This Week in Washington: House Energy and Commerce Committee chairmen and ranking members request information on Change Healthcare cyberattack impacts; FDA establishes CDER Center for Clinical Trial Innovation; House Energy and Commerce Committee Oversight and Investigations Subcommittee holds hearing concerning improper payments.

Congress

House

House Energy and Commerce Committee Chairmen and Ranking Members Request Information on Impacts of Change Healthcare Cyberattack

On April 15, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) and two subcommittee chairmen, Brett Guthrie (R-KY) and Morgan Griffith (R-VA), in addition to Ranking Member Frank Pallone (D-NJ) and two subcommittee ranking members Anna Eshoo (D-CA) and Kathy Castor (D-FL) sent a letter to UnitedHealth Group Chief Executive Officer Sir Andrew Witty concerning the Change Healthcare cyberattack.

The chairmen and ranking members are requesting information on the actions UnitedHealth took to address and resolve the attack and on the outreach it conducted to inform the healthcare community of potential disruptions.

For more information, click here.

House Veterans Affairs Committee Subcommittee on Health Marks Up 11 Healthcare Bills

On April 16, the House Veterans Affairs Committee Subcommittee on Health marked up and reported out of committee 11 healthcare bills, including bills related to emergency transportation, maternal health and hyperbaric oxygen therapy. One of the bills concerns the inclusion of psychiatric drugs in the Department of Veterans Affairs drug formulary.

The bills are:

H.R. 3584, Veterans CARE Act: Directs the Secretary of Veterans Affairs (VA Secretary) to conduct and support research on the efficacy and safety of medicinal cannabis.

H.R. 3644, ACT for Veterans Act: Extends the authorization period for emergency treatment in non-Department of Veterans Affairs medical facilities under the Veterans Community Care Program.

H.R. 3649, Veterans National Traumatic Brain Injury Treatment Act: Directs the VA Secretary to establish a pilot program to furnish hyperbaric oxygen therapy to a veteran who has a traumatic brain injury or post-traumatic stress disorder.

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

H.R. 5530, VA Emergency Transportation Access Act: Prohibits the VA Secretary from making changes to the Department of Veterans Affairs rate of payment or reimbursement provided for transportation of veterans and other eligible individuals on special modes of transportation.

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

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

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

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

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

H.R. 3303, Maternal Health for Veterans Act: Supports programs of the Department of Veterans Affairs relating to the coordination of maternity healthcare.

For more information, click here.

House Energy and Commerce Committee Subcommittee on Health Holds Hearing on Health Sector Cybersecurity

On April 16, the House Energy and Commerce Committee Subcommittee on Health held a hearing to discuss healthcare cybersecurity practices and vulnerabilities. Subcommittee members also discussed the possibility of amending HIPAA to give healthcare entities more clearinghouse options following a cyberattack. The Change Healthcare cyberattack prompted the subcommittee to look into this. Witnesses were:

  • Greg Garcia, Executive Director for Cybersecurity at the Healthcare Sector Coordinating Council
  • Robert Sheldon, Senior Director of Public Policy and Strategy at CrowdStrike
  • John Riggi, National Advisor for Cybersecurity and Risk at the American Hospital Association
  • Scott MacLean, Board Chair for the College of Healthcare Information Management Executives (CHIME)
  • Adam Bruggeman, MD, Orthopedic Surgeon at Texas Spine Center

For more information, click here.

House Energy and Commerce Committee Oversight and Investigations Subcommittee Holds Hearing Concerning Improper Payments

On April 16, the House Energy and Commerce Committee Oversight and Investigations Subcommittee held a hearing to discuss improper Medicare and Medicaid payments. The hearing focused on the fiscal implications of improper payments and ways to strengthen their oversight. Witnesses were:

  • The Honorable Gene Dodaro, Comptroller General of the Government Accountability Office
  • The Honorable Christi Grimm, Inspector General of the Department of Health and Human Services
  • Timothy Hill, MPA, Medicaid and CHIP Payment and Access Commission Member
  • Michael Chernew, Ph.D, Medicare Payment Advisory Commission Chair

For more information, click here.

House Appropriations Committee Agriculture, Rural Development and FDA Subcommittee Holds Hearing on President’s FY2025 FDA Budget Request

On April 18, the House Appropriations Committee Agriculture, Rural Development and Food and Drug Administration (FDA) Subcommittee held a hearing to discuss the president’s fiscal year 2025 budget request for the FDA. The FDA Commissioner testified.

For more information, click here.

Senate

Senate HELP Committee Ranking Member Sends Letter Concerning FDA Classification of CDS Software

On April 17, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf concerning the September 2022 final guidance, which seeks to regulate clinical decision support (CDS) software as a medical device.

The ranking member believes that the FDA’s categorization of CDS as a medical device disregards congressional intent and may jeopardize access to advanced tools used to improve patient care. Congress excluded CDS software from being categorized as a medical device in the 21st Century Cures Act.

For more information, click here.

Senate Finance Committee Majority Staff Release Report on State Attorneys General Misusing Authority to Obtain Transgender Care Records

On April 16, the Senate Finance Committee majority staff released a report concerning transgender healthcare record requests by state attorneys general in Tennessee, Indiana, Missouri and Texas. The majority staff reviewed information on such requests and how medical providers responded to them.

The majority staff discovered that some state attorneys general are misusing their Medicaid investigative and consumer protection authorities to obtain sensitive health records of teens and adults seeking gender-affirming care. The staff also found that some providers complied with the request for health records while others refused, citing patient privacy concerns.

For more information, click here.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.