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House Energy and Commerce Health Subcommittee Holds Legislative Hearing on 19 Bills. Lawmakers discussed 19 pieces of legislation designed to support patients and caregivers in the key areas of autism, heart defects,...more
Happy 2024! The entire Saul Ewing Health Law Practice Group wishes you and yours a healthy and prosperous new year and successful (and compliant) activities in the health care delivery system this year and beyond....more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for November 2023. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new General...more
On October 20, 2023, the Office of Inspector General of the Department of Health and Human Services (“OIG”) issued an unfavorable Advisory Opinion No. 23-08 to a supplier of cochlear implants coupled with external sound...more
On October 13, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion No. 23-07. In this opinion, the OIG responded favorably to a proposed arrangement whereby...more
In October 2023, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) published Advisory Opinion 23-07 and approved a plan by a multi-specialty physician practice to pay its employed...more
The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) recently considered the question whether an employed physician can be paid bonus compensation relating to procedures performed by the...more
On Oct. 13, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-07 approving a multispecialty physician practice’s proposal to pay bonuses to each of its...more
The U.S. Department of Health & Human Services Office of the Inspector General (OIG) on Oct. 13, 2023, posted Advisory Opinion No. 23-07 detailing a favorable response to a proposal by a Requestor to pay bonuses to its...more
On October 13, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-07, approving a physician practice’s proposal to pay its physician-employees a portion of the...more
Late last week, the Department of Health and Human Services Office of the Inspector General (“OIG”) posted Advisory Opinion No. 23-07 affirming the broad protection available for compensation to employed physicians under the...more
On August 18, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 23-05, finding that an entity’s proposal to facilitate referring surgeons’ ownership of turnkey...more
The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable Advisory Opinion on Aug. 15, 2023, involving an intraoperative neuromonitoring (IONM) services arrangement. The Advisory...more
The US Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently evaluated the risks associated with certain intraoperative neuromonitoring (IONM) services arrangements in its release of...more
On August 18, the Office of Inspector General in the Department of Health and Human Services (“OIG”) issued Advisory Opinion 23-05 in which it concluded that a proposed arrangement involving the formation of a company...more
We hope that you, like Congress, enjoyed some time off last week and are ready to dive in—for a few days at least. As we previously reminded you, the House is only in session 12 days in July, then away for August recess, and...more
In this session, McDermott Will & Emery Partners Denise Burke, Tony Maida and Monica Wallace discussed top issues and enforcement trends that physician practice management companies (PPMs) and ambulatory surgery centers...more
Nearly 25 years ago, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) created a regulatory safe harbor to the federal Anti-Kickback Statute (AKS) for physician investment in...more
On November 1, 2022, CMS published a final rule to update the payment policies, payment rates, and other provisions for services furnished under the Medicare Outpatient Prospective Payment System (OPPS) and the Ambulatory...more
The Centers for Medicare and Medicaid Services (CMS) issued the calendar year (CY) 2023 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Proposed Rule on July 15, 2022. The Proposed...more
On April 25, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued a favorable Advisory Opinion regarding a medical device company (Company) in which physicians who order the...more
On July 19, 2021, the Centers for Medicare and Medicaid Services (CMS) released the Calendar Year (CY) 2022 Hospital Outpatient Prospective System (OPPS) and Ambulatory Surgical Center (ASC) Proposed Rule (Proposed Rule). In...more
On April 26, 2021, the Department of Health and Human Services Office of Inspector General (“OIG”) issued favorable Advisory Opinion No. 21-02 regarding a proposed investment in an ambulatory surgery center (“ASC”) by a...more
In a recent advisory opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) concluded that certain investments by a health system, manager and physicians in an ambulatory surgery center...more
Fresenius to defend itself from FCA suit following whistleblower allegations - A former employee alleges Fresenius engaged in arrangements with hospitals and nephrologists to ensure patient referrals to its dialysis...more