[Title 21 CFR 805]
[Code of Federal Regulations (annual edition) - April 1, 1999 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Subchapter H - MEDICAL DEVICES]
[Part 805 - CARDIAC PACEMAKER REGISTRY]
[From the U.S. Government Printing Office]


21FOOD AND DRUGS81999-04-011999-04-01false805PART 805FOOD AND DRUGSFOOD AND DRUG ADMINISTRATION,MEDICAL DEVICES
PART 805--CARDIAC PACEMAKER REGISTRY--Table of Contents




                      Subpart A--General Provisions

Sec.
805.1  Scope.
805.3  Definitions.

                  Subpart B--Submission of Information

805.10  Submission of information by physicians and providers.
805.20  How to submit information.
805.25  Confidentiality.

    Authority: 42 U.S.C. 1395y(h), 1395y note.

    Source: 52 FR 27763, July 23, 1987, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 805.1  Scope.

    (a) This part provides for a nationwide cardiac pacemaker registry 
and requires any physician and any provider of services who requests or 
receives payment from Medicare for the implantation, removal, or 
replacement of permanent cardiac pacemakers and pacemaker leads to 
submit certain information to the registry. If the physician or the 
provider of services does not submit the information according to this 
part and 42 CFR 409.19(a) and 410.64(a), HCFA, which administers the 
Medicare program, will deny payment to the physician or the provider. 
FDA will use the information submitted to the registry to track the 
performance of permanent pacemakers and pacemaker leads and to perform 
studies and analyses regarding the use of the devices, and to transmit 
data to HCFA to assist HCFA in administering the Medicare program and to 
other Department of Health and Human Services'

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components to carry out statutory responsibilities.
    (b) Information submitted to the registry by a physician or a 
provider of services (and any release by FDA or HCFA of that 
information) does not necessarily reflect a conclusion by the submitter, 
FDA, or HCFA that the information constitutes an admission that a 
pacemaker device or lead failed to operate within its performance 
specifications. A submitter need not admit, and may deny, that the 
information submitted to the registry constitutes an admission that the 
pacemaker device or lead failed to operate within its performance 
specifications.
    (c) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.



Sec. 805.3  Definitions.

    (a) FDA means the Food and Drug Administration.
    (b) HCFA means the Health Care Financing Administration.
    (c) A pacemaker or pacemaker device is a device that produces 
periodic electrical impulses to stimulate the heart. It consists of two 
basic components: a pulse generator and one or more leads. See 
Sec. 870.3610 for a more detailed definition.
    (d) A pacemaker lead is a flexible, insulated wire connected at one 
end to a pacemaker's pulse generator and at the other end to the heart. 
It transmits electrical stimuli to and from the heart. See 
Sec. 870.3680(b) for a more detailed definition.
    (e) A physician is a doctor of medicine or osteopathy legally 
authorized to practice medicine and surgery by applicable laws of the 
State in which he or she performs such function or actions. (This 
definition includes an osteopathic practitioner.)
    (f) A PRO is a Utilization and Quality Control Peer Review 
Organization that contracts with the Secretary of Health and Human 
Services to review health care services funded by the Medicare program 
to determine whether those services are reasonable, medically necessary, 
furnished in the appropriate setting, and are of a quality which meets 
professionally recognized standards.
    (g) A provider is a hospital, skilled nursing facility, 
comprehensive outpatient rehabilitation facility, home health agency, or 
a hospice that has in effect an agreement to participate in Medicare.
    (h) A warranty is an express or implied guarantee, under contract or 
State law, of the integrity of a pacemaker device or pacemaker lead and 
of the manufacturer's responsibility for the repair or replacement of 
defective parts of a pacemaker device or pacemaker lead.
    (i) Any terms defined in section 201 of the Federal Food, Drug, and 
Cosmetic Act will have that definition.



                  Subpart B--Submission of Information



Sec. 805.10  Submission of information by physicians and providers.

    A physician or a provider of services that requests or receives 
payment from Medicare for the implantation, removal, or replacement of a 
permanent cardiac pacemaker device or pacemaker lead shall submit the 
following information on a specified form to HCFA for inclusion in the 
pacemaker registry provided for by FDA under Sec. 805.1:
    (a) Provider number.
    (b) Patient's health insurance claim number (HICN).
    (c) Patient's name.
    (d) Date of the procedure.
    (e) Identification number (used by PRO's) and name of the physician 
who ordered the procedure.
    (f) Identification number (used by PRO's) and name of the operating 
physician.
    (g) For each device (pulse generator, atrial lead, ventricular lead) 
implanted during the procedure about which the report is being made: the 
name of the manufacturer, model number, serial number, and the warranty 
expiration date.
    (h) For each device (pulse generator, atrial lead, ventricular lead) 
removed or replaced during the procedure about which the report is being 
made: the name of the manufacturer; model number; serial number; the 
warranty expiration date, if known; the date the device was initially 
implanted, if known;

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whether a device that was replaced was left in the body; if the device 
was not left in the body, whether it was returned to the manufacturer.

(Information collection requirements approved by the Office of 
Management and Budget under control number 0910-0234)



Sec. 805.20  How to submit information.

    Information shall be submitted to the registry in the form and 
manner required under general instructions of the Medicare program (see 
42 CFR 409.19(a) and 410.64(a)).



Sec. 805.25  Confidentiality.

    (a) FDA and HCFA will keep confidential, and will not reveal to the 
public, any specific information that identifies by name a recipient of 
any pacemaker device or lead or that would otherwise identify a specific 
recipient.
    (b) Public disclosure of all other information under this part will 
be governed by the Freedom of Information Act (5 U.S.C. 552), the 
Privacy Act of 1974 (5 U.S.C. 552a), the Department of Health and Human 
Services' public information regulations (45 CFR part 5), FDA's public 
information regulations (21 CFR part 20), and HCFA's public information 
regulations (subpart B of 42 CFR part 401).