As previously discussed in our prior blog post, on August 1, 2025, the Department of Health and Human Services (HHS) issued a Notice announcing a much-anticipated 340B Rebate Model Pilot Program (Pilot Program). Subsequently,...more
On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The...more
7/31/2025
/ Department of Health and Human Services (HHS) ,
Drug Pricing ,
Healthcare ,
Hospitals ,
Manufacturers ,
Medicare ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reporting Requirements ,
Section 340B
The Department of Justice has launched a number of enforcement actions targeting pharmacies for alleged violations of the False Claims Act (FCA). Recently, Walgreens has been the subject of two noteworthy government...more
6/10/2025
/ Controlled Substances ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Medicaid ,
Pharmacies ,
Prescription Drugs ,
Retailers ,
Settlement ,
Walgreens
Massachusetts has expanded regulatory oversight of health care transactions by imposing False Claims Act liability on health care owners and investors for changes including failure to disclose violations. On January 8, 2025,...more
State Law Permitting Dispensation of Emergency Contraception by Vending Machines -
Legislation passed in 2022 in Massachusetts and in 2023 in Connecticut removes barriers for college students trying to obtain emergency...more
5/20/2024
/ Abortion ,
Colleges ,
Dobbs v. Jackson Women’s Health Organization ,
Healthcare ,
Patient Access ,
Pregnancy ,
Reproductive Healthcare Issues ,
Roe v Wade ,
Universities ,
Vending Machines ,
Women's Rights
On February 8, 2024, the U.S. Department of Health and Human Services (HHS) issued a final rule (Final Rule) updating federal “Part 2” regulations to more closely align the requirements applicable to substance use disorder...more
On September 27, 2023, the Health Resources and Services Administration (HRSA) issued a Notice in the Federal Register applicable to all 340B Program hospitals that formally ends a COVID-era waiver of the long-standing HRSA...more
10/30/2023
/ Coronavirus/COVID-19 ,
Drug Pricing ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
HRSA ,
Medicaid ,
Office of Pharmacy Affairs Information System (OPAIS) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health Emergency ,
Registration Requirement ,
Section 340B ,
Waivers
On June 27, 2023, Connecticut Governor Ned Lamont signed into law Public Act 23-204, “An Act Concerning the State Budget for the Biennium Ending June 30, 2025, and Making Appropriations Therefor, and Provisions Related to...more
8/10/2023
/ Connecticut ,
Employer Liability Issues ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Healthcare Workers ,
Hospitals ,
Labor Reform ,
New Legislation ,
Nurses ,
Over-Time ,
Public Acts ,
State Budgets ,
State Labor Laws ,
Wage and Hour
On June 27, 2023, Connecticut Governor Ned Lamont signed into law Public Act 23-204, “An Act Concerning the State Budget for the Biennium Ending June 30, 2025, and Making Appropriations Therefor, and Provisions Related to...more
8/9/2023
/ Connecticut ,
Employer Liability Issues ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Healthcare Workers ,
Hospitals ,
Labor Reform ,
Nurses ,
Over-Time ,
Public Acts ,
State Budgets ,
State Labor Laws ,
Wage and Hour
On June 27, 2023, Connecticut Governor Ned Lamont signed into law Public Act 23-171“An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs” (Act), which includes changes to the state’s implementation of the...more
7/13/2023
/ Connecticut ,
Drug Pricing ,
Healthcare ,
Healthcare Costs ,
Healthcare Reform ,
Medical Reimbursement ,
New Legislation ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Public Acts ,
Section 340B
The Office of Inspector General (OIG) recently issued two notable compliance updates, of which health care organizations should take note as the COVID-19 public health emergency ends and regulatory compliance activities ramp...more
The Office of Inspector General (OIG) issued two notable compliance updates today, of which health care organizations should take note as the COVID-19 public health emergency ends and regulatory compliance activities ramp up....more
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
CYBERSECURITY -
South Dakota Governor Bans State Workers from Using TikTok -
It is estimated that some 80 million Americans and more than one billion people use TikTok. It is well known that TikTok has a direct...more
On November 28, 2022, the Department of Health and Human Services (HHS) issued a proposed rule to modify the confidentiality protections of Substance Use Disorder (SUD) patient treatment records under 42 CFR Part 2 (Part 2)...more
11/30/2022
/ CARES Act ,
Comment Period ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Breach ,
Patient Rights ,
PHI ,
Proposed Rules ,
Substance Abuse
We follow up on our previous blog post concerning the U.S. Supreme Court’s unanimous ruling in favor of 340B hospitals. The Supreme Court previously held that “absent a survey of hospitals’ acquisition costs, HHS may not vary...more
10/6/2022
/ American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Medical Reimbursement Plans ,
Medicare ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Prescription Drugs ,
SCOTUS ,
Section 340B
A physician in Washington state pled guilty on September 28, 2022, to a criminal charge of conspiring to accept kickbacks related to fraudulent genetic testing. According to the Department of Justice (DOJ), the physician...more
10/3/2022
/ Criminal Conspiracy ,
Criminal Investigations ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Genetic Testing ,
Guilty Pleas ,
Healthcare ,
Healthcare Fraud ,
Kickbacks ,
Medicare Beneficiaries ,
Physicians ,
Telehealth ,
Telemarketing
What To Do When The Government Knocks On Your Lab’s Door -
The volume of federal enforcement actions involving laboratories has increased dramatically over the last few years. Not a month seems to pass without a press...more
7/15/2022
/ Clinical Laboratories ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Healthcare ,
Hospitals ,
Infectious Diseases ,
Life Sciences ,
Pharmaceutical Industry ,
Price Transparency ,
Virus Testing
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
Connecticut Governor Ned Lamont recently signed legislation to expand the scope of practice of advanced practice registered nurses (APRNs), nurse-midwives, and physician assistants (PAs) to perform certain forms of abortion....more
As previously addressed on this blog, Connecticut Governor Ned Lamont recently signed into law the state’s fiscal year 2023 budget (HB5506) (Act). Among other things, the Act prohibits homemaker-companion or home health...more
5/17/2022
/ Connecticut ,
Employer Liability Issues ,
Employment Contract ,
Hiring & Firing ,
Home Health Care ,
Home Healthcare Workers ,
Labor Reform ,
New Legislation ,
No-Hire/No-Solicitation Agreements ,
Restrictive Covenants ,
State Labor Laws
A federal court in Delaware recently determined that the Health Resources and Services Administration (HRSA) – the federal agency responsible for administering the 340B drug pricing program – did not comply with the...more
On November 12, 2021, the Centers for Medicare & Medicaid Services (CMS) issued finalized guidance (“Guidance”) clarifying that hospitals can share space, services, or personnel with another hospital or health care provider...more
To ensure the continued availability of health care workers, on November 12, 2021, the Massachusetts Department of Public Health (DPH) issued Order 2021-13 (COVID-19 Public Health Emergency Order No. 2021-13), extending...more