[Federal Register: September 24, 2004 (Volume 69, Number 185)]
[Rules and Regulations]
[Page 57226-57230]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24se04-16]
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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.
[[Page 57227]]
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--
[[Page 57228]]
(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