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.

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 21st 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.

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