Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 243: HIPAA Compliance and Potential Changes with Shannon Lipham of Maynard Nexsen
HHS OIG’s Nursing Facility: Industry Segment-Specific Compliance Program Guidance
False Claims Act Insights - Will Recent Leadership Changes Lead to FCA Enforcement Policy Changes?
Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast
Healthcare Industry Segment-Specific Compliance Program Guidances (ICPGs)
2025 Outlook: The Department of Health and Human Services Under the Second Trump Administration – Diagnosing Health Care
New HIPAA Final Rule: Key Changes to Reproductive Health Care Privacy - Thought Leaders in Health Law®
Navigating the Labyrinth of Private Equity Investments in Health Care – Diagnosing Health Care
HHS Office for Civil Rights Director Melanie Fontes Rainer on Progress and News at OCR
ERISA Blog | Changes to the HIPAA Privacy Rules A Primer for Self-Insured Group Health Plans
Hospice Insights Podcast - A Refresh: What’s New in the New OIG General Compliance Program Guidance
The Presumption of Innocence Podcast: Special Edition | Episode 36 - Rolling Change: The DEA Turns Over a New Leaf on Marijuana Scheduling
Understanding the HHS OIG’s General Compliance Program Guidance
OMG. . .The OIG is at it Again
The FTC's Health Privacy Enforcement Actions
Medical Device Legal News with Sam Bernstein: Episode 19
Episode 303 --- Deep Dive into the HHS-OIG Compliance Program Guidance
Counsel That Cares - The Private Payer's Perspective on Value-Based Care
Medical Device Legal News with Sam Bernstein: Episode 17
A single incident that may have started as a personal vendetta or an extortion threat seven years ago has cost a Florida health care system $800,000, and comes on the heels of an unrelated breach suffered by a different...more
When I litigated False Claims Act (FCA) cases at the U.S. Department of Justice (DOJ), it was common practice for settlements to require Corporate Integrity Agreements (CIAs) setting forth ongoing duties and responsibilities...more
Scientist and pharmaceutical researcher Andrew P. Mallon—who first reported to NIH and others in 2016 his suspicions that then-Athira Pharma CEO Leen Kawas falsified data in published papers—filed the whistleblower suit...more
The HHS Office of Inspector General (OIG), in connection with its enforcement responsibilities, must exclude a party from the federal health care programs if the party is found to have violated certain federal laws. This type...more
December 2024 was an active month for the U.S. Department of Health and Human Services ("HHS"), Office for Civil Rights ("OCR"). OCR announced (i) a $1.19 million civil monetary penalty ("CMP") against Gulf Coast Pain...more
We just want to provide a friendly reminder that, before key staff depart for the holidays, HIPAA covered entities and business associates should finalize their compliance with the 2024 HIPAA amendments related to...more
Last week, HHS Office of Civil Rights (OCR) announced a settlement with a Pennsylvania provider (the Provider) concerning an alleged violation of the HIPAA Privacy Rule. Specifically, the Provider impermissibly disclosed a...more
Welcome to the Fall 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance...more
On October 31, 2024, the U.S. Department of Health and Human Services (“HHS”), Office of Civil Rights (“OCR”) announced a $500,000 settlement with Plastic Surgery Associates of South Dakota (“PSA”) concerning potential...more
Let’s review for a moment. It’s not a HIPAA violation to be a victim of ransomware. It’s not a HIPAA violation to pay a ransom. It’s up to the covered entity (CE) to determine if a security or privacy incident is a...more
On May 29, 2024, the U.S. Department of Health and Human Services’ Office of Inspector General (HHS OIG) announced a $12 million settlement with Innovasis Inc., a medical device manufacturer, and two of its senior executives...more
On July 1, 2024, the U.S. Department of Health and Human Services (“HHS”) Office For Civil Rights (“OCR”) announced a $950,000 settlement with Heritage Valley Health System (“Heritage Valley”) and a three-year Corrective...more
The Association of American Universities (AAU) and the Council on Governmental Relations (COGR) are among a handful of groups “urging the Biden administration to rescind a policy proposal that would threaten the American...more
H. Lee Moffitt Cancer Center & Research Institute Hospital Inc. in Tampa, Florida, has agreed to pay $19.564 million to settle false claims allegations over claims submitted to federal health care programs for items and...more
On February 6, 2024, the HHS Office for Civil Rights (“OCR”) announced a settlement with Montefiore Medical Center (“MMC”) for alleged HIPAA Security Rule violations and MMC agreed to pay $4.75 million and enter into a...more
In a case that may hit a raw compliance nerve, Ascension Macomb Oakland Hospital in Michigan has agreed to pay $100,000 in a settlement with the HHS Office of Inspector General (OIG) over free services provided to certain...more
The following is a summary of selected 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...more
Report on Patient Privacy 23, no. 10 (October, 2023) Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals will pay California $49 million to resolve allegations that they unlawfully disposed of hazardous waste,...more
On June 28, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a settlement (resolution agreement and corrective action plan) with iHealth Solutions (also known as Advantum Health)...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for April 2023. We discuss several criminal and civil enforcement actions related to the Anti-Kickback Statute (AKS) and the...more
Report on Patient Privacy 20, no. 10 (October 2020) - September was quite the month for enforcement actions by the HHS Office for Civil Rights (OCR). The agency announced eight settlements totaling more than $10 million....more
In a flurry of recent activity, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has announced eight resolution agreements since September 15, 2020. These resolution agreements settle...more
Report on Medicare Compliance 29, no. 30 (August 24, 2020) - A federal court on Aug. 17 blocked HHS from enforcing its revised definition of sex discrimination in Sec. 1557, which prohibits discrimination on the basis of...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. 20 (June 1, 2020) - The HHS Office of Inspector General (OIG) has unveiled its “OIG Strategic Plan: Oversight of COVID-19 Response and Recovery.” Its goals are protecting people, funds...more