This Week in Washington: Congress Passes Appropriations to Fund Government Through Fiscal Year 2023


House and Senate Pass FY 2022 Omnibus Appropriations Package

On March 9, the House of Representatives passed the Fiscal Year (FY) 2022 omnibus appropriations package. That vote was followed by Senate passage the next day. The appropriations package totals $1.5 trillion in funding, which includes approximately $14 billion for assistance to Ukraine. Notably, a measure that would have allocated $15 billion for COVID-19 relief was cut from the package after members opposed the way in which it was funded.

President Biden is likely to sign the appropriations package into law this week.

The appropriations package allocates $108.3 billion to the Department of Health and Human Services (HHS), an increase of $11.3 billion from the year prior. This total includes:

  • $1 billion to establish Advanced Research Projects Agency for Health (ARPA-H) within the HHS Office of the Secretary to accelerate scientific breakthroughs for ALS, Alzheimer’s disease, diabetes and cancer, among other diseases.
  • $45 billion for the National Institutes of Health (NIH), an increase of $2.25 billion from FY 2021.
  • $8.5 billion for the Centers for Disease Control and Prevention (CDC), an increase of $582 million from FY 2021.
  • $6.5 billion for the Substance Abuse and Mental Health Services Administration (SAMHSA), an increase of $530 million from FY 2021.
  • $4 billion for the Centers for Medicare and Medicaid Services’ (CMS) administrative expenses, an increase of $50 million from FY 2021

In addition, the appropriations package extends pandemic health emergency (PHE) telehealth waivers to 151 days past the end of the PHE, continuing the Medicare originating site flexibility. The package also requires HHS, CMS and the Office of the Inspector General (OIG) to study telehealth utilization and develop recommendations and reforms to prevent fraud by June 15, 2023. The package also includes a provision to allow hospitals to file attestations to maintain their 340B eligibility even if their payer mixes would typically disqualify them from the 340B program. In addition, the appropriations package allocates $30 million to improve maternal health and would extend higher Medicaid funding for U.S. territories until Dec. 13. The package would also give the FDA the authority to regulate synthetic nicotine.

The 2022 Appropriations bill can be found here.

The report language on the Departments of Labor, Health and Human Services, Education and Related Agencies can be found here.

The House Appropriations Committee’s summary of the Appropriations language related to Labor, Health and Human Services, Education and related agencies can be found here.


Rep. DeLauro Introduces Standalone COVID-19 Relief Bill

On March 9, House Appropriations Committee Chair Rosa DeLauro (D-CT) introduced the Coronavirus Supplemental Appropriations Act, a standalone bill that would provide $15.6 billion to continue managing the COVID-19 pandemic. The bill does not include any offsets from state and local fiscal relief funds. This bill was introduced after a measure that would have allocated $15 billion for COVID-19 relief efforts was cut from the Appropriations package that passed the House of March 9.

The bill text can be found here.

Rep. Moulton Introduces Bill to Facilitate Veterans’ Use of Medical Marijuana

On March 8, Rep. Seth Moulton (D-CT) introduced a bill that aims to increase veterans’ use of medical marijuana to treat post-traumatic stress disorder, anxiety and chronic pain. The bill would require the Veterans’ Affairs (VA) medical providers to acknowledge medical cannabis as a legitimate alternative treatment and establish legal protections so veterans who use cannabis do not lose their benefits. The bill would also establish partnerships and programs to train VA providers on medical marijuana and medical cannabis.

The bill text can be found here.

Rep. Pallone Introduces Bill to Strengthen Requirements for the FDA’s Accelerated Approval Program

On March 7, Rep. Frank Pallone (D-NJ), chair of the House Energy and Commerce Committee, introduced the Accelerated Approval Integrity Act, which would provide the Food and Drug Administration (FDA) with additional authority to ensure that drugs that receive accelerated approval provide a clinical benefit to patients. The bill would require manufacturers to carry out post-approval studies on drugs that receive accelerated approval, and also require manufacturers and the FDA to agree on the parameters of these studies prior to the FDA’s granting accelerated approval. In addition, the bill outlines procedures for withdrawing accelerated approval, and when this would occur.

The bill text can be found here.

House Energy and Commerce to Discuss Health Legislation

The House Committee on Energy and Commerce Subcommittee on Health will hold a hearing titled “The Future of Medicine: Legislation to Encourage Innovation and Improve Oversight” on March 17 at 10:30 a.m. The hearing will include a discussion of a number of healthcare bills, which can be found below.

  • R. 1730, the Speeding Therapy Access Today Act of 2021
  • R. 2565, the FDA Modernization Act of 2021
  • R. 3085, the Equity in Neuroscience and Alzheimer’s Clinical Trials (ENACT) Act of 2021
  • R. 3927, the Manufacturing API, Drugs, and Excipients (MADE) in America Act 
  • R. 4472, the Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act of 2021 
  • R. 4511, the FDA Advancing Collection of Transformative Science (FACTS) Act
  • R. 5030, the Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act
  • R. 5566, the Finding Orphan-disease Remedies With Antifungal Research and Development (FORWARD) Act of 2021
  • R. 5585, the Advanced Research Project Agency–Health (ARPA-H) Act
  • R. 6000, the Cures 2.0 Act
  • R. 6584, the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act
  • R. 6888, the Helping Experts Accelerate Rare Treatments Act of 2022
  • R. 6963, the Accelerated Approval Integrity Act of 2022
  • R. 6972, the Give Kids a Chance Act
  • R. 6973, the Enhanced Access to Affordable Medicines Act
  • R. 6988, the Drug Manufacturing Innovation Act
  • R. 6996, the Accelerating Access for Patients Act
  • R. 7006, the Improving the Nation’s Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies (INSPECTIONS) Act 
  • R. 7008, the Pre-Approval Information Exchange Act
  • R. 7032, the Increasing Transparency in Generic Drug Applications Act
  • R. 7035, the Biologics Market Transparency Act
  • R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes


Sens. Murphy and Stabenow and Reps. Porter and Dingell Introduce Bill to Close Health Coverage Gaps for Public Servants

On March 11, Sens. Chris Murphy (D-CT) and Debbie Stabenow (D-MI) along with Reps. Katie Porter (D-CA) and Debbie Dingell (D-MI) introduced the Closing Health Coverage Gaps for Public Servants Act. The bill would sunset self-funded nonfederal governmental health plans from opting out of federal parity requirements for behavioral healthcare. This would apply to health plans for firefighters, police, public school teachers and state and city workers. In addition, the bill would expand coverage for postmastectomy reconstructive surgery and mother and newborn standards.

The bill text can be found here.

Sens. Capito and Shaheen and Reps. McKinley and Thompson Introduce Bill to Increase Access to Prescription Digital Therapeutics

On March 10, Sens. Shelley Moore Capito (R-WV) and Jeanne Shaheen (D-NH) along with Reps. David McKinley (R-WV) and Mike Thompson (D-CA) introduced the Access to Prescription Digital Therapeutics Act of 2022. The bill aims to extend Medicare coverage to prescription digital therapeutics (PDTs), which are software-based disease treatments that provide cognitive therapy and are prescribed by providers. PDTs can be used to treat a number of diseases and conditions, including substance use disorders, behavioral health issues, diabetes and Parkinson’s disease.

The bill text can be found here.

Sen. Grassley Calls on FTC Commissioner to Study PBM Practices

On March 9, Sen. Chuck Grassley (R-IA), Ranking Member of the Senate Judiciary Committee, wrote to Federal Trade Commission (FTC) Chair Lina Khan regarding the FTC’s Feb. 17 deadlocked vote on whether to initiative a study into pharmacy benefit managers’ (PBMs) business practices. In the letter, Sen. Grassley called on Chair Khan to move forward with a study to investigate PBM practices. He said that this study would determine how PBMs determine prescription drug prices and lead to a better understanding of how money flows in the prescription drug marketplace.

The letter can be found here.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.