The US Departments of Justice and Health and Human Services recently issued a press release on the formation of a new False Claims Act Working Group, signaling to the healthcare industry an increased focus on anti-fraud...more
Effective March 3, 2025, the US Department of Health and Human Services (HHS) rescinded its long-standing policy that had waived a statutory exemption under the Administrative Procedure Act (APA) from notice and comment...more
The old adage—March comes in like a lion and goes out like a lamb—didn’t quite hold true for the hospice sector, which experienced a late-month flurry of activity. The government gave the hospice sector a lot to consider,...more
The US Department of Health and Human Services Office of Inspector General (OIG) released on November 6 its General Compliance Program Guidance (GCPG), a helpful new resource for the healthcare industry that consolidates...more
The US Department of Health and Human Services Office of Inspector General (OIG) released its new General Compliance Program Guidance (GCPG) on November 6, 2023. The GCPG is designed to serve as a reference guide for the...more
The US Centers for Medicare & Medicaid Services (CMS) has implemented a final rule, effective November 13, 2023, designed to enhance the oversight of hospice providers throughout the United States and increase regulatory...more
The US Department of Health and Human Services Office of Inspector General (OIG) recently released Advisory Opinion No. 23-04, which found that fraud and abuse risks were sufficiently low in light of certain safeguards to...more
The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of...more
The US Department of Justice and Department of Health and Human Services Office of Inspector General have identified a wire fraud scheme to sell false and fraudulent nursing degree diplomas and transcripts. Coined as...more
The HHS Office of Inspector General (OIG) has, for the last several years, been actively auditing hospices regarding their Medicare regulatory and billing compliance, with a national hospice audit in the works. Recently, OIG...more
Following the US Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, the federal government has issued various guidance to healthcare providers reinforcing federal legal protections or requirements...more
The HHS Office of Inspector General (OIG) recently announced its Office of Audit Services plans to conduct a nationwide review of hospice eligibility, focusing on those Medicare hospice beneficiaries who haven't had an...more
The Centers for Medicare and Medicaid Services (CMS) announced that it had restarted the Targeted Probe and Educate (TPE) audit process, effective September 1, 2021. More recently, the Medicare Administrative Contractors for...more
The US Department of Health and Human Services (HHS) recently announced that it will make $25.5 billion available in new COVID-19 relief funds to providers through the Health Resources and Services Administration (HRSA). To...more
The US Department of Health and Human Services recently announced the establishment of the Office of Climate Change and Health Equity (OCCHE). Noting that the OCCHE is “the first office of its kind at the national level to...more
The US Department of Health and Human Services (HHS) announced on Friday, January 15, 2021, one month before the former reporting deadline, that it will push back the CARES Act Provider Relief Fund (PRF) reporting timeline...more
Modifications also include public disclosure of accreditation organization survey information and intermediate civil penalty remedies for noncompliance. The Consolidated Appropriations Act, 2021 (Pub. L. 116-260), signed into...more
The US Department of Health and Human Services’ Office of Inspector General updated the warranty safe harbor to account for bundled product and service warranties to reflect realities of healthcare product sales, but rejects...more
12/15/2020
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Manufacturers ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Safe Harbors ,
Stark Law ,
Warranties
The US Department of Health and Human Services (HHS) issued two welcome announcements on October 22 relating to the CARES Act Relief Fund Provider Relief Fund (PRF). First, the agency expanded the pool of eligible recipients...more
Imagine you are the primary caretaker for your 94-year-old terminally ill mother who lives in your home while under hospice care during the coronavirus (COVID-19) pandemic. ...more
Companies marketing products or services for coronavirus (COVID-19) should be aware of key areas of healthcare law and regulation, including Food and Drug Administration regulation, clinical laboratory testing oversight,...more
7/9/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Immunity ,
Product Defects ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Risk Mitigation ,
Suppliers ,
Supply Chain ,
Telehealth
With just days left until provider attestations are due related to acceptance of CARES Act Provider Relief Funds, the US Department of Health and Human Services (HHS) recently updated its FAQs providing some additional...more
The government watchdog agencies continue to focus their attention on Medicare oversight of hospice providers, with two recent reports from the US Government Accountability Office (GAO) and the HHS Office of Inspector General...more
Highlighting the US Department of Health and Human Services’ (HHS) efforts to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare and Medicaid...more
In keeping with its recent recommendations to CMS, the Office of Inspector General for the US Department of Health and Human Services (OIG) is recommending increased oversight and compliance reporting requirements for...more