What’s in Your Operating Agreement? Legal Tips for Healthcare Providers
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 244: The Future of Independent Physician Practices with Ray Waldrup of The Leaders Rheum
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 242: Business Planning in Healthcare & Life Sciences with Jennifer McEwen of Maynard Nexsen
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 240: Independent Practice In Dermatology with Dr. Darragh and Dr. Shuler of Carolina Dermatology
The Trend of Threatening Physicians for Personal Gain
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
ADA Compliance for Medical and Dental Practices: Responding to Inquiries and Investigations
Beyond the Bylaws: The Medical Staff Show | The Role of Bylaws in Medical Staff Governance, Part II
Exit Strategies for Healthcare Employment Agreements
Episode 230: Innovations in Cancer Treatment with Dr. Ray DuBois of MUSC Hollings Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 229: Public Health in South Carolina with Dr. Edward Simmer of SC Dept of Public Health
Beyond the Bylaws: The Medical Staff Show - The Role of Bylaws in Medical Staff Governance, Part I
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 224: Healthcare Practice Operations with Steve McPheeters of HighFive Healthcare
Hospice Insights Podcast - Controlling the Narrative: A New Tactic for Auditors and ALJs
Compliance and Value-Based Care
The Presumption of Innocence Podcast: Episode 53 - Diagnosis: Innocent – A Doctor’s Journey to Acquittal
Hospice Insights Podcast - Meet the New Laws, Same as the Old Laws: Overpayment Recoupment Update
False Claims Act Insights - Reality Checks: How to Approach Healthcare Transactions Without Triggering FCA Liability
Hospice Insights Podcast - What's Good and Bad in Hospice Right Now: A Conversation with Greg Grabowski, Partner at Hospice Advisors
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 211: Cybersecurity and Privacy Risks for the Healthcare Industry with Brandon Robinson of Maynard Nexsen
The U.S. Court of Appeals for the Seventh Circuit recently rejected an effort by the federal government to extend the federal Anti-Kickback Statute (AKS) to a marketing company in the absence of influence by the company over...more
On April 14, 2025, the U.S. Court of Appeals for the Seventh Circuit issued its opinion in United States v. Sorensen, No. 24-1557, reversing the criminal conviction of Mark Sorensen, the owner of SyMed Inc., a...more
For decades, both state and federal courts in Michigan have routinely applied the learned intermediary doctrine in products liability cases involving prescription medical products. Under the doctrine, a manufacturer’s duty to...more
In Himes v. Somatics, LLC, No. S273887, 2024 WL 3059637 (Cal. June 20, 2024), the Supreme Court of California delivered a win to the defense, upholding the learned intermediary doctrine in cases involving prescription drugs...more
News Briefs - More States Introducing 'Conscience' Healthcare Bills - A new Montana law will provide sweeping legal protections to healthcare practitioners who refuse to prescribe marijuana or participate in procedures and...more
On February 7, the Department of Justice (DOJ) issued a press release indicating that settlements and judgments under the False Claims Act (FCA) exceeded $2.2 billion in the fiscal year ending September 30, 2022. Of this...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more
A developing line of cases across the nation may have large implications for medical device manufacturers defending against failure-to-warn claims. While a treating physician’s failure to read or rely on the manufacturer’s...more
A series of recent rulings out of the Southern District of Texas in an inferior vena cava (IVC) filter case reflect how well-planned discovery can lead to a successful multipronged summary judgment motion and can effectively...more
On August 2, 2021, the U.S. Food and Drug Administration (FDA) published a final rule to amend its “intended use” regulations, codified at 21 CFR § 801.4 for medical devices and 21 CFR § 201.128 for drugs. This updated final...more
Although Big Pharma has taken deserved heat for selling its drugs by slathering doctors with cheesy tchotchkes, lavish or even cheap meals, and pricey trips, as well as lucrative consulting and speaking opportunities, medical...more
On January 12, 2021, the U.S. Food and Drug Administration (FDA) released the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (Action Plan). The Action Plan expresses...more
On November 15, 2019, the Centers for Medicare and Medicaid Services ("CMS") finalized changes to the Open Payments Program as part of the CY 2020 Physician Fee Schedule Final Rule....more
• On July 29, 2019, CMS released its proposed 2020 Physician Fee Schedule rule, which includes the much anticipated proposed regulatory changes to the Sunshine Act/Open Payments program (“Open Payments”). The proposed...more
Last week, the federal HHS Office of Inspector General (OIG) gave the greenlight to allow a virtual care company and pharmaceutical manufacturer to loan patients free smartphones, so the patients (which include Medicare...more
On Jan. 29, 2019, the Office of Inspector General (OIG), in Advisory Opinion 19-2, issued its first opinion on the new "promotes access to care" exception to the beneficiary inducement Civil Monetary Penalties (CMP) law and...more
In Advisory Opinion 18-10, issued September 10, 2018, the OIG permitted a manufacturer of surgical devices and wound care products to implement a warranty program under which the manufacturer's hospital customers could...more
Drug and device manufacturers will need to update their reporting systems and provide new training to their sales staff in the coming years based on changes to the Physician Payment Sunshine Act included in the final opioid...more
A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more
Yesterday, An Act To Prohibit Certain Gifts to Health Care Practitioners became law in Maine without the signature of the Governor. 32 MRSA § 13759 prohibits licensed pharmaceutical and medical device manufacturers and...more
Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products. On January 18, 2017, FDA published two...more
CMS published the 2015 Open Payment Data on June 30, 2015. CMS has presented tables in its press release showing the highest paid specialties and highest paying companies. ...more
On Monday, December 15, 2014, CMS published guidance regarding pharmaceutical and medical device manufacturers’ obligations under the Open Payments requirements to report payments they provide indirectly to U.S. physicians in...more
Last week, a New Jersey federal court allowed medical device maker Boston Scientific Neuromodulation Corp. (“Boston Scientific”) to proceed with counterclaims against two of its former employees for violating their contracts...more
Last month the Food & Drug Administration (FDA) announced still further relaxation of its oversight over anything qualifying as a “medical device data system,” or MDDS. The announcement should come as welcome news to a great...more