Philips received a warning letter from the FDA in February, which the Agency posted on Tuesday, stating that an inspection of the tech giant's manufacturing facility in Suzhou, China, that makes CT and ultrasonography systems revealed it was not in compliance with the Quality System Regulation's good manufacturing requirements.
The FDA said an inspection of the facility in October showed the...
The Access to Prescription Digital Therapeutics Act, initially introduced in the U.S. Senate in 2022 and reintroduced in March of this year, aims to amend the Social Security Act to provide Medicare and Medicaid coverage and reimbursement for prescription digital therapeutics.
Jennifer Mathieu, senior vice president of professional and government affairs at the Academy of Managed Care Pharmacy (...
In part two of our two-part series, Patrick J. Kennedy, former U.S. Representative and founder of The Kennedy Forum, and Nawal Roy, CEO and founder of global behavioral health data platform Holmusk, discuss with MobiHealthNews how coverage for mental health has changed since the signing of the parity act and what steps the partners are taking to help lawmakers draft even more effective bills to...
Patrick J. Kennedy, former U.S. Representative and founder of the Kennedy Forum, is a leading voice on mental health and addiction. During his 16 years in the U.S. House of Representatives serving Rhode Island's First Congressional District he coauthored and sponsored the Mental Health Parity and Addiction Equity Act, which requires insurers to cover mental health and substance use disorders the...
During the first year of the COVID-19 public health emergency, Medicare improperly paid for $580 million of psychotherapy care, including $348 million of telehealth services, according to an audit by the Department of Health and Human Services' Office of the Inspector General.
The report, which estimated that Medicare paid for $1 billion of psychotherapy that year, included more than 13.5 million...
After years of slow movement advancing telehealth, remote patient monitoring and other digital health technologies, the landscape changed rapidly during the COVID-19 pandemic, said Jodi Daniel, managing director of Crowell Health Solutions.
At HIMSS23, Daniel, who previously served as the founding director of the Office of Policy in the Office of the National Coordinator for Health Information...
We’re witnessing massive demographic and market shifts that will accelerate the race to value-based healthcare. Case in point: The Medicare Payment Advisory Commission (MedPAC) predicts that Medicare Advantage enrollment will soon eclipse traditional Medicare for the first time.
With more people becoming eligible for Medicare than ever before, our healthcare system is experiencing the broad shift...
Last month, two large retail and pharmacy companies made big moves in healthcare delivery: Amazon completed its purchase of One Medical, and CVS Health announced plans to buy Oak Street Health.
The deals aren't unexpected, said Christopher Lis, managing director of global healthcare intelligence at J.D. Power. More than 31 million people are now enrolled in Medicare Advantage plans, key...
The healthcare status quo for Medicaid and other underserved patients frequently leaves them in the lurch, said Cityblock Health CEO and cofounder Dr. Toyin Ajayi.
They may have infrequent access to the medical system, hampered by transportation issues or the need to take time off work. Doctors' offices can be busy, and they may not have enough time to address concerns. Meanwhile, racial and...
