The AHA May 18 expressed concern that certain enforcement mechanisms contemplated for health care providers to further interoperability in the 21st Century Cures 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.”
The committee is poised to begin marking up the legislation, which 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.
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 of the bill that would have added requirements and regulatory burden to 340B hospitals. Those provisions have been removed from the current version of the bill pending before the committee.
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.