On April 11, 2023 – one month in advance of the end of the COVID-19 public health emergency (PHE) on May 11, 2023 – the federal Office for Civil Rights (OCR) confirmed that various Notifications of Enforcement Discretion...more
On April 11, 2023 – one month in advance of the end of the COVID-19 public health emergency (PHE) on May 11, 2023 – the federal Office for Civil Rights (OCR) confirmed that various Notifications of Enforcement Discretion...more
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
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
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
The Wolcott school system in Wolcott, Connecticut has been recovering for four months from a ransomware attack that hit its system at the end of the school year. Last week, it was hit with a second attack. According to...more
9/13/2019
/ Consumer Privacy Rights ,
Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Debt Collectors ,
Digital Assets ,
Educational Institutions ,
Enforcement Actions ,
Financial Services Industry ,
Hackers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Medical Records ,
Municipalities ,
NIST ,
Personally Identifiable Information ,
Ransomware ,
TCPA
According to reports, a Georgia-based physician who previously pleaded guilty to criminal violations of the Health Insurance Portability and Accountability Act (HIPAA) received six months of probation from a Massachusetts...more
On November 2, 2018, the New Jersey Attorney General announced a settlement worth up to $200,000 with a former medical transcription company responsible for a breach affecting medical records of up to 1,654 patients of a New...more
The Office of Inspector General (OIG) recently announced the creation of a cybersecurity team focused on combating threats within the Department of Health & Human Services (HHS), and within the health care industry. ...more
In late August, the Attorney General of the State of New York announced a $200,000 settlement with a New York-based non-profit organization that provides services to developmentally disabled individuals and their families...more