Medical Device Legal News with Sam Bernstein: Episode 8
Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion
The Next Wave From OIG: Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Audits
Grounded in the OIG’s General Compliance Program Guidance and DOJ’s Evaluation of Corporate Compliance Programs, our immersive, three-and-a-half-day, classroom-style Healthcare Basic Compliance Academy equips compliance...more
On July 9, 2025, Dr. Mohammed Ahmad of Avon, Ohio, pleaded guilty to making false statements related to health care matters in connection with a telemedicine scheme involving durable medical equipment (DME). ...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2025, including Centers for Medicare & Medicaid Services (CMS) updates to Medicare Advantage (MA) and other Medicare programs....more
The U.S. Court of Appeals for the Seventh Circuit recently rejected an effort by the federal government to extend the federal Anti-Kickback Statute (AKS) to a marketing company in the absence of influence by the company over...more
On April 14, 2025, the U.S. Court of Appeals for the Seventh Circuit issued its opinion in United States v. Sorensen, No. 24-1557, reversing the criminal conviction of Mark Sorensen, the owner of SyMed Inc., a...more
On April 14, the Seventh Circuit in United States v. Sorensen issued a decision reversing a jury conviction and narrowing the scope of the Anti-Kickback Statute (AKS) as applied to marketers and advertisers....more
Manishkumar Patel of Pelham Manor, NY recently pleaded guilty in connection with a healthcare fraud and kickback scheme involving the sale of fraudulent prescriptions to pharmacies, durable medical equipment suppliers, and...more
Telemedicine companies are supposed to facilitate medically necessary services to beneficiaries over the telephone via licensed medical professionals. In reality, however, many of these “telemedicine companies” are...more
The Office of Inspector General in the Department of Health and Human Services (“OIG”) recently issued Advisory Opinion 23-08 in which it concluded that a proposed arrangement involving a supplier’s durable medical equipment,...more
FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more
Government Brings FCA Action Against Laboratory Companies - On July 18, 2023, the US Department of Justice (DOJ) announced it has filed a complaint against multiple laboratory companies and their owner, Patrick...more
Here’s a selection of recent healthcare frauds from New Jersey. On April 17, John Sher of Margate was sentenced to 37 months in prison and ordered to pay $2.77 million in restitution and $327,987 in forfeiture for defrauding...more
On February 7, 2023, the Department of Justice (DOJ) announced its annual False Claims Act (FCA) recoveries for fiscal year 2022. DOJ recovered $2.2 billion from a total of 351 settlements and judgments—the second-highest...more
Home health-related fraud and dentists behaving badly (see this week’s earlier posts) have both been notable recent trends, but the U.S. Department of Justice (DOJ) has been even busier lately cracking down on fraud involving...more
The Department of Justice (“DOJ”) recently announced two settlement agreements, both involving durable medical equipment (“DME”) companies, following allegations that the companies had violated the Anti-Kickback...more
The following is a summary of the federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported are...more
On July 20, 2022, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert cautioning physicians and other health care practitioners to use “heightened scrutiny” when entering into telemedicine arrangements that...more
The July 20, 2022 Special Fraud Alert describes findings from what OIG describes as “dozens of investigations of fraud schemes involving companies that purported to provide telehealth, telemedicine, or telemarketing services”...more
On June 6, 2022, the U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG), released its spring 2022 semiannual report to Congress. The semiannual report covers the period of October 1, 2021 to...more
The following is a summary of the federal Health and Human Services agency’s Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported are based...more
On June 17, 2022, OIG issued a favorable advisory opinion allowing involving an arrangement in which a durable medical equipment (DME) manufacturer makes zero-interest financing available to its customers. The advisory...more
Department of Health and Human Services Office of Inspector General (“OIG”) Advisory Opinion 22-13 Issued: June 23, 2022 This opinion addresses a durable medical equipment (“DME”) manufacturer’s arrangements with...more
Physician consolidation continued on a robust pace this past year, despite, or maybe because of, the Pandemic. Physician-owned orthopedic practices appear to be no exception to this trend. Interestingly, orthopedic...more
Under the Federal Ethics in Patient Referrals Act (more commonly known as “Stark”), if a physician has a financial relationship with an entity, the physician may not refer patients to the entity for medical services payable...more