This Week in Washington: Senate Finance Committee releases discussion draft concerning generic drug shortages; FDA releases laboratory-developed tests final rule; Administration extends ACA subsidies for Deferred Action for Childhood Arrivals (DACA) recipients.

CONGRESS

HOUSE

• House Energy and Commerce Committee Subcommittee on Health Holds Hearing on Medicaid Proposals
• House Ways and Means Committee To Mark Up Two-Year Telehealth Extension
• House Veterans Affairs Committee Mark Up Includes Six Healthcare Bills

SENATE

• Senate Finance Committee Releases Discussion Draft Concerning Generic Drug Shortages
• Twenty-Two Senators Send Letter Concerning VA Access to Non-Opioid Pain Alternatives
• Senate HELP Committee Holds Hearing on Minority Healthcare Professional Shortages and Maternal Mortality
• Senate Armed Services Committee Subcommittee on Personnel Holds Hearing on DOD Prescription Drug Shortage Capabilities
• MACPAC Chair and Appointed Members Announced

ADMINISTRATION

• CMS Releases Draft Guidance Concerning Second Round of Medicare Drug Price Negotiation Program
• CMS Announces New IDR Resubmission Process
• CMS Releases Guide Concerning Healthcare Options for Individuals Released from Incarceration
• CMS Issues Reminder Concerning 2024 MIPS Improvement Activities
• FDA Releases Draft Guidance Concerning Laboratory Developed Tests
• FDA CDER Releases 2023 Annual Report
• FDA to Host Listening Session to Discuss Advisory Committees
• FTC Extends Comment Period on RFI Concerning Private Equity Role in Healthcare

PROPOSED RULES

• CMS Proposed Rule Updates Payment Rates for Inpatient and LTC Hospitals for FY2025
• CMS Proposed Rule Updates Inpatient Rehabilitation Facility PPS Rates for FY2025
• CMS Proposed Rule Would Update Hospice Payment Rate and Cap Amount for FY2025
• CMS Proposed Rule Would Update Inpatient Psychiatric Facility PPS Rates for FY2025
• CMS Proposed Rule Would Update Skilled Nursing Facility PPS Rates for FY2025
• FDA Proposed Rule Would Ban Electrical Stimulation Devices
• FDA Proposed Rule Establishes Criteria for Drug Products with Demonstrable Compounding Difficulties

FINAL RULES

• CMS Final Rule Expands Access to Healthcare for DACA Recipients
• HHS OCR Final Rule Strengthens Protections Against Disability Discrimination
• HHS OCR Final Rule Prevents Discrimination in Grant Programs
• IHS Final Rule Removes Outdated Regulations
• DOL EBSA Final Rule Rescinds 2018 Association Health Plan Rule
• FDA Releases Final Rule Concerning Laboratory Developed Tests
• FTC Final Rule Revises Health Breach Notification Rule
• CMS Releases Final Rule Concerning Nondiscrimination in Health Programs
• CMS Releases Final Rule Concerning Medicaid and CHIP Access to Care
• CMS Final Rule Implements SNF Minimum Staffing Levels
• CMS Releases Final Rule Concerning Access to Medicaid Services
• HHS OCR Releases Rule Concerning HIPAA Reproductive Care Privacy
• HRSA Final Rule Revises 340B Administrative Dispute Resolution Process
• CMS Releases CY2025 Medicare Advantage and Part D Final Rule
• CMS Releases Notice of Benefit and Payment Parameters for 2025 Final Rule
• CMS Releases Final Rule Concerning STLDI Plans
• CMS Final Rule Amends Medicaid Eligibility and Enrollment Process
• FDA Final Rule Implements Direct-To-Consumer Prescription Drug Ad Standards
• FDA Issues Final Rule Regarding Mammography Quality Standards

REPORTS

• GAO Releases Report Concerning Strategic National Stockpile Coordination Challenges
• CBO Presentation Highlights Healthcare Areas that It Requests New Research On

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House

House Energy and Commerce Committee Subcommittee on Health Holds Hearing on Medicaid Proposals

On April 30, the House Energy and Commerce Committee Subcommittee on Health held a hearing to discuss proposals aimed at improving Medicaid program access and integrity. One of the proposals would prohibit the Centers for Medicare and Medicaid Services’ (CMS) minimum nursing home staffing rule from being implemented.

The proposals are:

H.R. 124, Byron Nash Renal Medullary Carcinoma Awareness Act of 2023: Supports education on the risk of renal medullary carcinoma for individuals with sickle cell disease eligible to receive care under Medicaid.

H.R. 468, Building America’s Health Care Workforce Act: Extends nursing home waivers to retain temporary nurse aides for more than 120 days and allows competency requirement evaluations to be conducted at nursing homes that employ temporary nurse aides.

H.R. 670, Think Differently Database Act: Establishes a publicly available clearinghouse within the Department of Health and Human Services (HHS) to improve accessibility of health service information and resources for individuals with intellectual disabilities.

H.R. 3227, Ensuring Seniors’ Access to Quality Care Act: Modifies requirements that prohibit nursing homes subject to civil monetary penalties from running nurse aide training and competency evaluations, so long as the facility has addressed deficiencies and has not been found to have deficiencies related to patient harm or quality of care for more than two years.

H.R. 7513, Protecting America’s Seniors Access to Care Act: Prohibits the Secretary of HHS from finalizing regulations that would require long-term care facilities to adhere to minimum staffing standards.

H.R. 7573, Stop Unfair Medicaid Recoveries Act: Repeals the requirement that States establish a Medicaid Estate Recovery Program and limits the ability of States to place liens on a Medicaid beneficiary’s property.

H.R. 8084, To amend title XIX of the Social Security Act to require States to verify certain eligibility criteria for individuals enrolled for medical assistance quarterly, and for other purposes: Requires States to perform quarterly verifications of the Social Security Administration’s Death Master File and disenroll deceased individuals enrolled for medical assistance under the State plan.

H.R. 8089, To amend title XIX of the Social Security Act to require certain additional provider screening under the Medicaid program: Requires certain additional provider screening under the Medicaid program.

H.R. 8094, To amend title XIX of the Social Security Act to modify certain asset recovery rules: Modifies asset recovery under a State plan and allows States to choose to not pursue adjustments or recoveries of medical assistance through property liens, if after the death of an individual, the individual’s home would be transferred to another individual who is eligible for Medicaid or has an income that is 138 percent of the Federal Poverty Level or below.

H.R. 8106, To amend title XIX of the Social Security Act to remove the requirement that an individual need an institutional level of care in order to qualify for home and community-based services under a Medicaid waiver: Amends waivers to allow States to provide home and community-based services (HCBS) to beneficiaries who do not meet an institutional level of care and requires States to report on the state of waiting lists for HCBS care.

H.R. 8107, To amend title XIX of the Social Security Act to remove certain age restrictions on Medicaid eligibility for working adults with disabilities: Amends the Medicaid buy-in program to repeal the eligibility pathway age limit of 65 to allow current beneficiaries to continue to be able to retain coverage through the program.

H.R. 8108, To amend title XIX of the Social Security Act to require medical assistance under the Medicaid program for certain home and community-based services for military families: Requires States that currently provide Medicaid coverage for HCBS to dependents of military families to maintain the coverage for care in the event that the family moves out of state for active duty.

H.R. 8109, To amend the Deficit Reduction Act of 2005 to make permanent the Money Follows the Person rebalancing demonstration: Permanently extends the Money Follows the Person rebalancing demonstration to support the transition from living in an inpatient facility to HCBS, for long-term services and supports-eligible individuals.

H.R. 8110, To amend title XIX of the Social Security Act to make permanent the State option to extend protection against spousal impoverishment for recipients of home and community-based services under Medicaid: Permanently extends spousal impoverishment protections for beneficiaries receiving HCBS.

H.R. 8111, To amend title XIX of the Social Security Act to ensure the reliability of address information provided under the Medicaid program: Streamlines processes for States and managed care organizations to update address information for currently enrolled beneficiaries to ensure that beneficiaries reside in the State.

H.R. 8112, To amend title XIX of the Social Security Act to require certain additional provider screening under the Medicaid program: Requires states to check the CMS Data Exchange database to identify providers who have been removed from participating in the Medicaid program.

H.R. 8113, To amend title XIX of the Social Security Act to require reporting on certain directed payments under the Medicaid program: Requires States to report on provider-level data from amounts paid by the State through state-directed payments.

H.R. 8114, To prohibit the Secretary of Health and Human Services from finalizing a rule proposed by the Centers for Medicare and Medicaid Services to place certain limitations on Medicaid payments for home and community-based services: Prohibits the Secretary of HHS from finalizing regulations that would require pass-through payment requirements for HCBS.

H.R. 8115, To amend title XIX of the Social Security Act to allow for the deferral or disallowance of portions of payments for certain managed care violations under Medicaid: Establishes enforcement mechanisms for the Secretary of HHS to make partial deferrals of payments to Medicaid managed care organizations to ensure compliance with federal laws.

For more information, click here.

House Ways and Means Committee To Mark Up Two-Year Telehealth Extension

On May 8, the House Ways and Means Committee will mark up a two-year extension of Medicare telehealth flexibilities that are set to expire at the end of the year. The House and Senate have been discussing whether flexibilities should be extended or made permanent.

House Veterans Affairs Committee Mark Up Includes Six Healthcare Bills

On May 1, the House Veterans Affairs Committee marked up and reported out of committee 21 bills, including six healthcare bills regarding preventative health evaluations, medical facilities and quality management and administrative investigations. One of the bills concerns the inclusion of psychiatric drugs in the Department of Veterans Affairs (VA) drug formulary.

The bills are:

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

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

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

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

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

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

In addition, the committee marked up 15 bills concerning veteran benefits, work study opportunities, employment barriers, claims and appeals processes and fraud prevention efforts.

For more information, click here.

Senate

Senate Finance Committee Releases Discussion Draft Concerning Generic Drug Shortages

On May 3, the Senate Finance Committee released a discussion draft to address and mitigate generic drug shortages. The draft would establish a voluntary Medicare Drug Shortage Prevention and Mitigation Program that would require participants to meet minimum standards and requirements to receive Medicare incentive payments. They include:

• Minimum three-year contracts with generic drug manufacturers;
• Purchase volume and stable pricing commitments;
• Contingency contracts with alternate manufacturers;
• Prohibition of exclusive provider contracting requirements; and
• Transparency standards to address quality control issues.

In addition, the draft would modify the Medicaid Drug Rebate Program to allow for reductions or waivers to the inflation rebate for certain generic drugs in the event of a shortage.

The committee is requesting comments on the proposal. Comments are due by June 6.

For more information, click here.

Twenty-Two Senators Send Letter Concerning VA Access to Non-Opioid Pain Alternatives

On April 16, Sen. Jeanne Shaheen (D-NH) and 21 other senators sent a letter to Department of Veterans Affairs (VA) Secretary Denis McDonough concerning access to non-opioid pain alternatives throughout the VA healthcare system.

The senators are urging the VA to stop utilizing opioid treatments for acute pain and are requesting information on the:

• Number of non-opioid pain alternatives currently on the VA National Formulary;
• Steps the VA has taken to transition away from opioids to treat acute pain;
• Frequency at which VA facilities and community care sites dispense and use non-opioid pain alternatives; and
• Actions Congress could take to help facilitate VA efforts.

For more information, click here.

Senate HELP Committee Holds Hearing on Minority Healthcare Professional Shortages and Maternal Mortality

On May 2, the Senate Health, Education, Labor and Pensions Committee held a hearing to discuss the shortage of minority healthcare professionals and maternal mortality. During the hearing, Ranking Member Bill Cassidy (R-LA) urged the Senate Finance Committee to expand and allocate graduate medical education residency slots in underserved communities. Witnesses were:

• The Honorable Laphonza Butler, United States Senator, California
• The Honorable Michael C. Burgess, MD, United States Congressman, Twenty-Sixth Congressional District of Texas
• Yolanda Lawson, MD, President of the National Medical Association
• Samuel Cook, MD, Resident at the Morehouse School of Medicine
• Michael Galvez, MD, Valley Children’s Hospital, Co-Creator of National Latino Physician Day
• Jaines Andrades, DNP, AGACNP-BC, Nurse Practitioner at Baystate Health
• Brian Stone, MD, FACS, President of Jasper Urology Associates

For more information, click here.

Senate Armed Services Committee Subcommittee on Personnel Holds Hearing on DOD Prescription Drug Shortage Capabilities

On April 30, the Senate Armed Services Committee Subcommittee on Personnel held a hearing to examine Department of Defense (DOD) biomedical research and development capabilities and discuss how the department addresses prescription drug shortages. Members also discussed the possibility of granting DOD authority to manufacture prescription drugs to combat shortages. Witnesses were:

• The Honorable Lester Martínez-López, Assistant Secretary of Defense for Health Affairs, Department of Defense
• David J. Smith, Deputy Assistant Secretary of Defense for Health Readiness Policy and Oversight, Department of Defense
• Mark Dertzbaugh, Principal Assistant for Research and Technology, United States Army Medical Research and Development Command
• Matthew R. Beebe, Director of Acquisition (J7), Defense Logistics Agency
• Melissa Barber, Postdoctoral Fellow, Yale Law School, Yale School of Medicine and Affiliate, Yale Collaboration for Regulatory Rigor, Integrity and Transparency
• Bryce H. P. Mendez, Specialist in Defense Health Care Policy, Congressional Research Service
• Colonel Victor A. Suarez, USA (Ret.), Founder and Principal Growth Partner, Blu Zone Bioscience and Supply Chain Solutions, LLC.

For more information, click here.

MACPAC Chair and Appointed Members Announced

On May 2, Government Accountability Office Comptroller General Gene L. Dodaro announced the appointment of a new chairman and two members, in addition to the reappointment of four members, to the Medicaid and Children’s Health Insurance Program Payment and Access Commission (MACPAC). They are:

• Verlon Jones, MPA, Executive Vice President and Chief Safety Officer at Acentra Health and MACPAC Chair
• Robert Duncan, MBA, Executive Vice President and Chief Operating Officer at Connecticut Children’s Hospital-Hartford, MACPAC Vice Chair
• Doug Brown, RPh, MBA, Senior Vice President of Value and Access at COEUS Consulting
• Michael Nardone, MPA, Former Director of the Disabled and Elderly Health Program Group at the Centers for Medicare and Medicaid Services Center for Medicaid and CHIP Services
• Heidi Allen, PhD, MSW, Associate Professor at Columbia University School of Social Work
• John McCarthy, MPA, Founding Partner at Speire Healthcare Strategies

For more information, click here.

Administration

CMS Releases Draft Guidance Concerning Second Round of Medicare Drug Price Negotiation Program

On May 3, the Centers for Medicare and Medicaid Services (CMS) released draft guidance concerning the second round of negotiations under the Medicare Drug Price Negotiation Program. CMS is requesting comments on the draft guidance. Comments are due by July 2.

For more information, click here.

CMS Announces New IDR Resubmission Process

On May 1, the Centers for Medicare and Medicaid Services announced the release of a new process for resubmitting Independent Dispute Resolution disputes that were originally batched or bundled improperly.

For more information, click here.

CMS Releases Guide Concerning Healthcare Options for Individuals Released from Incarceration

On April 30, the Centers for Medicare and Medicaid Services and the Office of Justice Programs released a joint guide to assist recently released incarcerated individuals with understanding their healthcare service and insurance coverage options.

For more information, click here.

CMS Issues Reminder Concerning 2024 MIPS Improvement Activities

On April 30, the Centers for Medicare and Medicaid Services announced it is accepting improvement activity proposals for the Merit-based Incentive Payment System. Proposals are due by July 1.

For more information, click here.

FDA Releases Draft Guidance Concerning Laboratory Developed Tests

On April 30, the Food and Drug Administration (FDA) released two draft guidances outlining enforcement policies the FDA may issue for certain in vitro diagnostic devices and laboratory-developed tests during the absence or declaration of a Section 564 emergency. The FDA is requesting comments on the guidance. Comments are due by July 5.

For more information on the guidance concerning in vitro devices, click here.

For more information on the guidance concerning laboratory-developed tests, click here.

FDA CDER Releases 2023 Annual Report

On April 30, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research released the 2023 Office of New Drugs Annual Report. The report highlights drugs approved, guidances and reports released and public meetings held by the FDA in 2023.

For more information, click here.

FDA to Host Listening Session to Discuss Advisory Committees

On April 29, the Food and Drug Administration (FDA) announced that it will host a listening session on June 13 to discuss how the composition, use and processes of FDA advisory committees can be improved.

For more information, click here.

FTC Extends Comment Period on RFI Concerning Private Equity Role in Healthcare

On May 1, the Federal Trade Commission announced that the comment period for a request for information examining the impact of private equity and corporate ownership in healthcare will be extended until June 5.

For more information, click here.

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.

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

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 has not yet been submitted to the Federal Register but will go into effect 60 days after submission. 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 Final Rule Implements Direct-To-Consumer Prescription Drug Ad Standards

On Nov. 21, the Food and Drug Administration (FDA) released a final rule to implement 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

GAO Releases Report Concerning Strategic National Stockpile Coordination Challenges

On May 2, the Government Accountability Office (GAO) released a report concerning strategic national stockpile (SNS) coordination challenges that jurisdictions faced during the COVID-19 and Mpox public health emergencies.

After surveying public health officials and reviewing guidance and documentation, the GAO discovered that jurisdictions struggled to understand the SNS inventory and the role of federal agencies, in addition to requesting and receiving assets. The GAO also found that HHS has not yet clearly defined roles for agencies that work with SNS assets. The GAO conducted this study because a provision in the Coronavirus Aid, Relief and Economic Security Act required it to report on the federal response to the COVID-19 pandemic.

For more information, click here.

CBO Presentation Highlights Healthcare Areas that It Requests New Research On

On April 29, the Congressional Budget Office (CBO) released a presentation highlighting the healthcare areas it is requesting new research on. The CBO has called for research on how:

• Healthcare providers would respond to shocks to revenues or costs;
• Changes in Medicaid’s benefit for long-term services and supports would affect the federal budget;
• Federal policies related to pricing drugs would affect innovation in the pharmaceutical industry; and
• Medicare’s coverage of anti-obesity medication would affect the federal budget.

For more information, click here.

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