Page:United States Statutes at Large Volume 108 Part 5.djvu/928

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108 STAT. 4418 PUBLIC LAW 103-432—OCT. 31, 1994 " (ii) INFORMATION ON PAYMENT AMOUNT AND CHARGES. —If a supplier distributes a certificate of medical necessity containing any of the information permitted to be supplied under clause (i), the supplier shall also list on the certificate of medical necessity the fee schedule amount and the supplier's charge for the medical equipment or supplies being furnished prior to distribution of such certificate to the physician, "(iii) PENALTY.— Any supplier of medical equipment and supplies who knowingly and willfully distributes a certificate of medical necessity in violation of clause (i) or fails to provide the information required under clause (ii) is subject to a civil money penalty in an amount not to exceed $1,000 for each such certificate of medical necessity so distributed. The provisions of section 1128A (other than subsections (a) and (b)) shall apply to civil money penalties under this subparagraph in the same manner as they apply to a penalty or proceeding under section 1128A(a). "(B) DEFINITION. —For purposes of this paragraph, the term 'certificate of medical necessity' means a form or other document containing information required by the carrier to be submitted to show that an item is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. "(3) COVERAGE AND REVIEW CRITERIA.— The Secretary shall annually review the coverage and utilization of items of medical equipment and supplies to determine whether such items should be made subject to coverage and utilization review criteria, and if appropriate, shall develop and apply such criteria to such items. "(4) DEFINITION. — The term 'medical equipment and supplies' means— "(A) durable medical equipment (as defined in section 1861(n)); "(B) prosthetic devices (as described in section 1861(s)(8)); "(C) orthotics and prosthetics (as described in section 1861(s)(9)); "(D) surgical dressings (as described in section 1861(s)(5)); "(E) such other items as the Secretary may determine; and "(F) for purposes of paragraphs (1) and (3)— "(i) home dialysis supplies and equipment (as described in section 1861(s)(2)(F)), "(ii) immunosuppressive drugs (as described in section 1861(s)(2)(J)), "(iii) therapeutic shoes for diabetics (as described in section 1861(s)(12)), ' "(iv) oral drugs prescribed for use as an anticancer therapeutic agent (as described in section 1861(s)(2)(Q)), and "(v) self-administered erythropoetin (as described in section 1861(s)(2)(P)).".