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TrialCard will be submitting comments to CMS and are encouraging our manufacturer partners and patient advocacy groups to do the same. CMS states, “We believe manufacturers have the ability to establish coverage criteria around their manufacturer assistance programs to ensure the benefit goes exclusively to the consumer or patient.”ĬMS announced a 30-day public comment period on this proposal, which ends July 20, 2020.
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The Proposed Rule places responsibility on pharmaceutical manufacturers to ensure that copay assistance benefits are provided entirely to the patient to maintain exclusion from best price determination. Pharmacy Benefit Managers (PBMs) and health plan sponsors take advantage of these funds to reduce their cost burden for many drugs.
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With the advent of copay accumulator and maximizer programs in recent years, the full value of copay assistance is not always applied to the benefit of the patient.
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On June 19, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a Proposed Rule that addresses the impact copay accumulator adjustment programs have on manufacturer copay assistance programs specifically, their exclusion from best price determination.Ĭurrent regulations around best price determination allow for manufacturer assistance offers to be excluded “to the extent that the program benefits are provided entirely to the patient and the pharmacy, agent, or other entity does not receive any price concession.”
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