Wenstrup’s bipartisan bill aims to protect medical innovation, development

U.S. Rep. Brad Wenstrup (R-OH) recently proposed a bipartisan bill that would authorize the extension of pass-through status under the Medicare program for the innovation and development of certain drugs and devices impacted by the COVID-19 pandemic.

“Our nation’s medical community made necessary changes, sacrifices and restrictions over the last year to prioritize combating COVID-19, but medical innovation and development should not be compromised,” Rep. Wenstrup said. 

The congressman on Oct. 16 sponsored the Protecting Access to Innovation During COVID-19 Act, H.R. 8624, with cosponsor U.S. Rep. Sanford Bishop (D-GA) to ensure patients continue accessing new drugs and devices during and beyond the pandemic, according to a bill summary provided by Rep. Wenstrup’s office.

“This May, I joined Rep. Sanford Bishop in sending a letter to Health and Human Services and the Centers for Medicare and Medicaid Services [CMS] asking them to extend the pass-through period for new drugs and new devices,” said Rep. Wenstrup, “and I’m proud to join Rep. Bishop again on this bill to ensure that we don’t punish medical innovation because of closures that occurred during the public health emergency.”

According to the lawmaker’s statement, CMS allows for an initial separate payment for new devices and drugs in the hospital-based outpatient department and ambulatory surgery center settings using pass-through status, which encourages the use of innovative products. CMS then collects utilization data from the procedures using such products during a specified time period to determine how to adjust the payment for the service.

During the COVID-19 pandemic, the Surgeon General and CMS urged the cancellation of all elective medical procedures, according to Rep. Wenstrup’s statement, which noted that a majority of the products that qualify for pass-through status are furnished during elective procedures, and therefore would skew utilization data.

If enacted, H.R. 8624 would give the U.S. Department of Health and Human Services Secretary authority to give a product with pass-through status an extension if the secretary determined that the cost of the product was unable to be accurately calculated due to the COVID-19 pandemic.

The bill has garnered support from the American Society of Cataract and Refractive Surgery, the American Academy of Ophthalmology, the American Association of Neurological Surgeons, among others. 

“During the ongoing public health emergency, physicians are striving to provide the highest quality care and that means being able to use new drugs, devices or biologics,” said American Association of Orthopaedic Surgeons President Joseph A. Bosco. “This legislation helps ensure the access and flexibilities needed to adopt innovative technologies during these uncertain times.”