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
Podcast - Data Privacy and Tracking Technology Compliance
Podcast - A Conversation on Cannabis: Are Challenges or Changes Coming?
Heed Caution: Takeaways From the OIG's Advance Care Planning Report
2023 Human Resources Outlook Podcast Series: EMEA
Telehealth Risk Report: What the Government Found
UPIC Report Card: The OIG’s Evaluation of the UPICs Provides Insight Into the Future of Hospice Audits
HIPAA Tips With Williams Mullen - Telehealth After the Pandemic
Beyond Hospice: The OIG Renews Its Scrutiny of Home Health Agencies
The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-07 (the “Opinion”), to a nonprofit tax-exempt grant-making...more
Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more
Each summer in recent years, the U.S. Department of Justice (DOJ) and associated fraud enforcement partners have indicted many health care defendants, in multiple cases across the country. This summer continued the tradition....more
The OIG, the nation’s leader in fighting fraud, waste and abuse of Medicare, Medicaid and other HHS programs, periodically publishes reports on how federal healthcare programs could improve....more
Although most health care lawyers and compliance officers who review and analyze physician compensation understand that fair market value (FMV) is important, the nuances around FMV are sometimes missed....more
The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more
On July 22 and July 23, Health and Human Services (HHS) Office of Inspector General (OIG) published two advisory opinions for proposals by pharmaceutical manufacturers to provide fertility support to patients receiving their...more
On July 22, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion 24-05, evaluating two manufacturer-sponsored assistance programs under the federal Anti-Kickback...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more
At the end of last year, the US Department of Health and Human Services Office of Inspector General (OIG) issued an Advisory Opinion (AO 23-11, the Opinion) in which OIG approved an arrangement where a medical device...more
On July 31, 2024, the Department of Health and Human Services (HHS) final rule, 89 FR 54662, establishing disincentives for certain healthcare providers that have committed information blocking, will become effective. This...more
As the largest public funder of biomedical research in the world, the National Institutes of Health (“NIH”) annually funds over $38 billion in extramural research, including about $6 billion for clinical trials. On May 28,...more
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
On June 24, 2024, the Department of Health and Human Services (HHS) finalized the Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking (Disincentive Rule) under the 21st Century...more
On June 24, 2024, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) at the Department of Health and Human Services (HHS) issued the 21st...more
On July 1, 2024, the U.S. Department of Health and Human Services (HHS) released a final rule outlining financial penalties, referred to as “disincentives” throughout the rule, for healthcare providers that engage in conduct...more
This year’s annual Compliance Institute (CI) provided a strong reminder of just how fortunate we are to have such a strong relationship with the U.S. Department of Health and Human Services Office of Inspector General (OIG)....more
On July 1, 2024, the U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) published a final rule...more
On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 24-04, a favorable opinion analyzing a refund and discount program designed to alleviate the...more
On June 24, 2024, the U.S. Department of Health and Human Services (HHS) released a final rule establishing stringent financial penalties, referred to as “disincentives,” for healthcare providers found to have committed...more
On June 24, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced a final rule that establishes disincentives for certain health care providers that have committed information...more
On June 27, 2024, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services, Office of Inspector General (“HHS-OIG”), along with other federal and state law enforcement partners, announced...more
On July 1, 2024, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) published a final rule in...more