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
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
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
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
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 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
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
On June 23, 2021, Connecticut Governor Ned Lamont signed into law Public Act 21-2 “An Act Concerning Provisions Related To Revenue And Other Items To Implement The State Budget For The Biennium Ending June 30, 2023” (PA...more
On June 21, 2021, the Occupational Safety and Health Administration (OSHA) adopted its COVID19 Healthcare Emergency Temporary Standard (ETS). Employers providing health care services will be required to comply with new...more
6/21/2021
/ Coronavirus/COVID-19 ,
Emergency Management Plans ,
Employer Liability Issues ,
Essential Workers ,
Health and Safety ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Workers ,
Infectious Diseases ,
New Guidance ,
OSHA ,
Personal Protective Equipment ,
Public Health ,
Workplace Safety
On March 14, 2021, Connecticut Governor Lamont issued Executive Order 10C (EO 10C), which extends provisions of Public Act 20-2 (PA 20-2), a law passed by the Connecticut legislature in July 2020 that “provided additional...more
3/22/2021
/ Coronavirus/COVID-19 ,
Executive Orders ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance ,
Infectious Diseases ,
Patient Access ,
State and Local Government ,
Telecommunications ,
Telehealth ,
Telemedicine
On January 28, 2021, the Department of Health and Human Services (HHS) issued a Fifth Amendment to HHS’s Declaration under the Public Health Readiness and Emergency Preparedness Act (PREP Act) that provides liability immunity...more
2/1/2021
/ Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Immunity ,
Infectious Diseases ,
Liability ,
Medical Malpractice ,
Patient Access ,
Public Health Emergency ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Vaccinations
On December 10, 2020, the U.S. Department of Health and Human Services (HHS) announced proposed changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, which is one of several rules that...more
HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP Regulations -
On November 30 and December 2, 2020, the Department of Health and Human Services Office of Inspector...more
The Robinson+Cole Health Law Group is committed to examining and reporting on issues important to the health care and life sciences industries. Below are excerpts from our Health Law Diagnosis blog, where we post on fraud and...more
On November 3, 2020, a Massachusetts Federal District Court issued a notable decision on the applicability of the state’s medical peer review privilege in a federal proceeding, determining that the privilege does not apply to...more
On November 20, 2020, the Department of Health & Human Services (HHS) released heavily anticipated final rules revising the regulatory exceptions to the Physician Self-Referral Law (also known as the Stark Law), the...more
Health care providers interested in applying for additional CARES Act Provider Relief funding from the Phase 3 General Distribution have until November 6, 2020 to submit an application to the Department of Health & Human...more