[Federal Register Volume 69, Number 250 (Thursday, December 30, 2004)]
[Notices]
[Pages 78442-78444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-28158]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9026-N]
RIN 0938-AN112


Medicare Program; Timeline for Publication of Medicare Final 
Regulations After Proposed or Interim Final Regulations

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

ACTION: Notice.

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SUMMARY: This notice implements section 902 of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003, which 
establishes a general 3-year timeline for publishing a Medicare final 
regulation after a proposed regulation or an interim final regulation 
has been published. In accordance with the statute, this notice permits 
an extension of a published timeline under exceptional circumstances. 
The notice also establishes a transition period for publishing Medicare 
final regulations for previously published interim final regulations.

EFFECTIVE DATE: This notice is effective on December 30, 2004.

FOR FURTHER INFORMATION CONTACT: Renee Swann, (410) 786-4492.

SUPPLEMENTARY INFORMATION:

I. Background and Legislative Authority

    The general statutory authority for the Department to issue 
Medicare regulations is found in section 1871 of the Social Security 
Act (the Act). Specifically, section 1871(a)(1) of the Act authorizes 
us to publish regulations to administer the Medicare program. Section 
1871(a)(2) of the Act states that, with the exception of national 
coverage determinations, we must publish a regulation ``that 
establishes or changes a substantive legal standard governing the scope 
of benefits, the payment for services, or the eligibility of 
individuals, entities, or organizations to furnish or receive services 
or benefits* * *''
    Before issuing a final regulation, section 1871(b)(1) of the Act 
generally requires us to publish a proposed regulation that solicits 
comments (for at least 60 days) from the public. There are, however, 
several exceptions that permit the Secretary to issue final regulations 
or interim final regulations without first obtaining advance public 
comments.
    Executive Order 12866 (issued on September 20, 1993) requires that 
all Federal agencies prepare an agenda of all regulations under 
development or review, at a time and in a manner specified by the 
Administrator of the Office of Information and Regulatory Affairs, of 
the Office of Management and Budget.
    We announce in the Semi-Annual Unified Regulations Agenda the 
regulations we plan to publish during the 12-month period following 
publication of the Agenda in the Federal Register. The Agenda is 
generally published in April and October each year.
    In October 2001, to better serve all of our constituencies, 
including our health care providers, we began publishing regulations on 
the fourth Friday of every month (except when a statutory deadline 
demands otherwise), and we began issuing a quarterly publication called 
the Quarterly Provider Update (QPU). The QPU is publicly available on 
the Internet and lists all of the regulations that we plan to publish 
in the coming quarter, as well as the publication date and page 
reference to all regulations published in the previous quarter. The QPU 
is published on the CMS web site at http://qa.cms.hhs.gov/providerupdate/main.asp.
    On December 8, 2003, the Medicare Prescription Drug, Improvement, 
and Modernization Act of 2003 (MMA, Pub. L. 108-173) was enacted. 
Section 902 of the MMA added a new paragraph (a)(3) to section 1871 of 
the Act. New section 1871(a)(3)(A) of the Act requires the Secretary, 
in consultation with the Director of the Office of Management and 
Budget, to establish a standardized timeline for the publication of a 
Medicare final regulation after the

[[Page 78443]]

publication of a proposed or an interim final regulation. Section 
1871(a)(3)(B) of the Act allows the timeline for publishing Medicare 
final regulations to vary based on the complexity of the regulation, 
the number and scope of comments received, and other related factors. 
The timeline for publishing the final regulation, however, cannot 
exceed 3 years from the date of publishing the proposed regulation or 
interim final regulation, unless there are exceptional circumstances. 
The Secretary may extend the initial targeted publication date of the 
final regulation, if the Secretary provides public notice including a 
brief explanation of the justification for the variation no later than 
the regulation's previously established proposed publication date.
    Section 1871(a)(3)(C) of the Act states that a Medicare interim 
final regulation will not continue in effect if the final regulation is 
not published before the expiration of the regular timeline, unless a 
notice of continuation (for a 1-year period) is published in the 
Federal Register before the proposed publication date for the final 
regulation. The notice of continuation must establish a new timeline 
and provide an explanation for missing the previous timeline. If the 
notice is published before the end of the previous timeline, the 
timeline for publishing the final regulation will be extended for 1 
additional year. The statute allows for additional extensions if this 
process is followed for additional continuation notices.
    Section 1871(a)(3)(D) of the Act requires the Secretary to report 
annually to the Congress on all instances when the Secretary failed to 
publish a Medicare final regulation within the applicable timeline and 
to provide an explanation for failing to meet the timeline.
    The provisions of section 902 of the MMA were effective on the date 
of enactment of the MMA (that is, December 8, 2003). Section 902 of the 
MMA instructs the Secretary to provide an appropriate transition for 
previously published Medicare interim final regulations.

II. Timeline of Regulatory Documents

A. Medicare Final Regulations for Proposed Regulations and Interim 
Final Regulations

    We are continuing to improve our efforts to be more responsive to 
Medicare beneficiaries. Thus, we are establishing a timeline for 
publishing Medicare final regulations. We believe these changes will 
enhance our ability to better serve Medicare beneficiaries and to be 
better business partners with the health care community.
    In accordance with section 902(a) of the MMA, we will publish all 
future Medicare final regulations within 3 years from the publication 
date of the proposed regulation or interim final regulation, unless 
there is good cause or there are exceptional circumstances. We will 
consult with the Office of Management and Budget and set regulation-
specific timelines for publishing Medicare final regulations on a case-
by-case basis within the 3-year standardized timeline. We will continue 
to use the QPU to announce all CMS regulations that we will publish 
during the quarter.
    We will continue to announce the timelines for all CMS regulations 
in the Semi-Annual Unified Regulations Agenda for the period covered by 
the Agenda. Except for certain Medicare payment regulations and certain 
other statutorily-mandated regulations, we scheduled all Medicare final 
regulations for publication within the 3-year standardized time limit 
in the current Unified Agenda. We do not intend to delay publishing a 
Medicare final regulation for 3 years if we are able to publish it 
sooner.
    If it appears likely that we will miss the applicable timeline for 
finalizing a Medicare interim final regulation, we will publish a 
notice of continuation announcing the extended timeline and furnish a 
brief explanation for the delay.
    Although we do not believe that section 902 of the MMA prohibits 
the Secretary from finalizing every proposed regulation that was 
published more than 3 years before December 8, 2003, we recognize that 
section 902 of the MMA may be susceptible to more than one 
interpretation. Accordingly, out of an abundance of caution, we are 
interpreting section 902 of the MMA as rendering ineffective most 
Medicare proposed regulations that have not been finalized within 3 
years of the proposed regulation publication dates. This also includes 
proposed regulations published before December 8, 2003, unless there is 
good cause. In those limited cases when we believe there is good cause, 
that is, when the agency finds that the notice and comment procedure is 
impracticable, unnecessary, or contrary to the public interest, we will 
publish the proposed regulation as an interim final regulation. The 
interim final regulation will be subject to the 3-year standard 
timeline set by section 902 of the MMA. Otherwise, if we believe that 
the substance of a proposed regulation rendered ineffective by the 
statute should move forward, we will publish the proposed regulation 
with an appropriate timeline, not to exceed 3 years.

B. Appropriate Transition for Previously Published Medicare Interim 
Final Regulations

    The enactment of the MMA brought about the most extensive revisions 
to the Medicare program since its inception in 1965. As a result, we 
must develop and publish numerous regulations by specific statutory 
effective dates. In addition to this new priority workload, we must 
annually publish numerous proposed and final regulations that are 
required by the statute to update the various Medicare payment systems. 
Section 902 of the MMA recognizes the need for a transition period to 
allow for the publication of Medicare final regulations for those 
interim final regulations that were published before the enactment of 
the MMA (that is, December 8, 2003). It is our intention to publish 
these Medicare final regulations as time allows while publishing other 
regulations required by the statute, but no later than December 8, 
2006.
    In accordance with the Congress' instruction to devise an 
appropriate transition for existing interim final regulations, we will 
be extending all Medicare interim final regulations that have not been 
finalized for 3 years from the date of passage of the MMA until 
December 8, 2006. Over the course of the 3 years, we will be reviewing 
the Medicare interim final regulations to determine the basis for 
finalizing the regulation and the possible impact of not implementing a 
final regulation. If we determine that a regulation needs to be 
repealed, we will issue a separate rulemaking document. For those 
Medicare interim final regulations that we do not finalize within 3 
years, the regulation will expire in accordance with the statute, and 
we will take the appropriate actions to amend the Code of Federal 
Regulations.
    In accordance with the provisions of Executive Order 12866, this 
notice has been reviewed by the Office of Management and Budget.

    Authority: Section 1871 of the Social Security Act (42 U.S.C. 
1395hh).

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


[[Page 78444]]


    Dated: March 31, 2004.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.

    Approved: August 6, 2004.
Tommy G. Thompson,
Secretary.
[FR Doc. 04-28158 Filed 12-29-04; 8:45 am]
BILLING CODE 4120-01-P