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)).".
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