On September 10, 2025, the U.S. Court of Appeals for the Fifth Circuit dismissed an appeal of the federal court ruling vacating key provisions of the HIPAA reproductive health care regulations, which appears to signal the end of the Purl case (previously discussed here) and to confirm the end of provisions of the HIPAA
OIG Shines Spotlight on Billing for Remote Patient Monitoring
This post is co-authored by Seth Orkand, co-chair of Robinson+Cole’s Government Enforcement + White-Collar Defense Team.
On August 25, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued a new report (Report) highlighting trends in remote patient monitoring (RPM) Medicare billing, recommending stronger oversight to ensure compliance in billing
Appellate Court Gives Go-Ahead for 340B Contract Pharmacy Insulin Pricing Suit to Proceed
This post was co-authored with Antitrust + Trade Regulation lawyer Jennifer Driscoll.
On August 6, 2025, the U.S. Court of Appeals for the Second Circuit issued an opinion allowing a case challenging drug pricing changes to proceed. The case, an antitrust action brought by health centers against certain insulin manufacturers, arises from alleged anticompetitive
New York Streamlines CON Requirements for Medical Facility Construction Projects
On August 6, 2025, the New York Department of Health finalized and made effective significant changes to the Certificate of Need (CON) review process for health facility construction projects. The changes amend § 710.1 of Title 10 of the New York Codes, Rules, and Regulations (NYCRR), streamlining regulatory review and raising cost thresholds to reflect
HRSA Publishes 340B Rebate Pilot Program FAQs
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, the Health Resources and Services Administration (HRSA), which administers the 340B program, issued a set of FAQs providing additional guidance
Connecticut Enacts Wide-Ranging Health Care Law Modifying Various Existing Rules and Laws
On June 25, 2025, Connecticut Governor Ned Lamont signed into law Public Act No. 25-97, “An Act Concerning Various Revisions to the Public Health Statutes” (the Act). The Act includes a wide range of provisions affecting patient confidentiality, hospital and provider licensure, scope of practice, civil penalties, and Connecticut’s statewide health information exchange. Significant
Connecticut Governor Signs Bill Adding Requirements for Hospitals and Expanding DPH’s Enforcement Scope
On June 25, 2025, Connecticut Governor Ned Lamont signed into law Public Act No. 25-96, “An Act Concerning the Department of Public Health’s Recommendations Regarding Various Revisions to the Public Health Statutes” (the Act). The Act includes several new requirements for hospitals, as well as new authority for the Department of Public Health (DPH)
OIG Green Lights MSO Model Arrangement for Telehealth Platforms in New Advisory Opinion
On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-03 (the Advisory Opinion), in which OIG approved of a proposed arrangement under which a management support organization and a physician-owned professional corporation (the Requestors) would enter into an arrangement involving the leasing of clinical employees
False Claims Act Enforcement of Pharmacy Pricing & Prescribing Practices: The Walgreens Cases
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 settlements related to alleged FCA violations.
Allegations Related to Medicaid Billing for Generic Medications
In the first, on March 27, 2025, the U.S.
MA and CT Pave the Way for Emergency Contraception Vending Machines
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 contraception pills like Plan B One-Step. In light of uncertainty around abortion protections following the Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health