Section 3109

SEC. 3109. EXEMPTION OF CERTAIN PHARMACIES FROM ACCREDITATION REQUIREMENTS.

[a] In General- Section 1834[a][20] of the Social Security Act [42 U.S.C. 1395m[a][20]], as added by section 154[b][1][A] of the Medicare Improvements for Patients and Providers Act of 2008 [Public Law 100-275], is amended--

[1] in subparagraph [F][i]--

[A] by inserting 'and subparagraph [G]' after 'clause [ii]'; and

[B] by inserting ', except that the Secretary shall not require a pharmacy to have submitted to the Secretary 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 services furnished on or after January 1, 2011, in implementing 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 requirement shall not apply to such pharmacies; and

'[II] the Secretary may apply to such pharmacies an alternative accreditation requirement established by the Secretary if the Secretary determines 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 determined 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 pharmacies selected annually, to verify that the pharmacy meets the criteria described in subclauses [I] and [II]. Materials submitted under the preceding 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 subsection [a] by program instruction or otherwise.

[c] Rule of Construction- Nothing in the provisions of or amendments made by this section shall be construed as affecting the application of an accreditation requirement for pharmacies to qualify for bidding in a competitive acquisition area under section 1847 of the Social Security Act [42 U.S.C. 1395w-3].