In March 2011, GAO fulfilled its statutory mandate in this regard by issuing a Report to Congress in which it recommended that CMS “assess payment adequacy when oral-only ESRD drugs are included in the bundled payment and ensure availability of reliable data for monitoring treatment of mineral and bone disorder.”
Note that section 217 of P.L. 113-93, the Protecting Access to Medicare Act of 2014 (i.e., the “doc fix”), which was signed into law on April 1, delineates several revisions to the Medicare ESRD PPS, including delayed implementation – to January 1, 2024, of the oral-only ESRD-related drugs in the ESRD PPS, among other changes.
On Sept. 10, 2014, CMS announced that it is postponing the implementation of Star ratings for dialysis facilities on its Dialysis Facility Compare website until January 2015. Citing stakeholder feedback, the agency says the delay – from the originally anticipated October 1, 2014 date – will “allow more time for consumer education about appropriate use of the ratings for making decisions about treatment” while enabling “dialysis facilities extra time to review their ratings and fine tune verification and correction processes for data submission” to Medicare’s Dialysis Facility Compare website.
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 nonoral 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.