What’s Next In Washington? – June Edition – Government Contracts, Procurement & PPP

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 117^th 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 20^th 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 25^th 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 12^th, 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 1^st, 2022.

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