Medicare regulators have recently proposed a groundbreaking initiative that could revolutionize the reimbursement landscape for developers of software designed to treat medical conditions. Historically, these developers have faced challenges in gaining a foothold in the healthcare industry due to reimbursement difficulties. However, the Medicare proposal aims to change this by offering payment for digital mental health treatments, marking a significant milestone in the field.
The proposed codes cover FDA-cleared digital mental health treatments that are provided to patients by healthcare providers as part of ongoing behavioral health treatment. These codes not only allow clinicians to bill for supplying the treatments but also for management services, such as reviewing data from apps and communicating with the patients. Stakeholders’ comments on the Medicare proposal are expected to be submitted in the coming weeks.
In a related development, the announcement was made today that a major revamp will take place within the healthcare regulatory landscape. Offices dedicated to technology, data, and artificial intelligence (AI) will be moved to the Office of the National Coordinator for Health Information Technology (ONC). This move comes as concerns grow regarding AI and cybersecurity threats in medicine. It also reflects the efforts of various interested factions, including IT vendors and device companies, to influence the regulation of emerging technologies.
ONC, responsible for developing and enforcing data standards for health systems, has gained significant influence in recent years due to the critical role data plays in healthcare. The expanded role of the office will enhance oversight of health data and AI while streamlining the health department’s internal use of new technology. The newly formed office, to be headed by the current ONC chief, will be known as the Office of Health Data and AI Regulation.
Meanwhile, the FDA’s chief devices regulator, who has held the position since 2009, recently announced his departure. While an interim replacement has been appointed, the long-term successor remains unknown. Under the leadership of the departing regulator, the FDA’s devices center has significantly increased the number of authorized products and introduced programs to facilitate the market entry of innovative medical devices. Notably, efforts to regulate AI-enabled medical devices and digital health technologies have been spearheaded during his tenure.
Regarding health tech issues, presumptive Democratic presidential nominee has yet to reveal her stance. However, experts and insiders anticipate her positions to align closely with those of . Harris has actively participated in AI events, including a summit on AI safety hosted by former U.K. prime minister . During this event, she emphasized the importance of developing AI technology safely. Harris has also secured support from prominent companies to promote the safe development of AI. Her history of representing Silicon Valley in Congress may influence her approach to healthcare technology if she assumes the presidency.