78442 Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 

OMB control 

numbers 

Approved CFR Sections in Title 42, Title 45, and Title 20 (Note: Sections in Title 45 are preceded by ‘‘45 CFR,’’ and sections 

in Title 20 are preceded by ‘‘20 CFR’’) 

0938–0802 ........ 419.43 

0938–0818 ........ 410.141, 410.142, 410.143, 410.144, 410.145, 410.146, 414.63 

0938–0829 ........ 422.568 

0938–0832 ........ 489 and 491 

0938–0833 ........ 483.350–483.376 

0938–0841 ........ 431.636, 457.50, 457.60, 457.70, 457.340, 457.350, 457.431, 457.440, 457.525, 457.560, 457.570, 457.740, 457.750, 

457.810, 457.940, 457.945, 457.965, 457.985, 457.1005, 457.1015, 457.1180 

0938–0842 ........ 412.23, 412.604, 412.606, 412.608, 412.610, 412.614, 412.618, 412.626, 413.64 

0938–0846 ........ 411.352–411.361 

0938–0857 ........ 419 

0938–0860 ........ 419 

0938–0866 ........ 45 CFR Part 162 

0938–0872 ........ 413.337, 483.20 

0938–0873 ........ 422.152 

0938–0874 ........ 45 CFR Parts 160 and 162 

0938–0878 ........ 422 Subpart F & G 

0938–0883 ........ 45 CFR Parts 160 and 164 

0938–0884 ........ 405.940 

0938–0887 ........ 45 CFR 148.316, 148.318, 148.320 

0938–0897 ........ 412.22, 412.533 

0938–0907 ........ 412.230, 412.304, 413.65 

0938–0910 ........ 422.624, 422.626, 422.620 

0938–0911 ........ 426.400, 426.500 

0938–0916 ........ 483.16 

0938–0920 ........ 438.6, 438.8, 438.10, 438.12, 438.50, 438.56, 438.102, 438.114, 438.202, 438.206, 438.207, 438.240, 438.242, 438.402, 

438.404, 438.406, 438.408, 438.410, 438.414, 438.416, 438.710, 438.722, 438.724, 438.810 

0938–0921 ........ 414.804 

[FR Doc. 04–28156 Filed 12–29–04; 8:45 am] 

BILLING CODE 4120–01–P

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.

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 

Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 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)

78444 Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 

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

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–4077–FN] 

RIN 0928–ZA59 

Medicare Program; Approval of the 

National Committee for Quality 

Assurance Deeming Authority for 

Medicare Advantage Local Preferred 

Provider Organizations

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS.

ACTION: Final notice.

SUMMARY: This final notice announces 

the approval of the National Committee 

for Quality Assurance for deeming 

authority as a national accreditation 

program for local preferred provider 

organizations that wish to participate in 

the Medicare Advantage program.

FOR FURTHER INFORMATION CONTACT:

Gwyneveyre Pasquale, (410) 786–7701. 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services through a managed care 

organization (MCO) that has a Medicare 

Advantage (MA) (formerly, 

Medicare+Choice) contract with the 

Centers for Medicare & Medicaid 

Services (CMS). The regulations 

specifying the Medicare requirements 

that must be met in order for an MCO 

to enter into an MA contract with CMS 

are located at 42 CFR part 422. These 

regulations implement Part C of Title 

XVIII of the Social Security Act (the 

Act), which specifies the services that 

an MCO must provide and the 

requirements that the organization must 

meet to be an MA contractor. Other 

relevant sections of the Act are Parts A 

and B of Title XVIII and Part A of Title 

XI pertaining to the provision of 

services by Medicare certified providers 

and suppliers. 

Generally, for an organization to enter 

into an MA contract, the organization 

must be licensed by the State as a risk 

bearing organization as set forth in part 

422 of our regulations. Additionally, the 

organization must file an application 

demonstrating that it meets other 

Medicare requirements in part 422 of 

our regulations. Following approval of 

the contract, we engage in routine 

monitoring and oversight audits of the 

MA organization to ensure continuing 

compliance. The monitoring and 

oversight audit process is 

comprehensive and incorporates 

ongoing analysis of various performance 

data in addition to biennial audits by 

CMS staff who use a written protocol 

that itemizes the Medicare requirements 

the MA organization must meet. 

As an alternative for some Medicare 

requirements, an MA organization may 

be exempt from CMS monitoring of 

certain requirements in subsets listed in 

section 1852(e)(4)(B) of the Act as a 

result of an MA organization’s 

accreditation by a CMS–approved 

accrediting organization (AO); that is, 

the Secretary deems that the Medicare 

requirements are met based on a 

determination that the AO’s standards 

are at least as stringent as Medicare 

requirements. As we specify at 

§ 422.157(b)(2) of our regulations, the 

term for which an AO may be approved 

by CMS may not exceed 6 years. For 

continuing approval, the AO must reapply to CMS. 

The applicant organization is 

generally recognized as an entity that 

accredits MCOs that are licensed as a 

health maintenance organization (HMO) 

or a preferred provider organization 

(PPO). 

II. Deeming Application Approval 

Process 

Section 1852(e)(4)(C) of the Act 

requires that within 210 days of receipt 

of an application, the Secretary shall 

determine whether the applicant meets 

criteria specified in section 1865(b)(2) of 

the Act. Under these criteria, the 

Secretary will consider for a national 

accreditation body, its requirements for 

accreditation, its survey procedures, its 

ability to provide adequate resources for 

conducting required surveys and 

supplying information for use in 

enforcement activities, its monitoring 

procedures for provider entities found 

out of compliance with the conditions 

or requirements, and its ability to 

provide the Secretary with necessary 

data for validation. 

Section 1865(b)(3)(A) of the Act 

further requires that we publish, within 

60 days of receipt of an organization’s 

complete application, a notice 

identifying the national accreditation 

body making the request, describing the 

nature of the request, and providing at 

least a 30-day public comment period. 

We must publish a finding of approval 

or denial of the application within 210 

days from the receipt of the completed 

application. 

III. Provisions of the Proposed Notice 

On September 24, 2004, we published 

a proposed notice in the Federal 

Register (69 FR 57310) announcing the 

National Committee for Quality 

Assurance’s (NCQA’s) request for 

recognition as a national accreditation 

program for PPOs that wish to 

participate in the MA program. This 

notice informed the public of our 

consideration of NCQA’s application for 

approval as a deeming authority for MA 

organizations that are licensed as a PPO 

for the following six categories: 

• Quality improvement. 

• Access to services. 

• Antidiscrimination. 

• Information on advance directives. 

• Provider participation rules.

• Confidentiality and accuracy of 

enrollees’ records. 

In the notice, we described our 

evaluation criteria. Under § 422.158(a), 

we conducted a review of NCQA’s 

application in accordance with the 

criteria specified by our regulations, 

which include, but are not limited to, 

the following: 

• The equivalency of NCQA’s 

requirements for PPOs to CMS’

comparable MA organization 

requirements. 

• NCQA’s survey process, to 

determine the following: 

+ The frequency of surveys. 

+ The types of forms, guidelines, and 

instructions used by surveyors. 

+ Descriptions of the accreditation 

decision making process, deficiency 

notification and monitoring process, 

and compliance enforcement process. 

• Detailed information about 

individuals who perform accreditation 

surveys including—

+ Size and composition of the survey 

team; 

+ Education and experience 

requirements for the surveyors; 

+ In-service training required for 

surveyor personnel; 

+ Surveyor performance evaluation 

systems; and 

+ Conflict of interest policies relating 

to individuals in the survey and 

accreditation decision process. 

• Descriptions of the organization’s—

+ Data management and analysis 

system; 

+ Policies and procedures for 

investigating and responding to 

complaints against accredited 

organizations; and 

+ Types and categories of 

accreditation offered and MA 

organizations currently accredited 

within those types and categories.