Author: Alex Stoflet

Alex Stoflet

Alex works on transactional matters to help facilitate mergers, acquisitions, and other business relationships between health care entities and on regulatory matters to help health care entities understand the requirements for compliance in carrying out their health care and business functions.

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“Pathways to Success” – CMS Finalizes Overhaul of National ACO Program

Alex Stoflet

On December 21, 2018, CMS announced a final rule, subsequently published in the December 31 issue of the federal register, significantly overhauling the Medicare Shared Savings Program (“MSSP”). Among the important changes in the final rule is a redesign of MSSP’s participation options. Under MSSP, providers of services and suppliers participating in an Accountable Care...

FDA Testing New Approaches for Review of Digital Health Device Applications

Alex Stoflet

On January 7, 2019, FDA Commissioner Scott Gottlieb announced significant updates to the FDA’s pilot Software Pre-Certification Program, sometimes referred to more broadly as a Digital Health Pre-Certification Program (“Pre-Cert”). Pre-Cert was originally announced in 2017 as part of the FDA’s Digital Health Innovation Action Plan. The FDA envisions the program as a streamlined process...

FDA Issues Guidance on Drug and Device Manufacturer Communications: Part II – Medical Product Communications that are Consistent with the FDA-Required Labeling

Alex Stoflet

On June 12, the FDA issued guidance that clarifies its recommendations for certain product communications made by medical product manufacturers, packers, and distributors (collectively “firms”). The guidance, “Medical Product Communications That Are Consistent With the FDA-Required Labeling” (the “Guidance”), explains the FDA’s views on firms’ communication of information that is not contained in the FDA-required...

FDA Issues Guidance on Drug and Device Manufacturer Communications: Part I – Health Care Economic Information and Unapproved Products/Use Communications with Payors

Alex Stoflet

On June 12, the FDA issued guidance that clarifies its recommendations for certain medical product communications. The guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers” (the “Guidance”), provides answers to common questions about the communications between medical product manufactures, packers, and distributors (“firms”), and insurance companies,...

EHR Vendors Beware: eClinicalWorks Settles with DOJ for $155 Million

Alex Stoflet

The Department of Justice (“DOJ”) announced on May 31, 2017, a $155 million settlement of its lawsuit alleging False Claims Act (“FCA”) and Anti-Kickback Statute (“AKS”) violations committed by eClinicalWorks (“eCW”), one of the nation’s largest electronic health records (“EHR”) software vendors. Brendan Delaney, the original qui tam plaintiff in the case, will receive approximately...

OIG Interprets and Incorporates Statutory Exceptions to CMP Law

Alex Stoflet

As of January 6, 2017, final rules published by the United States Department of Health and Human Services Office of the Inspector General (the “OIG”) implementing certain exceptions to the Civil Monetary Penalty law (“CMP”) took effect. The CMP rules were published alongside final rules regarding safe harbors to the federal Anti-Kickback Statute (“AKS”), about...

CMS FINALIZES RULE FOR EMERGENCY PREPAREDNESS REQUIREMENTS

Alex Stoflet

The Centers for Medicare and Medicaid Services (“CMS”) published a final rule for emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers in the Federal Register on September 16, 2016. Noting the timeliness of the rule’s publication, which also happens to coincide with peak Atlantic hurricane season,  CMS Deputy Administrator and Chief Medical Officer...