Page:United States Statutes at Large Volume 124.djvu/445

124 STAT. 419 PUBLIC LAW 111–148—MAR. 23, 2010 such evidence of accreditation prior to January 1, 2011’’ before the semicolon at the end; and (2) by adding at the end the following new subparagraph: ‘‘(G) APPLICATION OF ACCREDITATION REQUIREMENT TO CERTAIN PHARMACIES.— ‘‘(i) IN GENERAL.—With respect to items and serv- ices furnished on or after January 1, 2011, in imple- menting quality standards under this paragraph— ‘‘(I) subject to subclause (II), in applying such standards and the accreditation requirement of subparagraph (F)(i) with respect to pharmacies described in clause (ii) furnishing such items and services, such standards and accreditation require- ment shall not apply to such pharmacies; and ‘‘(II) the Secretary may apply to such phar- macies an alternative accreditation requirement established by the Secretary if the Secretary deter- mines such alternative accreditation requirement is more appropriate for such pharmacies. ‘‘(ii) PHARMACIES DESCRIBED.—A pharmacy described in this clause is a pharmacy that meets each of the following criteria: ‘‘(I) The total billings by the pharmacy for such items and services under this title are less than 5 percent of total pharmacy sales, as deter- mined based on the average total pharmacy sales for the previous 3 calendar years, 3 fiscal years, or other yearly period specified by the Secretary. ‘‘(II) The pharmacy has been enrolled under section 1866(j) as a supplier of durable medical equipment, prosthetics, orthotics, and supplies, has been issued (which may include the renewal of) a provider number for at least 5 years, and for which a final adverse action (as defined in section 424.57(a) of title 42, Code of Federal Regulations) has not been imposed in the past 5 years. ‘‘(III) The pharmacy submits to the Secretary an attestation, in a form and manner, and at a time, specified by the Secretary, that the pharmacy meets the criteria described in subclauses (I) and (II). Such attestation shall be subject to section 1001 of title 18, United States Code. ‘‘(IV) The pharmacy agrees to submit materials as requested by the Secretary, or during the course of an audit conducted on a random sample of phar- macies selected annually, to verify that the phar- macy meets the criteria described in subclauses (I) and (II). Materials submitted under the pre- ceding sentence shall include a certification by an accountant on behalf of the pharmacy or the submission of tax returns filed by the pharmacy during the relevant periods, as requested by the Secretary.’’. (b) ADMINISTRATION.—Notwithstanding any other provision of law, the Secretary may implement the amendments made by sub- section (a) by program instruction or otherwise. 42 USC 1395m note. Criteria.