Washington Healthcare Update

February 19, 2024

This Week in Washington: House Energy and Commerce Committee Subcommittee on Health holds hearing on a range of legislation concerning public health programs, patient wellbeing and caregiver support; HHS and FTC request information on group purchasing organization and drug wholesaler business practices.

Congress

House

Senate

Administration

Proposed Rules

Final Rules

Courts

Reports

CBO Cost Estimates

Note

House

House Energy and Commerce Committee Subcommittee on Health Holds Hearing on Multiple Patient and Caregiver Proposals

On Feb. 14, the House Energy and Commerce Committee Subcommittee on Health held a hearing to discuss proposals aimed at improving public health, emergency medical services, maternal and pediatric health, disease research and prevention, support for family caregivers and access to care for patients.

The proposals were:

H.R. 6160, To amend the Public Health Service Act to reauthorize a lifespan respite care program: Reauthorizes the Lifespan Respite Care Program through fiscal year 2028. The Lifespan Respite Care Program empowers coordinated state systems to provide accessible, community-based respite care services for family caregivers of children and adults.

H.R. 7208, To reauthorize the Traumatic Brain Injury program: Reauthorizes certain Traumatic Brain Injury (TBI) programs aimed at improving TBI prevention, patient advocacy systems and access to TBI rehabilitation.

H.R. 7251, To amend the Public Health Service Act to reauthorize certain poison control programs: Reauthorizes certain poison control programs including the maintenance of the national toll-free phone number, the promotion of poison control center utilization and the maintenance of a program that awards grants to accredited poison control centers.

H.R. 7153, To reauthorize the Dr. Lorna Breen Health Care Provider Protection Act, and for other purposes: Reauthorizes the Dr. Lorna Breen Health Care Provider Protection Act which works to prevent suicide and burnout, as well as address mental and behavioral health conditions among healthcare professionals. The legislation would direct the Secretary of the Department of Health and Human Services (HHS) to prioritize the allocation of resources for healthcare professional mental health and substance use disorder services.

H.R. 6960, Emergency Medical Services for Children Reauthorization Act of 2024: Reauthorizes the Emergency Medical Services for Children Program for fiscal years 2024 through 2029.

H.R. 4646, SIREN Reauthorization Act: Reauthorizes and modifies the Rural Emergency Medical Services Training and Equipment Assistance Program for fiscal years 2024 through 2028.

H.R. 7213, Autism Collaboration, Accountability, Research, Education, and Support (CARES) Act of 2024: Reauthorizes the Autism Coordination Committee, the Developmental Disabilities Surveillance and Research Program and other programs concerning autism education, early detection and intervention for fiscal years 2025 through 2029.

H.R. 7189, Congenital Heart Futures Reauthorization Act of 2024: Reauthorizes a national congenital heart disease research, surveillance and awareness program through fiscal year 2029.

H.R. 7218, Building Our Largest Dementia (BOLD) Infrastructure for Alzheimer’s Act of 2024: Reauthorizes programs focused on improving Alzheimer’s disease and other related dementia education, early detection, diagnosis, patient and caregiver support, risk reduction and other activities at currently appropriated levels for fiscal years 2025 through 2029.

H.R. 2706, Charlotte Woodward Organ Transplant Discrimination Prevention Act: Prohibits healthcare providers from denying or restricting an individual’s access to organ transplants solely on the basis of the individual’s disability, except in limited circumstances.

H.R. 620, Alzheimer’s Accountability and Investment Act: Requires the National Institutes of Health (NIH) to continue to submit an annual budget estimate to Congress to achieve the initiatives and goals included in the National Plan to Address Alzheimer’s Disease.

H.R. 619, NAPA Reauthorization Act: Reauthorizes the National Alzheimer’s Project through 2035, updates the project’s purpose and expands the membership and reporting requirements of the Advisory Council on Alzheimer’s Research, Care and Services.

H.R. 6829, Cardiomyopathy Health Education, Awareness, Research, and Training in the Schools (HEARTS) Act of 2023: Directs HHS to develop and distribute educational materials regarding cardiomyopathy, automated external defibrillators and cardiopulmonary resuscitation to school administrators, educators, health professionals and families. It would also direct the Centers for Disease Control and Prevention to report on its national cardiomyopathy surveillance and research activities to Congress.

H.R. 7224, To amend the Public Health Service Act to reauthorize the Stop, Observe, Ask, and Respond to Health and Wellness Training Program: Reauthorizes the Stop, Observe, and Respond to Health and Wellness Training Program through fiscal year 2029. The program trains healthcare and social service providers to identify potential human trafficking victims and work with law enforcement as well has address other issues related to human trafficking.

H.R. 7300, Reauthorization of the Family-to-Family Health Information Centers: Reauthorizes funding for family-to-family health information centers through fiscal year 2029.

H.R. 7268, DeOndra Dixon INCLUDE Project Act of 2024: Reauthorizes the NIH Investigation of Co-Occurring Conditions Across the Lifespan to Understand Down Syndrome Project and requires the NIH to report on the program’s progress and related research.

H.R. 5012, SHINE for Autumn Act of 2023: Allows HHS to award grants for data collection and reporting related to still births and requires HHS to issue guidelines and educational materials regarding proper training and processes for the collection of stillbirth data. It would also require HHS to establish a perinatal pathology fellowship program within an existing training program.

H.R. 3916, SCREENS for Cancer Act of 2023: Reauthorizes the National Breast and Cervical Cancer Early Detection Program through fiscal year 2028 and modifies and updates program reporting requirements.

H.R. 4534, Women and Lung Cancer Research and Preventive Services Act of 2023: Requires HHS to conduct an interagency review on the status of women with lung cancer and to identify research and education opportunities.

For more information, click here.

House Committee on Veterans Affairs Subcommittee on Health Holds Hearing on VA Use of Artificial Intelligence

On Feb. 15, the House Committee on Veterans Affairs Subcommittee on Health held a hearing to examine the current and potential future uses of artificial intelligence at the Department of Veterans Affairs. Announced witnesses were:

  • Charles Worthington, Chief Technology Officer and Chief Artificial Intelligence Officer at the Department of Veterans Affairs
  • Gil Alterovitz, Ph.D., Director of the Department of Veterans Affairs National Artificial Intelligence Institute
  • Carolyn Clancy, M.D., Assistant Under Secretary for Health at the Department of Veterans Affairs Office of Discovery, Education and Affiliate Networks
  • Prashant Natarajan, Author
  • Gary Velasquez, Chief Executive Officer of Cogitativo
  • Charles Rockefeller, Co-Founder and Head of Partnerships at CuraPatient
  • David Newman-Toker, M.D., Ph.D., Director of the Johns Hopkins School of Medicine Armstrong Institute Center for Diagnostic Excellence

For more information, click here.

House Energy and Commerce Committee Chairmen Request GAO Study on Sales of Lab Equipment

On Feb. 12, 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 Comptroller General Gene Dodaro, requesting the Government Accountability Office (GAO) examine the sale of used and excess laboratory equipment and protective clothing by the Department of Health and Human Services and the Department of Agriculture.

The chairmen are warning that the sale of this equipment could facilitate biological terrorism or warfare and are requesting the GAO investigate how federal agencies oversee the sales and exports of dual-use biological equipment.

For more information, click here.

Editor’s Note: The House is in recess until Feb. 28 and the first appropriations deadline is March 1.

Senate

Senate Finance Committee Chairman Sends Letter Concerning Data Broker Sale of Personal Information

On Feb. 13, Senate Finance Committee Chairman Ron Wyden (D-OR) sent a letter to Federal Trade Commission (FTC) Chair Lina Khan and U.S. Securities and Exchange Commission (SEC) Chair Gary Gensler concerning the sale of personal information by data broker Near Intelligence, Inc.

The chairman is concerned about the Near Intelligence, Inc. sale of location and device data it obtained from individuals without first obtaining their informed consent. Sen. Wyden is requesting the FTC to intervene in the company’s bankruptcy proceedings to ensure that all personal data is destroyed and is also requesting the SEC to examine whether misleading statements made by the company to investors constitute securities fraud.

For more information, click here.

Senators Form Medicare Payment Reform Working Group

On Feb. 9, Sens. Blackburn (R-TN), Thune (R-SD), Barrasso (R-WY), Stabenow (D-MI), Warner (D-VA) and Cortez Masto (D-NV) announced that they would form a Medicare payment reform working group to explore and propose long-term reforms to the physician fee schedule and make updates to the Medicare Access and CHIP Reauthorization Act.

For more information, click here.

Editor’s Note: When senators return after the Presidents Day recess, they will have to address the impeachment of Secretary of Homeland Security Alejandro Mayorkas. No other business can be done on the senate floor while the impeachment trial is ongoing.

Administration

HHS Releases 2023 Update to Equity Action Plan

On Feb. 14, the Department of Health and Human Services (HHS) released the 2023 update to its Equity Action Plan. The plan outlines the five priority areas HHS is focused on to advance equity and improve access to federal healthcare programs and activities.

For more information, click here.

HHS Launches Postpartum Maternal Health Collaborative

On Feb. 14, the Department of Health and Human Services launched the Postpartum Maternal Health Collaborative. The collaborative seeks to strengthen coordination between federal, state and local community experts to develop solutions to improve postpartum mortality.

For more information, click here.

HHS and FTC Issue RFI on Drug Wholesalers and Group Purchasing Organizations

On Feb. 14, the Department of Health and Human Services (HHS) and the Federal Trade Commission (FTC) issued a request for information to better understand healthcare group purchasing organization (GPO) and drug wholesaler market concentration and contracting practices. HHS and the FTC are concerned that GPOs and drug wholesalers may be contributing to generic drug shortages. Comments will be accepted until April 15.

For more information, click here.

HHS OIG Releases Report Concerning Compliance of Medicare COVID-19 Telehealth Requirements

On Feb. 14, the Department of Health and Human Services Office of Inspector General released a report concerning compliance with Medicare requirements by physicians and practitioners who provided evaluation and management services via telehealth during the COVID-19 pandemic.

For more information, click here.

CMS Releases Improving Postpartum Care Affinity Group Highlights Brief

On Feb. 16, the Centers for Medicare and Medicaid Services released a highlights brief regarding the Improving Postpartum Care Affinity Group. The group convened in 2021 to support nine state Medicaid and Children’s Health Insurance Program agencies in improving health outcomes among postpartum people. The nine states were GA, KS, KY, MO, MT, OK, SC, TX and WY.

For more information, click here.

CMS Releases Additional Guidance Concerning Medicare Prescription Payment Plan

On Feb. 15, the Centers for Medicare and Medicaid Services released additional guidance concerning the Medicare Prescription Payment Plan. The guidance outlines program requirements concerning outreach and education, pharmacy processes and operational considerations. The program will allow certain Medicare beneficiaries to pay for out-of-pocket prescription drug costs in monthly payments.

For more information, click here.

CMS Releases Updated Instructions on MSP Eligibility and Enrollment Processes

On Feb. 9, the Centers for Medicare and Medicaid Services released updated instructions regarding eligibility and enrollment processes for the Medicare Savings Programs and state payment of Medicare premiums.

For more information, click here.

FDA Approves Xolair

On Feb. 16, the Food and Drug Administration approved Xolair (omalizumab), an injection that seeks to reduce allergic reactions and anaphylaxis in adults and children over one year of age with immunoglobulin E-mediated food allergy.

For more information, click here.

FDA CDER Releases FY 2023 Drug Safety Priorities Report

On Feb. 15, the Food and Drug Administration Center for Drug Evaluation and Research (CDER) released its fiscal year 2023 Drug Safety Priorities Report. The report outlines the actions the CDER took to address medication impurities and contaminants, fraudulent products, compounded medications, drug overdoses and marketed medications in 2023.

For more information, click here.

FDA Extends Genetic Metabolic Diseases Advisory Committee Nomination Deadline

On Feb. 15, the Food and Drug Administration announced that the nomination deadline for academicians and clinicians to serve on the new Genetic Metabolic Diseases Advisory Committee has been extended until March 12.

For more information, click here.

FDA Publishes Product-Specific Guidances

On Feb. 15, the Food and Drug Administration published a new batch of product-specific guidances intended to support the development of generic drugs and new drug application approvals.

For more information, click here.

FDA Approves First Medication to Treat Severe Frostbite

On Feb. 14, the Food and Drug Administration approved Aurlumyn (iloprost), an injection to treat severe frostbite in adults who are at-risk of amputation. Aurlumyn is a vasodilator that helps open blood vessels and prevent blood clotting.

For more information, click here.

FDA Releases Guidance Concerning the Charging of Investigational Drugs Under an IND

On Feb. 14, the Food and Drug Administration released guidance concerning the charging of investigational drugs under an investigational new drug (IND) application. The guidance is intended to inform stakeholders about the implementation of regulations concerning the charging of investigational drugs under IND applications.

For more information, click here.

FDA Releases Guidance Concerning Clinical Trail Data Monitoring Committees

On Feb. 12, the Food and Drug Administration released guidance concerning the use of data monitoring committees in clinical trials. The guidance is intended to assist clinical trial sponsors in determining when it is useful to use an independent data monitoring committee or data and safety monitoring board.

For more information, click here.

Proposed Rules

CDC Proposes Rule Amending HHS List of Select Agents and Toxins

On Jan. 30, the Centers for Disease Control and Prevention (CDC) released a proposed rule that amends the Department of Health and Human Services’ list of select agents and toxins that have the potential to pose a severe threat to public health and safety. The proposed rule would:

  • Remove Brucella abortus, Brucella melitensis and Brucella suis from the select agent list;
  • Add definitions and provisions to further clarify inactivation of select agents;
  • Add requirements for reporting discoveries of select agents and toxins;
  • Implement new provisions for facility verification requirements for registered biosafety level 3 and animal biosafety level 3 laboratories; and
  • Update the terminology and clarify the specific clade that is a specific agent by changing “Monkeypox virus” to “Mpox virus (clade I).”

The CDC is requesting comments on the proposed changes and seeks feedback on whether they would create additional burdens for regulated entities.

Public comments will be accepted until April 1, 2024. For more information, click here.

CMS Releases Proposed Rule Concerning Medicare Accrediting Organizations

On Feb. 8, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule concerning the oversight of Medicare accrediting organizations (AOs). The proposed rule seeks to strengthen oversight of AOs, reduce conflicts of interest and promote consistency in survey processes. It would:

  • Apply state survey agency (SSA) accountability standards to AOs;
  • Address conflicts of interest and place certain limitations on the fee-based consulting services AOs provide to healthcare facilities they accredit;
  • Prohibit AO owners, surveyors, employees and their immediate families from having an interest in or relationship with a healthcare facility they accredit or from accessing or having input in survey results;
  • Require AOs to report specific information to CMS about how they will monitor, prevent and handle conflicts of interest;
  • Require AOs with poor performance to submit a publicly reported correction plan; and
  • Align AO survey activity requirements and staff training with those of SSAs.

CMS is seeking comments from stakeholders and AOs on how to refine and revise AO oversight standards and processes and is requesting information on the timeframes and expectations for the submission of AO applications.

Public comments will be accepted until April 15, 2024. For more information, click here.

FDA Proposes Rule Regarding Classification of Wound Dressings and Washes

On Nov. 30, the Food and Drug Administration (FDA) released a proposed rule that would classify certain types of wound dressings and liquid wound washes containing antimicrobials and other chemicals, as solid wound dressings. The FDA currently regulates gel, cream, ointment and liquid wound dressings and washes as unclassified devices requiring premarket notification.

Under the proposed rule, the FDA would classify wound dressings and liquid wound washes with a high level of antimicrobial resistance concern as Class III medical devices. In addition, wound dressings and washes with a medium or low level of antimicrobial resistance would be classified as Class II medical devices.

Public comments will be accepted until Feb. 28, 2024. For more information, click here.

IHS Proposed Rule Removes Outdated Regulations

On Jan. 8, the Indian Health Service (IHS) released a proposed rule that aims to remove outdated regulations in the Code of Federal Regulations that do not align with current statutory text of the Hyde Amendment. The proposed rule intends to eliminate confusion regarding the legal effect of outdated regulations and seeks to align IHS guidelines with congressional guidelines governing the Department of Health and Human Services.

Public comments will be accepted until March 8, 2024. For more information, click here.

Final Rules

FDA Releases Final Rule Regarding Biologics License Applications and Master Files

On Feb. 9, the Food and Drug Administration released a final rule regarding biologics license applications and the use of master files by applications licensed under the Public Health Services Act (PHS Act). The final rule will:

  • Clarify that formerly approved applications for biologics products that have been deemed licenses for the biological products under the PHS Act can continue to incorporate by reference DS/DSI/DP information contained in a drug master file, if the information was referenced at the time the application was deemed to be a license;
  • Amend regulations concerning the referencing of information contained in master files by biologics license applications;
  • Clarify that investigational new drug applications for products that would be subject to licensure under the PHS Act may incorporate by reference any information in a master file; and
  • Amend regulations to address the use of master files for the constituent parts of combination products licensed under the PHS Act.

The final rule will go into effect on March 13, 2024. For more information, click here.

HHS Office of the Secretary Final Rule Establishes Health Resources Priorities and Allocation System

On Feb. 9, the Department of Health and Human Services (HHS) Office of the Secretary released a final rule that establishes the Health Resources Priorities and Allocations System (HRPAS). HRPAS covers health resources pursuant to the authority under section 101(a) of the Defense Production Act of 1950. The final rule will:

  • Establish standards and procedures by which HHS may require acceptance and priority performance of certain contracts or orders to promote national defense over other contracts with respect to health resources; and
  • Set new standards by which HHS may allocate services, materials and facilities to promote the national defense.

The final rule will go into effect on March 11, 2024. For more information, click here.

OCR Releases Final Rule Concerning SUD Patient Record Confidentiality

On Feb. 8, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released a final rule concerning the confidentiality of substance use disorder (SUD) patient records, that seeks to increase coordination among providers treating SUD patients and strengthen confidentiality protections. The final rule will:

  • Permit the use and disclosure of Part 2 records based on a single patient consent given once for all future uses, including disclosures of treatment, payment and healthcare operations;
  • Permit redisclosure of Part 2 records by Health Insurance Portability and Accountability Act covered entities and business associates;
  • Grant patients under Part 2, the right to obtain an accounting of disclosures and the right to request restrictions on disclosures;
  • Expand prohibitions on the use and disclosure of Part 2 records in civil, criminal, administrative and legislative proceedings; and
  • Grant HHS enforcement authority to impose potential civil money penalties for Part 2 violations.

In addition to the OCR, the Substance Abuse and Mental Health Services Administration is proposing the rule. Covered entities must comply with the rule by Feb. 16, 2026.

The final rule will go into effect on April 16, 2024. For more information, click here.

ACL Final Rule Updates Regulations for Implementing OAA Programs

On Feb. 6, the Administration for Community Living (ACL) released a final rule that would update regulations for implementing Older American Act (OAA) programs that provide seniors with services including meals, job training, homemaker services, transportation services, adult day care services, nutrition assistance, caregiver support and more. The final rule will:

  • Clarify requirements for state and area plans on aging and detail requirements for coordination among tribal, state and local programs;
  • Improve consistency of definitions and operations between state and tribal programs;
  • Specify fiscal requirements, who is eligible to receive services and how funds can be used;
  • Clarify required state and local agency policies and procedures and establish expectations regarding conflicts of interest;
  • Require state agencies to streamline processes for area agencies on aging to receive approval and establish contracts and commercial relationships;
  • Provide guidance on the National Family Caregiver Support Program and the Native American Caregiver Support Program;
  • Update definitions, modernize requirements and clarify flexibilities within OAA nutrition programs; and
  • Clarify the role of aging networks in promoting alternatives to guardianship.

Regulated entities will have until Oct. 1, 2025, to fully comply with the final rule.

The final rule will go into effect on March 15, 2024. For more information, click here.

SAMHSA Final Rule Seeks to Expand Access to Medications for Opioid Use Disorder

On Jan. 31, the Substance Abuse and Mental Health Services Administration released a final rule that updates regulations concerning opioid treatments programs (OTPs) and seeks to expand access to medications for opioid use disorder. The final rule will:

  • Make COVID-19 flexibilities that expanded eligibility for patients to obtain take-home methadone doses permanent;
  • Allow new patients who will be treated by an OTP with methadone to be evaluated via audio-visual telehealth platforms;
  • Allow new patients who will be treated by an OTP with buprenorphine to be evaluated via audio-only telehealth platforms;
  • Allow nurse practitioners and physician assistants to order medications in OTPs;
  • Eliminate the requirement that patients demonstrate a full year of addiction before being eligible for treatment;
  • Expand access to interim treatment and allow patients to initiate medication treatment while awaiting further services; and
  • Promote patient-centered models of care.

In addition, the rule removes outdated language among regulations and implements new definitions reflecting current medical usage.

The final rule will go into effect on April 2, 2024. For more information, click here.

FDA Final Rule Amends Quality System Regulation Device CGMP Practice Requirements

On Jan. 31, the Food and Drug Administration (FDA) released a final rule that amends the medical device current good manufacturing practice requirements of the Quality System Regulation and aligns them with device quality management system standards set by the International Organization for Standardization. The final rule will:

  • Incorporate by reference, ISO 13485 standards for medical device quality management systems;
  • Rename the title of Code of Federal Regulations Part 820 – Quality System Regulation to Quality Management System Regulation; and
  • Establish additional requirements that clarify certain expectations and concepts used in ISO 13485.

The final rule will go into effect and the FDA will begin enforcing the new management system standard requirements on Feb. 2, 2026.

For more information, click here.

CMS Final Rule Improves Prior Authorization Process and Access to Health Information

On Jan. 17, the Centers for Medicare and Medicaid Services released a final rule that seeks to expand access to health information and improve the prior authorization process. The final rule will:

  • Require Medicare Advantage organizations, Medicaid and Children’s Health Insurance Program fee-for-service programs and managed care plan entities to send prior authorization decisions within 72 hours for expedited requests and seven calendar days for standard requests for medical items and services;
  • Require impacted payers to include a specific reason for denying a prior authorization request, publicly report prior authorization metrics and implement a Health Level 7 Fast Healthcare Interoperability Resources Prior Authorization application programming interface (API);
  • Require impacted payers to include information about prior authorizations in their current Patient Access API and implement a Provider Access API to retrieve patient claims, encounter, clinical and prior authorization data;
  • Add a new Electronic Prior Authorization measure for eligible clinicians under the Merit-based Incentive Payment System Promoting Interoperability performance category; and
  • Require hospitals and critical access hospitals in the Medicare Promoting Interoperability Program to report their use of payers’ Prior Authorization APIs to submit an electronic prior authorization request.

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

OCR Final Rule Strengthens Conscience Protections

On Jan. 9, the Department of Health and Human Services Office for Civil Rights (OCR) released a final rule that seeks to strengthen the process for enforcing federal conscience laws and provide new protections against conscience and religious discrimination. The final rule will:

  • Partially rescind a May 2019 conscience final rule that was deemed unlawful by three federal district courts. The rule strengthened the rights of healthcare workers to refuse to provide services such as abortions and gender-affirming care based on moral and religious beliefs;
  • Restore OCR’s role in overseeing the enforcement process for federal healthcare conscience protection statutes;
  • Strengthen protections against discrimination on the basis of conscience;
  • Encourage entities to post a notice of rights to inform providers and patients of their rights under federal healthcare conscience protection statutes; and
  • Implement a severability provision to preserve portions of the rule if part of the rule is deemed unlawful.

In addition, the final rule states that OCR investigations will be prompt and clarifies that certain conscience statutes apply to more than just providers.

The final rule will go into effect on March 11, 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 that implements new standards for direct-to-consumer (DTC) television and radio prescription drug advertisements. The final rule will require advertisers to:

  • Present information using language that is clear and readily understandable by consumers;
  • Place textual information against a contrasting background for a sufficient duration, using a font style and size that is easily legible;
  • Announce prescription drug information in the same volume, articulation and pacing used in the rest of the ad;
  • Certify that no distracting representations including statements, text, images or sounds are used during the ad’s major statement; and
  • Simultaneously present visual and audible information for ads in television format.

The final rule complements a final guidance the FDA issued in June that outlined how advertisers should present quantitative efficacy and risk information in DTC promotional labeling and ads.

The final rule will go into effect on May 20, 2024. The compliance date of the rule is Nov. 20, 2024.

For more information, click here.

FDA Issues Final Rule Regarding Mammography Quality Standards

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

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

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

Courts

U.S. District Court of the Western District of Texas Dismisses PhRMA Lawsuit Against Medicare Drug Price Negotiation Program

On Feb. 12, U.S. District Court of the Western District of Texas Judge David Alan Ezra dismissed a lawsuit led by the Pharmaceutical Research and Manufacturers of America (PhRMA) which challenged the legality of the Medicare Drug Price Negotiation Program.

Judge Ezra ruled that the National Infusion Center Association (NICA), one of the plaintiffs of the case, did not possess the subject-matter jurisdiction necessary to bring the lawsuit and therefore dismissed the NICA from the case. Due to the NICA being the only plaintiff to reside in Texas, Judge Ezra dismissed the case entirely. The case was dismissed “without prejudice” which means PhRMA and the other plaintiffs can refile the case.

Reports

GAO Releases Report Concerning Student Veteran Use of Mental Health Services

On Feb. 15, the Government Accountability Office (GAO) released a report concerning the use of mental healthcare services by student veterans and efforts the Department of Veterans Affairs (VA) has taken to address student veteran mental health needs through the Veterans Integration to Academic Leadership Program.

After reviewing documentation and interviewing VA officials, the GAO discovered that student veterans seek mental healthcare services at a higher rate than that of the total veteran population and that the VA does not currently communicate information concerning the implementation of campus-based mental health support programs. The GAO conducted this study because a provision in the Support the Resiliency of Our Nation’s Great Veterans Act of 2022 required it to study student veteran mental health needs.

For more information, click here.

CBO Cost Estimates

CBO Releases Worksheet Concerning How Changes in Revenues and Outlays would Affect Debt-Service Costs, Deficits and Debt

On Feb. 16, the Congressional Budget Office (CBO) released an interactive worksheet that allows users to see how revenues and outlays would increase or decrease net interest costs, deficits and debt. The worksheet is intended to generate results that approximate those the CBO would produce when projecting debt-service costs.

For more information, click here.

CBO Releases Cost Estimate of H.R. 766, Dr. Michael C. Burgess Preventive Health Savings Act

On Feb. 15, the Congressional Budget Office (CBO) released a cost estimate of H.R. 766, the Dr. Michael C. Burgess Preventive Health Savings Act. The legislation would require the CBO to estimate the budgetary effects over a 30-year period, for legislation related to preventive healthcare services.

The CBO predicts that H.R. 766 will have no impact on direct spending, revenues or the federal deficit and that the administrative expenses associated with implementing the bill would total less than $500,000 over the 2024-2029 period.

For more information, click here.

Note:

There will be no Washington Health Care Update next week. The next newsletter will be published March 4.

Authors

Stephanie Kennan
Senior Vice President
Federal Public Affairs
Washington, DC
Gina Sherick
Policy Consultant
Federal Public Affairs
Washington, DC