In a recent advisory opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) concluded that certain investments by a health system, manager and physicians in an ambulatory surgery center (ASC) did not create a substantial risk of fraud and abuse under the federal Anti-Kickback Statute (AKS) even though the
Recreational Cannabis Statutes’ Impact on NY and NJ Employers
New York and New Jersey recently legalized recreational marijuana within less than 6 weeks of each other. While both acts prohibit employers from taking action against employees at least 21 years old who use marijuana recreationally and restrict employers from denying these employees’ employment rights and privileges based solely on marijuana use, it begs the
OIG Warns on COVID-19 Vaccine Billing
In an April 15 notice on its COVID-19 portal, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) reminded healthcare providers that COVID-19 vaccines must be administered at no out-of-pocket cost to patients. OIG has received complaints from patients that their providers charged them for COVID-19 vaccines.
Under the Centers for
HIPAA in an Evolving Health Care Environment
On April 6, Rivkin Radler’s Ben Malerba gave a presentation to members of the Coalition for Behavioral Health. The presentation was entitled “HIPAA in an Evolving Health Care Environment: Proposed Changes for 2021 and Response to COVID-19.”
The Coalition for Behavioral Health provides policy, advocacy, training and technical assistance to more than 100 community-based behavioral
NYS Legalizes Gestational Surrogacy: Changes for Health Care Providers
On February 16, 2021, the Governor enacted the Child-Parent Security Act (“the Act”) through emergency regulations, legalizing compensated gestational surrogacy in New York State.
With gestational surrogacy, a surrogate gestates an embryo for the intended parents. The embryo may contain the genetic material of the intended parents or donor gametes. Traditional surrogacy, where the
Free Drug Program Avoids Sanctions Under AKS
In a recent advisory opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) determined not to impose sanctions under the federal Anti-Kickback Statute (AKS) on a drug manufacturer program that offers a free drug to certain eligible patients. The manufacturer uses personalized medicine technology to make the drug from
Pandemic response, fraud and abuse top Biden’s enforcement priorities
A March 24 article in Wolters Kluwer’s Health Law Daily, “STRATEGIC PERSPECTIVES: Pandemic response, fraud and abuse top Biden’s enforcement priorities,” quoted healthcare industry experts who predict increased enforcement in the areas of fraud and abuse, False Claims Act (FCA) cases, and pandemic-related waivers. Rivkin Radler’s Robert Hussar was quoted in the
Shapiro Quoted on CBD Warning Letters in Vitamin Retailer
A March 26 article in Vitamin Retailer, “FDA Warns Selling of Topical CBD Products Violates FD&C Act,” discussed the two warning letters recently issued by the U.S. Food and Drug Administration (FDA) to two companies for selling topical pain relief products containing CBD. The FDA claims that the sale of the products
FDA Warns that Topical Pain-Relief Products Containing CBD Violate FD&C Act
This week, the U.S. Food and Drug Administration (FDA) issued Warning Letters that effectively declare that the presence of cannabidiol (CBD) as an inactive ingredient in topical over-the-counter (OTC) drug products is a violation of the federal Food, Drug, and Cosmetic Act (FD&C Act).
In a news release issued on March 22, 2021 the FDA
Time For CEs, BAs to Take Right of Access Seriously
A March 11 article in the Health Care Compliance Association’s Report on Patient Privacy, “In Wake of 16th OCR Settlement, Time For CEs, BAs to Take Right of Access Seriously,” discussed the Right of Access Initiative that the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) has been pursuing since