HHS is taking aim at high prescription drug costs through three new programs announced Feb. 14.
The models are designed to make medications more affordable for Medicare and Medicaid recipients and the CMS Innovation Center will test them. The three models are:
1. The Medicare $2 Drug List, also called the Medicare High-Value Drug List Model: Under this model, CMS would encourage Medicare Part D plans to offer a low, fixed copay — across all four phases of cost-sharing — for a standardized list of generic drugs used to treat chronic illnesses.
"Patients picking plans that participate in the model will have more certainty that their out-of-pocket costs for these generic drugs will be capped at a maximum of $2 per month per drug," HHS said.
2. Cell and Gene Therapy Access Model: To rein in patients' costs for new cell and gene therapies, CMS would coordinate with state Medicaid agencies to create multistate, outcomes-based deals with certain drug manufacturers. These agreements would help Medicaid patients access the new therapies, which can cost as much as $1 million per dose, as they enter the market.
3. Accelerating Clinical Evidence Model: Because investigative drugs under the FDA's accelerated approval process don't always have "established evidence of improvement in a clinical endpoint" before they're cleared for the market, this proposal would create payment methods for these drugs to spur "timely confirmation trials," CMS said. The agency's aim is to shrink Medicare's extra spending from these accelerated track drugs — which HHS found cost the U.S. about $18 billion in three years.
The models come after President Joe Biden signed an executive order Oct. 14, which gave HHS 90 days to develop a plan to lower drug costs.
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