This Week in Washington: House Ways and Means Committee marks up healthcare bills related to new technologies and coverage for weight loss drugs; CMS releases CY2025 Home Health and End-Stage Renal Disease PPS proposed rules; Supreme Court overturns Chevron Doctrine and dismisses Idaho EMTALA case.

CONGRESS

HOUSE OF REPRESENTATIVES

• House Appropriations Subcommittee Acts on Labor-HHS FY2025 Bill
• House Ways and Means Committee Marks Up Four Healthcare Bills
• House Ways and Means Committee Subcommittee on Health Holds Hearing on Value-Based Care
• House Energy and Commerce Committee Chairmen Send Letter Concerning FDA Foreign Drug Inspections
• Members Send Letter Concerning TRICARE Pharmacy Program Exclusive Contract
• Members Send Letter Concerning AI and Algorithms Used For MA Prior Authorizations
• Members Send Letter Concerning March-In Rights

SENATE

• Senate Finance Committee Chairman Sends Letter Concerning PBM Contracting Practices
• Senators Send Letter Concerning Medicare Beneficiary Access to Diagnostic Scans

COURTS

• U.S Supreme Court Dismisses Idaho EMTALA Case
• U.S. Supreme Court Overturns Chevron Doctrine

ADMINISTRATION

• CMS Announces State RFA for CGT Access Model
• CMS Announces 64 Part B Rebatable Drugs Eligible for Reduced Coinsurance
• CMS Announces NOFO Application Period for TMaH Model
• CMS Releases Pharmacy FAQ Concerning HIV PrEP NCD
• FDA Releases Draft Guidance Concerning Clinical Trial Diversity Action Plans
• FDA Releases Guidance Concerning LDT Small Entity Compliance

PROPOSED RULES

• CMS Releases CY2025 End-Stage Renal Disease PPS Proposed Rule
• CMS Releases CY2025 Home Health PPS Proposed Rule
• CMS Proposed Rule Would Establish Increasing Organ Transplant Access Model

FINAL RULES

• CMS Final Rule Establishes Disincentives for Health Information Blocking
• FDA Final Rule Revises Medical Gas CGMP, Postmarketing Safety Reporting and Labeling
• CMS Final Rule Implements Changes Related to Standards for Electronic Prescribing and Health IT
• CMS Final Rule Expands Access to Healthcare for DACA Recipients
• HHS OCR Final Rule Strengthens Protections Against Disability Discrimination
• 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 Releases Final Rule Concerning Access to Medicaid Services
• FDA Issues Final Rule Regarding Mammography Quality Standards

REPORTS

• CBO Releases Cost Estimates for H.R. 5074, 7512 and 7513
• CBO Releases Report on the Effects of Extending ARPA Expanded Premium Tax Credit

NOTE

• Newsletter Update

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House of Representatives

The House of Representatives is in district work period.

Senate

The Senate is in state work period.

House of Representatives

House Appropriations Subcommittee Acts on Labor-HHS FY2025 Bill

On June 27, the House Appropriations Committee Labor, Health and Human Services (HHS), Education and Related Agencies Subcommittee marked up and reported out of committee the FY 2025 Labor-HHS-Ed appropriations bill. The bill would:

• Fund HHS at $107 billion, $8.5 billion less than in FY 2024 ;
• Cut Centers for Disease Control and Prevention funding by 22 percent and eliminate 23 programs;
• Maintain funding for the National Institutes of Health (NIH) at $48 billion and eliminate 12 NIH centers;
• Decrease Title X family planning grants and prevent federal funds from being used for abortion;
• Increase funding for the National Cancer Institute to $7.875 billion;
• Fund the Administration for Strategic Preparedness and Response at $3 billion;
• Maintain funding for the HHS Office for Civil Rights at $40 million;
• Increase funding for Substance Abuse and Mental Health Services Administration’s substance use prevention block grants; and
• Allocate $400 million to prevent rural hospital closures and increase rural residency programs.

For more information, click here.

House Ways and Means Committee Marks Up Four Healthcare Bills

On June 27, the House Ways and Means Committee marked up and reported out of committee four healthcare bills concerning multi-cancer early detection screening, breakthrough medical devices, anti-obesity drugs and a Medicare cognitive impairment detection benefit. One of the bills would allow Medicare to cover the cost of anti-obesity medications.

The bills are:

H.R. 1691, Ensuring Patients Access to Critical Breakthrough Products Act of 2023: Provides a specific pathway for immediate transitional Medicare coverage of breakthrough medical devices for four years once the device has been approved by the Food and Drug Administration (FDA).

H.R. 2407, Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act: Expands access to transitional Medicare coverage and reimbursement for FDA-approved multi-cancer early detection screening tests.

H.R. 8816, American Medical Innovation and Investment Act: Would update coverage evidence development requirements and includes provisions related to innovation.

H.R. 4818, Treat and Reduce Obesity Act of 2023: Allows Medicare to cover anti-obesity medications for new Medicare beneficiaries who already had a non-Medicare plan covering the medicine at least one year before enrolling in the federal health program.

For more information, click here.

House Ways and Means Committee Subcommittee on Health Holds Hearing on Value-Based Care

On June 26, the House Ways and Means Committee Subcommittee on Health held a hearing concerning value-based care. Members discussed how to define and measure high quality care services, increase Medicare Physician Fee Schedule payments and address rural healthcare provider challenges. Witnesses were:

• Sarah Chouinard, Main Street Health, Chief Medical Officer
• Stephen Nuckolls, Coastal Carolina Health Care and PA, Chief Executive Officer
• Matthew Philip, Duly Health and Care, Chief Medical Officer
• Robert Berenson, Urban Institute Fellow

For more information, click here.

House Energy and Commerce Committee Chairmen Send Letter Concerning FDA Foreign Drug Inspections

On June 21, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) and two subcommittee chairmen, Brett Guthrie (R-KY) and Morgan Griffith (R-VA), sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf, concerning the FDA Foreign Drug Inspection Program.

A committee analysis of FDA inspections demonstrated variations in inspection outcomes. The chairmen are requesting the FDA submit records and documents concerning inspector:

• Anti-bribery and gratuity training materials;
• Performance evaluation metrics;
• Selection process; and
• Background checks and periodic personnel reviews.

For more information, click here.

Members Send Letter Concerning TRICARE Pharmacy Program Exclusive Contract

On June 26, Rep. Carter (R-GA) and 20 other representatives sent a letter to Assistant Secretary of Defense for Health Affairs Dr. Lester Martinez-Lopez and Defense Health Agency (DHA) Director Lieutenant General Telita Crosland, concerning the DHA’s decision to grant an exclusive contract to a pharmacy benefit manager (PBM) to administer the TRICARE pharmacy program.

The members are concerned that the PBM denies coverage of expensive specialty drugs, increases the cost of generic drugs and engages in anti-competitive practices. They are requesting the DHA provide information on TRICARE pharmacies, care denials and network adequacy requirements.

The letter was also signed by Sens. Warren (D-MA), Rounds (R-SD) and Welch (D-VT).

For more information, click here.

Members Send Letter Concerning AI and Algorithms Used For MA Prior Authorizations

On June 25, Rep. Chu (D-CA) and 45 other members of Congress sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure concerning the use of artificial intelligence (AI) and algorithmic software by Medicare Advantage (MA) providers during prior authorization coverage decisions. The members are concerned these tools result in erroneous denials of care for beneficiaries and are urging CMS to:

• Clarify the specific elements that must be contained in denial notices;
• Establish an approval process to review AI and algorithmic tools and their inputs;
• Review algorithms and AI tools currently being used;
• Prohibit the use of AI/algorithmic tools and software in coverage denials until a systematic review of their use can be completed;
• Clarify how CMS distinguishes between uses of algorithms or software that account for individual circumstances and those that do not; specify what criteria, methods or data will be used to determine their distinction; and clarify how this requirement will be enforced and communicated to plans;
• Outline when MA organizations are able to use internal coverage criteria when making medical necessity determinations for basic Medicare benefits; and
• Impose a minimum time period during which MA plans cannot issue a termination notice after their prior termination decision has been reversed by a Medicare contractor.

The letter was also signed by Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sanders (I-VT) and Sens. Warren (D-MA), Smith (D-MN), Braun (R-IN) and Brown (D-OH).

For more information, click here.

Members Send Letter Concerning March-In Rights

On May 29, Reps. Buchanan (R-FL) and Smith (R-NE) and Sens. Blackburn (R-TN) and Tillis (R-NC) sent a letter to Director of the National Institute of Standards and Technology (NIST) and Undersecretary of Commerce for Standards and Technology Laurie Locascio, expressing their concern over a Draft Interagency Guidance Framework for Considering the Exercise of March-in Rights.

The members are concerned that allowing the federal government to invoke march-in rights to force a patent holder to share the intellectual property of their product if they refuse to adjust the product’s price will:

• Stifle competition;
• Decrease innovation; and
• Hinder public-private collaboration and the development of new products.

For more information, click here.

Senate

Senate Finance Committee Chairman Sends Letter Concerning PBM Contracting Practices

On June 24, Senate Finance Committee Chairman Ron Wyden (D-OR) sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, urging CMS to strengthen oversight and regulatory enforcement of Medicare Part D program requirements for plan sponsors and pharmacy benefit managers (PBMs).

The chairman is concerned that PBMs are not adhering to a CMS final rule that prohibits plan sponsors and PBMs from retroactively assessing direct and indirect renumeration fees or claims submitted by pharmacies under Medicare Part D. The chairman is urging CMS to:

• Enforce “Any Willing Pharmacy” requirements by ensuring that PBMs reimburse pharmacies at a minimum of the cost to acquire and dispense covered prescription drugs;
• Enforce through auditing, the pharmacy price concessions provision included in the CMS Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Program final rule, which requires all pharmacy price concessions be applied to negotiated prices at the point of sale under Part D;
• Implement standardized pharmacy measures, including evaluation and reporting or plan performance measures that CMS has finalized in pending rulemaking;
• Review formal and informal complaints about PBM contracting practices under Part D received during the past 18 months to determine if the number of complaints is higher than in prior years; and
• Provide information within 60 days, on the number of formal or informal complaints received about PBM contracting practices during the past 18 months, a description of the type of complaints received and their disposition.

For more information, click here.

Senators Send Letter Concerning Medicare Beneficiary Access to Diagnostic Scans

On June 25, Sen. Blackburn (R-TN) and 14 other senators sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, urging CMS to strengthen Medicare beneficiary access to Positron Emission Tomography and Single Photon Emission Computed Tomography diagnostic scans.

The senators request that CMS address packaging of payment for diagnostic radiopharmaceuticals in the upcoming calendar year 2025 rulemaking on Hospital Outpatient Prospective Payment System to expand access to diagnostic scans in hospital outpatient settings.

For more information, click here.

Courts

U.S Supreme Court Dismisses Idaho EMTALA Case

On June 27, in a 6-3 opinion, the U.S. Supreme Court dismissed a case about whether an Idaho law limiting abortions is pre-empted by the Emergency Medical Treatment and Labor Act (EMTALA). The decision reinstates a lower court ruling that temporarily allowed hospitals in the state to perform emergency abortions to protect the life of the mother and the health of the mother.

U.S. Supreme Court Overturns Chevron Doctrine

On June 28, in a 6-3 opinion, the U.S. Supreme Court overturned the Chevron doctrine of over 40 years, that required courts to defer to federal agencies’ reasonable interpretations of ambiguous statutes. The overturning of the doctrine limits the authority of regulatory agencies and may lead to legal challenges against:

• Federal rules concerning the administration of health insurance programs including Medicare, Medicaid and public health programs;
• The Medicare Drug Price Negotiation Program;
• The Food and Drug Administration’s authority to regulate pharmaceuticals;
• The Food and Drug Administration’s authority to regulate Laboratory Developed Tests (LDTs); and
• National Institutes of Health rules relating to clinical trial transparency and requirements.

Administration

CMS Announces State RFA for CGT Access Model

On June 28, the Centers for Medicare and Medicaid Services announced the release of the State Request for Applications for the Cell and Gene Therapy Access Model, which would increase access to potentially life-changing treatments for Medicaid beneficiaries with rare and severe diseases. Applications are due by Feb. 28, 2025.

For more information, click here.

CMS Announces 64 Part B Rebatable Drugs Eligible for Reduced Coinsurance

On June 26, the Centers for Medicare and Medicaid Services announced 64 Medicare Part B drugs that will be eligible for lowered coinsurance rates between July 1 and September 30, 2024. The drugs will have a lowered Part B coinsurance rate from July 1, 2024 – September 30, 2024, since each drug company raised prices faster than the rate of inflation. Over 750,000 people with Medicare use these drugs annually, which treat conditions such as osteoporosis, cancer, and infections.

For more information, click here.

CMS Announces NOFO Application Period for TMaH Model

On June 26, the Centers for Medicare and Medicaid Services announced that it is accepting notice of funding opportunity applications for the Transforming Maternal Health Model, which would improve health outcomes for mothers and infants enrolled in Medicaid and the Children’s Health Insurance Program. Applications are due by Sept. 20.

For more information, click here.

CMS Releases Pharmacy FAQ Concerning HIV PrEP NCD

On June 25, the Centers for Medicare and Medicaid Services released a technical frequently asked questions guide for pharmacies, to assist in preparing for a potential change in coverage and clarify how Medicare Part B claims for PrEP can be submitted. If the proposed NCD is implemented, it would result in a change to how Medicare coverage would be able to get PrEP, making it available without cost-sharing (i.e., deductibles or copays).

For more information, click here.

FDA Releases Draft Guidance Concerning Clinical Trial Diversity Action Plans

On June 26, the Food and Drug Administration released draft guidance to assist sponsors in conducting clinical studies that meet requirements for the submission of Diversity Action Plans.

For more information, click here.

FDA Releases Guidance Concerning LDT Small Entity Compliance

On June 25, the Food and Drug Administration (FDA) released guidance concerning small entity compliance with the FDA laboratory developed test (LDT) final rule. The guidance describes how the FDA will phase out its general enforcement discretion approach for LDTs and how small entities can come into compliance with final rule regulations.

For more information, click here.

Proposed Rules

CMS Releases CY2025 End-Stage Renal Disease PPS Proposed Rule

On June 27, the Centers for Medicare and Medicaid Services (CMS) released the calendar year (CY) 2025 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) proposed rule. The proposed rule would:

• Increase the ESRD PPS base rate by $2.18 to $273.20. CMS projects a 3.9 percent increase in total payments for hospital-based ESRD facilities and 2.1 percent increase in total payments for freestanding facilities;
• Adjust the Acute Kidney Injury (AKI) dialysis payment rate to be $273.20;
• Implement a new ESRD PPS-specific wage index;
• Expand the list of ESRD outlier services to include drugs and biological products;
• Incorporate technical changes to the methodologies for calculating outlier services fixed-dollar loss amounts and Medicare allowable payment amounts;
• Modify the Low-Volume Payment Adjustment (LVPA) and create a two-tiered LVPA;
• Provide information on how CMS will operationalize the inclusion of oral-only drugs and biological products into the ESRD PPS;
• Allow payment for AKI dialysis services furnished to beneficiaries in their homes;
• Permit ESRD facilities to bill Medicare for the home and self-dialysis training add-on payment adjustment for beneficiaries with AKI;
• Update ESRD facility Conditions for Coverage; and
• Modify the ESRD Quality Incentive Program.

Public comments will be accepted until Aug. 26, 2024. For more information, click here.

CMS Releases CY2025 Home Health PPS Proposed Rule

On June 26, the Centers for Medicare and Medicaid Services (CMS) released the calendar year (CY) 2025 Home Health Prospective Payment System (PPS) proposed rule. The proposed rule would:

• Reduce net home health payments by an estimated $280 million in CY2025, 1.7 percent less relative to the current year;
• Decrease the base payment rate by 4.1 percent due to the implementation of the Patient-Driven Groupings Model;
• Add a new standard to the Home Health Agency (HHA) Conditions of Participation that would require HHAs to develop, apply and maintain a policy for accepting patients to service;
• Adopt and modify certain patient assessment items related to health-related social needs in the Home Health Quality Reporting Program;
• Revise infection prevention and control requirements for long-term care facilities; and
• Require reporting of data related to respiratory syncytial virus and influenza beginning Jan. 1, 2025.

Public comments will be accepted until Aug. 26, 2024. For more information, click here.

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.

Final Rules

CMS Final Rule Establishes Disincentives for Health Information Blocking

On June 24, the Centers for Medicare and Medicaid Services (CMS) released a final rule that would establish disincentives for healthcare providers that interfere with, prevent or materially discourage access, exchange or use of electronic health information (EHI). Disincentives for entities who engage in information blocking will consist of the following:

• Hospitals under the Medicare Promoting Interoperability Program will experience a reduction of the market basket update by 75 percent;
• Critical access hospitals will experience a reduction from 101 to 100 percent of reasonable costs;
• Clinicians in the Medicare Merit-based Incentive Payment System (MIPS) will receive a score of zero in the MIPS Promoting Interoperability performance category;
• Accountable care organization providers will be ineligible to participate in the Medicare Shared Savings Program for at least one year and may not be eligible to receive revenue they earn through the program.

In addition to CMS, the Department of Health and Human Services Office of the National Coordinator for Health Information Technology is proposing the rule.

The rule will go into effect on July 31, 2024. For more information, click here.

FDA Final Rule Revises Medical Gas CGMP, Postmarketing Safety Reporting and Labeling

On June 17, the Food and Drug Administration (FDA) released a final rule that will revise current good manufacturing practices, postmarketing safety reporting and labeling that apply to certain medical gases. The final rule will:

• Add operations required to produce a medical gas to the list of operations that are performed by its manufacturer;
• Specify requirements for the declaration of net quantity of contents in the labeling of designated medical gases and medically appropriate combinations;
• Require standard format labeling for all designated medical gases;
• Revise medical gas container labeling regulations; and
• Implement medical gas cleaning, adverse event reporting and certification ownership transfer requirements.

The rule will go into effect on Dec. 18, 2025. For more information, click here.

CMS Final Rule Implements Changes Related to Standards for Electronic Prescribing and Health IT

On June 13, the Centers for Medicare and Medicaid Services (CMS) Office of the National Coordinator for Health Information Technology (ONC) released a final rule that will revise Medicare Prescription Drug Benefit and ONC regulations to implement changes concerning required electronic prescribing and health information technology (IT) standards.

The final rule will require Part D sponsors, prescribers and dispensers of covered Part D to:

• Comply with standards CMS has adopted directly or is requiring by cross-referencing standards ONC adopts for electronically transmitting prescriptions; and
• Use National Council for Prescription Drug Programs (NCPDP) Formulary and Benefit (F&B) standard version 3.0 or comply with a standard adopted by ONC after Jan. 1, 2027.

The rule will also require Part D sponsor real-time benefit tools to comply with a standard adopted by ONC and will cross-reference the Health Insurance Portability and Accountability Act of 1996 regulations in 45 CFR part 162 for eligibility transactions.

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

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 (OCR) 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.

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 rule will go into effect on July 29, 2024. 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 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.

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

CBO Releases Cost Estimates for H.R. 5074, 7512 and 7513

On June 26, the Congressional Budget Office (CBO) released cost estimates for H.R. 5074, Kidney PATIENT Act of 2023; H.R. 7512, Real-Time Benefit Tool Implementation Act; and H.R. 7513, Protecting America’s Seniors’ Access to Care Act.

The CBO projects that over the 2024-2034 period:

H.R. 5074: This bill delays a change to the payment methodology under Medicare for oral drugs that are used to treat end-stage renal disease (ESRD). Under current regulations, beginning January 1, 2025, the Centers for Medicare & Medicaid Services will incorporate payments for oral-only ESRD drugs into the ESRD prospective payment system rather than issuing separate payments to ESRD facilities. The bill delays implementation of this policy until January 1, 2033, or until an approved intravenous drug is available, whichever is earlier. CBO estimates that the legislation will increase or decrease budget outlays by $500,000.

H.R. 7512: Requires the Centers for Medicare and Medicaid Services to roll out a digital tool allowing doctors to price shop for medicine before prescribing medicine to their patients. The legislation would have no effect on federal budget outlays.

H.R. 7513: Would repeal the Biden administration’s rule increasing staffing in nursing homes. The CBO estimates that the legislation would decrease federal outlays by $22 billion.

For more information, click here.

CBO Releases Report on the Effects of Extending ARPA Expanded Premium Tax Credit

On June 24, the Congressional Budget Office (CBO) released a report outlining the effects of permanently extending the expansion of the American Rescue Plan Act (ARPA) premium tax credit and the costs of that credit for Deferred Action for Childhood Arrivals (DACA) recipients. The premium tax credit lowers the out-of-pocket cost of health insurance premiums for individuals who purchase coverage through the marketplaces.

The CBO projects that a permanent extension of the credit would over the 2025-2034 period:

• Increase the budget deficit by $335 billion;
• Increase direct spending by $275 billion;
• Decrease revenues by $60 billion; and
• Increase the number of individuals with health insurance coverage by 3.4 million.

For more information, click here.

Note

The next Washington Healthcare Update will be published on July 15.