Kelly-led health care transparency bill passes Ways & Means Committee

WASHINGTON, D.C. -- Last week, the House Ways & Means Committee passed the National Coverage Determination Transparency Act, legislation led by U.S. Reps. Mike Kelly (R-PA), Chairman of the Ways & Means Subcommittee on Tax, and Brett Guthrie (R-KY), Chair of the House Energy & Commerce Subcommittee on Health,

The legislation aims to increase transparency for the National Coverage Determination process at the Centers for Medicare and Medicaid Services. The bill was included as part of H.R. 8816, the "American Medical Innovation and Investment Act," which passed the Ways & Means Committee during a vote Thursday. H.R. 8816 now advances to the full House of Representatives for consideration.

"Increasing transparency into the medical device approval process will improve innovation in health care, ultimately benefitting patients. This legislation allows seniors to access care as quickly as possible through a more predictable regulatory process," said Rep. Kelly. "I'm proud to work with Rep. Guthrie and my Ways and Means colleagues to pass this critical legislation and to make health care more transparent for American seniors."

"Medical devices seeking approval should be given a clear, consistent, and efficient process to follow. Unfortunately, too many companies do not realize their application is even incomplete or missing information until a rejection is received from the federal government after waiting in limbo," said Ways & Means Committee Chairman Jason Smith (R-MO). "Congressman Kelly's legislation would correct this issue by requiring federal health agencies to notify applicants in a timely manner of any incomplete information so companies have a fair shot at bringing their devices to market and allow patients to benefit from new technologies as soon as possible."

"One of my top priorities as Chairman of the Health Subcommittee is to increase transparency across the health care sector. In addition to knowing the true costs of care, patients, especially seniors, deserve access to the most innovative treatments," said Rep. Guthrie. "By increasing the transparency of the National Coverage Determination process, seniors will be able to access care as quickly as possible through a more predictable regulatory process. I will always work to ensure Americans receive the best and most expedient care possible, and this bill helps to accomplish that goal."

BACKGROUND

The National Coverage Determination (NCD) process at the Centers for Medicare and Medicaid Services (CMS) operates with little transparency and often misses its current statutory deadlines, leaving innovators, providers, and most importantly seniors, at the mercy of this opaque process.

This legislation tackles this issue through a three-pronged approach:

• Clarifies that the timeline for making a National Coverage Determination begins on the date the Secretary receives a National Coverage Determination application.
• Requires the Secretary to determine within 30 days of receiving such applications whether these are complete and further allows the Secretary to work directly with the product sponsor to update the application to resubmit to CMS.
• Finally, requires the Secretary to make all complete NCD applications publicly available on CMS' website.

Click here to view the text of the National Coverage Determination Transparency Act.