Physicians call out 21st Century Cures Act

The 21st Century Cures Act (H.R. 6) has gained support from the ACR and other radiologists for its provision to repeal the 25% professional component multiple procedure payment reduction (MPPR), but there are those who have concerns about the bill’s potential impact.

In a recent commentary for The New England Journal of Medicine, two doctors from the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital—Jerry Avorn, MD, and Aaron S. Kesselheim, MD—addressed their own problems with the bill, writing that some of its provisions “could lead to the approval of drugs and devices that are less safe or effective than existing criteria would permit.”

“Over the past 80 years, this country's regulatory approach has embraced steadily improving criteria for accurately assessing therapeutic efficacy and risk,” the authors wrote. “Patients and physicians would not benefit from legislation that instead of catapulting us into the future, could actually bring back some of the problems we thought we had left behind in the 20th century.”

One of the bills primary objectives is to accelerate the approval of new products by the Food and Drug Administration (FDA). But the process in place is already “quite efficient,” the authors wrote, and the bill’s ideas about speeding up the process even more are worrisome.    

The bill would also impact the approval of high-risk medical devices, the authors explained, taking importance away from detailed clinical trials. In addition, third-party organization would be allowed to play a crucial role in the approval of devices.

“Another section would allow device makers to pay a third-party organization to determine whether the manufacturer can be relied on to assess the safety and effectiveness of changes it makes to its devices, in place of submitting an application to the FDA,” the authors wrote. “Thus certified by the external company, a device maker would be authorized to continue to assess its own products on an ongoing basis.”

In their commentary, Avorn and Kesselheim do note that parts of H.R. 6 could help the pharmaceutical industry in a positive way, especially the included increases to the budget of the National Institutes of Health (NIH) and the creation of a new “NIH Innovation Fund.”

“Together, this support would help counteract the effects of sequestration and budget cuts that have reduced the purchasing power of the NIH to its lowest level in years,” the authors wrote. “Given the crucial role that NIH-funded research plays in generating the findings on which so many new drugs are based, this boost would be a welcome development.”

The 21st Century Cures Act is expected to be voted on by the House of Representatives any day now. It easily passed out of the House Energy and Commerce Committee back in May. The American Hospital Association (AHA), College of Healthcare Information Management Executives (CHIME) and American Telemedicine Association (ATA) have all detailed their own problems with the bill, which were different than the points raised by Avorn and Kesselheim in the NEJM.