Clinical laboratories have until May 30, 2017 to make required reports to the Centers for Medicare & Medicaid Services (“CMS”) regarding payment rates paid by private payors for certain diagnostic tests and the volume of such tests furnished for such payors, according to a CMS announcement on March 30, 2017. Last year CMS issued a...
On February 8th, the Department of Justice (DOJ) Criminal Division, Fraud Section issued new guidance (available here) on how it evaluates the effectiveness of a corporate compliance program when conducting an investigation of a corporation. This guidance is significant as it is the first of its kind since the confirmation of the new U.S. Attorney...
Not relying on Congress to take action on the Affordable Care Act, the Centers for Medicare and Medicaid Services (“CMS”) has proposed new regulations intended to attract health insurance issuers back into ACA health insurance exchanges and stabilize the individual and small group insurance markets. On February 17, 2017 CMS proposed a set of modifications...
On February 17, 2017 the Office of the Inspector General (OIG) posted a Drug Pricing and Reimbursement Web portfolio on its website that, according to the OIG announcement, “pulls together the HHS OIG’s body of work since 2010 as well as other relevant items that relate to drug pricing and reimbursement in HHS programs.” The...
President Trump signed an executive order (the “Order”) on January 30th, 2017 aiming to reduce bureaucracy by requiring agencies to remove two regulations for every one new regulation they implement. The cost of any new regulation should be offset by the elimination of these other two previously issued regulations. The Order could have major consequences...
Author’s note: Dorsey Health Strategies (DHS), a healthcare business consultancy founded by Dorsey & Whitney, offers a comprehensive array of business advisory and regulatory services to health industry clients; accordingly, DHS articles will address healthcare business challenges and regulatory considerations. Since telehealth/virtual care/digital health is an area of expertise at Dorsey Health Strategies, this article...
One of President Trump’s first actions in office was to sign an Executive Order stating that his Administration will seek to repeal the Affordable Care Act (the “Act”). In the meantime, President Trump directed the executive branch to take “all actions consistent with law to minimize the unwarranted economic and regulatory burdens of the Act,...
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...
The 21St Century Cures Act, Pub. L. No. 114-255, 130 Stat. 1033, was signed into law on December 13, 2016. This expansive statute addresses topics ranging from investigational drug clinical trial design, mental health program funding and insurance coverage, to a new Medicare benefit for home infusion therapy, among many others. This post focuses on...
On January 6, 2017, two new safe harbors to the federal anti-kickback statute (the “AKS”) will become effective pursuant to a final rule published by the United States Department of Health and Human Services Office of the Inspector General (the “OIG”) on December 7, 2016. The final rule also codifies safe harbors for certain AKS...
Alissa SmithAlissa represents health systems, hospitals, pharmacies, long-term care providers, home he...
Hannah McCallumHannah brings specialized knowledge and real-life experience to help her clients make infor...
Andrew BrantinghamAndrew's experience spans a wide range of industries, and has particular depth in...
Rebecca BrommelBecki assists clients in the areas of litigation and administrative law wit...
Katie CownieKatie has worked on business and corporate issues for more than 20 years. Many of...
Lillie CoxLILLIE ASSISTS A WIDE ARRAY OF HEALTHCARE INDUSTRY CLIENTS WITH CORPORATE TRANSACT...
Ross C. D'EmanueleRoss works in the health care provider, payor, and drug and medical device segment...
Nathan EbnetAs an associate in Dorsey's trial group, Nate Ebnet helps clients achieve their g...
Katie Ervin CarlsonKatie helps employers make day-to-day decisions that are legally sound and that re...
Elise FesterElise counsels a wide variety of clients in the Health Care industry on regulatory...
Adam FreedAdam provides strategic advice to health care providers through all stage...
Randall HansonRandall is an associate in Dorsey’s health transactions and regulations practice group.
Alan IversonAlan is a litigator in Dorsey’s trial group with a focus on clients in...
Michael JenkinsMike serves clients in highly regulated industries, including health care and gam...
Carson LambCarson’s transactional practice focuses on aiding clients in navigating...
Jamie McCartyJamie counsels clients in the healthcare industry in connection with complex busi...
Neal N. PetersonNeal regularly advises clients regarding compliance with laws specific to the he...
Mara SandersMara regularly advises clients on matters of state and federal regulatory complia...
Vanessa J. SzalapskiAs an associate in the Trial Group, Vanessa serves clients in both federal and s...
Claire H. ToppClaire works in three diverse sectors – health care, tax exempt organizations,...