The House Energy and Commerce Committee today voted 51-0 to approve H.R. 6, the 21st Century Cures Act. The cost of the $13 billion legislation is not offset by cuts in payments for hospital services – a concern that was expressed this week by the AHA in letters to the committee.

The legislation is intended to overhaul drug development. The measure includes an increase of $10 billion in funding over five years for the National Institutes of Health, changes to the regulatory authority of the Food and Drug Administration, and provisions focused on electronic health records (EHR), telemedicine, and drug manufacturing and development, among others.

In a series of letters sent to the committee before its markup of the bill, the AHA expressed concern over how some of the proposals under consideration could affect hospitals.

 

Interoperability. The AHA May 18 expressed concern that certain enforcement mechanisms contemplated for health care providers to further interoperability in the legislation are inappropriate and could have significant unintended consequences.

“We appreciate the inclusion of provisions to further interoperability in Subtitle A of Title III of the 21st Century Cures legislation,” AHA Executive Vice President Rick Pollack said in a letter to the House Energy and Commerce Committee. “However, we are concerned that the heavy-handed and duplicative enforcement mechanisms contemplated for providers could have significant unintended consequences, including undermining new models of care and setting up an environment where well-intentioned providers face significant penalties for small mistakes.”

Pollack said the AHA appreciates the committee’s intent to hold vendors accountable for the design and marketing of interoperable products. He recommended the committee direct the Federal Trade Commission to study anti-competitive behavior by EHR vendors.

“We still lack significant technical capabilities and infrastructure to support efficient and effective health information exchange,” Pollack wrote. “We believe that there are positive steps that would further our shared goals, such as more robust testing of health information technology products and greater commitment to developing and maturing data standards.”

 

Concerns about 340B changes. In a separate letter to the committee, Pollack also raised the AHA’s concerns about a provision in the draft of the Cures legislation that would have made significant changes to the 340B Drug Pricing Program.

“While the AHA appreciates the committee’s attempts to address the administration of the 340B program, we are concerned that the committee is choosing to legislate important changes to the 340B program at a time when release of long-awaited regulatory guidance from the Department of Health and Human Services is imminent,” Pollack wrote.

The AHA expressed concern with a number of provisions that were included in a discussion draft that would have added requirements and regulatory burden to 340B hospitals. Those provisions were removed from the bill before its adoption.

The AHA also urged the committee to strike a better balance between requirements imposed on hospitals and pharmaceutical manufacturers.

 “Given the increasingly high cost of pharmaceuticals, the 340B program provides critical support to help hospitals’ efforts to serve the most disadvantaged in our society and build healthy communities,” Pollack wrote. 

 

Antimicrobial drug provision. In a May 20 letter, the AHA urged the committee not to cut payments to hospitals to pay for Section 2123 of the legislation, which provides for additional payment under Medicare Part A with respect to patient discharges involving new antimicrobial drugs.

“While the AHA supports efforts to encourage the development and responsible use of new antimicrobial drugs, the language in Section 2123 cuts payments to hospitals to pay for the new program,” wrote Pollack. “We urge the committee to either allocate additional money outside the current DRG system to be used to provide this additional payment or remove Section 2123 from the legislation.” The committee did not cut hospital payments to pay for the antimicrobial drugs.

Lawmakers agreed to pay for the legislation using a variety of offsets, including the sale of eight million barrels of oil for eight years from the Strategic Petroleum Reserve, bringing in about $5.2 billion.