Browse Advisory Opinions

Concerning a pharmaceutical company's proposal to establish a patient assistance program to provide outpatient prescription drugs to financially-needy Medicare Part D enrollees entirely outside of the Part D benefit.

Concerning a pharmaceutical company's proposal to establish a patient assistance program to provide outpatient prescription drugs to financially-needy Medicare Part D enrollees entirely outside of the Part D benefit.

Concerning a pharmaceutical manufacturer's proposal to establish a patient assistance program to provide the company's drugs to financially-needy Medicare Part D enrollees outside of the Part D benefit.

Concerning a free clinic's practice of dispensing drugs on behalf of patient assistance programs ("PAPs") sponsored by pharmaceutical manufacturers that provide free drugs to financially-needy patients, including some patients enrolled in the Medicare Part D outpatient prescription drug benefit.

Concerning a pharmaceutical company patient assistance program that provides free outpatient prescription drugs to financially-needy Medicare Part D enrollees entirely outside of the Part D benefit.

Concerning the waiver of Part B cost-sharing obligations for equipment and supplies used by Medicare beneficiaries to monitor blood glucose levels in a clinical trial sponsored by the National Institutes of Health.

Concerning an ambulance company's proposed arrangement to collect a fixed annual subscription fee in lieu of Medicare Part B cost-sharing amounts from its members.

Concerning a proposed arrangement that would involve a company developing and managing distinct part inpatient rehabilitation units located within general acute care hospitals in exchange for a management fee calculated on a per patient per day basis.

Concerning a proposed modification to a drug company's patient assistance program to pay Medicare Part B cost-sharing amounts for financially needy beneficiaries following surgery.

Concerning the waiver of Part B cost-sharing obligations for equipment and supplies used by Medicare beneficiaries to monitor blood glucose levels in a clinical trial sponsored by the National Institutes of Health.

Concerning whether the offering of discounts to customers, based on their purchases of dialysis equipment and supplies - some of which 05/be reimbursed under different Medicare part B methodologies - would violate the administrative authorities related to the anti-kickback statute.

Whether waiving Medicare Part A and Part B copayment and deductible obligations for participants in a clinical study sponsored by the Health Care Financing Administration and the National Heart, Lung, and Blood Institute.

Whether donations by Company X ("Company X") to Organization A ("Organization A") (an independent, 501(c)(3) charitable organization) for the purpose of funding a program to pay for Supplementary Medical Insurance ("Medicare Part B") or Medicare Supplementary Health Insurance ("Medigap") premiums for financially needy Medicare beneficiaries with end-stage renal disease.

It is permissible for a charitable organization partly funded by kidney dialysis providers to pay Medicare Part B, Medigap and other health insurance premiums for end-stage renal disease patients who are financially needy.