This Week in Washington: President Biden Selects Judge Ketanji Brown Jackson to Nominate to the Supreme Court

Congress

Upcoming Hearings

House

• Rep. McMorris Rodgers and Sen. Burr Oppose Additional $3 Billion for HRSA’s Uninsured Program

Administration

• President Biden Announces Plan to Nominate Judge Kentanji Brown Jackson to the Supreme Court
• White House Announces Actions to Address the Impact of COVID-19 on People with Disabilities and Older Adults
• President Biden Extends National Emergency
• CMS Announces Cancellation of Geo Model and Redesign of GPDC Model
• CMS Removes ACO Transformation Track from CHART Model
• FDA to Hold Public Meeting for Final Assessment of the Biosimilar User Fee Act
• CDC Changes Vaccine Recommendations to Mitigate Myocarditis
• HRSA Distributes $560 Million in Provider Relief Funds
• FTC Issues Request for Information on the Effect of PBMs’ Practices

Other Activity

• DOJ Challenges UnitedHealth and Change’s Planned Merger

Proposed Rules

• 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• FDA Issues Draft Guidance on Developing Non-Addictive Opioid Alternatives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• FDA Releases Draft Guidance on Formal Meetings Between the FDA and Sponsors or Requesters for OTC Monograph Drugs
• 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• FDA Releases Draft Guidance on the Process Device Makers Should Use to Notify Agency of Critical Device Supply Shortages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

Courts

• Texas Federal Judge Strikes Down Part of HHS’s Surprise Billing Interim Final Rule

Reports

• NIH Study on COVID-19-Related Discrimination
• ASPR Report on Efforts to Strengthen Public Health Supply Chain and Industrial Base
• NIST Practice Guide Focused on Increasing Privacy Controls in Remote Patient Monitoring
• CBO Working Report on the Economic Impacts of Single-Payer Healthcare Systems
• GAO Report on Information Sharing in Residential Facilities
• ASPE Report on Uninsured Rate Among Black Americans

Upcoming Hearings

March 1

House Committee on Education and Labor Subcommittee on Health, Employment, Labor and Pensions Hearing: “Improving Retirement Security and Access to Mental Health Benefits”
10:15 a.m.
The hearing page can be found here.

March 2

House Ways and Means Committee Hearing: “Substance Use, Suicide Risk, and the American Health System”
10:00 a.m.
The hearing page can be found here.

House Committee on Energy and Commerce Subcommittee on Oversight and Investigations Hearing: “Lessons from the Frontline: COVID-19’s Impact on American Health Care”
10:30 a.m.
The hearing page can be found here.

Congress

House

Rep. McMorris Rodgers and Sen. Burr Oppose Additional $3 Billion for HRSA’s Uninsured Program

On Feb. 22, Rep. Cathy McMorris Rodgers (R-WA) and Sen. Richard Burr (R-NC) wrote to the Department of Health and Human Services (HHS) Secretary Xavier Becerra regarding the Health Resources and Services Administration’s (HRSA) uninsured program, which is used to reimburse providers for COVID-19 testing, treatments and vaccines to individuals without health insurance. Rep. McMorris Rodgers and Sen. Burr noted that Congress has already allocated $18.3 billion for this program through the provider relief fund, and stated that they oppose the Biden administration’s request for an additional $3 billion.

The full letter can be found here.

Administration

President Biden Announces Plan to Nominate Judge Kentanji Brown Jackson to the Supreme Court

On Feb. 25, President Biden announced that he would be nominating Judge Ketanji Brown Johnson to the Supreme Court to fill the spot left by Justice Stephen Breyer’s retirement. Judge Johnson currently serves on the U.S. Court of Appeals for the D.C. Circuit. If Judge Johnson is confirmed, she would be the first Black woman to serve on the Supreme Court.

White House Announces Actions to Address the Impact of COVID-19 on People with Disabilities and Older Adults

On Feb. 24, the White House announced actions the administration will take to meet the needs of people with disabilities and older adults who have contracted and recovered from COVID-19. The actions include equipping schools with support for vulnerable students, expanding the Department of Health and Human Services’ (HHS) Disability Information and Access Line, making COVID-19 testing guidance more accessible, developing accessible at-home COVID-19 tests and other measures.

The White House fact sheet can be found here.

President Biden Extends National Emergency

On Feb. 22, the President Biden published a notice that extended the national emergency declaration due to the COVID-19 pandemic past March 1. This allows the pandemic-related Medicare and Medicaid coverage flexibilities to continue. The notice does not specify an end date for the emergency declaration.

The notice can be found here.

CMS Announces Cancellation of Geo Model and Redesign of GPDC Model

On Feb. 24, the Centers for Medicare and Medicaid Services (CMS) announced the permanent cancellation of the Geographic Direct Contracting Model (“Geo Model”) effective immediately. The Geo Model launched in December 2020 but was paused in March 2021 due to stakeholder concerns. CMS stated that the Geo Model does not align with CMS’s vision for accountable care.

In addition, CMS announced the redesign of the Global and Professional Direct Contracting (GPDC) Model in an effort to advance health equity and respond to stakeholder feedback. The GPDC Model will be renamed the Accountable Care Organization (ACO) Realizing Equity, Access, and Community Health (REACH) Model, and the transition between models will take place on Jan. 1, 2023. Current participants in the GPDC Model will need to meet the requirements for the new ACO REACH Model in order to continue participating.

The Center for Medicare and Medicaid Innovation released a Request for Applications (RFA) for the ACO REACH Model to solicit participants. CMS will hold a webinar on the RFA on March 1 at 4:00 p.m. Registration information can be found here.

A CMS press release with additional information can be found here.

CMS Removes ACO Transformation Track from CHART Model

On Feb. 22, the Centers for Medicare and Medicaid Services (CMS) announced that it removed the Accountable Care Organizations (ACOs) Transformation Track from its Community Health Access and Rural Transformation (CHART) Model. The ACO Transformation Track, which was created under the Trump administration, would provide up to 20 rural ACOs with advanced payments for joining the Medicare Shared Savings Program. ACO Transformation Track’s implementation was delayed for a year in March 2021, so it has never been in effect. CMS stated that the agency is working on a broader strategy to increase accountable care in rural areas.

FDA to Hold Public Meeting for Final Assessment of the Biosimilar User Fee Act

On Feb. 24, the Food and Drug Administration (FDA) announced that it would be holding a virtual public meeting titled “Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act (BsUFA)” on March 22 from 9:30 a.m. to 12:30 p.m.

Additional information about the event can be found here.

CDC Changes Vaccine Recommendations to Mitigate Myocarditis

On Feb. 22, the Centers for Disease Control and Prevention (CDC) changed its vaccine recommendations for males from 12-39 years of age to reduce the risk of myocarditis. The recommendation now encourages this population to wait for 8 weeks after their first dose of an mRNA COVID-19 vaccine to get their second dose. This is a longer timeframe than CDC’s previously recommended three to four weeks between doses. The CDC emphasizes that certain populations, including immunocompromised and elderly patients, should still prioritize having a shorter wait time, approximately three or four weeks, between the first and second doses of the Pfizer and Moderna vaccine.

HRSA Distributes $560 Million in Provider Relief Funds

On Feb. 24, the Health Resources and Services Administration (HRSA) released $560 million of provider relief funds to 4,100 providers. The funds will be used for staff recruitment and retention. The recent distribution leaves $5.4 billion in the provider relief fund.

FTC Issues Request for Information on the Effect of PBMs’ Practices

On Feb. 24, the Federal Trade Commission (FTC) announced a Request for Information (RFI) to solicit public input on how Pharmacy Benefit Managers’ (PBM) practices are affecting drug affordability and access. The RFI seeks feedback on a wide range of issues in the PBM market and their impact on patients, physicians, pharmacies and other businesses across the distribution system. Public comments will be accepted until April 25, 2022.

The RFI comes after FTC commissioners held a Feb. 18 vote on a motion to study PBM’s pricing and contractual practices and their effects on independent pharmacies. The vote was 2-2, meaning that the study would not move forward.

The RFI can be found here.

Other Activity

DOJ Challenges UnitedHealth and Change’s Planned Merger

On Feb. 24, the Department of Justice (DOJ) filed a suit against the planned $13.8 billion merger between the UnitedHealth Group’s Optum unit and the technology company Change Healthcare. UnitedHealth and Change had announced their plans to move forward to close the merger deal after their timing agreement for merger review with the DOJ ended on Feb. 22. In the Feb. 24 lawsuit, the DOJ stated that the proposed merger would give UnitedHealth access to its rival health insurers’ competitively sensitive information, which could give the company an unfair advantage.

Proposed Rules

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.

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.

Courts

Texas Federal Judge Strikes Down Part of HHS’s Surprise Billing Interim Final Rule

On Feb 23, the District Court for the Eastern Division of Texas struck down part of the Health and Human Services’ (HHS) interim final rule that governs the arbitration process for resolving payment disputes between out-of-network providers and health insurers as detailed in the No Surprises Act. The judge stated that HHS did not follow the Administrative Procedure Act when it implemented the interim final rule, and that the rule does not follow the text of the No Surprises Act.

The lawsuit was brought by the Texas Medical Association, which argued that the interim final rule would harm patients and went against congressional intent.

Reports

NIH Study on COVID-19-Related Discrimination

On Feb. 24, the National Institutes of Health (NIH) released a study that found that in the U.S., racial and ethnic minority population groups were more likely to experience COVID-19-related discrimination than white adults. COVID-19-related discrimination can be defined as being threated or harassed based on one person’s perception that another has COVID-19.

The full study can be found here.

ASPR Report on Efforts to Strengthen Public Health Supply Chain and Industrial Base

On Feb. 24, the Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) released a report titled “Public Health Supply Chain and Industrial Base One-Year Report.” The report notes the improvements to public health and medical supply chain challenges since the beginning of the COVID-19 pandemic and details how HHS has implemented the recommendations in the “National Strategy for a Resilient Public Health Supply Chain.” The report also details additional challenges that remain to strengthening the medical supply chain and industrial base.

The full report can be found here.

NIST Practice Guide Focused on Increasing Privacy Controls in Remote Patient Monitoring

On Feb. 24, the Department of Commerce’s National Institute of Standards and Technology (NIST) released a practice guide titled “Securing Telehealth Remote Patient Monitoring (RPM) Ecosystem” that examines how providers can use technology to conduct (RPM) without compromising patient privacy. The practice guide contains lessons learned from a laboratory experiment carried out by the National Cybersecurity Center of Excellence’s (NCCoE) and industry partners on the ways that healthcare delivery organizations can implement cybersecurity and privacy controls to improve RPM resiliency.

The practice guide can be found here.

CBO Working Report on the Economic Impacts of Single-Payer Healthcare Systems

On Feb. 23, the Congressional Budget Office (CBO) published a working paper titled “Economic Effects of Five Illustrative Single-Payer Health Care Systems.” The working paper analyzes the economic and distributional implications of five illustrative single-payer healthcare systems. The analysis finds that economic output would be between 0.3 percent lower and 1.8 percent higher than the benchmark economy 10 years after the implementation of a single-payer system. This analysis does not include the economic impact of financing the single-payer system.

The working paper can be found here.

GAO Report on Information Sharing in Residential Facilities

On Feb. 23, the Government Accountability Office (GAO) issued a report titled “HHS Should Facilitate Information Sharing Between States to Help Prevent and Address Maltreatment in Residential Facilities.” The report notes that several state agencies work with federally funded residential facilities for youth to prevent and address maltreatment. The report focuses on challenges states face in collecting maltreatment data, and suggestions that could improve this and how federal agencies could better support state efforts. The GAO recommended that the Department of Health and Human Services (HHS) work with the Department of Education to facilitate information-sharing across states on ways to prevent and address maltreatment in residential facilities.

The full report can be found here.

ASPE Report on Uninsured Rate Among Black Americans

On Feb. 22, the Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) released a report titled “Health Insurance Coverage and Access to Care Among Black Americans: Recent Trends and Key Challenges.” The report found that the uninsured rate of Black Americans under age 65 decreased from 20 percent to 12 percent from the years 2011 to 2019. The report notes that this decline correlates with the implementation of the Affordable Care Act (ACA) provisions starting in 2010.

The full report can be found here.