The two-phase blueprint includes actions Trump 'may direct HHS to take immediately' and other items under consideration for the future.
White House officials unveiled on Friday the broad contours of a plan to counteract rising prescription drug prices.
The 44-page document, titled "American Patients First," includes a three-page outline of the Trump administration's two-phase blueprint.
The first phase involves actions the president "may direct HHS to take immediately," and the second involves additional items under active HHS consideration, for which the department is soliciting feedback, the document states.
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Those two phases are reflected in each of the four key strategies the plan proposes to undertake: improved competition, better negotiation, incentives for lower list prices, and lowering out-of-pocket costs.
Although stakeholders generally said they appreciate the administration's goals, some said they want more detail on the specifics of the White House's plan.
The language from the document's three-page blueprint outline is reproduced below:
1. Increased competition
Immediate Actions
- Steps to prevent manufacturer gaming of regulatory processes such as Risk Evaluation and Management Strategies (REMS)
- Measures to promote innovation and competition for biologics
- Developing proposals to stop Medicaid and Affordable Care Act programs from raising prices in the private market
Further Opportunities
- Considering how to encourage sharing of samples needed for generic drug development
- Additional efforts to promote the use of biosimilars
2. Better negotiation
Immediate Actions
- Experimenting with value-based purchasing in federal programs
- Allowing more substitution in Medicare Part D to address price increases for single-source generics
- Reforming Medicare Part D to give plan sponsors significantly more power when negotiating with manufacturers
- Sending a report to the President on whether lower prices on some Medicare Part B drugs could be negotiated for by Part D plans
- Leveraging the Competitive Acquisition Program in Part B.
- Working across the Administration to assess the problem of foreign free-riding
Further Opportunities
- Considering further use of value-based purchasing in federal programs, including indication-based pricing and long-term financing
- Removing government impediments to value-based purchasing by private payers
- Requiring site neutrality in payment
- Evaluating the accuracy and usefulness of current national drug spending data
- Investigating tools to address foreign government threats of compulsory licensing or IP theft that may be harming innovation and development, driving up U.S. drug prices
3. Incentives for lower list prices
Immediate Actions
- FDA evaluation of requiring manufacturers to include list prices in advertising
- Updating Medicare’s drug-pricing dashboard to make price increases and generic competition more transparent
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Further Opportunities
- Measures to restrict the use of rebates, including revisiting the safe harbor under the Anti-Kickback statute for drug rebates
- Additional reforms to the rebating system
- Using incentives to discourage manufacturer price increases for drugs used in Part B and Part D
- Considering fiduciary status for Pharmacy Benefit Managers (PBMs)
- Reforms to the Medicaid Drug Rebate Program
- Reforms to the 340B Drug Discount Program
- Considering changes to HHS regulations regarding drug copay discount cards
4. Lowering out-of-pocket Costs
Immediate Actions
- Prohibiting Part D contracts from preventing pharmacists’ telling patients when they could pay less out-of-pocket by not using insurance
- Improving the usefulness of the Part D Explanation of Benefits statement by including information about drug price increases and lower cost alternatives
Further Opportunities
- More measures to inform Medicare Part B and D beneficiaries about lower cost alternatives
- Providing better annual, or more frequent, information on costs to Part D beneficiaries