Washington Healthcare Update

May 20, 2024

This Week in Washington: House appropriators release FY2025 topline appropriations levels; Senate Finance Committee releases white paper on Medicare physician payment reforms; House Energy and Commerce Committee Subcommittee on Health marks up 21 bills.

Congress

House

Senate

Administration

Proposed Rules

Final Rules

Reports

House

House Appropriators Release FY2025 Topline Funding Amounts

On May 16, House appropriators released topline funding amounts for the fiscal year (FY) 2025 appropriations bills. The proposed funding levels total roughly $1.6 trillion and would increase defense spending by 1 percent and decrease non-defense spending by 6 percent. The funding levels are lower than the spending caps agreed to in the debt limit deal from last year.

House appropriators are proposing to allocate:

  • $25.9 billion to the Food and Drug Administration and related agencies; and
  • $184. 6 billion to the Department of Health and Human Services and related agencies.

In addition, House appropriators released the markup schedule of bills and announced they are aiming to approve them by mid-July.

For more information, click here.

House Energy and Commerce Committee Subcommittee on Health Marks Up 21 Bills

On May 16, the House Energy and Commerce Committee Subcommittee on Health marked up and reported out of committee 21 bills that extend Medicare telehealth flexibilities, facilitate rare pediatric disease innovation, improve the Medicaid enrollment process for out-of-state providers and strengthen Medicaid fraud prevention.

The bills are:

H.R. 3433, Give Kids a Chance Act: Amends the Federal Food, Drug and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations.

H.R. 7188, Shandra Eisenga Human Cell and Tissue Product Safety Act: Requires the Department of Health and Human Services Secretary (HHS Secretary) to conduct a national, evidence-based education campaign to increase public and healthcare provider awareness regarding the potential risks and benefits of human cell and tissue products transplants.

H.R. 6033, Supporting Patient Education and Knowledge (SPEAK) Act of 2023: Requires the HHS Secretary to establish a task force to improve access to healthcare information technology for non-English speakers.

H.R. 7858, Telehealth Enhancement for Mental Health Act of 2024: Establishes a Medicare incident to modifier for mental health services furnished through telehealth.

H.R. 7623, Telehealth Modernization Act of 2024: Makes certain telehealth flexibilities under the Medicare program permanent.

H.R. 1406, Sustainable Cardiopulmonary Rehabilitation Services in the Home Act: Permanently extends certain in-home cardiopulmonary rehabilitation flexibilities established in response to COVID-19.

H.R. 7856, PREVENT DIABETES Act: Provides for coverage of the Medicare Diabetes Prevention program.

H.R. 5394, Expanding Remote Monitoring Access Act: Ensures appropriate access to remote monitoring services furnished under the Medicare program.

H.R. 1199, Facilitating Innovative Nuclear Diagnostic Act of 2023: Ensures equitable payment and preserves Medicare beneficiary access to diagnostic radiopharmaceuticals under the Medicare hospital outpatient prospective payment system.

H.R. 6020, Honor Our Living Donors Act: Eliminates consideration of the income of organ recipients in providing reimbursement of expenses to donating individuals.

H.R. 455, To amend the Controlled Substances Act to fix a technical error in the definitions: Amends the Controlled Substances Act to fix a technical error in the definitions.

H.R. 7213, Autism Collaboration, Accountability, Research, Education, and Support (CARES) Act of 2024: Enhances activities of the National Institutes of Health with respect to research on autism spectrum disorder and reauthorizes programs relating to autism.

H.R. 670, Think Differently Database Act: Directs the HHS Secretary to establish a clearinghouse on intellectual disabilities.

H.R. 8084, LIVE Beneficiaries Act: Requires States to verify certain eligibility criteria for individuals enrolled for medical assistance quarterly.

H.R. 8089, Medicare and Medicaid Fraud Prevention Act of 2024: Requires certain additional provider screening under the Medicaid program.

H.R. 8111, To amend title XIX of the Social Security Act to ensure the reliability of address information provided under the Medicaid program: Ensures the reliability of address information provided under the Medicaid program.

H.R. 8112, To amend title XIX of the Social Security Act to further require certain additional provider screening under the Medicaid program: Requires certain additional provider screening under the Medicaid program.

H.R. 4758, Accelerating Kids’ Access to Care Act: Streamlines enrollment under the Medicaid program of certain providers across State lines.

H.R. 3227, Ensuring Seniors’ Access to Quality Care Act: Amends titles XVIII and XIX of the Social Security Act with respect to nursing facility requirements.

H.R. 468, Building America’s Health Care Workforce Act: Extends the COVID-19 Emergency Declaration Blanket Waiver relating to training and certification of nurse aides.

H.R. 4534, Women and Lung Cancer Research and Preventive Services Act: Requires the HHS Secretary and Secretaries of Defense and Veterans Affairs, to conduct an interagency review to evaluate the status of and identify opportunities related to research on women and lung cancer.

For more information, click here.

House Committee on Oversight and Accountability Marks Up BIOSECURE Act

On May 15, the House Committee on Oversight and Accountability marked up and reported out of committee nine bills, including H.R. 8333, the BIOSECURE Act. The legislation would prohibit federal agencies from contracting with or procuring equipment or supplies from certain foreign-owned biotechnology providers after 2032.

In March, the Senate Homeland Security and Governmental Affairs Committee reported out of committee a version of the bill with a shorter timeline.

For more information, click here.

Senate

Senate Finance Committee Chairman and Ranking Member Release White Paper on Medicare Doctor Payment Reform

On May 17, Senate Finance Committee Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) released a white paper on Medicare Doctor Payment Reform. The white paper outlines potential policy reforms to streamline clinician payment systems that include:

  • Creating sustainable payment updates to ensure clinicians can own and operate their practices;
  • Incentivizing alternative payment models that reward providing better care at a lower cost;
  • Rethinking how Medicare measures quality care;
  • Improving primary care;
  • Supporting chronic care benefits in Medicare fee-for-service; and
  • Ensuring continued access to telehealth.

For more information, click here.

Senate HELP Committee Majority Staff Release Report Concerning Weight Loss Drug Spending

On May 15, the Senate Health, Education, Labor and Pensions Committee majority staff released a report concerning the impact weight loss drugs could have on prescription drug spending. The majority staff used data on drug net pricing and uptake percentage to assess potential impacts.

The majority staff found that if 50 percent of adults with obesity took weight loss drugs, total spending could equal $411 billion per year and cost the Medicare and Medicaid programs $166 billion per year. The majority staff also found that lower weight loss drug prices could significantly reduce total spending.

For more information, click here.

Senate HELP Committee Schedules Markup of Seven Healthcare Bills

On May 23, the Senate Health, Education, Labor and Pensions Committee will mark up seven healthcare bills that will reauthorize programs relating to Alzheimer’s disease, child emergency medical services, poison control programs and lifespan respite care. The bills are:

S. 3679, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act: Reauthorizes the Dr. Lorna Breen Health Care Provider Act through fiscal year 2029 to promote the use of mental health and substance use disorder services by healthcare providers.

S. 3765, Emergency Medical Services for Children Reauthorization Act of 2024: Reauthorizes the Emergency Medical Services for Children program through fiscal year 2029.

S. 4351, A bill to amend the Public Health Service Act to reauthorize certain poison control programs: Reauthorizes certain poison control programs through fiscal year 2029.

S. 3775, BOLD Infrastructure for Alzheimer’s Reauthorization Act of 2024: Reauthorizes the Building Our Largest Dementia Infrastructure for Alzheimer’s Act through fiscal year 2029.

S. 4325, A bill to amend the Public Health Service Act to reauthorize the program relating to lifespan respite care, and for other purposes: Reauthorizes the Lifespan Respite Care program through fiscal year 2029.

S. 3757, Congenital Heart Futures Reauthorization Act of 2024: Reauthorizes the Centers for Disease Control and Prevention’s Congenital Heart Disease, Research, Surveillance and Awareness Program through fiscal year 2029.

S. 4045, East Palestine Health Impact Monitoring Act of 2024: Requires the Secretary of Health and Human Services to award a grant, contract or cooperative agreement to an eligible entity to study the public health impacts resulting from the February 2023 train derailment in East Palestine, OH.

For more information, click here.

Senate AI Working Group Releases Roadmap for AI Policy

On May 15, the Senate Bipartisan Artificial Intelligence (AI) Working Group released the Roadmap for Artificial Intelligence Policy. The roadmap outlines considerations for committees of jurisdiction that are developing legislation concerning AI.

The roadmap encourages committees to:

  • Ensure appropriate guardrails and safety measures are implemented to protect patients from fraud and abuse;
  • Support the National Institutes of Health in developing and improving AI technologies;
  • Make healthcare and biomedical data available for machine learning and data science research;
  • Ensure that the Department of Health and Human Services and other healthcare agencies have the tools to weigh the benefits and risks of AI-enabled products; and
  • Promote innovation of AI systems and examine Centers for Medicare and Medicaid Services’ reimbursement mechanisms to strengthen accountability, appropriate use and broad application of AI in all populations.

For more information, click here.

Senate Judiciary Committee Announces Hearing on Prescription Drug Access and Affordability

On May 21, the Senate Judiciary Committee will hold a hearing on prescription drug market competition, accessibility and affordability. Witnesses are:

  • William Feldman, MD, DPhil, MPH, Associate Physician at the Brigham and Women’s Hospital Division of Pulmonary and Critical Care Medicine
  • David Mitchell, President and Founder of Patients for Affordable Drugs
  • Adam Mossoff, Professor of Law at the George Mason University Antonin Scalia Law School
  • Arti Rai, Elvin R. Latty Duke Law Distinguished Professor of Law
  • Jocelyn Ulrich, Vice President of Policy and Research at PhRMA

For more information, click here.

Senate HELP Committee Holds Hearing on Dental Care

On May 16, the Senate Health, Education, Labor and Pensions Committee held a hearing on dental care. Committee members discussed factors that could be exacerbating dental care issues, including the lack of affordable dental insurance, oral health workforce pipelines and incentives for providers to offer rural dental care services. Witnesses were:

  • Lisa Simon, Associate Physician of Brigham and Women’s Hospital and Member of the Harvard Medical School Faculty
  • Myechia Minter-Jordan, MD, MBA, President and CEO of CareQuest Institute for Oral Health
  • Brian Jeffrey Swann, DMD, MPH, Co-Chair of the National Dental Association Global Oral Health Outreach and Member of the Remote Area Medical Board of Directors
  • Gordon Roswell Isbell, III, DMD, MAGD, Past Trustee of the Academy of General Dentistry

For more information, click here.

Senate Finance Committee Holds Hearing on Rural Healthcare

On May 16, the Senate Finance Committee held a hearing to discuss rural healthcare challenges. During the hearing, Chairman Ron Wyden (D-OR) stated that the committee could begin working on permanently extending telehealth flexibilities. Witnesses were:

  • Michael Topchik, Executive Director of the Chartis Center for Rural Health
  • Jeremy P. Davis, MHA, President and Chief Executive Officer of Grande Ronde Hospital
  • Lori Rodefeld, MS, Director of GME Development at the Wisconsin Collaborative for Rural Graduate Medical Education
  • Keith J. Mueller, Ph.D., Gerhard Hartman Professor of Health Management and Policy and Director of the Rural Policy Research Institute

For more information, click here.

Pay PCPs Act Introduced

On May 15, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) and Sen. Whitehouse (D-RI) introduced the Pay PCPs Act. This legislation would:

  • Establish a hybrid Medicare payment system that would reward primary care providers based on patient health outcomes;
  • Reduce cost-sharing for patients who participate in certain primary care activities and services; and
  • Create a new technical advisory committee to help the Centers for Medicare and Medicaid Services (CMS) determine Medicare fee schedule rates.

In addition, the senators have issued a request for information on what the structure and makeup of the advisory committee should be and how CMS can strengthen its role in setting fee-for-service payment rates.

For more information, click here.

Administration

HHS ONC Announces Funding Opportunity for AI and Behavioral Health IT Projects

On May 13, the Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) announced that it is accepting applications for the Leading Edge Acceleration Project in Health Information Technology funding opportunity. The ONC is particularly interested in applications that aim to:

  • Develop innovative ways to improve healthcare-data quality to support responsible development of artificial intelligence tools in healthcare; and
  • Accelerate the adoption of health IT in behavioral health settings.

Applications are due by July 12. For more information, click here.

CMS Releases Statement Concerning MDRP Proposed Rule Stacking Provision

On May 15, the Centers for Medicare and Medicaid Services announced that it will not finalize the best drug price “stacking” provision in the Medicaid Drug Rebate Program proposed rule it released in May 2023. The provision would have redefined a drug’s best price as the net price of the combined total of rebates associated with the drug.

For more information, click here.

FDA Releases New Product-Specific Guidances

On May 16, the Food and Drug Administration released new product-specific guidances intended to facilitate the development of generic drugs.

For more information, click here.

FDA Adds 191 AI/ML-Enabled Medical Devices to Marketed List

On May 13, the Food and Drug Administration added 191 artificial intelligence/machine learning (AI/ML)-enabled devices to the list of devices it has approved for marketing.

For more information, click here.

Proposed Rules

CMS Proposed Rule Would Establish Increasing Organ Transplant Access Model

On May 8, the Centers for Medicare and Medicaid Services released a proposed rule that would establish the Increasing Organ Transplant Access (IOTA) Medicare payment model. The IOTA Model would be a mandatory, six-year model and would begin on Jan. 1, 2025.

The model aims to:

  • Increase access to kidney transplants for end-stage renal disease patients;
  • Improve quality of care for people seeking kidney transplants;
  • Reduce disparities among individuals undergoing the kidney transplant process; and
  • Facilitate the efficiency and capability of transplant hospitals selected to participate.

Public comments will be accepted until July 16, 2024. For more information, click here.

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.

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 Hospice Outcomes and Patient Evaluation (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 selection, 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 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 Final Rule Expands Access to Healthcare for DACA Recipients

On May 3, the Centers for Medicare and Medicaid Services released a final rule to expand access to healthcare for Deferred Action for Childhood Arrivals (DACA) recipients. The rule will allow DACA recipients to:

  • Enroll in a Qualified Health Plan through the Affordable Care Act Health Insurance Marketplace; and
  • Obtain coverage through a Basic Health Program.

DACA recipients and other newly eligible individuals will be able to select a health plan through the Marketplace during a 60-day special enrollment period following the implementation of the rule.

The rule will go into effect on Nov. 1, 2024. For more information, click here.

HHS OCR Final Rule Strengthens Protections Against Disability Discrimination

On May 1, the Department of Health and Human Services (HHS) Office for Civil Rights released a final rule that prohibits discrimination on the basis of disability and strengthens protections for disabled individuals under Section 504 of the Rehabilitation Act. The rule will:

  • Ensure that medical treatment decisions are not based on negative biases and stereotypes about disabled individuals or judgements that a disabled individual is a burden on others;
  • Prohibit the use of measures, assessments or tools that discount the value of a life extension on the basis of disability;
  • Define what accessibility means for websites and mobile applications and ensure that services delivered through these platforms are accessible to and usable by disabled individuals;
  • Adopt U.S. Access Board standards for accessible medical diagnostic equipment;
  • Outline requirements to ensure nondiscrimination in the services provided by HHS-funded child welfare agencies; and
  • Clarify obligations to provide services in integrated services.

In addition, the rule aligns existing requirements with the Americans with Disabilities Act.

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

HHS OCR Final Rule Prevents Discrimination in Grant Programs

On April 30, the Department of Health and Human Services (HHS) Office for Civil Rights and the Assistant Secretary for Financial Resources released a final rule that affirms nondiscrimination in HHS-funded programs and services. The rule will:

  • Clarify and reaffirm the prohibition of discrimination on the basis of sex, including sexual orientation and gender identity, in HHS programs; and
  • Confirm protections in programs, services and grants that provide aid to refugees, early childhood education services, substance use disorder treatments, community mental health services, maternal and child health services and community services.

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

IHS Final Rule Removes Outdated Regulations

On April 30, the Indian Health Service (IHS) released a final rule that aligns IHS regulations with current text of the Hyde Amendment and 25 U.S. Code 1676.

The rule will go into effect on May 30, 2024. For more information, click here.

DOL EBSA Final Rule Rescinds 2018 Association Health Plan Rule

On April 30, the Department of Labor (DOL) Employee Benefits Security Administration released a final rule that rescinds a DOL final rule released in 2018, which modified the definition of “employer” under federal law and expanded the availability of Association Health Plans.

The U.S. District Court for the District of Columbia ruled that provisions in the rule were an unreasonable interpretation of the Employee Retirement Income Security Act in 2019.

The rule will go into effect on July 1, 2024. For more information, click here.

FDA Releases Final Rule Concerning Laboratory Developed Tests

On April 29, the Food and Drug Administration (FDA) released a final rule that will classify laboratory-developed tests (LDTs) and in vitro diagnostic (IVD) products as medical devices subject to rules under the Federal Food, Drug and Cosmetic Act. The rule will phase out the FDA’s general enforcement discretion approach for most LDTs over four years and require compliance with:

  • Medical device regulation, correction and removal reporting and compliant file quality system requirements after one year;
  • Registration, listing, labeling and investigational use requirements after two years;
  • Quality system requirements in 21 CFR Part 820 after three years;
  • Premarket review requirements for high-risk IVDs offered as LDTs (unless a premarket submission has been received by the beginning of this stage) after three and a half years; and
  • Premarket review requirements for moderate- and low-risk IVDs after four years.

LDTs developed by a healthcare system laboratory that target unmet needs of patients, those approved by New York State’s Clinical Laboratory Evaluation Program and tests first marketed prior to May 6, are exempted from the rule.

The rule will go into effect on July 5, 2024. For more information, click here.

FTC Final Rule Revises Health Breach Notification Rule

On April 26, the Federal Trade Commission (FTC) released a final rule that revises the Health Breach Notification Rule that requires vendors of personal health records (PHR) and related entities not covered by the Health Insurance Portability and Accountability Act, to notify individuals and the FTC of unsecured PHR data breaches. The rule will:

  • Modify the definition of PHR identifiable health information and add new definitions for covered healthcare provider and healthcare services or supplies;
  • Clarify that a “breach of security” includes an unauthorized acquisition of identifiable health information that occurs as a result of a data security breach or unauthorized disclosure;
  • Revise the definition of a PHR-related entity to make clear that the rule applies to entities that offer products and services through online services, including mobile applications;
  • Clarify multiple sources of PHR identifiable health information;
  • Expand the use of electronic notification and consumer notice content; and
  • Require covered entities to report breaches involving 500 or more individuals to the FTC at the same time notices are sent to affected individuals and no later than 60 calendar days after discovery of the breach.

The final rule has not yet been submitted to the Federal Register but will go into effect 60 days after submission.

For more information, click here.

CMS Releases Final Rule Concerning Nondiscrimination in Health Programs

On April 26, the Centers for Medicare and Medicaid Services released a final rule that revises Section 1557 of the Affordable Care Act to advance health equity and reduce disparities. The rule will:

  • Apply nondiscrimination standards to all Department of Health and Human Services (HHS)-administered health programs and activities;
  • Reinstate Section 1557’s application to health insurance issuers that receive federal financial assistance;
  • Affirm that sex discrimination protections apply to discrimination on the basis of sexual orientation, gender identity, pregnancy and sex characteristics and stereotypes;
  • Require state and federally-facilitated exchanges, recipients of federal financial assistance and HHS programs to inform individuals that language assistance services and auxiliary aids are available; and
  • Require covered entities to train staff on Section 1557 policies.

The rule also clarifies nondiscrimination requirements for telehealth services and patient care decision support tools.

The rule will go into effect on July 5, 2024. Some provisions of the rule will be phased in to allow covered entities to come into compliance.

For more information, click here.

CMS Releases Final Rule Concerning Medicaid and CHIP Access to Care

On April 22, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will improve access to care, strengthen quality and health outcomes and address health equity issues for Medicaid and Children’s Health Insurance Program (CHIP) managed care enrollees.

The rule will:

  • Establish maximum wait times for obstetric, primary care and outpatient mental health and substance use disorder services;
  • Require states to implement a remedy plan for managed care organizations that fail to meet required standards;
  • Prohibit the use of separate payment terms;
  • Remove the requirement that providers must be in-network with managed care plans to receive state-directed payments; and
  • Require managed care plans to report any identified or recovered overpayments to states within 30 calendar days.

In addition, the rule will implement revisions concerning In Lieu of Service and Setting, External Quality Review and the Medicaid and CHIP Quality Rating System.

The rule will go into effect on July 9, 2024. For more information, click here.

CMS Final Rule Implements SNF Minimum Staffing Levels

On April 22, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will establish minimum staffing levels for long-term care (LTC) and skilled-nursing facilities (SNFs) and strengthen transparency of worker compensation. The rule will require facilities to:

  • Have a registered nurse (RN) on-site 24 hours a day, seven days a week;
  • Provide a minimum of 3.48 hours of nursing care per resident day, including a minimum of 0.55 hours of care from a RN and 2.45 hours of care from a nurse aide per resident day;
  • Use evidence-based methods when planning care for their residents and the facility assessment when assessing the needs of each resident in the facility;
  • Develop staffing plans to maximize recruitment and retention of staff in accordance with Executive Order 14095; and
  • Implement new Medicaid Institutional Payment Transparency Reporting provisions.

The rule will be implemented in phases across a three-year period. Nursing homes may apply for a temporary exemption to the rule but must meet certain hardship criteria. Notably, there are two bills in Congress that, if enacted, would prevent the rule from going forward.

The rule will go into effect on June 21, 2024. For more information, click here.

CMS Releases Final Rule Concerning Access to Medicaid Services

On April 22, the Centers for Medicare and Medicaid Services (CMS) released a final rule to improve access to care, service quality and outcomes under Medicaid fee-for-service (FFS), managed care and home and community-based services (HCBS). The rule will require states to:

  • Rename and expand the scope of Medical Care Advisory Committees and require states to establish a Beneficiary Advisory Committee;
  • Meet nationwide incident management system standards for monitoring HCBS programs;
  • Ensure that a minimum of 80 percent of Medicaid payments for homemaker, home health aide and personal care services be spent on compensation for direct-care workers furnishing these services within six years;
  • Publicly publish all FFS Medicaid fee schedule payment rates; and
  • Establish and manage a grievance process for beneficiaries receiving HCBS in FFS plans.

The final rule will go into effect on July 9, 2024. For more information, click here.

HHS OCR Releases Rule Concerning HIPAA Reproductive Care Privacy

On April 22, the Department of Health and Human Services Office for Civil Rights (OCR) released a final rule concerning Health Insurance Portability and Accountability Act (HIPAA) reproductive healthcare privacy provisions. The rule will:

  • Prohibit the use or disclosure of reproductive healthcare protected health information (PHI) when it is requested to investigate or impose liability on patients and providers who seek, obtain or provide lawful reproductive healthcare services;
  • Require providers, health plans, clearinghouses and business associates to obtain a signed attestation that acknowledges PHI related to reproductive healthcare is not to be used for prohibited purposes; and
  • Require providers, health plans and clearinghouses to modify their Notice of Privacy Practices to support reproductive healthcare privacy.

The final rule will go into effect on June 25, 2024. For more information, click here.

HRSA Final Rule Revises 340B Administrative Dispute Resolution Process

On April 18, the Health Resources and Services Administration (HRSA) released a final rule that modifies requirements and procedures for the 340B Program administrative dispute resolution (ADR) process. The rule aims to make the process more accessible, administratively feasible and timely. It will:

  • Eliminate the $25,000 minimum dispute threshold for drug manufacturers and 340B providers;
  • No longer require the ADR process to be governed by the Federal Rules of Evidence and Civil Procedure;
  • Require members of the ADR panel to be 340B subject matter experts under the HRSA Office of Pharmacy Affairs;
  • Require parties to engage in good-faith efforts to resolve disputes before initiating the ADR process;
  • Prioritize the ADR process for disputes related to overcharging, discount diversion or duplicate discounts; and
  • Establish an ADR dispute appeal and reconsideration process.

The rule will go into effect on June 18, 2024. For more information, click here.

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 nine 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-eligible populations;
  • 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 (dual eligible special needs plans) 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 a 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.

FDA Issues Final Rule Regarding Mammography Quality Standards

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

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

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

Reports

HHS OIG Releases Report Concerning New Mexico Reconciliation of Capitated Payments

On May 8, the Department of Health and Human Services Office of Inspector General (OIG) released a report concerning the reconciliation of capitated payments for Community Benefit (CB) services in New Mexico. The OIG had previously recommended that New Mexico perform required reconciliations and refund the Federal share of any recoveries.

The OIG discovered that New Mexico performed the reconciliations but that it did not:

  • Recoup from managed care organizations, any overpayments identified in the CB services reconciliations;
  • Return the related Federal share of overpayments to the Federal Government; and
  • Provide support that enrollees were eligible to receive services at the nursing facility level-of-care rate.

For more information, click here.

GAO Releases Report Concerning SAMHSA Policy Lab Activities

On May 16, the Government Accountability Office (GAO) released a report concerning the Substance Abuse and Mental Health Services Administration Policy Lab. The GAO was interested in determining whether Policy Lab activities aligned with its statutory responsibilities.

After interviewing Policy Lab officials and subject matter experts, the GAO found that Policy Lab activities generally align with its statutory responsibilities. The GAO was required to review Policy Lab activities due to a provision in the Consolidated Appropriations Act of 2023.

For more information, click here.

SAMHSA Task Force on Maternal Mental Health Releases National Strategy to Improve Maternal Mental Health

On May 14, the Substance Abuse and Mental Health Services Administration Advisory Committee for Women’s Services Task Force on Maternal Mental Health released the National Strategy to Improve Maternal Mental Health Care. The National Strategy outlines best practices, methods and recommendations that aim to improve and strengthen maternal mental healthcare services.

In addition, the Task Force released its Report to Congress. The report summarizes findings on maternal mental health conditions and substance use disorders and intends to guide federal efforts to implement the national strategy.

For more information on the National Strategy, click here.

For more information on the Report to Congress, click here.

Authors

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