114 STAT. 2763A-522 PUBLIC LAW 106-554—APPENDIX F (2) REPORT.—Not later than 6 months after the date of the enactment of this Act, the Comptroller General shall submit to Congress a report on the study conducted under paragraph (1). SEC. 428. REPLACEMENT OF PROSTHETIC DEVICES AND PARTS. (a) IN GENERAL.—Section 1834(h)(1) (42 U.S.C. 1395m(h)(l)), as amended by section 427(a), is ftirther amended by adding at the end the following new subparagraph: "(G) REPLACEMENT OF PROSTHETIC DEVICES AND PARTS. — " (i) IN GENERAL.— Payment shall be made for the replacement of prosthetic devices which are artificial limbs, or for the replacement of any part of such devices, without regard to continuous use or useful lifetime restrictions if an ordering physician determines that the provision of a replacement device, or a replacement part of such a device, is necessary because of any of the following: "(I) A change in the physiological condition of the patient. "(II) An irreparable change in the condition of the device, or in a part of the device. "(Ill) The condition of the device, or the part of the device, requires repairs and the cost of such repairs would be more than 60 percent of the cost of a replacement device, or, as the case may ^e, of the part being replaced. (ii) CONFIRMATION MAY BE REQUIRED IF DEVICE OR PART BEING REPLACED IS LESS THAN 3 YEARS OLD.— If a physician determines that a replacement device, or a replacement part, is necessary pursuant to clause (i>- "(I) such determination shall be controlling; and J "(II) such replacement device or part shall be deemed to be reasonable and necessary for purposes of section 1862(a)(l)(A); except that if the device, or part, being replaced is less than 3 years old (calculated from the date on which the beneficiary began to use the device or part), the Secretary may also require confirmation of necessity of the replacement device or replacement part, as the case may be.". (b) PREEMPTION OF RULE. —The provisions of section 1834(h)(1)(G) as added by subsection (a) shall supersede any rule that as of the date of the enactment of this Act may have applied a 5-year replacement rule with regard to prosthetic devices. (c) EFFECTIVE DATE.—The amendment made by subsection (a) shall apply to items replaced on or after April 1, 2001. SEC. 429. REVISED PART B PAYMENT FOR DRUGS AND BIOLOGICALS AND RELATED SERVICES. (a) RECOMMENDATIONS FOR REVISED PAYMENT METHODOLOGY FOR DRUGS AND BIOLOGICALS.— (1) STUDY.— (A) IN GENERAL. —The Comptroller General of the United States shall conduct a study on the reimbursement
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