This Week in Washington: Senate HELP Committee Chair Patty Murray and Ranking Member Richard Burr Release Discussion Draft of Bipartisan Pandemic and Public Health Response Bill
Congress
Upcoming Hearings/Markups
House
- Bicameral Democratic Health Committee Members Express Support for Notice of Benefit and Payment Parameters for 2023
Senate
- Sens. Murray and Burr Release Discussion Draft of Bipartisan Pandemic Bill
Administration
- CMS Releases Final National Snapshot of 2022 Marketplace Open Enrollment Period
- CMS Announces $49 Million in Grants to Improve Medicaid and CHIP Coverage for Parents, Children and Pregnant People
- CMS to Begin Accepting Part D Senior Savings Model Applications for 2023
- CMS Releases Summary of the Medicare Shared Savings Program
- CMS to Publish Nursing Home Staffing Data
- CMS Innovation Center to Hold Listening Session
- FDA Issues Two Final Guidances on Medical Device Clinical Studies
- FDA Releases Guidance Document on Abbreviated New Drug Applications
- FDA Limits Use of Monoclonal Antibody Treatment for Omicron Variant
- CBER Announces CY 2022 Guidance Agenda
- HRSA Releases $2 Billion in COVID-19 Provider Relief Funds
Proposed Rules
- CMS Issues CY 2023 Medicare Advantage and Part D Proposed Rule
- FDA Releases Draft Guidance on the Process Device Makers Should Use to Notify Agency of Critical Device Supply Shortages
- FDA Issues Two Draft Guidances on Medical Devices Authorized During the COVID-19 Pandemic
- CMS Publishes Draft Guidance for Antisense Oligonucleotide Drug Products for Severe Diseases
- FDA Issues Draft Guidance on Premarket Submissions for Device Software Functions
Final Rules
- CMS Issues Final Rule to Revise Procedures for Announcing Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications
- FDA Issues Final Rule to Revoke Regulations for Human Tissue Intended for Transplantation Recovered Prior to 2005
- CMS Issues Durable Medical Equipment Final Rule
- FDA Issues Final Rule to Amend Laboratory Food Testing Requirements
Courts
- Supreme Court Justice Stephen Breyer Announces His Retirement
Reports
- GAO Report on the COVID-19 Response and Oversight
- GAO Report on USAID Oversight of COVID-19 Humanitarian Funds
- Departments of Labor, HHS and Treasury Issue 2022 Mental Health Parity and Addiction Equity Act Report
The House has a district work period this week.
Upcoming Hearings/Markups
February 1
Senate Health, Education, Labor and Pensions Committee Hearing: “Mental Health and Substance Use Disorders: Responding to the Growing Crisis”
10:00 a.m.
The hearing page can be found here.
Senate Committee on Commerce, Science, and Transportation Subcommittee on Consumer Protection, Product Safety, and Data Security Hearing: “Stopping COVID-19 Fraud and Price Gouging”
2:30 p.m.
The hearing page can be found here.
February 2
House Ways and Means Committee Hearing: “America’s Mental Health Crisis”
10:00 a.m.
The hearing page can be found here.
Senate Committee on Energy and Commerce Subcommittee on Consumer Protection and Commerce Hearing: “Pandemic Profiteers: Legislation to Stop Corporate Price Gouging”
10:30 a.m.
The hearing page can be found here.
House Veterans’ Affairs Committee Markup on A.N.S. TO H.R. 5575, RAISE ACT; H.R. 6411, STRONG VETERANS ACT
2:00 p.m.
The markup page can be found here.
Senate Committee on Finance Subcommittee on Fiscal Responsibility and Economic Growth Hearing: “The Hospital Insurance Trust Fund and the Future of Medicare Financing”
2:30 p.m.
The hearing page can be found here.
February 3
House Committee on Veterans’ Affairs Subcommittee on Health Hearing: “Close to Home: Supporting Vet Centers in Meeting the Needs of Veterans and Military Personnel”
10:00 a.m.
The hearing page can be found here.
House Committee on Energy and Commerce Subcommittee on Health Hearing: “FDA User Fee Reauthorization: Ensuring Safe and Effective Drugs and Biologics”
10:30 a.m.
The hearing page can be found here.
House Committee on Ways and Means Subcommittee on Health Hearing: “Bridging Health Equity Gaps for People with Disabilities and Chronic Conditions”
2:00 p.m.
The hearing page can be found here.
Congress
House
Bicameral Democratic Health Committee Members Express Support for Notice of Benefit and Payment Parameters for 2023
On Jan. 27, members of the Bicameral Democratic Health Committee wrote to Health and Human Services (HHS) Secretary Xavier Becerra and Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure expressing their support for the proposed Notice of Benefit and Payment Parameters (NBPP) 2023 Proposed Rule. The Proposed NBPP aims to improve shopping for healthcare coverage and advance equity for consumers purchasing Marketplace coverage, and was released on Dec. 28, 2021.
The letter was signed by Reps. Richard Neal (D-MA), Frank Pallone (D-NJ), Bobby Scott (D-VA) and Sens. Patty Murray (D-WA) and Ron Wyden (D-OR), who stated that the Proposed NBPP will lower healthcare costs and make coverage options more equitable.
The letter can be found here.
Senate
Sens. Murray and Burr Release Discussion Draft of Bipartisan Pandemic Bill
On Jan. 25, Senate Health, Education, Labor and Pensions Committee Chair Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC) released the discussion draft of the Prepare for and Respond to Existing Viruses, Emerging New Threats (PREVENT) and Pandemics Act. The bipartisan bill aims to strengthen public health, preparedness and response systems. Specifically, the bill would improve coordination among public health preparedness agencies, strengthen supply chain and government stockpiles of medical supplies, improve detecting and monitoring capabilities and establish an independent task force to carry out a review of the COVID-19 response. The bill would also expedite the Food and Drug Administration’s (FDA) review of medical countermeasures and require the Centers for Disease Control and Prevention (CDC) director be subject to Senate confirmation.
A press release on the discussion draft, which describes the bill’s measures in greater detail, can be found here.
The legislative text for the discussion draft can be found here.
Administration
CMS Releases Final National Snapshot of 2022 Marketplace Open Enrollment Period
On Jan. 27, the Centers for Medicare and Medicaid Services (CMS) reported that 14.5 million Americans signed up for or were automatically re-enrolled in 2022 individual market health insurance coverage through the Marketplaces during the Marketplace Open Enrollment Period (OEP). The OEP lasted from Nov. 1, 2021, to Jan. 15, 2022.
The press release with additional data can be found here.
CMS Announces $49 Million in Grants to Improve Medicaid and CHIP Coverage for Parents, Children and Pregnant People
On Jan. 27, the Centers for Medicare and Medicaid Services (CMS) announced that it would allocate $49.4 million to organizations that can help connect eligible children, parents and pregnant individuals to Medicaid and Children’s Health Insurance Program (CHIP) healthcare coverage. Grantees will receive up to $1.5 million over three years to improve Medicaid and CHIP enrollment and retention. Grant applications are accepted through March 28, 2022.
More information on the grants can be found here.
CMS to Begin Accepting Part D Senior Savings Model Applications for 2023
On Jan. 27, the Centers for Medicare and Medicaid Services (CMS) announced it would begin accepting applications for pharmaceutical manufacturers that want to participate in the CMS Innovation Center’s Part D Senior Saving (PDSS) Model in 2023. The PDSS Model is intended to provide Medicare beneficiaries with new Part D plans with affordable insulin prices. Model Drug manufacturers that are not currently participating in the program must apply by Feb. 4, 2022.
Additional information on the model and the application can be found here.
CMS Releases Summary of the Medicare Shared Savings Program
On Jan. 26, the Centers for Medicare and Medicaid Services (CMS) released its annual summary of the Medicare Shared Savings Program, Medicare’s national Accountable Care Organization (ACO) program. CMS says the data shows that ACOs are serving a growing patient population, and predicts that 11 million Medicare beneficiaries will be served by Shared Savings Program ACOs in 2022.
The recently released data can be found here.
CMS to Publish Nursing Home Staffing Data
On Jan. 26, the Centers for Medicare and Medicaid Services (CMS) announced it would start posting data on staff turnover rates and weekend staff levels for nursing homes.
The data will be posted on the Medicare.gov Care Compare website, which can be found here.
CMS Innovation Center to Hold Listening Session
The Centers for Medicare and Medicaid Services (CMS) Innovation Center will be hosting a listening session with representatives from patient advocate groups and research experts on Feb. 9 at 2:00 p.m. The objective of the listening session is to identify strategies to improve the Innovation Center’s beneficiary engagement and meet beneficiaries’ needs.
Register for the event here.
FDA Issues Two Final Guidances on Medical Device Clinical Studies
On Jan. 26, the Food and Drug Administration (FDA) issued two final guidances that make recommendations on how to best include patient perspectives in medical device clinical studies. The final guidance titled “Patient Engagement in the Design and Conduct of Medical Device Clinical Studies” describes how industry can voluntarily use patient engagement to improve clinical study design and clarifies how sponsors can receive FDA feedback. The second final guidance, titled “Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation,” describes potential measures for patient-reported outcomes and outlines best practices.
The Patient Engagement in the Design and Conduct of Medical Device Clinical Studies final guidance can be found here.
The Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation final guidance can be found here.
FDA Releases Guidance Document on Abbreviated New Drug Applications
On Jan. 26, the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research issued a guidance document titled “Good Abbreviated New Drug Application (ANDA) Submission Practices Guidance for Industry.” The guidance is intended to help applicants preparing to submit ANDAs to the FDA and to help applicants avoid common errors or deficiencies.
The guidance document can be found here.
FDA Limits Use of Monoclonal Antibody Treatment for Omicron Variant
On Jan. 24, the Food and Drug Administration (FDA) revised its authorizations for two monoclonal antibody treatments used to treat COVID-19. This decision comes after data shows that monoclonal antibody treatments bamlanivimab and estesevimab and REGEN-COV (casirivimab and imdevimab) are unlikely to be effective against the omicron variant. The two treatments are still authorized for other COVID-19 variants.
The press release can be found here.
CBER Announces CY 2022 Guidance Agenda
On Jan. 24, the Food and Drug Administration (FDA) announced that its Center for Biologics Evaluation and Research (CBER) published its list of guidance topics for Calendar Year (CY) 2022. The guidance agenda includes topics that currently have no guidance associated with them, topics where additional guidance could be helpful, and topics CBER has already issued Level 1 draft guidances on. Categories for CY 2022 include blood and blood components, tissues and advanced therapies and vaccines.
The guidance agenda can be found here.
HRSA Releases $2 Billion in COVID-19 Provider Relief Funds
On Jan. 25, the Health Resources and Services Administration (HRSA) announced that $2 billion of Provider Relief Fund Phase 4 general distribution payments would be made available to 7,660 providers this week. This announcement brings the total of Provider Relief Funding Phase 4 payment distributed to $11 billion. 82 percent of Phase 4 applications have now been processed.
Proposed Rules
CMS Issues CY 2023 Medicare Advantage and Part D Proposed Rule
On Jan. 12, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule titled “Medicare Program: Contract Year (CY) 2023 Policy and Technical Changes to the Medicare Advantage (MA) and Medicare Prescription Drug Benefit Programs.” The proposed rule makes a number of revisions to the following topics: MA and Part D regulations on marketing and communications, new or expanded MA and Part D plan criteria, MA and Part D plan quality ratings, provider network adequacy requirements, disaster or public emergency special requirements, medical loss ratio reporting, D-SNPs regulations and pharmacy price concessions. The proposed rule aims to lower out-of-pocket Medicare Part D prescription drug costs and improve health equity in MA and Part D.
Public comments are accepted until March 7, 2022.
The proposed rule can be found here.
FDA Releases Draft Guidance on the Process Device Makers Should Use to Notify Agency of Critical Device Supply Shortages
On Jan. 11, the Food and Drug Administration (FDA) issued a draft guidance to explain how device makers should notify the agency of potential shortages during or before public health emergencies. The guidance requests that manufacturers inform the FDA of meaningful supply disruptions at least six months in advance, and if this is not possible, to notify the FDA as soon as is “practicable,” and no later than seven days after a disruption happens. The guidance is almost identical to a May 2020 guidance, and its recommendations are nonbinding.
Public comments will be accepted until March 12, 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.
CMS Publishes Draft Guidance for Antisense Oligonucleotide Drug Products for Severe Diseases
On Dec. 8, the Food and Drug Administration (FDA) published a draft guidance document for industry titled “Investigational New Drug (IND) Submissions for Individualized Antisense Oligonucleotide (ASO) Drug Products for Severely Debilitating or Life-Threatening (SDLT) Diseases: Clinical Recommendations.” The guidance is intended to help sponsor-investigators interested in developing ASO products for rapidly progressive SDLT genetic diseases with clinical recommendations for IND applications.
Comments will be accepted until Feb. 4, 2022.
The guidance can be found here.
FDA Issues Draft Guidance on Premarket Submissions for Device Software Functions
On Nov. 3, the Food and Drug Administration (FDA) published new draft guidance titled “Content of Premarket Submissions for Device Software Functions.” The guidance provides information on documentation sponsors need to submit for FDA’s evaluation of the safety and effectiveness of device software functions. When final, the guidance will replace prior guidance issued in 2005.
Public comments will be accepted until Feb. 2, 2022.
The draft guidance can be found here.
Final Rules
CMS Issues Final Rule to Revise Procedures for Announcing Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications
On Jan. 13, the Food and Drug Administration (FDA) published a final rule titled “Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications.” The final rule amends medical device regulations regarding the procedures for announcing approvals and denials of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs).
The rule will be effective on Feb. 14, 2022.
The final rule can be found here.
FDA Issues Final Rule to Revoke Regulations for Human Tissue Intended for Transplantation Recovered Prior to 2005
On Jan. 13, the Food and Drug Administration (FDA) published a final rule titled “Revocation of the Regulations for Human Transplantation and Human Dura Mater.” The final rule revokes regulations for human tissue products intended for transplantation that were recovered before May 25, 2005, saying these regulations are outdated as no human tissue products remain in inventory from that time.
The final rule goes into effect on Feb. 14, 2022.
The rule can be found here.
CMS Issues Durable Medical Equipment Final Rule
On Dec. 28, the Centers for Medicare and Medicaid Services (CMS) published a final rule titled “Medicare Program; Durable Medical Equipment (DME), Prosthetics, Orthotics, and Supplies (DMEPOS) Policy Issues, and Level II of the Healthcare Common Procedure Coding System (HCPCS); DME Interim Pricing in the CARES Act; Durable Medical Equipment Fee Schedule Adjustments To Resume the Transitional 50/50 Blended Rates To Provide Relief in Rural Areas and Non-Contiguous Areas.” The final rule aims to increase access to certain DME by establishing methodologies to adjust the Medicare DMEPOS fee schedule amounts. In addition, the final rule sets procedures for creating benefit categories and payment determinations for new DMEPOS.
The final rule will go into effect on Feb. 28, 2022.
The final rule can be found here.
FDA Issues Final Rule to Amend Laboratory Food Testing Requirements
On Dec. 1, the Food and Drug Administration (FDA) issued a final rule titled “Laboratory Accreditation for Analyses of Foods.” The rule amends FDA regulations to establish a program for accredited laboratories to test food under certain circumstances.
The final rule will go into effect on Feb. 1, 2022.
The final rule can be found here.
Courts
Supreme Court Justice Stephen Breyer Announces His Retirement
On Jan. 26, Supreme Court Justice Stephen Breyer announced that he would be retiring at the end of the current term. Breyer is one of three liberal justices on the Supreme Court, and his retirement will allow President Biden to appoint a new justice.
Reports
GAO Report on the COVID-19 Response and Oversight
On Jan. 27, the Government Accountability Office (GAO) released a report titled “COVID-19: Significant Improvements are Needed for Overseeing Relief Funds and Leading Responses to Public Health Emergencies,” which is the agency’s 9th comprehensive report on the COVID-19 pandemic. The report explains recent data trends in the COVID-19 pandemic and the federal government’s response. In the report, the GAO makes five recommendations to agencies to improve their response to public health emergencies.
The report also explains that the GAO has added Department of Health and Human Services’ (HHS) preparation and response to public health emergencies (including COVID-19, other diseases and extreme weather events) to its High Risk List.
GAO Report on USAID Oversight of COVID-19 Humanitarian Funds
On Jan. 26, the Government Accountability Office (GAO) published a report titled “COVID-19: Better USAID Documentation and More-Frequent Reporting Could Enhance Monitoring of Humanitarian Efforts.” The report found that the U.S. Agency for International Development (USAID) did not consistently document how it is overseeing $908 million in congressional funding that was allocated for international humanitarian assistance related to the COVID-19 pandemic in 2020.
The full report can be found here.
Departments of Labor, HHS and Treasury Issue 2022 Mental Health Parity and Addiction Equity Act Report
On Jan. 25, the Departments of Labor, Health and Human Services (HHS), and Treasury issued a report titled “2022 Report to Congress on the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act (MHPAEA) of 2008.” The report suggests that health plans and health insurance issuers are not adequately providing mental health and substance-use disorder benefits. The report also includes recommendations to strengthen the MHPAEA’s consumer protections and details recent enforcement efforts.
The full report can be found here.
