POLICY BRIEFINGS

GOP Doc Caucus Opposes WH Vaccine Mandate


The GOP Doctors Caucus has issued a statement in opposition to President Joe Biden’s executive orders mandating the COVID-19 vaccine for all federal employees and private businesses with more than 100 employees. “It is un-American for the federal government to mandate what personal health choices private businesses must require of their employees... Here is the simple truth when seeking health information, Americans should not listen to politicians, cable news, or social media — talk to your doctor,” the lawmakers state.


House to Vote on CR Next Week


Majority Leader Steny Hoyer (D-Md.) expects the House of Representatives to vote on a stopgap spending bill the week of September 20, when the chamber returns to session from August recess. The potential length of the continuing resolution (CR) is still under debate. Hoyer also warned lawmakers that it may be necessary to add extra voting days in October to accommodate the chamber’s busy schedule. Federal funding is currently authorized through September 30.


Senate to Consider Emergency Aid this Month


Senate Majority Leader Chuck Schumer (D-N.Y.) announced last week that he aims to enact disaster relief funding in response to Hurricane Ida and other natural disasters by the end of September. The White House has requested $14 billion in emergency response spending for disasters that occurred prior to Hurricane Ida, which is estimated to require at least $10 billion in additional aid, be included the forthcoming government funding package. An additional $6.4 billion is requested to support various agencies working on Afghan resettlement.


Yellen Updates Estimated Deadline for Action on Debt Limit


Treasury Secretary Janet Yellen has updated her estimated debt-limit timeline, notifying Congress that extraordinary measures financing the government on a temporary basis will likely be exhausted during the month of October. After the debt limit was reinstated on August 1, the Treasury Department was forced to take “extraordinary measures” to prevent the U.S. from defaulting on its obligations. Yellen had previously estimated that those so-called extraordinary measures could be exhausted as early as September. If the Treasury exhausts all available extraordinary measures, the U.S. would be unable to meet its obligations for the first time in history. Action on the nation’s borrowing authority is currently expected to move with a continuing resolution (CR) to fund the federal government beyond the end of the fiscal year on September 30, a vote that would require bipartisan support from 60 members in the equally-divided Senate. Many Republicans, however, have expressed opposition to a clean debt increase or suspension, with some suggesting that any change be tied to spending cuts and entitlement reform. Forty-six of the 50 Senate Republicans have said that they will not support a debt limit increase.


Klobuchar Treated for Breast Cancer Earlier This Year


Sen. Amy Klobuchar (D-Minn.) announced last week that she was diagnosed with breast cancer in February and has since completed a successful course of treatment, having underwent a lumpectomy and radiation treatment. Her doctor has told her that her chance of getting cancer again is no greater than the average person. “It’s easy to put off health screenings, just like I did. But I hope my experience is a reminder for everyone of the value of routine health checkups, exams, and follow-through,” she wrote in a post on Medium.


HHS to Make More Provider Relief Funding Available


The U.S. Department of Health and Human Services (HHS) has announced the availability of $25.5 billion in new funding for health care providers affected by the COVID-19 pandemic. Providers who serve rural Medicaid, Children’s Health Insurance Program (CHIP), or Medicare patients will receive $8.5 billion in American Rescue Plan resources, and an additional $17 billion will be allocated from the Provider Relief Fund (PRF). According to HHS’ announcement, PRF Phase 4 allocations will be based on lost revenues and expenditures associated with the pandemic between July 1, 2020 and March 31, 2021 and will reimburse smaller providers operating on lower margins and working with underserved populations at a higher rate compared to other providers. Phase 4 will also include bonus payments for those serving Medicaid, CHIP, and/or Medicare patients. A single application will be used to apply for both programs; the application portal will open on September 29, 2021. HHS also made several other announcements regarding the PRF last week. Along with the release of the methodology used to calculate Phase 3 payments, HHS notes that providers who believe their payment was not calculated correctly will have the opportunity to request a reconsideration. Additional details about this process are forthcoming. Furthermore, because of recent natural disasters and the surge in the Delta variant, HHS will provide a final 60-day grace period for providers to complete the first period reporting requirements, which, before the grace period, was September 30, 2021. During the grace period, HHS will not initiate collection activities or similar enforcement actions for noncompliant providers.


HHS Releases Report on Lowering Drug Prices


The White House calls on Congress to pass a series of proposals aimed at cutting high drug prices in a new report issued last week. The plan, released by the U.S. Department of Health and Human Services (HHS) in response to a July executive order, expresses support for drug price negotiation, limits on price increases, promotion of competition in the pharmaceutical market, and more research into new treatments. It endorses a proposal backed by many Democrats that would allow the Medicare to directly negotiate the price of drugs, making the negotiated prices available to commercial insurance and employer-based plans as well. It also urges Congress to act to cap out-of-pocket spending for Part D beneficiaries, reduce price increases on existing drugs, increase generic and biosimilar competition, and to establish the President’s proposed Advanced Research Projects Agency for Health (ARPA-H). These components track the drug pricing provisions included in the House budget reconciliation bill, described above. The HHS report also outlines the potential of several administrative changes that would not require congressional action, including a potential Part B drug payment reform model, the use of value-based payments for drugs, increased transparency around prices, rebates, and out-of-pocket spending, and permitting drug importation from other countries. The report discusses reducing regulatory barriers that may slow the approval of lower-cost alternatives as well.


FDA Requests Input on Drug Pricing from Patent Office


The Food and Drug Administration (FDA) has sent a letter to the U.S. Patent and Trademark Office (PTO) requesting input on efforts to combat rising drug prices. The letter stems from President Joe Biden’s executive order to promote competition within the pharmaceutical industry. FDA asks whether PTO is considering means to limit patent thicketing and questions whether patent examiners should be given more time to review applications. In a separate letter sent to the PTO last week, Sens. Patrick Leahy (D-Vt.) and Thom Tillis (R-N.C.) urge the agency to reject patent applications that would undermine pharmaceutical competition.


2021 Key Deadlines and Expirations


As Congress returns from August recess, lawmakers will face a series of important deadlines and expirations in the coming weeks. Hart Health Strategies Inc. has compiled the following timeline for the forthcoming legislative period:

  • Sept. 13: Senate returns to session; E&C reconciliation markup
  • Sept. 14: W&M reconciliation markup
  • Sept. 15: Deadline for committees to report their portions of the reconciliation package
  • Sept. 20: House returns to session
  • Sept. 27: Deadline for House consideration of the Infrastructure Investment and Jobs Act (H.R. 3684)
  • Sept. 28: Comment deadline for Amendments to the FAR Buy American Act Requirements proposed rule to implement E.O. addressing domestic preferences in government procurement
  • Sept. 30: FY 2021 funding and other major programs (surface transportation and National Flood Insurance) expire; End date of emergency sick leave and family leave employer tax credits, SNAP benefit increase, COBRA premium subsidies, and VA cost-sharing waiver; FDA UFA reauthorization deadline for administration review and clearance; Majority Leader Schumer says Senate to enact emergency relief funding by end of the month
  • Fall 2021: Expected release of HELP Committee package to improve public health and medical preparedness and response programs
  • Fall 2021: Deadline for raising or suspending debt limit; Secretary Yellen estimates exhaustion of extraordinary measures during the month of October, CBO estimates October or November
  • Mid-Nov.: Limit on Dr. Woodcock’s ability to remain as Acting FDA Commissioner, unless an individual has been nominated for the position
  • Dec. 31: Expiration of certain tax extenders, including energy and mortgage insurance premiums; End date of expanded EITC, child tax credit, child and dependent care tax credit, employee retention credit, and Medicare sequestration suspension
  • Jan. 2022: Negotiated UFA agreement due to Congress
  • Jan. 31, 2022: End date of student loan repayment and interest accrual suspension


Upcoming Congressional Hearings and Markups


House Energy and Commerce Committee markup of the Build Back Better Act; 11:00 a.m.; September 13

House Ways and Means Committee markup of the Build Back Better Act; 9:00 a.m.; September 14



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