Page:United States Statutes at Large Volume 98 Part 1.djvu/1117

 PUBLIC LAW 98-369—JULY 18, 1984

98 STAT. 1069

"(2) The Secretary may, by regulation, require each provider of services— "(A) to return, to the manufacturer of the device or lead for testing under paragraph (3), any cardiac pacemaker device or lead which is removed from a patient and payment for the implantation or replacement of which was made or requested by such provider under this title, and "(B) not to charge any beneficiary for replacement of such a device or lead if the device or lead has not been returned in accordance with subparagraph (A). "(3) The Secretary may, by regulation, require the manufacturer of a cardiac pacemaker device or lead (A) to test or analyze each pacemaker device or lead for which payment is made or requested under this title and which is returned to the manufacturer by a provider of services under paragraph (2), and (B) to provide the results of such test or analysis to that provider, together with information and documentation with respect to any warranties covering such device or lead. In any case where the Secretary has reason to believe, based upon information in the pacemaker registry or otherwise available to him, that replacement of a cardiac pacemaker device or lead for which payment is or may be requested under this title is related to the malfunction of a device or lead, the Secretary may require that personnel of the Food and Drug Administration be present at the testing of such device by the manufacturer, to determine whether such device was functioning properly. "(4) The Secretary may deny payment under this title, in whole or in part and for such period of time as the Secretary determines to be appropriate, with respect to the implantation or replacement of a pacemaker device or lead of a manufacturer performed by a physician and provider of services after the Secretary determines (in accordance with the procedures established under paragraphs (2) and (3) of subsection (d)) that— "(A) the physician or provider of services has failed to submit information to the registry as required under paragraph (1)(C), "(B) the provider of services has failed to return devices and leads as required under paragraph (2)(A) or has improperly charged beneficiaries as prohibited under paragraph (2)(B), or "(C) the manufacturer of the device or lead has failed to perform and to report on the testing of devices and leads returned to it as required under paragraph (3).". (d) The Secretary of Health and Human Services shall promulgate Regulations. final regulations to carry out this section and the amendment made 42 USC 1395y by this section prior to January 1, 1985, and the amendment made ^°^^by subsection (c) shall apply to pacemaker devices and leads implanted or removed on or after the effective date of such regulations. ELIMINATION OF SPECIAL PAYMENT PROVISIONS FOR PREADMISSION DIAGNOSTIC TESTING

SEC. 2305. (a) Section 1833(a)(1) of the Social Security Act is 42 USC 1395Z. amended by striking out "(F) with respect to" and all that follows through "(G)" and inserting in lieu thereof "and (F)". (b) Section 1833(a) of such Act is amended— (1) by adding "and" at the end of paragraph (3); (2) by striking out "; and" at the end of paragraph (4) and inserting in lieu thereof a period; and

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