Unexpected events last month re-energized two key policy debates. In early May, a leaked draft opinion by Justice Samuel Alito showed that the Supreme Court is poised to overturn Roe v. Wade in its decision of Dobbs v. Jackson Women's Health Organization. Then, in late May, two mass shootings took place, which in turn has reinvigorated the national debate over gun control.

This month, Congress is poised to debate gun control legislation, reconcile differences over the U.S. Innovation and Competition Act, and begin markups on the appropriations for Fiscal Year (FY) 2023. They will also work to pass legislation on mental health, drug pricing, and user fee reauthorizations. Outside of Washington, primary elections continue throughout June.

See below for greater detail on key issues in this month's edition of What's Next in Washington? presented by the Foley & Lardner Federal Public Affairs team.

  1. Primary election season heats up in June
    1. 13 states have already held their primary elections, 20 more states will hold their elections in June, rounding out one of the busiest months in the Midterm cycle.
    2. All 435 seats in the House of Representatives and 35 Senate seats are in play this November. Democrats are defending slim majorities in both chambers.
      1. To keep track of all the primary elections, retiring Members of Congress, and ratings on all Senate races, the Foley team has created a handbook for everything you need to know about the 2022 Midterms.
        1. Please click here to read more.
  2. The House will begin its markup of appropriations for FY-2023
    1. House appropriators, including Chairwoman Rosa DeLauro (D-CT) and Ranking Member Kay Granger (R-TX), plan to begin their markup of the FY-2023 appropriations bills in June. The duo said they're aiming for votes to begin in July.
    2. Senate appropriators have recently confirmed that they aim to mark up all 12 appropriations bills in July.
      1. Senate Appropriations Chairman Patrick Leahy (D-VT) and Ranking Member Richard Shelby (R-AL) have both expressed a desire to enact funding prior to the end of the 117th Congress, when both Senators will retire.
    3. House and Senate appropriators have already conducted meetings on topline spending figures.
    4. Agency heads have testified before Congress on their FY-2023 budget requests, the hearings will continue through June.
  3. Conferee's continue to negotiate differences between the House & Senate versions of USICA
    1. Last month, lawmakers outlined the conference schedule for May and June. Leadership has set June 20th as its deadline to report the U.S. Innovation and Competition Act out of conference.
      1. This timeline is unlikely as the conference has already missed its deadline of May 25th to "close out" all legislative items.
      2. Sen. Todd Young (R-IN), the bill's original author alongside Majority Leader Chuck Schumer (D-NY), has stated that he doesn't anticipate the bill being ready until late August.
    2. There are still stark differences between the House-passed America COMPETES Act and USICA. This includes provisions on immigration exemptions, something that Republicans have said distracts from the original aim of the bill.
      1. Immigration provisions would seek to exempt those who hold a PhD from green card quotas. Advocates for the bill have stated that this provision would assist in training and developing the domestic workforce.
    3. Overall, the bill would provide $52 billion to build up domestic semiconductor production.
  4. Talks on reconciliation continue between Senate Democrats
    1. Dubbed the "Chuck and Joe Show" by Politico, Senate Majority Leader Chuck Schumer (D-NY) and Sen. Joe Manchin (D-WV) have been negotiating the terms of a new reconciliation package to replace the Build Back Better Act.
      1. Manchin announced back in December 2021 that he could not support the Build Back Better Act, a key pillar of President Biden's economic and social agenda.
    2. Senate Democrats were hoping for a deal to be reached on reconciliation package by Memorial Day. While talks have continued, no notable progress has been made yet and Manchin has indicated that negotiations would continue into June.
      1. Manchin has stated that he would like to see the bill combat inflation, drug pricing, and provide funding for climate provisions.
    3. Democrats in Congress and the Administration have urged the passage of a new reconciliation package to advance Biden's climate agenda.
      1. Department of Energy Secretary Jennifer Granholm stated that tax credits are needed to charter the transition to clean energy as outlined the Bipartisan Infrastructure Law.
    4. Manchin has been working on a separate energy package with Senate Republicans, including Lisa Murkowski (R-AK) and Kevin Cramer (R-ND).
      1. The package would focus on tax credits for clean energy sources, including wind, solar, carbon capture, and batteries.
      2. Additional focus would include reform of federal oil and gas leasing, and reduction of American dependence on foreign energy.
  5. A new health agency comes into focus
    1. In late May, the Department of Health and Human Services (HHS) Secretary Xavier Becerra named Adam H. Russell, D.Phil, as acting Deputy Director of the newly established Advanced Research Project Authority for Health (ARPA-H).He will begin his new role this month.
    2. ARPA-H was authorized in the Fiscal Year 2022 omnibus package that was enacted last March.
      1. This provision established the agency within HHS, but also gave HHS the opportunity to place ARPA-H within the National Institute of Health (NIH), if so desired.
      2. Secretary Becerra opted to house ARPA-H within NIH, with the caveat that the agency will not be housed within NIH's physical facilities, and the ARPA-H director will report directly to Becerra and not the NIH director.
    3. Congress is working to pass additional legislation that hones more prescriptive authorizing language.
      1. The House Energy and Commerce (E&C) Committee advanced legislation that would establish ARPA-H as an independent agency within HHS.
      2. The Senate Health, Education, Labor and Pensions (HELP) Committee advanced legislation that would establish ARPA-H within NIH but outside of DC.
      3. Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) proposed CURES 2.0, which would establish ARPA-H within NIH but outside of Washington, DC.
    4. Several states, including California, Maryland, Massachusetts, and Texas, among others, are vying for the opportunity to house the agency.
  6. Congress and the Administration prepare for the expiration of HHS' Public Health Emergency
    1. HHS Secretary Becerra extended the Public Health Emergency (PHE) declaration on April 12th, noting that states and agencies should prepare for an end to the flexibilities that the declaration has allowed throughout the pandemic.
    2. The Centers for Medicare and Medicaid Services (CMS) will hold its second monthly webinar in preparation for the restart of the Medicaid/CHIP redetermination process with continuous coverage coming to an end when the PHE expires.
      1. Approximately 15 million people are at risk for losing access to Medicaid or CHIP when flexibilities unwind.
      2. Following a letter from the administration urging them to start planning for an end to the PHE, Governors are planning to return to "normal operations" with regards to Medicaid and CHIP enrollment.
        1. State officials were promised 60 days' notice of HHS' intentions to let the declaration expire, so it is highly likely that Becerra will extend the PHE at least once more.
  7. Bipartisan talks continue on the expansion of telehealth options and mental health needs
    1. Following several months of hearings on barriers to access in mental health services, relevant House and Senate committees continue to work on legislation that will expand telehealth opportunities, reauthorize various SAMHSA programs, strengthen the mental health workforce, and allow for mental health coverage parity.
      1. In late May, House E&C unanimously advanced H.R. 7666, the Restoring Hope for Mental Health and Wellbeing Act of 2022. The full House vote and Senate markup of this bill have not yet been scheduled.
      2. Last week, Senate Finance released a draft telehealth proposal. This bill will compromise a portion of its mental health package, which is currently still being drafted.
        1. This legislation will expand telehealth services for Medicare beneficiaries and eliminate the requirement for infrequent in-person visits in order to qualify for tele-services.
      3. Senate HELP continues to work on a mental health package, though they have not yet released details on draft legislation. The House Ways and Means committee is in the planning stages of a Medicare-focused piece of legislation.
  8. Congress will continue to work towards passage of reauthorization legislation for the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA), Biosimilar User Fee Act (BsUFA), and Medical Device User Fee Amendments (MDUFA).
    1. Late last month, House E&C voted unanimously to pass their user fee reauthorization legislation out of committee.
    2. Senate HELP will mark up their legislation early this month.
      1. There is a possibility the bill will be delayed, as suggested recently by HELP Ranking Member Richard Burr (R-NC), due to the FDA's response to the infant formula shortage.
    3. User Fee programs for human prescription drugs and biologics, medical devices, and generic drugs and biosimilars are set to expire this year on October 1st, 2022.

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