3) The M+C organization's refusal to provide or pay for services, in whole or in part, including the type or level of services, that the enrollee believes should be furnished or arranged for by the M+C organization.
(4) Discontinuation of a service if the enrollee believes that continuation of the services is medically necessary.
(5) Failure of the M+C organization to approve, furnish, arrange for, or provide payment for health care services in a timely manner, or to provide the enrollee with timely notice of an adverse determination, such that a delay would adversely affect the health of the enrollee.
(a)
(b)
(c)
(1) Provide the enrollee with the information necessary to contact the M+C organization; and
(2) Comply with any other requirements specified by HCFA.
(d)
(e)
(1) Use approved notice language in a readable and understandable form;
(2) State the specific reasons for the denial;
(3) Inform the enrollee of his or her right to a reconsideration;
(4)(i) For service denials, describe both the standard and expedited reconsideration processes, including the enrollee's right to, and conditions for, obtaining an expedited reconsideration and the rest of the appeal process; and
(ii) For payment denials, describe the standard reconsideration process and the rest of the appeal process; and
(5) Comply with any other notice requirements specified by HCFA.
(f)
A. Revising paragraph (a).
B. Republishing the introductory text for paragraph (d).
C. Revising the introductory text to paragraph (d)(2) and revising paragraph (d)(2)(iii).
D. Adding a new paragraph (d)(2)(iv).
(a)
(d)
(2) Give the enrollee prompt oral notice of the denial and subsequently deliver, within 3 calendar days, a written letter that—
(iii) Informs the enrollee of the right to resubmit a request for an expedited determination with any physician's support; and
(iv) Provides instructions about the grievance process and its timeframes.
(b)
(c)
(d)
A. Revising paragraph (a).
B. Republishing the introductory text to paragraph (d).
C. Revising paragraph (d)(2).
(a)
(d)
(2) Give the enrollee prompt oral notice, and subsequently deliver, within 3 calendar days, a written letter that—
(i) Explains that the M+C organization will process the enrollee's request using the 30-day timeframe for standard reconsiderations;
(ii) Informs the enrollee of the right to file a grievance if he or she disagrees with the organization's decision not to expedite;
(iii) Informs the enrollee of the right to resubmit a request for an expedited reconsideration with any physician's support; and
(iv) Provides instructions about the grievance process and its timeframes.
A. Republishing the heading for paragraph (a) and revising paragraph (a)(1).
B. Republishing the heading for paragraph (d) and revising paragraphs (d)(2), (d)(3), and (d)(4).
C. Republishing the heading for paragraph (g) and revising paragraph (g)(2).
(a)
(d)
(2)
(3)
(4)
(g)
(2) When the issue is the M+C organization's denial of coverage based on a lack of medical necessity (or any substantively equivalent term used to describe the concept of medical necessity), the reconsidered determination must be made by a physician with expertise in the field of medicine that is appropriate for the services at issue. The physician making the reconsidered determination need not, in all cases, be of the same specialty or subspecialty as the treating physician.
(b)
(1) State the specific reasons for the entity's decisions in understandable language;
A reconsidered determination is final and binding on all parties unless a party other than the M+C organization files a request for a hearing under the provisions of § 422.602, or unless the reconsidered determination is revised under § 422.616.
(b)
A. Revising the section heading.
B. Redesignating paragraph (b) as paragraph (c).
C. Adding a new paragraph (b).
D. Revising newly designated paragraph (c).
(b)
(2)
(c)
(a)
(b)
(c)
(a)
(b)
(c)
(1) The reason why inpatient hospital care is no longer needed.
(2) The effective date and time of the enrollee's liability for continued inpatient care.
(3) The enrollee's appeal rights.
(4) Additional information specified by HCFA.
(b) HCFA reconsiders the specified determinations if the contract applicant or the M+C organization files a written request in accordance with § 422.650.
(c)
(d)
HCFA provides the M+C organization or contract applicant and the HCFA official or officials who made the contract determination reasonable opportunity, not to exceed the timeframe in which an M+C organization could choose to request a hearing as described at § 422.662, to present as evidence any documents or written statements that are relevant and material to the matters at issue.
(a) HCFA gives the M+C organization or contract applicant written notice of the reconsidered determination.
(b) The notice—
(1) Contains findings with respect to the contract applicant's qualifications to enter into, or the M+C organization's qualifications to remain under, a contract with HCFA under Part C of title XVIII of the Act;
(2) States the specific reasons for the reconsidered determination; and
(3) Informs the M+C organization or contract applicant of its right to a hearing if it is dissatisfied with the determination.
The following parties are entitled to a hearing:
(a) A contract applicant that has been determined in a reconsidered determination to be unqualified to enter into a contract with HCFA under Part C of title XVIII of the Act.
(a)
(b)
Securities and Exchange Commission.
Final rule.
The Securities and Exchange Commission is adopting Regulation S-P, privacy rules promulgated under section 504 of the Gramm-Leach-Bliley Act. Section 504 requires the Commission and other federal agencies to adopt rules implementing notice requirements and restrictions on a financial institution's ability to disclose nonpublic personal information about consumers. Under the Gramm-Leach-Bliley Act, a financial institution must provide its customers with a notice of its privacy policies and practices, and must not disclose nonpublic personal information about a consumer to nonaffiliated third parties unless the institution provides certain information to the consumer and the consumer has not elected to opt out of the disclosure. The Act also requires the Commission to establish for financial institutions appropriate standards to protect customer information. The final rules implement these requirements of the Gramm-Leach-Bliley Act with respect to investment advisers registered with the Commission, brokers, dealers, and investment companies, which are the financial institutions subject to the Commission's jurisdiction under that Act.
For information regarding the rules as they relate to brokers or dealers, contact George Lavdas or Jerome Roche, Office of Chief Counsel, Division of Market Regulation, (202) 942-0073, or regarding the rules as they relate to investment companies or registered investment advisers, Penelope W. Saltzman or Hugh P. Lutz, Office of Regulatory Policy, (202) 942-0690, Division of Investment Management, Securities and Exchange Commission, 450 5th Street, NW., Washington, DC 20549.
The Securities and Exchange Commission (the “Commission”) today is adopting new Regulation S-P, 17 CFR 248.1-248.30, under Title V of the Gramm-Leach-Bliley Act [Pub. L. No. 106-102, 113 Stat. 1338 (1999), to be codified at 15 U.S.C. 6801-6831], the Securities Exchange Act of 1934 [15 U.S.C. 78] (“Exchange Act”), the Investment Company Act of 1940 [15 U.S.C. 80a] (“Investment Company Act”), and the Investment Advisers Act of 1940 [15 U.S.C. 80b] (“Investment Advisers Act”).
Subtitle A of Title V of the Gramm-Leach-Bliley Act (“G-L-B Act” or the “Act”), captioned Disclosure of Nonpublic Personal Information (“Title V”), limits the instances in which a financial institution may disclose nonpublic personal information about a consumer to nonaffiliated third parties, and requires a financial institution to disclose to all of its customers the institution's privacy policies and practices with respect to information sharing with both affiliates and nonaffiliated third parties. Title V also requires the Office of the Comptroller of the Currency, Board of Governors of the Federal Reserve System, Federal Deposit Insurance Corporation, Office of Thrift Supervision (collectively, the “Banking Agencies”), Secretary of the Treasury, National Credit Union Administration, Federal Trade Commission (collectively with the Banking Agencies, the “Agencies”), and the Commission, after consulting with representatives of State insurance authorities designated by the National Association of Insurance Commissioners, to prescribe regulations necessary to carry out the purposes of Title V.
Commission representatives participated with representatives from the Agencies in drafting rules to implement Title V. As required by the G-L-B Act, the rules we are adopting today are, to the extent possible, consistent with and comparable to the rules adopted by the Agencies.
Title V also requires the Commission (and each of the Agencies) to establish appropriate standards for financial institutions subject to their jurisdiction to safeguard customer information and records. Regulation S-P includes requirements for investment advisers registered with the Commission (“registered advisers”), brokers, dealers (collectively, “broker-dealers”), and investment companies (“funds”) to adopt appropriate policies and procedures that address safeguards to protect this information.
On March 2, 2000, the Commission issued a notice of proposed rulemaking (the “proposal” or “proposed rules”).
Other commenters advocated that we extend privacy protections in a number of ways. These suggestions included requiring (i) financial institutions to provide consumers with access to information about them maintained by the institutions and the opportunity to correct errors, (ii) more detailed disclosures of the information collected and disclosed, and (iii) disclosures of a financial institution's privacy policies and practices earlier in the process of establishing a customer relationship.
The National Association of Insurance Commissioners (“NAIC”) submitted a comment on behalf of the State insurance authorities that generally supported the Commission's proposed rules. The NAIC also proposed various measures to provide certain protections for consumers, such as specifying means to exercise the right to opt out of the disclosure of information. The NAIC further advised the Commission to clarify the boundary of federal and State jurisdiction over privacy regulations and ensure that the financial privacy rules under the Act are compatible with the privacy rules relating to medical information that are to be issued by the Secretary of the Department of Health and Human Services (“HHS”) under the Health Insurance Portability and Accountability Act (“HIPAA”) of 1996.
We received approximately 20 letters from broker-dealers, funds, registered advisers, insured depository institutions, bank holding companies, and their representatives.
We have modified the proposed rules in light of the comments received.
The final Regulation presents the various sections in five subparts that consist of related sections. Related concepts are grouped together to make the rules easier to follow. A comparison table is included in section V to assist readers in locating provisions that appeared in the proposal. We also have added an Appendix to the final rules, setting out sample disclosures for broker-dealers, funds, and registered advisers to consider.
We are revising section 248.1, which identifies the purposes and scope of the rules. As stated in the proposal, the rule is intended to require a broker-dealer, fund, or registered adviser to provide notice to customers about its privacy policies and practices; to describe the conditions under which the institution may disclose nonpublic personal information about consumers to nonaffiliated third parties; and to provide a method for consumers to prevent the financial institution from disclosing that information to certain nonaffiliated third parties by “opting out” of that disclosure, subject to various exceptions as stated in the rules.
Most of the comments received on this section focused on the scope of the rules. Several commenters suggested that the Commission clarify how the rules apply to insurance companies. Section 505 of the G-L-B Act sets out the Commission's enforcement authority with respect to broker-dealers, funds, and registered advisers. The section explicitly excludes “persons providing insurance” from the Commission's (and the Agencies') enforcement authority (and, by operation of section 504(a)(1) of the G-L-B Act, from the Commission's and the Agencies' rulemaking authority). We believe that the G-L-B Act relies on the States to enforce Title V with respect to any insurance activities conducted by broker-dealers, funds, or registered advisers. Consistent with this reading of the statute, the final rule excludes the provision of insurance by a broker-dealer, fund, or registered adviser from the scope of Regulation S-P. If the insurance product also is a security, however, any broker-dealer or fund that provides that security, or registered adviser that provides advice with respect to that security is subject to Regulation S-P.
Several commenters stated that Regulation S-P should apply to foreign financial institutions that solicit business from individuals in the United States. As adopted, the requirements of Regulation S-P apply to any broker-dealer, fund, or investment adviser that is registered with the Commission, regardless of whether its consumers are U.S. persons or non-U.S. persons, and regardless of whether it conducts its activities through U.S. or non-U.S. offices or branches.
Several commenters suggested that the rule should not apply to entities that must comply with regulations proposed by HHS to implement the HIPAA.
We are revising section 248.2, which sets out a rule of construction intended to clarify the effect of the examples used in the rules, to include the sample clauses in the Appendix to the rules. As noted in the Proposing Release, the examples (and the sample clauses) are not intended to be exhaustive; rather, they are intended to provide guidance about how the rules would apply in specific situations.
Commenters generally agreed that examples are helpful in clarifying how the rules will work in specific circumstances. Some commenters also suggested that we include more examples, and provide examples of model disclosures. A few commenters suggested that the regulation state that a financial institution is not obligated to comply with an example but has the latitude to comply with the general rules in other ways. Other commenters also requested that we treat the examples as safe harbors or establish a presumption that compliance with the examples constitutes compliance with the rules. Others stated that the examples ought to be identical in each privacy regulation adopted by the Commission and the Agencies.
We agree that more examples would be helpful, and have included additional examples in appropriate places throughout the rules. We also have provided sample clauses in the Appendix to assist broker-dealers, funds, and registered advisers in drafting privacy notices. The sample clauses are provided to illustrate the level of detail we believe is appropriate. We caution financial institutions against relying on the sample disclosures without determining the relevance or appropriateness of the disclosure for their operations. We have used statutory terms, such as “nonpublic personal information” and “nonaffiliated third parties,” in the sample clauses to convey generally the subject of the clauses. However, a financial institution that uses these terms must provide sufficient information to enable consumers to understand what these terms mean in the context of the institution's notices.
We have not added a statement in the final rule regarding a financial institution's ability to comply with the rules in ways other than as suggested in the examples. The rule states that the facts and circumstances of each individual situation will determine whether compliance with an example constitutes compliance with the applicable rule.
(a)
(b)
(c)
We received a large number of comments on the proposed definition. Several commenters favored adopting the definition as proposed, with some advocating that the final rule include a requirement that disclosures be on a separate piece of paper in order to ensure that they will be conspicuous. Others stated that the definition was unnecessary, given the experience financial institutions have in complying
New standard for “clear and conspicuous.” The proposed definition developed the concept of “clear and conspicuous.” The phrase “designed to call attention to the nature and significance of the information contained” was intended to provide meaning to the term “conspicuous.” We believe that this standard will result in notices to consumers that communicate effectively the information consumers need in order to make an informed choice about the privacy of their information, including whether to open a brokerage account, purchase fund shares, or enter into an advisory contract with an adviser.
Examples of “clear and conspicuous.” We recognize that many of the examples are imprecise. We believe, however, that more prescriptive examples, while perhaps easier to conform to, likely would result in requirements that would be inappropriate in a given circumstance. To avoid this result, the examples provide generally applicable guidance about ways in which a broker-dealer, fund, or registered adviser may make a disclosure clear and conspicuous. We note that the examples do not mandate how to make a disclosure clear and conspicuous. A financial institution must decide for itself how best to comply with the general rule, and may use techniques not listed in the examples. To address concerns about the imprecision of the examples, we have incorporated several of the commenters' suggestions in the final rule for ways to make the guidance more helpful.
Combination of several notices. Commenters stated that a document may combine different types of disclosures that are subject to specific disclosure requirements under different regulations. For example, a fund that includes a privacy notice in its prospectus would have to make the privacy notice clear and conspicuous, and would have to prepare the prospectus according to certain standards under the Securities Act of 1933.
Disclosures on Internet web pages. Several commenters requested guidance on how they may clearly and conspicuously disclose privacy-related information on their Internet sites. Disclosures over the Internet may present some issues that will not arise in paper-based disclosures. Consumers may view various web pages within a financial institution's web site in a different order each time they access the site, aided by hypertext links. Depending on the hardware and software used to access the Internet, some web pages may require consumers to scroll down to view the entire page. To address these issues, the example concerning Internet disclosures states that broker-dealers, funds, and registered advisers may comply with the rule if they use text or visual cues to encourage scrolling down the page if necessary to view the entire notice and ensure that other elements on the web site (such as text, graphics, hypertext links, or sound) do not distract attention from the notice.
There is a range of approaches a broker-dealer, fund, or registered adviser could use based on current technology. For example, a broker-dealer could use a dialog box that pops up to provide the disclosure before a consumer provides information to a financial institution. Another approach would be a simple, clearly labeled graphic located near the top of the page or in close proximity to the financial institution's logo, directing the customer, through a hypertext link or hotlink, to the privacy disclosures on a separate web page.
(d)
Commenters suggested that the final rule treat information that is not organized and retrievable in an automated fashion as not “collected.” We disagree that information should not be deemed to be collected simply because it is not retrievable in an automated fashion. We believe that the method of retrieval is irrelevant to whether information should be protected under the rule. We agree, however, that the scope of the regulation should be refined, and have changed the definition of “collect” by using language from the Privacy Act of 1974.
Other commenters requested that the rule clarify that information that a broker-dealer, fund, or registered adviser receives but then immediately passes along without retaining a copy, is not “collected.” We believe that merely receiving information without retaining it would not be “collecting” the information. The final rule reflects this by stating that the information must be organized or retrievable by the financial institution.
(f)
(g)
Evaluation of a request for a financial product or service. The proposal defined “consumer” to mean an individual (and his or her legal representative) who obtains, from a financial institution, financial products or services that are to be used primarily for personal, family, or household purposes.
Many commenters disagreed that someone should be deemed a consumer of a financial institution by virtue of the institution evaluating nonpublic personal information provided by the individual in an application or otherwise. These commenters maintained that the individual has not obtained a financial product or service, as is required by the G-L-B Act. We believe, however, that a “financial product or service” includes the evaluation of information an individual provides to the financial institution in order to obtain some other financial product or service. Broker-dealers, funds, and registered advisers frequently provide a range of services in connection with the delivery of a financial product, including the evaluation of information provided by an individual. The evaluation may be the sole financial product or service delivered, or one of several services provided in connection with establishing a customer relationship. For example, an investor who seeks to invest in certain investment products, such as stock options, must provide a broker-dealer or registered adviser with nonpublic personal information in connection with the request. Based on this nonpublic personal information, the broker-dealer or registered adviser may open an account for the investor, but deny his or her request to invest in options. Whether the evaluation is the sole product or service or one of several, the institution's evaluation of the individual's information is a separate financial product or service.
The proposed definition of “consumer” also is consistent with one of the primary purposes of Title V: To enable an individual to restrict a financial institution from sharing nonpublic personal information about the individual with a nonaffiliated third party. The information an individual provides to a financial institution before a customer relationship is established is likely to contain precisely the types of information that the statute is designed to protect. This information is no less deserving of protection simply because an application is denied or withdrawn. For these reasons, we have retained in the examples in the definition of “consumer” an individual who provides nonpublic personal information to a broker-dealer or investment adviser in connection with obtaining brokerage or investment advisory services.
Loan sales. Several commenters requested clarification of circumstances in which a borrower becomes a consumer. The final rule provides that a person will be a consumer of any entity that holds ownership or servicing rights to an individual's loan.
Agents of financial institutions. Several commenters maintained that an individual should not be considered to be a consumer of an entity that is acting as agent for a financial institution.
Legal representative. We also agree with the suggestion by several commenters that the definition of “consumer” should clarify that a financial institution may satisfy the obligations stemming from a consumer relationship by dealing either with the individual who obtains a financial product or service from a financial institution or that individual's legal representative. We do not intend that the rule require a financial institution to send opt out and initial notices to
Trusts. We received several comments concerning whether an individual who obtains financial services in connection with trusts is a consumer or customer of a financial institution. Several commenters urged the Commission generally to exempt a financial institution from the requirements of the rules when it acts as a fiduciary or, in the alternative, to clarify the categories of individuals who are considered to be customers. Commenters proposed, for example, that individuals who are beneficiaries with current interests should be identified as customers, whereas individuals who are only
We believe that the definition of “consumer” in the G-L-B Act does not squarely resolve whether the beneficiary of a trust is a consumer of the financial institution that is the trustee. We agree with the commenters who concluded that, when the financial institution serves as trustee of a trust, neither the grantor nor beneficiary is a consumer or customer under the rules. Instead, the trust itself is the entity that obtains the financial services, and the rules do not apply because the trust is not an individual.
Requirements arising from consumer relationship. While the proposed and final rules define “consumer” broadly, we note that this definition will not result in any additional burden to a broker-dealer, fund, or registered adviser if (i) no customer relationship is established and (ii) the institution does not intend to disclose nonpublic personal information about the consumer to nonaffiliated third parties. Under the approach taken in the final rule, a broker-dealer, fund, or registered adviser is under no obligation to provide a consumer who is not a customer with any privacy disclosures unless it intends to disclose the consumer's nonpublic personal information to nonaffiliated third parties outside the exceptions in sections 248.14 and 248.15. The institution may disclose a consumer's nonpublic personal information to nonaffiliated third parties under the final rule, if it delivers the requisite notices and the consumer does not opt out. Thus, the rule allows a financial institution to avoid all of the rule's requirements for consumers who are not customers if the institution chooses not to share information about the consumers with nonaffiliated third parties. Conversely, if a broker-dealer, fund, or registered adviser chooses to share consumers' nonpublic personal information with nonaffiliated third parties, the financial institution is free to do so, provided it notifies consumers about the sharing and affords them a reasonable opportunity to opt out. In this way, the rule attempts to strike a balance between protecting an individual's nonpublic personal information and minimizing the burden on a financial institution.
(h)
(i)
Some commenters suggested that the rule adopt the definition of control used in Form BD to determine when an entity is a “control affiliate.”
We believe that a test based only on stock ownership is unlikely to be flexible enough to address all situations in which companies should be considered to be affiliated. In addition, the proposed definition of control is consistent with the definition in Form BD, except that the definition in Form BD creates a presumption of control in
(j), (k)
Point at which a consumer becomes a customer. Commenters criticized the vagueness of the standard for differentiating consumers from customers. Several suggested that the distinction should be based on when a consumer and financial institution enter into a written contract for a financial product or service.
We recognize that the distinction between consumers and customers will, in some instances, require a financial institution to make a judgment about whether a customer relationship is established. When an individual engages in a transaction and is not likely to expect further communication about that transaction from the financial institution (such as brokerage services as an accommodation to buy or liquidate securities), the individual will not have established a customer relationship as a result of that transaction. In other situations when a consumer typically would receive some measure of continued service following, or in connection with, a transaction (such as when a consumer opens a brokerage account, is the record owner of fund shares, or obtains investment advice), a customer relationship is established. We believe that the distinction set out in the proposed rule, as further clarified by the examples in the final rule of when a customer relationship is and is not established, provides a sufficiently clear line while retaining flexibility to address less clear-cut situations on a case-by-case basis.
Use of “isolated transaction” test. The final rule does not define the distinction between consumer and customer based solely on whether the transaction is an isolated event. We used this concept in an example in the proposed rule to illustrate one of the factors that may determine whether a relationship is of a continuing nature. Several commenters suggested that this approach was insufficiently precise to serve as a workable distinction between consumers and customers. We agree that the test may not be useful in all situations, but believe that it will help clarify the status of relationships in certain circumstances. Accordingly, the final rule retains the following example of an “isolated transaction”: providing brokerage services as an accommodation to buy or liquidate securities without the expectation of engaging in further transactions does not establish a customer relationship.
Purchase of insurance. Some commenters suggested that, in the context of financial institutions that engage in the sale of insurance and that are regulated by the Commission, the customer should be the policyholder and not the beneficiary. As discussed above, Regulation S-P does not apply to the provision of insurance by broker-dealers, funds, or registered advisers. A variable annuity or variable life insurance contract, however, is both an insurance product and a security.
Sales of loans. As noted above, several commenters raised questions about loan sales. They stated that when a financial institution sells the servicing rights for a loan to another financial institution, the borrower should not be considered a customer of both institutions. Commenters suggested that the entity with which the borrower communicates about the loan (
We believe that it is appropriate to consider that a loan transaction gives rise to only one customer relationship and that this customer relationship may be transferred in connection with a sale of part or all of the loan. In this way, the borrower will not be inundated by privacy notices, many of which might be from secondary market purchasers that the borrower did not know had any connection to his or her loan. We note, however, that a borrower will remain a consumer of the institution that transfers the servicing rights, as well as a consumer of any other institution that holds an interest in the loan.
Under the final rules, therefore, a financial institution will be considered to have established a customer relationship with any individual to whom it makes a loan.
Fund shares purchased through an intermediary. Several commenters suggested that an individual who is the record owner of fund shares should not be a fund's “customer” if the fund is limited, under its contract with the intermediary who sold the shares, to servicing the investor's account. The commenters argue that these investors would be confused by receiving privacy notices from the fund. We proposed a “bright line” example of record ownership to establish the customer relationship because the fund clearly has nonpublic personal information about its record owners that is personally identifiable. We do not believe that an investor who receives account statements and other information from a fund that services the investor's account will be confused by receiving notices regarding the fund's privacy policies and practices. Moreover, an investor is unlikely to know whether a fund is contractually limited in its use of the investor's nonpublic personal information or whether those contract terms may change. For these reasons, we are adopting the proposed example that record owners of fund shares are the fund's customers.
Fund complex. One commenter suggested that a customer of a fund should be considered a customer of the fund complex, which may include the fund's primary investment adviser, or that a fund customer, at least in some cases, should also be considered a customer of the fund's primary investment adviser. We noted in the Proposing Release that the record owner of fund shares has a customer relationship with both the fund and the principal underwriter (which is a broker-dealer) that sells the shares.
We recognize that the definition of “customer” may have disparate effects on the ability of some investment advisers to receive nonpublic personal information about fund investors. For example, if the underwriter of a fund is affiliated with the fund's investment adviser, the underwriter can share nonpublic personal information about its customers with the adviser. By contrast, if the underwriter is not affiliated with the fund's investment adviser, the underwriter can share this type of information only under an exception in section 248.13, 248.14, or 248.15, and the adviser's ability to reuse the information would be limited to the purpose for which it received the information. These limitations result from the language of the G-L-B Act, which defines affiliation in terms of “control,” and we are unwilling to modify the definition of “customer relationship” to alter the effect of that definition.
Transferred accounts. One commenter requested clarification about whether an investor becomes a consumer of a broker-dealer when the consumer's account is transferred to the broker-dealer. An individual who has an account with a broker-dealer or a contract with a registered adviser has established a customer relationship with that broker-dealer or adviser. Thus, the investor is a customer of that broker-dealer or registered adviser, regardless of whether the account was transferred at the customer's request or as the result of a merger, acquisition, or assignment. Accordingly, the final rule includes an example that an individual is a customer of a broker-dealer or registered adviser if the individual's account is transferred to the broker-dealer or adviser.
Trusts. The final rule adds an example to clarify that an individual will be deemed to establish a customer relationship when a broker-dealer, fund, or registered adviser acts as a custodian for securities or assets in an IRA.
(l)
(m)
For purposes of the privacy rules, this term is relevant in determining when an entity is an affiliate and when a broker-dealer, fund, or registered adviser may disclose information to a law enforcement agency.
(n)
Commenters suggested that the final rule include additional exceptions from the definition, such as for securitization trusts, debt buyers, and credit bureaus. We have not included these exceptions in the final rule. We believe it is inappropriate to exclude many of the activities suggested by commenters because the objective of the suggested exclusions can be achieved in other ways. Even if an entity is a financial institution as that term is used in the G-L-B Act, it will not have any disclosure responsibilities under the Act or this rule if it does not provide a financial product or service to a consumer. In most of the situations posited by the commenters, the entity in question will not meet that test and therefore will fall outside the scope of the rules with respect to privacy disclosures.
(o)
Several commenters criticized the proposed definition and suggested that the evaluation of application information should not be considered a financial product or service. For the reasons discussed above regarding the definition of “consumer,” we continue to believe that it is appropriate to retain evaluation or brokerage of information as within the scope of financial products or services covered by the rules.
(q)
(r)
(s)
We received very few comments in response to the proposed definition. One commenter requested that the final rule state that a disclosure of information to someone who is serving as a joint employee of two financial institutions should be deemed to have been disclosed to both financial institutions. We disagree with this result. Instead, we believe it is appropriate to deem the information to have been given to the financial institution that is providing the financial product or service in question. Thus, for example, if an employee of a bank is also an employee of a brokerage firm, information that employee receives in connection with a securities transaction conducted with the brokerage firm would be considered as received by the brokerage firm.
(t)
The proposed rules implemented the definition of “nonpublic personal information” under the G-L-B Act by restating the categories of information described above. The proposed rules treated information as publicly available if a broker-dealer, fund, or registered adviser
The final rule adopts an approach that we believe incorporates the benefits of both alternatives. As under the proposed rule, in the final rule information will be deemed to be “publicly available” and therefore excluded from the definition of “nonpublic personal information” if a broker-dealer, fund, or registered adviser reasonably believes that the information is lawfully made available to the general public from one of the three categories of sources listed in the rule.
The approach of the final rule is based on the underlying principle that a consumer in many circumstances can control the public availability or identification of his or her information and that a financial institution therefore should not assume that the information about that customer is in fact publicly available. Thus, even though a lender typically enters a mortgage in public records in order to protect its security interest, when a borrower can maintain the privacy of his or her personal information by owning the property and obtaining the loan through a separate legal entity, the customer's name would not appear in the public record. In the case of a telephone number, a person may request that his or her number be unlisted. Thus, in evaluating whether it is reasonable to believe that information is publicly available, a financial institution must determine whether the consumer has kept the information or his or her identity from being a matter of public record.
To implement the complex definition of “nonpublic personal information” that is provided in the statute, the final rule adopts a definition that consists, generally speaking, of (i) personally identifiable financial information, plus (ii) a consumer list or description or grouping of consumers (and publicly available information pertaining to the consumers) that is derived using any personally identifiable financial information that is
(u)
We received a large number of comments in response to the definition of “personally identifiable financial information.” Many commenters objected to including in the term certain identifying information that they did not view as “financial,” such as name, address, and telephone number. Many commenters argued that “personally identifiable financial information” should not include the fact that someone is a customer of a financial institution. These commenters noted that many customer relationships are matters of public record (such as would be the case, for instance, any time a transaction results in the recording of a security interest) while other customer relationships are matters of public knowledge (because consumers frequently disclose the relationships by writing checks, using credit cards, and so on). Many commenters stated that aggregate data about a financial institution's customers that lack personal identifiers should not be considered personally identifiable financial information.
Treatment of identifying information as financial. We continue to believe that it is appropriate to treat any information as “financial” information if a financial institution obtains it in order to provide
We are sensitive to the concern expressed by several commenters about the need for ready access to identifying information to locate individuals who are attempting to evade their financial obligations. These commenters suggested that names, addresses, and telephone numbers should not be treated as financial information. We believe, however, that this information is financial, and is covered by the G-L-B Act. Broker-dealers, funds, and registered advisers rely on a broad range of information, including information such as addresses and telephone numbers, when providing financial products or services. Broker-dealers, funds, and registered advisers use location information to provide a wide variety of financial services, such as sending account statements and disbursing funds to a consumer. We concluded that it would be inappropriate to exclude certain items of information from the definition of personally identifiable financial information simply because a particular broker-dealer, fund, or registered adviser might not rely on those items when providing a particular financial product or service.
Customer relationship as “personally identifiable financial information.” We disagree with those commenters who maintain that customer relationships should not be considered to be personally identifiable financial information. This information is “personally identifiable” because it identifies the individual as a customer of the institution. The information is financial because it reveals a financial relationship with the institution and the receipt of financial products or services from the institution.
Changes made to the definition. We have revised the definition of “personally identifiable financial information” to make it easier to read and understand. In addition, the final rule adds to the examples of information covered by the rule any information that the institution collects through an information-collecting device from a web server, often referred to as a “cookie.”
In addition, in response to many comments from the securities industry, the final rule also includes an example that clarifies that aggregate information (or “blind data”) lacking personal identifiers is not covered by the definition of “personally identifiable financial information.”
(v)
Many commenters questioned the appropriateness of excluding from the definition of “publicly available information” information that a person obtains over the Internet by using a password or complying with a similar restriction. These commenters noted that many Internet sites are available to a large number of people, each of whom needs a user name and identification number to access the sites. Several of these commenters suggested that it would be more appropriate to focus on whether the information was lawfully placed on the Internet.
We agree with these comments, and have revised the final rule to remove the reference to passwords or similar restrictions from the example of the Internet as a “widely distributed” medium of communication. In its place, we have substituted a standard that requires the information, whether from the Internet or otherwise, to be available on an unrestricted basis. Information that an individual specifically requests be compiled, such as information that a locator or “look up” service provides with respect to a particular individual that may combine confidential information in addition to publicly available information, will not be considered available to the general public on an unrestricted basis, regardless of whether the information is provided over the Internet or otherwise. The rule also states that an Internet site is not restricted merely because an Internet service provider or a site operator requires a fee or password, as long as access is otherwise available to the general public. One common use of passwords is to confine the access of web site users to specific, individual information. However, web site operators also may require user identifications and passwords as a method of tracking access rather than restricting access to the information available through the website. Internet service providers may charge fees to users to access the site rather than to restrict access to particular information. Other sites available to the general public, such as daily newspapers, also may charge a fee to access archived
We note that the concept of information being lawfully obtained was included in the proposal, and is retained in the final rule.
(w)
Sections 248.4 through 248.9 of Regulation S-P include requirements concerning the delivery of initial and annual notices about the privacy policies and practices of a financial institution, and about the opportunity and methods for consumers to opt out of their institution's sharing of their nonpublic personal information with nonaffiliated third parties.
We are revising the requirements relating to initial privacy notices to consumers, in response to issues raised by commenters. The G-L-B Act requires a financial institution to provide an initial notice of its privacy policies and practices in two circumstances. For customers, the notice must be provided at the time of establishing a customer relationship.
The proposed rules implemented these requirements by mandating that a financial institution provide the initial notice to an individual prior to the time a customer relationship is established and the opt out notice prior to disclosing nonpublic personal information to nonaffiliated third parties. The rule required these disclosures to be clear and conspicuous and to accurately reflect the institution's privacy policies and practices. The proposal also set out rules governing when a customer relationship is established and how a financial institution is to provide notice.
We received many comments raising concerns about proposed section 248.4. Most commenters from the securities industry raised questions about the time when initial notices must be provided, the point at which a customer relationship is established, and how initial notices may be provided.
Providing initial notices “prior to” time customer relationship is established. Almost all the commenters from the securities industry stated that, because the statute requires only that the initial notice be provided “at the time of establishing a customer relationship,” the regulation should not require that the notice be provided “prior to” the point when a customer relationship is established. Some of these commenters were concerned that the rule could be interpreted as requiring a financial institution to provide disclosures at a point different from when they must provide other federally mandated consumer disclosures during the process of establishing a customer relationship.
Although we believe many commenters misinterpreted the proposed language concerning the timing for providing initial notices, we have revised the rule to clarify the requirement. The final rule states that, as a general rule, the initial notice must be given not later than the time when a financial institution establishes a customer relationship.
Providing notices after customer relationship is established. Several commenters stated that the rule should provide financial institutions with the flexibility to deliver the initial notice
To accommodate the wide range of situations presented by the commenters, we have modified the examples of when subsequent delivery of the initial notice is appropriate, so that they now are more broadly applicable. As stated in the final rule in section 248.4(e), a broker-dealer, fund, or registered adviser may satisfy the delivery requirement by providing the initial notice within a reasonable time after establishing a customer relationship, in three instances. First, the institution may provide notice after the fact if the customer has not elected to establish the customer relationship.
We note that in most situations, a broker-dealer, fund, or registered adviser should give the initial notice at a point when the consumer still has a meaningful choice about whether to enter into the customer relationship.
In circumstances when it is appropriate to deliver an initial notice after the customer relationship is established, a broker-dealer, fund, or registered adviser should deliver the notice within a reasonable time thereafter. Several commenters requested that the final rule specify how many days a financial institution has in which to deliver the notice under these circumstances. However, we believe that a rule prescribing the maximum number of days would be inappropriate because (i) the circumstances of when an after-the-fact notice is appropriate are likely to vary significantly, and (ii) a rule that attempts to accommodate every circumstance is likely to provide more time than is appropriate in many instances. Therefore, we have retained the more general rule as set out in the proposal.
As we noted in the Proposing Release, nothing in the rule is intended to discourage a financial institution from providing an individual with a privacy notice at an earlier point in the relationship in order to make it easier for the individual to compare its privacy policies and practices with those of other institutions in advance of conducting transactions.
New notices not required for each new financial product or service. Several commenters asked whether a new initial notice is required every time a consumer obtains a financial product or service from that broker-dealer, fund, or registered adviser. These commenters suggested that a consumer would not materially benefit from repeated disclosures of the same information, and that requiring additional initial notices to be provided to the same consumer would be burdensome on financial institutions.
We agree that it would be burdensome, with little corresponding benefit to the consumer, to require a financial institution to provide the same consumer with additional copies of its initial notice every time the consumer obtains a financial product or service. Accordingly, the final rule states that a broker-dealer, fund, or registered adviser will satisfy the notice requirements when an existing customer obtains a new financial product or service if the institution's initial, revised, or annual notice (as appropriate) is accurate with respect to the new financial product or service.
Joint accountholders. We agreed with several commenters who recommended that the final rule state that a financial institution is not obligated to provide more than one notice to joint accountholders.
Mergers. A few commenters requested guidance on what notices are required in the event of a merger of two financial institutions or an acquisition of one financial institution by another. In such a situation, the need to provide new initial (and opt out) notices to the customers of the entity that ceases to exist will depend on whether the notices previously given to those customers accurately reflect the policies and practices of the surviving entity. If they do, the surviving entity will not be required under the rule to provide new notices.
As was stated in the Proposing Release, a financial institution may not fail to maintain the protections that it represents in the notice that it will provide.
We are adopting largely as proposed the requirements relating to annual privacy notices to consumers. Section 503 of the G-L-B Act requires a financial institution to provide notices of its privacy policies and practices at least annually to its customers “during the continuation” of a customer relationship. The proposed rules implemented this requirement by requiring a clear and conspicuous notice that accurately reflects the privacy policies and practices then in effect to be provided at least once during any period of twelve consecutive months.
Many commenters from the securities industry requested that the final rule permit annual notices to be given each calendar year, instead of every 12 months. A few commenters recommended that the rule require notices each calendar year, with no more than 15 months elapsing between mailings. To clarify the extent of financial institutions' flexibility, the final rule retains the general rule requiring annual notices but then provides an example, stating that a broker-dealer, fund, or registered adviser may select a calendar year as the
Several commenters suggested that a financial institution be permitted to make the annual notice available upon request only, particularly if there have been no material changes to the notice since it was last delivered. These commenters argued that little value is added by providing customers with additional copies each year of the same information. Some suggested that financial institutions be permitted to provide a “short-form” annual notice, in which the institution informs its customers that there has been no change to its privacy policies and practices and that the customers may obtain a copy upon request.
We have not amended the final rule to permit this approach, for two reasons. First, we believe that the G-L-B Act requires a full set of disclosures to each customer once a year.
We are revising the requirements for information to be included in initial and annual privacy notices. The revisions clarify the level of detail required in these notices, and permit a “short-form” initial notice in certain circumstances.
Section 503 of the G-L-B Act identifies the items of information that a broker-dealer, fund, or registered adviser must include in its initial and annual notices. Section 503(a) of the G-L-B Act sets out the general requirement that a financial institution must provide customers with a notice describing the institution's policies and practices with respect to, among other things, disclosing nonpublic personal information to affiliates and nonaffiliated third parties. Section 503(b) of the Act identifies certain elements that must be addressed in that notice.
The proposed rule implemented section 503 by requiring a financial institution to provide information concerning:
• The categories of nonpublic personal information that a broker-dealer, fund, or registered adviser may collect;
• The categories of nonpublic personal information that a broker-dealer, fund, or registered adviser may disclose;
• The categories of affiliates and nonaffiliated third parties to whom a broker-dealer, fund, or registered adviser discloses nonpublic personal information, other than those to whom information is disclosed under an exception in section 502(e) of the G-L-B Act;
• The broker-dealer, fund, or registered adviser's policies with respect to sharing information about former customers;
• The categories of information that are disclosed under agreements with third party service providers and joint marketers and the categories of third parties providing the services;
• A consumer's right to opt out of the disclosure of nonpublic personal information to nonaffiliated third parties;
• Any disclosures regarding affiliate information sharing opt outs a financial institution is providing under the Fair Credit Reporting Act; and
• The institution's policies and practices with respect to protecting the confidentiality, security, and integrity of nonpublic personal information.
Level of detail required. Many commenters observed that the level of detail required by the proposed rule would result in lengthy, complicated, and confusing disclosures. These comments have led us to revise the rule to clarify the level of detail required in a financial institution's initial and annual disclosures.
We do not intend to require a broker-dealer, fund, or registered adviser to publish lengthy disclosures that precisely identify every type of information collected or shared, the name of every entity with which the institution shares information, and a complete description of the technical specifications of how the institution protects its customers' records or the identity of each employee who has access to those records. Instead, the rule is intended to require notices that provide consumers with the types of third parties with which a financial institution shares nonpublic personal information, the types of information it shares, and the other information about the institution's privacy policies and practices listed above. The final rule, like the proposal, permits a broker-dealer, fund, or registered adviser to comply with these notice requirements by describing its privacy policies and practices.
In response to commenters' concerns that consumers will not read long, detailed disclosures, we have revised the examples of the disclosures to clarify the level of detail that we think is appropriate. We have provided sample clauses in the Appendix to the rules, and have set out a compliance guide below in this release. Because the examples are not exclusive, the final rule permits a financial institution to use different categories than those provided in the examples, thereby providing additional flexibility for financial institutions in complying with the disclosure requirements. In addition, we have revised the language that precedes the items of information to be addressed in the initial notice, to clarify that a broker-dealer, fund, or registered adviser is required only to address those items that apply to the institution. Thus, for instance, if an investment adviser does not disclose nonpublic personal information to third parties, it may simply omit any reference to the categories of affiliates
As noted in the Proposing Release, the required content is the same for both the initial and annual notices of privacy policies and practices.
Short-form initial notice. We have reconsidered the need to give consumers a copy of a financial institution's complete initial notice when there is no customer relationship. In these circumstances, we believe that the objectives of the statute can be accomplished in a less burdensome way than was proposed. Accordingly, we have exercised our exemptive authority under section 504(b) to create an exception to the general rule that a financial institution must provide both the initial and opt out notices to a consumer before disclosing nonpublic personal information about that consumer to nonaffiliated third parties.
Section 248.6(d) provides that a financial institution may provide a “short-form” initial privacy policy notice along with the opt out notice to a consumer with whom the institution does not have a customer relationship. The short-form notice must clearly and conspicuously state that the disclosure containing information about the institution's privacy policies and practices is available on request, and must provide one or more reasonable means by which the consumer may obtain a copy of the notice. We believe that the short-form is appropriate because a consumer who does not become a customer of a broker-dealer, fund, or registered adviser may have less interest in certain elements of the institution's privacy policies. Thus, the consumer may receive greater benefit from obtaining a short-form notice with the opt out notice, which informs the consumer about the categories of his or her information the institution may share and the categories of nonaffiliated third parties that may receive the information. The rule also requires a broker-dealer, fund, or registered adviser to provide a consumer who is interested in the more complete privacy disclosures with a reasonable means to obtain them.
Information about affiliate sharing. Several commenters suggested that the rule should not require that initial and annual notices include categories of affiliates with whom a financial institution shares information. These commenters noted that the Act specifically requires disclosures of categories of nonaffiliated third parties only, and that the only statutorily mandated disclosures concerning affiliate sharing are disclosures required, if any, concerning affiliate sharing under the Fair Credit Reporting Act (“FCRA”).
We believe that the language and legislative history of section 503 support requiring disclosures of affiliate sharing beyond what may be required by the FCRA. First, section 503(b) does not state that the items listed in the section are to be the only items set out in a financial institution's initial and annual disclosures. Instead, it uses the nonrestrictive phrase “shall include” when discussing the contents of the disclosures, thereby preserving flexibility for the Commission (which was expressly granted authority under section 503(a) to prescribe rules governing these notices) to require that additional items be addressed in the disclosures consistent with those specifically enumerated.
Second, section 503(a) states that the financial institution shall provide in its initial and annual notices “a clear and conspicuous disclosure * * * of such financial institution's policies and practices with respect to—(1) disclosing nonpublic personal information to affiliates and nonaffiliated third parties, consistent with section 502, including the categories of information that may be disclosed; * * *” While the FCRA disclosures would be a subset of the disclosures required by section 503(a)(1), they may not be sufficient to fully satisfy that requirement.
Third, the legislative history of the G-L-B Act suggests that Congress intended the disclosures to provide more information about affiliate sharing than what may be required under the FCRA.
As discussed above, we believe that in order to comply with the requirement that it disclose its policies and practices with respect to sharing information with affiliated and nonaffiliated third parties, a financial institution must describe the circumstances under which it will share information with affiliates. The ability of consumers to opt out of affiliate information sharing under the FCRA affects a financial institution's policies and practices with respect to disclosing information to its affiliates. Failing to include this information and an explanation of how the opt out right may be exercised would make the disclosures incomplete.
In addition, section 503 does not distinguish between the disclosures to be provided in the initial notice from those to be provided in the annual notice. Thus, section 503 suggests that any disclosures that are required under the FCRA must be included in both the initial and annual notices.
We interpret the “if any” language as an acknowledgment that not all institutions provide FCRA notices because not all institutions engage in the type of affiliate sharing covered by the FCRA. We do not believe that requiring the FCRA notice to appear as part of the annual notice under the privacy rules, modifies, limits, or supersedes the
Disclosures of the right to opt out. Other commenters suggested that the final rule eliminate the requirement that the initial and annual notices contain disclosures about a consumer's right to opt out. These commenters pointed out that the statute does not specifically require these disclosures.
As previously discussed, section 503(a) of the statute requires a financial institution to disclose its policies and practices with respect to sharing information, both with affiliated and nonaffiliated third parties. Given that a financial institution's practices with respect to sharing nonpublic personal information with nonaffiliated third parties will be affected by the opt out rights created by the statute, an institution will need to describe these opt out rights in order to provide a complete disclosure that satisfies the statute.
Other comments. We received many comments expressing support for a number of the provisions in proposed section 248.6. For example, several commenters agreed with the approach of permitting a financial institution to state generally that it makes disclosures to nonaffiliated third parties “as permitted by law” to describe disclosures made under one of the exceptions. Others agreed with the proposed flexibility to allow a disclosure to be based on current and contemplated information sharing. In light of these comments, we have adopted proposed section 248.6 with changes as discussed above. The final rule makes several other stylistic changes to the material in section 248.6 that are intended to make the rule easier to read.
We are adopting as proposed the requirement that any opt out notice provided by a broker-dealer, fund, or registered adviser be clear and conspicuous and accurately explain the right to opt out.
Joint accounts. We agree with the commenters who stated that a financial institution should have the option of providing one notice per account, regardless of the number of persons on the account, and the final rule includes a new section to address this issue.
Means of opting out. At the suggestion of many commenters, the final rule includes a provision that permits a broker-dealer, fund, or registered adviser to require that a consumer opt out through a specific means, if the means is reasonable for the consumer.
As was proposed, the examples provide that a broker-dealer, fund, or registered adviser may not require a consumer to write his or her own letter in order to opt out.
Duration of opt out. Several commenters requested changes to the proposed provision concerning duration of an opt out.
We agree with the commenters' suggestions. Under the final rule, a broker-dealer, fund, or registered adviser is to treat an opt out election made by a customer in connection with a prior customer relationship as applying solely to the nonpublic personal information that the institution collected during, or related to, that relationship. That opt out will continue until the customer revokes it.
Level of detail required in opt out notice. We are adopting as proposed the rule requirements for the form of the opt out notice.
One commenter suggested that, while a broker-dealer, fund, or registered adviser should have the option of providing an opt out notice that is sufficiently broad to cover anticipated disclosures, the institution also should be permitted to provide a customer who already has opted out with a new opt out notice in connection with a new financial product or service. If the consumer does not opt out a second time, the institution would be free to disclose nonpublic personal information obtained in connection with that financial product or service.
We agree that a broker-dealer, fund, or registered adviser should have the flexibility to provide opt out notices that are either narrowly tailored to specific types of nonpublic personal information and types of nonaffiliated third parties or that are more broadly worded to anticipate future disclosure plans. We note, however, that when a consumer has elected to opt out of sharing certain nonpublic personal information, the opt out remains in effect until the consumer affirmatively revokes the opt out. Similarly, when a consumer opts out after receiving an opt out notice that is broad enough to cover the new type of information the institution intends to share, the consumer does not have to opt out again.
Time by which opt out must be honored. We are adopting in the final rule the proposed requirement that a financial institution comply with an opt out election “as soon as reasonably practicable.”
We are adopting as proposed the rule regarding revised privacy notices.
The requirements for delivery of initial, annual, and opt out notices were set out in three different sections of the proposed rules.
Posting initial notices on an Internet web site. The final rule retains the proposed example of posting a notice on an Internet web site and requiring a consumer to acknowledge receipt of the notice as a step in the process of obtaining a financial product or service, as one way to comply with the rule.
Posting annual notices on an Internet web site. At the suggestion of several commenters, the final rule clarifies that a broker-dealer, fund, or registered adviser may reasonably expect a customer who uses the institution's Internet web site to obtain financial products or services will receive actual notice if the customer has agreed to accept notices at the institution's web site, and if the institution continuously posts a current notice of its privacy policies and practices in a clear and conspicuous manner on the web site.
Householding. Two commenters requested that the Commission permit broker-dealers and funds to deliver a single privacy notice to consumers who share the same address (“householding”). The Commission currently permits householding of prospectuses and fund shareholder reports, and the commenters argue that the same justifications that support the existing householding rules, such as reducing the number of duplicate documents investors receive, would apply with respect to privacy notices.
The example requires that the annual privacy notice be delivered with or in a prospectus or shareholder report that is householded because we believe that customers whose disclosure documents are householded also would consent to having their annual privacy notices householded. We cannot assume that the same would be true for other customers. The example also limits householding to annual privacy notices because we believe that any reduction in the number of initial notices consumers might receive due to householding would be minimal. Individuals who share the same address may not become consumers of a broker-dealer, fund, or registered adviser at the same time.
Disclosures to customers requesting no communication. We received comment that the final rule clarify that a financial institution may honor a customer's request not to receive information from the institution about his or her relationship with the institution. The final rule clarifies that a broker-dealer, fund, or registered adviser need not send an
Reaccessing a notice. The final rule provides an example that permits a broker-dealer, fund, or registered adviser to provide only the current privacy notice on a web site to someone seeking to obtain the privacy notice after having received the initial notice.
Joint notices. The final rule affirms that two or more financial institutions may provide a joint notice as long as the notice is accurate with respect to each institution.
Sections 248.10 through 248.12 of Regulation S-P contain limitations concerning (i) disclosure of nonpublic personal information to nonaffiliated third parties, (ii) redisclosure or reuse of information that a financial institution discloses to other parties, and (iii) sharing of account number information for marketing purposes.
We are adopting the limits on disclosure of nonpublic personal information to nonaffiliated third parties, substantially as proposed.
Most commenters on this section focused on the question of what is a reasonable opportunity to opt out. Some suggested that the rule permit a financial institution to begin sharing information immediately after it provides the opt out and initial notice in connection with an electronic transaction, such as an ATM transaction. Others advocated a mandatory delay of 120 days after the notices are provided.
We believe that the wide variety of suggestions underscores the appropriateness of a more general test rather than a mandatory waiting period in all cases. If a broker-dealer intends to disclose nonpublic personal information that it obtains through an isolated transaction and the consumer is provided a convenient means of opting out as part of the transaction, it would be reasonable not to force the broker-dealer to wait before sharing the information.
We are revising the limits on redisclosure and reuse to clarify their scope. The limits on redisclosure and reuse that apply to recipients of nonpublic personal information and their affiliates will depend on whether the information was provided under an exception in section 502(e) of the G-L-B Act.
Section 502(c) of the G-L-B Act provides that a nonaffiliated third party that receives nonpublic personal information from a financial institution must not, directly or indirectly through an affiliate, disclose that information to
The limits on redisclosure and reuse in the proposed rule reflected our belief that implicit in the joint marketing and enumerated exceptions is the idea that information may be used only for the purposes for which the third party received it.
We sought comment on the correct interpretation of “lawful” in the context of section 502(c), and whether a recipient of nonpublic personal information could “lawfully” disclose information if the disclosure complied with a notice provided by the institution that initially made the disclosure. Finally, we invited comment on whether the rules should require a financial institution that discloses nonpublic personal information to a nonaffiliated third party to develop policies and procedures to ensure that the third party complies with the limits on redisclosure of that information.
Limits on reuse and redisclosure. Commenters who disagreed with the proposal to impose limits on reuse argued that Congress, by addressing limits on redisclosures in section 502(c), provided the only limits that may be imposed on what a recipient of nonpublic personal information can do with that information. We disagree. Although section 502(c) does not expressly address reuse, reuse limitations are, as indicated, implicit in the provisions authorizing or permitting disclosures. For example, it would be inconsistent with the purposes of the Act to permit information disclosed in accordance with section 502(e)(1) (which permits disclosures as necessary to effect, administer, or enforce a transaction with a consumer or in connection with certain routine activities related to such a transaction) to be used for the third party recipient's marketing purposes. Moreover, permitting reuse without limits would undermine the protections afforded to a consumer who does not establish a customer relationship. Such a person does not receive notice that the disclosures under section 502(e) are even made because these disclosures do not entitle the consumer to any privacy or opt out notice. Thus, the limits on reuse are the only protection under the statute for a consumer who is not a customer. Accordingly, consistent with the purposes of the G-L-B Act, the rule limits the reuse of information received under an exception of the Act.
By contrast, when a consumer decides not to opt out after receiving adequate notices and the opportunity to do so, that consumer has decided to permit the broker-dealer, fund, or registered adviser to share his or her nonpublic personal information with the categories of entities identified in the institution's notices. The consumer's primary protection in the case of a disclosure falling outside the section 502(e) exceptions comes from receiving the mandatory disclosures and the right to opt out. The G-L-B Act provides additional protection in section 502(c) by restricting a recipient's ability to redisclose information to entities not affiliated with either the recipient or the financial institution making the initial disclosure. Thus, if a consumer permits a broker-dealer, fund, or registered adviser to disclose nonpublic personal information to the categories of nonaffiliated third parties that are described in the institution's notices, recipients of that nonpublic personal information appear authorized under the statute to make disclosures consistent with those notices.
Limits on redisclosure and reuse when information is received under section 502(e). If a broker-dealer, fund, or registered adviser
These same general rules apply to a third party other than a broker-dealer, fund, or registered adviser that receives nonpublic personal information from a broker-dealer, fund, or registered adviser. Thus, the third party receiving the information under one of the section 502(e) exceptions may disclose the information to its affiliates or to the affiliates of the broker-dealer, fund, or registered adviser that made the disclosure. The third party also may disclose and use the information under one of the section 502(e) exceptions as noted in the rule. The affiliates of the third party may disclose and use the information only to the extent permissible for the third party.
Limits on redisclosure and reuse when information is not received under section 502(e). If a broker-dealer, fund, or registered adviser receives nonpublic personal information
If a third party receives information from a broker-dealer, fund, or registered adviser outside one of the section 502(e) exceptions, the third party may disclose to its affiliates or to the affiliates of the broker-dealer, fund, or registered adviser. The third party also may disclose to any other person if the disclosure would be lawful if made by the broker-dealer, fund, or registered
If an entity receives information outside of one of the section 502(e) exceptions, that entity will in essence “step into the shoes” of the broker-dealer, fund, or registered adviser that made the initial disclosures. Thus, if the broker-dealer, fund, or registered adviser made the initial disclosures after representing to its consumers that it had carefully screened the entities to whom it intended to disclose the information, the receiving entity must comply with those representations. Otherwise, the subsequent disclosure by the receiving entity would not comply with the notices given to consumers and would not, therefore, be lawful. Even if these representations do not prevent the recipient from redisclosing the information, the recipient's ability to redisclose will be limited by whatever opt out instructions the consumer gave to the broker-dealer, fund, or registered adviser making the initial disclosures and by any new opt out instructions the consumer gives after the initial disclosure. The receiving entity, therefore, must have procedures in place to monitor continually the status of who opts out and to what extent. Given these practical limitations on the ability of a recipient to disclose under another institution's privacy and opt out notices, entities are most likely to redisclose under one of the section 502(e) exceptions (as implemented by sections 248.14 and 248.15 of the final rule).
Monitoring third parties. Most commenters stated that financial institutions should not have to monitor compliance with the redisclosure and reuse provisions of the rule, and we have decided not to revise the rule to impose a specific duty on broker-dealers, funds, and registered advisers to monitor third parties' use of nonpublic personal information they provide. The rule does not, however, address whether obligations to monitor reuse and redisclosure may arise in other contexts. Most of the commenters who requested that we not impose such a duty stated that they have contracts in place that limit the recipient's use of the information. In addition, the limits on reuse as stated in the final rule provide a basis for an enforcement action to be brought against an entity that violates those limits.
We are revising the proposed rule regarding limits on sharing account number information for marketing purposes
Disclosures to a financial institution's agent or service provider. Several financial institutions stated that they use agents or service providers to conduct marketing on the institution's behalf. This might occur, for example, when a broker-dealer instructs a service provider that assists in the delivery of required regulatory notices to include a “statement stuffer” about the broker-dealer's products and services. We recognize the need to disclose account numbers in this instance, and believe that this kind of disclosure poses little risk to the consumer.
Several commenters argued that the final rule should exclude disclosures to agents because they effectively act as the financial institution in marketing the financial products and services of the broker-dealer, fund, or registered adviser. We are concerned, however, that the agent of these financial institutions may engage in practices contrary to the institution's instructions. While a broker-dealer, fund, or registered adviser frequently will use agents to assist it in marketing its products, providing agents access to a consumer's account number may erode a consumer's protections. Accordingly, we have added an exception to permit a broker-dealer, fund, or registered adviser to disclose account numbers to an agent for the purpose of marketing the institution's financial product or services as long as the agent has no authority to initiate charges to the account.
Encrypted numbers. Many commenters urged us to exercise our exemptive authority to permit the transmission of account numbers in encrypted form or to clarify that the prohibition applies only to disclosure to nonaffiliated third parties who are not subject to one of the exceptions under sections 248.13, 248.14, or 148.15. Several commenters noted that financial institutions frequently use encrypted account numbers and other internal identifiers of an account to ensure that a consumer's instructions are properly executed. The inability to continue using these internal identifiers would increase the likelihood of errors in processing a consumer's instructions. These commenters also noted that if internal identifiers are not used, a consumer would have to provide an account number in order to ensure proper handling of a request. This procedure could expose the consumer to a greater risk than would the use of an internal tracking system that preserves the confidentiality of a number that may be used to access the account. One commenter also noted that customer account numbers are protected by strict contractual confidentiality provisions.
We believe an encrypted account number without the key is not the same as the number itself and thus falls outside the prohibition in section 502(d). The G-L-B Act focuses on numbers that provide
Sections 248.13 through 248.15 of Regulation S-P include exceptions from
We are adopting substantially as proposed an exception to the opt out requirements for service providers and joint marketing, with revisions to clarify the rule's scope.
Commenters expressed concern that routine servicing agreements between a financial institution and, for instance, a customer account servicer would be subject to the requirements of the proposed rules.
A few commenters also argued that it is illogical to impose requirements on service providers that receive information under section 502(b)(2) when no requirements are imposed on service providers that receive information under section 502(e). We believe, however, that a plain reading of section 502(b)(2) leads to that result.
The Proposing Release requested comment on whether the rule should include safeguards beyond those provided by the G-L-B Act to protect a financial institution from the risks that can arise from agreements with third parties. The majority of commenters who addressed the issue argued that the rule should not. We agree that the protections set out in the statute, as implemented by section 248.13(a)(1), are adequate for purposes of the privacy rules. Those protections require a financial institution to provide the initial notice required by section 248.4 as well as to enter into a contractual agreement with a third party that prohibits the third party from disclosing or using the information other than to carry out the purposes for which the institution disclosed the information, including use under an exception in sections 248.14 or 248.15 in the ordinary course of business to carry out those purposes. These limitations will preclude recipients from sharing a consumer's nonpublic personal information through a chain of third party joint marketing agreements.
Many commenters recommended that the Commission permit broker-dealers, funds, and registered advisers to grandfather prior joint marketing and servicing agreements, or permit institutions to comply with the requirements by notifying existing service providers about the privacy rules' requirements. One commenter stated that without a grandfather provision, institutions would need more than six months to review prior agreements and negotiate amendments with third parties. We believe that a balance must be struck that minimizes interference with existing contracts while preventing evasions of the regulation. To achieve these goals, the final rule provides that contracts entered into on or before July 1, 2000 must be brought into compliance with the provisions of section 248.13 by July 1, 2002.
We have revised the proposed exceptions to notice and opt out requirements for processing and servicing transactions
We received many comments from broker-dealers, funds, and registered
Several other commenters requested that the final rule provide specific examples of situations that would fall within the exception for processing and servicing customer accounts (such as transfers from a broker-dealer to its registered representatives, or as necessary to arbitrate a dispute, with the consent of the consumer's fiduciary or representative). Others stated that certain services, such as those provided by attorneys, are “necessary” to effect, administer, or enforce a transaction. We believe that disclosures to these types of professionals and under the circumstances posited by the commenters may be necessary to effect, administer, or enforce a transaction in a given situation. However, we have not listed specific types of disclosures in the regulation as necessarily falling within the scope of the exception because we are concerned that a general statement could be applied inappropriately to shelter disclosures that, in fact, are not necessary to effect, administer, or enforce a transaction.
Other commenters suggested that the final rule clarify, in situations in which a financial institution uses an agent to provide services to a consumer, that the consumer does not have to request directly or authorize the service provider to provide the financial product or service but may request it from the financial institution instead. For example, a consumer may ask the fund or its transfer agent for additional account information that the transfer agent provides as a service for the fund. We agree that the communication may be between the consumer and the service provider, and note that the rule governing agents as set out in the definition of “consumer” above provides the flexibility sought by the commenters. An individual will not be a consumer of an entity that is acting as agent for a broker-dealer, fund, or registered adviser in connection with that institution's providing a financial product or service to the consumer.
We are adopting as proposed the section that includes “other” exceptions to the notice and opt out requirements. As noted above, section 502(e) of the G-L-B Act contains several exceptions to the requirements that otherwise would apply to the disclosures of nonpublic personal information to nonaffiliated third parties. The proposed rule set out those exceptions for disclosures that are not made in connection with the administration, processing, servicing, or sale of a consumer's account, and made stylistic changes to the statutory language that were intended to clarify the exceptions.
Several commenters responded to the request for comment on whether the consent exception should include consumer safeguards, such as a requirement that the consent be written, be indicated by a signature on a separate line, or automatically terminate after a certain period of time. Some commenters favored the additional safeguards discussed in the proposal, while others maintained that safeguards are unnecessary. Several suggested that the consent exception include a provision noting that participation in a program where a consumer receives “bundled” products and services necessarily implies consent to the disclosure of information between the entities that provide the bundled products or services. Others suggested that certain terms and conditions be imposed on any consent agreement, such as a time by which the financial institution must stop disclosing nonpublic personal information once a consent is revoked.
We have declined to elaborate on the requirements for obtaining consent or the consumer safeguards that should be in place when a consumer consents. We believe that the resolution of this issue is appropriately left to the particular circumstances of a given transaction. We note that any broker-dealer, fund, or registered adviser that obtains the consent of a consumer to disclose nonpublic personal information should take steps to ensure that the limits of the consent are well understood by both the institution and the consumer. We also note that a consumer may always revoke his or her consent. In light of the safeguards already in place, we have decided not to adopt additional safeguards in the consent exception.
Many commenters offered specific suggestions for additional exceptions or revisions to the proposed exceptions. In some cases, the suggestions are accommodated elsewhere in the regulation (such as exceptions to permit disclosures to independent contractor registered representatives or attorneys to effect a transaction).
Sections 248.16 through 248.18 of Regulation S-P include provisions that explain the interaction between the regulation and certain other laws, and that provide an effective date and compliance date for the regulation.
We are adopting as proposed the section that explains the interaction between Regulation S-P and the Fair Credit Reporting Act.
Comments about this provision focused on whether the Commission, by requiring annual notice of a consumer's right to opt out under the FCRA, was modifying, limiting, or superseding the operation of the FCRA. For the reasons explained in the discussion of section 248.6, above, we do not believe that the annual disclosure mandated by the G-L-B Act affects in any way the obligations imposed by the FCRA.
We are adopting as proposed the section that explains the interaction between Regulation S-P and State laws.
Commenters on this section expressed concern about the potential differences between federal and State privacy laws. Several supported coordination and cooperation among federal and State regulators to ensure consistency in privacy policies. Some commenters requested clarification of whether a particular State law would be considered more restrictive, while others suggested that the final rules establish a choice of law principle for financial institutions operating in more than one State. These and other suggestions made by the commenters appear to exceed the scope of this rulemaking.
We are adopting as proposed the effective date for Regulation S-P of November 13, 2000, and are providing a compliance date of July 1, 2001.
Section 510 of the G-L-B Act states that, as a general rule, the relevant provisions of Title V take effect six months after the date on which rules are required to be adopted,
The Congressional Privacy Caucus, several members of Congress, and other commenters have urged the Commission and the Agencies not to delay the effective date past the date set forth in the G-L-B Act.
Many commenters also stated that a 30-day phase-in for initial notices to existing customers is not feasible, given the large number of notices, the short period of time allowed, and the competing demands on financial institutions at the time when the initial notices must be sent. A few suggested that the rule require initial notices to be sent only to people who establish customer relationships after the effective date of the rule, and allow a financial institution to send annual notices to existing customers at some point during the next 12 months and annually thereafter.
We agree that six months may be insufficient in certain instances for a financial institution to have ensured that its forms, systems, and procedures comply with the rule. In order to accommodate situations requiring additional time, we will give financial institutions until July 1, 2001 to be in full compliance with the regulation. Financial institutions are expected, however, to begin compliance efforts promptly, to use the period prior to June 30, 2001 to implement and test their systems, and to be in full compliance by July 1, 2001. Given that this provides financial institutions more than 12 months in which to comply with the rules, we have determined that there no longer is any need for a separate phase-in for providing initial notices. Thus, a financial institution will need to deliver all required opt out notices and initial notices before July 1, 2001. We believe that this extension represents a fair balance between those seeking prompt implementation of the protections afforded by the statute and those concerned about the reliability of the systems that are put in place.
We encourage financial institutions to provide disclosures as soon as practicable. Broker-dealers, funds, and registered agents that do not disclose nonpublic personal information to third parties have fewer burdens under the regulation (both in terms of the notice requirements and opt out mechanism) and should therefore be able to provide privacy notices to their consumers sooner. Depending on the readiness of an institution to process opt out elections, institutions might wish to consider including the privacy and opt out notices in the same mailing as is used to provide tax information or account statements to consumers in the first quarter of 2001 to increase the likelihood that a consumer will not mistake the notices for an unwanted solicitation.
The extension of the compliance date should provide much of the relief sought by those who suggested that initial notices should not be required for existing customers. By allowing financial institutions to deliver notices over a significantly longer period of time than was proposed, the concentrated burden that would have been imposed by the proposed rules is avoided. Accordingly, we have not adopted the suggestion that initial notices be required only for new customers after the effective date of the rule.
Broker-dealers, funds, and registered advisers need not give initial notices to customers whose relationships have terminated before the date by which institutions must be in compliance with the rules. Thus, if an account is inactive according to a financial institution's policies before July 1, 2001, then no initial notice would be required in connection with that account. However, because these former customers would remain consumers, a broker-dealer, fund, or registered adviser would have to provide a privacy and opt out notice to them if the institution intended to disclose their nonpublic personal information to nonaffiliated third parties beyond the exceptions in sections 248.14 and 248.15.
Full compliance with the rules' restrictions on disclosures is required on July 1, 2001. To be in full compliance, broker-dealers, funds, and registered advisers must have provided their existing customers with a privacy notice, an opt out notice, and a reasonable amount of time to opt out before that date. If these have not been provided, the disclosure restrictions will apply. This means that a broker-dealer, fund, or registered adviser would have to cease sharing customers' nonpublic personal information with nonaffiliated third parties on that date, unless it may share the information under an exception under sections 248.14 or 248.15. Broker-dealers, funds, and registered advisers that both provide the required notices and allow a reasonable period of time to opt out before July 1, 2001, may continue to share nonpublic personal information after that date for customers who do not opt out.
Commenters on this section supported the proposal, and we are adopting this section as proposed. Section 501 of the G-L-B Act directs the Commission (and the Agencies) to establish appropriate standards for financial institutions relating to administrative, technical, and physical safeguards to protect customer records and information. The rules implement this section by requiring every broker-dealer, fund, and registered adviser to adopt policies and procedures to address the safeguards described above. Consistent with the Act, the proposed rule further requires that the policies and procedures be reasonably designed to: (i) insure the security and confidentiality of customer records and information; (ii) protect against any anticipated threats or hazards to the security or integrity of customer records and information; and (iii) protect against unauthorized access to or use of customer records or information that could result in substantial harm or inconvenience to any customer.
Some commenters recommended that the Commission add an example to clarify that various financial institutions in a fund complex could satisfy the rule by adopting a single set of policies and procedures for the fund complex. We believe that a single set of policies and procedures for a fund complex could satisfy the rule's requirements, as long as those policies and procedures have been determined to be appropriate for each institution to which they apply.
In order to provide additional guidance to broker-dealers, funds, and registered advisers concerning the level of detail we believe is appropriate under the Act, we have prepared a variety of sample clauses for institutions to consider. We urge broker-dealers, funds, and registered advisers to carefully review whether these clauses accurately reflect a given institution's policies and practices before using the clauses. Broker-dealers, funds, and registered advisers are free to use different language and to include additional detail as they think is appropriate in their notices.
Below is a chart showing the comparison of the sections in the final privacy rules and the proposal. Only changes are noted.
To minimize the burden and costs to a broker-dealer, fund, or registered adviser (“you”) and generally clarify the operation of the final rules, we have included this guidance that you may use in conjunction with the sample clauses in the Appendix. This guidance specifically applies to you if you:
(1) do not have any affiliates;
(2) only disclose nonpublic personal information to nonaffiliated third parties in accordance with an exception under sections 248.14 or 248.15, such as in connection with servicing or processing a financial product or service that a consumer requests or authorizes; and
(3) do not reserve the right to disclose nonpublic personal information to
In addition, if you disclose nonpublic personal information in accordance with the exception in section 248.13 (for service providers and joint marketers) you also must include an accurate description of that information, as illustrated by the sample clause in section (K) below.
In general, if you disclose nonpublic personal information to nonaffiliated third parties only as authorized under an exception, then your only responsibilities under the regulation are to provide initial and annual privacy notices to each of your customers. You do not need to provide an opt out notice or opt out rights to your customers.
A.
B.
If one of your existing customers obtains a new financial product or service from you, then you need not provide another initial notice to that customer (section 248.4(d)) if the earlier notice covered the subsequent product.
For instance, if Alison Individual walks into Broker-Dealer for the first time on July 2, 2001, to open a cash account, then Broker-Dealer complies with section 248.4(a)(1) of the rules if it provides an initial notice to Alison together with the account agreement. When Alison opens her cash account, she becomes a customer of Broker-Dealer. Alison maintains her cash account and, six months later, returns to the Broker-Dealer to open a margin account. If the initial notice that the Broker-Dealer provided to Alison was accurate with respect to the margin account, then the Broker-Dealer need not provide another initial notice to her when she opens the margin account because it has provided a notice to Alison that covered the margin account when she opened her cash account.
C.
D.
E.
For example, assume that Broker-Dealer defines the 12-consecutive-month period as a calendar year and provides annual notices to all of its customers on October 1 of each year. If Alison Individual opens a cash account with Broker-Dealer on July 2, 2001, thereby becoming a customer, then Broker-Dealer must provide an initial notice to Alison together with the account agreement or earlier. Broker-Dealer must provide an annual notice to Alison by December 31, 2002. If Broker-Dealer provides an annual notice to Alison on October 1, 2002, as it does for other customers, then it must provide the next annual notice to Alison not later than October 1, 2003.
F.
G.
H.
• The categories of nonpublic personal information that you collect (section 248.6(a)(1));
• The fact that you do not disclose nonpublic personal information about your current and former customers to affiliates or nonaffiliated third parties, except as authorized by sections 248.14 and 248.15 (section 248.6(a)(2)-(4)). When describing the categories with respect to those parties, you are required to state only that you make disclosures to other nonaffiliated third parties as permitted by law (section 248.6(c));
• Your policies and practices with respect to protecting the confidentiality and security of nonpublic personal information (section 248.6(a)(8)).
For each of these items of information above, you may use a sample clause from the Appendix.
You may use a sample clause only if that clause accurately describes your actual policies and practices.
I.
•
•
•
J.
K.
L.
The Commission is sensitive to the costs and benefits that result from its rules and understands that the rules may impose costs on broker-dealers, funds, and registered advisers. Nevertheless, the rules implement the privacy provisions of Title V and, we believe, impose no costs in addition to those that would result from compliance with the G-L-B Act.
We believe that the requirements to provide opt out notices and to protect customer information will benefit consumers and customers by protecting the privacy of their nonpublic personal information. In addition, the requirements to provide initial and annual privacy notices will allow customers to compare the privacy policies of financial institutions.
We also believe that the rules provide greater certainty to the private sector on how to comply with the G-L-B Act because they are consistent with and comparable to the rules adopted by the Agencies. The examples in the rules and the sample clauses in the Appendix also should provide guidance on how the rules will be enforced with respect to broker-dealers, funds, and registered advisers. Finally, in order to reduce compliance burdens, the rules allow broker-dealers, funds, and registered advisers flexibility to distribute notices and to adopt policies and procedures to protect customer information that are best suited to the institution's business and needs. These benefits are difficult to quantify, and we received no data from commenters.
We estimate that approximately 5500 broker-dealers, 4300 funds, and 8100 registered advisers will be required to comply with the rules. In the first year after the rules are adopted, these institutions must comply with the following requirements: (i) Prepare notices describing the institution's privacy policies; (ii) provide an initial privacy notice and opt out notice to each consumer; (iii) provide an initial privacy notice to each new customer (who did not receive a notice when he or she was a consumer); (iv) provide an annual privacy notice to each existing customer; (v) adopt policies and procedures that address the protection of customer information and records. After the first year, broker-dealers, funds, and registered advisers would be required to revise notices only to reflect changes in their privacy policies. Similarly, these institutions would have to revise their policies and procedures on safeguarding customer information as appropriate to ensure the protection of the information.
In the Proposing Release, we estimated certain costs of complying with the proposed rules.
We received two comments on the cost-benefit analysis, both of which opined that we underestimated the costs and burdens of complying with Regulation S-P. One commenter suggested that we increase our estimate of the cost to mail annual notices to reflect the cost of providing revised privacy notices.
These commenters further noted that our estimates did not address other costs of compliance, including: Modifying existing systems and databases, developing new systems to track delivery of privacy notices and (if necessary) opt out elections, and training personnel. One commenter estimated that the overall cost of implementing the rules for a large firm would be at least $1 million. The other commenter provided no estimates for these additional costs. Neither commenter provided any specific data to explain the amount of time or the costs associated with the time they believe will be required to implement the rules.
The cost of developing and maintaining records of delivery of privacy notices and opt out elections, and costs for personnel training will vary greatly depending upon the size of the financial institution, its customer base, number of affiliates, and the extent to which the institution intends to share information. We have been unable to obtain any reliable information with which to quantify the amount of these costs. We recognize that the costs for a large institution that shares information with affiliates and nonaffiliated third parties and that has many customers may exceed $1 million, and that this could increase the compliance costs of the rules. We also believe that the costs for a small institution, such as a registered adviser, that has far fewer customers and does not share with affiliates or nonaffiliated third parties will be significantly less.
As discussed above, the privacy notices will allow customers of broker-dealers, funds, and registered advisers to compare the privacy policies of different institutions. This information is likely to result in some customers moving their accounts or relationships from one institution to another whose policies are better suited to the customers' needs. We are unable to estimate the number of customers who may make this transfer or the resulting economic impact on the industry. We do not believe, however, that customers would move their accounts from broker-dealers, funds, or investment advisers to a different type of financial institution (such as a bank), because we have no basis for assuming that the privacy policies adopted by 17,900 broker-dealers, investment companies, and registered investment advisers would not be sufficiently varied to address the needs of any customer.
Certain provisions of the rules contain “collection of information” requirements within the meaning of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The Commission published notice soliciting comments on the collection of information requirements in the Proposing Release,
The Commission has prepared a Final Regulatory Flexibility Analysis (“FRFA” or “analysis”) for Regulation S-P in accordance with 5 U.S.C. 604. The following summarizes the FRFA. A copy of the FRFA may be obtained by contacting Penelope W. Saltzman, Securities and Exchange Commission, 450 5th Street, NW., Washington, DC 20549-0506.
The analysis explains that Regulation S-P implements provisions of Title V and that, in general, Title V requires financial institutions to provide notice to consumers about the institution's privacy policies and practices. The statute also restricts the ability of a financial institution to share nonpublic personal information about consumers with nonaffiliated third parties, and allows consumers to prevent the institution from sharing nonpublic personal information about them with certain nonaffiliated third parties by “opting out” of the information sharing. In addition, Title V requires the Commission to establish appropriate standards for financial institutions subject to their jurisdiction to safeguard customer information and records.
Section 504 of the G-L-B Act authorizes the Commission and the Agencies to prescribe “such regulations as may be necessary” to carry out the purposes of Title V. As discussed in the analysis, we believe that by adopting rules implementing Title V that are consistent with and comparable to those of the Agencies, we will provide the private sector greater certainty on how to comply with the statute and clearer guidance on how the rules will be enforced with respect to the financial institutions subject to Title V that are under the Commission's jurisdiction.
The analysis states that the Proposing Release solicited comments on the IRFA, but we received none. Several commenters who addressed the proposed rules, however, suggested that the Commission reduce compliance burdens by, among other things, providing model forms, providing additional examples, adding additional flexibility for providing the initial notice, and extending the effective date. In response to these comments, we have
As explained in the analysis, the rules will affect all broker-dealers, funds, and registered advisers, including small entities.
The analysis explains that subject to certain exceptions, the rules generally require that a financial institution provide all of its
The rules also require a financial institution to provide its
The many exceptions to the general rules stated above are set forth in sections 248.13, 248.14, and 248.15. The analysis notes that in cases in which a financial institution enters into a contract with a nonaffiliated third party to undertake joint marketing or to have the third party perform certain functions on behalf of the institution, no opt out notice need be given. In those cases, the institution must disclose to the consumer that it is providing the information and enter into a contract with the third party that restricts the third party's use of the information and requires the third party to maintain confidentiality of the information.
As discussed in the analysis, compliance requirements will vary depending, for example, on an institution's information sharing practices, whether the institution already has or discloses a privacy policy, and whether the institution already has established an opt out mechanism. A financial institution would have to summarize its practices regarding its collection, sharing, and safeguarding of certain nonpublic personal information in its initial and annual notices. However, if the institution does not share that information (or shares only to the extent permitted under the exceptions), its privacy notice may be brief. We believe that many financial institutions already have privacy policies in place as part of usual and customary business practices, and that many broker-dealers, funds, and investment advisers currently do not share nonpublic personal information about consumers with nonaffiliated third parties except as would be consistent with one of the many exceptions in the rules.
To minimize the burden and costs of distributing privacy policies, the rules do not specify the method for distributing required notices. As discussed more fully in the analysis, a financial institution may include an initial privacy statement with other required disclosure statements, and may include an annual notice with periodic account statements. We estimate that the costs of distributing the notices will be minimal because an institution will include the notices in mailings or distributions that it already sends to consumers and customers.
The analysis explains that the rules require every broker-dealer, fund, and registered adviser to adopt policies and procedures reasonably designed to safeguard customer records and information. The IRFA noted, and we continue to believe, that most if not all financial institutions already have policies and procedures to address the safety and confidentiality of consumer records and information. Nevertheless, financial institutions may review and revise their policies after the rules are adopted. The amount of time an institution will spend reviewing and revising its policies will depend, among other things, on the institution's current policies and its sharing practices. The rules do not specify the means by which institutions must ensure the safety of customer information and records in order to allow each institution to tailor its policies and procedures to its own systems of information gathering and transfer, and the needs of its customers. As noted in the IRFA, Commission staff estimated that in the first year after the rules are adopted, a financial institution would spend an average of 30 hours to adopt or revise its policies.
Two commenters argued that we underestimated the costs of implementing Regulation S-P. As explained in the analysis, the commenters did not provide estimates of the amount of time or the costs to implement the rules. We have been unable to obtain reliable information regarding these costs. Therefore, we have not provided an estimate of the cost of implementing the rules for
The analysis explains that the Regulatory Flexibility Act directs the Commission to consider significant alternatives that would accomplish the stated objective, while minimizing any significant adverse impact on small entities. As noted above, we believe that a number of revisions made to the final rules will benefit small entities. Finally, the analysis notes that the rules contain performance rather than design standards. The rules do not specify the (i) form of privacy notices, (ii) method of delivery of the notices to customers and consumers, or (iii) policies and procedures that broker-dealers, funds, and registered advisers must adopt to ensure the privacy of the financial information and records of their customers and consumers. Therefore, the rules provide these entities substantial flexibility that allows them to meet the requirements of Regulation S-P in a way that best suits the institution's individual needs.
Section 23(a)(2) of the Exchange Act
Other financial institutions will be subject to substantially similar privacy notice and opt out requirements under rules adopted by the Agencies.
The rules do not dictate the privacy policies of any financial institution. Some customers may move their accounts from one institution to another based on the institution's privacy policies. Thus, the rules may promote competition among financial institutions based on customers' preferences regarding privacy policies.
Section 3(f) of the Exchange Act
The Commission is adopting Regulation S-P under the authority set forth in section 504 of the G-L-B Act [15 U.S.C. 6804], sections 17 and 23 of the Exchange Act [15 U.S.C. 78q, 78w], sections 31 and 38 of the Investment Company Act [15 U.S.C. 80a-30(a), 80a-37], and sections 204 and 211 of the Investment Advisers Act [15 U.S.C. 80b-4, 80b-11].
Brokers, Dealers, Investment advisers, Investment companies, Privacy, Reporting and recordkeeping requirements.
15 U.S.C. 6801-6809; 15 U.S.C. 78q, 78w, 80a-30(a), 80a-37, 80b-4, and 80b-11.
(a)
(1) Requires a financial institution to provide notice to customers about its privacy policies and practices;
(2) Describes the conditions under which a financial institution may disclose nonpublic personal information about consumers to nonaffiliated third parties; and
(3) Provides a method for consumers to prevent a financial institution from disclosing that information to most nonaffiliated third parties by “opting
(b)
The examples in this part and the sample clauses in appendix A of this part provide guidance concerning the rule's application in ordinary circumstances. The facts and circumstances of each individual situation, however, will determine whether compliance with an example or use of a sample clause, to the extent applicable, constitutes compliance with this part.
As used in this part, unless the context requires otherwise:
(a)
(1) That company is regulated under Title V of the G-L-B Act by the Federal Trade Commission or by a Federal functional regulator other than the Commission; and
(2) Rules adopted by the Federal Trade Commission or another federal functional regulator under Title V of the G-L-B Act treat the broker, dealer, or investment company, or investment adviser registered with the Commission as an affiliate of that company.
(b)
(c)(1)
(2)
(A) Present the information in the notice in clear, concise sentences, paragraphs, and sections;
(B) Use short explanatory sentences or bullet lists whenever possible;
(C) Use definite, concrete, everyday words and active voice whenever possible;
(D) Avoid multiple negatives;
(E) Avoid legal and highly technical business terminology whenever possible; and
(F) Avoid explanations that are imprecise and readily subject to different interpretations.
(ii)
(A) Use a plain-language heading to call attention to the notice;
(B) Use a typeface and type size that are easy to read;
(C) Provide wide margins and ample line spacing;
(D) Use boldface or italics for key words; and
(E) Use distinctive type size, style, and graphic devices, such as shading or sidebars when you combine your notice with other information.
(iii)
(A) Place the notice on a screen that consumers frequently access, such as a page on which transactions are conducted; or
(B) Place a link on a screen that consumers frequently access, such as a page on which transactions are conducted, that connects directly to the notice and is labeled appropriately to convey the importance, nature, and relevance of the notice.
(d)
(e)
(f)
(g)(1)
(2)
(ii) An individual is not your consumer if he or she provides you only with his or her name, address, and general areas of investment interest in connection with a request for a prospectus, an investment adviser brochure, or other information about financial products or services.
(iii) An individual is not your consumer if he or she has an account with another broker or dealer (the introducing broker-dealer) that carries securities for the individual in a special omnibus account with you (the clearing broker-dealer) in the name of the introducing broker-dealer, and when you receive only the account numbers and transaction information of the introducing broker-dealer's consumers in order to clear transactions.
(iv) If you are an investment company, an individual is not your consumer when the individual purchases an interest in shares you have issued only through a broker or dealer or investment adviser who is the record owner of those shares.
(v) An individual who is a consumer of another financial institution is not your consumer solely because you act as agent for, or provide processing or other services to, that financial institution.
(vi) An individual is not your consumer solely because he or she has designated you as trustee for a trust.
(vii) An individual is not your consumer solely because he or she is a beneficiary of a trust for which you are a trustee.
(viii) An individual is not your consumer solely because he or she is a participant or a beneficiary of an employee benefit plan that you sponsor or for which you act as a trustee or fiduciary.
(h)
(i)
(j)
(k)(1)
(2)
(A) The consumer has a brokerage account with you, or if a consumer's account is transferred to you from another broker-dealer;
(B) The consumer has an investment advisory contract with you (whether written or oral);
(C) The consumer is the record owner of securities you have issued if you are an investment company;
(D) The consumer holds an investment product through you, such as when you act as a custodian for securities or for assets in an Individual Retirement Arrangement;
(E) The consumer purchases a variable annuity from you;
(F) The consumer has an account with an introducing broker or dealer that clears transactions with and for its customers through you on a fully disclosed basis;
(G) You hold securities or other assets as collateral for a loan made to the consumer, even if you did not make the loan or do not effect any transactions on behalf of the consumer; or
(H) You regularly effect or engage in securities transactions with or for a consumer even if you do not hold any assets of the consumer.
(ii)
(1)
(m)
(1) The Board of Governors of the Federal Reserve System;
(2) The Office of the Comptroller of the Currency;
(3) The Board of Directors of the Federal Deposit Insurance Corporation;
(4) The Director of the Office of Thrift Supervision;
(5) The National Credit Union Administration Board; and
(6) The Securities and Exchange Commission.
(n)(1)
(2)
(i) Any person or entity with respect to any financial activity that is subject to the jurisdiction of the Commodity Futures Trading Commission under the Commodity Exchange Act (7 U.S.C. 1
(ii) The Federal Agricultural Mortgage Corporation or any entity chartered and operating under the Farm Credit Act of 1971 (12 U.S.C. 2001
(iii) Institutions chartered by Congress specifically to engage in securitizations, secondary market sales (including sales of servicing rights), or similar transactions related to a transaction of a consumer, as long as such institutions do not sell or transfer nonpublic personal information to a nonaffiliated third party.
(o)(1)
(2)
(p)
(q)
(r)
(s)(1)
(i) Your affiliate; or
(ii) A person employed jointly by you and any company that is not your affiliate (but
(2)
(t)(1)
(i) Personally identifiable financial information; and
(ii) Any list, description, or other grouping of consumers (and publicly available information pertaining to them) that is derived using any personally identifiable financial information that is not publicly available information.
(2)
(i) Publicly available information, except as included on a list described in paragraph (t)(1)(ii) of this section or when the publicly available information is disclosed in a manner that indicates the individual is or has been your consumer; or
(ii) Any list, description, or other grouping of consumers (and publicly available information pertaining to them) that is derived without using any personally identifiable financial
(3)
(ii) Nonpublic personal information does not include any list of individuals' names and addresses that contains only publicly available information, is not derived in whole or in part using personally identifiable financial information that is not publicly available information, and is not disclosed in a manner that indicates that any of the individuals on the list is a consumer of a financial institution.
(u)(1)
(i) A consumer provides to you to obtain a financial product or service from you;
(ii) About a consumer resulting from any transaction involving a financial product or service between you and a consumer; or
(iii) You otherwise obtain about a consumer in connection with providing a financial product or service to that consumer.
(2)
(A) Information a consumer provides to you on an application to obtain a loan, credit card, or other financial product or service;
(B) Account balance information, payment history, overdraft history, and credit or debit card purchase information;
(C) The fact that an individual is or has been one of your customers or has obtained a financial product or service from you;
(D) Any information about your consumer if it is disclosed in a manner that indicates that the individual is or has been your consumer;
(E) Any information that a consumer provides to you or that you or your agent otherwise obtain in connection with collecting on a loan or servicing a loan;
(F) Any information you collect through an Internet “cookie” (an information collecting device from a web server); and
(G) Information from a consumer report.
(ii)
(A) A list of names and addresses of customers of an entity that is not a financial institution; or
(B) Information that does not identify a consumer, such as aggregate information or blind data that does not contain personal identifiers such as account numbers, names, or addresses.
(v)(1)
(i) Federal, State, or local government records;
(ii) Widely distributed media; or
(iii) Disclosures to the general public that are required to be made by federal, State, or local law.
(2)
(B) You have a reasonable belief that information about your consumer is made available to the general public if you have taken steps to submit the information, in accordance with your internal procedures and policies and with applicable law, to a keeper of federal, State, or local government records that is required by law to make the information publicly available.
(C) You have a reasonable belief that an individual's telephone number is lawfully made available to the general public if you have located the telephone number in the telephone book or the consumer has informed you that the telephone number is not unlisted.
(D) You do not have a reasonable belief that information about a consumer is publicly available solely because that information would normally be recorded with a keeper of federal, State, or local government records that is required by law to make the information publicly available, if the consumer has the ability in accordance with applicable law to keep that information nonpublic, such as where a consumer may record a deed in the name of a blind trust.
(ii)
(iii)
(w)
(1) Any broker or dealer;
(2) Any investment company; and
(3) Any investment adviser registered with the Commission under the Investment Advisers Act of 1940.
(a)
(1)
(2)
(b)
(1) You do not disclose any nonpublic personal information about the consumer to any nonaffiliated third party, other than as authorized by §§ 248.14 and 248.15; and
(2) You do not have a customer relationship with the consumer.
(c)
(2)
(3)
(i) Effects a securities transaction with you or opens a brokerage account with you under your procedures;
(ii) Opens a brokerage account with an introducing broker or dealer that clears transactions with and for its customers through you on a fully disclosed basis;
(iii) Enters into an advisory contract with you (whether in writing or orally); or
(iv) Purchases shares you have issued (and the consumer is the record owner of the shares), if you are an investment company.
(d)
(1) You may provide a revised privacy notice, under § 248.8, that covers the customer's new financial product or service; or
(2) If the initial, revised, or annual notice that you most recently provided to that customer was accurate with respect to the new financial product or service, you do not need to provide a new privacy notice under paragraph (a) of this section.
(e)
(i) Establishing the customer relationship is not at the customer's election;
(ii) Providing notice not later than when you establish a customer relationship would substantially delay the customer's transaction and the customer agrees to receive the notice at a later time; or
(iii) A nonaffiliated broker or dealer or investment adviser establishes a customer relationship between you and a consumer without your prior knowledge.
(2)
(ii)
(iii)
(f)
(a)(1)
(2)
(b)(1)
(2)
(i) The individual's brokerage account is closed;
(ii) The individual's investment advisory contract is terminated;
(iii) You are an investment company and the individual is no longer the record owner of securities you have issued; or
(iv) You are an investment company and your customer has been determined to be a lost securityholder as defined in 17 CFR 240.17a-24(b).
(c)
(d)
(a)
(1) The categories of nonpublic personal information that you collect;
(2) The categories of nonpublic personal information that you disclose;
(3) The categories of affiliates and nonaffiliated third parties to whom you disclose nonpublic personal information, other than those parties to whom you disclose information under §§ 248.14 and 248.15;
(4) The categories of nonpublic personal information about your former customers that you disclose and the categories of affiliates and nonaffiliated third parties to whom you disclose nonpublic personal information about your former customers, other than those parties to whom you disclose information under §§ 248.14 and 248.15;
(5) If you disclose nonpublic personal information to a nonaffiliated third party under § 248.13 (and no other exception applies to that disclosure), a separate statement of the categories of information you disclose and the categories of third parties with whom you have contracted;
(6) An explanation of the consumer's right under § 248.10(a) to opt out of the disclosure of nonpublic personal information to nonaffiliated third parties, including the method(s) by which the consumer may exercise that right at that time;
(7) Any disclosures that you make under section 603(d)(2)(A)(iii) of the Fair Credit Reporting Act (15 U.S.C. 1681a(d)(2)(A)(iii)) (that is, notices regarding the ability to opt out of disclosures of information among affiliates);
(8) Your policies and practices with respect to protecting the confidentiality and security of nonpublic personal information; and
(9) Any disclosure that you make under paragraph (b) of this section.
(b)
(c)
(i) Information from the consumer;
(ii) Information about the consumer's transactions with you or your affiliates;
(iii) Information about the consumer's transactions with nonaffiliated third parties; and
(iv) Information from a consumer-reporting agency.
(2)
(ii) If you reserve the right to disclose all of the nonpublic personal information about consumers that you collect, you may simply state that fact without describing the categories or examples of the nonpublic personal information you disclose.
(3)
(i) Financial service providers;
(ii) Non-financial companies; and
(iii) Others.
(4)
(i) List the categories of nonpublic personal information you disclose, using the same categories and examples you used to meet the requirements of paragraph (a)(2) of this section, as applicable; and
(ii) State whether the third party is:
(A) A service provider that performs marketing services on your behalf or on behalf of you and another financial institution; or
(B) A financial institution with which you have a joint marketing agreement.
(5)
(6)
(i) Describe in general terms who is authorized to have access to the information; and
(ii) State whether you have security practices and procedures in place to ensure the confidentiality of the information in accordance with your policy. You are not required to describe technical information about the safeguards you use.
(d)
(2) A short-form initial notice must:
(i) Be clear and conspicuous;
(ii) State that your privacy notice is available upon request; and
(iii) Explain a reasonable means by which the consumer may obtain the privacy notice.
(3) You must deliver your short-form initial notice according to § 248.9. You are not required to deliver your privacy notice with your short-form initial notice. You instead may simply provide the consumer a reasonable means to obtain your privacy notice. If a consumer who receives your short-form notice requests your privacy notice, you must deliver your privacy notice according to § 248.9.
(4)
(i) Provide a toll-free telephone number that the consumer may call to request the notice; or
(ii) For a consumer who conducts business in person at your office, maintain copies of the notice on hand that you provide to the consumer immediately upon request.
(e)
(1) Categories of nonpublic personal information that you reserve the right to disclose in the future, but do not currently disclose; and
(2) Categories of affiliates or nonaffiliated third parties to whom you reserve the right in the future to disclose, but to whom you do not currently disclose, nonpublic personal information.
(f)
(a)(1)
(i) That you disclose or reserve the right to disclose nonpublic personal information about your consumer to a nonaffiliated third party;
(ii) That the consumer has the right to opt out of that disclosure; and
(iii) A reasonable means by which the consumer may exercise the opt out right.
(2)
(A) Identify all of the categories of nonpublic personal information that you disclose or reserve the right to disclose, and all of the categories of nonaffiliated third parties to which you disclose the information, as described in § 248.6(a)(2) and (3) and state that the consumer can opt out of the disclosure of that information; and
(B) Identify the financial products or services that the consumer obtains from you, either singly or jointly, to which the opt out direction would apply.
(ii)
(A) Designate check-off boxes in a prominent position on the relevant forms with the opt out notice;
(B) Include a reply form together with the opt out notice;
(C) Provide an electronic means to opt out, such as a form that can be sent via electronic mail or a process at your web site, if the consumer agrees to the electronic delivery of information; or
(D) Provide a toll-free telephone number that consumers may call to opt out.
(iii)
(A) The only means of opting out is for the consumer to write his or her own letter to exercise that opt out right; or
(B) The only means of opting out as described in any notice subsequent to the initial notice is to use a check-off box that you provided with the initial notice but did not include with the subsequent notice.
(iv)
(b)
(c)
(d)
(2) Any of the joint consumers may exercise the right to opt out. You may either:
(i) Treat an opt out direction by a joint consumer as applying to all of the associated joint consumers; or
(ii) Permit each joint consumer to opt out separately.
(3) If you permit each joint consumer to opt out separately, you must permit one of the joint consumers to opt out on behalf of all of the joint consumers.
(4) You may not require
(5)
(i) Send a single opt out notice to John's address, but you must accept an opt out direction from either John or Mary;
(ii) Treat an opt out direction by either John or Mary as applying to the entire account. If you do so, and John opts out, you may not require Mary to opt out as well before implementing John's opt out direction; or
(iii) Permit John and Mary to make different opt out directions. If you do so:
(A) You must permit John and Mary to opt out for each other.
(B) If both opt out, you must permit both to notify you in a single response (such as on a form or through a telephone call).
(C) If John opts out and Mary does not, you may only disclose nonpublic personal information about Mary, but not about John and not about John and Mary jointly.
(e)
(f)
(g)
(2) When a customer relationship terminates, the customer's opt out direction continues to apply to the nonpublic personal information that you collected during or related to that relationship. If the individual subsequently establishes a new customer relationship with you, the opt out direction that applied to the former relationship does not apply to the new relationship.
(h)
(a)
(1) You have provided to the consumer a clear and conspicuous revised notice that accurately describes your policies and practices;
(2) You have provided to the consumer a new opt out notice;
(3) You have given the consumer a reasonable opportunity, before you disclose the information to the nonaffiliated third party, to opt out of the disclosure; and
(4) The consumer does not opt out.
(b)
(i) Disclose a new category of nonpublic personal information to any nonaffiliated third party;
(ii) Disclose nonpublic personal information to a new category of nonaffiliated third party; or
(iii) Disclose nonpublic personal information about a former customer to a nonaffiliated third party, if that former customer has not had the opportunity to exercise an opt out right regarding that disclosure.
(2) A revised notice is not required if you disclose nonpublic personal information to a new nonaffiliated third party that you adequately described in your prior notice.
(c)
(a)
(b)(1)
(i) Hand-deliver a printed copy of the notice to the consumer;
(ii) Mail a printed copy of the notice to the last known address of the consumer;
(iii) For the consumer who conducts transactions electronically, post the notice on the electronic site and require the consumer to acknowledge receipt of the notice as a necessary step to obtaining a particular financial product or service; or
(iv) For an isolated transaction with the consumer, such as an ATM transaction, post the notice on the ATM screen and require the consumer to acknowledge receipt of the notice as a necessary step to obtaining the particular financial product or service.
(2)
(i) Only post a sign in your branch or office or generally publish advertisements of your privacy policies and practices; or
(ii) Send the notice via electronic mail to a consumer who does not obtain a financial product or service from you electronically.
(c)
(i) The customer uses your web site to access financial products and services electronically and agrees to receive notices at the web site and you post your current privacy notice continuously in a clear and conspicuous manner on the web site; or
(ii) The customer has requested that you refrain from sending any information regarding the customer relationship, and your current privacy notice remains available to the customer upon request.
(2)
(d)
(e)
(2)
(i) Hand-deliver a printed copy of the notice to the customer;
(ii) Mail a printed copy of the notice to the last known address of the customer; or
(iii) Make your current privacy notice available on a web site (or a link to another web site) for the customer who obtains a financial product or service electronically and agrees to receive the notice at the web site.
(f)
(g)
(a)(1)
(i) You have provided to the consumer an initial notice as required under § 248.4;
(ii) You have provided to the consumer an opt out notice as required in § 248.7;
(iii) You have given the consumer a reasonable opportunity, before you disclose the information to the nonaffiliated third party, to opt out of the disclosure; and
(iv) The consumer does not opt out.
(2)
(3)
(i)
(ii)
(iii)
(b)
(2) Unless you comply with this section, you may not, directly or through any affiliate, disclose any nonpublic personal information about a consumer that you have collected, regardless of whether you collected it before or after receiving the direction to opt out from the consumer.
(c)
(a)(1)
(i) You may disclose the information to the affiliates of the financial institution from which you received the information;
(ii) You may disclose the information to your affiliates, but your affiliates may, in turn, disclose and use the information only to the extent that you may disclose and use the information; and
(iii) You may disclose and use the information pursuant to an exception in §§ 248.14 or 248.15 in the ordinary course of business to carry out the activity covered by the exception under which you received the information.
(2)
(b)(1)
(i) To the affiliates of the financial institution from which you received the information;
(ii) To your affiliates, but your affiliates may, in turn, disclose the information only to the extent that you can disclose the information; and
(iii) To any other person, if the disclosure would be lawful if made directly to that person by the financial institution from which you received the information.
(2)
(i) You may use that list for your own purposes;
(ii) You may disclose that list to another nonaffiliated third party only if the financial institution from which you purchased the list could have lawfully disclosed the list to that third party. That is, you may disclose the list in accordance with the privacy policy of the financial institution from which you received the list, as limited by the opt out direction of each consumer whose nonpublic personal information you intend to disclose, and you may disclose the list in accordance with an exception in §§ 248.14 or 248.15, such as in the ordinary course of business to your attorneys, accountants, or auditors.
(c)
(1) The third party may disclose the information to your affiliates;
(2) The third party may disclose the information to its affiliates, but its affiliates may, in turn, disclose and use the information only to the extent that the third party may disclose and use the information; and
(3) The third party may disclose and use the information pursuant to an exception in §§ 248.14 or 248.15 in the ordinary course of business to carry out the activity covered by the exception under which it received the information.
(d)
(1) To your affiliates;
(2) To its affiliates, but its affiliates, in turn, may disclose the information only to the extent the third party can disclose the information; and
(3) To any other person, if the disclosure would be lawful if you made it directly to that person.
(a)
(b)
(1) To your agent or service provider solely in order to perform marketing for your own products or services, as long as the agent or service provider is not authorized to directly initiate charges to the account; or
(2) To a participant in a private label credit card program or an affinity or similar program where the participants in the program are identified to the customer when the customer enters into the program.
(c)
(a)
(i) Provide the initial notice in accordance with § 248.4; and
(ii) Enter into a contractual agreement with the third party that prohibits the third party from disclosing or using the information other than to carry out the purposes for which you disclosed the information, including use under an exception in §§ 248.14 or 248.15 in the ordinary course of business to carry out those purposes.
(2)
(b)
(c)
(a)
(1) Processing or servicing a financial product or service that a consumer requests or authorizes;
(2) Maintaining or servicing the consumer's account with you, or with another entity as part of a private label credit card program or other extension of credit on behalf of such entity; or
(3) A proposed or actual securitization, secondary market sale (including sales of servicing rights), or similar transaction related to a transaction of the consumer.
(b)
(1) Required, or is one of the lawful or appropriate methods, to enforce your rights or the rights of other persons engaged in carrying out the financial transaction or providing the product or service; or
(2) Required, or is a usual, appropriate, or acceptable method:
(i) To carry out the transaction or the product or service business of which the transaction is a part, and record, service, or maintain the consumer's account in the ordinary course of providing the financial service or financial product;
(ii) To administer or service benefits or claims relating to the transaction or the product or service business of which it is a part;
(iii) To provide a confirmation, statement, or other record of the transaction, or information on the status or value of the financial service or financial product to the consumer or the consumer's agent or broker;
(iv) To accrue or recognize incentives or bonuses associated with the transaction that are provided by you or any other party;
(v) To underwrite insurance at the consumer's request or for reinsurance purposes, or for any of the following purposes as they relate to a consumer's insurance: Account administration, reporting, investigating, or preventing fraud or material misrepresentation, processing premium payments, processing insurance claims, administering insurance benefits (including utilization review activities), participating in research projects, or as otherwise required or specifically permitted by federal or State law; or
(vi) In connection with:
(A) The authorization, settlement, billing, processing, clearing, transferring, reconciling or collection of amounts charged, debited, or otherwise paid using a debit, credit, or other payment card, check, or account number, or by other payment means;
(B) The transfer of receivables, accounts, or interests therein; or
(C) The audit of debit, credit, or other payment information.
(a)
(1) With the consent or at the direction of the consumer, provided that the consumer has not revoked the consent or direction;
(2)(i) To protect the confidentiality or security of your records pertaining to the consumer, service, product, or transaction;
(ii) To protect against or prevent actual or potential fraud, unauthorized transactions, claims, or other liability;
(iii) For required institutional risk control or for resolving consumer disputes or inquiries;
(iv) To persons holding a legal or beneficial interest relating to the consumer; or
(v) To persons acting in a fiduciary or representative capacity on behalf of the consumer;
(3) To provide information to insurance rate advisory organizations, guaranty funds or agencies, agencies that are rating you, persons that are assessing your compliance with industry standards, and your attorneys, accountants, and auditors;
(4) To the extent specifically permitted or required under other provisions of law and in accordance with the Right to Financial Privacy Act of 1978 (12 U.S.C. 3401
(5)(i) To a consumer reporting agency in accordance with the Fair Credit Reporting Act (15 U.S.C. 1681
(ii) From a consumer report reported by a consumer reporting agency;
(6) In connection with a proposed or actual sale, merger, transfer, or exchange of all or a portion of a business or operating unit if the disclosure of nonpublic personal information concerns solely consumers of such business or unit; or
(7)(i) To comply with federal, State, or local laws, rules and other applicable legal requirements;
(ii) To comply with a properly authorized civil, criminal, or regulatory investigation, or subpoena or summons by federal, State, or local authorities; or
(iii) To respond to judicial process or government regulatory authorities having jurisdiction over you for examination, compliance, or other purposes as authorized by law.
(b)
(2) A consumer may revoke consent by subsequently exercising the right to opt out of future disclosures of nonpublic personal information as permitted under § 248.7(f).
Nothing in this part shall be construed to modify, limit, or supersede the operation of the Fair Credit Reporting Act (15 U.S.C. 1681
(a)
(b)
(a)
(b)(1)
(2)
(c)
Every broker, dealer, and investment company, and every investment adviser registered with the Commission must adopt policies and procedures that address administrative, technical, and
(a) Insure the security and confidentiality of customer records and information;
(b) Protect against any anticipated threats or hazards to the security or integrity of customer records and information; and
(c) Protect against unauthorized access to or use of customer records or information that could result in substantial harm or inconvenience to any customer.
Financial institutions, including a group of financial holding company affiliates that use a common privacy notice, may use the following sample clauses, if the clause is accurate for each institution that uses the notice. (Note that disclosure of certain information, such as assets, income, and information from a consumer reporting agency, may give rise to obligations under the Fair Credit Reporting Act, such as a requirement to permit a consumer to opt out of disclosures to affiliates or designation as a consumer reporting agency if disclosures are made to nonaffiliated third parties.)
You may use this clause, as applicable, to meet the requirement of § 248.6(a)(1) to describe the categories of nonpublic personal information you collect.
We collect nonpublic personal information about you from the following sources:
• Information we receive from you on applications or other forms;
• Information about your transactions with us, our affiliates, or others; and
• Information we receive from a consumer reporting agency.
You may use one of these clauses, as applicable, to meet the requirement of § 248.6(a)(2) to describe the categories of nonpublic personal information you disclose. You may use these clauses if you disclose nonpublic personal information other than as permitted by the exceptions in §§ 248.13, 248.14, and 248.15.
We may disclose the following kinds of nonpublic personal information about you:
• Information we receive from you on applications or other forms, such as [
• Information about your transactions with us, our affiliates, or others, such as [
• Information we receive from a consumer reporting agency, such as [
We may disclose all of the information that we collect, as described [
You may use this clause, as applicable, to meet the requirements of §§ 248.6(a)(2), (3), and (4) to describe the categories of nonpublic personal information about customers and former customers that you disclose and the categories of affiliates and nonaffiliated third parties to whom you disclose. You may use this clause if you do not disclose nonpublic personal information to any party, other than as permitted by the exceptions in §§ 248.14 and 248.15.
We do not disclose any nonpublic personal information about our customers or former customers to anyone, except as permitted by law.
You may use this clause, as applicable, to meet the requirement of § 248.6(a)(3) to describe the categories of affiliates and nonaffiliated third parties to whom you disclose nonpublic personal information. You may use this clause if you disclose nonpublic personal information other than as permitted by the exceptions in §§ 248.13, 248.14, and 248.15, as well as when permitted by the exceptions in §§ 248.14 and 248.15.
We may disclose nonpublic personal information about you to the following types of third parties:
• Financial service providers, such as [
• Non-financial companies, such as [
• Others, such as [
We may also disclose nonpublic personal information about you to nonaffiliated third parties as permitted by law.
You may use one of these clauses, as applicable, to meet the requirements of § 248.6(a)(5) related to the exception for service providers and joint marketers in § 248.13. If you disclose nonpublic personal information under this exception, you must describe the categories of nonpublic personal information you disclose and the categories of third parties with whom you have contracted.
We may disclose the following information to companies that perform marketing services on our behalf or to other financial institutions with which we have joint marketing agreements:
• Information we receive from you on applications or other forms, such as [
• Information about your transactions with us, our affiliates, or others, such as [
• Information we receive from a consumer reporting agency, such as [
We may disclose all of the information we collect, as described [
You may use this clause, as applicable, to meet the requirement of § 248.6(a)(6) to provide an explanation of the consumer's right to opt out of the disclosure of nonpublic personal information to nonaffiliated third parties, including the method(s) by which the consumer may exercise that right. You may use this clause if you disclose nonpublic personal information other than as permitted by the exceptions in §§ 248.13, 248.14, and 248.15.
If you prefer that we not disclose nonpublic personal information about you to nonaffiliated third parties, you may opt out of those disclosures, that is, you may direct us not to make those disclosures (other than disclosures permitted by law). If you wish to opt out of disclosures to nonaffiliated third parties, you may [
You may use this clause, as applicable, to meet the requirement of § 248.6(a)(8) to describe your policies and practices with respect to protecting the confidentiality and security of nonpublic personal information.
We restrict access to nonpublic personal information about you to [
By the Commission.
Federal Emergency Management Agency (FEMA).
Notice.
This Notice provides listings of changes made to National Flood Insurance Program (NFIP) maps produced by FEMA effective during the last 6 months of 1999.
The listings include changes to NFIP maps that became effective July 1, 1999, through December 31, 1999.
Michael K. Buckley, P.E., Director, Technical Services Division, Mitigation Directorate, Federal Emergency Management Agency, Washington, DC 20472, (202)646-2756.
In accordance with Section 1360(i) of the National Flood Insurance Reform Act of 1994, this Notice is provided to inform interested parties of changes made by FEMA to NFIP maps. The two listings provided show communities affected by map changes made by letter and communities affected by physical map changes. For each Letter of Map Change, the first listing provides the map panel(s) affected, effective (determination) date of the change, case number, and determination type. For each physical map change, the Map Revision listing provides the map panel(s) affected and the effective date of the change. The listing also identifies: (1) those panels on which the Special Flood Hazard Areas have not been changed or have been changed only to incorporate the Letters of Map Change issued before the effective date; and (2) those panels for which a Flood Insurance Rate Map is produced for the first time, resulting only in changes to flood insurance and floodplain management requirements in the affected community. Future notices of changes to NFIP maps will be published approximately every 6 months.
Two listings are provided below. The first listing includes all Letters of Map Change issued by FEMA from July 1 through December 31, 1999. The following types of letters are included in the listing:
The second listing includes map panels that FEMA physically revised and republished from July 1 through December 31, 1999. For those map panels on which the Special Flood Hazard Areas have not been changed or have been changed only to incorporate Letters of Map Change issued before the effective date, two asterisks(**) are shown to the right of the map panel number. For those map panels for which a Flood Insurance Rate Map is produced for the first time, resulting only in changes to flood insurance and floodplain management requirements in the affected community, three asterisks(***) are shown to the right of the map panel number.