Federal Register / Vol. 65, No. 203 / Thursday, October 19, 2000 / Rules and Regulations 62645

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

42 CFR Parts 409, 410, 489, and 498

[HCFA–3045–F]

Medicare Program; Removal of the

Requirements for the Cardiac

Pacemaker Registry

AGENCY: Health Care Financing

Administration, HHS.

ACTION: Final rule.

SUMMARY: This final rule eliminates all

requirements and references regarding

the Cardiac Pacemaker Registry (the

Registry) in our regulations. It conforms

to the Food and Drug Administration’s

(FDA) recent final rule that required any

physician and any provider of services

who requests or receives Medicare

payment for the implantation, removal,

or replacement of permanent cardiac

pacemaker devices and pacemaker leads

to submit certain information to the

Registry. We used the information to

administer Medicare payment for these

devices. This rule implements an Act to

Repeal An Unnecessary Medical Device

Reporting Requirement passed by

Congress to eliminate duplicative and

unnecessary reporting.

EFFECTIVE DATE: This regulation is

effective October 19, 2000.

FOR FURTHER INFORMATION CONTACT:

Shana Olshan, (410) 786–3122.

SUPPLEMENTARY INFORMATION:

I. Background

On July 23, 1987, we and the FDA

jointly issued a final rule establishing

the national cardiac pacemaker registry

(52 FR 27756), as mandated by the

Deficit Reduction Act of 1984 (Public

Law 98–369). The final rule for the

Registry was codified in 21 CFR part

805. The scope of the regulation

provided that the FDA establish a

nationwide registry for cardiac

pacemakers and pacemaker leads. The

FDA used the information submitted to

the Registry to track the performance of

permanent pacemakers and pacemaker

leads and to perform studies and

analysis regarding the use of the

devices. They transmitted data to us to

administer the Medicare program, and

to other Federal components to carry

out statutory responsibilities.

On October 2, 1996, An act to Repeal

An Unnecessary Medical Device

Reporting Requirement (Public Law

104–224), which amended title XVIII of

the Social Security Act (the Act) (42

U.S.C. 1395), became law. The purpose

of the new law was to remove section

1862(h) (42 U.S.C. 1395y(h)) of the Act

to eliminate duplicative and

unnecessary reporting. The registry was

considered duplicative with the

requirements of section 519(e) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360i(e)), which requires that

manufacturers track and collect data for

certain devices, including permanently

implanted pacemakers and pacemaker

leads, from the manufacturer, through

the distribution chain, to the patient

using the device. In accordance with

this act, the FDA published a final rule

in the Federal Register revoking the

Registry on November 24, 1999 (64 FR

66105).

II. Provisions of the Regulation

In response to the FDA revocation of

the Registry, we are removing all

requirements and references regarding

the Registry that appear in our

regulations. These appear in 42 CFR

Parts 409, 410, 489, and 498. We are

revising § 409.1(e) to remove the phrase

‘‘* * * and section 1862(h) requires a

registry of pacemakers.’’ We are also

removing §§ 409.19 and 410.64, which

deal exclusively with requirements for

providers and physicians related to the

Registry. And we are removing and

reserving §§ 489.21(g) and 498.3(b)(10),

which contain cross references to

§§ 409.19 and 410.64.

III. Waiver of Proposed Rulemaking

and Delayed Effective Date

Under section 553(b)(B) of the

Administrative Procedure Act (APA),

we, for good cause, find that notice and

comment procedures are unnecessary

because we are not exercising discretion

in removing the references to the

Registry. And, under section 553(d)(3)

of the APA, we, for good cause, waive

the 30-day delay in the effective date

because Public Law 104–224 was selfimplementing.

IV. Regulatory Impact Analysis

We have reviewed this notice under

the threshold criteria of Executive Order

13132. We have determined that this

final rule will not have substantial

direct effects on the states, the

relationship between the national

government and the States, or the

distribution of power and

responsibilities among the various

levels of government.

Section 202 of the Unfunded

Mandates Reform Act of 1995 requires

that agencies assess anticipated costs

and benefits before issuing any rule that

may result in an expenditure by State,

local, or tribal governments, in the

aggregate, or by the private sector, of

$100 million in any one year. This final

rule will not have an effect on the

governments mentioned, and the private

sector costs will not be greater than the

$100 million threshold.

We have examined the impacts of this

rule as required by Executive Order

12866 (September 1993, Regulatory

Planning and Review) and the

Regulatory Flexibility Act (RFA)

(September 19, 1980 Public Law 96–

354). 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

annually). This rule is not a major rule

because costs will not meet this $100

million threshold. 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 $5 million or less annually.

Individuals and States are not included

in the definition of a small entity.

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 604 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 50 beds.

In accordance with the provisions of

Executive Order 12866, this final rule

was not reviewed by the Office of

Management and Budget.

List of Subjects

42 CFR Part 409

Health facilities, Medicare.

42 CFR Part 410

Health facilities, Health professions,

Kidney diseases, Laboratories,

Medicare, Rural areas, X-rays.

42 CFR Part 489

Health facilities, Medicare, Reporting

and recordkeeping requirements.

62646 Federal Register / Vol. 65, No. 203 / Thursday, October 19, 2000 / Rules and Regulations

42 CFR Part 498

Administrative practice and

procedure, Health facilities, Health

professions, Medicare, Reporting and

recordkeeping requirements.

For the reasons set forth in the

preamble, 42 CFR Chapter IV is

amended as follows:

PART 409—HOSPITAL INSURANCE

BENEFITS

A. Part 409 is amended as set forth

below.

1. The authority citation for part 409

is revised to read as follows:

Authority: Secs. 1102 and 1871 of the

Social Security Act (42 U.S.C. 1302 and

1395hh).

2. In § 409.1, paragraph (e) is revised

to read as follows:

§ 409.1 Statutory basis.

* * * * *

(e) Section 1862(a) specifies

exclusions from coverage.

* * * * *

3. Section 409.19 is removed.

PART 410—SUPPLEMENTARY

MEDICAL INSURANCE (SMI)

BENEFITS

B. Part 410 is amended as set forth

below.

1. The authority citation for part 410

continues to read as follows:

Authority: Secs. 1102 and 1871 of the

Social Security Act (42 U.S.C. 1302 and

1395hh).

§ 410.64 [Removed]

2. Section 410.64 is removed.

PART 489—PROVIDER AGREEMENTS

AND SUPPLIER APPROVAL

C. Part 489 is amended as set forth

below.

1. The authority citation for part 489

continues to read as follows:

Authority: Secs. 1102, 1819, 1861,

1864(m), 1866, and 1871 of the Social

Security Act (42 U.S.C. 1302, 1395i–3, 1395x,

1395aa(m), 1395cc, and 1395hh).

§ 489.21 [Amended]

2. In § 489.21, paragraph (g) is

removed and reserved.

PART 498—APPEALS PROCEDURES

FOR DETERMINATIONS THAT AFFECT

PARTICIPATION IN THE MEDICARE

PROGRAM AND FOR

DETERMINATIONS THAT AFFECT THE

PARTICIPATION OF ICFS/MR AND

CERTAIN NFS IN THE MEDICAID

PROGRAM

D. Part 498 is amended as set forth

below.

1. The authority citation for part 498

continues to read as follows:

Authority: Secs 1102 and 1871 of the

Social Security Act (42 U.S.C. 1302 and

1395hh).

§ 498.3 [Amended]

2. In § 498.3, paragraph (b)(11) is

removed and reserved.

Authority: Secs. 1102, 1819, 1861,

1864(m), 1866, and 1871 of the Social

Security Act (42 U.S.C. 1302, 1395i–3, 1395x,

1395aa(m), 1395cc, 1395hh, and 1895hh).

(Catalog of Federal Domestic Assistance

Program No. 93.773, Medicare Hospital

Insurance; Program No. 93.774, Medicare

Supplementary Medical Insurance)

Dated: April 18, 2000.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing

Administration.

Dated: May 31, 2000.

Donna E. Shalala,

Secretary.

[FR Doc. 00–26282 Filed 10–18–00; 8:45 am]

BILLING CODE 4120–01–P

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 20

[CC Docket No. 94–54; FCC 00–251]

Interconnection and Resale

Obligations Pertaining to Commercial

Mobile Radio Services; Correction

AGENCY: Federal Communications

Commission.

ACTION: Final rule; correction.

SUMMARY: On September 29, 2000, the

Commission published a document in

the Federal Register which established

service rules governing the manual

roaming responsibilities of Commercial

Mobile Radio Services (CMRS)

providers. This document makes

corrections to that document.

DATES: Effective November 28, 2000.

FOR FURTHER INFORMATION CONTACT: Paul

Murray at (202) 418–7240.

SUPPLEMENTARY INFORMATION: The

Commission, in its summary of the

Memorandum Opinion and Order

(MO&O), FR Doc. 00–24964, published

in the Federal Register of September 29,

2000 (65 FR 58477) released information

that requires correction. First, it

misstated the correct agency docket

number for the item (CC Docket No. 94–

54) in the headings section. Then, in the

SUPPLEMENTARY INFORMATION section of

the preamble, the Commission

erroneously incorporated a docket

number and the associated adoption and

release dates from another proceeding

into this item thereby omitting the

correct docket number for this

proceeding (CC Docket No. 94–54), the

correct adoption date of the MO&O (July

13, 2000), and the correct release date of

the MO&O (August 28, 2000). Further,

this item corrects the phone listing for

Paul Murray to 418–7240.

In FR Doc. 00–24964, published in the

Federal Register of September 29, 2000

(65 FR 58477), make the following

corrections:

(1) On page 58477, in the second

column, in the Agency Docket number,

correct ‘‘PR Docket No. 94–54’’ to read

‘‘CC Docket No. 94–54.’’

(2) On the same page, in the third

column, line four, correct ‘‘(202) 418–

0688’’ to read ‘‘(202) 418–7240.’’

(3) On the same page, in the same

column, line 11, correct ‘‘PR Docket No.

93–144’’ to read ‘‘CC Docket No. 94–

54.’’

(4) On the same page, in the same

column, line 12, correct ‘‘August 2,

2000’’ to read ‘‘July 13, 2000.’’

(5) On the same page, in the same

column, lines 12 and 13, correct

‘‘August 4, 2000’’ to read ‘‘August 28,

2000.’’

Federal Communications Commission.

Magalie Roman Salas,

Secretary.

[FR Doc. 00–26893 Filed 10–18–00; 8:45 am]

BILLING CODE 6712–01–P

DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric

Administration

50 CFR Part 679

[Docket No. 000211040–0040–01; I.D.

101200A]

Fisheries of the Exclusive Economic

Zone Off Alaska; Reallocation of

Pollock

AGENCY: National Marine Fisheries

Service (NMFS), National Oceanic and

Atmospheric Administration (NOAA),

Commerce.

ACTION: Reallocation.

SUMMARY: NMFS is reallocating

projected unused amounts of Bering Sea