Washington Healthcare Update

March 4, 2024

This Week in Washington: Congress averts government shutdown; President issues executive order concerning foreign exploitation of health data; Sen. McConnell announces he is stepping down as leader at the end of the term; State of the Union on Thursday.

Congress

House

Senate

Administration

Proposed Rules

Final Rules

Reports

Courts

House

Congress Passes CR and Averts Government Shutdown

On Feb. 29, the House and Senate passed a continuing resolution (CR), averting a partial government shutdown. The CR pushes back the deadlines of the Agriculture-FDA, Commerce-Justice-Science, Energy-Water, Interior-Environment, Military Construction-VA and Transportation-HUD appropriations bills to March 8.

The CR also pushes back the deadlines of the Defense, Financial Services, Legislative Branch, Homeland Security, Labor-HHS-Ed and State-Foreign Operations appropriations bills to March 22. It remains unclear what policy riders, if any, the Agriculture-FDA and HHS funding bills will contain.

On March 3, the legislative text of six funding bills was posted. Among them was funding for the FDA. The language calls for the FDA to reallocate at least $50 million to prioritize cosmetics oversight, alternatives to animal testing and mitigation of product shortages. It is expected that this legislation will be acted on by the House this week.

Skinny Health Package Announced

On March 3, the text of a healthcare spending package was released. It includes a 1.68 percent payment increase to the Medicare Fee Physician Schedule, partially mitigating a 3.4 percent cut that went into effect January 1. The package also includes $4.27 billion for community health centers (CHCs), less than the House passed in the Lower Costs, More Transparency Act but higher than the roughly 4 billion dollar cost of current continuing funding levels. The bill funds CHCs from October 2023 to the end of calendar year 2024. It also makes permanent a state plan amendment option to circumvent the IMD exclusion and permanently requires state Medicaid plans to cover state Medicaid assisted treatment.

Notably, this would establish behavioral health clinic services as an optional Medicaid benefit and requires HHS to issue guidance on how states can improve integrating behavioral health with primary care. In addition, there is increased funding for the Special Diabetes Program and the Special Diabetes Program for Native Americans and an increase in funding for graduate teaching medical programs. Left behind are several health priorities including hospital site-neutral policies, pharmacy benefit manager reforms and full reauthorization of the Pandemic and All Hazards Preparedness Act. However, some of these policies could be addressed later this year.

House Energy and Commerce Committee Subcommittee on Health Holds Hearing on Multiple Rare Disease Proposals

On Feb. 29, the House Energy and Commerce Committee Subcommittee on Health held a hearing to discuss proposals concerning patient access to rare disease treatments and care. The proposals discussed include:

H.R. 1092, Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act: Modifies the new drug approval process by requiring the Food and Drug Administration (FDA) to utilize patient-experience data as part of the benefit-risk assessment framework.

H.R. 3433, Give Kids a Chance Act: Authorizes the FDA to require pediatric cancer trials for new drugs that are used in combination with active ingredients that meet the standard of care for targeting pediatric cancer or have been approved to treat adult cancer and are directed at molecular targets.

H.R. 4758, Accelerating Kids Access to Care Act: Permits enrollment under Medicaid for eligible out-of-state providers by enabling providers to enroll in state Medicaid programs without additional screening requirements.

H.R. 5539, Optimizing Research Progress Hope and New (ORPHAN) Cures Act: Expands and clarifies the exclusion for orphan drugs under the Drug Price Negotiation Program, allowing drugs that treat multiple rare diseases to maintain their orphan drug status and remain exempt from Medicare drug negotiations.

H.R. 5547, Maintaining Investments in New Innovation (MINI) Act: Modifies the criteria for certain single source drugs to qualify for the Drug Price Negotiation Program after being approved for 11 years instead of 7 years.

H.R. 5663, ALS Better Care Act: Expands Medicare coverage to include relevant services for people diagnosed with amyotrophic lateral sclerosis and establishes a supplemental facility-based payment system that would cover outpatient services administered by a qualified provider.

H.R. 6020, Honor Our Living Donors Act: Prevents an organ recipient’s income from being considered when providing reimbursement for qualifying expenses incurred by a living organ donor during the donation process.

H.R. 6094, Providing Realistic Opportunity to Equal and Comparable Treatment (PROTECT) for Rare Act: Expands the definition of medically accepted indications in Medicare Part D and Medicaid to include treatments for rare diseases that are supported in peer-reviewed literature and clinical guidelines and do not otherwise have unfavorable reviews. The legislation also expedites coverage reviews for such treatments by private health insurers.

H.R. 6465, Preserving Life-saving Access to Specialty Medicines in America (PLASMA) Act: Modifies how plasma derived products are treated in relation to the Part D cost-sharing structure by phasing-in the increase in manufacturer rebates over five years under the existing pathway for small biotechnology manufacturers.

H.R. 6664, Innovation in Pediatric Drugs Act: Removes the existing exemption for orphan drugs to be studied in children after approval and authorizes the FDA to penalize companies that have not completed required pediatric studies on time. This legislation also increases funding for the National Institutes of Health Best Pharmaceuticals for Children’s Act program from $25 to $50 million through fiscal year (FY) 2027.

H.R. 6705, Effective Screening and Testing for Tuberculosis Act: Requires the Secretary of the Department of Health and Human Services (HHS) to treat certain tests for tuberculosis as breakthrough devices eligible for expedited development and priority review, and requires certain donor screening or testing to screen or test for active and latent tuberculosis.

H.R. 7188, Shandra Eisenga Human Cell and Tissue Product Safety Act: Requires the Secretary of HHS to conduct a national, evidence-based education campaign to increase public and healthcare provider awareness of the potential risks and benefits of human cell and tissue products transplants. This legislation also establishes civil monetary penalties for any person who violates human cell and tissue product requirements and requires the Secretary to submit a report on how the safety of such products could be improved.

H.R. 7248, FDA Modernization Act 3.0: Establishes a process for the qualification of nonclinical testing methods to replace the use of animals in nonclinical research.

H.R. 7383, Retaining Access and Restoring Exclusivity (RARE) Act: Clarifies the FDA’s interpretation of limiting orphan drug exclusivity to the approved indication rather than the potentially broader designation.

H.R. 7384, Creating Hope Reauthorization Act of 2024: Extends the FDA priority review voucher program from FY 2024 through FY 2028 to incentivize the development of drugs for rare pediatric diseases.

H.R. 7436, Antimicrobial Resistance Research Assessment Act: Requires the Government Accountability Office to report on the efforts of the federal government to address antimicrobial resistance, including the roles of each federal program in these efforts and recommendations to improve coordination.

H.R. , Patient Access Act: Prevents antikickback penalties from being applied to certain travel and lodging arrangements made between a drug manufacturer and an individual who is prescribed such a drug.

H.R. , Sickle Cell Disease Comprehensive Care Act: Allows state Medicaid programs to establish health homes for eligible beneficiaries with sickle cell disease.

For more information, click here.

House to Vote on Healthcare Bills Under Suspension of the Rules

This week, the House is expected to vote on several healthcare bills under suspension of the rules, which prohibits amendments from being introduced, limits floor debate and requires a two-thirds majority vote for legislation to pass. The bills include:

H.R. 498, 9-8-8 Lifeline Cybersecurity Responsibility Act of 2023: Strengthens cybersecurity protections for the 9-8-8 suicide prevention hotline.

H.R. 3838, Preventing Maternal Deaths Reauthorization Act of 2023: Reauthorizes through fiscal year (FY) 2028, federal support for state-based efforts aimed at reducing disparities in maternal health outcomes and improving maternal mortality review committees.

H.R. 3821, Firefighter Cancer Registry Reauthorization Act of 2023: Reauthorizes the National Firefighter Registry for Cancer through FY 2028.

H.R. 3836, Medicaid Primary Care Improvement Act: Clarifies that Medicaid programs are authorized to provide primary care services through direct primary care arrangements.

H.R. 3843, Action for Dental Health Act of 2023: Reauthorizes state grants that support dental health workforce activities in areas that face dental health provider shortages, through FY 2028.

H.R. 3391, Gabriella Miller Kids First Research Act 2.0: Reauthorizes the National Institutes of Health pediatric research initiative through FY 2028 and requires the Department of Health and Human Services to report to Congress about research funded through the initiative.

H.R. 4510, NTIA Reauthorization Act: Reauthorizes the National Telecommunications and Information Administration through FY 2025 and supports the expansion of broadband, which is used extensively in telehealth.

S. 206, END FENTANYL Act: Requires the Commissioner of U.S. Customs and Border Protection to update and review policies and manuals used during inspections at ports of entry to improve the discovery of drug and human smuggling.

Senate

Senate Minority Leader Announces He is Stepping Down as Leader at End of Term

On Feb. 28, Senate Minority Leader Mitch McConnell (R-KY) announced that he will be stepping down from his role as leader of the Senate Republican Conference at the end of this term. McConnell has been leading Senate republicans since 2007.

Sen. Grassley Requests Floor Vote on PBM Bills

Sen. Grassley (R-IA) recently urged Senate Majority Leader Chuck Schumer (D-NY) to schedule floor votes on a series of pharmacy benefit manager (PBM) bills that Senate committees favorably reported last year, after he received an update from the Federal Trade Commission (FTC) considering its ongoing investigation of PBM business practices.

The FTC reported that it has been unable to conclude its ongoing investigation because six major PBMs have failed to submit documents and data concerning their use of drug manufacturer rebates and fees, creation of drug formularies and pharmacy reimbursements. The PBMs include CVS Caremark, Express Scripts, OptumRx, Humana Pharmacy Solutions, Prime Therapeutics and MedImpact Healthcare Systems.

Sen. Duckworth’s Attempt to Seek Unanimous Consent on IVF Bill Fails

On Feb. 28, in response to the Alabama Supreme Court’s ruling concerning in vitro fertilization (IVF), Sen. Duckworth (D-IL) sought to pass by unanimous consent the Access to Family Building Act, a bill she introduced in 2022 which would establish a federal protection for IVF access. However, the bill was blocked by Sen. Hyde-Smith (R-MS).

Administration

White House Issues Executive Order Concerning Foreign Exploitation of Health Data

On Feb. 28, President Biden issued an executive order (EO) concerning the exploitation of U.S. health data. The EO seeks to ensure that grants, contracts and awards issued by the Departments of Health and Human Services, Defense and Veterans Affairs are not used to facilitate access to sensitive health data by countries of concern. The order urges the Departments of Justice and Homeland Security to develop security standards to block certain countries from accessing Americans’ data through commercial means, including via investment, vendor and employment relationships.

For more information, click here.

CDC Loosens COVID-19 Isolation Guidance

On March 1, the Centers for Disease Control and Prevention loosened its COVID-19 isolation guidance, stating that individuals who have been fever free without medication for 24 hours and whose symptoms are improving may return to work or school.

CDC Recommends Additional COVID-19 Vaccine Dose for People 65 and Older

On Feb. 28, the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices voted 11-1 in favor of recommending adults 65 years and older to receive an additional dose of the current COVID-19 vaccine.

For more information, click here.

CMS Releases 2024 Impact Assessment Report

On Feb. 28, the Centers for Medicare and Medicaid Services (CMS) announced the release of the 2024 National Impact Assessment of the CMS Quality Measures Report. The report outlines analyses of the quality measures used in twenty-six CMS quality and value-based incentive payment programs.

For more information, click here.

FDA Announces Vaccines and Related Biological Products Advisory Committee Meeting

On Feb. 27, the Food and Drug Administration announced that the Vaccines and Related Biological Products Advisory Committee will meet on May 16 to discuss and make recommendations on the selection of strains for the 2024-2025 COVID-19 vaccines.

For more information, click here.

FDA Withdraws Accelerated Approval of Pepaxto

On Feb. 23, the Food and Drug Administration (FDA) announced it would withdraw accelerated approval of Pepaxto (melphalan flufenamide), an injectable drug used alongside dexamethasone to treat certain patients with multiple myeloma. The FDA decided to withdraw approval because a post-approval trial did not show Pepaxto to be safe or effective.

For more information, click here.

FDA Issues Warning Over Measuring Blood Sugar with Wearable Devices

On Feb. 21, the Food and Drug Administration issued a warning to consumers, patients, caregivers and healthcare providers, stating that smartwatches and smart rings claiming to measure blood sugar without piercing the skin should not be used to measure glucose levels.

For more information, click here.

FTC Releases Agenda for Healthcare Private Equity Virtual Workshop

On Feb. 28, the Federal Trade Commission (FTC) released the agenda for a virtual workshop it will host on March 5 concerning private equity’s impact on healthcare. The event will feature presentations by FTC, Department of Health and Human Services and Centers for Medicare and Medicaid Services officials.

For more information, click here.

SAMHSA Announces $36.9 Million in Behavioral Health Grant Funding

On Feb. 26, the Substance Abuse and Mental Health Services Administration announced $36.9 million in new grant funding for behavioral health programs. The funding seeks to support programs focused on naloxone training, trauma-informed interventions, substance use disorder education and mental health and substance use prevention services.

For more information, click here.

Proposed Rules

CDC Proposes Rule Amending HHS List of Select Agents and Toxins

On Jan. 30, the Centers for Disease Control and Prevention (CDC) released a proposed rule that amends the Department of Health and Human Services’ list of select agents and toxins that have the potential to pose a severe threat to public health and safety. The proposed rule would:

  • Remove Brucella abortus, Brucella melitensis and Brucella suis from the select agent list;
  • Add definitions and provisions to further clarify inactivation of select agents;
  • Add requirements for reporting discoveries of select agents and toxins;
  • Implement new provisions for facility verification requirements for registered biosafety level 3 and animal biosafety level 3 laboratories; and
  • Update the terminology and clarify the specific clade that is a specific agent by changing “Monkeypox virus” to “Mpox virus (clade I).”

The CDC is requesting comments on the proposed changes and seeks feedback on whether they would create additional burdens for regulated entities.

Public comments will be accepted until April 1, 2024. For more information, click here.

CMS Releases Proposed Rule Concerning Medicare Accrediting Organizations

On Feb. 8, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule concerning the oversight of Medicare accrediting organizations (AOs). The proposed rule seeks to strengthen oversight of AOs, reduce conflicts of interest and promote consistency in survey processes. It would:

  • Apply state survey agency (SSA) accountability standards to AOs;
  • Address conflicts of interest and place certain limitations on the fee-based consulting services AOs provide to healthcare facilities they accredit;
  • Prohibit AO owners, surveyors, employees and their immediate families from having an interest in or relationship with a healthcare facility they accredit or from accessing or having input in survey results;
  • Require AOs to report specific information to CMS about how they will monitor, prevent and handle conflicts of interest;
  • Require AOs with poor performance to submit a publicly reported correction plan; and
  • Align AO survey activity requirements and staff training with those of SSAs.

CMS is seeking comments from stakeholders and AOs on how to refine and revise AO oversight standards and processes and is requesting information on the timeframes and expectations for the submission of AO applications.

Public comments will be accepted until April 15, 2024. For more information, click here.

IHS Proposed Rule Removes Outdated Regulations

On Jan. 8, the Indian Health Service (IHS) released a proposed rule that aims to remove outdated regulations in the Code of Federal Regulations that do not align with current statutory text of the Hyde Amendment. The proposed rule intends to eliminate confusion regarding the legal effect of outdated regulations and seeks to align IHS guidelines with congressional guidelines governing the Department of Health and Human Services.

Public comments will be accepted until March 8, 2024. For more information, click here.

Final Rules

HHS Final Rule Restores Religious Discrimination Protections in Social Services

On March 1, the Department of Health and Human Services (HHS) released a final rule that will restore religious discrimination protections for beneficiaries of federally funded social services and clarify the rights and obligations of organizations providing such services. The final rule will:

  • Require federal grantees that administer social service programs in the United States, such as job training, academic enrichment opportunities and housing services, to notify beneficiaries of their right to be free from discrimination on the basis of religion;
  • Make clear that all covered social service programs may not discriminate against beneficiaries on the basis of religion; and
  • Encourage government agencies that fund domestic programs to help beneficiaries identify alternative federally funded service providers in their area.

In addition to HHS, the Departments of Agriculture, Education, Homeland Security, Housing and Urban Development, Justice, Labor, Veterans Affairs and the U.S. Agency for International Development issued the rule.

The final rule will go into effect on April 3, 2024. For more information, click here.

CMS Final Rule to Cut Medicaid Disproportionate Share Hospital Payments

On Feb. 24, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will implement changes made to Social Security Act provisions governing Medicaid Disproportionate Share Hospital (DSH) payments by the Consolidated Appropriations Act of 2021 (CAA 2021).

CAA 2021 made several changes concerning Medicaid DSH payments. It notably modified the calculation of the Medicaid portion of the hospital-specific DSH limit to only include costs and payments for services furnished to beneficiaries for whom Medicaid is the primary payer for such services.

This final rule will:

  • Cut DSH payments by $8 billion annually from fiscal years 2024 to 2027;
  • Implement CAA 2021 changes to Medicaid DSH payments and clarify the timing and availability of data, methodology and technical requirements;
  • Revise regulatory payment and financing definitions in addition to other regulatory language that could be subject to misinterpretation;
  • Refine administrative procedures used by states to comply with federal regulations; and
  • Remove regulatory requirements that have been difficult to administer.

The final rule will go into effect on April 23, 2024. For more information, click here.

FDA Releases Final Rule Regarding Biologics License Applications and Master Files

On Feb. 9, the Food and Drug Administration released a final rule regarding biologics license applications and the use of master files by applications licensed under the Public Health Services Act (PHS Act). The final rule will:

  • Clarify that formerly approved applications for biologics products that have been deemed licenses for the biological products under the PHS Act can continue to incorporate by reference DS/DSI/DP information contained in a drug master file, if the information was referenced at the time the application was deemed to be a license;
  • Amend regulations concerning the referencing of information contained in master files by biologics license applications;
  • Clarify that investigational new drug applications for products that would be subject to licensure under the PHS Act may incorporate by reference any information in a master file; and
  • Amend regulations to address the use of master files for the constituent parts of combination products licensed under the PHS Act.

The final rule will go into effect on March 13, 2024. For more information, click here.

HHS Office of the Secretary Final Rule Establishes Health Resources Priorities and Allocation System

On Feb. 9, the Department of Health and Human Services (HHS) Office of the Secretary released a final rule that establishes the Health Resources Priorities and Allocations System (HRPAS). HRPAS covers health resources pursuant to the authority under section 101(a) of the Defense Production Act of 1950. The final rule will:

  • Establish standards and procedures by which HHS may require acceptance and priority performance of certain contracts or orders to promote national defense over other contracts with respect to health resources; and
  • Set new standards by which HHS may allocate services, materials and facilities to promote the national defense.

The final rule will go into effect on March 11, 2024. For more information, click here.

OCR Releases Final Rule Concerning SUD Patient Record Confidentiality

On Feb. 8, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released a final rule concerning the confidentiality of substance use disorder (SUD) patient records, that seeks to increase coordination among providers treating SUD patients and strengthen confidentiality protections. The final rule will:

  • Permit the use and disclosure of Part 2 records based on a single patient consent given once for all future uses, including disclosures of treatment, payment and healthcare operations;
  • Permit redisclosure of Part 2 records by Health Insurance Portability and Accountability Act covered entities and business associates;
  • Grant patients under Part 2, the right to obtain an accounting of disclosures and the right to request restrictions on disclosures;
  • Expand prohibitions on the use and disclosure of Part 2 records in civil, criminal, administrative and legislative proceedings; and
  • Grant HHS enforcement authority to impose potential civil money penalties for Part 2 violations.

In addition to the OCR, the Substance Abuse and Mental Health Services Administration is proposing the rule. Covered entities must comply with the rule by Feb. 16, 2026.

The final rule will go into effect on April 16, 2024. For more information, click here.

ACL Final Rule Updates Regulations for Implementing OAA Programs

On Feb. 6, the Administration for Community Living (ACL) released a final rule that would update regulations for implementing Older American Act (OAA) programs that provide seniors with services including meals, job training, homemaker services, transportation services, adult day care services, nutrition assistance, caregiver support and more. The final rule will:

  • Clarify requirements for state and area plans on aging and detail requirements for coordination among tribal, state and local programs;
  • Improve consistency of definitions and operations between state and tribal programs;
  • Specify fiscal requirements, who is eligible to receive services and how funds can be used;
  • Clarify required state and local agency policies and procedures and establish expectations regarding conflicts of interest;
  • Require state agencies to streamline processes for area agencies on aging to receive approval and establish contracts and commercial relationships;
  • Provide guidance on the National Family Caregiver Support Program and the Native American Caregiver Support Program;
  • Update definitions, modernize requirements and clarify flexibilities within OAA nutrition programs; and
  • Clarify the role of aging networks in promoting alternatives to guardianship.

Regulated entities will have until Oct. 1, 2025, to fully comply with the final rule.

The final rule will go into effect on March 15, 2024. For more information, click here.

SAMHSA Final Rule Seeks to Expand Access to Medications for Opioid Use Disorder

On Jan. 31, the Substance Abuse and Mental Health Services Administration released a final rule that updates regulations concerning opioid treatments programs (OTPs) and seeks to expand access to medications for opioid use disorder. The final rule will:

  • Make COVID-19 flexibilities that expanded eligibility for patients to obtain take-home methadone doses permanent;
  • Allow new patients who will be treated by an OTP with methadone to be evaluated via audio-visual telehealth platforms;
  • Allow new patients who will be treated by an OTP with buprenorphine to be evaluated via audio-only telehealth platforms;
  • Allow nurse practitioners and physician assistants to order medications in OTPs;
  • Eliminate the requirement that patients demonstrate a full year of addiction before being eligible for treatment;
  • Expand access to interim treatment and allow patients to initiate medication treatment while awaiting further services; and
  • Promote patient-centered models of care.

In addition, the rule removes outdated language among regulations and implements new definitions reflecting current medical usage.

The final rule will go into effect on April 2, 2024. For more information, click here.

CMS Final Rule Improves Prior Authorization Process and Access to Health Information

On Jan. 17, the Centers for Medicare and Medicaid Services released a final rule that seeks to expand access to health information and improve the prior authorization process. The final rule will:

  • Require Medicare Advantage organizations, Medicaid and Children’s Health Insurance Program fee-for-service programs and managed care plan entities to send prior authorization decisions within 72 hours for expedited requests and seven calendar days for standard requests for medical items and services;
  • Require impacted payers to include a specific reason for denying a prior authorization request, publicly report prior authorization metrics and implement a Health Level 7 Fast Healthcare Interoperability Resources Prior Authorization application programming interface (API);
  • Require impacted payers to include information about prior authorizations in their current Patient Access API and implement a Provider Access API to retrieve patient claims, encounter, clinical and prior authorization data;
  • Add a new Electronic Prior Authorization measure for eligible clinicians under the Merit-based Incentive Payment System Promoting Interoperability performance category; and
  • Require hospitals and critical access hospitals in the Medicare Promoting Interoperability Program to report their use of payers’ Prior Authorization APIs to submit an electronic prior authorization request.

The final rule will go into effect on April 8, 2024. For more information, click here.

OCR Final Rule Strengthens Conscience Protections

On Jan. 9, the Department of Health and Human Services Office for Civil Rights (OCR) released a final rule that seeks to strengthen the process for enforcing federal conscience laws and provide new protections against conscience and religious discrimination. The final rule will:

  • Partially rescind a May 2019 conscience final rule that was deemed unlawful by three federal district courts. The rule strengthened the rights of healthcare workers to refuse to provide services such as abortions and gender-affirming care based on moral and religious beliefs;
  • Restore OCR’s role in overseeing the enforcement process for federal healthcare conscience protection statutes;
  • Strengthen protections against discrimination on the basis of conscience;
  • Encourage entities to post a notice of rights to inform providers and patients of their rights under federal healthcare conscience protection statutes; and
  • Implement a severability provision to preserve portions of the rule if part of the rule is deemed unlawful.

In addition, the final rule states that OCR investigations will be prompt and clarifies that certain conscience statutes apply to more than just providers.

The final rule will go into effect on March 11, 2024. For more information, click here.

FDA Final Rule Implements Direct-To-Consumer Prescription Drug Ad Standards

On Nov. 21, the Food and Drug Administration (FDA) released a final rule that implements new standards for direct-to-consumer (DTC) television and radio prescription drug advertisements. The final rule will require advertisers to:

  • Present information using language that is clear and readily understandable by consumers;
  • Place textual information against a contrasting background for a sufficient duration, using a font style and size that is easily legible;
  • Announce prescription drug information in the same volume, articulation and pacing used in the rest of the ad;
  • Certify that no distracting representations including statements, text, images or sounds are used during the ad’s major statement; and
  • Simultaneously present visual and audible information for ads in television format.

The final rule complements a final guidance the FDA issued in June that outlined how advertisers should present quantitative efficacy and risk information in DTC promotional labeling and ads.

The final rule will go into effect on May 20, 2024. The compliance date of the rule is Nov. 20, 2024.

For more information, click here.

FDA Issues Final Rule Regarding Mammography Quality Standards

On March 9, 2023, the Food and Drug Administration (FDA) issued a final rule that updates the regulations implemented by the Mammography Quality Standards Act of 1992. The FDA has decided to update the regulations due to advancements made in mammography technology and information. The final rule will:

  • Improve the delivery of mammography services;
  • Strengthen communication of healthcare information;
  • Require mammography facilities to provide patients with additional health information;
  • Ensure the availability of qualified mammography personnel;
  • Bolster medical outcome audits;
  • Modernize technological aspects of mammography services; and
  • Implement enforcement tools to deal with noncompliant facilities.

The rule will go into effect on Sept. 10, 2024. For more information, click here.

Reports

HHS OIG Releases Report Concerning COVID-19 Effects on Nursing Homes

On Feb 29, the Department of Health and Human Services Office of Inspector General released a report concerning the effects of the COVID-19 pandemic on nursing homes. The report discusses various challenges nursing homes experienced concerning staffing, funding, vaccination rates and testing protocols.

For more information, click here.

GAO Releases Report Concerning Biomedical Research Duplication

On Feb. 29, the Government Accountability Office (GAO) released a report concerning the practices used by the Advanced Research Projects Agency for Health (ARPA-H), the National Institutes of Health, the Biomedical Advanced Research and Development Authority and the Food and Drug Administration, to help avoid unnecessary biomedical research duplication.

After reviewing agency information and documents and interviewing officials, the GAO discovered that the ARPA-H Interagency Advisory Committee charter does not clearly define how participating members agree to share information to avoid ARPA-H unnecessary research duplication. The GAO conducted this study because it was required to issue reports on potential duplication in the Department of Health and Human Services’ biomedical research and development portfolio by a provision in the 2023 Consolidated Appropriations Act.

For more information, click here.

GAO Releases Report Concerning VA Organization of Suicide Prevention Programs

On Feb. 29, the Government Accountability Office (GAO) released a report concerning the organization of the Department of Veterans Affairs (VA) Office of Mental Health and Suicide Prevention (OMHSP). The OMHSP oversees the VA Suicide Prevention Program and the Veterans Crisis Hotline.

In July 2023, the Veterans Health Administration approved a number of changes to the organizational structure of the OMHSP and the placement of suicide prevention programs. This GAO report examines OMHSP’s organizational structure and the benefits and challenges of incorporating VA suicide prevention programs within the office. The GAO conducted this study because a provision in the Commander John Scott Hannon Veterans Mental Health Care Improvement Act of 2019 required it to review the VA’s management of mental health and suicide prevention services.

For more information, click here.

GAO Releases Report Concerning Autism Research and Support Services

On Feb. 28, the Government Accountability Office (GAO) released a report concerning how well the National Institutes of Health (NIH) has coordinated and monitored federal autism activities to prevent duplicative efforts.

After reviewing NIH documentation and gathering information from 19 federal agencies that conduct autism activities, the GAO discovered that processes used by the NIH Office of National Autism Coordination to coordinate activities were not documented and that NIH efforts partially followed interagency coordination leading practices. The GAO conducted this study because it was asked to examine coordination and monitoring of federal autism activities.

For more information, click here.

GAO Releases Report Concerning HHS and CDC Efforts on Maternal Health

On Feb. 21, the Government Accountability Office (GAO) released a report concerning efforts the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) should focus on to improve maternal health outcomes.

After reviewing agency documentation and interviewing officials, the GAO discovered that HHS has not yet stated whether the White House Blueprint for Addressing the Maternal Health Crisis performance measurement strategy follows key practices. It also discovered that the CDC has not yet established quantitative targets for the Perinatal Quality Collaborative program. The GAO conducted this study because a provision in the Coronavirus Aid, Relief and Economic Security Act required it to report on maternal health during the pandemic.

For more information, click here.

Courts

Summary of Supreme Court Cases that will Impact the Healthcare Sector

Below is a summary of ongoing Supreme Court cases that will impact the healthcare sector:

Loper Bright Enterprises v. Raimondo/Relentless, Inc. v. Department of Commerce

This case involves federal oversight of herring fishing, and the Magnuson-Stevens Fishery Conservation and Management Act (MSA) could impact the government’s regulatory power broadly and therefore has significant implications for the health care sector.

The justices are considering whether to overturn the long-held doctrine known as the “Chevron deference” in which the courts have given leeway to federal agencies to interpret laws whether ambiguous or subject to multiple interpretations. If the doctrine were overturned, it is likely that more federal rules will face closer scrutiny from the courts. This would have the effect of limiting authority of regulatory agencies and could wreak havoc in the administration of government insurance programs like Medicare and Medicaid as well as public health programs.

Idaho v. United States; Moyle v. United States

The Emergency Medical Treatment and Labor Act (EMTALA) requires hospitals that accept Medicare funding and have emergency rooms to provide treatment required to stabilize the medical condition of any individual who arrives at a hospital’s emergency department with an “emergency medical condition.” The primary purpose of the law is to ensure that hospitals do not refuse to treat patients with emergencies who do not have the ability to pay for their care.

In 2020, Idaho passed the Defense of Life Act. The legislation made it a crime for any healthcare provider to perform an abortion unless “the physician determines, in his good faith medical judgement and based on the facts known to the physician at the time, that the abortion was necessary to prevent the death of the pregnant woman”. The legislation contained a trigger which specified that it would only go into effect thirty days after the power to regulate any aspect of abortion not protected by federal law was returned to individual states. This happened in June 2022 when the Supreme Court overturned Roe v. Wade and Planned Parenthood v. Casey.

Idaho v. United States and Moyle V. United States present similar issues, but the Idaho case was brought by the Idaho Attorney General and the Moyle case was brought bey the state’s republican-controlled legislature.

The trial court that heard the cases held that EMTALA preempts Idaho’s abortion ban. The court held that federal law requires Idaho hospitals to provide patients who are at risk of “serious impairment to bodily functions,” “serious dysfunction of any bodily organ or part” or other nonfatal consequence defined as medical emergencies by EMTALA. The U.S. Supreme Court granted certiorari in January and the lower court ruling was stayed. Oral arguments are expected in April.

Alliance for Hippocratic Medicine v. FDA

In this case, the Supreme Court will consider whether the Food and Drug Administration (FDA) improperly exercised its regulatory authority when it broadened access to the abortion pill, mifepristone.

The plaintiffs in this case are suing the FDA over regulatory actions it has taken concerning mifepristone access. Mifepristone was first approved by the FDA in 2000 and the agency required the drug to be prescribed in person, over three visits to a doctor. Since 2016, the FDA has expanded access to the drug by allowing patients to obtain mifepristone prescriptions through telemedicine appointments and receive the drug through the mail. It also expanded the timeframe patients could take the pill from seven weeks of pregnancy to ten weeks.

Plaintiffs argue that in expanding access, the FDA failed to follow proper regulatory actions because it did not study the safety of mifepristone under the labeled conditions of use despite being required to do so by the Federal Food, Drug and Cosmetic Act. They also argue that the FDA violated the Pediatric Research and Equity Act because the agency did not require objective clinical investigations or safety assessments on the effect of mifepristone in patients who took the drug past the original seven-week timeframe. In its brief, the government says the FDA has “maintained that scientific judgement across five presidential administrations, while updating the drug’s approved conditions of use based on additional evidence and experience.

The U.S. Supreme Court on Feb. 20 rejected a bid by three states – Idaho, Kansas and Missouri – to intervene in the case. The states intervention motion was tailored to maintain the litigation should the Court find that the conservative physicians lacked standing to sue the FDA over its decisions related to the pill. This decision comes ahead of the March 24 oral arguments before the Court.

This ruling could have implications beyond access to the abortion pill. Court challenges such as these could open the door for others to sue to block approval of existing or new drugs that may be considered controversial. Manufacturers may be reluctant to bring to market new drugs and treatments if they are concerned that a court ruling could block their future use.

In addition, to this case, the generic mifepristone manufacturer GenBioPro is challenging West Virginia’s abortion ban and an ob-gyn is challenging the abortion restrictions in North Carolina which includes that mifepristone be dispensed in person by a physician following a state-mandated counseling session and a 72-hour waiting period. In both cases, plaintiffs argue that the FDA’s authorization and regulation of mifepristone preempt state law banning the use of medication or regulating its use more strictly. These cases have not reached the U.S. Supreme Court yet.

Murthy vs. Missouri

In this case, the Supreme Court will consider whether COVID-19 misinformation is protected speech and decide whether the federal government violated the First Amendment when it urged social media companies to remove posts and delete the accounts of users who posted or shared content containing misinformation concerning COVID-19 origins, mask effectiveness, vaccine safety and shutdown measures.

The plaintiffs in this suit argue that federal officials “coerced, threatened, and pressured” social media companies to censor them and thereby violated their free speech rights. Lawyers representing federal officials argue that the federal government simply requested social media operators to remove the posts and never demanded them to do so.

The decision of this case could have large implications on federal health agencies and officials and their ability to effectively communicate and message public health initiatives. This is particularly true for agencies such as the Centers for Disease Control and Prevention, who are tasked with distributing accurate and reliable information to mitigate the spread of viruses and diseases.

Authors

Stephanie Kennan
Senior Vice President
Federal Public Affairs
Washington, DC
Gabriel Wiedenhoever
Research Associate
Federal Public Affairs
Washington, DC
Gina Sherick
Policy Consultant
Federal Public Affairs
Washington, DC