February 19, 2021
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...
January 21, 2021
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 Stephen Hahn has stepped down and has been replaced by acting Commissioner Dr.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...
December 4, 2020
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...
November 24, 2020
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...
September 2, 2020
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...
Photo Credit: Alex Wong/Getty Images
March 9, 2020
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...
September 6, 2019
Abhinav Shashank is the cofounder and CEO at Innovaccer Inc. Abhinav has led the San Francisco-based healthcare data activation platform company since its inception in 2014. Under his supervision, Innovaccer developed its proprietary healthcare data activation platform.
We dream of a healthcare system that encircles all citizens and connects them to the common thread of care, which is built on...
July 30, 2019
Looking to solve the problem of health record interoperability, this afternoon CMS unveiled a new pilot program dubbed “Data at the Point of Care” (DPC), which will employ an API to help give providers access to their patient’s medical data. The pilot is part of a larger CMS initiative called MyHealthEData, which is focused on giving patients more access to their medical data.
“That burden on...
July 19, 2019
Digital health-focused moves from payers throughout the last quarter ranged from partnership agreements and program launches to acquisitions and CMS coverage rulings. Several such headlines came from major players like Cigna, UnitedHealth Group, pharmacy benefit managers (PBMs) and various Blue Cross plans, and frequently involved digital health mainstays such as Livongo, Fitbit, Doctor on Demand...