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February 12, 2024

This Week in Health Policy for February 12

This Week (February 12 - 16)

The Senate is scheduled to be out of session this week, but Senate Majority Leader Chuck Schumer (D-NY) suggested they could convene to finish a national security supplemental funding package. The House is scheduled to be in session.

House Energy and Commerce Subcommittee on Health will hold a hearing on "Legislative Proposals to Support Patients and Caregivers."

  • Date: Wednesday, February 14 at 10am ET
  • More information available here.

House Committee on Veterans' Affairs Subcommittee on Health will hold a hearing on "Artificial Intelligence at VA: Exploring its Current State and Future Possibilities."

  • Date: Thursday, February 15 at 10am ET
  • More information available here.

House Committee on Veterans' Affairs Subcommittee on Technology Modernization will hold a hearing on "Electronic Health Record Modernization Deep Dive: Can the Oracle Pharmacy Software Be Made Safe and Effective?"

  • Date: Thursday, February 15 at 8am ET
  • More information available here.

House Committee on Oversight and Accountability will hold a hearing on "Assessing America's Vaccine Safety Systems, Part 1"

  • Date: Thursday, February 15 at 10am ET
  • More information available here.

Last Week (February 5 - 9)

Health Care Highlights

House passes provision banning QALYs. On Wednesday (February 7), the House voted 211-208, along party lines, to pass the Protecting Health Care for All Patients Act of 2023 (HR 485), which would prevent all federal health programs from using Quality Adjusted Life Years (QALYs) or other similar measures to help lower drug prices. The bill is unlikely to be taken up in the Democrat-controlled Senate or be signed into law by the President, who issued a Statement of Administration Policy (SAP) opposing the bill.

Senators unveil new bipartisan working group on Medicare physician pay reform. On Friday (February 9), Sens. Catherine Cortez Masto (D-NV), Marsha Blackburn (R-TN), John Thune (R-SD), John Barrasso (R-WY), Debbie Stabenow (D-MI), and Mark Warner (D-VA) announced the formation of a new working group to explore and propose long-term reforms to the Medicare Physician Fee Schedule and needed updates to the Medicare Access and CHIP Reauthorization Act (MACRA). The announcement says the bipartisan working group aims to ensure financial stability for providers, promote access to quality care, and incentivize the use of emerging health care technology.

HHS finalizes CARES Act rule on substance use disorder care. On Thursday (February 8), HHS finalized a rule implementing a CARES Act provision to increase coordination among providers treating patients with substance use disorders by updating patient consent rules and strengthening confidentiality protections through potential civil monetary penalties. Click here for a press release. Click here for a fact sheet.

CMS updates policy on texting patient orders. On Thursday (February 8), CMS issued a quality standard memo that updates its current policy for texting patient orders to allow hospitals and critical access hospitals (CAHs) the flexibility to include text orders, via a secure platform, to be entered into the patient's medical record or electronic health record in a manner that is compliant with the medical record Conditions of Participation (CoPs).

CMS announced proposed rule to strengthen accrediting organization oversight. On Thursday (February 8), CMS issued a notice of proposed rulemaking to strengthen oversight of accrediting organizations (AOs) in part by aligning AO standards with those of state Survey Agencies and preventing conflicts of interest with health care facilities accredited by such organizations. Click here for a fact sheet.

CMS issues FAQ on MA plans' use of AI. On Tuesday (February 6), CMS issued a new FAQ document that provides additional clarifications for Medicare Advantage plans on required coverage criteria and utilization management practices, including providing specific examples for post-acute care and utilization of algorithms or artificial intelligence to estimate length of stay.

New Mexico receives CMS OK for Medicaid mobile crisis intervention teams. On Tuesday (February 6), CMS announced that it has approved New Mexico's proposal for community-based mobile crisis intervention teams to provide Medicaid covered services and connect eligible individuals experiencing a crisis to a behavioral health provider.

HRSA takes new actions to modernize OPTN. On Tuesday (February 6), the Health Resources and Services Administration (HRSA) announced updates related to its Organ Procurement and Transplantation Network (OPTN) Modernization Initiative, including issuing requests for proposals (RFPs) to support multiple different contract awards, increasing transparency through new data reporting requirements to address pre-waitlist and organ procurement practices, and launching the discovery and development phase of the process to modernize the organ matching technology. In 2023, Congress enacted legislation authorizing HRSA to expand competition for OPTN contracts and transform the system. Click here for a press release.

HHS unveils strategy to combat vector-borne diseases. On Tuesday (February 6), HHS released the National Public Health Strategy to Prevent and Control Vector-Borne Diseases in People (VBD National Strategy). The strategy represents the largest formal federal coordinated effort to control and prevent vector-borne diseases and the public health challenges they pose. Click here for a release.

SAMHSA, ONC unveil behavioral health IT initiative. On Monday (February 5), the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Office of the National Coordinator for Health Information Technology (ONC) announced a new initiative to invest more than $20 million over three years to advance behavioral health IT interoperability standards. The initiative will identify and pilot a set of behavioral health specific data elements to be incorporated in a new USCDI+ domain for behavioral health.

Hearings, Markups, and Other Committee Activity

House Ways & Means Committee held a hearing on "Examining Chronic Drug Shortages in the United States." On Tuesday (February 6), the House Ways and Means Committee held a hearing on "Examining Chronic Drug Shortages in the United States." Witnesses who testified before the committee represented oncologists, drug distributors, non-profit drug manufacturers, and economists and academics. During the hearing, there was bipartisan consensus that the US must do more to reduce the reliance on foreign countries in the drug supply chain, increase transparency into active pharmaceutical ingredients (APIs), and address misaligned incentives that favor low-cost drugs over quality. Witnesses spoke about a multipronged solution that should include transparency into raw materials, early notification systems for manufacturing problems, increasing reimbursement for low-cost generic injectables in shortage, as well as trade and tax incentives to attract domestic or near-shore manufacturers.

  • More information available here.

House Energy & Commerce Oversight and Investigations Subcommittee held a hearing on "Protecting American Health Security: Oversight of Shortcomings in the FDA's Foreign Drug Inspection Program." On Tuesday (February 6), the Subcommittee held a hearing focused on the FDA's Foreign Drug Inspection Program. The Subcommittee heard from a panel of witnesses representing public health activists, legal experts with experience representing FDA-regulated entities, and the Government Accountability Office (GAO). Discussion focused on the FDA's unannounced inspection and translation pilot programs, increasing transparency into API sourcing locations, and proper resourcing to ensure FDA can complete needed inspections both domestically and abroad. Subcommittee Chair Morgan Griffith (R-VA) said he plans to hold additional hearings on FDA's Foreign Drug Inspection Program.

  • More information available here.

House Oversight Committee held a markup of legislation related to prescription drug costs, regulatory burdens, and more. On Tuesday (February 6), the Committee advanced several bills, including:

  • H.R. 6283, the Delinking Revenue from Unfair Gouging Act, which was ordered to be favorably reported, as amended, would bar pharmacy benefit managers (PBM) that contract with plans offering health benefits under the Federal Employees Health Benefits program from engaging in spread pricing, patients steering and would require that they de-link the fees they charge insurers from the price of drugs.
  • H.R. 7219, the Information Quality Assurance Act, which was ordered to be favorably reported, would require federal agencies to rely on the best, reasonably available scientific, technical, demographic, economic, financial, and statistical information to support new rules and guidance.
  • H.R. 262, the All Economic Regulations are Transparent (ALERT) Act, which was ordered to be favorably reported, as amended, would require federal agencies to submit monthly updates to the Office of Information Regulatory Affairs on regulatory plans, including details on expected costs and economic effects of rule.
  • More information available here.

House Budget Committee held a markup of the Preventative Health Savings Act and other bills. On Tuesday (February 6), the Committee voted 30-0 to advance a bipartisan bill introduced by Rep. Michael Burgess (R-TX), as amended. The bill would enable the Congressional Budget Office to calculate the budgetary effects of certain bills related to preventive care on a 30-year basis as opposed to the standard 10-year projection to better capture long-term cost savings. The Committee approved an amendment that updates the definition of preventive health and requires that requests for CBO to include a 30-year score be bipartisan and include the chairs and ranking members of the House Budget Committee and other committees of jurisdiction. The amendment also clarifies that a 30-year score is a supplementary estimate and does not ensure compliance with the Congressional Budget Act of 1974.

  • More information available here.

Senate HELP Committee held a hearing on "Why Does the United States Pay, by Far, the Highest Prices in the World for Prescription Drugs?" On Thursday (February 8), the Committee held a hearing on drug prices. During the hearing, the Committee heard from two panels: first, a panel of the CEOs of three pharmaceutical companies and second, a panel representing patient advocates and academics. The bulk of the hearing centered around the panel of CEOs who faced tough questions from both parties on the price discrepancies between the US and abroad and the burden that places on US patients. Republicans largely spoke favorably of market solutions and addressing anticompetitive practices, while Democrats spoke favorably of the Inflation Reduction Act's (IRA) Drug Price Negotiation Program and questioned the companies' spending on R&D compared with spending on stock buybacks, CEO compensation, and marketing.

  • More information available here.

Senate Finance Committee held a hearing on "Artificial Intelligence and Health Care: Promise and Pitfalls." On Thursday (February 8), the Committee held a hearing on artificial intelligence (AI) and health care. Five witnesses, representing AI research and development in both academia and the private sector, provided testimony. The hearing centered on the importance of balancing the need to support innovations in health care AI technology while also protecting patients — particularly those who belong to more vulnerable populations. There was a frequent focus on what kind of regulatory framework would be able to strike such a balance, with many noting the importance of flexibility given the fast pace of AI developments.

  • More information available here.

Reports, Studies, and Journals

Congressional Budget Office: The Budget and Economic Outlook: 2024 to 2034. The report projects that spending on Medicare will increase by about $65 billion in 2024 driven by larger payments to Medicare Advantage and Part D payments, while Medicaid expenditures will decrease by $58 billion driven by the Medicaid redetermination process.

Health Affairs: Addressing Housing-Related Social Needs Through Medicaid: Lessons From North Carolina's Healthy Opportunities Pilots Program. The study examines North Carolina's Healthy Opportunities pilot program to support Medicaid enrollees with health-related social needs and highlights lessons learned that can be applied by policymakers.

Government Accountability Office: Veterans Affairs: Improvements Needed in Estimating Funding for Potential Future Health Emergencies. The report provides recommendations to address VA's need for an analytical model to build on lessons learned from the COVID-19 pandemic and to project costs for future public health emergencies.

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Contact Information

For additional information concerning this Alert, please contact:

Washington Council Ernst & Young