Health Law Alert

HHS again makes HIPAA enforcement-related headlines, but not for the same reason it had in the recent past. At the end of April, HHS issued a “Notification of Enforcement Discretion Regarding HIPAA Civil Monetary Penalties” (the “Enforcement Discretion Notice”) in which it announces reduced annual limits for HIPAA violations based […]

Beginning on April 1, 2019, CMS started using a Preclusion List as a basis for denying claims for Medicare Advantage, Part D and PACE claims. The concept of the Preclusion List was finalized a year earlier in CMS-4182-F, Contract Year 2019 Policy and Technical Changes to the Medicare Advantage Cost […]

At this year’s Health Care Compliance Association Compliance Institute, Joanne Chiedi, Principal Deputy Inspector General of Health and Human Services (“HHS”) spoke about innovation in health care and the important role of compliance, recommending that compliance have “a seat – and a voice – at the innovation table.” Ms. Chiedi […]

In 1994, the HIV crisis was at its height, and confidentiality of HIV testing and test results was a grave concern. The Nebraska Unicameral enacted an unusual statute, requiring that no HIV test be administered without first obtaining the patient’s informed consent to the test. This was unusual because the […]

Medical devices are subject to numerous regulations and an intensive approval process to verify their safety for patient use–but what about the software that powers these devices? How secure is the software that operates insulin pumps or pacemakers? In addition to the requirement that medical device software meet general Food […]