Health Update (October 13)
Relief Talks Stalled
On Tuesday (Oct. 6), President Trump called off negotiations on an additional COVID-19 relief package until after the election. The announcement comes after months of failed negotiations between House Speaker Nancy Pelosi (D-CA) and Treasury Secretary Steven Mnuchin. However, the White House reversed course later in the week and offered a $1.8 trillion package.
Senate Majority Leader Mitch McConnell (R-KY) said on Friday (Oct. 9) he thinks it unlikely that a package will be agreed upon and passed prior to the election.
Application Open for PRF Phase 3 Funding
The application for Phase 3 General Distribution funds opened on Monday (Oct. 5). The application will remain open until Nov. 6.
Last week, the Trump Administration announced an additional $20 billion will be made available for healthcare providers who have already received funding through the Provider Relief Fund (PRF) in Phase 3 of the program. Applicants that have not yet received PRF dollars will be eligible to receive up to two percent of their patient care revenue. The remainder of the $20 billion will be distributed based on: a provider’s change in operating revenues from patient care; a provider’s change in operating expenses from patient care, including expenses incurred related to coronavirus; and payments already received through prior PRF distributions.
To view the PRF application portal, click here.
CMS Announces New Medicare Repayment Terms for COVID-19 Loans
On Thursday (Oct. 8), CMS amended terms for payments under the Accelerated and Advance Payment (AAP) Program. Repayment will now begin one year from the issuance date of each provider or supplier’s accelerated or advance payment.
To view a fact sheet on the update, click here.
To view FAQs, click here.
Walden, Alexander Seek Comments on 340B Program
House Energy and Commerce Ranking Member Greg Walden (R-OR) and Senate Health, Education, Labor and Pensions Chairman Lamar Alexander (R-TN) are seeking input on how to best improve and modernize the 340B Drug Pricing Program.
“The 340B program has evolved and grown exponentially over the past 15 years, underscoring the need for clarity. For too long, 340B has been governed by guidance and other subregulatory actions that do not carry the weight of law. Ultimately, the Health Resources and Services Administration’s (HRSA) ability to hold all participants accountable, while ensuring adequate oversight and program administration, is limited,” the members said in a statement.
McCarthy, Brady Unveil the GROWTH Act
On Friday (Oct. 9), House Minority Leader Kevin McCarthy (R-CA) and House Ways and Means Ranking Member Kevin Brady (R-TX) introduced H.R. 11, the Commitment to American GROWTH Act. The legislation offers various incentives to achieve medical independence from China, including: a 10.5 percent credit of net income for the sale of eligible medical products; a 30 percent credit for new investments in advanced manufacturing equipment or machinery used in the U.S. to manufacture medicines and medical devices; modifications on R&D credits; and changes to passive loss rules for losses and credits attributable to medical countermeasures research of pre-revenue pass-through business.
Additionally, the bill makes modifications to the 2017 Tax Cuts and Jobs Act (TCJA). Modifications include: making permanent the full expensing provision; doubling the R&D credit; and allowing companies to bring back IP from offshore without any immediate tax cost.
To view the full legislation text, click here.
To view a section by section of the bill, click here.
FDA Vaccine Guidance
On Tuesday (Oct. 6), the FDA released industry guidance on emergency use authorizations (EUA) for COVID-19 vaccines. The guidelines include strict requirements for approval, including a requirement that the vaccine lower the rate of COVID-19 by 50% or better and a two-month watching period after study subjects receive the vaccine.
The FDA hopes the guidelines will renew public trust that a vaccine is being upheld to strict scientific standards. After months of disagreement, the White House signed off on the plan.
Under the guidelines, it is unlikely a vaccine will be made available by election day.
To view the guidance, click here.
Officials Work Out Discount Card Details
Public health officials are working to send out $200 prescription drug cards to seniors prior to the election. The cards would be paid for by the Medicare trust-fund, and are estimated to cost around $7.9 billion, including $51 million for card creation and distribution. According to a draft proposal obtained by Politico, another $19 million will be spent to send out letters notifying seniors of the program. White House Chief of Staff Mark Meadows and CMS Administrator Seema Verma are leading the initiative.
Democrats have questioned whether the move is politically motivated given the rush to send out the cards before Nov. 3. The White House has pushed back on this claim.
“This has nothing to do with politics. It’s good policy and demonstrates the president is continuing to deliver on his promises to our nation’s seniors,” said Judd Deere, a White House spokesperson.
Bright Leaves Federal Post
On Tuesday (Oct. 6), former BARDA director and whistleblower Rick Bright’s lawyers announced he has left the federal government.
“Dr. Bright was forced to leave his position at NIH because he can no longer sit idly by and work for an administration that ignores scientific expertise, overrules public health guidance and disrespects career scientists, resulting the [sic.] in the sickness and death of hundreds of thousands of Americans,” lawyers Debra Katz and Lisa Banks said in a statement.
Bright was removed from his position at BARDA in April, an action he alleged was linked to his opposition to political pressure from the agency regarding COVID-19 treatments, such as hydroxychloroquine.
An NIH spokesperson confirmed Bright is no longer employed by the agency, but declined further comment.
 Diamond, Dan, “Verma, Meadows push to finalize $200 drug-card plan for seniors by Election Day,” Politico Pro, 8 Oct. 2020. https://link.edgepilot.com/s/eb16c17a/KbTc67MmjUCXKQair7lR1Q?u=https://subscriber.politicopro.com/article/2020/10/verma-meadows-push-to-finalize-200-drug-card-plan-for-seniors-by-election-day-2006512
 Diamond, Dan, “HHS whistleblower Rick Bright resigns from government,” Politico Pro, 6 Oct. 2020. https://link.edgepilot.com/s/2b701293/I8PaI7Zcu0mjZ2Fn4xojaw?u=https://subscriber.politicopro.com/article/2020/10/hhs-whistleblower-rick-bright-resigns-from-government-3984446