Health Policy Report (8/24)

Capitol Hill Update

Over this past weekend, House lawmakers convened for a rare Saturday session, passing (257-150) legislation that seeks to shore up the U.S. Postal Service (USPS). House Oversight and Government Reform Chairwoman Carolyn Maloney’s (D-NY) bill would: (1) provide the USPS with $25 billion to cover revenue losses; (2) reverse service and operational changes implemented earlier this year; and (3) require that all election-related mail be treated as first-class to ensure priority delivery. While 26 House Republicans joined all Democrats in voting for the Delivering for America Act, the measure is not expected to be taken up in the GOP-controlled Senate. The Trump Administration issued a veto threat against the bill late last Friday, arguing that USPS “needs reforms that will return it to a trend of long-term financial self-sufficiency.”

Meanwhile, both chambers will resume their August district work period, and are not expected to convene for legislative business until next month. As COVID-19 relief talks remain deadlocked, the Senate is scheduled to reconvene on Tuesday, Sept. 8. House lawmakers are not scheduled to vote until the week of Sept. 14, but will convene for Committee Work Days during the week of Sept. 7. Lawmakers in both chambers will receive 24-hours’ notice of any scheduled votes during the balance of this month.

Senate Republicans Circulate ‘Skinny’ COVID-19 Relief Package

With pressure continuing to mount on getting a COVID-19 relief measure passed, Senate Republicans drafted and circulated a slimmed-down version of their HEALS Act last week. The Delivering Immediate Relief to America’s Families, Schools and Small Businesses Act (text) touches on a host of provisions from the Senate GOP’s opening offer on the next round of pandemic relief legislation, including language on liability protections, extending the Paycheck Protection Program (PPP) with additional funding, and establishing a $105 billion education stabilization fund. It would also provide new money for COVID-19 testing, tracing, vaccine, and treatment efforts, extend the pandemic unemployment insurance program at an extra $300 per week, and provide grant funding for the U.S. Postal Service (USPS) if its cash-on-hand balance dips below $8 billion. The measure has yet to be formally introduced by Senate leadership and could be subject to further changes prior to the official rollout. With no plans to return early from the August district work period as of now, Senators could try and tack this bill onto a forthcoming stopgap funding measure at the end of September. However, a path forward remains uncertain as House Democratic leadership has been opposed to passing smaller measures in lieu of a broader pandemic relief package.

Health-focused measures included in the bill included an additional $29 billion for the Public Health and Social Services Emergency Fund (PHSSEF). This includes including $20 billion to the Biomedical Advanced Research and Development Authority (BARDA) for expenses related to manufacturing, purchase, and production of vaccines and therapeutics, $6 billion for planning, promoting, distributing, and administering vaccines, and $2 billion to shore up the strategic national stockpile. It also provides $16 billion for COVID-19 testing and tracing efforts.

Biden Criticizes Trump Administration Response to COVID-19 in Acceptance Speech

In his formal nomination acceptance speech at the Democratic National Convention last Thursday, former Vice President Joe Biden criticized the president’s response to the coronavirus pandemic and noted it would be the defining issue of the November election. He said the president has continued to “wait for a miracle,” but said “no miracle is coming.” Biden explained that, if elected, he would immediately implement a sweeping pandemic response plan, which the current administration still lacks more than six months into the pandemic.

His national plan is based on input from leading public health officials, including numerous high-level Obama administration deputies such as: Zeke Emanuel, a key Affordable Care Act architect; David Kessler, the former Food and Drug Administration commissioner; Nicole Lurie, the former assistant health secretary for preparedness and response; and Vivek Murthy, the former surgeon general. Additionally, the Democratic presidential nominee would scale up testing, implement mandatory mask requirements in all 50 states, and daily COVID-19 briefings conducted by scientists. The Trump campaign responded that Biden was “behind the curve” on the pandemic and accused the former vice president of rewriting history regarding the president’s reaction and his own.

Members of Congress Open Investigations on USPS Ability to Handle Mail-Order Prescriptions 

Members in both the House and Senate opened investigations into the U.S. Postal Service’s ability to efficiently and safely deliver mail-order prescriptions last week, among increased concerns over the Administration’s action against the agency. According to the American College of Physicians, the Department of Veterans Affairs fills 80 percent of its prescriptions by mail and many people in rural areas often rely on mail-order prescriptions. Additionally, an increasing number of people have received their prescriptions by mail since the start of the COVID-19 pandemic. The Kaiser Family Foundation recently estimated that mail delays could impact mail-order prescriptions for over 13 million Medicare Part D and large employer plan enrollees.

On Monday, House Energy and Commerce Democratic leaders launched an investigation into whether the Trump administration’s changes to the USPS will delay delivery of critical prescription drugs during the COVID-19 pandemic. Energy and Commerce Committee Chairman Frank Pallone (D-NJ), Energy and Commerce Health Subcommittee Chairwoman Anna Eshoo (D-CA), and Oversight and Investigations Chairwoman Diana DeGette (D-CO) will be questioning online pharmacies, pharmacy benefit managers, and trade associations on the impacts of the USPS delays on prescription drug delivery. Last Thursday, Sens. Elizabeth Warren (D-MA) and Bob Casey (D-PA) also announced they would open an investigation into delays in mail-order prescriptions, noting that recent “sabotage” of the USPS by the Trump administration had threatened delivery of essential goods. The Senators wrote to five major pharmacies and pharmacy benefit managers to request information on the number of mail-in prescriptions they have filled each month this year. They noted that the Postmaster General’s announcement that changes to the USPS would be delayed until after the election did not allay their concerns, and said it was unclear whether the changes would be reversed.

FDA Barred From Reviewing Some Coronavirus Tests

The administration announced last Wednesday that it will allow individual laboratories to develop their own coronavirus tests without Food and Drug Administration (FDA) review. The Department of Health and Human Services (HHS) will require notice and comment rulemaking before the FDA can require premarket review of laboratory-developed tests. HHS explained that the announcement is consistent with two executive orders on reducing regulations and associated costs, and establishes a long-standing argument by the laboratory industry that the FDA does not have the authority to regulate laboratory-developed tests. The FDA has countered that it does have the authority, though has not traditionally used it, and Members of Congress have recently introduced bills to codify the agency’s role in regulating the tests. Additionally, the health agency noted that some tests have been proven to be faulty and require additional oversight.