United States: Washington Healthcare Update | June 26, 2023

This Week in Washington: Senate Appropriations Committee meets to figure out top-line numbers; Majority Leader Schumer leads Senate in developing a policy response to artificial intelligence; and CMS proposes new Medicare coverage pathway for breakthrough devices

Congress

House

House Appropriators Approved Six Funding Bills

As Congress left town for their Fourth of July break, the House Committee on Appropriations approved six appropriation bills for FY 2024. That includes Energy-Water, Defense, Military Construction-VA, Legislative Branch, Agriculture-FDA and Homeland Security. The current fiscal year ends on Sept. 30, and Congress plans to be in recess for all of August.

Two Hundred Thirty-Three Representatives Send Letter Concerning Prior Authorization

On June 21, Rep. DelBene (D-WA) led a group of 230 representatives in sending a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra and Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure. The letter was also signed by 61 senators. It urges CMS to speed up the prior authorization process for Medicare Advantage (MA) plans and calls on CMS to implement provisions from the Improving Seniors' Timely Access to Care Act. The provisions seek to:

• Establish real-time prior authorization for routine matters;
• Increase detailed transparency metrics; and
• Implement a 24-hour deadline for MA plans to respond to prior authorization requests for urgent care.

For more information, click here.

Senate

Senate Majority Leader Releases Policy Response to AI

On June 22, Senate Majority Leader Chuck Schumer (D-NY) released a policy outline concerning artificial intelligence (AI) titled the SAFE Innovation Framework for AI. The Majority Leader is concerned about the rise of unregulated AI technologies and has urged since April for the Senate to begin creating a regulatory framework to protect U.S. consumers and national security from them. The SAFE Innovation Framework is five principles from which legislation or regulations can be developed. The principles are:

• Protect U.S. national security from AI threats and strengthen economic security for workers who may lose their jobs to AI technologies;
• Support efforts to protect intellectual property, tamp down on misinformation and bias, and address copyright concerns and liability;
• Curtail harmful AI technologies, ensure that AI systems align with democratic values and promote AI societal benefits;
• Determine what data and information the federal government and the American public should know about AI developer content and systems; and
• Strengthen US-led AI innovation and promote security, transparency and accountability.

In addition, the Majority Leader announced that he will convene multiple AI insight forums later this year where AI experts will be asked to provide information on topics such as risk management, intellectual property, liability, privacy and national security concerns.

For more information, click here.

Senate Appropriations Committee Marks Up Agriculture-FDA Funding Bill

On June 22, the Senate Appropriations Committee met to agree on the top-line numbers for budget functions from which the appropriations bills will be derived. This is setting up a fight with the House because of significant differences in the two bodies' top-line numbers overall.

Also on June 22, the Senate Appropriations Committee reported out of committee the fiscal year (FY) 2024 funding bill for Agriculture, Food and Drug Administration, and Rural Development. The Senate bill is about $1 billion more than the House version. However, the House bill relies on clawing back $8 billion in unspent pandemic-era funds, a move that is likely dead on arrival in the Senate.

The Senate bill would allocate $3.55 billion in base funding to the FDA in FY 2024, a $20 million net increase compared to FY 2023. Total FDA funding with user fee revenues included is $6.63 billion. The $20 million increase will go toward funding cosmetics oversight, food safety, device and drug shortages, neuroscience research and ALS research programs.

For more information, click here.

CONNECT for Health Act Reintroduced

On June 15, Sens. Schatz (D-HI), Wicker (R-MS), Cardin (D-MD), Thune (R-SD), Warner (D-VA) and Hyde-Smith (R-MS) reintroduced the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act. The legislation would:

• Permanently remove telehealth service geographic restrictions;
• Expand telehealth service originating sites to include patient homes and other sites;
• Remove in-person visit requirements for telemental health services;
• Allow health centers and rural health centers to provide telehealth services permanently;
• Allow telehealth service restrictions to be waived during a public health emergency; and
• Require more data to be collected on telehealth usage, quality of care and improvement options.

A companion bill was introduced in the House by Reps. Thompson (D-CA), Matsui (D-CA), Schweikert (R-AZ) and Johnson (R-OH).

For more information, click here.

Medical Supply Chain Resiliency Act

On June 22, Sens. Carper (D-DE) and Tillis (R-NC) introduced the Medical Supply Chain Resiliency Act. The legislation seeks to strengthen U.S. economic resilience and combat medical device, treatments and equipment shortages. It would authorize the president to engage in trade negotiations with "trusted trading partner" countries to increase access to medical goods and supplies for patients in the U.S. and overseas.

For more information, click here.

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