Senate Bill Would Speed Device Access for Seniors

July 31, 2015

A bipartisan group of U.S. senators is hoping to ease access to innovative devices for Medicare patients through the creation of self-pay arrangements with their healthcare providers.

Sen. Rob Portman (R-Ohio) introduced the Accelerating Innovation in Medicine Act of 2015, S. 1757, with cosponsors Sens. Martin Heinrich (D-N.M.), John Thune (R-S.D.) and Michael Bennet (D-Colo.) that would allow devicemakers to designate products to be excluded from government payment programs at an early stage of production. The group says it will increase patient access to medical devices and save taxpayers money.

“The current medical device process is cumbersome and limits access to innovative devices and procedures for seniors who are willing to pay out of pocket,” Portman says in a prepared statement. “Our bill simply allows seniors to take government out of the equation by purchasing these devices themselves rather than through Medicare. Ultimately, it will help to ensure patients and physicians have access to the most innovative medical technologies.”

As written, the bill would allow device companies to provide written consent to the FDA to have their products placed on the AIM list when they submit applications for approval or clearance. A device will be on the list for an initial three-year period and remain posted for subsequent three-year periods. To keep its device on the list after the initial period, a company would have to submit published or publically available data on clinical studies completed for the product.

HHS shall maintain the list and make it available to the public, updating it at least monthly, according to the bill.

A companion piece of legislation, H.R. 2597, was introduced in June by Rep. Erik Paulsen (R-Minn.), who was joined by cosponsors Reps. Ron Kind (D-Wisc.), John Shimkus (R-Ill.) and Mimi Walters (R-Calif.). It has been referred to the Committee on Ways and Means, as well as Energy and Commerce.

Read the bill here www.fdanews.com/08-03-15-senatebill.pdf. — Elizabeth Hollis