This Week in Washington: Congress Passes Appropriations to Fund Government Through Fiscal Year 2023
Upcoming Hearings
Congress
House
- Rep. DeLauro Introduces Standalone COVID-19 Relief Bill
- Rep. Moulton Introduces Bill to Facilitate Veterans’ Use of Medical Marijuana
- Rep. Pallone Introduces Bill to Strengthen Requirements for the FDA’s Accelerated Approval Program
- House Energy and Commerce to Discuss Health Legislation
Senate
- Sens. Murphy and Stabenow and Reps. Porter and Dingell Introduce Bill to Close Health Coverage Gaps for Public Servants
- Sens. Capito and Shaheen and Reps. McKinley and Thompson Introduce Bill to Increase Access to Prescription Digital Therapeutics
- Sen. Grassley Calls on FTC Commissioner to Study PBM Practices
Administration
- HHS Launches Test to Treat Initiative
- CMS Innovation Center to Hold Roundtable on Safety Net Providers’ Participation in Innovation Center Models
- HRSA to Distribute $35 Million to Improve Community Mental Health for Children and Young Adults
Proposed Rules
- FDA Releases Draft Guidance on Verification System Requirements for Certain Prescription Drugs
- HHS Issues RFI on the Impact of COVID-19 Misinformation
- DHS Issues Notice of Proposed Rulemaking to Edit Public Charge Definition
- FDA Issues Proposed Rule to Amend Medical Device Manufacturing Practice Requirements
- FDA Issues Draft Guidance on Developing Non-Addictive Opioid Alternatives
- FDA Issues Proposed Rule with Potential Standards for Wholesale Drug Distributors and Third-Party Logistics Providers
- FDA Issues Proposed Rule to Amend Certain Prescription Drug Marketing Regulations
- FDA Releases Draft Guidance on Formal Meetings Between the FDA and Sponsors or Requesters for OTC Monograph Drugs
- FDA Issues Two Draft Guidances on Medical Devices Authorized During the COVID-19 Pandemic
Final Rules
- Final Rule to Change Qualifications for Products to be Considered “Made in America” Released
- HHS Delays SUNSET Final Rule Implementation
Courts
- Texas Supreme Court Blocks Clinics’ Challenge to Abortion Law
Reports
- CBO Report on Efforts to Increase Transparency Within the Agency
- GAO Report on IHS Third-Party Collections
- GAO Report on Geographic Adjustments to Physician Payments
- FDA Releases FY 2021 GDUFA Science and Research Report
Upcoming Hearings
March 15
Senate Health, Education, Labor and Pensions Committee Hearing: “S._, PREVENT Pandemics Act”
10:00 a.m.
The hearing page can be found here.
March 16
House Committee on Ways and Means Subcommittee on Worker and Family Support Hearing: “Worker and Family Support Subcommittee Hearing on Improving Family Outcomes Through Home Visiting”
10:00 a.m.
The hearing page can be found here.
Senate Finance Committee Hearing: “Prescription Drug Price Inflation: An Urgent Need to Lower Drug Prices in Medicare”
10:00 a.m.
The hearing page can be found here.
House Committee on Veterans’ Affairs Subcommittee on Health Hearing to discuss: H.R. 4993, the Veterans Emergency Care Reimbursement Act of 2021; H.R. 5738, the Lactation Spaces for Veteran Moms Act; H.R. 5754, the Patient Advocate Tracker Act; H.R. 5819, the Autonomy for Disabled Veterans Act; H.R. 5941, the Fairness for Rural Veterans Act of 2021; H.R. 6647, to amend title 38, United States Code, to make certain improvements relating to the eligibility of veterans to receive reimbursement for emergency treatment furnished through the Veterans Community Care program, and for other purposes; H.R. 6823, the Elizabeth Dole Home and Community Based Services for Veterans and Caregivers Act of 2022; Discussion Draft, Long-term Care Veterans Choice Act”
2:00 p.m.
The hearing page can be found here.
Senate Committee on Armed Services Subcommittee on Personnel Hearing: “To receive testimony on the health effects of exposure to airborne hazards, including toxic fumes from burn pits”
3:00 p.m.
The hearing page can be found here.
March 17
House Committee on Energy and Commerce Subcommittee on Health Hearing: “The Future of Medicine: Legislation to Encourage Innovation and Improve Oversight”
10:30 a.m.
The hearing page can be found here.
House Veterans’ Affairs Committee Hearing: “Building a Better VA: Addressing Healthcare Workforce Recruitment and Retention Challenges”
2:00 p.m.
The hearing page can be found here.
Congress
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.
House
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
Senate
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.
Administration
HHS Launches Test to Treat Initiative
On March 8, the Department of Health and Human Services (HHS) launched the Test to Treat Initiative. The initiative allows individuals who test positive for COVID-19 to be assessed by a provider at a pharmacy clinic or qualified community health center that can prescribe antiviral pills to treat COVID-19 on the spot. This initiative aims to increase individuals’ access to antiviral treatments when appropriate, and decrease the likelihood of these individuals’ developing severe COVID-19.
The fact sheet can be found here.
CMS Innovation Center to Hold Roundtable on Safety Net Providers’ Participation in Innovation Center Models
The Centers for Medicare and Medicaid Services (CMS) Innovation Center will hold an event titled “Roundtable on Safety Net Provider Participation in CMS Innovation Center Models” on March 16 from 1:00-3:00 p.m. The roundtable will gather stakeholder feedback on how CMS can best support safety net providers’ participation in value-based care and CMS Innovation Center models.
Registration information for the event can be found here.
HRSA to Distribute $35 Million to Improve Community Mental Health for Children and Young Adults
On March 9, the Health Resources and Services Administration (HRSA) announced that $35 million in grants would be distributed through the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Office of Minority Health (OMH) to improve community mental health and suicide prevention programs directed at children and young adults.
Information on the grant programs can be found here.
Proposed Rules
FDA Releases Draft Guidance on Verification System Requirements for Certain Prescription Drugs
On March 9, the Food and Drug Administration released draft guidance titled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” The draft guidance details the statutory verification system requirements that products need to comply with under the Federal Food, Drug, and Cosmetic Act as amended by the Drug Supply Chain Security Act. Specifically, the draft guidance provides information on verification system requirements to quarantine and investigate products determined to be illegitimate. The guidance document includes non-binding recommendations.
Comments will be accepted until May 9, 2022.
The draft guidance can be found here.
HHS Issues RFI on the Impact of COVID-19 Misinformation
On March 7, the Department of Health and Human Services’ (HHS) Office of the Surgeon General published a notice titled “Request for Information: Impact of Health Misinformation in the Digital Information Environment in the United States Throughout the COVID-19 Pandemic.” The Office of the Surgeon General is seeking input on COVID-19 misinformation online to better understand the impact of misinformation on healthcare infrastructure and public health.
Public comments will be accepted until May 2, 2022.
The notice can be found here.
DHS Issues Notice of Proposed Rulemaking to Edit Public Charge Definition
On Feb. 24, the Department of Homeland Security (DHS) issued a notice of proposed rulemaking titled “Public Charge Ground of Inadmissibility,” which would make the public charge standard less restrictive, as it would no longer include people receiving Medicaid and Supplemental Nutrition Assistance Program (SNAP) benefits.
Under the current law, a noncitizen seeking admission to the U.S. or seeking a visa or status must prove that they are not “likely to become a public charge” in order to be admitted to the U.S. The new proposed rule states that someone is likely to become a public charge if they are “likely to become primarily dependent on the government for subsistence,” which includes the receipt of public cash assistance for income maintenance or long-term institutionalization at government expense. This represents a change from the 2019 Public Charge Final Rule definition of public charge, which also considered receipt of Medicaid, public housing or SNAP benefits as making someone a “public charge.” The 2019 final rule has not been in effect since 2021.
Public comments will be accepted until April 25, 2022.
The notice of proposed rulemaking can be found here.
FDA Issues Proposed Rule to Amend Medical Device Manufacturing Practice Requirements
On Feb. 23, the Food and Drug Administration (FDA) published a proposed rule titled “Medical Devices; Quality System Regulation Amendments.” The proposed rule would amend the Quality System Regulation’s device current good manufacturing practice (CGMP) requirements to align more closely with international device standards.
Public comments are accepted until May 24, 2022.
The proposed rule can be found here.
FDA Issues Draft Guidance on Developing Non-Addictive Opioid Alternatives
On Feb. 9, the Food and Drug Administration (FDA) published a draft guidance titled “Development of Non-Opioid Analgesics for Acute Pain.” The guidance provides recommendations to companies for developing non-opioid analgesics for acute pain lasting up to 30 days. The guidance includes information about what type of data would be necessary to demonstrate acute pain management. The guidance stresses the FDA’s commitment to providing non-addictive alternatives to opioids and decreasing exposure to opioids.
Public comments are accepted until April 11, 2022.
The draft guidance can be found here.
FDA Issues Proposed Rule with Potential Standards for Wholesale Drug Distributors and Third-Party Logistics Providers
On Feb. 4, the Food and Drug Administration (FDA) issued a proposed rule titled “National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics.” The proposed rule includes proposed national standards for the licensing of prescription drug wholesale distributors and third-party logistics providers.
Public comments are accepted until June 6, 2022.
The proposed rule can be found here.
FDA Issues Proposed Rule to Amend Certain Prescription Drug Marketing Regulations
On Feb. 4, the Food and Drug Administration (FDA) issued a proposed rule titled “Certain Requirements Regarding Prescription Drug Marketing.” The proposed rule would amend certain drug marketing regulations of the Federal Food, Drug, and Cosmetic Act to reflect changes resulting from the Drug Supply Chain Security Act.
Public comments are accepted until April 5, 2022.
The proposed rule can be found here.
FDA Releases Draft Guidance on Formal Meetings Between the FDA and Sponsors or Requesters for OTC Monograph Drugs
On Feb. 4, the Food and Drug Administration (FDA) released a notice to announce the availability of draft guidance for industry titled “Formal Meetings Between the FDA and Sponsors or Requestors of Over-the-Counter (OTC) Monograph Drugs.” The draft guidance makes non-binding recommendations to industry on the procedures and principles for formal meetings between the FDA and sponsors or requestors for OTC monograph drugs.
Comments will be accepted until April 8, 2022.
The draft guidance can be found here.
FDA Issues Two Draft Guidances on Medical Devices Authorized During the COVID-19 Pandemic
On Dec. 23, the Food and Drug Administration (FDA) issued two draft guidance documents related to medical devices that received Emergency Use Authorization (EUA) during the COVID-19 pandemic. The guidance documents, titled “Transition Plan for Medical Devices Issued EUAs During the COVID-19 Public Health Emergency (PHE)” and “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the COVID-19 PHE,” are intended to help manufacturers and stakeholders adapt to the eventual resumption of normal operations upon the end of the PHE.
Public comments will be accepted until March 23, 2022.
The guidance document titled “Transition Plan for Medical Devices Issued EUAs During the COVID-19 Public Health Emergency” can be found here.
The guidance document titled “Transition Plan for Medical Devices that Fall Within Enforcement Policies Issued During the COVID-19 Public Health Emergency” can be found here.
Final Rules
Final Rule to Change Qualifications for Products to be Considered “Made in America” Released
On March 4, the Department of Defense, the General Services Administration and the Aeronautics and Space Administration announced a final rule policy that aims to increase manufacturing of critical supplies in the U.S. as part of President Biden’s “Made in America” policy. The final rule would require pharmaceutical companies that want their products to qualify as being “Made in America” for federal procurement purposes to increase the percentage of drug ingredients made in the U.S. from 55 percent to 75 percent in the next seven years. Specifically, the final rule would increase the threshold to 60 percent in 2022, 65 percent in 2024 and 75 percent in 2029. In addition, the rule will allow the government to apply price preferences to select drug products and components that will support the expansion of the domestic supply chain. The final rule will go into effect on Oct. 25, 2022.
The White House Fact Sheet on the final rule can be found here.
The final rule can be found here.
HHS Delays SUNSET Final Rule Implementation
On March 4, the Department of Health and Human Services (HHS) released a final rule to postpone the final rule titled “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET Final Rule). The SUNSET final rule was first published on Jan. 19, 2021, and was set to go into effect on March 22, 2022. The final rule would establish a new process to review HHS regulations, with automatic expiration of regulations that meet certain circumstances. The final rule will now be delayed further and will go into effect on Sept. 22, 2022.
The final rule can be found here.
Courts
Texas Supreme Court Blocks Clinics’ Challenge to Abortion Law
On March 11, the Texas Supreme Court ruled that state medical licensing officials are not considered enforcers of the abortion law Senate Bill 8, and therefore cannot be sued by clinics that oppose the law and are trying to halt it. Senate Bill 8 bans abortions after six weeks of pregnancy and took effect in September 2021. This decision further narrows the avenues for abortion providers to challenge the law going forward. Senate Bill 8 is expected to remain in place.
Reports
CBO Report on Efforts to Increase Transparency Within the Agency
On March 9, the Congressional Budget Office (CBO) released a report titled “Transparency at CBO: Future Plans and a Review of 2021.” The CBO states that in 2021, CBO’s efforts to increase transparency included testifying before Congress, releasing data, evaluating estimates and conducting outreach. The report states that in 2021, the CBO will focus on explaining its analysis methods, providing additional information to clarify CBO’s cost estimates and publishing a periodic compendium of options to reduce the federal budget deficit.
The report can be found here.
GAO Report on IHS Third-Party Collections
On March 10, the Government Accountability Office (GAO) released a report titled “Indian Health Service (IHS): Information on Third-Party Collections and Processes to Procure Supplies and Services.” The report states that IHS has delegated some oversight of its third-party collections, that is, payments for patients’ care received from Medicaid, Medicare or private insurers. The report details the process the IHS uses to oversee these funds.
The full report can be found here.
GAO Report on Geographic Adjustments to Physician Payments
On March 7, the Government Accountability Office (GAO) released a report titled “Medicare: Information on Geographic Adjustments to Physician Payments for Physicians’ Time, Skills, and Effort.” The GAO report notes that the Centers for Medicare and Medicaid Services uses geographic practice cost indices (GPCI) to adjust Medicare physician payments. The GAO carried out an analysis and found that aggregate Medicare payments would decrease under three hypothetical changes: (1) removing the work GPCI floor, which would raise the national average; (2) removing the floor and one-quarter adjustment; or (3) removing the work GPCI entirely.
The full report can be found here.
FDA Releases FY 2021 GDUFA Science and Research Report
On March 7, the Food and Drug Administration (FDA) released the “Fiscal Year (FY) 2021 Generic Drug User Fee Amendments (GDUFA) Science and Research Report,” which summarizes research activities and outcomes from the GDUFA Science and Research program in 2021. The GDUFA Science and Research program supports the development of innovative methodologies to establish drug equivalence standards and develop safe generic drugs. The report also includes general and product-specific guidances that resulted from the research.
The report can be found here.
