Washington Healthcare Update

March 25, 2024

This Week in Washington: Congress passes remaining appropriations bills; House Energy and Commerce Committee marks up 17 healthcare bills; CMS announces coverage for some Wegovy prescriptions.

Congress

House

Senate

Administration

Proposed Rules

Final Rules

Reports

Note

House

Congress Passes Remaining Appropriations Bills

On March 22, Congress passed a $1.2 trillion funding package that included the Defense, Financial Services, Homeland Security, Labor-HHS-Education, Legislative Branch and State-Foreign Operations appropriations bills.

The Department of Health and Human Services will receive $117 billion, a $955 million dollar increase compared to last year. $48.6 billion will go towards the National Institutes of Health to improve Alzheimer’s, cancer, mental health and diabetes research. The funds will:

  • Support the 9-8-8 Suicide and Crisis Lifeline Program;
  • Bolster Organ Procurement and Transplantation Network Modernization Initiative reforms;
  • Strengthen Health Resources and Services Administration telehealth efforts;
  • Expand rural health grants; and
  • Increase efforts to counter the flow of illicit fentanyl.

Funding for the Advanced Research Projects Agency for Health and tuberculosis activities will remain flat and funding for family planning, global health and COVID-19 programs will be cut. The agreement includes a legacy ban on using federal funds to match patients to their health records with a unique ID and a requirement for HHS to report on COVID-19 countermeasure claims that have not been resolved in the vaccine injury compensation program.

Not included in the appropriations package were proposals addressing pharmacy benefit managers, healthcare transparency and community health center funding increases.

House Energy and Commerce Committee Marks Up 17 Healthcare Bills

On March 20, the House Energy and Commerce Committee marked up and reported out of committee 17 healthcare bills concerning emergency medical services, Alzheimer’s caregiver and patient support, poison control centers, cancer screening programs and lifespan respite care.

The bills were:

H.R. 619, NAPA Reauthorization Act: Reauthorizes the National Alzheimer’s Project through 2035, updates the project’s purpose and expands the membership and reporting requirements of the Advisory Council on Alzheimer’s Research, Care and Services.

H.R. 620, Alzheimer’s Accountability and Investment Act: Requires the National Institutes of Health (NIH) to continue to submit an annual budget estimate to Congress to achieve the initiatives and goals included in the National Plan to Address Alzheimer’s Disease.

H.R. 7218, Building Our Largest Dementia (BOLD) Infrastructure for Alzheimer’s Act of 2024: Reauthorizes programs focused on improving Alzheimer’s disease and other related dementia education, early detection, diagnosis, patient and caregiver support, risk reduction and other activities at currently appropriated levels for fiscal years 2025 through 2029.

H.R. 4581, Maternal and Child Health Stillbirth Prevention Act of 2024: Clarifies that evidence-based activities and research focused on reducing the incidence of stillbirth are permissible uses of the Maternal and Child Health Services Block Grant.

H.R. 2706, Charlotte Woodward Organ Transplant Discrimination Prevention Act: Prohibits healthcare providers from denying or restricting an individual’s access to organ transplants solely on the basis of the individual’s disability, except in limited circumstances.

H.R. 4646, SIREN Reauthorization Act: Reauthorizes and modifies the Rural Emergency Medical Services Training and Equipment Assistance Program for fiscal years 2024 through 2028.

H.R. 6160, To amend the Public Health Service Act to reauthorize a lifespan respite care program: Reauthorizes the Lifespan Respite Care Program through fiscal year 2028. The Lifespan Respite Care Program empowers coordinated state systems to provide accessible, community-based respite care services for family caregivers of children and adults.

H.R. 6960, Emergency Medical Services for Children Reauthorization Act of 2024: Reauthorizes the Emergency Medical Services for Children Program for fiscal years 2024 through 2029.

H.R. 7153, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act: Reauthorizes the Dr. Lorna Breen Health Care Provider Protection Act which works to prevent suicide and burnout, as well as address mental and behavioral health conditions among healthcare professionals. The legislation would direct the HHS Secretary to prioritize the allocation of resources for healthcare professional mental health and substance use disorder services.

H.R. 7251, Poison Control Centers Reauthorization Act of 2024: Reauthorizes certain poison control programs including the maintenance of the national toll-free phone number, the promotion of poison control center utilization and the maintenance of a program that awards grants to accredited poison control centers.

H.R. 7224, To amend the Public Health Service Act to reauthorize the Stop, Observe, Ask and Respond to Health and Wellness Training Program: Reauthorizes the Stop, Observe, and Respond to Health and Wellness Training Program through fiscal year 2029. The program trains healthcare and social service providers to identify potential human trafficking victims and work with law enforcement as well as address other issues related to human trafficking.

H.R. 7208, Dennis John Beningo Traumatic Brain Injury Program Reauthorization Act: Reauthorizes certain Traumatic Brain Injury (TBI) programs aimed at improving TBI prevention, patient advocacy systems and access to TBI rehabilitation.

H.R. 6829, Cardiomyopathy Health Education, Awareness, and Research, and AED Training in the Schools (HEARTS) Act of 2024: Directs HHS to develop and distribute educational materials regarding cardiomyopathy, automated external defibrillators and cardiopulmonary resuscitation to school administrators, educators, health professionals and families. It would also direct the Centers for Disease Control and Prevention to report on its national cardiomyopathy surveillance and research activities to Congress.

H.R. 7189, Congenital Heart Futures Reauthorization Act of 2024: Reauthorizes a national congenital heart disease research, surveillance and awareness program through fiscal year 2029.

H.R. 7406, DeOndra Dixon INCLUDE Project Act of 2024: Authorizes the NIH Investigation of Co-occurring Conditions across the Lifespan to Understand Down Syndrome Project and requires the NIH to report to Congress on the program’s progress and related research.

H.R. 3916, SCREENS for Cancer Act of 2024: Reauthorizes the National Breast and Cervical Cancer Early Detection Program through fiscal year 2028 and modifies and updates program reporting requirements.

H.R. 5074, Kidney PATIENT Act: Delays the implementation of the inclusion of oral-only End Stage Renal Disease (ESRD) drugs in the Medicare ESRD Prospective Payment System.

In addition, the committee marked up 11 bills concerning energy, infrastructure and communication technologies.

For more information, click here.

House Veterans’ Affairs Committee Subcommittee on Health Holds Hearing on Pending Healthcare Legislation

On March 21, the House Committee on Veterans’ Affairs held a legislative hearing to discuss pending healthcare bills. One of the bills concerns the inclusion of psychiatric drugs in the Department of Veterans Affairs drug formulary.

The bills were:

H.R. 3584, Veterans CARE Act: Directs the Secretary of Veterans Affairs (VA Secretary) to conduct and support research on the efficacy and safety of medicinal cannabis.

H.R. 3644, ACT for Veterans Act: Extends the authorization period for emergency treatment in non-Department of Veterans Affairs medical facilities under the Veterans Community Care Program.

H.R. 3649, Veterans National Traumatic Brain Injury Treatment Act: Directs the VA Secretary to establish a pilot program to furnish hyperbaric oxygen therapy to a veteran who has a traumatic brain injury or post-traumatic stress disorder.

H.R. 4424, Vietnam Veterans Liver Fluke Cancer Study Act: Directs the VA Secretary to study and report on the prevalence of cholangiocarcinoma in veterans who served in the Vietnam theater of operations during the Vietnam era.

H.R. 5530, VA Emergency Transportation Access Act: Prohibits the VA Secretary from making changes to the Department of Veterans Affairs rate of payment or reimbursement provided for transportation of veterans and other eligible individuals on special modes of transportation.

H.R. 6324, Fiscal Year 2024 Veterans Affairs Major Medical Facility Authorization Act: Authorizes major medical facility projects for the Department of Veterans Affairs for fiscal year 2024.

H.R. 6373, Veterans STAND Act: Directs the VA Secretary to offer annual preventative health evaluations to veterans with a spinal cord injury or disorder and increase access to assistive technologies.

H.R. 7347, To amend title 38, United States Code, to direct the Secretary of Veterans Affairs to report on whether the Secretary will include certain psychedelic drugs in the formulary of the Department of Veterans Affairs: Directs the VA Secretary to report on whether the Secretary will include certain psychedelic drugs in the formulary of the Department of Veterans Affairs.

H.R. 3225, BUILD for Veterans Act of 2023: Improves the management and performance of the capital asset programs of the Department of Veterans Affairs.

H.R. 5794, Veterans Affairs Peer Review Neutrality Act of 2023: Eliminates conflicts of interest in conduct of quality management and administrative investigations by the Veterans Health Administration.

H.R. 5247, Expedited Hiring for VA Trained Psychiatrists Act of 2023: Improves the authority of the VA Secretary to hire psychiatrists.

H.R. 3303, Maternal Health for Veterans Act: Supports programs of the Department of Veterans Affairs relating to the coordination of maternity healthcare.

For more information, click here.

House Passes Bill to Extend CBO Cost Estimate Period for Preventive Healthcare Legislation

On March 19, the House passed H.R. 766, the Dr. Michael C. Burgess Preventive Health Savings Act. The legislation would require the Congressional Budget Office (CBO) to calculate the budgetary effects for 30 years for healthcare policies related to preventive care. The CBO currently limits its cost estimates to a single 10-year period. The reason for this move is that the CBO often scores preventive health policies as costing funds, which makes passage difficult because the provisions usually need to be paid for meaning that other services must be reduced. It is believed that a longer budget window estimate would show that in the out years the policies would save federal funds. It is unclear whether the Senate will take up the legislation.

House Energy and Commerce Committee Chairmen Request GAO Investigation of 9-8-8 Funding

On March 20, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) and two subcommittee chairmen, Brett Guthrie (R-KY) and Morgan Griffith (R-VA), sent a letter to Government Accountability Office (GAO) Comptroller General Gene Dodaro, requesting the GAO investigate funding for the 9-8-8 Suicide and Crisis Lifeline Program.

The chairmen are interested in knowing the extent to which states and grantees have used Substance Abuse and Mental Health Administration COVID-19 supplemental funding for the 9-8-8 program and are looking for information on how remaining funds will be used.

For more information, click here.

House Energy and Commerce Committee Subcommittee on Health Holds Hearing on Regulation of Clinical Tests

On March 21, the House Energy and Commerce Committee Subcommittee on Health held a hearing to discuss diagnostic test regulation and the potential impacts of a proposed Food and Drug Administration rule that would classify in-vitro diagnostic products as devices and subject them to oversight under medical device authorities. Witnesses were:

  • Susan Van Meter, President of the American Clinical Laboratory Association (ACLA)
  • Zach Rothstein, JD, Executive Director of AdvaMedDx
  • Donald S. Karcher, MD, FCAP, President of the College of American Pathologists (CAP)
  • Jeff Allen, PhD, President and CEO of Friends of Cancer Research
  • Dara L. Aisner, MD, PhD, Medical Director at the Colorado Molecular Correlates Laboratory, Professor of Pathology at the University of Colorado and Representative of the Academic Coalition for Effective Laboratory Developed Tests

For more information, click here.

House Ways and Means Committee Holds Hearing on President’s FY2025 Budget Request for HHS

On March 20, the House Committee on Ways and Means held a hearing to discuss the President’s Fiscal Year 2025 Budget Request for the Department of Health and Human Services. The Secretary of the Department of Health and Human Services testified.

For more information, click here.

House Appropriations Committee Holds Hearing on President’s FY2025 Budget Request for HHS

On March 20, the House Appropriations Committee held a hearing to discuss the President’s Fiscal Year 2025 Budget Request for the Department of Health and Human Services. The Secretary of the Department of Health and Human Services testified.

For more information, click here.

House Committee on Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic Holds Hearing on Vaccine Safety Systems

On March 21, the House Committee on Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic held a hearing to discuss federal vaccine injury reporting and compensation systems. Witnesses were:

  • Patrick Whelan, M.D., Ph.D., Associate Clinical Professor of Pediatrics at the UCLA Division of Rheumatology
  • David Gortler, Pharm.D., Senior Research Fellow for Public Health Policy and Regulation at the Heritage Foundation
  • Renée Gentry, Director of the George Washington University Vaccine Injury Litigation Clinic
  • Yvonne “Bonnie” Maldonado, M.D., Chief of the Division of Infectious Diseases at the Stanford University School of Medicine Department of Pediatrics

For more information, click here.

Ninety-Six Representatives Send Letter Concerning Change Healthcare Cyberattack

On March 19, Rep. Miller-Meeks (R-IA) and 95 other representatives sent a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra regarding the Change Healthcare cyberattack.

In the letter, the members state that HHS should:

  • Ensure that timely payments are made to Medicare, Medicaid and Children’s Health Insurance Program providers;
  • Address the inability of patients to receive timely access to medications due to patient identity and eligibility verification disruptions; and
  • Continue its discussions with United Health Group, Change Healthcare and Optum.

For more information, click here.

Thirty-Nine Representatives Send Letter Concerning No Surprises Act Implementation

On March 20, Rep. Wenstrup (R-OH) and 38 other representatives sent a letter to Departments of Health and Human Services, Labor and Treasury Secretaries Xavier Becerra, Julie Su and Janet Yellen, concerning the implementation of the No Surprises Act.

The members are urging the departments to:

  • Enable parties to include or batch all items and services associated with a single patient encounter;
  • Require payors to share additional information with providers, including on whether a claim is eligible for the federal independent dispute process (IDR);
  • Create a process for the government to assist IDR entities to reduce any backlogs in processing disputes; and
  • Require that payors subject to the IDR process register with the departments and provide information concerning the applicability of the IDR process to items or services covered by the plan.

For more information, click here.

Republican Study Committee Releases FY2025 Budget Plan

On March 20, the Republican Study Committee released its fiscal year 2025 Budget Plan. Concerning healthcare reforms, the plan aims to:

  • Repeal the $35 price cap on insulin and the $2000 Inflation Reduction Act out-of-pocket cap;
  • Eliminate Medicare’s authority to negotiate prescription drug costs;
  • Transition the Medicare program to a premium support system;
  • Convert Medicaid, the Affordable Care Act, and the Children’s Health Insurance Program into five block grants and cut funding by $4.5 trillion over the next ten years;
  • Expand Health Savings Accounts and Association Health Plans; and
  • Allow the construction of new Physician Owned Hospitals.

For more information, click here.

Senate

Senate HELP Committee Ranking Member Sends Letter Concerning Change Healthcare Cyberattack

On March 21, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) and Sen. Tuberville (R-AL) sent a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra concerning HHS’ response to the Change Healthcare cyberattack.

The senators are requesting information on the steps HHS has taken to respond to the attack and on how the agency has assisted providers who were unable to process or receive timely payments following the attack.

For more information, click here.

Health Care Cybersecurity Improvement Act of 2024 Introduced

In response to the Change Health cyberattack issues, on March 22, Sen. Warner (D-VA) introduced the Health Care Cybersecurity Improvement Act of 2024. The legislation would modify the Medicare Hospital Accelerated Payment and Medicare Part B Advance Payment programs to allow advance and accelerated payments to be made to healthcare providers in the event of a cyberattack so long as the provider and its vendors meet minimum cybersecurity standards.

For more information, click here.

Senators Send Letter Concerning Essential Health Benefits

On March 19, Sens. Kaine (D-VA), Baldwin (D-WI), Markey (D-MA), Smith (D-MN) and Luján (D-NM) sent a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra and Centers for Medicare and Medicaid Services Administrator Chiquita Brooks-LaSure concerning essential health benefits (EHB) coverage.

The senators are urging HHS to address EHB coverage gaps by initiating rulemaking to update and revise EHBs. They are urging HHS to institute a minimum standard of coverage that applies to every EHB category, establish a permanent structure for regularly reviewing and updating EHBs and expand the scope of services within the current EHB categories.

For more information, click here.

Administration

CMS Announces Coverage for Some Wegovy Prescriptions

On March 21, the Centers for Medicare and Medicaid Services announced that Medicare prescription drug plans can provide coverage for Wegovy, a weight loss drug, for individuals who are prescribed the drug to reduce their risk of heart attacks in addition to their obesity.

This action was viewed as an important step forward in gaining Medicare coverage for obesity drugs.

White House Issues Executive Order Concerning Women’s Health Research and Innovation

On March 18, President Biden signed an executive order (EO) that aims to advance women’s health research and innovation. The EO seeks to:

  • Integrate women’s health across the federal research portfolio;
  • Prioritize investments in women’s health research;
  • Incentivize new research on women’s midlife health; and
  • Help assess unmet needs.

For more information, click here.

CMS Launches ACO Primary Care Flex Model

On March 19, the Centers for Medicare and Medicaid Services (CMS) announced the Accountable Care Organization (ACO) Primary Care Flex Model. The model intends to broaden access to high-quality primary care for underserved Medicare populations and address health disparities. The model will launch on Jan. 1, 2025.

For more information, click here.

FDA Launches Funding Opportunity for Digital Health in Clinical Trials

On March 18, the Food and Drug Administration announced a new funding opportunity for clinical trial digital health tool (DHT) developers. The funding is intended to facilitate DHT innovation to treat disease earlier, improve health outcomes and strengthen remote clinical trial access. Applications are due May 20.

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.

FDA Proposed Rule Establishes Criteria for Drug Products with Demonstrable Compounding Difficulties

On March 20, the Food and Drug Administration released a proposed rule that would establish criteria for the lists of drug products or categories of drug products that present demonstrable difficulties for compounding under the Federal Food, Drug and Cosmetic Act.

The proposed rule would:

  • Create separate lists for 503A and 503B products that present demonstrable difficulties for compounding;
  • Establish six criteria used to determine which list/lists products are placed on; and
  • Add oral solid modified-release drug products that employ coated systems, liposome drug products and drug products produced using hot melt extrusion as categories to the 503A and 503B product lists.

Public comments will be accepted until June 18, 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.

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.

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.

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

CBO Releases Answers to Questions for the Record Following House Energy and Commerce Committee Health Subcommittee Hearing

On March 22, the Congressional Budget Office (CBO) released answers to questions submitted for the record during a House Energy and Commerce Committee Subcommittee on Health hearing held on January 31 concerning federal subsidies for health insurance and policies to reduce the prices paid by commercial insurers.

For more information, click here.

CBO Releases Answers to Questions for the Record Following House Committee on the Budget Hearing

On March 22, the Congressional Budget Office (CBO) released answers to questions submitted for the record during a House Budget Committee hearing held on February 14 concerning the CBO’s analysis of the outlook for the budget and the economy.

For more information, click here.

CBO Releases Preliminary Analysis Timeline for H.R. 1770, Equitable Community Access to Pharmacist Services Act

On March 22, Congressional Budget Office (CBO) Director Phillip L. Swagel announced that the CBO will likely complete a preliminary analysis of H.R. 1770, the Equitable Community Access to Pharmacist Services Act, by June 2024. The legislation would allow pharmacists to bill Medicare directly for providing certain vaccinations and for the evaluation and management of certain conditions, including influenza.

For more information, click here.

CBO Releases Presentation on Impact of Medicare Coverage of Anti-Obesity Drugs on the Federal Budget

On March 20, the Congressional Budget Office (CBO) released a presentation concerning the impact that Medicare coverage of anti-obesity medications (AOMs) would likely have on the federal budget.

The CBO predicts that coverage of AOMs at their current prices would increase the deficit over the next ten years but noted that this could change beyond a ten-year period due to changes in AOM drug prices and their long-term effects on the use of other healthcare products and services. The CBO also noted that it is looking for research on:

  • Factors affecting the use of AOMs including take-up rates and patients’ adherence to drugs on the market; and
  • Expectations about the prices and effectiveness of AOMs that are being developed.

For more information, click here.

CBO Releases Presentation Concerning Work Related to Federal Spending on Healthcare

On March 20, the Congressional Budget Office (CBO) released a presentation on the work it has conducted related to federal spending on healthcare and the recent slowdown of such spending.

Included in the presentation is a call for new research on why federal healthcare subsidies have slowed. The CBO is interested in understanding whether:

  • Affordable Care Act productivity adjustments reduce the quantity of services supplied;
  • The slowdown is explained by “greater use of medication to control cardiovascular risk factors”;
  • The slowdown is explained by a shift toward the diffusion of cost-saving technologies; and
  • Providers feel that they are being judged on quality and total cost of care.

For more information, click here.

CBO Releases Report Concerning Long-Term Budget Outlook

On March 20, the Congressional Budget Office (CBO) released a report concerning the budget outlook from 2024 to 2054. The CBO predicts that by 2054, the deficit will increase to 8.5 percent of gross domestic product (GDP) and that public debt will reach 166 percent of GDP.

In addition, the CBO predicts that outlays will reach 27.3 percent of GDP and that revenues will reach 18.8 percent of GDP.

For more information, click here.

Note

The next Washington Healthcare Update will be published on April 15.

Authors

Stephanie Kennan
Senior Vice President
Federal Public Affairs
Washington, DC
Gina Sherick
Policy Consultant
Federal Public Affairs
Washington, DC