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
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
In our recent publication, “The Impact of Tariffs on the Insurance Industry,” we explored how the sweeping tariff policy announced by President Donald Trump is affecting various insurance sectors....more
The U.S. Department of Justice (DOJ) recently published a final rule on the accessibility of medical diagnostic equipment (MDE) and other accessibility-related practices that promises to have broad impact on the health care...more
On September 26, 2024, the Centers for Medicare & Medicaid Services’ (CMS) Durable Medical Equipment (DME) Medicare Administrative Contractors (DME MACs), Noridian Healthcare Solutions, LLC and CGS Administrators, LLC,...more
Applicable Provider Types: Any individual or entity that receives Medicare reimbursement for selling or renting DMEPOS - Is Your Entity in Compliance? Most durable medical equipment, prosthetics, orthotics and...more
DOJ Launches Corporate Whistleblower Awards Pilot Program - On August 1, the US Department of Justice (DOJ) announced the details of its new Corporate Whistleblower Awards Pilot Program. According to the DOJ, the...more
The Master List for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) comes from a November 2019 final rule that created the list to serve as a library of items that have been identified as potential...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
On April 10, Virginia-based nurse practitioner Daphne Jenkins was sentenced to prison for her participation in a $7.8 million telemedicine fraud scheme that involved medically unnecessary orders for durable medical equipment...more
Cooperation Spares Former NBA Shooting Guard From Prison - Former National Basketball Association (NBA) shooting guard, Antoine Wright, was sentenced to time served after he pled guilty to conspiracy and aggravated...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
Government enforcement activities focused on tele-fraudsters remained active in 2023, but did not break substantial new ground. Several significant criminal resolutions last year involved allegations that were similar to each...more
It pays to look closely. Buried deep within a 205-page and 1230-page Federal Register final rules publication, the Centers for Medicare & Medicaid Services (“CMS”) initiated impactful changes for pharmacies and Durable...more
On January 3, 2024, the New York State Office of the Medicaid Inspector General (“OMIG”) posted its 2024 Work Plan. This is the first update since its 2019 – 2020 Work Plan and OMIG notes that the Work Plan does not reflect...more
Colorado and New York are not waiting for the Fair Credit Reporting Act rulemaking to eliminate creditor use of medical debt announced by the CFPB in September 2023. As we previously blogged, in the past two years, Equifax,...more
...Innovation in connected medical devices is critical to advances in health care outcomes, user experience, and reducing costs. These exciting technologies also can be challenging when it comes to navigating the complex...more
On November 22, 2023, while many were preparing for the Thanksgiving holiday, the Office of Inspector General (OIG) posted a consumer alert (Alert) warning the public about a fraud scheme involving monthly billing for remote...more
Cutting-edge technology is desirable to consumers for its ability to deliver innovative solutions, improved efficiency, enhanced user experiences, and the promise of staying ahead in an ever-evolving digital landscape. The...more
In recent years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to pay for non-face-to-face services that improve care coordination for Medicare...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
Continuing a now annual tradition, the Centers for Medicare & Medicaid Services (CMS) has included expansions and enhancements to its authorities to deny enrollment or revoke a provider’s Medicare billing privileges...more
FDA releases updated guidance regarding the Q-Submission Program; C.R. Bard faces an unusual result in its patent dispute with AngioDynamics; A nurse practitioner pleads guilty to committing health care fraud by using...more
On January 31, 2020, pursuant to Section 319 of the Public Health Service Act, the secretary of the U.S. Department of Health & Human Services (HHS) determined that a public health emergency (PHE) exists due to the soaring...more