07.21.21

Bipartisan Senators Reintroduce Legislation to Improve Seniors’ Access to Breakthrough Medical Innovations

Today, Senators Richard Burr (R-NC), Michael Bennet (D-CO), Tom Carper (D-DE), and Tim Scott (R-SC) reintroduced the New Opportunities for Value to Extend Lives (NOVEL) Act. This bipartisan legislation would update coding, coverage, and payment processes at the Centers for Medicare and Medicaid Services (CMS) to improve seniors’ access to life-saving medical innovations.  

“The United States has historically been the undisputed leader in biomedical innovation,” said Senator Burr. “Unfortunately, Medicare too often fails to swiftly provide access to the most up-to-date medical innovations. It’s essential that Medicare policies are able to keep pace with the dynamic pipeline of 21st century products, so seniors can access breakthrough treatments without unnecessary delay. This bipartisan legislation takes the important step of updating Medicare’s coding, coverage, and payment rules and enhancing coordination between CMS and FDA. I’m proud to work with Senators Bennet, Carper, and Scott on this important bill.” 

“Currently, it takes years to code new medical technologies and ensure they are covered by Medicare,” said Senator Bennet. “For high-risk patients who need these technologies, years can be too long to wait. Our bipartisan NOVEL Act will help new technologies reach patients faster and save lives and costs to our health care system.”

“Millions of seniors in Delaware and across our nation rely on Medicare for health care services,” said Senator Carper. “Yet too often, Medicare cannot provide our seniors with swift access to emerging and lifesaving medical technologies because of the obsolete policies in place. This bill will help improve government processes to make new, innovative medical products available to seniors on Medicare without needless delays. I’m proud to introduce this bill that can make a real difference in the lives of our seniors.”

Background:

The Centers for Medicare and Medicaid Services (CMS) is the single largest payer of health care services in this country, with more than 60 million seniors and individuals with disabilities relying on Medicare alone. For this reason, Medicare coding, coverage, and payment policies have an outsize impact on not only seniors’ access to care, but decisions made by innovators and their investors as to how best to allocate research capital, and therefore, the future pipeline of life-saving medical innovations.

Currently, CMS does not have a clear pathway for timely coverage of novel medical products once approved by the Food and Drug Administration (FDA), which can leave seniors enrolled in Medicare without quick access to these often life-saving treatments. CMS can take a year or more to make a coverage decision following an FDA approval of a treatment or therapy. For example, in the fall of 2017, FDA approved two new immunotherapy treatments for certain types of cancers, known as chimeric antigen receptor (CAR) T cell therapies. CMS did not make a decision to cover those cancer treatments until August of 2019, roughly two years after these cutting-edge therapies were approved by FDA.

The NOVEL Act would bring greater transparency, predictability, and urgency to CMS coding, coverage, and payment decisions for novel medical products, defined as those that receive a “breakthrough” designation or “regenerative medicine advanced therapy” designation at the FDA. Specifically, this legislation would provide a clear and speedier pathway to coverage for these cutting-edge therapies.

Senators Burr, Bennet, Carper, and Scott first introduced the NOVEL Act on July 30, 2019.