This week in Washington: President sends budget request to Congress.

Upcoming Hearings/Markups

Congress

House

• House Passes Bill to Extend Medicare Sequester Moratorium
• House Passes Eight Health Care Bills
• House Members Divided on Fentanyl Analogue Scheduling
• Rep. Kevin Brady to Retire

Senate

• Senate Finance Hearing to Consider Nominees for CMS Administrator and HHS Deputy Secretary
• Bipartisan Bill Would Require Cost-Free Breast Cancer Diagnostic Tests
• Senators Ask HHS Secretary Becerra to Enforce Hospital Price Transparency Rule

Administration

• President Biden’s FY 2022 Discretionary Budget Request to Congress
• HHS Secretary Becerra Approves Illinois Waiver for One-Year Postpartum Coverage
• HHS to Roll Back Title X “Gag Rule”
• HHS Secretary Becerra Confirms That Department Will Have Feedback Process on Surprise Billing
• CMS Extends 2022 Deadline for Primary Care First Demonstration
• Consumers First Coalition Recommends CMS Undertake Medicare Reforms
• IRS Suspends Requirement That Taxpayers Repay Advanced Premium Tax Credits
• FDA Details Plan for Remote Facility Inspections
• FDA Abandons Trump-Era Plan to Let Some Devices Skip Pre-market Review Process
• U.S. Trade Representative Tells Pharmaceutical Companies to Increase COVID-19 Vaccine Access in Developing Countries
• CDC’s Advisory Committee on Immunization Practices to Reconvene April 23 to Discuss Johnson & Johnson Vaccine Pause

Proposed Rules

• CMS Issues Proposed Rule on Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities
• CMS Issues Proposed Rule Updating Hospice Payment and Cap Increase
• CMS Issues Proposed Rule on Inpatient Rehabilitation Facility Prospective Payment System

Courts

• Biden Administration Asks the Supreme Court Not to Hear Insurers’ CSR Case
• ACOG, FDA and HHS Ask Court to Pause Mifepristone Lawsuit

Reports

• GAO Report on COVID-19 Vaccine Availability
• GAO Report on the Scheduling of Fentanyl-Related Substances
• Urban Institute Report on Potential Impact of Making ACA Credits Permanent

Upcoming Hearings/Markups

April 20

House Appropriations Committee, Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Hearing: “The Food and Nutrition Service, USDA”
10:00 a.m.
For more information, click here.

Senate Health, Education, Labor, and Pensions Committee Hearing: “COVID-19 Recovery: Supporting Workers and Modernizing the Workforce Through Quality Education, Training, and Employment Opportunities”
10:00 a.m.
For more information, click here.

Senate Appropriations Hearing: “The American Jobs Plan: Infrastructure, Climate Change, and Investing in our Nation’s Future”
10:30 a.m.
For more information, click here.

April 21

Senate Judiciary Committee, Subcommittee on Criminal Justice and Counterterrorism Hearing: “Behavioral Health and Policing: Interactions and Solutions”
10:00 a.m.
For more information, click here.

April 22

Senate Health, Education, Labor and Pensions Committee Hearing: “Protecting U.S. Biomedical Research: Efforts to Prevent Undue Foreign Influence”
10:00 a.m.
For more information, click here.

House

House Passes Bill to Extend Medicare Sequester Moratorium

On April 13, the House of Representatives voted 384-38 to pass a bill that would eliminate the 2 percent cut to all Medicare payments, known as sequestration, until the end of 2021. In addition, the legislation would make several changes to the rural health clinic provisions included in the Consolidated Appropriations Act of 2021. The bill would increase FY 2030 sequester cuts to pay for the change. The bill was passed by the Senate last month, and President Biden is expected to sign it into law.

House Passes Eight Health Care Bills

This week, the House of Representatives passed the following eight bills:

• H.R. 172, the “United States Anti-Doping Agency Reauthorization Act of 2021,” was introduced by Reps. Mike Thompson (D-CA), Bill Johnson (R-OH) and Diana DeGette (D-CO). The bill would extend and increase the authorization level for the U.S. Anti-Doping Agency (USADA) through fiscal year 2030, empower the agency to encourage a positive sporting environment for young athletes by providing educational materials on sportsmanship, character building and healthy performance, and would improve anti-doping efforts in the United States by encouraging federal agencies to coordinate and share information with USADA to prevent the use of performance-enhancing drugs and methods. The bill passed on the House floor by a vote of 381-37.
• S. 578, the “Food Allergy Safety, Treatment, Education, and Research Act of 2021” or the “FASTER Act of 2021,” was introduced by Sen. Tim Scott (R-SC). The bill would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to include sesame as a major allergen. The bill would also require the Department of Health and Human Services (HHS) to report specific recommendations and strategies to reduce risks related to food allergies, including recommendations for the development of a regulatory process to add additional foods or ingredients to the list of major food allergens. The bill passed on the House floor by a vote of 415-11.
• H.R. 189, the “John Lewis NIMHD Research Endowment Revitalization Act,” was introduced by Reps. Nanette Diaz Barragan (D-CA), Earl “Buddy” Carter (R-GA) and Van Taylor (R-TX). The bill authorizes the National Institute on Minority Health and Health Disparities to facilitate research on minority health disparities through research endowments at current or former centers of excellence. The bill passed on the House floor by voice vote.
• H.R. 941, the “Timely ReAuthorization of Necessary Stem-cell Programs Lends Access to Needed Therapies Act of 2021” or the “TRANSPLANT Act of 2021,” was introduced by Reps. Doris Matsui (D-CA), Gus Bilirakis (R-FL) and Chellie Pingree (D-ME). The bill would reauthorize the C.W. Bill Young Cell Transplantation Program and the National Cord Blood Inventory to facilitate lifesaving bone marrow and umbilical cord blood donations to help patients suffering from blood cancers, disorders and diseases. The bill would also require HHS to review the state of science related to adult stem cells and birthing tissues for the purpose of potentially including in the program, and would require the National Institutes of Health, in consultation with other agencies, to further the field of regenerative medicine and commission a report by the Comptroller General on the state of the regenerative medicine workforce. The bill passed on the House floor by a vote of 415-2.
• S. 164, the “Advancing Education on Biosimilars Act of 2021,” was introduced by Sens. Margaret Wood Hassan (D-NH) and Bill Cassidy (R-LA). The legislation would help provide patients and health care providers with greater information about biologics and biosimilars by requiring the Food and Drug Administration (FDA) to establish a public website with educational materials, including what products are interchangeable, as well as how to report any adverse events. The bill would also support the development of continuing education programs for health care providers about biologics. The bill passed on the House floor by a vote of 412-8.
• S. 415, the “Ensuring Innovation Act,” was introduced by Sens. Bill Cassidy (R-LA), Tina Smith (D-MN) and Roger Marshall (R-KS). The legislation clarifies that five-year new chemical entity eligibility is only available for drugs containing no active component that has previously been approved in the United States. This would help reduce drug costs and improve access to more affordable generic drugs by ensuring that market exclusivity, which can delay generic drugs from entering the market, is only made available to truly innovative products. The bill passed on the House floor by voice vote.
• H.R. 1002, the “Debarment Enforcement of Bad Actor Registrants Act of 2021” or the “DEBAR Act of 2021,” was introduced by Rep. Bob Latta (R-OH). The bill would amend the Controlled Substances Act to allow the attorney general to prohibit any registrant from manufacturing, distributing or dispensing a controlled substance or a List I chemical if that registrant meets or has met any of the conditions for suspension or revocation of registration, or has a history of prior suspension or revocations. The bill passed on the House floor by a vote of 411-5.
• H.R. 1899, the “Ensuring Compliance Against Drug Diversion Act,” was introduced by Rep. Morgan Griffith (R-VA). The bill terminates the controlled substance registration of any registrant if the registrant dies, ceases legal existence, discontinues business or professional practice, or surrenders registration. A registrant who ceases legal existence or discontinues business is required to notify the Drug Enforcement Administration (DEA). Registrants must receive written consent from DEA in order to assign or transfer a registration, and they are also required to return certain documentation if a registrant’s work is discontinued. The bill passed on the House floor by a vote of 412-5.

Two of the bills, the Advancing Education on Biosimilars Act and the Ensuring Innovation Act, previously passed the Senate and are on their way to President Biden’s desk.

House Members Divided on Fentanyl Analogue Scheduling

In an April 14 Energy and Commerce Committee Subcommittee on Health hearing, several House Republicans expressed support for legislation that would extend or make permanent the Schedule 1 classification for fentanyl-related substances. On the other hand, some Democrats expressed support for a bill that would use harm-reduction strategies to address the fentanyl crisis.

In 2018, the Trump administration temporarily scheduled fentanyl-related substances as Schedule 1, which means that these substances are classified as illicit drugs with high potential for abuse and no potential medical use. Congress extended this classification in 2020 but it is set to expire on May 6. If the deadline is not extended past May 6, the Drug Enforcement Agency (DEA) will schedule individual fentanyl analogues once they are discovered, as was done prior to the Schedule 1 designation. Stakeholders express concern that allowing the Schedule 1 designation to end would make it more complicated to prosecute individuals for fentanyl distribution.

For more information on the hearing, click here.

Rep. Kevin Brady to Retire

On April 13, Rep. Kevin Brady (R-TX), ranking member and former chair of the House Ways and Means Committee, stated that he would not be running for reelection in 2022. He is currently serving his 13th term.

Senate

Senate Finance Hearing to Consider Nominees for CMS Administrator and HHS Deputy Secretary

On April 15, the Senate Finance Committee held a hearing to consider the nominations of Andrea Joan Palm to be deputy secretary of Health and Human Services (HHS) and Chiquita Brooks-LaSure to be administrator of the Centers for Medicare and Medicaid Services (CMS). Member questions centered on waivers, telehealth, equity, border policy, behavioral health and drug pricing.

Bipartisan Bill Would Require Cost-Free Breast Cancer Diagnostic Tests

On April 13, the Access to Breast Cancer Diagnosis Act of 2021 was reintroduced by Sens. Jeanne Shaheen (D-NH) and Roy Blunt (R-MO). The bill would require group health plans and individual insurers to cover diagnostic breast cancer tests that may be needed following an additional screening. The legislation was previously introduced in the last Congress. Under current law, plans are required to provide breast cancer screenings at no cost. Approximately 10 percent of breast cancer screenings require follow-up testing, which can include mammograms, ultrasounds and MRIs and can cost patients hundreds or thousands of dollars and result in delayed treatment.

Senators Ask HHS Secretary Becerra to Enforce Hospital Price Transparency Rule

On April 13, Senate Energy and Commerce Committee members, including Chair Frank Pallone (D-NJ), ranking member Cathy McMorris Rodgers (R-WA), Health Subcommittee Chairwoman Anna G. Eshoo (D-CA) and Health Subcommittee ranking member Brett Guthrie (R-KY) wrote a letter to Health and Human Services (HHS) asking Secretary Xavier Becerra to ensure that hospitals are complying with the Hospital Price Transparency Rule.

The Hospital Price Transparency Rule, which went into effect Jan. 1, 2021, requires hospitals to make public the list of standard charges for items and services in a consumer-friendly format. The charges that need to be made public include gross charges, discount cash price, payer-specific negotiated charges and de-identified minimum and maximum negotiated charges for all items and services. HHS can issue warnings, request an action plan and issue penalties for hospitals found to be noncompliant with the rule.

Administration

President Biden’s FY 2022 Discretionary Budget Request to Congress

On April 9, President Biden released his discretionary budget request to Congress for fiscal year (FY) 2022, the so-called “skinny budget.” The budget includes additional funds for home- and community-based services (HCBS), addressing the opioid crisis and improving rural health. The budget builds off the priorities stated in the proposed infrastructure plan (the American Jobs Plan), and the final budget that incorporates both proposals will be released later this spring.

Policies that are included in both the FY 2022 discretionary funding request and the American Jobs Plan include funding for HCBS. The FY 2022 funding request would provide an additional $551 million for HCBS, on top of the $400 billion allocated under the American Jobs Plan. The new request would devote $10.7 billion to help states and tribes end the opioid crisis, a $3.9 billion increase from what was enacted in 2021. President Biden also included in his budget preview $1.6 billion for the Community Mental Health Service block grant program and a funding increase for the Health Resources and Services Administration (HRSA) to help rural health care providers. The Biden administration also seeks a $65 million increase in rural broadband funding compared to last year, and $200 million to reduce maternal mortality and morbidity.

There are no drug pricing measures in the discretionary budget outline, but they are expected to appear in President Biden’s budget request later this spring.

The official budget request can be found here.

HHS Secretary Becerra Approves Illinois Waiver for One-Year Postpartum Coverage

On April 12, 2021, the Department of Health and Human Services (HHS) marked Black Maternal Health Week by announcing actions to expand health care coverage and improve maternal health outcomes. HHS Secretary Xavier Becerra announced that he had approved the department’s first 1115 waiver that will allow Illinois to provide full Medicaid benefit coverage for mothers during the first year after delivery. Becerra also announced a Notice of Funding Opportunity (NOFO) to allocate $12 million over four years to the Rural Maternity and Obstetrics Management Strategies (FMOMS) program to expand new mothers’ access to care in rural communities.

HHS to Roll Back Title X “Gag Rule”

On April 14, the Biden administration announced its plans to roll back the Trump administration’s 2019 “gag rule” that prevented Title X grantees from talking about or referring patients for abortion services. The resulting legal battle went to the Supreme Court on Feb. 22, but the American Medical Association, Planned Parenthood and other stakeholders asked the court to dismiss the case since President Biden’s Health and Human Services (HHS) department planned to revoke the rule.

The Biden administration issued a notice of proposed rulemaking to replace the 2019 Title X final rule with a different version of the rule from 2000. In addition, President Biden’s recent budget request would increase the Title X program funding by 18.7 percent.

The Biden administration stated that the 2019 final rule had serious public health consequences and cut the number of Title X grantees by 25 percent, which could have led to more than 180,000 unintended pregnancies.

HHS Secretary Becerra Confirms That Department Will Have Feedback Process on Surprise Billing

On April 15, Health and Human Services (HHS) Secretary Xavier Becerra told members of the House Appropriations Committee that he would seek input from stakeholders before enacting a policy to fix surprise billing, although he did not explicitly commit to using the rulemaking process.

The No Surprises Act, which bars providers from billing patients more than the in-network charges for emergency treatment performed at an out-of-network hospital or by an out-of-network physician, is set to go into effect in 2022. Rep. Andy Harris (R-MD) expressed concern that HHS could issue an interim rule to implement the No Surprises Act without gathering feedback.

CMS Extends 2022 Deadline for Primary Care First Demonstration

On April 12, the Centers for Medicare and Medicaid Services (CMS) announced it will give providers and payers more time to apply to be a part of the second round of the Primary Care First demonstration. Primary Care First was created to encourage primary care providers to take on more financial risk for the outcomes of their patients. The deadline for practice applications has been extended to May 21 and the deadline for payer applications has been extended to June 18. The first group of model participants for Primary Care First started in January.

Consumers First Coalition Recommends CMS Undertake Medicare Reforms

In an April 13 statement, Consumers First, a coalition of beneficiary, union and employer-sponsored insurance advocates, stated that the Biden administration should administratively reform Medicare. The coalition states that the recommended changes would: prevent market consolidation, improve cost transparency, increase site-neutral payments and augment the number of mandatory alternative payment models.

Consumers First issued an agenda for the Department of Health and Human Services (HHS) that details Medicare reforms that the coalition states would improve health care affordability and equity. The proposal also recommends that CMS move away from fee-for-service payment models and expand the number of mandatory Medicare alternative payment models. In addition, Consumers First stated that the administration should create national data and interoperability standards.

IRS Suspends Requirement That Taxpayers Repay Advanced Premium Tax Credits

On April 9, the Internal Revenue Service (IRS) officially suspended a requirement that taxpayers repay the government for excess advanced premium tax credits (APTC) paid under the Affordable Care Act (ACA) for FY 2020. The IRS also stated that anyone who already filed their tax return with payments will be reimbursed and should not file an amended return.

The ACA requires people to estimate their next year’s income to determine eligibility for tax credits and then reconcile the estimate with true income during tax season. However, the pandemic disrupted many consumers’ estimates, especially since Congress did not exempt federal unemployment assistance from income. The passage of the American Rescue Plan Act paused repayments due to excess APTCs for FY 2020 but does not impact people who received fewer APTCs than they were owed or who will get a refund.

FDA Details Plan for Remote Facility Inspections

In an April 14 guidance, the Food and Drug Administration (FDA) released long-awaited guidance detailing the agencies’ plans to carry out remote facility inspections during the COVID-19 pandemic.

In the guidance, the FDA states it can use remote inspections for a number of facility evaluations, including pre-approval and pre-license inspections, post-approval inspections, surveillance inspections, follow-up and compliance inspections, and bioresearch inspections. To be eligible for remote inspections, facilities need to have an acceptable inspection history with no previous data integrity concerns. The guidance also tells facilities how to best prepare for remote inspections.

FDA has restarted its domestic facility inspections, but some pre-approval inspections, especially for generic drugs, cannot be conducted due to travel restrictions.

FDA Abandons Trump-Era Plan to Let Some Devices Skip Pre-market Review Process

On April 15, the Food and Drug Administration (FDA) announced that it is withdrawing the list of 83 Class II devices and one unclassified device type that the Trump administration had proposed to permanently exempt from 510(k) pre-market review. The Jan. 15 Trump-era notice called for a permanent exemption from the 510(k) pathway during the COVID-19 pandemic for a number of devices.

The American Medical Association opposed the permanent exemption and cited potential risks to patients.

U.S. Trade Representative Tells Pharmaceutical Companies to Increase COVID-19 Vaccine Access in Developing Countries

On April 14, U.S. Trade Representative (USTR) Katherine Tai told pharmaceutical companies they must be prepared to make “sacrifices” to ensure that people in developing countries have access to COVID-19 vaccines. Tai’s statement follows a request by India and South Africa that the World Trade Organization (WTO) approve a temporary waiver of intellectual property rights for COVID-19 vaccines and treatments. The U.S. pharmaceutical industry is opposed to the proposed waiver and argues it would undermine incentives for innovation and would not improve shortages. The U.S. and the European Union have opposed the waiver request since it was first raised in October, but the change in administration has raised hopes that President Biden would alter this position.

CDC’s Advisory Committee on Immunization Practices to Reconvene April 23 to Discuss Johnson & Johnson Vaccine Pause

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) met on April 14 to discuss whether it is safe to resume administering the Johnson & Johnson COVID-19 vaccine in the U.S. In that meeting, the ACIP stated more information was needed from the Food and Drug Administration (FDA) and the CDC before any decisions or recommendations could be made. The CDC is accepting public comment on the April 14 meeting until April 19.

On April 13, the FDA and the CDC recommended that the Johnson & Johnson vaccine be suspended in the U.S. following six cases of cerebral venous sinus thrombosis (CVST). All 50 states and several pharmacies immediately suspended the use of the Johnson & Johnson vaccine after the recommendation.

The ACIP will reconvene on April 23 from 11:00 a.m. to 5:00 p.m.

Proposed Rules

CMS Issues Proposed Rule on Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities

On April 8, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule titled “Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year (FY) 2022. In the rule, CMS proposes increasing skilled nursing facilities’ (SNF) pay a net 1.3 percent, or $444 million, in FY 2022, and to add two new quality reporting measures in FY 2021: vaccination rates among health care workers and health care–acquired infections.

The proposed rule also asks for public comments on potential ways to readjust the Patient Driven Payment Model (PDPM), a patient payment classification system created in 2019 to be budget-neutral but that data shows caused an unintended $1.7 billion increase in payments in fiscal 2020. It is possible that the data was affected by the COVID-19 pandemic.

CMS proposes to add a new claims-based measure, Healthcare-Associated Infections (HAI), to the quality reporting, which would use Medicare fee-for-service claims data to estimate the rate of health care–associated infections acquired during nursing home care that result in hospitalization. The goal is to assess which nursing homes have higher rates of infections acquired during care. The proposed rule also suggests several changes to the SNF Quality Reporting Program and seeks feedback on plans to define digital quality measures for the program. The proposed rule would also alter the SNF Value-Based Purchasing Program, which offers incentive payments to nursing homes based on the quality of care.

Public comments on the proposed rule will be accepted until June 7.

The rule can be found here.

CMS Issues Proposed Rule Updating Hospice Payment and Cap Increase

On April 8, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule titled “Medicare Program: FY 2022 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, Hospice and Home Health Quality Reporting Program Requirements.” The proposed rule would increase payments in FY 2022 by 2.3 percent, or $530 million. Providers that do not meet the quality reporting requirements will receive a 2 percentage point reduction to their annual market basket update. The proposed rule also would increase the aggregate payment cap from $30,683.93 in 2021 to $31,389.66 for fiscal year 2022, a 2.3 percent increase.

The proposed rule would also revise the labor shares based on the compensation cost weights for each level of care, with labor share at 74.6 percent for continuous home care, 64.7 percent for routine home care, 60.1 percent for inpatient respite care and 62.8 percent for general inpatient care. In addition, the proposed rule would make the pseudo-patient waiver for hospice aide competency testing permanent and let pseudo-patients be used for hospice aide competency training. It would also have hospices conduct a competency evaluation related to whatever deficiencies and related skills a hospice aide supervisor noted. Also, the rule would allow CMS to modify the Hospice Quality Reporting Program by adding measures meant to promote health equity measures.

Comments are accepted until June 7.

The proposed rule can be found here.

CMS Issues Proposed Rule on Inpatient Rehabilitation Facility Prospective Payment System

On April 7, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule titled “Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2022 and Updates to the IRF Quality Reporting Program.” The proposed rule would update Medicare payment policies and rates for facilities under the Inpatient Rehabilitation Facility (IRF) Prospective Payment System (PPS) and the IRF Quality Reporting Program (QRP) for fiscal year (FY) 2022. CMS is publishing this proposed rule consistent with the legal requirements to update Medicare payment policies for IRFs on an annual basis.

For FY 2022, CMS proposes to update the IRF PPS payment rates by 2.2 percent based on the proposed IRF market basket update of 2.4 percent, less a 0.2 percentage point multi-factor productivity (MFP) adjustment. IRFs that do not meet reporting requirements are subject to a 2 percentage point (2.0 percent) reduction in their annual increase factor. With the objective of advancing racial equity, CMS plans to utilize several social determinants of health measures and is seeking feedback. In addition, the rule proposes using COVID-19 vaccination coverage measures and updating transfer of health (TOH) information to determine quality of care.

Comments are accepted until June 7.

The proposed rule can be found here.

Courts

Find a comprehensive look at “The Courts and Healthcare Policy” here.

Biden Administration Asks the Supreme Court Not to Hear Insurers’ CSR Case

In an April 9 brief, the Biden administration asked the Supreme Court not to take up an insurers’ lawsuit over the Affordable Care Act’s (ACA) cost-sharing reductions (CSR), stating that the federal appeals court had correctly determined that money insurers gained from increasing silver-level premiums can be deducted from the damages owed.

ACOG, FDA and HHS Ask Court to Pause Mifepristone Lawsuit

On April 13, the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS) and the American College of Obstetricians and Gynecologists (ACOG) filed a joint motion with the U.S. Court of Appeals for the 4th Circuit. In the motion, the FDA, HHS and ACOG requested that the court pause ACOG’s lawsuit against the FDA in light of the agency’s recent decision to temporarily lift the in-person prescribing and dispensing requirements for the abortion medication mifepristone. The parties stated that they need additional time to determine how the case should proceed.

On April 12, the FDA recently lifted the restrictions around prescribing mifepristone for the remainder of the COVID-19 public health emergency. However, experts have noted that state-level restrictions in place continue to present barriers to access.

ACOG first went to court in May 2020 in an attempt to lift the requirements and allow the drug to be provided through telehealth. In July 2020, a Maryland federal court ruled in favor of ACOG. This decision was stayed by the Supreme Court in January 2021, pending a decision by the 4th Circuit. The case is now at a crossroads given the FDA’s decision to lift the restrictions.

Reports

GAO Report on COVID-19 Vaccine Availability

On April 14, the Government Accountability Office (GAO) issued a report titled “COVID-19: Efforts to Increase Vaccine Availability and Perspectives on Initial Implementation.”

The report states that the federal government has taken steps to make more COVID-19 vaccine doses available, such as helping vaccine companies expand manufacturing capacity and designating new vaccination sites. The report notes that the government expects to have enough doses available for all adults in the U.S. by the end of May. The report states that state and local health officials reported challenges such as not knowing how many doses they would get or when. GAO’s prior work has found that timely, clear and consistent communication about vaccine availability is essential to ensure public confidence.

The full report can be found here.

GAO Report on the Scheduling of Fentanyl-Related Substances

On April 12, the Government Accountability Office (GAO) issued a report titled “Synthetic Opioids: Considerations for the Class-Wide Scheduling of Fentanyl-Related Substances.” The report notes that substances related to fentanyl were temporarily classified as Schedule 1 substances by the Drug Enforcement Agency (DEA) in 2018, designating them as illicit drugs with high abuse potential and no medical use. The report identified possible tradeoffs for classifying fentanyl analogues after the temporary classification expires on May 6.

The report states that if the temporary scheduling order is allowed to expire, the DEA could individually schedule specific fentanyl substances to prosecute cases. This would require evidence of abuse potential and may not deter the creation of new substances.

If the temporary scheduling order is made permanent through legislative scheduling, the report notes that some substances with potential medical uses could be included in Schedule 1. In addition, this scheduling could reduce incentives to make new fentanyl substances. There is concern that this will result in lengthy criminal sentences that exacerbate racial disparities in sentencing.

Fentanyl-related substances could be legislatively scheduled with modifications to the temporary scheduling order. The report states that these modifications could include removing barriers to research and streamlining the process for removing substances from Schedule 1 if they are found to have no abuse potential.

The full report can be found here.

Urban Institute Report on Potential Impact of Making ACA Credits Permanent

A recent report by the Urban Institute found that the number of uninsured people in the U.S. would fall by 4.2 million and marketplace coverage would increase by 5.1 million in 2022 if Congress made the Affordable Care Act (ACA) tax credits enacted under the American Rescue Plan permanent. The report comes as congressional Democrats and the Biden administration are expected to push for a permanent expansion of the ACA tax credits as part of the upcoming infrastructure package.

The Urban Institute states that increased enrollment due to more generous subsidies would improve the risk pool and reduce premiums by about 15 percent. The Institute predicted that making the tax credits permanent would cause approximately 317,000 people to switch from non-ACA–compliant plans to an ACA product.

The Urban Institute report shows a greater impact than the Congressional Budget Office’s (CBO) assumptions for the provisions. The CBO estimated that the temporary provision would reduce the number of uninsured Americans by 1.3 million and increase marketplace coverage by 1.7 million in 2022. The Urban Institute noted that its own estimates are not directly comparable to the CBO’s because they rely on different assumptions.