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On July 31, 2023, the California Office of Health Care Affordability (“OHCA”) released draft regulations concerning pre-transaction review of so-called “Material Change Transactions” as part of its legislative mandate to review transactions which could have potential impacts on the costs of health care in the State of California.  When approved, final regulations would be effective January 1, 2024. The draft regulations contemplate a dramatic expansion of state review of transactions affecting health care services.  The draft regulations are to be discussed at a public regulatory workshop to be convened by OHCA on August 15, 2023, at its Sacramento offices. OHCA will accept public comments on the draft regulations through August 31, 2023, submitted to CMIR@HCAI.CA.GOV.Continue Reading New Regulations on Health Care Transactions in California

Contract management has quickly and importantly developed into an area of focus for in-house counsel and business stakeholders. Effective contract management systems can increase internal accountability and decrease wait times and costs. Further, increased ownership and investment in the maintenance of contractual obligations allows for companies to better track data, including dollars spent, time spent, and results to report to key stakeholders. Given the benefits of effective contract management programs, it is unsurprising that leaders look to develop and implement their own contract management system.Continue Reading Developing an Effective Contract Management Program

Last month, The Economist published a call to action titled, “There is a worrying amount of fraud in medical research: And a worrying unwillingness to do anything about it.”[1] The article is the latest in a sequence of alarms that some clinical researchers might not be as squeaky clean as we would hope them to be. Senior DOJ officials have in turn emphasized in public remarks that investigating clinical research shortcomings is now a Justice Department priority, with the whistleblower bar following suit.Continue Reading DOJ Continues to Eye Clinical Researchers (and the Universities and Hospitals Employing Them)

In the wake of a record number of Covid-19 cases and with flu season around the corner, Governor Tony Evers and Wisconsin Department of Health Secretary Designee Andrea Palm issued a new emergency order on October 1, 2020. Emergency Order #2 is designed to help address an anticipated surge in healthcare staffing needs.
Continue Reading Emergency Order #2 Targets Staffing Demands in Wisconsin Healthcare Facilities

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The hospice industry expressed collective disappointment when the Centers for Medicare & Medicaid Services declined additional time for implementing new election statement and addendum requirements. On October 1, 2020, hospices will need updated forms, processes and training to address new payment conditions. In this episode, Meg Pekarske and Andrew Brenton review the new rule’s key…

In a Policy Statement released on April 3, 2020, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) announced that it will exercise its enforcement discretion and not impose administrative sanctions under the federal Anti-Kickback Statute (AKS) for certain financial arrangements related to COVID-19 covered by the blanket waivers issued by the Secretary of HHS on March 30, 2020 (the Blanket Waivers). The Blanket Waivers apply to sanctions for potential violations of the federal Physician Self-Referral Law (also known as the Stark Law) with respect to specific “COVID-19 Purposes,” which Husch Blackwell summarized in a recent blog. The OIG’s Policy became effective upon release (while the Blanket Waivers are retroactively effective March 1, 2020), and will terminate upon termination of the Blanket Waivers, unless otherwise specified by the OIG.
Continue Reading OIG Follows Suit and Announces Policy to Exercise Enforcement Discretion for Certain Kickbacks Amid COVID-19 Crisis