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
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
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
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
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
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 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
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
A group of New Jersey home health care companies (collectively, the BAYADA Companies), have agreed to pay $17 million to resolve claims that they violated the False Claims Act and Anti-Kickback Statute. Home Health Agency...more
On February 4, 2021, the Department of Justice (“DOJ”), Office of Public Affairs, issued a Press Release (the “DOJ Press Release”) announcing that Kelly Wolfe, President of Regency, Inc., a medical billing company located in...more
Neurosurgeons' Compensation in Top 10 Percent Nationwide Gives Rise to Stark Act and FCA Claims - In United States ex re. Bookwalter v. UPMC, 946 F. 3d 162 (3d Cir. 2019), the court ruled that the relators stated a Stark...more
In recent years, civil enforcement efforts involving the FCA have grown significantly. Today, the FCA impacts a vast array of businesses, as it is commonly used to redress false claims for government funds involving...more
On August 8, 2016, the U.S. government filed a Statement of Interest in an ongoing False Claims Act (FCA)/Anti-Kickback Statute (AKS) case, U.S. ex rel. Herman v. Coloplast Corp., No. 1:11-cv-12131 (D....more
Federal prosecutors have turned their attention to physicians for Medicare fraud prosecution. Physicians who participate in the Medicare program have to be aware of the significant risks of Medicare fraud....more
The common industry practice of compensating independent contractor sales representatives on a "percentage of sales" commission basis may be creating an enhanced risk of False Claims Act liability for illegal kickbacks in...more
Last year was another busy year in health care fraud enforcement. In 2012, the Office of Inspector General for the Department of Health and Human Services (HHS-OIG) reported total expected recoveries of $6.9 billion from all...more