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…
The beginning of July always brings fireworks, cookouts, patriotic festivities, and a laundry list of new laws with a July 1 effective date. This year is no different, as several new laws applicable to health care providers were enacted by the Indiana General Assembly during the 2024 legislative…
Covered Entities as defined in the Health Insurance Portability and Accountability Act and its implementing regulations (“HIPAA”), including health care providers and health plans, must have HIPAA policies and procedures in place to protect the privacy and security of patients’ protected health…
Just over a year after the rule was first proposed, and after receiving over 400 comments, the Centers for Medicare and Medicaid Services (“CMS”) finalized its managed care access, finance, and quality rule (“Final Rule”). While the rule covers a wide range of managed care topics in its 895 pages,1…
On April 26, 2024, the U.S. Department of Health and Human Services Office for Civil Rights (“HHS-OCR”) published a final rule (the “Rule”), which amends the HIPAA Privacy Rule to afford greater reproductive health care privacy protection. Highlights of the new Rule that will have a practical…
