In the second half of 2020, President Trump released several executive orders (EO) related to drug pricing. EOs describe broad policy goals that then are implemented via regulation or guidance by a given agency. That means that implementation of these policies, if it occurs, can take anywhere from weeks to years and there will likely be opportunities for further advocacy. Here are links to the recent EOs that are relevant to bleeding disorders patients and providers:
1. Executive Order on Access to Affordable Life-saving Medications: This EO and an proposed rule released thereafter require community health centers (CHCs) to price insulin and Epipens at 340B or acquisition pricing for low-income, underinsured and uninsured people. This does not affect HTCs, but we are keeping our eyes out for any additional policies that affect other types of 340B providers.
2. Executive Order on Increasing Drug Importation to Lower Prices for American Patients: This EO and subsequent rulemaking seeks to promote importation of some drugs from Canada. States and pharmacies can apply to import drugs, though as of today, no states have completed the process is just beginning and many implementation concerns have been raised by both manufacturers and Canadian health officials.
3. Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen: This directs HHS to finalize a 2019 proposed rule that would require rebates in Medicare Part D to be passed onto patients. It may be difficult for this policy to actually be enacted because the EO says the policy cannot increase premiums, patient out-of-pocket costs or Federal spending and the proposed rule was found to affect these areas.
4. Executive Order on Lowering Drug Prices by Putting America First: This EO seeks to ensure that the prices for some drugs in Medicare Parts B and D are not higher than prices paid in other countries (also called a “most favored nation” policy). The policy for Part B drugs was called the International Pricing Index when first proposed in 2018, though the potential expansion of the policy into Part D is new. Any implementing rules would make more clear whether any bleeding disorders treatments would be included.
NHF will continue to monitor for implementation of these policies and any additional Executive Orders or regulations that are released affecting our community.