On March 29, 2023, the Department of Justice’s (DOJ) Office for the Eastern District of Michigan announced a notable set of three settlements (collectively, the Settlement) in excess of $69 million dollars total with a...more
4/5/2023
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Physicians ,
Self-Referral ,
Self-Referral Disclosure Protocol ,
Settlement Agreements ,
Stark Law
The Centers for Medicare & Medicaid Services (CMS) recently issued a Fact Sheet (Fact Sheet) providing guidance on the impact of the end of the federal COVID-19 Public Health Emergency (PHE) on certain regulatory waivers,...more
3/17/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Coronavirus/COVID-19 ,
Health Insurance ,
Healthcare ,
Infectious Diseases ,
Medicaid ,
Medicare ,
New Guidance ,
Public Health Emergency ,
Telehealth ,
Waivers
The Centers for Medicare & Medicaid Services (CMS) recently issued a Fact Sheet (Fact Sheet) providing guidance on the impact of the end of the federal COVID-19 Public Health Emergency (PHE) on certain regulatory waivers,...more
3/16/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Coronavirus/COVID-19 ,
Health and Safety ,
Health Insurance ,
Healthcare ,
Infectious Diseases ,
Medicaid ,
Medicare ,
New Guidance ,
Public Health ,
Public Health Emergency ,
Telehealth
On February 24, 2023, the federal Drug Enforcement Administration (DEA) issued a pair of proposed rules to make permanent certain “telemedicine flexibilities” related to the prescribing of controlled substances via telehealth...more
3/3/2023
/ Controlled Substances ,
Controlled Substances Act ,
Coronavirus/COVID-19 ,
DEA ,
Healthcare ,
Patient Access ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Public Health Emergency ,
Ryan Haight Act ,
Telehealth ,
Telemedicine
New York Governor Vetoes Act Prohibiting Establishment and Expansion of For-Profit Hospices -
On December 23, 2022, New York Governor Kathy Hochul vetoed Assembly Bill Number A8472 “An Act To Amend The Public Health Law,...more
1/6/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Elder Care ,
For-Profit Corporations ,
Governor Vetoes ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Facilities ,
Healthcare Reform ,
Hospice ,
Medicare ,
Medicare Part B ,
New York
On December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule (Proposed Rule) which proposes certain policy and technical changes to Medicare regulations, including a notable change to the...more
1/4/2023
/ 60-Day Rule ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Medicare ,
Overpayment ,
Overpayment Recovery Time Limits ,
Proposed Rules ,
Regulatory Agenda
On October 5, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-19 (Advisory Opinion), in which it determined that a proposed oncology drug discount arrangement could constitute grounds for the...more
On September 26, 2022, the United States Department of Justice (DOJ) announced a $900 million settlement with pharmaceutical company Biogen Inc., which arose from alleged violations of the federal False Claims Act (FCA) and...more
The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently issued new guidance (Guidance) on the use of remote communication technologies to deliver audio-only telehealth in accordance with...more
6/28/2022
/ Coronavirus/COVID-19 ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Reform ,
HIPAA Security Rule ,
Infectious Diseases ,
New Guidance ,
OCR ,
Patient Access ,
Relief Measures ,
Remote Proceedings ,
Telehealth ,
Telemedicine
On June 15, 2022, the U.S. Supreme Court unanimously ruled in favor of “340B” hospitals in a notable statutory interpretation case concerning how the federal Medicare program reimburses hospitals for prescription drugs. The...more
6/16/2022
/ American Hospital Association ,
American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Appeals ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Hospitals ,
Medical Reimbursement ,
Medicare ,
Medicare Act ,
Prescription Drugs ,
SCOTUS ,
Section 340B ,
Statutory Interpretation
On June 2, 2022, the Federal Trade Commission announced a pair of antitrust enforcement actions to block pending health system transactions that, according to it, would harm competition in the provision of inpatient general...more
Connecticut Governor Ned Lamont recently signed into law Public Act No. 22-58, “An Act Concerning the Department of Public Health’s Recommendations Regarding Various Revisions to the Public Health Statutes” (the Act). The Act...more
Certain COVID-19 emergency declaration blanket waivers are being phased out by the federal government, and health care providers should take steps to determine whether current arrangements are compliant. As background, in...more
5/10/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Elder Care ,
ESRD ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Hospice ,
Infectious Diseases ,
Long Term Care Facilities ,
New Guidance ,
Nursing Homes ,
Public Health Emergency ,
Waivers
The federal Office of Inspector General (OIG) recently published a report (OIG Report) as part of a series of analyses of the expansion and utilization of telehealth in response to the COVID-19 public health emergency. In...more
3/22/2022
/ Coronavirus/COVID-19 ,
Health Care Providers ,
Healthcare ,
Infectious Diseases ,
Medicare ,
OIG ,
Patient Access ,
Relief Measures ,
Rural Areas ,
Telehealth ,
Telemedicine
CYBERSECURITY -
CISA/FBI Advisory Warns of Destructive Malware Used Against Ukraine -
The Cybersecurity and Infrastructure Security Agency (CISA) and the FBI issued a joint advisory this week alerting organizations of...more
3/4/2022
/ Artificial Intelligence ,
Cyber Attacks ,
Cyber Crimes ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Data Security ,
FBI ,
Hackers ,
Homeland Security Cybersecurity & Infrastructure Security Agency (CISA) ,
Identity Theft ,
Information Blocking Rules ,
Malware ,
Passwords ,
Personal Data ,
Personally Identifiable Information ,
Popular ,
Russia ,
T-Mobile ,
Ukraine ,
Vulnerability Assessments
Effective February 3, 2022, the Massachusetts Board of Registration in Medicine (BoRM), which oversees physician licensure and the practice of medicine, updated its “Policy on Telemedicine in the Commonwealth” (Policy) to...more
On February 28, 2022, the Office of the National Coordinator for Health Information Technology (ONC) issued data on information blocking claims received since April 5, 2021, the effective date of information blocking...more
3/3/2022
/ 21st Century Cures Act ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Information Blocking Rules ,
Information Technology ,
ONC ,
Regulatory Requirements
The Food and Drug Administration (FDA) has recently undertaken a number of notable actions with respect to vaccines in response to the ongoing COVID-19 pandemic....more
In a per curiam decision issued January 13, 2022, the U.S. Supreme Court upheld the federal health care worker vaccine mandate rule, finding that the Department of Health & Human Services (HHS) Centers for Medicare & Medicaid...more
1/14/2022
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Constitutional Challenges ,
Coronavirus/COVID-19 ,
Employer Liability Issues ,
Employer Mandates ,
Healthcare Workers ,
Infectious Diseases ,
Lack of Authority ,
SCOTUS ,
Vaccinations ,
Virus Testing ,
Workplace Safety
On December 2, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a memorandum to state survey agencies indicating that it will not enforce its Interim Final Rule (the “Rule”) regarding health care worker...more
12/14/2021
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Corporate Counsel ,
Employer Liability Issues ,
Employer Mandates ,
Essential Workers ,
Healthcare Facilities ,
Healthcare Workers ,
Infectious Diseases ,
Interim Final Rules (IFR) ,
Preliminary Injunctions ,
Vaccinations ,
Workplace Safety
On November 4, 2021, the Centers for Medicare & Medicaid Services (CMS) issued heavily anticipated emergency regulations requiring COVID-19 vaccination of eligible staff at health care facilities that participate in the...more
11/5/2021
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
Employer Liability Issues ,
Employer Mandates ,
Essential Workers ,
Health and Safety ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Workers ,
Infectious Diseases ,
Interim Final Rules (IFR) ,
Public Health Emergency ,
Vaccinations ,
Workplace Safety
On September 9, 2021 President Biden announced a COVID-19 Action Plan entitled “Path out of the Pandemic” (the “Plan”) which comprises a six-pronged national strategy aimed at combatting COVID-19. The Plan includes a number...more
9/14/2021
/ Biden Administration ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
Employer Liability Issues ,
Employer Mandates ,
Essential Workers ,
Federal Contractors ,
Federal Employees ,
Health and Safety ,
Healthcare Workers ,
Infectious Diseases ,
OSHA ,
Public Health Emergency ,
Vaccinations ,
Workplace Safety
On August 19, 2021, Connecticut Governor Ned Lamont issued Executive Order No. 13C (the “Order”) to expand access to COVID-19 vaccination information for patients and providers (and school nurses) as public health authorities...more
On June 7, 2021, Connecticut Governor Ned Lamont signed into law Public Act 21-26 “An Act Concerning Various Revisions to the Public Health Statutes” (the “Act”). ...more
In June 2021, the Centers for Medicare and Medicaid Services (CMS) issued a notable interpretation of the Physician Self-Referral Law (aka the Stark Law) in Advisory Opinion No. CMS-AO-2021-01 (Advisory Opinion) regarding...more