This Week in Washington: President releases FY2025 Budget; House Energy and Commerce Committee Health Subcommittee marks up 19 healthcare bills; Senate Finance and HELP Committee Chairmen send letter concerning preventive care services cost-sharing; CMS issues guidance on Change Health cyberattack and advanced payments.

CONGRESS

HOUSE

• House Energy and Commerce Committee Subcommittee on Health Marks Up 19 Healthcare Bills
• House Ways and Means Committee Holds Hearing Concerning Home Care Access in Rural and Underserved Communities
• Telehealth Modernization Act of 2024 Introduced
• 340B PATIENTS Act Introduced
• Bipartisan Primary and Virtual Care Affordability Act Introduced

SENATE

• Senate Finance and HELP Committee Chairmen Send Letter Concerning Preventive Care Service Cost-Sharing
• Senate HELP Committee Ranking Member Requests Information on Regulation of Clinical Tests
• Senate Finance Committee Holds Hearing on the President’s FY2025 Budget Request for HHS
• Delivering Unified Access to Lifesaving Services (DUALS) Act of 2024 Introduced
• Senate Committee on Homeland Security and Governmental Affairs Passes the Prohibiting Foreign Access to American Genetic Information Act of 2024
• MACPAC Releases March 2024 Report to Congress
• MedPAC Releases March 2024 Report to Congress

ADMINISTRATION

• White House Releases the President’s Budget for Fiscal Year 2025
• HHS Secretary Sends Letter to Healthcare Leaders Concerning Change Healthcare Cyberattack
• CMS Announces Advanced Payments for Providers Impacted by Change Healthcare Cyberattack and Releases Fact Sheets
• FDA Approves Rezdiffra
• FDA Releases Draft Guidance Concerning Nonprescription Drug Annual Reportable Labeling Changes
• FDA Releases Draft Guidance Regarding Early Alzheimer’s Disease Drug Development

PROPOSED RULES

• CDC Proposes Rule Amending HHS List of Select Agents and Toxins
• CMS Releases Proposed Rule Concerning Medicare Accrediting Organizations

FINAL RULES

• HHS Final Rule Restores Religious Discrimination Protections in Social Services
• CMS Final Rule to Cut Medicaid Disproportionate Share Hospital Payments
• OCR Releases Final Rule Concerning SUD Patient Record Confidentiality
• SAMHSA Final Rule Seeks to Expand Access to Medications for Opioid Use Disorder
• CMS Final Rule Improves Prior Authorization Process and Access to Health Information
• FDA Final Rule Implements Direct-To-Consumer Prescription Drug Ad Standards
• FDA Issues Final Rule Regarding Mammography Quality Standards

REPORTS

• HHS OIG Releases Medicaid Fraud Control Units FY2023 Annual Report
• CMS Releases Report to Congress on Best Practices in the Money Follows the Person Demonstration
• FDA Releases Paper on Medical Products and AI
• GAO Releases Report Concerning Medicaid Managed Care
• CBO Releases Cost Estimates for Healthcare Bills Favorably Reported by the House Energy and Commerce Committee in December 2023

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House

House Energy and Commerce Committee Subcommittee on Health Marks Up 19 Healthcare Bills

On March 12, the House Energy and Commerce Committee Subcommittee on Health marked up and reported out of committee 19 healthcare bills concerning Alzheimer’s disease, cancer screenings, lifespan respite care, rural emergency services training, pediatric care services, maternal health and mental health and substance use disorder treatment programs.

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. 5012, SHINE for Autumn Act of 2023: Allows the Department of Health and Human Services (HHS) to award grants for data collection and reporting related to still births and requires HHS to issue guidelines and educational materials regarding proper training and processes for the collection of stillbirth data. The bill also requires HHS to establish a perinatal pathology fellowship program within an existing training program.

H.R. 4581, Maternal and Child Health Stillbirth Prevention Act of 2023: 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, Traumatic Brain Injury Program Reauthorization Act of 2024: 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, Research and Training in the Schools (HEARTS) Act of 2023: 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 2023: 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.

H.R. 5526, Seniors’ Access to Critical Medications Act of 2023: Makes permanent a waiver issued by the Centers for Medicare and Medicaid Services which allows Medicare patients to receive medications by mail and allows family members or caregivers to obtain medications on a patient’s behalf.

For more information, click here.

House Ways and Means Committee Holds Hearing Concerning Home Care Access in Rural and Underserved Communities

On March 12, the House Committee on Ways and Means held a hearing to discuss the challenges patients in rural and underserved communities face when accessing home care services. Announced witnesses were:

• Bell Maddux, Home Dialysis Patient and Working Mother
• Roy Underhill, Hospital at Home Patient
• Nathan Starr, Medical Doctor and Lead Hospitalist of the Intermountain Healthcare Castell Home Services Tele-Hospitalist Program
• Chris Altchek, Founder and CEO of Cadence
• Ateev Mehrotra, Professor of Health Care Policy and Medicine at Harvard Medical School and Hospitalist at the Beth Israel Deaconess Medical Center

For more information, click here.

Telehealth Modernization Act of 2024 Introduced

On March 12, Reps. Carter (R-GA), Rochester (D-DE), Steube (R-FL), Sewell (D-AL), Miller-Meeks (R-IA), Van Drew (R-NJ) and Morelle (D-NY) introduced the Telehealth Modernization Act of 2024. The legislation seeks to ensure permanent access to telehealth services for Medicare beneficiaries and extends those flexibilities to federally qualified health centers and rural health clinics.

For more information, click here.

340B PATIENTS Act Introduced

On March 12, Rep. Matsui (D-CA) introduced the 340B Pharmaceutical Access to Invest in Essential, Needed Treatments and Support (340B PATIENTS) Act. The legislation would:

• Clarify that manufacturers are required to offer 340B discount prices to covered entities regardless of the manner or location in which a drug is dispensed, including if a covered entity uses a contract pharmacy to dispense 340B drugs to the entity’s patients;
• Ensure that manufacturers cannot place conditions on the ability of a covered entity to purchase and use 340B drugs, regardless of the manner or location in which the drug is dispensed, including through contract pharmacies; and
• Impose civil monetary penalties on manufacturers that violate these statutory requirements and prohibitions.

For more information, click here.

Bipartisan Primary and Virtual Care Affordability Act Introduced

On March 13, Reps. Schneider (D-IL) and Wenstrup (R-OH) introduced the Bipartisan Primary and Virtual Care Affordability Act. The legislation seeks to enhance the affordability of primary care and telehealth for patients with high-deductible health plans.

For more information, click here.

Senate

Senate Finance and HELP Committee Chairmen Send Letter Concerning Preventive Care Service Cost-Sharing

On March 11, Senate Finance Committee Chairman Ron Wyden (D-OR) and Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sanders (I-VT) sent a letter to Departments of Health and Human Services, Labor and Treasury Secretaries Xavier Becerra, Julie Su and Janet Yellen, concerning health insurers and providers charging individuals cost-sharing for receiving preventive healthcare services.

The chairmen are concerned that insurers inappropriately charge patients for preventive services such as immunizations and HIV and colon cancer screenings. They urged the departments to issue guidance to address inappropriate cost-sharing and to audit Federally Facilitated Marketplace and employer-sponsored health insurers to ensure that preventative services are fully covered.

For more information, click here.

Senate HELP Committee Ranking Member Requests Information on Regulation of Clinical Tests

On March 13, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) announced that he is requesting information from stakeholders concerning how the regulation of clinical tests could be improved.

Specifically, Sen. Cassidy would like to know how the Food and Drug Administration’s regulatory framework for diagnostics and the Clinical Laboratory Improvement Advisory regulatory framework for laboratory-developed tests could be reformed and improved. Responses are due by April 3.

For more information, click here.

Senate Finance Committee Holds Hearing on the President’s FY2025 Budget Request for HHS

On March 14, the Senate Finance Committee held a hearing to discuss President Biden’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.

Delivering Unified Access to Lifesaving Services (DUALS) Act of 2024 Introduced

On March 14, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) and Sens. Carper (D-DE), Cornyn (R-TX), Warner (D-VA), Scott (R-SC) and Menendez (D-NJ) introduced the Delivering Unified Access to Lifesaving Services (DUALS) Act of 2024.

The legislation seeks to improve coverage for individuals enrolled in Medicare and Medicaid, known as dual eligibles. The bill would:

• Require each state to select, develop and implement a comprehensive, integrated health plan for dual-eligible beneficiaries;
• Require plans to develop and update care coordination plans, establish ombudsman offices and provide a care coordinator for each beneficiary;
• Reduce “look-alike” plans that target dual-eligible beneficiaries, create a single appeals process and reduce third-party marketing organization incentives to target beneficiaries;
• Require every state to allow the establishment of the Program of All-Inclusive Care for the Elderly (PACE);
• Allow enrollment in a PACE program at any time in the month; and
• Expand PACE coverage to individuals under the age of 55.

For more information, click here.

Senate Committee on Homeland Security and Governmental Affairs Passes the Prohibiting Foreign Access to American Genetic Information Act of 2024

On March 6, the Senate Committee on Homeland Security and Governmental Affairs marked up and reported out of committee the Prohibiting Foreign Access to American Genetic Information Act of 2024. The legislation, sponsored by committee chairman Gary Peters (D-MI) and Sen. Hagerty (R-TN), would:

• Ban all biotechnology companies that are owned or controlled by a foreign adversary’s government from receiving U.S. taxpayer dollars through federal contracts, grants and loans; and
• Implement a fast-track ban on biotechnology companies with close ties to the Chinese Communist Party including the BGI Group, MGI, Complete Genomics, WuXi AppTec and their subsidiaries.

Similar legislation was introduced in the House by Reps. Gallagher (R-WI) and Krishnamoorthi (D-IL), the Chairman and Ranking Member of the House Select Committee on the Strategic Competition Between the United States and the Chinese Communist Party.

For more information, click here.

MACPAC Releases March 2024 Report to Congress

On March 15, the Medicaid and Children’s Health Insurance Program Payment and Access Commission released its March 2024 Report to Congress. The report’s three chapters focus on:

• Engaging beneficiaries through Medical Care Advisory Committees to inform Medicaid policymaking;
• Denials and appeals in Medicaid Managed Care; and
• Annual Analysis of Medicaid Disproportionate Share Hospital Allotments to States.

For more information, click here.

MedPAC Releases March 2024 Report to Congress

On March 15, the Medicare Payment Advisory Commission (MedPAC) released its March 2024 Report to Congress. The report outlines the recommendations MedPAC is making for updating traditional fee-for-service provider payment rates and for providing additional resources to acute care hospitals and clinicians who serve low-income Medicare beneficiaries.

The reports also contains information on the status of ambulatory surgical centers, the Medicare Advantage program and the Part D prescription drug program.

For more information, click here.

Administration

White House Releases the President’s Budget for Fiscal Year 2025

On March 11, the White House released the President’s Budget for fiscal year (FY) 2025. The President is requesting $130.7 billion for the Department of Health and Human Services, a 1.7 percent increase from FY2023 and $7.2 billion for the Food and Drug Administration, a 7.4 percent increase from FY2023.

Among the health provisions, the President proposes to:

• Permanently extend premium tax credits for health coverage purchased through the Health Insurance Marketplace;
• Allow states to extend existing 12-month continuous eligibility for all children up to three years of age and continuous eligibility for children from birth up to six years of age;
• Expand the number of drugs subject to price negotiation under the Medicare Drug Price Negotiation Program; and
• Extend the $2000 dollar Medicare cap on out-of-pocket prescription drug costs and the $35 dollar cost-sharing cap for insulin to the commercial market.

The budget request also proposes to increase financial incentives to hospitals to defend against cyberattacks, expand coverage of substance use disorder and mental health benefits and ban facility fees for telehealth and certain outpatient services.

For more information, click here.

HHS Secretary Sends Letter to Healthcare Leaders Concerning Change Healthcare Cyberattack

On March 10, Department of Health and Human Services Secretary Xavier Becerra and Department of Labor Acting Secretary Julie Su sent a letter to healthcare leaders outlining the actions the White House is urging UnitedHealth Group and health insurers to take to alleviate ongoing disruptions caused by the Change Healthcare cyberattack.

For more information, click here.

CMS Announces Advanced Payments for Providers Impacted by Change Healthcare Cyberattack and Releases Fact Sheets

On March 9, the Centers for Medicare and Medicaid Services (CMS) released a fact sheet outlining the accelerated and advance payments it made available to Part A and Part B providers and suppliers who are experiencing claims disruptions as a result of the Change Healthcare cyberattack.

In addition, on March 13, CMS released an additional fact sheet answering frequently asked questions (FAQs) it has received concerning the accelerated and advance payments.

For more information on the accelerated and advance payment fact sheet, click here.

For more information on the FAQ fact sheet, click here.

FDA Approves Rezdiffra

On March 14, the Food and Drug Administration approved Rezdiffra (resmetirom), the first treatment for adult patients with noncirrhotic, non-alcoholic steatohepatitis with moderate to advanced liver scarring.

For more information, click here.

FDA Releases Draft Guidance Concerning Nonprescription Drug Annual Reportable Labeling Changes

On March 12, the Food and Drug Administration released draft guidance intended to assist applicants of approved and abbreviated new drug applications for nonprescription drug products, with documenting minor drug product labeling changes in their next annual report.

For more information, click here.

FDA Releases Draft Guidance Regarding Early Alzheimer’s Disease Drug Development

On March 11, the Food and Drug Administration released draft guidance intended to assist drug manufacturers in the clinical development of drugs for the treatment of the stages of sporadic Alzheimer’s disease that occur before the onset of overt dementia.

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.

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

HHS OIG Releases Medicaid Fraud Control Units FY2023 Annual Report

On March 14, the Department of Health and Human Services Office of Inspector General (OIG) released the fiscal year 2023 Medicaid Fraud Control Units annual report. The report outlines analysis the OIG conducted on data submitted by Medicaid Fraud Control Units concerning convictions, civil settlements, judgements and recoveries.

For more information, click here.

CMS Releases Report to Congress on Best Practices in the Money Follows the Person Demonstration

On March 12, the Centers for Medicare and Medicaid Services released a report to Congress concerning best practices in the Money Follows the Person (MFP) Demonstration. The MFP Demonstration seeks to improve access to home and community-based services for Medicaid-eligible individuals who require long-term services and supports.

For more information, click here.

FDA Releases Paper on Medical Products and AI

On March 15, the Food and Drug Administration (FDA) released a paper concerning medical products and artificial intelligence (AI). The paper outlines the four areas that FDA medical product centers are focused on to ensure the responsible and ethical development, deployment, use and maintenance of AI-powered medical products.

For more information, click here.

GAO Releases Report Concerning Medicaid Managed Care

On March 14, the Government Accountability Office (GAO) released a report concerning Medicaid managed care plan denial appeals and grievances data. The GAO was asked to examine appeals and grievances data and the limitations the Centers for Medicare and Medicaid Services (CMS) has encountered in using the data to enhance oversight and transparency of managed care.

The GAO found that CMS does not require states to report on the outcomes of enrollee appeals or the number of denials and that the agency has made limited progress on its plans to analyze the data and make it publicly available.

For more information, click here.

CBO Releases Cost Estimates for Healthcare Bills Favorably Reported by the House Energy and Commerce Committee in December 2023

On March 13, the Congressional Budget Office (CBO) released cost estimates for 21 healthcare-bills concerning pharmacy benefit managers, Medicare prescription drug cost-sharing, telehealth services, Parkinson’s disease and diabetes self-management training, that the House Energy and Commerce Committee reported out of committee in December 2023.

The CBO estimates that ten of the bills would affect direct spending over the 2024-2034 period and that five bills would increase spending subject to appropriation.

For more information, click here.