On May 7, 2019, the Department of Justice (“DOJ”) released new guidance for trial attorneys in the DOJ’s civil division regarding how entities under False Claims Act investigation can receive credit for cooperation.  The release of this new guidance follows public comments delivered in March by Michael Granston, director of DOJ’s civil fraud section, noting

On Friday April 26, 2019, the US Department of Health and Human Services (“HHS”) issued a notification regarding HHS’ use of Civil Monetary Penalties (“CMP”) under the Health Insurance Portability and Accountability Act (“HIPAA”) as amended by the Health Information Technology for Economic and Clinical Health (“HITECH”) Act.  https://www.federalregister.gov/documents/2019/04/30/2019-08530/enforcement-discretion-regarding-hipaa-civil-money-penalties.  The notice provides: “As a

The Centers for Medicare & Medicaid Services (“CMS”) has published a final rule that will expand access to telehealth services for Medicare Advantage (“MA”) plan enrollees.[1] CMS Administrator Seema Verma characterized the agency’s latest policymaking efforts as “a historic step in bringing innovative technology to Medicare beneficiaries” and a way for the agency to

On February 14, 2019, the Centers for Medicare & Medicaid Services (“CMS”) announced the Emergency Triage, Treatment and Transport reimbursement model (the “ET3 Model”), a demonstration project that aims to provide improved flexibility to ambulance crews addressing 911-initiated emergency calls for Medicare beneficiaries.

CMS plans to release its Request for Applications (“RFA”) to solicit participation

On April 2, 2019, FDA issued a press release featuring a statement from FDA Commissioner Scott Gottlieb announcing the Agency’s latest enforcement actions taken against companies engaging in unlawful marketing of cannabidiol (CBD) products.  Coming just days before Gottlieb’s anticipated departure from the Agency, this news otherwise is unsurprising given recent events on the federal

Despite recent welcome news to the home health agency (“HHA”) industry in Florida, Illinois, Michigan, and Texas following an end to Centers for Medicare & Medicaid Services’ (“CMS’s”) long-standing HHA provider enrollment moratoria, CMS subsequently announced that it would place some newly enrolled HHAs in a provisional period of enhanced oversight. The purpose

On March 15, 2019, the Centers for Medicare & Medicaid Services (CMS) released proposed changes to its methodology for calculating Civil Money Penalties (CMPs) for Medicare Advantage (MA) and Part D Prescription Drug Plan (MA and Part D) sponsors.  The proposed changes would impact both the calculation methodology for 2019 as well as the CMP

Consumer privacy protection continues to be top of mind for regulators given a climate where technology companies face scrutiny for lax data governance and poor data stewardship.  Less than a year ago, California passed the California Consumer Privacy Act (CCPA) of 2018, to strengthen its privacy laws.  In many regards, the CCPA served as

The Office of Inspector General (“OIG”) for the Department of Health and Human Services recently issued an Advisory Opinion that provides insight into how the agency evaluates arrangements that deal with the integration of technology, medicine, and patient monitoring under the federal Anti-Kickback Statute (“AKS”). In Advisory Opinion No. 19-02, OIG evaluated whether a

On February 15, 2019, the U.S. Food and Drug Administration (“FDA”) finalized two guidance documents regarding regenerative medicine therapies (see FDA’s announcement here). This development comes nearly 14 months after FDA issued both guidance documents in draft form, which also coincided with FDA’s announcement of a new comprehensive regenerative medicine policy framework intended to