ML Strategies has posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
This week’s update focuses on developments around the 21st Century Cures Initiative and the expansion of the Pioneer ACO Program. The new draft legislation for the 21st Century Cures Initiative includes increased funding for the National Institutes of Health (NIH) and a new version of the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act. The SOFTWARE Act would exempt health software products from FDA regulation except where FDA determines the product would pose a “significant risk to patient safety.” The draft legislation currently includes only placeholders on interoperability and telemedicine, key issues that lawmakers will need to work through. On the ACO front, The Pioneer ACO program is the first program to meet the Centers for Medicare & Medicaid Services (CMS) Office of the Actuary’s approval for expansion. HHS Secretary Sylvia Burwell formalized the administration's intention to expand the program.
Past Health Care Updates are available here.