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
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
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
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
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for March 2023. We discuss several criminal and civil enforcement actions that involve Anti-Kickback Statute (AKS) and...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
The U.S. Government is warning health care practitioners to be on the lookout for fraud in connection with companies that offer products and services using telemedicine. On July 20, 2022, the U.S. Department of Health...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 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
The U.S. Department of Health and Human Services (HHS) Office of the Inspector General (OIG) published a Special Fraud Alert (Fraud Alert) on July 20, 2022, warning healthcare providers "to exercise caution when entering into...more
HHS-OIG issued a new Special Fraud Alert on relationships with “purported telemedicine companies” on July 20, 2022. The Special Fraud Alert comes on the heels of a nationally coordinated takedown charging dozens of...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
Durable medical equipment (DME) is particularly important for many Medicare beneficiaries. However, companies that manufacture and sell DME need to be careful because there are strict federal regulations outlining almost...more
Report on Medicare Compliance 29, no. 25 (July 13, 2020) - Ophthalmic Consultants PA in Sarasota, Florida, agreed to pay $4.8 million to settle false claims allegations that it billed Medicare and other federal payers...more
Report on Medicare Compliance 29, no. 2 (January 20, 2020) - - The HHS Office of Inspector General has updated its Work Plan, which includes an item on early discharges from inpatient rehabilitation facilities to home...more
In the final quarter of calendar year 2019, the Department of Health and Human Services Office of Inspector General (“OIG”) released its Semiannual Report to Congress (the “Report”). The Report covers the six-month period...more
Congress - Hearings/Markups - House Judiciary Committee: "TBA Markup on CREATES Act, Pay-for-Delay Legislation" - The House Judiciary Committee is planning a markup on the CREATES Act and pay-for-delay legislation....more
Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more
The US Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) released proposed updates to its Calendar Year (CY) 2017 Home Health Prospective Payment System (HH PPS) in the July 5, 2016,...more
Nearly four years after publishing their joint interim final rule with comment period, effective November 2, 2011 (IFC), the OIG and CMS (Agencies) have finalized the waivers of various fraud and abuse laws in the context of...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
On May 28, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) published a proposed rule to establish a prior authorization process for certain durable medical equipment,...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