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
CMS posted an expanded set, dated April 29, of Medicare regulatory flexibility measures for hospice organizations related to the coronavirus (COVID-19) pandemic, supplementing the previous COVID hospice flexibilities guidance...more
US President Donald Trump signed the Paycheck Protection Program and Healthcare Enhancement Act (HR 266) into law on April 24. HR 266 appropriates $483 billion in new spending, including $321 billion for the Payment...more
Medicare (and in the future Medicaid) providers that receive grant money under the CARES Act Relief Fund must pay close attention to the terms and conditions of the assistance and rigorously document how the funds are used to...more
Hospice officials identified both best practices and challenges that hospice employees face when disposing of controlled substances in a patient’s home. The US Government Accountability Office (GAO) released a report on April...more
In managing the quickly evolving healthcare landscape during this current crisis, healthcare companies should be wary of fraudsters who attempt to divert critical resources. ...more
The coronavirus (COVID-19) has created the most dire public health and economic crisis in generations, and the US government is under intense pressure to provide the necessary relief to US citizens, healthcare providers, and...more
Aided by ingenuity and growing regulatory flexibility, retail pharmacies across the country are finding ways to serve their customers while reducing face-to-face contact. Protocols may vary by state. ...more
The Centers for Medicare & Medicaid Services (CMS) issued a statement on March 9 related to actions the agency is taking to protect the health and safety of patients and providers. CMS urges providers to stay abreast of CDC...more
3/11/2020
/ Best Practices ,
China ,
Coronavirus/COVID-19 ,
Crisis Management ,
Emergency Management Plans ,
Health and Safety ,
Healthcare Facilities ,
Hospice ,
Infectious Diseases ,
Long Term Care Facilities ,
Long-Term Care ,
Nursing Homes ,
Policies and Procedures ,
Public Health ,
Risk Management