Archive
Wade Emmert
CMS finalizes “reasonable and necessary” definition, expedited breakthrough device coverage process
On January 14, 2021, the Centers for Medicare & Medicaid Services (CMS) published a final rule that, for the first time, adopts a regulatory standard for…
Large Health System Agrees To Pay $200,000 as Part of OCR’s Fourteenth Right of Access Initiative Settlement
In its first enforcement action of 2021, on January 12th, the United States Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) announced…
HIPAA Safe Harbor Bill Becomes Law; Requires HHS to Incentivize Security
The legislation directs HHS to take into account a covered entity’s or business associate’s use of industry-standard security practices within the course of 12 months, when…
Texas, Pennsylvania hospitals lose lawsuit challenging Medicare payments
The hospitals said HHS wrongly calculated their Medicare disproportionate share hospital payments for fiscal year 2015, using the wrong data. As a result, the hospitals appealed…
Improper CBD Product Marketing Lands in FDA’s Crosshairs
The FDA issued warning letters to five companies for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the sale of cannabidiol…
The United States and Tennessee Resolve False Claims Act Claims Relating to “P-Stim” Devices
A physician and two chiropractors agreed to pay the United States and Tennessee a total of $1.72 million to resolve liability under the False Claims Act…
Revisions to Stark Law Rules Covering Physician Profit Sharing and Bonuses
CMS also clarified that if a group has five or fewer physicians, overall profits means the profits from DHS from the entire group; but if a…
OIG Issues New Guidance Regarding Big-Box Store Gift Cards as Patient Incentives
OIG has taken the position that gift cards to “big-box” retailers are identified as impermissible “cash or cash equivalent” incentives under the Civil Monetary Penalties Law.
What Stark law, anti-kickback changes mean for value-based care at ASCs
The changes to the Anti-Kickback Statute make it easier to enter into value-based care arrangements, especially if providers take full risk. The exceptions create flexibility in…
The OCR Settles another Investigation under the HIPAA Right of Access Initiative
OCR has settled its thirteenth enforcement action under the HIPAA Right of Access Initiative, which involved a primary care physician practicing in the State of Georgia.…