For reimbursement services support, email us at info@girsinc.com or call us at 901-834-9119.
On July 24, 2020, President Trump signed four executive orders (EOs) on drug pricing directing the Secretary of Health and Human Services (HHS) to take several steps, to deliver lower cost prescription drugs to ensure Americans are getting the lowest price possible for their drugs. The EOs also includes some benefits for industry, too.
The four executive orders address:
1) Access to insulin and injectable epinephrine through the 340B Drug Discount Program
The first EO directs federally qualified health centers that participate in the 340B Drug Pricing Program to pass on discounts on insulin and epinephrine to certain low-income Americans. This EO directs the Department of Health and Human Services (HHS) to use, as appropriate, existing authority to allow the reimportation of insulin products where there is an emergency.
2) Prescription Drug Importation
The second EO allows State to apply to the FDA to create a program to safely import and re-import certain drugs, approve the re-importation of insulin products manufactured in the United States, and produce an alleyway for extensive use of personal importation waivers at authorized pharmacies in the United States. This EO also orders the Secretary of HHS to complete the rulemaking process to allow for the importation of certain drugs from Canada.
3) Prescription Drug Rebate
The third EO requires HHS to put a plan in place to remove rebates and discounts received by pharmacy benefit managers from drug manufacturers, making sure patients benefit from available discounts at the pharmacy counter.
4) Lowest Comparable Drug Cost
The fourth and final Order certifies that the United States will pay the lowest price obtainable in economically comparable countries for Medicare Part B drugs, referred to as “favored nations”.
The EOs do not stipulate what drugs it will cover, but certain drugs can be exempted from the executive order if they’re too expensive to make in the U.S., or if they are not currently manufactured in the U.S. The EOs covers certain medical supplies that are deemed essential, as well.
While the EOs were designed to have U.S. drug prices commensurate with their costs overseas, there is concern in the pharmaceutical industry. Pfizer’s CEO Albert Bourla told investors that “President Donald Trump’s executive orders aimed at lowering U.S. prescription drug costs will cause “enormous destruction” as the pharmaceutical industry races to develop vaccines and treatments for the coronavirus.”
Implementation is not finalized on each of the EOs.
If Congress does not oppose it, these EOs will be effective on or around August 24.
At this time, no official decision has been made. GIRS will continue to track the status of the orders. An update will follow when new information is released.
What is the Implication of this order to the #medtech industry?
If implemented the EOs could have significant impacts for drug manufacturers, providers, and patients.
We recommend:
- continuing to monitor the development
- be ready to comment on any regulations
- have strong reimbursement strategies in place to gain favorable coverage for your Products
If you do these things, it will help your organization minimize future challenges.
Sources:
Disclaimer: The information in this blog is based on payer information which is dynamic. It is accurate at the time of posting but should not be construed to be reimbursement or legal advice. CPT® is the trademark of the American Medical Association (AMA).
About GIRS
For more than 17 years, GIRS has been assisting medical technology manufacturers with their market uptake and reimbursement strategies so that patients can have access to the care that they need. To implement successful market access strategies, the GIRS Value Discovery Landscape Assessments® team and the Payer Advocacy Compass® team work together to develop and implement foundation reimbursement landscape and payer advocacy strategies to obtain positive coverage, appropriate payment, and innovative payer contracting arrangements to improve market uptake. For more information, email us at info@girsinc.com or call us at 901-834-9119.