This Week in Washington: House Ways and Means Committee marks up telehealth legislation; CMS extends state Medicaid unwinding flexibilities; Senate HELP Committee ranking member releases white paper outlining possible NIH reforms.

CONGRESS

HOUSE

• House Ways and Means Committee Marks Up Telehealth Legislation
• House Energy and Commerce Committee Chairmen Send Letter Concerning ASPR Management of SNS Funding
• Forty Representatives Send Letter Concerning Hospice Benefit Integrity Issues
• House Energy and Commerce Committee Subcommittee on Health Announces Hearing with FDA Officials

SENATE

• Senate HELP Committee Ranking Member Releases White Paper Outlining Possible NIH Reforms
• Sen. Marshall to Reintroduce Improving Seniors’ Timely Access to Care Act

ADMINISTRATION

• White House Releases Policy on Oversight of Biological Agent and Toxins Research
• CMS Releases Guidance Concerning Eligibility Determinations and Extension of Section 1902(e)(14)(A) Waivers
• CMS Provides Update on Unauthorized Plan Switching and Enrollments
• FDA Releases Guidance on Medical Device Remanufacturing
• FDA Requests Information on Clinical Research Terminology Definitions

PROPOSED RULES

• CMS Proposed Rule Would Establish Increasing Organ Transplant Access Model
• 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• IHS Final Rule Removes Outdated Regulations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

• CMS Releases Quarterly Medicaid and CHIP MAGI Application Processing Time Report
• CMS Releases 2024 Medicare Trustees Report
• GAO Releases Report Concerning CMS Hospice Oversight

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House

House Ways and Means Committee Marks Up Telehealth Legislation

On May 8, the House Ways and Means Committee marked up and reported out of committee six bills that preserve telehealth and health-at-home service flexibilities, prevent rural hospital closures, strengthen ambulance service access and expand the number of doctors and nurses in rural communities.

The bills are:

H.R. 8261, Preserving Telehealth, Hospital and Ambulance Access Act: Expands Medicare telehealth flexibilities for two years, Hospital-at-Home flexibilities for five years and Medicare supplemental payments for rural hospitals and ambulance services.

H.R. 7931, Preserving Emergency Access in Key Sites (PEAKS) Act: Permanently expands Medicare emergency ambulance coverage for mountainous communities.

H.R. 8245, Rural Hospital Stabilization Act: Establishes grants to help rural hospitals stabilize their finances and carry out minor renovations, care delivery training and equipment acquisition.

H.R. 8244, Ensuring Seniors’ Access to Quality Care Act: Allows nursing homes to continue operating their certified nurse assistant training program if they incur fines, so long as the fines are unrelated to direct resident care.

H.R. 8235, Rural Physician Workforce Preservation Act: Ensures 10 percent of the 1,200 Medicare Graduate Medical Education slots reserved for rural hospitals are appropriately distributed.

H.R. 8246, Second Chances for Rural Hospitals Act: Expands Rural Emergency Hospital (REH) eligibility by allowing hospitals that have been closed since 2014 to become a REH and receive additional funding.

For more information, click here.

House Energy and Commerce Committee Chairmen Send Letter Concerning ASPR Management of SNS Funding

On May 9, House Energy and Commerce Committee Chairman Cathy McMorris Rogers (R-WA) and two subcommittee chairmen, Brett Guthrie (R-KY) and Morgan Griffith (R-VA), sent a letter to Assistant Secretary for Preparedness and Response Dawn O’Connell, concerning the Administration for Strategic Preparedness and Response’s (ASPR) management of supplemental funding for the strategic national stockpile (SNS).

The chairmen are concerned that ASPR has:

• Inadequately managed SNS funding;
• Awarded few vendor-managed inventory contracts to resupply SNS products; and
• Granted SNS warehouse contracts to companies lacking technical expertise.

For more information, click here.

Forty Representatives Send Letter Concerning Hospice Benefit Integrity Issues

On May 7, Rep. Blumenauer (D-OR) and 39 other representatives sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure regarding deficiencies, fraud and abuse among hospice providers enrolled in the Medicare program.

The members are concerned that fraudulent hospice providers are enrolling in and receiving payments from the Medicare program and are urging CMS to strengthen its oversight of hospice programs.

For more information, click here.

House Energy and Commerce Committee Subcommittee on Health Announces Hearing with FDA Officials

On May 22, the House Energy and Commerce Committee Subcommittee on Health will hold a hearing to discuss the Food and Drug Administration’s (FDA) regulation of drugs, biologics and medical devices. The directors of the FDA Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research and Center for Devices and Radiological Health will testify.

For more information, click here.

Senate

Senate HELP Committee Ranking Member Releases White Paper Outlining Possible NIH Reforms

On May 9, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) released a white paper on the National Institutes of Health (NIH), outlining proposals to modernize and reform NIH transparency, research integrity and grant management.

The ranking member is urging the NIH to:

• Facilitate biomedical competition and innovation;
• Utilize artificial intelligence to prioritize grants;
• Reorganize the Intramural Research Program;
• Address inconsistencies in research claims; and
• Implement new oversight tools to identify grant compliance violations.

For more information, click here.

Sen. Marshall to Reintroduce Improving Seniors’ Timely Access to Care Act

On May 8, Sen. Marshall (R-KS) announced that he will reintroduce the Improving Seniors’ Timely Access to Care Act. This legislation would shift Medicare Advantage prior authorization to an electronic system and establish a real-time decision process.

The bill passed the House in Sept. 2022 but did not pass the Senate due to a Congressional Budget Office (CBO) cost estimate that predicted the bill would cost $16 billion to implement. However, the release of a Centers for Medicare and Medicaid Services final rule establishing an electronic prior authorization system resulted in the CBO reducing the bill’s cost estimate to zero.

Administration

White House Releases Policy on Oversight of Biological Agent and Toxins Research

On May 6, the White House released the Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential. The policy outlines the federal oversight framework for research on biological agents and toxins that could threaten public health and national security.

For more information, click here.

CMS Releases Guidance Concerning Eligibility Determinations and Extension of Section 1902(e)(14)(A) Waivers

On May 9, the Centers for Medicare and Medicaid Services (CMS) released guidance concerning Medicaid and Children’s Health Insurance Program (CHIP) eligibility renewal strategies, application determinations and processing times.

In addition, CMS released guidance concerning unwinding-related flexibilities and announced that it is extending section 1902(e)(14) waivers through June 30, 2025.

For more information on the Medicaid and CHIP application guidance, click here.

For more information on the 1902(e)(14) waiver guidance, click here.

CMS Provides Update on Unauthorized Plan Switching and Enrollments

On May 6, the Centers for Medicare and Medicaid Services provided an update on its efforts to resolve unauthorized plan switches and enrollments by Marketplace agents and brokers.

For more information, click here.

FDA Releases Guidance on Medical Device Remanufacturing

On May 10, the Food and Drug Administration released guidance concerning the remanufacturing of medical devices. The guidance intends to clarify whether activities performed on devices should be considered servicing or remanufacturing.

For more information, click here.

FDA Requests Information on Clinical Research Terminology Definitions

On May 6, the Food and Drug Administration (FDA) and National Institutes of Health (NIH) announced they are requesting information on definitions related to clinical study design terminology developed by an FDA-NIH working group. Comments are due by June 24.

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 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 2023 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

CMS Releases Quarterly Medicaid and CHIP MAGI Application Processing Time Report

On May 9, the Centers for Medicare and Medicaid Services released the Quarterly Modified Adjusted Gross Income Application Processing Time Report. The report highlights the average number of days elapsed between the date states received an application and conducted a final eligibility determination.

For more information, click here.

CMS Releases 2024 Medicare Trustees Report

On May 6, the Centers for Medicare and Medicaid Services released the 2024 Medicare Trustees Report. The report evaluates the short- and long-term financial status of the Federal Hospital Insurance (HI) and Federal Supplementary Medicare Insurance (SMI) Trust Funds.

Trustees project that the HI Trust Fund will be depleted in 2036, five years later than predicted last year, due to:

• Strong economic activity;
• Lower inpatient hospital and home health agency costs; and
• The exclusion of medical education expenses in costs used to develop Medicare Advantage spending totals.

For more information, click here.

GAO Releases Report Concerning CMS Hospice Oversight

On May 8, the Government Accountability Office (GAO) released a report concerning Centers of Medicare and Medicaid Services’ (CMS) oversight of hospices and the steps it has taken to prioritize the administration of overdue hospice surveys.

After reviewing documentation and interviewing CMS and provider and consumer group officials, the GAO discovered that:

• CMS has not implemented internal guidance concerning the use of enforcement tools for hospices not complying with quality standards;
• 15 percent of hospices that had at least one standard survey in each three-year reporting cycle between 2017 and 2022 were cited with serious quality deficiencies; and
• 10 percent of hospices participating in Medicare for 36 months or more were overdue for a survey.

The GAO conducted this study because it was required to report on hospice quality of care and CMS’ oversight of such care by a provision in the Consolidated Appropriations Act of 2021.

For more information, click here.