[Federal Register Volume 69, Number 185 (Friday, September 24, 2004)]
[Rules and Regulations]
[Pages 57226-57230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21206]



[[Page 57226]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 411

[CMS-1810-IFC2]
RIN-0938-AK67


Medicare Program; Physicians' Referrals to Health Care Entities 
With Which They Have Financial Relationships (Phase II); Correcting 
Amendment

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Interim final rule with comment period; correcting amendment.

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SUMMARY: In the March 26, 2004 issue of the Federal Register (69 FR 
16054), we published an interim final rule with comment period that 
incorporated into regulations certain provisions of the physician self-
referral prohibition in section 1877 of the Social Security Act. The 
effective date of that rule was July 26, 2004. This correcting 
amendment corrects a technical error identified in the March 26, 2004 
interim final rule. Specifically, this rule reinstates the physician 
self-referral advisory opinion regulations, which were inadvertently 
deleted from Part 411 in the March 26, 2004 interim final rule.

DATES: This rule is effective July 26, 2004. To be assured 
consideration, comments must be received at one of the addresses 
provided below, no later than 5 p.m. on November 23, 2004.

ADDRESSES: In commenting, please refer to file code CMS-1810-IFC. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of three ways (no duplicates, 
please):
    1. Electronically. You may submit electronic comments on specific 
issues in this regulation to http://www.cms.hhs.gov/regulations/ecomments. (Attachments should be in Microsoft Word, WordPerfect, or 
Excel; however, we prefer Microsoft Word.)
    2. By mail. You may mail written comments (one original and two 
copies) to the following address ONLY:
    Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attention: CMS-1810-IFC2, P.O. Box 8011, Baltimore, MD 
21244-8011.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments (one original and two copies) before the 
close of the comment period to one of the following addresses. If you 
intend to deliver your comments to the Baltimore address, please call 
telephone number (410) 786-7195 in advance to schedule your arrival 
with one of our staff members.
    Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, 
SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD 
21244-1850.
    (Because access to the interior of the HHH Building is not readily 
available to persons without Federal Government identification, 
commenters are encouraged to leave their comments in the CMS drop slots 
located in the main lobby of the building. A stamp-in clock is 
available for persons wishing to retain a proof of filing by stamping 
in and retaining an extra copy of the comments being filed.)
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.
    We are only accepting comments on whether to reinstate the 
physician self-referral advisory opinion regulations, not on the 
substance of the regulations themselves.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Joanne Sinsheimer, (410) 786-4620.

SUPPLEMENTARY INFORMATION:

Need for Correction

    This correction is necessary to reinstate the regulation text for 
Sec.  411.370 through Sec.  411.389 (regarding the physician self-
referral advisory opinion process), which was inadvertently deleted 
from Part 411 in the March 26, 2004 interim final rule. We note that we 
are updating an incorrect address to be used in submitting advisory 
opinions.

Collection of Information

    The requirements in Sec.  411.370 through Sec.  411.389 are subject 
to the Paperwork Reduction Act; however, these requirements are 
currently approved under OMB control 0938-0714 with a current 
expiration date of October 31, 2004. Note that the information 
collection package containing these approved requirements is currently 
at OMB awaiting re-approval.

Waiver of Proposed Rulemaking

    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register to provide a period for public comment before the 
provisions of a rule take effect. We can waive this procedure, however, 
if we find good cause that notice and comment procedure is 
impracticable, unnecessary, or contrary to the public interest and 
incorporate a statement of the finding and the reasons for it into the 
rule issued.
    We find it unnecessary, impracticable, and contrary to the public 
interest to offer an opportunity to comment on this rule before it 
becomes effective. This rule merely corrects the inadvertent removal of 
certain regulatory provisions regarding the physician self-referral 
advisory opinion process. The deleted advisory opinion regulations have 
been in effect since they were first published on January 9, 1998 in an 
interim final rule with comment period. We never proposed to remove or 
revise these regulations, and they were not the subject of the March 
26, 2004 interim final rule. Nothing in the preamble to the March 26, 
2004 interim final rule indicated any intent to remove or revise the 
advisory opinion regulations. In fact, the preamble referred several 
times to the existence of the advisory opinion process. But for the 
omission of an ellipsis at the end of the regulatory text for Part 411 
at 69 FR 16142 of the March 26, 2004 interim final rule, these 
regulations would not have been removed. Reinstatement of these 
regulations does not impose any additional burden on the public. 
Delaying the effective date of this rule pending prior notice and an 
opportunity for public comment would be impracticable because it would 
create uncertainty as to the appropriate procedures and standards that 
the agency would apply in receiving and processing requests for 
advisory opinions. The absence of these regulations in the CFR could 
increase the burden on both the agency and the public. For these 
reasons, we find it unnecessary and impracticable to provide an 
opportunity to comment on the technical correction made by this rule. 
Moreover, it would be contrary to the public interest for us to require 
members of the public to draft and submit advisory opinion requests, 
and for us to issue advisory opinions, in the absence of any rules to 
guide the process. We believe that the comment period established by 
this interim final rule will protect the public's interest in this 
rulemaking. Therefore, we find good cause to waive the opportunity to 
receive public comments on this rule prior to its effective date.

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Retroactive Application

    We ordinarily designate an interim final rule to be effective at 
least 30 days from the date of publication. Under 5 U.S.C. 553(d), a 
rule may have a retroactive effective date if the agency finds good 
cause and incorporates a statement of the finding and the reasons for 
it into the rule issued. Section 1871 of the Social Security Act, as 
amended by section 903(a) of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 (MMA), provides that a 
substantive change in regulations may be applied retroactively if the 
Secretary determines that ``failure to apply the change retroactively 
would be contrary to the public interest.''
    We believe that there is good cause to reinstate Sec.  411.370 
through Sec.  411.389 retroactively and that failure to reinstate these 
regulations retroactively would be contrary to the public interest. We 
have issued two advisory opinions since July 26, 2004, and we are 
currently reviewing approximately 30 advisory opinion requests that 
were submitted under an MMA mandate related to an 18-month moratorium 
on physician referrals to specialty hospitals in which they have an 
ownership interest. We need to issue all advisory opinions related to 
the moratorium well before the moratorium expires in June 2005. We 
believe that it would be contrary to the public interest for us to 
require members of the public to draft and submit advisory opinion 
requests, and for us to issue advisory opinions, in the absence of any 
rules to guide the process and to increase its efficiency. In addition, 
retroactive reinstatement of the rules removes any uncertainty 
regarding whether appropriate procedures and standards were followed 
with respect to advisory opinions issued after July 26, 2004.

List of Subjects in 42 CFR Part 411

    Kidney diseases, Medicare, Reporting and recordkeeping 
requirements.

    Accordingly, 42 CFR chapter IV is corrected by making the following 
correcting amendments:

PART 411--EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE 
PAYMENT

    1. The authority citation for part 411 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).

Subpart J--Financial Relationships Between Physicians and Entities 
Furnishing Designated Health Services

    2. In Subpart J, Sec. 411.370 is added to read as follows.


Sec.  411.370  Advisory opinions relating to physician referrals.

    (a) Period during which CMS will accept requests. The provisions of 
Sec.  411.370 through Sec.  411.389 apply to requests for advisory 
opinions that are submitted to CMS after November 3, 1997, and before 
August 21, 2000, and to any requests submitted during any other time 
period during which CMS is required by law to issue the advisory 
opinions described in this subpart.
    (b) Matters that qualify for advisory opinions and who may request 
one. Any individual or entity may request a written advisory opinion 
from CMS concerning whether a physician's referral relating to 
designated health services (other than clinical laboratory services) is 
prohibited under section 1877 of the Act. In the advisory opinion, CMS 
determines whether a business arrangement described by the parties to 
that arrangement appears to constitute a ``financial relationship'' (as 
defined in section 1877(a)(2) of the Act) that could potentially 
restrict a physician's referrals, and whether the arrangement or the 
designated health services at issue appear to qualify for any of the 
exceptions to the referral prohibition described in section 1877 of the 
Act.
    (1) The request must involve an existing arrangement or one into 
which the requestor, in good faith, specifically plans to enter. The 
planned arrangement may be contingent upon the party or parties 
receiving a favorable advisory opinion. CMS does not consider, for 
purposes of an advisory opinion, requests that present a general 
question of interpretation, pose a hypothetical situation, or involve 
the activities of third parties.
    (2) The requestor must be a party to the existing or proposed 
arrangement.
    (c) Matters not subject to advisory opinions. CMS does not address 
through the advisory opinion process--
    (1) Whether the fair market value was, or will be, paid or received 
for any goods, services, or property; and
    (2) Whether an individual is a bona fide employee within the 
requirements of section 3121(d)(2) of the Internal Revenue Code of 
1986.
    (d) Facts subject to advisory opinions. CMS considers requests for 
advisory opinions that involve applying specific facts to the subject 
matter described in paragraph (b) of this section. Requestors must 
include in the advisory opinion request a complete description of the 
arrangement that the requestor is undertaking, or plans to undertake, 
as described in Sec.  411.372.
    (e) Requests that will not be accepted. CMS does not accept an 
advisory opinion request or issue an advisory opinion if--
    (1) The request is not related to a named individual or entity;
    (2) CMS is aware that the same, or substantially the same, course 
of action is under investigation, or is or has been the subject of a 
proceeding involving the Department of Health and Human Services or 
another governmental agency; or
    (3) CMS believes that it cannot make an informed opinion or could 
only make an informed opinion after extensive investigation, clinical 
study, testing, or collateral inquiry.
    (f) Effects of an advisory opinion on other Governmental authority. 
Nothing in this part limits the investigatory or prosecutorial 
authority of the OIG, the Department of Justice, or any other agency of 
the Government. In addition, in connection with any request for an 
advisory opinion, CMS, the OIG, or the Department of Justice may 
conduct whatever independent investigation it believes appropriate.

    3. Sections 411.372 and 411.373 are added to subpart J to read as 
follows.


Sec.  411.372  Procedure for submitting a request.

    (a) Format for a request. A party or parties must submit a request 
for an advisory opinion to CMS in writing, including an original 
request and 2 copies. The request must be addressed to: Centers for 
Medicare & Medicaid Services, Department of Health and Human Services, 
Office of Financial Management, Division of Premium Billing and 
Collections, Mail Stop C3-09-27, Attention: Advisory Opinions, 7500 
Security Boulevard, Baltimore, MD 21244-1850.
    (b) Information CMS requires with all submissions. The request must 
include the following:
    (1) The name, address, telephone number, and Taxpayer 
Identification Number of the requestor.
    (2) The names and addresses, to the extent known, of all other 
actual and potential parties to the arrangement that is the subject of 
the request.
    (3) The name, title, address, and daytime telephone number of a 
contact person who will be available to discuss the request with CMS on 
behalf of the requestor.
    (4) A complete and specific description of all relevant information 
bearing on the arrangement, including--

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    (i) A complete description of the arrangement that the requestor is 
undertaking, or plans to undertake, including: the purpose of the 
arrangement; the nature of each party's (including each entity's) 
contribution to the arrangement; the direct or indirect relationships 
between the parties, with an emphasis on the relationships between 
physicians involved in the arrangement (or their immediate family 
members who are involved) and any entities that provide designated 
health services; the types of services for which a physician wishes to 
refer, and whether the referrals will involve Medicare or Medicaid 
patients;
    (ii) Complete copies of all relevant documents or relevant portions 
of documents that affect or could affect the arrangement, such as 
personal services or employment contracts, leases, deeds, pension or 
insurance plans, financial statements, or stock certificates (or, if 
these relevant documents do not yet exist, a complete description, to 
the best of the requestor's knowledge, of what these documents are 
likely to contain);
    (iii) Detailed statements of all collateral or oral understandings, 
if any; and
    (iv) Descriptions of any other arrangements or relationships that 
could affect CMS's analysis.
    (5) Complete information on the identity of all entities involved 
either directly or indirectly in the arrangement, including their 
names, addresses, legal form, ownership structure, nature of the 
business (products and services) and, if relevant, their Medicare and 
Medicaid provider numbers. The requestor must also include a brief 
description of any other entities that could affect the outcome of the 
opinion, including those with which the requestor, the other parties, 
or the immediate family members of involved physicians, have any 
financial relationships (either direct or indirect, and as defined in 
section 1877(a)(2) of the Act and Sec.  411.351), or in which any of 
the parties holds an ownership or control interest as defined in 
section 1124(a)(3) of the Act.
    (6) A discussion of the specific issues or questions the requestor 
would like CMS to address including, if possible, a description of why 
the requestor believes the referral prohibition in section 1877 of the 
Act might or might not be triggered by the arrangement and which, if 
any, exceptions to the prohibition the requestor believes might apply. 
The requestor should attempt to designate which facts are relevant to 
each issue or question raised in the request and should cite the 
provisions of law under which each issue or question arises.
    (7) An indication of whether the parties involved in the request 
have also asked for or are planning to ask for an advisory opinion on 
the arrangement in question from the OIG under section 1128D(b) of the 
Act (42 U.S.C. 1320a-7d(b)) and whether the arrangement is or is not, 
to the best of the requestor's knowledge, the subject of an 
investigation.
    (8) The certification(s) described in Sec.  411.373. The 
certification(s) must be signed by--
    (i) The requestor, if the requestor is an individual;
    (ii) The chief executive officer, or comparable officer, of the 
requestor, if the requestor is a corporation;
    (iii) The managing partner of the requestor, if the requestor is a 
partnership; or
    (iv) A managing member, if the requestor is a limited liability 
company.
    (9) A check or money order payable to CMS in the amount described 
in Sec.  411.375(a).
    (c) Additional information CMS might require. If the request does 
not contain all of the information required by paragraph (b) of this 
section, or, if either before or after accepting the request, CMS 
believes it needs more information in order to render an advisory 
opinion, it may request whatever additional information or documents it 
deems necessary. Additional information must be provided in writing, 
signed by the same person who signed the initial request (or by an 
individual in a comparable position), and be certified as described in 
Sec.  411.373.


Sec.  411.373  Certification.

    (a) Every request must include the following signed certification: 
``With knowledge of the penalties for false statements provided by 18 
U.S.C. 1001 and with knowledge that this request for an advisory 
opinion is being submitted to the Department of Health and Human 
Services, I certify that all of the information provided is true and 
correct, and constitutes a complete description of the facts regarding 
which an advisory opinion is sought, to the best of my knowledge and 
belief.''
    (b) If the advisory opinion relates to a proposed arrangement, in 
addition to the certification required by paragraph (a) of this 
section, the following certification must be included and signed by the 
requestor: ``The arrangement described in this request for an advisory 
opinion is one into which [the requestor], in good faith, plans to 
enter.'' This statement may be made contingent on a favorable advisory 
opinion, in which case the requestor should add one of the following 
phrases to the certification:
    (1) ``if CMS issues a favorable advisory opinion.''
    (2) ``if CMS and the OIG issue favorable advisory opinions.''

    4. Section 411.375 is added to subpart J to read as follows.


Sec.  411.375  Fees for the cost of advisory opinions.

    (a) Initial payment. Parties must include with each request for an 
advisory opinion submitted through December 31, 1998, a check or money 
order payable to CMS for $250. For requests submitted after this date, 
parties must include a check or money order in this amount, unless CMS 
has revised the amount of the initial fee in a program issuance, in 
which case, the requestor must include the revised amount. This initial 
payment is nonrefundable.
    (b) How costs are calculated. Before issuing the advisory opinion, 
CMS calculates the costs the Department has incurred in responding to 
the request. The calculation includes the costs of salaries, benefits, 
and overhead for analysts, attorneys, and others who have worked on the 
request, as well as administrative and supervisory support for these 
individuals.
    (c) Agreement to pay all costs. (1) By submitting the request for 
an advisory opinion, the requestor agrees, except as indicated in 
paragraph (c)(3) of this section, to pay all costs the Department 
incurs in responding to the request for an advisory opinion.
    (2) In its request for an advisory opinion, the requestor may 
designate a triggering dollar amount. If CMS estimates that the costs 
of processing the advisory opinion request have reached or are likely 
to exceed the designated triggering dollar amount, CMS notifies the 
requestor.
    (3) If CMS notifies the requestor that the actual or estimated cost 
of processing the request has reached or is likely to exceed the 
triggering dollar amount, CMS stops processing the request until the 
requestor makes a written request for CMS to continue. If CMS is 
delayed in processing the request for an advisory opinion because of 
this procedure, the time within which CMS must issue an advisory 
opinion is suspended until the requestor asks CMS to continue working 
on the request.
    (4) If the requestor chooses not to pay for CMS to complete an 
advisory opinion, or withdraws the request, the requestor is still 
obligated to pay for all costs CMS has identified as costs it

[[Page 57229]]

incurred in processing the request for an advisory opinion, up to that 
point.
    (5) If the costs CMS has incurred in responding to the request are 
greater than the amount the requestor has paid, CMS, before issuing the 
advisory opinion, notifies the requestor of any additional amount that 
is due. CMS does not issue an advisory opinion until the requestor has 
paid the full amount that is owed. Once the requestor has paid CMS the 
total amount due for the costs of processing the request, CMS issues 
the advisory opinion. The time period CMS has for issuing advisory 
opinions is suspended from the time CMS notifies the requestor of the 
amount owed until the time CMS receives full payment.
    (d) Fees for outside experts. (1) In addition to the fees 
identified in this section, the requestor also must pay any required 
fees for expert opinions, if any, from outside sources, as described in 
Sec.  411.377.
    (2) The time period for issuing an advisory opinion is suspended 
from the time that CMS notifies the requestor that it needs an outside 
expert opinion until the time CMS receives that opinion.

    5. Sections 411.377 through 411.380 are added to subpart J to read 
as follows.


Sec.  411.377  Expert opinions from outside sources.

    (a) CMS may request expert advice from qualified sources if CMS 
believes that the advice is necessary to respond to a request for an 
advisory opinion. For example, CMS may require the use of accountants 
or business experts to assess the structure of a complex business 
arrangement or to ascertain a physician's or immediate family member's 
financial relationship with entities that provide designated health 
services.
    (b) If CMS determines that it needs to obtain expert advice in 
order to issue a requested advisory opinion, CMS notifies the requestor 
of that fact and provides the identity of the appropriate expert and an 
estimate of the costs of the expert advice. As indicated in Sec.  
411.375(d), the requestor must pay the estimated cost of the expert 
advice.
    (c) Once CMS has received payment for the estimated cost of the 
expert advice, CMS arranges for the expert to provide a prompt review 
of the issue or issues in question. CMS considers any additional 
expenses for the expert advice, beyond the estimated amount, as part of 
the costs CMS has incurred in responding to the request, and the 
responsibility of the requestor, as described in Sec.  411.375(c).


Sec.  411.378  Withdrawing a request.

    The party requesting an advisory opinion may withdraw the request 
before CMS issues a formal advisory opinion. This party must submit the 
withdrawal in writing to the same address as the request, as indicated 
in Sec.  411.372(a). Even if the party withdraws the request, the party 
must pay the costs the Department has expended in processing the 
request, as discussed in Sec.  411.375. CMS reserves the right to keep 
any request for an advisory opinion and any accompanying documents and 
information, and to use them for any governmental purposes permitted by 
law.


Sec.  411.379  When CMS accepts a request.

    (a) Upon receiving a request for an advisory opinion, CMS promptly 
makes an initial determination of whether the request includes all of 
the information it will need to process the request.
    (b) Within 15 working days of receiving the request, CMS--
    (1) Formally accepts the request for an advisory opinion;
    (2) Notifies the requestor about the additional information it 
needs; or
    (3) Declines to formally accept the request.
    (c) If the requestor provides the additional information CMS has 
requested, or otherwise resubmits the request, CMS processes the 
resubmission in accordance with paragraphs (a) and (b) of this section 
as if it were an initial request for an advisory opinion.
    (d) Upon accepting the request, CMS notifies the requestor by 
regular U.S. mail of the date that CMS formally accepted the request.
    (e) The 90-day period that CMS has to issue an advisory opinion set 
forth in Sec.  411.380(c) does not begin until CMS has formally 
accepted the request for an advisory opinion.


Sec.  411.380  When CMS issues a formal advisory opinion.

    (a) CMS considers an advisory opinion to be issued once it has 
received payment and once the opinion has been dated, numbered, and 
signed by an authorized CMS official.
    (b) An advisory opinion contains a description of the material 
facts known to CMS that relate to the arrangement that is the subject 
of the advisory opinion, and states CMS's opinion about the subject 
matter of the request based on those facts. If necessary, CMS includes 
in the advisory opinion material facts that could be considered 
confidential information or trade secrets within the meaning of 18 
U.S.C. 1095.
    (c)(1) CMS issues an advisory opinion, in accordance with the 
provisions of this part, within 90 days after it has formally accepted 
the request for an advisory opinion, or, for requests that CMS 
determines, in its discretion, involve complex legal issues or highly 
complicated fact patterns, within a reasonable time period.
    (2) If the 90th day falls on a Saturday, Sunday, or Federal 
holiday, the time period ends at the close of the first business day 
following the weekend or holiday;
    (3) The 90-day period is suspended from the time CMS'
    (i) Notifies the requestor that the costs have reached or are 
likely to exceed the triggering amount as described in Sec.  
411.375(c)(2) until CMS receives written notice from the requestor to 
continue processing the request;
    (ii) Requests additional information from the requestor until CMS 
receives the additional information;
    (iii) Notifies the requestor of the full amount due until CMS 
receives payment of this amount; and
    (iv) Notifies the requestor of the need for expert advice until CMS 
receives the expert advice.
    (d) After CMS has notified the requestor of the full amount owed 
and has received full payment of that amount, CMS issues the advisory 
opinion and promptly mails it to the requestor by regular first class 
U.S. mail.

    6. Section 411.382 is added to subpart J to read as follows.


Sec.  411.382  CMS's right to rescind advisory opinions.

    Any advice CMS gives in an opinion does not prejudice its right to 
reconsider the questions involved in the opinion and, if it determines 
that it is in the public interest, to rescind or revoke the opinion. 
CMS provides notice to the requestor of its decision to rescind or 
revoke the opinion so that the requestor and the parties involved in 
the requestor's arrangement may discontinue any course of action they 
have taken in accordance with the advisory opinion. CMS does not 
proceed against the requestor with respect to any action the requestor 
and the involved parties have taken in good faith reliance upon CMS's 
advice under this part, provided--
    (a) The requestor presented to CMS a full, complete and accurate 
description of all the relevant facts; and
    (b) The parties promptly discontinue the action upon receiving 
notice that CMS had rescinded or revoked its approval, or discontinue 
the action within a reasonable ``wind down'' period, as determined by 
CMS.

[[Page 57230]]


    7. Section 411.384 is added to subpart J to read as follows.


Sec.  411.384  Disclosing advisory opinions and supporting information.

    (a) Advisory opinions that CMS issues and releases in accordance 
with the procedures set forth in this subpart are available to the 
public.
    (b) Promptly after CMS issues an advisory opinion and releases it 
to the requestor, CMS makes available a copy of the advisory opinion 
for public inspection during its normal hours of operation and on the 
DHHS/CMS Web site.
    (c) Any predecisional document, or part of such predecisional 
document, that is prepared by CMS, the Department of Justice, or any 
other Department or agency of the United States in connection with an 
advisory opinion request under the procedures set forth in this part is 
exempt from disclosure under 5 U.S.C. 552, and will not be made 
publicly available.
    (d) Documents submitted by the requestor to CMS in connection with 
a request for an advisory opinion are available to the public to the 
extent they are required to be made available by 5 U.S.C. 552, through 
procedures set forth in 45 CFR part 5.
    (e) Nothing in this section limits CMS's obligation, under 
applicable laws, to publicly disclose the identity of the requesting 
party or parties, and the nature of the action CMS has taken in 
response to the request.

    8. Sections 411.386 through 411.389 are added to subpart J to read 
as follows.


Sec.  411.386  CMS's advisory opinions as exclusive.

    The procedures described in this subpart constitute the only method 
by which any individuals or entities can obtain a binding advisory 
opinion on the subject of a physician's referrals, as described in 
Sec.  411.370. CMS has not and does not issue a binding advisory 
opinion on the subject matter in Sec.  411.370, in either oral or 
written form, except through written opinions it issues in accordance 
with this subpart.


Sec.  411.387  Parties affected by advisory opinions.

    An advisory opinion issued by CMS does not apply in any way to any 
individual or entity that does not join in the request for the opinion. 
Individuals or entities other than the requestor(s) may not rely on an 
advisory opinion.


Sec.  411.388  When advisory opinions are not admissible evidence.

    The failure of a party to seek or to receive an advisory opinion 
may not be introduced into evidence to prove that the party either 
intended or did not intend to violate the provisions of sections 1128, 
1128A or 1128B of the Act.


Sec.  411.389  Range of the advisory opinion.

    (a) An advisory opinion states only CMS's opinion regarding the 
subject matter of the request. If the subject of an advisory opinion is 
an arrangement that must be approved by or is regulated by any other 
agency, CMS's advisory opinion cannot be read to indicate CMS's views 
on the legal or factual issues that may be raised before that agency.
    (b) An advisory opinion that CMS issues under this part does not 
bind or obligate any agency other than the Department. It does not 
affect the requestor's, or anyone else's, obligations to any other 
agency, or under any statutory or regulatory provision other than that 
which is the specific subject matter of the advisory opinion.

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: September 15, 2004.
Ann Agnew,
Executive Secretary to the Department.
[FR Doc. 04-21206 Filed 9-23-04; 8:45 am]
BILLING CODE 4120-01-P