On Wednesday, the Centers for Medicare & Medicaid Services (CMS) released its proposed calendar year 2025 physician fee schedule, which includes recommendations on coverage of digital health tools, including digital therapeutics and telehealth services.
To support access to behavioral health services, CMS proposed that Medicare pay for digital mental health treatment devices used in...
When evaluating new opportunities in any sector it is important to understand non-market influences – the role legislation, regulation, relationships, etc. have on things such as competitive advantage and new entrants - perhaps none more so than in healthcare.
The Centers for Medicaid and Medicare (CMS) operates as the nation’s largest payer, and the healthcare industry at large is heavily...
Remote monitoring (RM) could revolutionize the way care is provided for people with chronic disease, particularly for people of color and low-income people, who experience worse outcomes than the general population as a result of systemic racism and discriminatory policies.
Unfortunately, scarce provider reimbursement for RM services and devices presents a barrier to adoption and risks...
The Biden administration is continuing to lock in leadership at the U.S. Department of Health and Human Services with a handful of new appointments.
At the top of the list is the department's new administrator for the Senate's consideration, Chiquita Brooks-LaSure. An Obama-era policy official, she was most recently managing director at Manatt Health where she provided policy analysis and...
The start of the Biden administration has signaled a changing of the guard throughout the U.S. Department of Health and Human Services.
For the FDA, Commissioner Dr. Stephen Hahn has stepped down and has been replaced by acting Commissioner Dr. Janet Woodcock. She joined the agency's Center for Biologics Evaluation and Research in 1984 and held the position of Center for Drug Evaluation and...
In Part 1 of this article, we introduced Medicare and its covered services, along with rationales for digital health startups to engage with the nation’s largest payer. These motivations include Medicare’s large and growing beneficiary base, access to the nation’s largest and most influential payer, and movement toward value-based care.
Despite these opportunities, startups have been relatively...
Despite its attractive large market size, Medicare has long frustrated early stage healthcare companies. The complex federal health insurance system, mired in statutory constraints, has arguably discouraged entry from would-be external innovators.
Regulations intended to prevent fraud, waste, and abuse, also create barriers to adoption for innovative value-creating products and services. The goal...
Abbott announced yesterday that its recently cleared FreeStyle Libre 2 integrated continuous glucose monitoring (CGM) system is now covered by the Centers for Medicare and Medicaid Services (CMS), and available to Medicare beneficiaries with diabetes who meet eligibility criteria.
Indicated for diabetes management in patients aged four years or older, the updated version of Abbott's system can...
This morning the US Department of Health and Human Services dropped its long-awaited final rules on interoperability, information blocking and patient access.
While the two final documents from the HHS Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) specify a number of new requirements laid out in the 21st...
