In his first major announcement since taking office, FDA Commissioner Scott Gottlieb, M.D. finalized a major reorganization plan that had been under development since 2013. The reorganization, termed “Program Alignment,” reassigns field staff based on product type rather than geographic regions. Under the new organizational model, inspection and compliance staff in FDA’s Office of Regulatory Affairs will specialize in the five commodities and two enforcement areas:
In a notice published in the Federal Register on Friday, May 19, 2017, the Health Resources and Services Administration announced that it would further delay the effective date of a final rule applicable to all drug manufacturers participating in the 340B Drug Pricing Program.
In recent months, a number of bills have been introduced or passed in Congress that would ease federal health care programs’ restrictions on telehealth. Currently, Medicare has strict limitations on telehealth. But bipartisan groups of Senators have introduced two bills seeking to expand telehealth services covered by Medicare.
On May 10, 2017, the US Department of Health & Human Services (HHS) announced a settlement with Texas-based Memorial Hermann Health System (MHHS) for $2.4 million due to MHHS’s unauthorized disclosure of patient protected health information (PHI). HHS also announced that HHS and MHHS entered into a Resolution Agreement, and MHHS agreed to a corrective action plan.
The Department of Health and Human Services recently issued an important new compliance guide, called Measuring Compliance Program Effectiveness: A Resource Guide. The Guide is a combined effort of HHS’s Office of Inspector General and the Health Care Compliance Association and provides guidance on evaluating compliance program effectiveness based on the input of 40 compliance professionals and OIG staff.
Health Care partner Linda Baumann and associates Hillary Stemple and Kathryn Steffen authored an article for Bloomberg BNA’s Health Law Reporter on the revised Voluntary Self-Referral (Stark) Disclosure Protocol, which the Centers for Medicare and Medicaid Services posted on March 28, 2017.
The Federal Communications Commission recently solicited public comment on how it can better facilitate broadband-enabled health care solutions by adopting new policies or removing existing regulatory barriers. Initial comments are due on May 24, while reply comments are due June 8 of this year.