This Week in Washington: Senate Finance Committee Chairman sends letters concerning healthcare cybersecurity measures; House Energy and Commerce Committee Oversight and Investigations Subcommittee holds hearing on 340B program; CMS releases 2025 updates to Medicaid and CHIP core set quality measures.

CONGRESS

HOUSE

• House Energy and Commerce Committee Oversight and Investigations Subcommittee Holds Hearing on 340B Program
• Forty-Four Representatives Send Letter Concerning CKD Federal Screening Recommendation
• Members Request Information on How Congress Should Draft Medical Innovation Legislation
• Members Send Letter Concerning Coverage of Digital Therapeutics

SENATE

• Senate Finance Committee Chairman Sends Letter Concerning Cybersecurity Measures
• Senate Finance and HELP Committee Chairmen Send Letter Concerning Data Analytics Companies
• Senators Send Letter Concerning OPO Pancreata Procurement Practices
• Senators Send Letter Concerning Mental Health Parity Proposed Rule

ADMINISTRATION

• CMS Sends Letter Concerning 2025 Updates to Medicaid and CHIP Quality Measures
• FDA Releases Guidance Concerning Platform Technology Designation Program
• FDA Releases Draft Guidance Concerning Bioresearch Monitoring Inspections
• HRSA Announces $15 Million Investment for Rural MOMS Program
• SAMHSA Expands CCBHC Medicaid Demonstration Program

PROPOSED RULES

• CMS Proposed Rule Would Establish Increasing Organ Transplant Access Model
• FDA Proposed Rule Establishes Criteria for Drug Products with Demonstrable Compounding Difficulties

FINAL RULES

• FDA Final Rule Allows Owner of Refused Device to Provide Testimony
• CMS Final Rule Expands Access to Healthcare for DACA Recipients
• HHS OCR Final Rule Strengthens Protections Against Disability Discrimination
• 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 Final Rule Concerning STLDI Plans
• FDA Issues Final Rule Regarding Mammography Quality Standards

REPORTS

• HHS OIG Releases Spring 2024 Semiannual Report to Congress
• CBO Releases Cost Estimate of H.R. 7218, BOLD Infrastructure for Alzheimer’s Reauthorization Act of 2024
• CBO Releases Presentation on Impacts of Extreme Temperatures on Medicare Population
• FDA Releases CY2023 Drug Shortages Report to Congress
• GAO Releases Report Concerning Over-the-Counter Hearing Aids
• GAO Releases Report Concerning VA Community Care Networks Mental Health Adequacy
• GAO Releases Report Concerning Disabled Healthcare Workforce and Provider Training
• GAO Releases Report Regarding Medicaid Managed Care Plan Prior Authorization Decisions

COURTS

• U.S. District Court Rules Against CMS in Medicare Advantage Star Ratings Lawsuit

---

House

House Energy and Commerce Committee Oversight and Investigations Subcommittee Holds Hearing on 340B Program

On June 4, the House Energy and Commerce Committee Oversight and Investigations Subcommittee held a hearing on the 340B Drug Pricing Program. Members discussed whether the program is operating effectively and whether more transparency and oversight is needed to determine if 340B participants are using program savings appropriately.

The hearing comes a week after Rep. Bucshon (R-IN) introduced the 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act, which would clarify 340B program operations and ensure savings are used to benefit patients.

Witnesses were:

• Anthony DiGiorgio, D.O., MHA, University of California, San Francisco Health Neurosurgeon
• Sue Veer, President and CEO of Carolina Health Center
• William Smith, PhD, Senior Fellow and Director of Pioneer Life Sciences Initiative at the Pioneer Institute
• Matthew Perry, President and CEO, Genesis Healthcare System

For more information, click here.

Forty-Four Representatives Send Letter Concerning CKD Federal Screening Recommendation

On June 3, Rep. Bucshon (R-IN) and 43 other representatives sent a letter to Agency for Healthcare Research and Quality Director Robert Otto Valdez and U.S. Preventive Services Task Force (USPSTF) Chairman Wanda Nicholson concerning the development of a federal screening recommendation for people at high risk of chronic kidney disease (CKD).

The members are urging the USPSTF to recognize clinical diseases such as diabetes and hypertension as independent risk factors for CKD and to ensure that access to screening for vulnerable populations is not inadvertently restricted.

For more information, click here.

Members Request Information on How Congress Should Draft Medical Innovation Legislation

On June 6, Reps. Bucshon (R-IN) and DeGette (D-CO) sent a letter to healthcare stakeholders requesting information on how Congress should draft legislation to facilitate medical innovation and build on the 21^st Century Cures Act and the Cures 2.0 Act.

The members request information on:

• Whether provisions of the Cures 2.0 Act that have been finalized through legislation or executive action meet needs that the original Cures 2.0 Act aimed to address;
• What elements are missing that are essential for further medical innovation; and
• What reforms or incentives are needed to enhance or improve the structure of agencies, programs and offices.

Comments are due by Aug. 2. For more information, click here.

Members Send Letter Concerning Coverage of Digital Therapeutics

On May 31, Reps. Hern (R-OK), Thompson (D-CA), Pfluger (R-TX) and Matsui (D-CA) sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure concerning Medicare coverage of digital therapeutics.

The members are concerned that CMS has not yet clarified payment and coding for many digital therapeutics under existing benefit categories. They are urging CMS to pay for therapeutics when they fall under the durable medical equipment benefit category and are furnished incident to a physician service.

Senate

Senate Finance Committee Chairman Sends Letter Concerning Cybersecurity Measures

On June 5, Senate Finance Committee Chairman Ron Wyden (D-OR) sent a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra concerning healthcare company cybersecurity measures. The chairman is concerned over HHS’ policy that allows healthcare companies to self-regulate their cybersecurity practices and is urging HHS to:

• Require minimum, mandatory technical cybersecurity standards for systemically important entities (SIE), including clearinghouses and large health systems;
• Mandate SIEs to adopt resiliency requirements;
• Conduct periodic cybersecurity audits of covered entities and business associates; and
• Provide technical assistance on cybersecurity to healthcare providers.

In addition, the chairman sent a letter to Federal Trade Commission Chairman Lisa S. Khan and U.S. Securities and Exchange Commission Chairman Gary Gensler requesting they investigate whether a lack of multi-factor authentication and cybersecurity best practices facilitated a recent cyberattack that impacted providers across the country.

For more information on the HHS letter, click here.

For more information on the FTC letter, click here.

Senate Finance and HELP Committee Chairmen Send Letter Concerning Data Analytics Companies

On May 29, Senate Finance and Health, Education, Labor and Pensions Committee Chairmen Ron Wyden (D-OR) and Bernie Sanders (I-VT) sent a letter concerning the practice of self-insured employer-sponsored group health plans, to route out-of-network payment negotiations through third-party data analytics companies.

The chairmen are concerned that:

• Data analytics company negotiations significantly reduce plan payments for out-of-network services and increase costs for patients; and
• Data analytics software used to determine payment rates presents a conflict of interest between a plan’s liability for out-of-network claims and responsibility to provide benefits pursuant to the Employee Retirement Income Security Act.

For more information, click here.

Senators Send Letter Concerning OPO Pancreata Procurement Practices

On June 6, Senate Finance Committee Chairman Ron Wyden (D-OR) and Sens. Grassley (R-IA), Cardin (D-MD) and Young (R-IN) sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, concerning the procurement of pancreata by organ procurement organizations (OPOs).

The senators are concerned that OPOs are not using procured pancreata for research specific to islet cell transplantation and are instead procuring them to fulfill OPO recertification conditions. The senators urge CMS to strengthen oversight of OPOs and:

• Amend existing regulation to clarify that research for purposes of OPO recertification is defined as islet cell transplantation;
• Recommend that research be carried out under a Food and Drug Administration-approved clinical trial; and
• Validate and monitor the accuracy of data submitted by OPOs consistent with the definition of pancreata recovered for research.

For more information, click here.

Senators Send Letter Concerning Mental Health Parity Proposed Rule

On June 6, Democrat Sens. Murphy (CT), Welch (VT), Padilla (CA), Markey (MA), Smith (MN), Klobuchar (MN) and Luján (NM) sent a letter to Department of Health and Human Services Secretary Xavier Becerra, Employee Benefits Security Administration Assistant Secretary Lisa Gomez and Internal Revenue Service Deputy Commissioner Douglas O’Donnell, concerning a 2023 proposed rule that aims to strengthen enforcement of the 2008 Mental Health Parity and Addiction Equity Act.

The senators are concerned that patients are unable to access mental health and substance use disorder services due to low reimbursement rates that prevent providers from joining insurance networks and offering critical care to patients. They are urging the departments to finalize the proposed rule as soon as possible.

For more information, click here.

Administration

CMS Sends Letter Concerning 2025 Updates to Medicaid and CHIP Quality Measures

On May 30, the Centers for Medicare and Medicaid Services sent a letter to state health officials, outlining the 2025 updates to the core set of children’s healthcare quality measures for Medicaid and the Children’s Health Insurance Program and the core set of quality measures for adults enrolled in Medicaid.

For more information, click here.

FDA Releases Guidance Concerning Platform Technology Designation Program

On May 29, the Food and Drug Administration released guidance concerning the Platform Technology Designation Program for drug development. The guidance outlines:

• Eligibility factors for receiving a platform technology designation;
• Potential benefits of receiving a designation;
• How to leverage data from designated platform technologies;
• How to discuss a planned designation request as part of a milestone meeting;
• The recommended content of a designation request submission; and
• The review timelines for a designation request.

For more information, click here.

FDA Releases Draft Guidance Concerning Bioresearch Monitoring Inspections

On June 4, the Food and Drug Administration (FDA) released draft guidance concerning processes and practices applicable to bioresearch monitoring inspections. The draft guidance outlines:

• The types of records and information required to be provided during an inspection; and
• Best practices for communication between the FDA and industry before or during an inspection or request for records or information.

For more information, click here.

HRSA Announces $15 Million Investment for Rural MOMS Program

On June 3, the Department of Health and Human Services Health Resources and Services Administration announced that it will invest $15 million through the Rural Maternity and Obstetrics Management Strategies Program to strengthen maternal care and reduce disparities in rural communities.

For more information, click here.

SAMHSA Expands CCBHC Medicaid Demonstration Program

On June 4, the Substance Abuse and Mental Health Services Administration announced that it had added 10 new states to the Certified Community Behavioral Health Clinic Medicaid Demonstration Program. The program provides states with funding needed to expand access to mental health and substance use services.

The states are AL, IA, IL, IN, KS, ME, NH, NM, RI and VT.

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.

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

FDA Final Rule Allows Owner of Refused Device to Provide Testimony

On May 31, the Food and Drug Administration (FDA) released a final rule that amends a policy that allows the agency to destroy a device valued at $2,500 or less that has been refused admission into the United States (U.S.).

The final rule will allow the owner or consignee of a refused device valued at $2,500 or less to present testimony when the FDA intends to administratively destroy it.

The rule will go into effect on July 1, 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 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.

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 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 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 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.

FDA Issues Final Rule Regarding Mammography Quality Standards

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

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

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

Reports

HHS OIG Releases Spring 2024 Semiannual Report to Congress

On June 3, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Spring 2024 Semiannual Report to Congress. The report highlights the work the OIG has undertaken to address risks, problems, abuses and deficiencies arising from the administration of HHS programs and operations over the last six months.

For more information, click here.

CBO Releases Cost Estimate of H.R. 7218, BOLD Infrastructure for Alzheimer’s Reauthorization Act of 2024

On May 29, the Congressional Budget Office (CBO) released a cost estimate for H.R. 7218, the Building Our Largest Dementia Infrastructure for Alzheimer’s Reauthorization Act of 2024. The legislation would provide the Centers for Disease Control and Prevention $33 million in grants to support public health awareness and evidence-based practices related to Alzheimer’s disease and dementia through 2029.

The CBO projects that the bill would cost $139 million over the 2024-2029 period and $26 million after 2029.

For more information, click here.

CBO Releases Presentation on Impacts of Extreme Temperatures on Medicare Population

On May 31, the Congressional Budget Office released a presentation concerning the effects of extreme temperatures on the Medicare population. The presentation outlines the impacts extreme temperatures have on emergency department (ED) visits, ED spending and mortality among Medicare beneficiaries.

For more information, click here.

FDA Releases CY2023 Drug Shortages Report to Congress

On June 6, the Food and Drug Administration (FDA) released its calendar year (CY) 2023 Drug Shortages Report to Congress. The report provides:

• Background on drug shortages and FDA efforts to address them;
• Analyses of data collected and evaluated by the FDA Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research during CY 2023;
• Summaries on FDA activities intended to address future drug shortages; and
• Lists of definitions and statutory language.

For more information, click here.

GAO Releases Report Concerning Over-the-Counter Hearing Aids

On June 6, the Government Accountability Office (GAO) released a comprehensive report on over-the-counter (OTC) hearing aids. The report describes:

• What OTC hearing aids are;
• Existing research on the effect of OTC hearing aids on access to hearing loss treatment;
• Food and Drug Administration (FDA) and other federal agency oversight of OTC hearing aids; and
• Key issues relating to OTC hearing aids.

The GAO conducted this study because it was asked to examine consumer access to hearing loss treatment following the FDA final rule concerning OTC hearing aids.

For more information, click here.

GAO Releases Report Concerning VA Community Care Networks Mental Health Adequacy

On June 3, the Government Accountability Office (GAO) released a report that examines how the Department of Veterans’ Affairs (VA) assesses Community Care Networks (CCN) adequacy for mental health and the extent to which the VA collects information on the factors that contribute to scheduling timeliness challenges. After interviewing officials and reviewing CCN contracts, the GAO discovered that:

• The methodology the VA uses to assess specialty care network adequacy excludes claims that do not meet applicable standards; and
• The VA lacks comprehensive information on the factors that contribute to scheduling challenges.

The GAO conducted this study because it was asked to review VA CCN adequacy for mental health.

For more information, click here.

GAO Releases Report Concerning Disabled Healthcare Workforce and Provider Training

On May 30, the Government Accountability Office (GAO) released a report that examines the prevalence of people with disabilities in the healthcare workforce and the manner in which providers are trained to treat disabled individuals.

After interviewing officials and stakeholder organizations and reviewing Annual Disability Statistics Compendiums information, the GAO discovered that:

• People with disabilities comprised 8.0 percent of the healthcare support workforce and 4.2 percent of the healthcare practitioner and technician workforce; and
• Disability training for healthcare providers is not widely required or standardized.

The GAO conducted this study because it was asked to examine the prevalence of people with disabilities in the healthcare workforce and to describe how providers are trained to meet the health needs of people with disabilities.

For more information, click here.

GAO Releases Report Regarding Medicaid Managed Care Plan Prior Authorization Decisions

On May 29, the Government Accountability Office (GAO) released a report that examines how managed care plans authorize services, how states oversee plans’ service authorization and how the Centers for Medicare and Medicaid Services (CMS) oversee state efforts to monitor plan service authorizations.

After reviewing documentation and interviewing state officials, the GAO discovered that CMS:

• Has not specified how states should monitor prior authorization decisions or assessed if states are sufficiently monitoring plans; and
• Has not clearly defined whether plans can require prior authorization for Medicaid Early and Periodic Screening, Diagnostic and Treatment (EPSDT) services when the state Medicaid program does not have such requirements.

The GAO conducted this study because it was asked to review children’s access to EPSDT services under managed care by House Energy and Commerce Committee Ranking Member Frank Pallone (D-NJ).

For more information, click here.

Courts

U.S. District Court Rules Against CMS in Medicare Advantage Star Ratings Lawsuit

On June 3, U.S. District Court for the District of Columbia Judge Carl J. Nichols ruled that the Centers for Medicare and Medicaid Services (CMS) miscalculated the Medicare Advantage (MA) Star Rating of a MA health maintenance organization in California. The judge ordered CMS to pay $250 million in bonus payments that the MA organization did not receive after its star rating fell from 4.5 to 3.5.

The MA plan filed a lawsuit against CMS in December 2023, arguing that it violated the Administrative Procedure Act when it announced it would make changes to the methodologies used to determine star ratings for the 2024 plan year. The changes resulted in a decrease of several MA plan star ratings. This ruling could result in other MA plans filing similar lawsuits against CMS.