This Week in Washington: Senate Finance Committee holds hearing on AI use in healthcare; CMS makes corrections to 2024 Hospital Outpatient Prospective Payment Rates; House passes ban on QALYs.

House

House Budget Committee Favorably Reports Dr. Michael C. Burgess Preventive Health Savings Act

On Feb. 6, the House Budget Committee marked up and reported out of committee the Doctor Michael C. Burgess Preventive Health Savings Act. The legislation would require the Congressional Budget Office (CBO) to calculate the budgetary effects for two additional 10-year periods, for healthcare policies that result in reductions to budget outlays. The CBO currently limits its cost estimates to a single 10-year period.

House Committee On Ways And Means Holds Hearing On Chronic Drug Shortages

On Feb. 6, the House Committee on Ways and Means held a hearing to examine and discuss chronic drug shortages. Announced witnesses were:

  • Stephen Schleicher, M.D., MBA, Chief Medical Officer at Tennessee Oncology
  • Eugene Cavacini, Senior Vice President and Chief Operating Officer at McKesson Pharmaceutical Solutions and Services (PSaS)
  • Allan Coukell, BSc, Senior Vice President for Public Policy at Civica Rx
  • Stephen Schondelmeyer, PharmD, Ph.D., Director of the University of Minnesota College of Pharmacy PRIME Institute
  • Julie Gralow, M.D., Chief Medical Officer and Executive Vice President at ASCO
  • Jeromie Ballreich, Ph.D., Associate Research Professor at the Johns Hopkins Bloomberg School of Public Health

For more information, click here.

House Energy And Commerce Committee Oversight And Investigations Subcommittee Holds Hearing on FDA Foreign Drug Inspection Program

On Feb. 6, the House Energy and Commerce Committee Oversight and Investigations Subcommittee held a hearing to discuss the Food and Drug Administration Drug Inspection Program and evaluate its current status, challenges and shortcomings. Announced witnesses were:

  • Dinesh S. Thakur, Public Health Activist at the Thakur Family Foundation, Inc.
  • John W.M. Claud, Counsel at Hyman, Phelps and McNamara
  • Mary Denigan-Macauley, Director of Public Health at the Government Accountability Office

For more information, click here.

House Passes Bill Banning QALYs

On Feb. 7, the House passed the Protecting Health Care for All Patients Act on a 211-208 vote. The legislation would ban quality-adjusted life years (QALYs) from being used in coverage and payment determinations for federal health programs including Medicare. QALYs are a measure used to assess disease burden and evaluate how well medical treatments lengthen or improve a patient’s life.

For more information, click here.

FDA Modernization Act 3.0 Introduced

On Feb. 6, Rep. Carter (R-GA) introduced the Food and Drug Administration Modernization Act 3.0. The legislation aims to reduce the use of animals in nonclinical testing by improving the predictivity of nonclinical testing methods, decreasing the development time for biological products and drugs and facilitating the development, qualification and adoption of testing methods.

For more information, click here.

Ensuring Pathways to Innovative Cures Act Introduced

On Feb. 1, Reps. Guthrie (R-KY), Murphy (R-NC) and Davis (D-NC) introduced the Ensuring Pathways to Innovative Cures Act. The legislation seeks to clarify that small-molecule drugs can stay on the market for 11 years before the Centers for Medicare and Medicaid Services could consider them for price negotiation.

For more information, click here.

Chair Cathy McMorris Rodgers Announces Retirement

On Feb. 8, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) announced that she will retire at the end of her term. Her retirement is notable as the committee is already set to lose a large number of senior Republican members including Reps. Burgess (TX), Bucshon (IN), Duncan (SC), Curtis (UT), Pence (IN) and Armstrong (ND).

Senate

Senate HELP Committee Holds Hearing on Prescription Drug Costs

On Feb. 8, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing to examine the cost of prescription drugs. Announced witnesses were:

  • Joaquin Duato, Johnson and Johnson Chief Executive Officer
  • Robert Davis, Merck Chief Executive Officer
  • Chris Boerner, Bristol Myers Squibb Chief Executive Officer
  • Peter Maybarduk, J.D., Access to Medicines Director at Public Citizen
  • Tahir Amin, LL.B., Chief Executive Officer at Initiative for Medicines, Access and Knowledge
  • Darius Lakdawalla, Ph.D., Director of Research at the University of Southern California Schaeffer Center

In addition, HELP committee majority staff released a report concerning the profits Johnson and Johnson, Merck and Bristol Meyer Squibb made in 2022 and the median price they charged for certain medications in the U.S. compared to other countries over the last two decades.

For more information on the hearing, click here.

For more information on the report, click here.

Senate Finance Committee Holds Hearing on Role of AI in Healthcare

On Feb. 8, the Senate Finance Committee held a hearing to discuss the use of artificial intelligence algorithms and systems in healthcare. Announced witnesses were:

  • Peter Shen, Head of Digital and Automation for North America at Siemens Healthineers
  • Mark Sendak, M.D., MPP, Co-Lead of the Health AI Partnership
  • Michelle M. Mello, J.D., Ph.D., Professor of Health Policy and Law at Stanford University
  • Ziad Obermeyer, M.D., Associate Professor and Blue Cross of California Distinguished Professor at the University of California – Berkeley
  • Katherine Baicker, Ph.D., University of Chicago Provost

For more information, click here.

Senate 340B Working Group Releases Sustain 340B Act Discussion Draft

On Feb. 2, the Senate 340B Working Group released a legislative discussion draft of the Supporting Underserved and Strengthening Transparency, Accountability and Integrity Now and for the Future of 340B Act. The discussion draft outlines proposed changes to the 340B program concerning contract pharmacies, child sites, discount duplications, user fees and the definition of a 340B patient.

The working group is seeking feedback from 340B stakeholders on the proposals, and comments will be accepted until April 1.

For more information, click here.

MACPAC Releases Policy Brief On Medicaid Spending On High-Cost Drugs

On Feb. 6, the Medicaid and Children’s Health Insurance Program Payment and Access Commission released a policy brief concerning Medicaid spending on high-cost drugs. The brief outlines how much the Medicaid program spent per claim on brand name and generic drugs from 2018 to 2021 and includes recommendations on how states can address the growing costs of specialty drugs and ensure that beneficiaries can access them.

For more information, click here.

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