Draft legislation on a waterfront of health care innovation topics seeks to improve the discovery, development and delivery of new cures. The proposed law includes a number of promising provisions, while other potential elements need refinement before moving forward, physicians told Congress last week.
The 21st Century Cures Act is taking a comprehensive look at the entire cycle of interrelated health activities, from research and through adoption into clinical practice. The act would bring a variety of public policies, including modifications to regulatory oversight. The initiative would bridge the gap between medical science and legislative action and regulations that slow progress.
In a letter to the U.S. House of Representatives Committee on Energy & Commerce, the AMA outlined key areas of the draft law that will have positive and concrete impacts on innovation and improved patient care in.
“Physicians, along with patients, are at the forefront of a fundamental transformation in health care resulting from the intersection of genetic and genomic breakthroughs, the rapid growth of digital capabilities and the resultant new tools for patients and physicians,” the letter said.
Effectively leveraging these new capabilities will require new research pathways with greater roles for physicians and patients, strategic modernization of regulatory oversight, coverage and payment flexibilities and a workable, interoperable data-sharing infrastructure. Specifically, the AMA called for the following recommendations:
- Electronic health record (EHR) interoperability needs major improvement. This is critical for researchers, regulators, insurers, physicians and patients and would accelerate access to new tests and treatments, moving data and information out of silos. This includes reform of the meaningful use program.
- Telemedicine innovation should move forward, including removing Medicare’s geographic restrictions on telemedicine services coverage and removing restrictions on telemedicine in alternative payment models.
- Diagnostic regulation must be modernized, including withdrawal of the Food and Drug Administration proposal to regulate medical practice, which will stifle innovation and undermine successful public health programs and capabilities.
- Clinical data registries should be improved, taking into account registries that already exist. The law proposes the creation of a new category of registries without acknowledging existing registries under the meaningful use program, Physician Quality Reporting System and other regulations. Alignment in this area is crucial to health care transformation.
Launched last year, the 21st Century Cures Act is undergoing review and comments from a variety of health care groups. Staff from the Committee on Energy & Commerce addressed physicians at the AMA’s National Advocacy Conference last week, reiterating the need for EHR interoperability and stressing Congress’ desire to encourage innovation without overregulating.
The AMA will continue to work with Congress on refining the legislation.
