On May 26, the U.S. Department of Justice (DOJ) announced criminal charges against 14 defendants in six states for participation in healthcare fraud schemes related to the COVID-19 pandemic. The coordinated takedown involved fraudulent claims for laboratory testing, telemedicine fraud, pharmacy fraud, payment of kickbacks for referrals, and alleged misappropriation of COVID-19 Provider Relief Fund
FDA Issues Medical Device Safety Guidance for MRI Facilities
On May 19, the U.S. Food and Drug Administration (FDA) issued final guidance for assessing the safety and compatibility of medical devices within magnetic resonance imaging facilities. The guidance applies to implanted devices, external devices like insulin pumps and pulse oximeters, and any other devices that may be brought into MRI rooms, but not to
EHR Company in $3.8M Kickback Settlement
The U.S. Department of Justice recently announced that CareCloud Health, a Florida-based developer of electronic health records software, agreed to pay $3.8 million to resolve a whistleblower’s allegations that it paid illegal kickbacks to generate sales of its products. CareCloud’s marketing referral program called the “Champions Program” allegedly violated the federal Anti-Kickback Statute (AKS) and
OIG Issues Favorable Advisory Opinion on Hospital/Physician Joint Venture ASC
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
Insurance Fraud Scheme Lands Chiropractor in Prison
The U.S. Department of Justice (DOJ) announced on April 13 that James Spina, a licensed chiropractor and the unlawful operator of Dolson Avenue Medical, P.C. (DAM), was sentenced to nine years in prison and three years of post-release supervision. DAM, a multi-disciplinary medical practice in Middletown, New York, purported to provide a variety of pain
Bristol-Myers Squibb Settles MDRP Underpayment Claim for $75 Million
The U.S. Department of Justice recently announced that Bristol-Myers Squibb (BMS) agreed to pay $75 million, plus interest, to resolve allegations that it knowingly underpaid rebates owed under the Medicaid Drug Rebate Program (MDRP). Of that total, $41 million plus interest will be paid to the federal government and the remainder to various state Medicaid
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