Washington Healthcare Update

April 15, 2024

This Week in Washington: Senate HELP Committee Chairman requests comments on Long COVID draft proposal; CMS announces proposed Transforming Episode Accountability Model; CMS releases FY2025 Inpatient and Long-Term Care Hospital Prospective Payment System proposed rule.

Congress

House

Senate

Administration

Proposed Rules

Final Rules

Reports

House

House Energy and Commerce Committee Subcommittee on Health Holds Hearing on Telehealth Service Proposals

On April 10, the House Energy and Commerce Committee Subcommittee on Health held a hearing to discuss proposals concerning telehealth service access, reimbursement and geographic restrictions. The proposals were:

H.R. 134, To amend Title XVIII of the Social Security Act to remove geographic requirements and expand originating sites for telehealth services: Allows any location in the United States, including a beneficiary’s home, to be considered an originating site for the purpose of furnishing telehealth services under Medicare.

H.R. 1110, KEEP Telehealth Options Act of 2023: Requires the Department of Health and Human Services Secretary (HHS Secretary) to publish a report on the provision of telehealth services under Medicare, Medicaid and the Children’s Health Insurance Program (CHIP) during the COVID-19 emergency and requires the Medicare Payment and Medicaid and CHIP Payment Advisory Commissions to study the risk of fraudulent activities related to the expansion of telehealth.

H.R. 3432, Telemental Health Care Access Act of 2023: Eliminates certain geographic restrictions and in-person Medicare coverage requirements to promote access to mental and behavioral telehealth services.

H.R. 3875, Expanded Telehealth Access Act: Permanently expands practitioner eligibility for payment for telehealth services under Medicare to include physical therapists, speech-language pathologists, audiologists and occupational therapists and assistants.

H.R. 4189, CONNECT for Health Act of 2023: Removes the geographic requirements for telehealth originating sites, expands the scope of originating sites, allows more practitioners to furnish telehealth services and removes geographic restrictions on telehealth services furnished by Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs) to improve Medicare reimbursement of telehealth services.

H.R. 5541, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act: Temporarily allows authorized healthcare professionals to provide mental health telehealth services across state lines during a declared national emergency.

H.R. 5611, Helping Ensure Access to Local Telehealth (HEALTH) Act of 2023: Allows Medicare coverage of telehealth services to include audio-only communications, implements a permanent payment system for telehealth services furnished by FQHCs and RHCs and eliminates originating site requirements for telehealth services furnished by them.

H.R. 6033, Supporting Patient Education and Knowledge (SPEAK) Act of 2023: Directs the HHS Secretary to convene a task force to assess barriers and develop recommendations to improve access to health information systems for non-English speakers.

H.R. 7149, Equal Access to Specialty Care Everywhere (EASE) Act of 2024: Requires the Center for Medicare and Medicaid Innovation to conduct a pilot program that would assess the impact of furnishing certain specialty healthcare services through telehealth and other remote technologies.

H.R. 7623, the Telehealth Modernization Act of 2024: Makes certain telehealth flexibilities permanent under Medicare by removing geographic restrictions, expanding eligibility for practitioners, retaining the waiver process for modifying telehealth services covered under Medicare, implementing a permanent payment system for telehealth services furnished by RHCs and FQHCs, allowing clinically appropriate use of telehealth for hospice care and home dialysis and allowing the use of audio-only telecommunications technology.

H.R. 7711, Advancing Access to Telehealth Act: Removes Medicare telehealth geographic restrictions, allows the use of audio-only telecommunications technology and eliminates in-person requirements for certain services furnished through telehealth.

H.R. 7858, Telehealth Enhancement for Mental Health Act of 2024: Directs the HHS Secretary to implement a coding modifier to identify telehealth claims for services that are key components of the care process and furnished by non-physician clinicians or support staff.

H.R. 7856, the PREVENT DIABETES Act: Establishes a diabetes prevention program under Medicare and sunsets the Medicare Diabetes Prevention Program Expanded Model.

H.R. 7863, To require the Secretary of Health and Human Services to issue guidance on furnishing behavioral health services via telehealth to individuals with limited English proficiency under Medicare program: Requires the HHS Secretary to issue guidance for providers on best practices for furnishing behavioral health services via telehealth to Medicare beneficiaries with limited English proficiency.

H.R. , Hospital Inpatient Services Modernization Act: Extends regulatory flexibilities associated with the Hospital at Home programs to allow acute hospitals to provide certain inpatient services outside of the hospital setting.

For more information, click here.

House Republican Appropriators Announce Subcommittee Assignment Changes

On April 11, House Republican appropriators announced new subcommittee chair assignments, a day after the House Republican Conference elected Rep. Cole (R-OK) to become the next chairman of the House Appropriations Committee. They are:

  • Valadao (R-CA) as Legislative Branch Subcommittee Chairman;
  • Womack (R-AR) as Transportation-HUD Subcommittee Chairman; and
  • Joyce (R-OH) as Financial Services Subcommittee Chairman.

In addition, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) announced changes to the committee’s subcommittee assignments. They include:

  • Pence (R-IN) to join the Subcommittee on Environment, Manufacturing and Critical Materials and to leave the Subcommittee on Innovation, Data and Commerce;
  • Weber (R-TX) to serve as Vice Chair of the Subcommittee on Communications and Technology;
  • Allen (R-GA) to join the Subcommittee on Energy, Climate and Grid Security and to leave the Subcommittee on Innovation, Data and Commerce;
  • Balderson (R-OH) to join the Subcommittee on Health and to leave the Subcommittee on Communications and Technology;
  • Miller-Meeks to join the Subcommittee on Communications and Technology;
  • Obernolte (R-CA) to join the Subcommittee on Innovation, Data and Commerce and to leave the Subcommittee on Environment, Manufacturing and Critical Materials; and
  • James (R-MI) to join the Subcommittee on Innovation, Data and Commerce and the Subcommittee on Environment, Manufacturing and Critical Materials.

Senate

Senate HELP Committee Chairman Requests Comments on Long COVID Draft Proposal

On April 9, Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sanders (I-VT) released a draft proposal concerning Long COVID. The draft proposal would:

  • Provide $1 billion in mandatory funding per year for 10 years to the National Institutes of Health (NIH) to respond to and address Long COVID;
  • Create a centralized coordinating entity for Long COVID research activities at the NIH;
  • Require the NIH to establish a new grant process for clinical trials related to Long COVID;
  • Establish an NIH Long COVID research advisory board and Long COVID database; and
  • Require federal entities to provide continued education and support on Long COVID risks.

The chairman is seeking comments on the proposal. Comments are due by April 23, 2024.

For more information, click here.

Senate Finance Committee Chairman Issues Statement on CMS MA and Part D Final Rule

On April 5, Senate Finance Committee Chairman Ron Wyden (D-OR) issued a statement in response to the release of a Centers of Medicare and Medicaid Services final rule concerning Medicare Advantage (MA) and Part D. The rule contains several policy changes recommended by the chairman.

In his statement, the chairman announced that the rule will strengthen protections against deceptive and high-pressure marketing practices for seniors, prohibit middlemen selling of seniors’ personal information, and ensure that MA plans provide access to mental health professionals.

For more information, click here.

Senate Finance Committee Holds Hearing on Medicare Physician Payment

On April 11, the Senate Finance Committee held a hearing to discuss Medicare physician payment and chronic care coverage. This hearing is considered a step towards considering physician payment reform. Witnesses were:

  • Amol Navathe, MD, Ph.D., Professor of Health Policy and Medicine at the University of Pennsylvania
  • Steven P. Furr, MD, FAAFP, President of the American Academy of Family Physicians
  • Patricia L. Turner, MD, MBA, FACS, Executive Director and Chief Executive Officer at the American College of Surgeons
  • Melanie Matthews, Chief Executive Officer of Physicians of Southwest Washington (PSW)

For more information, click here.

Senate Finance Committee Subcommittee on Health Care Holds Hearing on Federal Health Programs’ SUD Care

On April 9, the Senate Finance Committee Subcommittee on Health Care held a hearing to discuss how substance use disorder care in federal health programs can be improved. Witnesses were:

  • Brendan Saloner, Ph.D., Bloomberg Professor of American Health at the Johns Hopkins University Bloomberg School of Public Health
  • Malcolm Horn, Ph.D., LCSW, MAC, SAP, Chief Behavioral Health Officer at Rimrock Foundation
  • Sarah Bagley, MD, MSc, Associate Professor of Medicine and Pediatrics, Associate Program Director, Grayken Fellow in Addiction Medicine at the Boston Medical Center and Boston University Chobanian and Avedisian School of Medicine
  • Paul J. Christine, MD, Ph.D., Assistant Professor of Medicine at the University of Colorado School of Medicine and Denver Health

For more information, click here.

Preserving Emergency Access in Key Sites Act Introduced

On April 10, Sens. Machin (D-WV) and Capito (R-WV) introduced the Preserving Emergency Access in Key Sites (PEAKS) Act. The legislation would:

  • Allow Critical Access Hospitals (CAHs) in rural, mountainous areas to operate ambulatory services under a special enhanced Medicare payment model;
  • Reimburse CAHs for ambulatory services if there is no other ambulatory base within 15 miles of the facility; and
  • Ensure that a CAH located in a mountainous area does not lose its designation if a new facility is constructed within 15 miles.

A companion bill was introduced in the House by Reps. Miller (R-WV) and Caraveo (D-CO).

For more information, click here.

Welcome Back to the Health Care Workforce Act Introduced

On April 9, Sen. Kaine (D-VA) introduced the Welcome Back to the Health Care Workforce Act. The bill would direct the Health Resources and Services Administration to establish a grant program to:

  • Support communities in local- and state-level partnerships with healthcare organizations to connect internationally educated healthcare professionals with resources they need to enter the healthcare workforce;
  • Address barriers internationally educated healthcare professionals face when trying to enter the healthcare workforce;
  • Assist with obtaining overseas academic or training records and provide support throughout the U.S. licensing and credentialing process;
  • Develop work-force readiness, peer support, mentoring and career counseling opportunities; and
  • Create opportunities to complete prerequisite courses, education training and English-language learning.

For more information, click here.

Administration

CDC Launches Public Health Strategy for 2024-2025

On April 11, the Centers for Disease Control and Prevention launched its updated Public Health Data Strategy for 2024-2025. The strategy outlines data and policy actions needed to address challenges in data exchange between public health organizations and state, tribal and local authorities.

For more information, click here.

CMS Announces Proposed Transforming Episode Accountability Model

On April 10, the Centers for Medicare and Medicaid Services announced the proposed Transforming Episode Accountability Model. The model would be a five-year, mandatory episode-based payment model that would begin in January 2026. It aims to advance testing and evaluation of episode-based care to improve quality of care for patients and lower costs.

For more information, click here.

CMS Releases 2025 Medicare Advantage and Part D Rate Announcement

On April 1, the Centers for Medicare and Medicaid Services (CMS) released the 2025 Medicare Advantage (MA) and Part D Rate Announcement. CMS expects federal payments to MA plans to increase by an average of 3.7 percent and MA payments to private health plans to rise from $500 to $600 billion in 2025.

For more information, click here.

HRSA Announces $51 Million Funding Opportunity to Support Individuals Returning from Incarceration

On April 9, the Health Resources and Services Administration (HRSA) announced that it would make $51 million in funding available for HRSA-funded health centers, to strengthen health services for formerly incarcerated individuals and to facilitate their reentry into communities. Applications are due June 10, 2024.

For more information, click here.

Relyvrio Pulled from Market

On April 4, Amylyx Pharmaceuticals announced that it would pull Relyvrio off the market, after late-stage clinical trial data indicated that it failed to show benefits for ALS patients. The company announced that the decision was made following discussions with the Food and Drug Administration.

Proposed Rules

CMS Proposed Rule Updates Payment Rates for Inpatient and LTC Hospitals for FY2025

On April 10, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the Medicare fee-for-service payment rates and policies for inpatient and long-term care hospitals (LTCHs) for fiscal year (FY) 2025.

The proposed rule would:

  • Increase LTCH standard rate payments by 1.2 percent;
  • Raise the fixed-loss amount for high-cost outlier payments to $90,921, reducing overall standard rate payments by 1.3 percent;
  • Rebase the LTCH market basket using a 2022 base year;
  • Adopt and modify patient assessment items related to health-related social needs within the LTCH Quality Reporting Program;
  • Require LTCHs to collect and report specific data related to living situation, food and utilities beginning in FY2028; and
  • Extend the window in which patient assessments must be done from three to four days after admission.

CMS is also requesting comments on two requests for information related to the development of a LTCH QRP (Quality Reporting Program) Star Rating System and future QRP measures.

The American Hospital Association is upset about the proposed rule and stated in a press release that the payment update is inadequate and will exacerbate resource challenges for hospitals.

Public comments will be accepted until June 10, 2024. For more information, click here.

CMS Proposed Rule Updates Inpatient Rehabilitation Facility PPS Rates for FY2025

On March 29, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the prospective payment system (PPS) rates for inpatient rehabilitation facilities (IRFs) for fiscal year (FY) 2025 and modify the IRF Quality Reporting Program (QRP).

The proposed rule would:

  • Update the IRF PPS payment rates by 2.8 percent or $255 million;
  • Update the IRF PPS wage index using Office of Management and Budget statistical area delineations of revised census data;
  • Phase out the rural adjustment for IRFs that transition from rural to urban status under the new Core-Based Statistical Areas; and
  • Adopt four new items into the IRF Patient Assessment Instrument, modify the Transportation item and remove the “Admission Class” assessment item, beginning on Oct. 1, 2026.

In addition, CMS is requesting comments on two requests for information concerning the development of an IRF QRP Star Rating System and future QRP measures.

Public comments will be accepted until May 28, 2024. For more information, click here.

CMS Proposed Rule Would Update Hospice Payment Rate and Cap Amount for FY2025

On March 28, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the Medicare hospice payment and aggregate cap amounts for fiscal year (FY) 2025 and modify the Hospice Quality Reporting Program (HQRP).

The proposed rule would:

  • Update the hospice payment rate by 2.6 percent, an estimated increase of $705 million;
  • Implement a hospice cap amount of $34,364.85;
  • Add two new process measures to the HQRP;
  • Implement the HOPE patient-level data collection tool beginning in FY2025 to replace the Hospice Item Set structure; and
  • Modify the Hospice Consumer Assessment of Healthcare Providers and Systems Survey.

In addition, CMS is seeking comments on a request for information concerning the implementation of a separate payment mechanism to account for high-intensity palliative care services.

Public comments will be accepted until May 28, 2024. For more information, click here.

CMS Proposed Rule Would Update Inpatient Psychiatric Facility PPS Rates for FY2025

On March 28, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the prospective payment system (PPS) rates for inpatient psychiatric facilities (IPFs) for fiscal year (FY) 2025 and modify the IPF Quality Reporting Program (QRP).

The proposed rule would:

  • Update IPF PPS payment rates by 2.7 percent;
  • Revise IPF PPS patient-level adjustment factors;
  • Require IPFs to submit patient-level quality data every quarter;
  • Increase the cost of electroconvulsive therapy to $660.30 per treatment; and
  • Adopt one new measure under the IPF QRP.

In addition, CMS is requesting comments on two requests for information concerning the development of an IPF PPS Patient Assessment Instrument and potential revisions to the IPF PPS Facility-Level Adjustment Factors.

Public comments will be accepted until May 28, 2024. For more information, click here.

CMS Proposed Rule Would Update Skilled Nursing Facility PPS Rates for FY2025

On March 28, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the prospective payment system (PPS) rates for skilled nursing facilities (SNFs) for fiscal year (FY) 2025 and modify the SNF Quality Reporting Program (QRP) and Value-Based Purchasing (VBP) Program.

The proposed rule would:

  • Update SNF PPS rates by 4.1 percent, or $1.3 billion;
  • Revise ICD-10 code mappings to improve payment and coding accuracy;
  • Expand CMS’ ability to impose financial penalties on nursing homes for health and safety deficiencies;
  • Add four new social determinants of health (SDOH) assessments and modify one SDOH assessment item for the SNF QRP beginning in FY2027; and
  • Adopt a measure retention and removal policy and update the Total Nurse Staffing measure and case-mix methodology in the SNF VBP program.

In addition, CMS is requesting comments on two requests for information concerning future updates to the Non-Therapy Ancillary component of the Patient-Driven Payment Model and SNF QRP quality measures.

Public comments will be accepted until May 28, 2024. For more information, click here.

FDA Proposed Rule Would Ban Electrical Stimulation Devices

On March 26, the Food and Drug Administration (FDA) released a proposed rule that would ban electrical stimulation devices (ESDs) intended for self-injurious behavior (SIB) or aggressive behavior (AB). The FDA believes the devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling.

The proposed rule would:

  • Designate ESDs for SIB or AB as banned devices; and
  • Apply the ban to devices already in use, commercially distributed and those set to be sold or commercially distributed in the future.

Public comments will be accepted until May 28, 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

CMS Releases CY2025 Medicare Advantage and Part D Final Rule

On April 4, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will amend regulations for the Medicare Advantage (MA), Part D, Cost Plan and Programs of All-Inclusive Care for the Elderly programs. The rule will:

  • Codify 9 core chronic diseases and HIV/AIDS to the Part D Medication Therapy Management Program eligibility criteria;
  • Add the “Outpatient Behavioral Health” facility-specialty type to network adequacy standards;
  • Cap compensation for MA plan agents and brokers;
  • Require MA organizations to establish bibliographies for each of the Special Supplemental Benefits for the Chronically Ill that they include in their bid;
  • Streamline enrollment for dual-eligible beneficiaries and limit out-of-network patient cost-sharing for certain plans serving dual-eligibles;
  • Require Quality Improvement Organizations to review the appeals process for enrollees if their MA plan terminates coverage for certain post-acute care services; and
  • Lower the D-SNP look-alike threshold from 80 to 70 percent.

In addition, the rule will standardize the MA Risk Adjustment Data Validation appeals process and provide Part D sponsors flexibility to substitute lower cost biosimilar biological products for reference products.

The final rule will go into effect on June 3, 2024 but the applicability of the provisions depend on plan coverage dates. For more information, click here.

CMS Releases Notice of Benefit and Payment Parameters for 2025 Final Rule

On April 2, the Centers for Medicare and Medicaid Services (CMS) released the Notice of Benefit and Payment Parameters for 2025 final rule, which finalizes standards for issuers, Marketplaces and requirements for agents, brokers, direct-enrollment entities and assisters. The rule will:

  • Implement new network adequacy standards on State and State-based Marketplaces;
  • Allow states to add routine non-pediatric dental benefits as an Essential Health Benefit (EHB);
  • Revise prescription drug benefits;
  • Simplify plan choice and selection by revising the Marketplace re-enrollment hierarchy and the EHB-Benchmark Plan update process;
  • Align special enrollment period coverage dates with regular coverage effective dates;
  • Enhance standards and guaranteed consumer protections;
  • Establish new marketplace call center standards; and
  • Implement a Federally-Facilitated Marketplace user fee rate of 1.5 percent and a State-based Marketplace user fee rate of 1.2 percent of total monthly premiums.

In addition to CMS, the Department of Treasury is proposing the rule.

The final rule will go into effect on June 4, 2024. For more information, click here.

CMS Releases Final Rule Concerning STLDI Plans

On March 28, the Centers for Medicare and Medicaid Services (CMS) released a final rule that restricts the length of short-term, limited-duration insurance (STLDI) plans. The rule will:

  • Limit the initial coverage period of an STLDI plan to no more than three months;
  • Cap the maximum coverage period to four months;
  • Prohibit plan “stacking” by considering multiple plan purchases from the same issuer as a renewal or extension;
  • Require plan and fixed indemnity policy applications, enrollment, reenrollment and consumer-facing marketing materials to be more transparent; and
  • Revise requirements for hospital indemnity or other fixed indemnity insurance to be considered an excepted benefit in the group and individual health insurance markets.

In addition to CMS, the Internal Revenue Service and the Employee Benefits Security Administration are proposing the rule.

The final rule will go into effect on June 17, 2024. For more information, click here.

CMS Final Rule Amends Medicaid Eligibility and Enrollment Process

On March 27, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will streamline the process of eligibility determinations, enrollment and renewal processes for Medicaid, the Children’s Health Insurance Program (CHIP) and the Basic Health Program. The rule will:

  • Prohibit CHIP premium lock-out periods and annual and lifetime limits on CHIP benefits;
  • Remove the State option to require a waiting period prior to CHIP enrollment;
  • Modernize eligibility determination information and documentation recordkeeping requirements for states;
  • Eliminate the State option to require in-person interviews as part of the application and renewal processes for non-MAGI (modified adjusted gross income) beneficiaries;
  • Implement provisions aimed at simplifying the coverage enrollment and renewal process for individuals 65 and older or living with a disability; and
  • Require states to use specific types of available information to update an individual’s address.

In addition, the rule will grant individuals 15 days to return information requested for an initial application and 30 days when needed to retain enrollment.

The final rule will go into effect on June 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, which 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.

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

AHIP, AMA and NAACOS Release Report Outlining Value-Based Care Payment Best Practices

On April 10, America’s Health Insurance Plans, the American Medical Association and the National Association of ACOs (Accountable Care Organizations) released a report outlining voluntary best practices for value-based care (VBC) payment arrangements. The report focuses on seven payment domains, which include:

  • Patient Attribution;
  • Benchmarking;
  • Risk Adjustment;
  • Quality Performance Impact on Payment;
  • Levels of Financial Risk;
  • Payment Timing and Accuracy; and
  • Incentivizing for VBC Practice Participant Performance.

For more information, click here.

GAO Releases Report Concerning DOD Clinical Adverse Action Process

On April 11, the Government Accountability Office (GAO) released a report concerning the Department of Defense’s (DOD) clinical adverse action process. The report examines the Defense Health Agency’s (DHA) adherence to clinical adverse action requirements.

After reviewing documentation of clinical adverse action cases initiated by four facilities and interviewing DHA officials, the GAO discovered that the facilities did not always adhere to certain requirements and that the DHA did not always report providers within required timeframes to the National Practitioner Data Bank. The GAO conducted this study because a provision in the National Defense Authorization Act for Fiscal Year 2022 required it to review DOD’s clinical adverse action process.

For more information, click here.

GAO Releases Report Regarding Coast Guard Telehealth Usage and Challenges

On April 10, the Government Accountability Office (GAO) released a report describing how the Coast Guard has used telehealth to improve access to care to personnel in remote areas. The report also highlights challenges that have limited the Coast Guard’s use of telehealth.

After interviewing officials and reviewing documents, the GAO discovered that information technology infrastructure issues and the lack of or inconsistency of internet connectivity aboard vessels and bases limited the availability and use of telehealth services. The GAO conducted this study because a provision in the James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 required it to report on the Coast Guard telehealth program.

For more information, click here.

GAO Releases Report Concerning Indian Health Service Clinician Screening

On April 8, the Government Accountability Office (GAO) released a report concerning how the Indian Health Service (IHS) reviews and verifies the professional qualifications of clinicians. The report also examines administrative tasks performed by IHS clinicians at federally operated facilities.

After reviewing policies and documents, the GAO discovered that existing IHS oversight methods did not ensure adherence to all of IHS’ credentialing and privileging requirements and that the time spent on administrative tasks by IHS clinicians varied. The GAO conducted this study because it was asked to review IHS clinician screening and the performance of administrative tasks.

For more information, click here.

GAO Releases Report Concerning Health Center Revenue and Grant Funding

On April 8, the Government Accountability Office (GAO) released a report concerning health center revenue and grant funding.

After analyzing Health Resources and Services Administration (HRSA) data and documentation, the GAO discovered that health center total revenue rose from $28.7 billion in 2018 to $42.9 billion in 2022, driven primarily by Medicaid revenue. The GAO also discovered that HRSA had awarded about $34 billion in grant funding through its Health Center Program. The GAO conducted this study because it was asked to review health centers’ revenue, grant funding and efforts to meet certain access-to-care requirements.

For more information, click here.

Healthcare Leadership Council Releases Report Concerning Value-Based Payment Models

On April 11, the Healthcare Leadership Council released a report outlining recommendations for how value-based care can be advanced. The report highlights steps to accelerate the transition from traditional fee-for-service payment models to models that prioritize value, prevention and wellness.

For more information, click here.

HHS OIG Releases Report Concerning Medicaid Managed Care MH/SUD Parity Requirements

On March 25, the Department of Health and Human Services Office of Inspector General (OIG) released a report concerning state compliance with Medicaid managed care mental health and substance use disorder (MH/SUD) parity requirements.

After reviewing the managed care contracts of eight states, the OIG discovered that CMS did not ensure that the states complied with MH/SUD parity requirements. The OIG also determined that the states and their managed care contract organizations did not conduct required parity analyses and did not make documentation of compliance available to the public.

The states were AZ, IL, KS, MS, NJ, NY, SC and TX.

For more information, click here.

Authors

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