Articles and Blogs

It isn’t only the U.S. Food & Drug Administration (“FDA”) and Drug Enforcement Agency (“DEA”) that are interested in all things cannabis. Today, the FDA followed earlier warning letters[1] by posting yet another press release regarding an October 10, 2019 warning letter that was issued jointly by the FDA and the Federal Trade Commission (“FTC”)…Read More

On October 9, 2019, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule (the “Proposed Rule”) to amend the regulations interpreting the Stark Law. The Proposed Rule revises material portions of the Stark Regulations and includes critically necessary guidance on leasing arrangements subject to the Stark Law. This article provides a summary…Read More

House Committees Advance Pelosi Drug Plan Thursday was a busy day in Washington as the lower chamber tackled drug pricing legislation. The House Energy and Commerce Committee advanced (30-22) an updated version (H.R. 3) of House Speaker Nancy Pelosi’s drug pricing reform package and the House Education and Labor Committee also passed it on a…Read More

Centers for Medicare & Medicaid Services (“CMS”) is revising its Nursing Home Compare Five-Star Quality Rating System to add a red alert icon to a skilled nursing facility’s profile if the facility has had a high-level abuse citation and/or repeat abuse citations. Changes to CMS Nursing Home Compare Website On October 7, 2019, CMS announced…Read More

On September 6, 2019, OIG issued Advisory Opinion No. 19-05 (“the Opinion”) regarding the proposed purchase of real estate from an entity owned and managed, in part, by an excluded individual. The facts that gave rise to the Opinion involved a community health center receiving federal grant funding and Medicare reimbursement which was looking to…Read More

On October 9, 2019, both the Health and Human Services Office of Inspector General (“OIG”) and Centers for Medicare & Medicaid Services (“CMS”) issued proposed rules pertaining to the Anti-Kickback Statute safe harbor and Civil Monetary Penalties Law exception for EHR Donations (“EHR Donation Rules”), as well as a new safe harbor and exception for…Read More

On October 9, 2019, the Centers for Medicare & Medicaid Services (“CMS”) released a much anticipated proposed rule (“Proposed Rule”) aimed at modernizing and streamlining the Federal Stark Regulations. The Proposed Rule is one component of the Department of Health and Human Services (“HHS”) recently launched “Regulatory Sprint to Coordinated Care” and is intended to…Read More