ACP Offers Advice on How to Bolster the 21st Century Cures Act of 2016

Advocate Masthead

Using lessons learned from the pandemic, ACP encourages investment in pandemic preparedness, improving data interoperability and enhancing the public health infrastructure

Sept. 27, 2024 (ACP) -- The American College of Physicians is weighing in on how Congress can build upon the 21st Century Cures Act of 2016.

The 21st Century Cures Act authorized $6.3 billion to streamline the drug and medical device approval process, promote increased use of electronic health records and advance telehealth, among other priorities.

Much has happened since the Cures Act was signed into law in 2016, namely the COVID-19 pandemic.

“We made a lot of progress in medical innovation and improved our capabilities to share digital health care data, both of which helped us as we navigated our way through a global pandemic,” said Vy Oxman, ACP senior associate for legislative affairs. “However, what the pandemic has taught us is that there are gaps in our health care infrastructure, and we need to further invest in initiatives to ensure that our country has a strong foundation in place to prevent and quickly support the health care system during future pandemics.”

In response to a Request for Information (RFI) for the next iteration of the Cures Act from Rep. Diana DeGette and Rep. Larry Bucshon, M.D., in June 2024, ACP detailed actionable steps that would strengthen the Cures initiative, including improving health care data interoperability, enhancing the public health infrastructure and bolstering pandemic preparedness.

There are several bills that ACP supports, which would address these areas. The College is urging Congress to include them in the next Cures 2.0 package. “ACP has been a strong advocate for policies to improve health care data sharing, and we are working to ensure that more will be done to advance interoperability,” Oxman said. “We would also like to see more investments in our public health infrastructure and pandemic preparedness so that as a country, the U.S. will be well prepared and equipped to support doctors and patients in the next public health emergency (PHE).”

ACP supports the development of a modern national public health data infrastructure capable of real-time, bidirectional data sharing, and the establishment of a pilot program for public health data availability. This recommendation is featured in the ACP policy paper “Modernizing the United States' Public Health Infrastructure.”

“Our current public health infrastructure lacks common data standards, interoperable systems to share information and the capability to share data in real time,” Oxman explained. “It is imperative that Congress address this issue.”

A related area of concern for ACP is the complexity of information-blocking regulations, which likely affect members in their daily practice.

“While the Cures law provided progress in data interoperability, the College has concerns about how the regulations required by the law, such as regulations for interoperability and information blocking, which are very complex, could lead to unintended consequences, including increases in physician burden and higher health care costs. We plan to work with Congress to address these concerns.” Oxman noted.

In its response, ACP pointed out that patient matching and identification issues inhibit progress toward interoperability and digital data exchange. ACP supports the Patient Matching and Transparency in Certified Health IT Act of 2024. “The bill aligns with ACP's policy to support best practices for patient matching and identification to improve patient safety and expand interoperability efforts in health care,” Oxman said. Another issue of concern is data privacy. The Cures Act enhanced both patient and clinician access to personal health information (PHI). However, once PHI is disclosed to the mobile app or other digital health tool, it loses its Health Insurance Portability and Accountability Act (HIPAA) privacy protections. The limits of these interoperability and access initiatives support the need for broader industry guardrails and public and private consensus on a national privacy framework that incorporates the expanding digital health landscape. “We encourage Congress to pass the American Privacy Rights Act, which would establish the nation's first comprehensive federal consumer data privacy framework.”

To stay one step ahead of any future pandemics or PHEs, Congress should “sufficiently and consistently” fund and support pandemic preparedness, and the federal government should develop and maintain a federal pandemic preparedness and response plan, she said. ACP underscored in the RFI the importance of reauthorizing the Pandemic and All-Hazards Preparedness Act (PAHPA). PAHPA authorizes medical response programs to provide medical personnel, equipment and other support when requested by states.

One very critical program under PAHPA is the Strategic National Stockpile and ACP strongly supports strengthening the program.

The critical nature of a strong supply chain was another lesson learned from the pandemic, according to Oxman. “Funding from the Cures initiative paved the way for the U.S. to accelerate the development of COVID-19 vaccines,” she said. “This allowed our country to protect and secure our vaccine development supply chain.”

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