New Executive Orders on “Lowering Drug Prices by Putting America First”
The President signed new Executive Orders aimed at lowering drug prices. The Orders repeal the original Order signed on 7/24 and expand the drugs to include both Medicare Parts B and D.
Published: 09.30.2020
What: The President signed new Executive Orders aimed at lowering drug prices. The Orders repeal the original Order signed on 7/24 and expand the drugs to include both Medicare Parts B and D. The idea is that Medicare would refuse to pay more for drugs than the lower prices paid by other developed nations. Just to clarify, this Order does not lower drug prices for those who are not on Medicare.As a result of the President’s plan, the Department of Health and Human Services (HHS) issued a final rule and guidance from the Food and Drug Administration (FDA) to open the pathway for states to use to safely import prescription drugs to lower patients drug costs. (For additional information, please see below – HHH Final Rule.)
HHS solicited private-sector proposals on allowing Americans to get lower-cost FDA-approved drugs and insulins from American pharmacies via importation and reimportation. (For additional information, please see below – HHS- Request for Proposals regarding Waivers for Individual Prescription Drug Importation Programs and Request for Proposals regarding Insulin Reimportation Programs.)
HHS released the 2021 Medicare Advantage and Medicare Part D Premium landscape, showing that average 2021 premiums for Medicare Advantage plans are expected to decline 34.2% from 2017 while plan choice, benefits, and enrollment continue to increase, and that Part D premiums will be down 12% from 2017, with over 1,600 drug plans offering insulin at no more than $35 per month. (For additional information, please see below –CMS Medicare Part-D Premium Landscape.)
Also, HHS issued a notice of proposed rulemaking from the Health Resources and Services Administration to pass on steep discounts at community health centers on insulin and epinephrine to Americans who are uninsured or have high cost-sharing, including health center patients with diabetes. (For additional information, please see below – Health Resources & Services Administration.)
When: The Order instructs the Secretary of the Department of Health and Human Services (HHS) to begin the rulemaking process to test new payment models. While federal rulemaking has begun, finality could take months to complete, so the Orders are unlikely to have an immediate impact. Plus, pharma industry stakeholders threaten to challenge these measures in court; perhaps further delaying implementation.
If these orders come to fruition, employer group pharmacy plans that are considered creditable, may lose its status if Medicare Part D drug prices are reduced. Although, this perceived matter is something that we will continue to monitor as things further unfold.
For additional information, please see the following:
Executive Order on Lowering Drug Prices by Putting America First, issued September 13, 2020
whitehouse.gov/presidential-actions/executive-order-lowering-drug-prices-putting-america-first-2/
HHH Final Rule
hhs.gov/sites/default/files/importation-final-rule.pdf
FDA Guidance for Industry
hhs.gov/sites/default/files/importation-guidance.pdf
HHS – Request for Proposals regarding Waivers for Individual Prescription Drug Importation Programs
hhs.gov/sites/default/files/individual-prescription-drug-importation-programs.pdf
Request for Proposals regarding Insulin Reimportation Programs
hhs.gov/sites/default/files/insulin-reimportation-programs.pdf
CMS- Medicare Part D Premium Landscape
cms.gov/newsroom/press-releases/trump-administration-announces-historically-low-medicare-advantage-premiums-and-new-payment-model
Health Resources & Services Administration
hrsa.gov/about/news/press-releases/proposed-rule-affordable-access-medications
HHS – HHS Takes Action as Part of President Trump’s Healthcare Plan
hhs.gov/about/news/2020/09/24/hhs-takes-action-as-part-of-president-trumps-healthcare-plan.html
