Payers, Providers, and Patients – Oh My! Is Crowell & Moring’s biweekly health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors. In this episode, hosts Payal Nanavati and Joe Records discuss recent FDA guidance related to digital health with Jodi Daniel and Shaina Vinayek. For more information on this topic, please see our previous blog post. Subscribe to Payers, Providers, and Patients – Oh…

In September 2019, the Food & Drug Administration (FDA) issued a new draft “Clinical Decision Support Software” guidance for public comments, which are due December 26, 2019. Concurrently, the agency published updates to four related guidance documents centered on regulation of digital health software products along with a consolidated summary titled “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act,”[1] but is not…

Payers, Providers, and Patients – Oh My! Is Crowell & Moring’s biweekly health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors. In this “deep dive” episode, hosts Payal Nanavati and Joe Records talk to Barbara Ryland about benefits under Medicare Part C. Subscribe to Payers, Providers, and Patients – Oh My! at: PodBean | SoundCloud | Apple Podcasts…

As of October 3, 2019, the Office of Management and Budget completed its review of the proposed rules for “modernizing and clarifying” the Physician Self-Referral Regulations and revising the safe harbors under the Anti-Kickback Statute and rules regarding the Beneficiary Inducement Civil Monetary Penalties Law. These regulations were the subject of two Requests for Information (RFIs) issued by the Centers for Medicare & Medicaid (CMS) and the HHS Office of the Inspector General (OIG) in…

Last week, Tennessee proposed to the Centers of Medicare and Medicaid Services (“CMS”) the first of its kind Medicaid block grant program, which would constitute a fundamental restructuring of the Tennessee Medicaid program. The proposal is intended to implement Tennessee House Bill 1280, enacted in May of 2019, which directed the governor to request CMS to approve the block grant through a Section 1115 waiver amendment. Tennessee currently operates its Medicaid program (“TennCare”) through…

On August 26, North Carolina passed a law allowing small businesses to band together to offer group health insurance through association health plans (“AHPs”). The Small Business Health Care Act, passed without the governor’s signature, authorizes the formation of large group health plans for association members, including small businesses and sole proprietors. However, these plans can be implemented only if they do not violate federal law, and the federal regulations authorizing this form of…