Shortly after President Joe Biden was sworn in, the White House released a series of Executive Orders and statements articulating the immediate agenda for his Administration. The agenda includes actions to address the COVID-19 pandemic, promote racial equity, stabilize the economy and improve access to health care.
Regulatory Freeze:
On Inauguration Day, the President issued a memorandum to all federal agency and department heads to pause the issuance of new regulations and the implementation of regulations that have not yet taken effect. This regulatory freeze affects multiple federal regulations related to market access, many of which we have written about in this blog. As of this writing, regulations on hold or delayed include:
- The Medicare Rebate rule
- Implementation postponed to 2023 by a federal court
- Rule on Patient Assistance Programs, Best Price and AMP
- Most Favored Nation Pricing in Medicare Part B
- This proposal was previously stopped by a federal court
- Rules on Medicare Part D Electronic Prior Authorizations
- 340B pricing at community health centers for insulin and epinephrine
- Delayed until July 20, 2021
The regulatory hold does not impact policies that are already in effect, like the drug importation regulations. The rules allowing states and Indian Tribes to develop programs to import medications from Canada went into effect November 30, 2020. However, right before the effective date, the Canadian government blocked “bulk” exportation of medications if it would cause or worsen a shortage. In addition, PhRMA and the Council for Affordable Health Coverage filed a lawsuit to stop implementation of the program. In the meantime, a handful of states have submitted applications to the FDA for approval of their importation programs, but to date, none have been approved.
Access to Care:
The Biden Administration’s agenda also includes a focus on expanding access to health care coverage. The President signed an Executive Order in late January 2021 focused on strengthening Medicaid and the Affordable Care Act (ACA). That Order directs the Secretary of HHS to consider establishing a special enrollment period in the federally facilitated health insurance marketplaces (which is currently underway). It also directs agency heads to carefully review all Medicaid and ACA regulations to determine whether they are consistent with the Biden Administration’s policies. The agency heads will decide whether to suspend, revise or rescind any regulations that are not aligned with the current Administration’s positions.
Finally, the President’s COVID-19 relief legislative proposal sent to Congress included provisions to federally subsidize COBRA coverage and to enhance the subsidies for individual marketplace premiums.
What About Congress?:
While there has been a flurry of legislative proposals related to drug pricing and coverage over the past few years, the bills did not get very far, due in part to the political makeup of Congress. Now, Democrats may have the votes they need to get something across the finish line. The latest COVID-19 relief bill included a sunset of the cap on Medicaid rebates. Starting in 2023, the total rebate cap of 100% AMP will go away, meaning some manufacturers could be on the hook for rebates that exceed AMP—particularly those with penny pricing right now. The latest discussion on the Hill is that drug pricing legislation (like Medicare negotiation of Part D prices) could be included as pay for in a larger infrastructure bill.
Contact Viking Healthcare Solutions for help with your strategic planning.
Viking Healthcare Solutions has established itself as the premier provider of corporate account services and strategic planning support for the pharmaceutical and biotech industries. VHS Insights, our research division, specializing in payer profiling, market research and analytics, can help you find answers to inform your payer strategy. We support traditional and rare/specialty organizations to create, maintain, defend, and protect access to your product throughout its lifecycle. Bank on our experience to help you achieve successful product commercialization. Contact us at www.vikinghcs.com/connect.