This Week in Washington: Supreme Court Overturns Roe v. Wade and Rules in Becerra v. Empire Health Foundation

Upcoming Hearings

Congress

House

• House Committee on Energy and Commerce Subcommittee on Health to Consider 11 Healthcare Bills
• House Appropriations Committee Advances FY 2023 Spending Bill for Agriculture, Rural Development, FDA and Related Agencies
• House Appropriations Committee Subcommittee on Labor, Health and Human Services, Education, and Related Agencies Approves FY 2023 Spending Bill
• House Passes Legislative Package to Address Mental Health and Substance Abuse
• House Passes the Amended ARPA-H Act

Senate

• Sens. Baldwin, Gillibrand and Warren Lead Letter Calling on FDA to Update Discriminatory Blood Donation Policies
• Senate Passes Gun Control Bill with Mental Health Provisions
• Senate Commerce, Science, and Transportation Committee Advances the Pharmacy Benefit Manager Transparency Act
• Sens. Shaheen and Collins Introduce Bill to Cap Insulin Costs

Administration

• President Biden Announces Intended Nominee for the White House Office of Science and Technology Policy
• HHS Announces Approval of Colorado’s 1332 Waiver to Expand Coverage
• HHS Publishes Fact Sheet on How Premiums Could be Impacted if the American Rescue Plan Expires
• HHS Announces 13 Programs to Take Part in the Justice40 Initiative
• CMS Announces Children Aged Six Months to Five Years are Eligible for COVID-19 Vaccines Without Cost Sharing
• CDC Recommends Pfizer and Moderna COVID-19 Vaccines for Children
• FDA Issues Marketing Denial Orders to JUUL Labs
• FDA Announces Rare Neurodegenerative Diseases Action Plan
• FDA Announces Plans for Potential Rule to Reduce Nicotine Levels in Cigarettes
• HUD Announces New Initiative to Address Homelessness with Focus on Rural Areas

Proposed Rules

• CMS Publishes End-Stage Renal Disease Prospective Payment System Proposed Rule
• CMS Releases Home Health Prospective Payment Systems Rate Update Proposed Rule
• CMS Publishes Proposed Rule on Funding Methodology and Changes to Basic Health Program Regulations
• FDA Announces Request for Public Comments for Adding Maximum Daily Exposure Information to Inactive Ingredient Database

Final Rules

• HHS Issues Final Rule Withdrawing SUNSET Rule
• CMS Releases Notice of Benefit and Parameters for 2023 Final Rule
• Final Rule to Change Qualifications for Products to be Considered “Made in America” Released

Courts

• Supreme Court Overturns Roe v. Wade
• Supreme Court Rules in Favor of HHS in Case of Becerra v. Empire Health Foundation

Reports

• GAO Report on Agency Use of Regulatory Flexibilities During the COVID-19 Pandemic
• GAO Report on Need for a Public Health Situational Awareness Network
• CBO Publishes Cost Estimate of Eight Executive Actions
• CBO Releases Cost Estimate for the Restoring Hope for Mental Health and Well-Being Act of 2022

Upcoming Hearings

June 27

House Committee on Oversight Hearing: “Examining the 2022 National Drug Control Strategy and the Federal Response to the Overdose Crisis”

June 28

House Committee on Energy and Commerce Subcommittee on Oversight and Investigations Hearing: “Protecting America’s Seniors: Oversight of Private Sector Medicare Advantage Plans”
11:00 a.m.

House Committee on Homeland Security Subcommittee on Intelligence and Counterterrorism Hearing: “Combating Ransomware: From our Small Towns in Michigan to DC”
11:00 a.m.

June 29

House Committee on Energy and Commerce Subcommittee on Health Hearing: “Investing in Public Health: Legislation to Support Patients, Workers, and Research”
11:00 a.m. The subcommittee will consider 11 health bills. See below for more information.

Congress

House

House Committee on Energy and Commerce Subcommittee on Health to Consider 11 Healthcare Bills

On June 29, the House Committee on Energy and Commerce Health Subcommittee on Health will consider 11 healthcare bills. The bills can be found below.

• H.R. 2007, the Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021
• H.R. 3773, the Pediatricians Accelerate Childhood Therapies (PACT) Act of 2021
• H.R. 5141, the Maximizing Outcomes through Better Investments in Lifesaving Equipment for (MOBILE) Health Care Act
• H.R. 5442, the Fix Nondisclosure of Influence in Health Research Act
• H.R. 5478, the Protecting the Integrity of our Biomedical Research Act of 2021
• H.R. 6305, the Protect America’s Biomedical Research Enterprise Act of 2021
• H.R. 7565, the NIH Implementing a Maternal health and Pregnancy Outcomes Vision for Everyone (IMPROVE) Act of 2022
• H.R. 7845, the NIH Clinical Trial Diversity Act of 2022
• H.R. 8151, the Building a Sustainable Workforce for Healthy Communities Act
• H.R. 8163, the Improving Trauma Systems and Emergency Care Act
• H.R. 8169, the Rural Telehealth Access Task Force Act

House Appropriations Committee Advances FY 2023 Spending Bill for Agriculture, Rural Development, FDA and Related Agencies

On June 23, the House Committee on Appropriations voted 31-26 to advance the Fiscal Year 2023 Agriculture, Rural Development, Food and Drug Administration (FDA), and Related Agencies Appropriations bill. The bill provides $27.2 billion total, with $3.66 billion designated for the FDA. The bill’s report can be found here.

House Appropriations Committee Subcommittee on Labor, Health and Human Services, Education, and Related Agencies Approves FY 2023 Spending Bill

On June 23, the House Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies approved its fiscal year (FY) 2023 funding bill by a voice vote. The bill allocates $242.1 billion to strengthen public health infrastructure, increase funding for the National Institutes of Health and fund the new Advanced Research Projects Agency for Health (ARPA-H) research agency. The bill now goes to the full Appropriations committee for a markup.

House Passes Legislative Package to Address Mental Health and Substance Abuse

On June 22, the House voted to pass the Restoring Hope for Mental Health and Well-Being Act with a vote of 402-20. The legislative package would reauthorize a number of federal health programs, direct the Centers for Medicare and Medicaid Services (CMS) to update its Medicaid in Schools program guidance and allow states to provide Medicaid or Children’s Health Insurance Program (CHIP) coverage to incarcerated youth. The bill would also create a Behavioral Health Crisis Coordinating Office within the Substance Abuse and Mental Health Services Administration (SAMHSA) to increase access to crisis care.

House Passes the Amended ARPA-H Act

On June 22, the House voted 336-85 to pass the Advanced Research Projects Agency for Health (ARPA-H) Act. The bill authorizes the creation of ARPA-H, the new biomedical research agency, and allocates $500 million to fund it from 2023 to 2027. The bill was recently amended to remove a requirement that the ARPA-H director require Senate confirmation and to prohibit the director from awarding grants or contracts to foreign research entities.

Senate

Sens. Baldwin, Gillibrand and Warren Lead Letter Calling on FDA to Update Discriminatory Blood Donation Policies

On June 24, Sens. Tammy Baldwin (D-WI), Kirsten Gillibrand (D-NY) and Elizabeth Warren (D-MA) led 23 members in a letter to Health and Human Services (HHS) Secretary Xavier Becerra and Food and Drug Administration (FDA) Commissioner Robert Califf requesting an update on the FDA’s efforts to change their discriminatory blood donor deferral policies. In the letter, the senators state that the current three-month donor deferral blood donation policy for men who have sex with men stigmatizes and harms the LGBTQ community and decreases the eligible donor base.

Senate Passes Gun Control Bill with Mental Health Provisions

On June 23, the Senate voted 65-33 to pass the Bipartisan Safer Communities Act, a bipartisan gun control bill. The bill, which provides new protections for victims of domestic violence, improves screenings for individuals under 21 buying a gun and incentivizes states to implement “red flag laws,” also includes resources to address mental health. The healthcare measures in the bill include additional funding for telehealth programs to expand mental health services and support for community-based mental health programs. The Congressional Budget Office (CBO) cost estimate of the bill can be found here.

Senate Commerce, Science, and Transportation Committee Advances the Pharmacy Benefit Manager Transparency Act

On June 22, the Senate Committee on Commerce, Science, and Transportation voted to advance the Pharmacy Benefit Manager (PBM) Transparency Act to the full Senate. The bill would ban unfair and deceptive pricing schemes and require PBMs to report to the Federal Trade Commission (FTC) money gained from spread pricing and pharmacy fees.

Sens. Shaheen and Collins Introduce Bill to Cap Insulin Costs

On June 22, Sens. Jeanne Shaheen (D-NH) and Susan Collins (R-ME) introduced the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act. The bill would cap insulin costs at $35 a month.

Administration

President Biden Announces Intended Nominee for the White House Office of Science and Technology Policy

On June 21, President Biden announced that he will nominate Dr. Arati Prabhakar to be Director of the White House Office of Science and Technology Policy.

HHS Announces Approval of Colorado’s 1332 Waiver to Expand Coverage

On June 23, the Department of Health and Human Services (HHS) announced that it had approved Colorado’s 1332 State Innovation Waiver, which would expand state health insurance to 10,000 people. The waiver creates a “Colorado Option” health coverage plan, which would make insurance more affordable with the objective of reducing racial and ethnic health disparities.

HHS Publishes Fact Sheet on How Premiums Could be Impacted if the American Rescue Plan Expires

On June 22, the Department of Health and Human Services (HHS) published a fact sheet on what could happen to healthcare premiums if Congress does not extend the American Rescue Plan premium tax credits, which are set to expire at the end of 2022.

HHS Announces 13 Programs to Take Part in the Justice40 Initiative

On June 24, the Department of Health and Human Services (HHS) announced that 13 of its programs would be included in the Justice40 Initiative. The Justice40 initiative, which was created in July 2021, calls on federal agencies to deliver to disadvantaged communities 40 percent of the benefits of investments into climate, clean energy, affordable housing and clean water.

CMS Announces Children Aged Six Months to Five Years are Eligible for COVID-19 Vaccines Without Cost Sharing

On June 22, the Centers for Medicare and Medicaid Services (CMS) announced that children with Medicaid and Children’s Health Insurance Program (CHIP) coverage that are aged six months to five years are eligible for COVID-19 vaccines without cost-sharing.

CDC Recommends Pfizer and Moderna COVID-19 Vaccines for Children

On June 24, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices voted in favor of recommending the Moderna COVID-19 vaccine for children aged 6 to 17.

On June 18, the CDC’s Advisory Committee voted to recommend the Pfizer and Moderna vaccines for children. The Moderna vaccine can be administered to children aged 6 months to 5 years and the Pfizer vaccine for children aged 6 months to 4 years.

FDA Issues Marketing Denial Orders to JUUL Labs

On June 23, the Food and Drug Administration (FDA) issued marketing denial orders (MDOs) to JUUL Labs, meaning that JUUL must stop selling and distributing all its products currently marketed in the U.S. The FDA stated that JUUL’s applications seeking marketing authorization for its products lacked sufficient evidence than the products would protect public health.

FDA Announces Rare Neurodegenerative Diseases Action Plan

On June 23, the Food and Drug Administration (FDA) announced its Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS). The action plan is a five-year strategy to advance the development of medical products to treat rare neurodegenerative diseases and increase patient access to these products.

FDA Announces Plans for Potential Rule to Reduce Nicotine Levels in Cigarettes

On June 21, the Food and Drug Administration (FDA) released a plan for potential future regulation to establish a maximum level of nicotine in cigarettes and other combusted tobacco products. The objective of the plan is to limit the amount of nicotine in cigarettes and reduce their addictiveness. According to the plan, the FDA has until May 2023 to formally introduce the rule, which would then go through the rulemaking process.

HUD Announces New Initiative to Address Homelessness with Focus on Rural Areas

On June 22, the Department of Housing and Urban Development (HUD) announced the Initiative for Unsheltered and Rural Homelessness, which is a package of resources to address homelessness and homeless encampments with funds set aside for efforts to combat homelessness in rural areas. The new initiative will allocate $365 million and includes grant funds with vouchers that will improve communities’ capacity to connect vulnerable individuals and families with housing, healthcare and support services.

Proposed Rules

CMS Publishes End-Stage Renal Disease Prospective Payment System Proposed Rule

On June 21, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule titled “Medicare Program: End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, etc.” The proposed rule would update the End-Stage Renal Disease (ESRD) Prospective Payment System and the payment rate for renal dialysis service provided by an ESRD facility for people with acute kidney injury for calendar year 2023. In addition, the rule includes requests for information on potential payment adjustments for new renal dialysis drugs and products and health equity issues.

CMS Releases Home Health Prospective Payment Systems Rate Update Proposed Rule

On June 17, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Medicare Program: Calendar Year 2023 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Program Requirements; etc.” The proposed rule would update Medicare payment policies and rates for home health agencies (HHAs). A CMS fact sheet says the rule would update home health payment and home infusion therapy rates for Fiscal Year 2023. In addition, the rule would end the suspension of non-Medicare and non-Medicaid data for HHA patients and expand the baseline years in the Expanded Home Health Value-Based Purchasing (HHVBP) Model.

Public comments will be accepted until Aug. 16, 2022.

CMS Publishes Proposed Rule on Funding Methodology and Changes to Basic Health Program Regulations

On May 25, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule titled “Basic Health Program; Federal Funding Methodology for Program Year 2023 and Proposed Changes to Basic Health Program Regulations.” The proposed rule includes information on how federal payment amounts for states establishing a Basic Health Program under the Affordable Care Act will be determined in program year 2023.

Public comments will be accepted until June 24, 2022.

FDA Announces Request for Public Comments for Adding Maximum Daily Exposure Information to Inactive Ingredient Database

On March 22, the Food and Drug Administration (FDA) issued a notice titled “Prioritizing the Addition of Maximum Daily Exposure Information and Removing Dosage Form Information From the Inactive Ingredient Database” to establish a public docket and request public comment. The public comments will help the FDA determine how to best prioritize maximum daily exposure (MDE) information for inactive ingredients that are not currently included in the Centers for Drug Evaluation and Research’s Inactive Ingredient Database, as well as if the database should be restructured by removing dosage form information.

Public comments will be accepted until June 21, 2022.

Final Rules

HHS Issues Final Rule Withdrawing SUNSET Rule

On May 27, the Department of Health and Human Services (HHS) published a final rule to withdraw the “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET)” Final Rule of 2021. The SUNSET rule was originally set to go into effect on March 22, 2021, but was delayed until Sept. 22, 2022, following a lawsuit. The SUNSET rule would have required HHS to review every rule to determine if it was still applicable after 10 years, and any rules not reviewed within that time frame would be automatically eliminated. In its withdrawal of the SUNSET rule, HHS stated that the rule faced significant opposition from stakeholders and would not expedite rulemaking.

The rule is effective immediately.

CMS Releases Notice of Benefit and Parameters for 2023 Final Rule

On April 28, the Centers for Medicare and Medicaid Services (CMS) announced the 2023 Notice of Benefit and Payment Parameters Final Rule, which aims to strengthen plan coverage offered on the federal Marketplace. The final rule will require healthcare.gov plans to offer a standardized version of each product an issuer sells in each metal tier for plan year 2023. The final rule also finalizes exchange user fees, updates quality improvement standards related to health equity and reduces the number of verification requirements for special enrollment periods. The regulations will go into effect on July 1, 2022.

A CMS fact sheet on the final rule can be found here.

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 that would 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.

Courts

Supreme Court Overturns Roe v. Wade

On June 24, the Supreme Court ruled 6-3 to overturn Roe v. Wade, eliminating the constitutional right to abortion that had been in place since 1973. As a result, almost half of the states are expected to severely limit or ban abortion altogether. In the majority opinion, Justice Alito stated that neither the Due Process Clause of the Fourteenth Amendment nor any other part of the Constitution protects the right to abortion. The decision is expected to have considerable ramifications for healthcare in the U.S.

Supreme Court Rules in Favor of HHS in Case of Becerra v. Empire Health Foundation

On June 24, the Supreme Court ruled 5-4 in favor of the Department of Health and Human Services (HHS) in the case of Becerra v. Empire Health Foundation, a case that questioned if HHS correctly interpreted a formula that determines disproportionate share hospital (DSH) payments that supplement hospitals that serve low-income patients.

Medicare statute dictates that HHS calculate DSH payments with a formula based on two percentages, the Medicare fraction and the Medicaid fraction, which are added together. In the 2005 rule, HHS changed the Medicare fraction calculation by counting patients as “entitled” to Medicare Part A benefits if they are “eligible” for them. Empire Health Foundation challenged the rule, arguing that the interpretation of Medicare statute led to lower payments to hospitals than they deserve. In its decision, the Supreme Court asserted that HHS’s understanding of the formula was correct and was consistent with the DSH provisions of the Medicare Act.

Reports

GAO Report on Agency Use of Regulatory Flexibilities During the COVID-19 Pandemic

On June 23, the Government Accountability Office (GAO) published a report titled “COVID-19: Agencies Increased Use of Some Regulatory Flexibilities and Are Taking Steps to Assess Them.” The report found that 23 of the 24 major agencies surveyed reported implementing regulatory flexibilities because of the COVID-19 pandemic. Of the 24 agencies, 15 reported having completed an assessment of at least one regulatory flexibility to understand successes or challenges, and 10 agencies reported having used at least one such assessment to inform decision-making.

GAO Report on Need for a Public Health Situational Awareness Network

On June 23, the Government Accountability Office (GAO) published a report titled “COVID-19: Pandemic Lessons Highlight Need for Public Health Situational Awareness Network.” The report states that federal laws required the Department of Health and Human Services (HHS) to develop an electronic network to improve public health situational awareness during a public health emergency in 2006, but this network is still not operational. The GAO recommended that HHS prioritize developing this network.

CBO Publishes Cost Estimate of Eight Executive Actions

On June 22, the Congressional Budget Office (CBO) published a report with information on the cost of eight executive actions taken by the Biden administration. The report is in response to a request made by Rep. Jason Smith (R-MO-08).

CBO Releases Cost Estimate for the Restoring Hope for Mental Health and Well-Being Act of 2022

On June 21, the Congressional Budget Office (CBO) released a cost estimate for the Restoring Hope for Mental Health and Well-Being Act of 2022. CBO estimates that implementing the bill would reduce the deficit by $200 million from 2022 to 2032.