No problem with AKF Part D assistance program, HHS says

08/28/2006

ROCKVILLE, Md.--The U.S. Department of Health and Human Services said the American Kidney Fund's proposed Medicare Part D assistance program would not violate federal law, thus paving the way for the nonprofit group to build the program.

"Our Medicare Part D assistance programs will help to close the coverage gap that many individuals with CKD and ESRD have encountered," Carol Lynn Halal, AKF managing director fro programs, said in a statement. "The OIG's favorable opinion allows us to move forward with out plans to develop these vital new programs and begin fundraising for their implementation."

The Medicare Part D Assistance Program is designed to help patients facing higher payments in and out of what is known as the "doughnut hole," which is when beneficiaries will not receive assistance with drug payments. When drug costs reach $2,250, patients will pay an additional $2,850 before Medicare Part D continues coverage.

Under the AKF program, pharmaceutical manufacturers and other organizations can make donations to the AKF to help subsidize Medicare Part D premiums for kidney disease patients, patient cost-sharing obligations, and/or cost-sharing for condition-specific products, such as bone disease.

In July, The AKF and Genzyme Corp. teamed up to launch a program that will provide Renagel to Medicare patients who can't afford co-payments for the phosphorus drug.

The AKF asked the Office of the Inspector General to review whether its assistance program would clash with the Social Security Act, which doesn't allow inducement of beneficiaries. In a statement, the OIG said the program's structure is "not likely to influence improperly and beneficiary's selection of a particular provider, practitioner, supplier or product."

Patient eligibility for the Part D program will be based on the applicant's medical condition and financial need, according to the AKF. The group added that the first-come, first-serve grants will be issued "without regard to the interests of any contributor or any contributor affiliates, the applicant's choice of product, provider, practitioner, supplier of insurance company, and without regard to whether the referring person or organization has contributed to the Part D programs."

In its opinion, the OIG said the AKF can also begin other condition-specific programs intended to help kidney disease patients, and added that the AKF's discretion to use the contributions to the Part D program "will be absolute, independent and autonomous."

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