[Federal Register Volume 65, Number 203 (Thursday, October 19, 2000)]
[Rules and Regulations]
[Pages 62645-62646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-26282]



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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.

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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 Sec. 409.1(e) to remove the phrase ``* * * and section 
1862(h) requires a registry of pacemakers.'' We are also removing 
Secs. 409.19 and 410.64, which deal exclusively with requirements for 
providers and physicians related to the Registry. And we are removing 
and reserving Secs. 489.21(g) and 498.3(b)(10), which contain cross 
references to Secs. 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 self-implementing.

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.

[[Page 62646]]

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 Sec. 409.1, paragraph (e) is revised to read as follows:


Sec. 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).


Sec. 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).


Sec. 489.21  [Amended]

    2. In Sec. 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).


Sec. 498.3  [Amended]

    2. In Sec. 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