Smucker Legislation to Increase Seniors’ Access to Medical Products Advances in Committee

Washington-Rep. Lloyd Smucker's (PA-11) Timeline Integrity for Medicare Evidence Development (TIMED) Act was advanced in the Ways and Means Committee during a markup.

This bill introduced by Rep. Smucker was included as a part of the American Medical Innovation and Investment Act, H.R. 8816.

Smucker's bill would provide Medicare beneficiaries with greater access to innovative medical devices and drugs while increasing transparency for medical manufacturers and the broader public by reforming the Centers for Medicare and Medicaid Services' (CMS) Coverage with Evidence Development (CED) process.

"Breakthrough and innovative medical drugs and devices offer potentially life-saving treatments to our nation's seniors. It is crucial that CMS works to expedite the coverage determination process to ensure Medicare beneficiaries are not limited in their access to these products," Rep. Smucker said."It is especially critical that the CED process be reformed to ensure that seniors in rural communities, without easy access to a clinical trial or data registry, can still benefit from promising devices and drugs."

"Medicare's Coverage with Evidence Development (CED) program has demonstrated potential to bring a pathway for certain health care devices and services to reach Medicare patients," said Chairman Smith of the Ways and Means Committee."Unfortunately, the timeline over which these items graduate to full coverage is unclear, slow, and leaves many applicants in regulatory limbo. Congressman Smucker's legislation would bring more transparency and efficiency to this opaque process by requiring CMS to provide clear timelines for products in the CED program."

Background:

Under the Social Security Act, CMS covers items and services that are deemed "reasonable and necessary" which is typically done through a national coverage policy through a National Coverage Determination (NCD). In 2005, CMS created an alternative coverage decision known as "coverage with evidence development" (CED), which requires an FDA-approved item or service to only be covered when provided to beneficiaries within a clinical trial or data registry. Notably, CMS is not held to any timeline when implementing CED. This practice effectively denies coverage of innovative products to Medicare beneficiaries who live in rural areas removed from medical centers capable of running a clinical trial or do not have access to a medical provider who can participate in a data registry.

The TIMED Act (H.R. 8849) would:

• Establish a timeline for CMS' use of CED to encourage the agency to more expeditiously review the data generated by the product sponsor and move the product towards a coverage redetermination.
• Require CMS to post the date that CED was implemented for each product on its website to provide transparency.
• Ensure Medicare beneficiaries have equitable access to groundbreaking medical items and services.