Pharmaceutical companies should not end their patient assistance programs because of the implementation of the Medicare Part D drug program, according to a statement from the Centers for Medicare and Medicaid Services.
Companies can continue to provide free and reduced-cost drugs to Medicare beneficiaries as long as it is done outside of the Part D benefit.
For example, a pharmaceutical company can provide coverage for certain drugs that are part of the Medicare Part D benefit, but no claims for payment can be filed with the Medicare Part D drug plan for that medication and the cost of the medication will not be counted toward the beneficiary's true out-of-pocket costs, according to CMS.
The Department of Health and Human Services' Office of Inspector General (OIG) issued a special advisory bulletin last November warning that pharmaceutical companies would be at risk under the federal antikickback statute if they paid all or a portion of a Medicare beneficiary's Part D cost sharing for their company's products. But the OIG bulletin outlined alternative program designs that would allow Medicare beneficiaries to continue to receive assistance.
“The bulletin also makes clear that pharmaceutical companies may choose to provide free or reduced-price drugs to financially needy Part D beneficiaries, [as] long as the assistance program is properly structured and the free or reduced-price drugs are provided entirely outside the Part D benefit,” the CMS statement said.