Indiana recently enacted Senate Enrolled Act 140 (SEA 140), a significant overhaul of pharmacy reimbursement practices intended to greatly impact pharmacy benefit manager (“PBM”) vertical integration. SEA 140 introduces multiple changes to how pharmacy benefits are managed and delivered in Indiana,…
In a significant development for healthcare employment law, Indiana’s Senate Enrolled Act No. 475 (“SEA 475”) broadens existing restrictions on physician noncompete agreements to include nearly all physician types—not just primary care providers. Building on Senate Enrolled Act No. 7, which took…
After months of back and forth, with the fate of tele-prescribing in limbo, the Department of Health and Human Services (“HHS”) signaled its continued commitment to some COVID-19 era telemedicine expansions by the recent issuance of two final rules: (1) Expansion of Buprenorphine Treatment via…
A recent advisory opinion from the Office of Inspector General (“OIG”) provides welcome clarity and encouragement to community health centers looking for ways to incentivize patient access to care. Advisory Opinion 25-02 continues the OIG’s favorable support of strategies designed to connect…
Non-profit healthcare entities may soon have greater flexibility when it comes to patient assistance programs that subsidize the cost of prescription drugs for their patients residing in rural areas. Generally, such programs risk violating the patient remuneration prohibition under the federal…
The Massachusetts Board of Registration in Pharmacy (the “Board”) announced, via updated Non-Resident Licensure FAQs on November 19, 2024, that it will now require non-resident pharmacies to be licensed in order to dispense prescription products into the state. Massachusetts has historically…
Under the HIPAA Breach Notification Rule, entities regulated under HIPAA must report breaches affecting less than 500 individuals to the Department of Health and Human Services (“HHS”) within sixty days following the end of each calendar year. Therefore, the deadline to report 2024 breaches…
OCR Director Melanie Fontes Rainer released an announcement on January 7, 2025 recapping OCR’s HIPAA accomplishments and enforcements in 2024. (“Announcement”). In the Announcement, Rainer highlights new rules implemented and enforcement actions taken by her agency in 2024. Covered entities should…
As we previously reported, CMS issued a Final Rule implementing certain requirements in the Affordable Care Act regarding the disclosure of ownership, managerial and other information for Medicare and Medicaid participating nursing facilities. Most notable and complicated of these new requirements…
Under the False Claims Act (“FCA”), whistleblowers (known as qui tam relators) are able to initiate and direct the litigation of cases that seek recovery for alleged injuries to the federal government. 31 U.S.C. § 3730(b). The penalties for FCA violations are astronomical – with penalties up to…
Restrictive covenants in Indiana have long been a topic of litigation and debate for health care providers, private practices, and health systems. Historically, and before there were statutory restrictions for physician non-competes, there is a long line of cases that have required physician…
Effective July 31, 2024, health care providers will be subject to “disincentives” for committing information blocking. As codified under the 21st Century Cures Act, information blocking is when an “actor” (e.g. health care provider) interferes with the access, exchange, or use of electronic health…
