New legislation may impact the Medicare member experience through changes to coverage and services. On June 22, 2021, Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) released a draft bipartisan legislation known as Cures 2.0. This proposal is a follow-up to their 21st Century Cures Act of 2016. Cures 2.0 lays out advances in medical research, public health and pandemic preparation, health literacy, clinical trial diversity, and healthcare coverage. Here is a quick rundown of its impact on Medicare coverage and services—and, ultimately, the Medicare user experience—if passed.
Coverage of breakthrough medical devices
After medical devices receive Food and Drug Administration (FDA) approval, it can take up to four years for Medicare coverage to be processed. With the new Cures 2.0 rule, breakthrough devices receive immediate coverage for four years upon FDA approval. After this transitional period, the Centers for Medicare & Medicaid Services (CMS) will determine whether this coverage continues. This four-year period also enables clinical studies involving Medicare patients to conclude. And it will push new devices into the market with swift Medicare coverage that otherwise may not occur without this new provision.
Legislators initially set the rule’s effective date for March 15, 2021. However, delays caused by the Biden administration’s regulatory freeze, as well as doubts from insurers that covering all devices can have a strong or positive impact on the Medicare population, pushed the effective date once to May 15 and again to December 15.
Expanded telehealth services
As telehealth continues to rise in the United States due to the COVID-19 pandemic, Cures 2.0 aims to further expand telehealth access for Medicare patients. It removes restrictions on geographic and originating sites and broadens categories of eligible providers and services. Although geographic limitations are temporarily waived during the pandemic, there are still concerns over post-pandemic telehealth services.
Increased access to genetic testing and precision medicine
Genetic testing helps diagnose certain conditions, identifies risk for diseases and assists with family planning, allowing patients to make informed decisions about their health and receive treatment if necessary. Cures 2.0 includes increased access to genetic testing and federal support for testing in children with rare diseases. Medicare will also cover genomic precision medicine consultations provided by certain healthcare providers. A pilot program will be launched in up to five states to test the initiative’s delivery and payment methods.
Modernizing the CMS
The proposal also focuses on CMS coverage and care modernization. To tackle this, the Secretary of Health and Human Services must submit a report to Congress within a year on the capabilities and deficiencies of CMS computer services. This is expected to provide a better understanding of how to manage CMS programs while keeping up with technological and scientific changes. A second report will cover digital alternatives to treatment and therapies, a standardized process to determine product eligibility and payment methods.
What’s next for how this legislation may impact the Medicare member experience?
The release of the draft legislation brings forth hope for advances in medicine and healthcare. The Medical Device Manufacturers Association and AdvaMed, a MedTech company, released supportive statements, as did the Association of Clinical Research Organizations. But there are also potential challenges and uncertainty. DeGette and Upton plan to release the final bill after Congress returns from its annual August recess. Until then, insurers, providers and patients must wait and see.
Corporate Insight closely monitors the digital patient and member experience across leading health systems as well as health and Medicare plans. Within our Medicare Monitor research services, we see leading firms responding to changes in policy and legislation to provide care for Medicare members. For further insights and continuing changes to the nation’s leading healthcare organizations, please read more on our blog.