On May 11, The Trump Administration released “American Patients First,” the President’s blueprint to lower drug prices and reduce out-of-pocket costs, along with a request for information. The Blueprint was framed as advancing four specific goals:
- Reducing list prices;
- Improving government’s ability to negotiate better prices;
- Encouraging competition through rapid entry to market of generics and biosimilars; and
- Lowering patient out-of-pocket expenses.
The Blueprint proposes a broad number of changes to prescription drug programs in several federal health care programs – such as Medicare, Medicaid and other safety net programs – as well as Food and Drug Administration policies that should impact commercial and federal health care program access to affordable prescription drugs.
While some of these proposals can be undertaken through immediate regulatory or subregulatory actions, others are still on the drawing boards at the U.S. Department of Health and Human Services and some will require congressional action to implement. The Blueprint proposes a select number of programmatic and design changes, yet the Administration is seeking feedback for a large number of lingering questions.
Initial review appears to show an increased access to lower-cost alternative generics. But closer review is needed on proposed changes to the Medicare Part D Prescription Drug Benefit Program and the Part B drug reimbursement methods to alleviate concerns the changes may limit patient access to medically necessary alternative brand or specialty treatments and result in additional administrative burdens on physicians and patients. The proposal may also eliminate the requirement that Part D plans include a minimum of two drugs proven to be effective in each therapeutic category or pharmacologic class, if available.
The Medical Association will be closely monitoring the Administration’s “American Patients First” Blueprint and will keep our members updated on any new developments as they become available.