Section 10336

SEC. 10336. GAO STUDY AND REPORT ON MEDICARE BENEFICIARY ACCESS TO HIGH-QUALITY DIALYSIS SERVICES.

[a] Study-

[1] IN GENERAL- The Comptroller General of the United States shall conduct a study on the impact on Medicare beneficiary access to high-quality dialysis services of including specified oral drugs that are furnished to such beneficiaries for the treatment of end stage renal disease in the bundled prospective payment system under section 1881[b][14] of the Social Security Act [42 U.S.C. 1395rr[b][14]] [pursuant to the proposed rule published by the Secretary of Health and Human Services in the Federal Register on September 29, 2009 [74 Fed. Reg. 49922 et seq.]]. Such study shall include an analysis of--

[A] the ability of providers of services and renal dialysis facilities to furnish specified oral drugs or arrange for the provision of such drugs;

[B] the ability of providers of services and renal dialysis facilities to comply, if necessary, with applicable State laws [such as State pharmacy licensure requirements] in order to furnish specified oral drugs;

[C] whether appropriate quality measures exist to safeguard care for Medicare beneficiaries being furnished specified oral drugs by providers of services and renal dialysis facilities; and

[D] other areas determined appropriate by the Comptroller General.

[2] SPECIFIED ORAL DRUG DEFINED- For purposes of paragraph [1], the term 'specified oral drug' means a drug or biological for which there is no injectable equivalent [or other non-oral form of administration].

[b] Report- Not later than 1 year after the date of the enactment of this Act, the Comptroller General of the United States shall submit to Congress a report containing the results of the study conducted under subsection [a], together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate.