[Federal Register Volume 70, Number 167 (Tuesday, August 30, 2005)]
[Proposed Rules]
[Pages 51321-51325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17175]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 410

[CMS-6024-P]
RIN 0938-AN10


Medicare Program; Prior Determination for Certain Items and 
Services

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

ACTION: Proposed rule.

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SUMMARY: Section 938 of the Medicare Prescription Drug, Improvement, 
and Modernization Act of 2003 requires the Secretary to establish a 
process for Medicare contractors to provide eligible participating 
physicians and beneficiaries with a determination of coverage relating 
to medical necessity for certain physicians' services before the 
services are furnished. This rule is intended to afford the physician 
and beneficiary the opportunity to know the financial liability for a 
service before expenses are incurred. This proposed rule would 
establish reasonable limits on physicians' services for which a prior 
determination of coverage may be requested and discusses generally our 
plans for establishing the procedures by which those determinations may 
be obtained.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on October 31, 2005.

ADDRESSES: In commenting, please refer to file code CMS-6024-P. 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 to http://www.cms.hhs.gov/regulations/ecomments or to http://www.regulations.gov 
(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-6024-
P, P.O. Box 8017, Baltimore, MD 21244-8017.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.

[[Page 51322]]

    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.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Misty Whitaker, (410) 786-3087.

SUPPLEMENTARY INFORMATION:
    Submitting Comments: We welcome comments from the public on all 
issues set forth in this rule to assist us in fully considering issues 
and developing policies. You can assist us by referencing the file code 
CMS-6024-P and the specific ``issue identifier'' that precedes the 
section on which you choose to comment.
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. CMS posts all electronic 
comments received before the close of the comment period on its public 
Web site as soon as possible after they have been received. Hard copy 
comments received timely will be available for public inspection as 
they are received, generally beginning approximately 3 weeks after 
publication of a document, at the headquarters of the Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, 
Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 
p.m. To schedule an appointment to view public comments, phone 1-800-
743-3951.

I. Background

    [If you choose to comment on issues in this section, please include 
the caption ``BACKGROUND'' at the beginning of your comments.]
    Section 1862(a)(1)(A) of the Social Security Act (the Act) 
prohibits Medicare payments for items and services that are not 
reasonable and necessary for the diagnosis and treatment of an illness 
or injury. However, section 1879 of the Act provides that under certain 
circumstances Medicare will pay for services that are not considered 
reasonable and necessary if both the beneficiary and physician did not 
know and could not have reasonably been expected to know that Medicare 
payment would not be made.
    A physician may be held financially liable for noncovered services 
he or she furnishes if, for example, the Medicare contractor or CMS 
publishes specific requirements for those services or the physician has 
received a denial or reduction of payment for the same or similar 
service under similar circumstances. In cases where the physician 
believes that the service may not be covered as reasonable and 
necessary, an acceptable advance notice of Medicare's possible denial 
of payment must be given to the patient if the physician does not want 
to accept financial responsibility for the service. These notices are 
referred to as Advance Beneficiary Notices (ABNs).
    ABNs must be given in writing, in advance of providing the service; 
include the description of service, as well as reasons why the service 
would not be covered; and must be signed and dated by the beneficiary 
to indicate that the beneficiary will assume financial responsibility 
for the service if Medicare payment is denied or reduced.
    Notwithstanding these ABNs, there is the potential that 
beneficiaries may be discouraged from obtaining services because they 
are uncertain whether or not Medicare contractors will deem them 
reasonable and necessary. Currently, beneficiaries can find out whether 
or not items or services are generally covered. However, when there is 
a question of whether Medicare will cover a specific item or service 
for a particular beneficiary under specific circumstances, there 
currently exists no process by which the beneficiary or his or her 
physician can find out if that item or service would be considered 
reasonable and necessary for that beneficiary before incurring 
financial liability.
    To address this issue, section 938 of the Medicare Prescription 
Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173, 
enacted on December 8, 2003) (MMA) requires the Secretary to establish 
a process whereby eligible requesters may submit to the contractor a 
request for a determination, before the furnishing of the physician's 
service, as to whether the physician's service is covered consistent 
with the applicable requirements of section 1862(a)(1)(A) of the Act 
(relating to medical necessity). This MMA section also provides that an 
eligible requester is either: A participating physician, but only with 
respect to physicians' services to be furnished to an individual who is 
entitled to benefits and who has consented to the physician making the 
request for those services; or an individual entitled to benefits, but 
only with respect to a physician's service for which the individual 
receives an advance beneficiary notice under section 1879(a) of the 
Act.
    Requesting a prior determination under this proposed process is at 
the discretion of the eligible beneficiary or physician. Full knowledge 
regarding financial liability for the service would be available to 
physicians and beneficiaries before expenses are incurred, but prior 
determination of coverage is not required for submission of a claim.
    This proposed rule would establish reasonable limits on the 
physicians' services for which a prior determination of coverage may be 
requested and discusses generally our plans for establishing the 
process by which prior determinations may be obtained. The procedures 
that Medicare contractors would use to make the determinations would be 
established in our manuals.

II. Provisions of the Proposed Rule

    [If you choose to comment on issues in this section, please include 
the caption ``Provisions of the Proposed Rule'' at the beginning of 
your comments.]
    Section 1869(h)(1) of the Act, as added by section 938 of the MMA, 
requires the Secretary to establish a prior determination process for 
certain physicians' services. Sections 1869(h)(3) through (6) of the 
Act are specific with respect to various aspects of the prior 
determination process, and we intend to follow these and any other 
applicable provisions in establishing the prior determination process. 
We intend to issue the detailed procedures through our instructions to 
contractors in our manuals.
    Section 1869(h)(2) of the Act, as added by section 938 of the MMA, 
requires the Secretary to establish by regulation reasonable limits on 
the

[[Page 51323]]

physicians' services for which a prior determination may be requested. 
This section provides that in establishing the reasonable limits, the 
Secretary may consider the dollar amount involved with respect to the 
physician's service, administrative costs and burdens, and other 
relevant factors.
    We evaluated national data on physicians' services including 
payment amounts, utilization, and denial rates. We considered using 
denial rates as one of the factors to be considered, but we have 
decided to use other factors instead. Although a service may have a 
relatively high denial rate, that number may be insignificant depending 
on the number of services performed annually.
    Based on our analysis, we are proposing to establish an initial 
pool of eligible physicians' services comprised of at least those 50 
services with the highest allowed average charges that are performed at 
least 50 times annually. We will exclude from this initial pool any 
services for which a national or local coverage determination exists 
that, based on CMS' judgment, has sufficiently specific reasonable and 
necessary criteria to permit the beneficiary or physician to know 
whether the service is covered without a prior determination. We expect 
the number of physicians' services in the final list, after excluding 
services with adequate national and local coverage determinations, may 
be fewer than 50. We propose to start with at least 50 physicians' 
services in the initial pool, but may expand the number of services 
eligible for the prior determination pool in the future if the need 
arises. In addition, we propose to allow prior determination for 
plastic and covered dental surgeries that may be covered by Medicare 
and that have an average allowed charge of at least $1,000.
    Specifically, in 42 CFR 410.20(d)(1), we propose to define a prior 
determination of medical necessity as a decision by a Medicare 
contractor, before a physician's service is furnished, as to whether or 
not the physician's service is covered consistent with the requirements 
of section 1862(a)(1)(A) of the Act relating to medical necessity.
    In Sec.  410.20(d)(2), we propose that each Medicare contractor 
must, through the procedure established in CMS instructions, allow 
requests for prior determinations from eligible requesters under the 
contractor's respective jurisdiction for those services identified by 
CMS and posted on that specific Medicare contractor's Web site. Only 
those services listed on the date the request for a prior determination 
is made would be subject to prior determination.
    Each contractor's list would consist of the following: At least the 
50 most expensive physicians' services listed in the national ceiling 
fee schedule amount of the Medicare Physician Fee Schedule Database 
performed at least 50 times annually minus those services excluded by 
Sec.  410.20(d)(3) (with adequate national or local coverage 
determinations); and plastic and dental surgeries that may be covered 
by Medicare and that have an average allowed charge of at least $1,000.
    We have three reasons for proposing to establish the limit on 
physicians' services based on the dollar amount of the service and 
including certain plastic and dental surgeries. First, beneficiaries 
are more likely to be discouraged from obtaining the most expensive 
physicians' services because they are uncertain whether or not they 
would have to incur financial liability if Medicare does not pay for 
the service. The plastic and dental surgeries included are also 
relatively expensive, and there may be significant individual 
considerations in determining what is covered and what is excluded. 
Second, the majority of these services tend to be non-emergency 
surgical procedures generally performed in an inpatient setting. Since 
these services are not typically emergency services, beneficiaries 
would have adequate time to request a prior determination. Third, 
limiting prior determinations to these services is reasonable given the 
administrative cost to process each prior determination request.
    In Sec.  410.20(d)(3), we propose that those services for which 
there is a national coverage determination (NCD) in effect or a local 
coverage determination/local medical review policy (LCD/LMRP) in effect 
through the local contractor at the time of the request for prior 
determination will not be eligible for prior determination. This 
exclusion only applies when the NCD or LCD/LMRP, in CMS' judgment, 
provides the sufficiently specific reasonable and necessary criteria 
for the specific procedure for which the prior determination is 
requested.
    Our reason for this provision is that many national and local 
policies already provide the information necessary to make an informed 
decision about whether or not the service will be covered. In 
establishing the prior determination procedures through our manuals, we 
will instruct CMS contractors that, in cases where a prior 
determination is requested but an NCD or LCD/LMRP exists, the 
contractor will send the beneficiary a copy of that policy along with 
the explanation of why a prior determination will not be made.
    The lists will be consistent across all Medicare contractors except 
for the services excluded because of the presence of a local coverage 
determination. To ensure consistency, we will compile the list of at 
least 50 services with the highest allowed charges performed at least 
50 times annually and the plastic and dental surgeries that Medicare 
may cover under some circumstances and that have an average allowed 
charge of at least $1,000. We will then exclude those services that 
have an NCD that provides the sufficiently specific reasonable and 
necessary criteria for that specific procedure. Each Medicare 
contractor will then exclude the services for which that contractor has 
a local policy and post the remaining services by Healthcare Common 
Procedure Coding System procedure code and code description on its Web 
site.
    In Sec.  410.20(d)(4), we propose that CMS may increase the number 
of services in the initial pool that are eligible for prior 
determination (over the minimum of 50) through manual instructions. Our 
reason for this provision is to ensure that CMS can provide for prior 
determinations for additional services when we detect a need. Sections 
1869(h)(3) through (6) of the Act are specific with respect to various 
aspects of the prior determination process. Therefore, in Sec.  
410.20(d)(5), we specify those mandatory provisions. The detailed 
procedures to be followed by our contractors will be published in our 
manual instructions. Section 410.20(d)(5)(i) generally explains the 
prior determination process and accompanying documentation that may be 
required. Section 410.20(d)(5)(ii) describes how contractors will 
respond to prior determination requests. The statute provides that 
notice will be provided ``within the same time period as the time 
period applicable to the contractor providing notice of initial 
determinations on a claim for benefits under section 1869(a)(2)(A) of 
the Act.'' Therefore, the statute requires that contractors must mail 
the requestor the decision no later than 45 days after the request is 
received. Contractors will be instructed to process the requests as 
quickly as possible (but no longer than 45 days), taking into 
consideration the beneficiary's physical condition, the urgency of 
treatment, and the availability of the necessary documentation. We are 
soliciting comments on this issue.
    Section 410.20(d)(5)(iii) explains the binding nature of a positive

[[Page 51324]]

determination. Section 410.20(d)(5)(iv) explains the limitation on 
further review.

III. Collection of Information Requirements

    Under the Paperwork Reduction Act (PRA) of 1995, we are required to 
provide 30-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the PRA of 1995 requires that 
we solicit comment on the following issues:
    <bullet> The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
    <bullet> The accuracy of our estimate of the information collection 
burden.
    <bullet> The quality, utility, and clarity of the information to be 
collected.
    <bullet> Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    Therefore, we are soliciting public comments on the information 
collection requirement discussed below, which are subject to the PRA.

Section 410.20 Physicians' Services

    Prior determination of medical necessity for physicians' services. 
Before a physician's service is furnished, an eligible requester, such 
as a physician or beneficiary, may request an individualized decision, 
a ``Prior Determination of Medical Necessity,'' by a Medicare 
contractor as to whether or not the physician's service is covered 
consistent with the requirements of section 1862(a)(1)(A) of the Act 
relating to medical necessity.
    The burden associated with this proposed requirement would be the 
time spent by a requester to provide the appropriate level of 
documentation, as outlined in this section, to a Medicare contractor so 
that the contractor can provide a ``Prior Determination of Medical 
Necessity.''
    We estimate 5000 requests will be made on an annual basis and it 
will require 15 minutes per request, for an annual burden of 1,250 
hours.
    If you comment on any of these information collection and record 
keeping requirements, please mail copies directly to the following:
    Centers for Medicare & Medicaid Services, Office of Strategic 
Operations and Regulatory Affairs, Regulations Development and 
Issuances Group, Attn: John Burke, CMS-6024-P, Room C5-14-03, 7500 
Security Boulevard, Baltimore, MD 21244-1850; and
    Office of Information and Regulatory Affairs, Office of Management 
and Budget, Room 10235, New Executive Office Building, Washington, DC 
20503, Attn: Christopher Martin, CMS Desk Officer, CMS-6024-P, 
<a href="/cdn-cgi/l/email-protection#cb88a3b9a2b8bfa4bba3aeb99486aab9bfa2a58ba4a6a9e5aea4bbe5aca4bd"><span class="__cf_email__" data-cfemail="f2b19a809b81869d829a9780adbf9380869b9cb29d9f90dc979d82dc959d84">[email protected]</span></a>. Fax (202) 395-6974.

IV. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
major comments in the preamble to that document.

V. Regulatory Impact Statement

    We have examined the impact of this rule as required by Executive 
Order 12866 (September 1993, Regulatory Planning and Review), the 
Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-354), 
section 1102(b) of the Social Security Act, the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, distributive impacts, and equity). A regulatory impact 
analysis (RIA) must be prepared for major rules with economically 
significant effects ($100 million or more in any 1 year). This rule 
does not reach the economic threshold and thus is not considered a 
major rule. Furthermore, this rule would not result in an increase in 
benefit spending.
    The RFA requires agencies to analyze options for regulatory relief 
of small businesses. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and government agencies. 
Most hospitals and most other providers and suppliers are small 
entities, either by nonprofit status or by having revenues of $6 
million to $29 million in any 1 year. Individuals and States are not 
included in the definition of a small entity. We are not preparing an 
analysis for the RFA because we have determined that this rule would 
not have a significant economic impact on a substantial number of small 
entities.
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a rule may have a significant impact on 
the operations of a substantial number of small rural hospitals. This 
analysis must conform to the provisions of section 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 of a Metropolitan 
Statistical Area and has fewer than 100 beds. We are not preparing an 
analysis for section 1102(b) of the Act because we have determined that 
this rule would not have a significant impact on the operations of a 
substantial number of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule that may result in expenditure in any 1 year by State, 
local, or tribal governments, in the aggregate, or by the private 
sector, of $110 million. This rule would have no consequential effect 
on the governments mentioned or on the private sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State 
and local governments, preempts State law, or otherwise has Federalism 
implications. Since this regulation would not impose any costs on State 
or local governments, the requirements of E.O. 13132 are not 
applicable.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.

List of Subjects in 42 CFR Part 410

    Health facilities, Health professions, Kidney diseases, 
Laboratories, Medicare, Reporting and recordkeeping requirements, Rural 
areas, X-rays.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services proposes to amend 42 CFR chapter IV as set forth 
below:

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

Subpart B--Medical and Other Health Services

    1. The authority citation for part 410 continues to read as 
follows:

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


[[Page 51325]]


    2. Section 410.20 is amended by adding new paragraph (d) to read as 
follows:


Sec.  410.20  Physicians' services.

* * * * *
    (d) Prior determination of medical necessity for physicians' 
services.
    (1) Definition: A ``Prior Determination of Medical Necessity'' 
means an individual decision by a Medicare contractor, before a 
physician's service is furnished, as to whether or not the physician's 
service is covered consistent with the requirements of section 
1862(a)(1)(A) of the Act relating to medical necessity.
    (2) Each Medicare contractor will, through the procedures 
established in CMS manual instructions, allow requests for Prior 
Determinations of Medical Necessity from eligible requesters under its 
respective jurisdiction for those services identified by CMS and posted 
on that specific Medicare contractor's Web site. Only those services 
listed on the date the request for a prior determination is made are 
subject to prior determination. Each contractor's list will consist of 
the following:
    (i) At least the 50 most expensive physicians' services listed in 
the national ceiling fee schedule amount of the Medicare Physician Fee 
Schedule Database performed at least 50 times annually minus those 
services excluded by paragraph (d)(3) of this section; and
    (ii) Plastic and dental surgeries that may be covered by Medicare 
and that have an average allowed charge of at least $1,000.
    (3) Within the services designated in paragraphs (d)(2)(i) and 
(d)(2)(ii) of this section, those services for which there is a 
national coverage determination (NCD) in effect or a local coverage 
determination/local medical review policy (LCD/LMRP) in effect through 
the local contractor at the time of the request for prior determination 
will be excluded from the list of services eligible for prior 
determination. This provision only applies when, in CMS' judgment, the 
national or local policy provides the sufficiently specific reasonable 
and necessary criteria for the specific procedure for which the prior 
determination is requested.
    (4) CMS may increase the number of services that are eligible for 
prior determination through manual instructions.
    (5) Under section 1869(h)(3) through (6) of the Act, the procedures 
established in CMS manual instructions will include the following 
provisions:
    (i) Request for prior determination.
    (A) In general. An eligible requester may submit to the contractor 
a request for a determination, before the furnishing of a physicians' 
service, as to whether the physicians' service is covered under this 
title consistent with the applicable requirements of section 
1862(a)(1)(A) of the Act (relating to medical necessity).
    (B) Accompanying documentation. The Secretary may require that the 
request be accompanied by a description of the physicians' service, 
supporting documentation relating to the medical necessity for the 
physicians' service, and other appropriate documentation. In the case 
of a request submitted by an eligible requester who is described in 
section 1869(h)(1)(B)(ii) of the Act, the Secretary may require that 
the request also be accompanied by a copy of the advance beneficiary 
notice involved.
    (ii) Response to request.
    (A) General rule. The contractor will provide the eligible 
requester with notice of a determination as to whether--
    (1) The physicians' service is so covered;
    (2) The physicians' service is not so covered; or
    (3) The contractor lacks sufficient information to make a coverage 
determination with respect to the physicians' service.
    (B) Contents of notice for certain determinations.
    (1) Noncoverage. If the contractor makes the determination 
described in paragraph (d)(5)(ii)(A)(2) of this section, the contractor 
will include in the notice a brief explanation of the basis for the 
determination, including on what national or local coverage or 
noncoverage determination (if any) the determination is based, and a 
description of any applicable rights under section 1869(a) of the Act.
    (2) Insufficient information. If the contractor makes the 
determination described in paragraph (d)(5)(ii)(A)(3) of this section, 
the contractor will include in the notice a description of the 
additional information required to make the coverage determination.
    (C) Deadline to respond. That notice will be provided within the 
same time period as the time period applicable to the contractor 
providing notice of initial determinations on a claim for benefits 
under section 1869(a)(2)(A) of the Act.
    (D) Informing beneficiary in case of physician request. In the case 
of a request by a participating physician, the process will provide 
that the individual to whom the physicians' service is proposed to be 
furnished will be informed of any determination described in paragraph 
(d)(5)(ii)(A)(2) of this section (relating to a determination of non-
coverage) and the right to obtain the physicians' service and have a 
claim submitted for the physicians' service.
    (iii) Binding nature of positive determination. If the contractor 
makes the determination described in paragraph (d)(5)(ii)(A)(1) of this 
section, that determination will be binding on the contractor in the 
absence of fraud or evidence of misrepresentation of facts presented to 
the contractor.
    (iv) Limitation on further review.
    (A) General rule. Contractor determinations described in paragraph 
(d)(5)(ii)(A)(2) of this section or (d)(5)(ii)(A)(3) of this section 
(relating to pre-service claims) are not subject to further 
administrative appeal or judicial review.
    (B) Decision not to seek prior determination or negative 
determination does not impact right to obtain services, seek 
reimbursement, or appeal rights. Nothing in this paragraph will be 
construed as affecting the right of an individual who--
    (1) Decides not to seek a prior determination under this paragraph 
with respect to physicians' services; or
    (2) Seeks such a determination and has received a determination 
described in paragraph (d)(5)(ii)(A)(2) of this section, from receiving 
(and submitting a claim for) those physicians' services and from 
obtaining administrative or judicial review respecting that claim under 
the other applicable provisions of this section. Failure to seek a 
prior determination under this paragraph with respect to physicians' 
services will not be taken into account in that administrative or 
judicial review.
    (C) No prior determination after receipt of services. Once an 
individual is provided physicians' services, there will be no prior 
determination under this paragraph with respect to those physicians' 
services.

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program.)
    Dated: September 29, 2004.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.

    Approved: August 23, 2005.
Michael O. Leavitt,
Secretary.
[FR Doc. 05-17175 Filed 8-29-05; 8:45 am]
BILLING CODE 4120-01-P


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