COVID-19 significantly affected home-based care providers, such as home health agencies (HHAs) and hospices, whose staff had to overcome both physical and mental burdens of going into patients’ homes to deliver care,...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
In a proposed rule issued on December 27, 2022 to make technical changes to the Medicare Advantage Program, the Centers for Medicare and Medicaid Services (CMS) buried in the regulatory arcana a material legal change to the...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 CMS Healthcare Staff Vaccination Rule takes aim at ensuring that eligible healthcare workers are soon vaccinated against COVID-19. The interim final rule requires providers and suppliers to fully implement the IFR as a...more
The US Department of Health and Human Services, Office of Inspector General (OIG) recently transmitted a memorandum to the Center for Medicaid and CHIP Services detailing the findings of the Massachusetts state auditor's...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
A notable headline from the August 12 MLN Connects Newsletter for healthcare providers states “CMS Resumes Targeted Probe & Educate Program.” Designed to help providers reduce claim denials and appeals, CMS suspended...more
We hope you were able to join us for our July Fast Break on the US Court of Appeals for the Fourth Circuit's recently affirmed $114 million judgment in United States v. Mallory. If not, you missed a great session, featuring...more
January 28 was designated as “health day” for President Joe Biden’s early push of executive orders, with two new executive actions added to a growing list. The Executive Order on Strengthening Medicaid and the Affordable Care...more
President Joe Biden’s first days in office have focused heavily on issues of diversity, inclusion, equity, and human rights as applied across federal agencies and programs. We anticipate that this pattern will continue and...more
1/28/2021
/ Anti-Discrimination Policies ,
Biden Administration ,
Census ,
Coronavirus/COVID-19 ,
DACA ,
Executive Orders ,
Immigration Reform ,
Infectious Diseases ,
LGBTQ ,
Personal Protective Equipment ,
Race Relations ,
Social Equity Programs ,
Transgender ,
Travel Ban
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 (OIG) recently issued important updates to its Anti-Kickback Statute (AKS) safe harbor rules that provide additional legal protections and...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
The Centers for Medicare and Medicaid Services (CMS) recently announced that it intends to resume both prepayment and postpayment medical reviews conducted by the Medicare Administrative Contractors, Supplemental Medical...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
In an informative decision for challenging rules that portend government overreach, the US Court of Appeals for the District of Columbia Circuit upholds the invalidation of the Centers for Medicare and Medicare Services’ drug...more
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