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 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
...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
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
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 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 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 Situation: The practice of manufacturers making available to customers favorable and even zero-interest financing for significant purchases of medical devices is understood to be common and often expected by customers...more
This Week in Washington: Senate HELP Committee Chair Patty Murray and Ranking Member Richard Burr Release Discussion Draft of Bipartisan Pandemic and Public Health Response Bill....more
For the past two years, telemedicine companies, durable medical equipment suppliers, pharmacies, and individuals and entities that market to such entities have been at the center of DOJ gunsights. In 2019, the Department...more
On November 4, 2020, CMS proposed that all continuous glucose monitors (CGMs) would be considered durable medical equipment (DME), replacing a prior policy set forth in CMS Ruling 1682-R (effective January 12, 2017) that...more
As of June 11, 2020, the USPTO’s Official Manual of Acceptable Identifications (ID Manual) has been revised to add, re-classify, and clarify existing entries for personal protective equipment such as masks and gloves....more
Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
In this episode, Husch Blackwell's Meg Pekarske and Bryan Nowicki discuss the latest round of audits from the Office of Inspector General (OIG) which focus on Durable Medical Equipment (DME), supplies and their “relatedness”...more
Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. Note that because Congress will be in recess for the Memorial Day holiday, the next “Capitol Hill Healthcare...more
CMS recently hosted a special open door forum soliciting reactions on whether to eliminate Certificate of Medical Necessity (CMN) and Durable Medical Equipment Information forms as required documents to determine medical...more
On May 28, 2015, the OIG published a revised version of its Work Plan for Fiscal Year (FY) 2015. As previously reported, the original version of the FY 2015 Work Plan was published in October and summarized the OIG's ongoing...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
The focus by the Centers for Medicare & Medicaid Services (CMS) on Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) as an area rife with unnecessary utilization and a high improper payment rates...more
CMS Releases Proposed Rule on Prior Authorizations for DMEPOS Items – On May 22, 2014, CMS released a Proposed Rule setting out a prior authorization process for certain types durable medical equipment, prosthetics,...more
CMS recently took the unusual step of issuing an Advance Notice of Proposed Rulemaking (ANPR) regarding changes to Medicare payment methodologies for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS)...more
The Centers for Medicare & Medicaid Services ("CMS") recently announced that the agency is seeking public comments as it moves toward nationwide implementation of the Medicare Durable Equipment, Prosthetics, Orthotics, and...more
On August 6, 2013, in a case with possible implications for other providers of nontaxable services, Pennsylvania’s Commonwealth Court ruled, en banc, that a medical group’s MRI and CT scan equipment does not qualify for the...more