Gradually, data is being recognized as an asset in an increasingly data-hungry healthcare industry. In the tenth episode of Sheppard Mullin’s Health-e Law Podcast, Arti Bedi Pullins, President and Chief Healthcare Officer at QuestionPro, discusses how industry players can recognize the value of data as an asset with Sheppard Mullin’s Digital Health Team co-chairs, Sara Shanti and Phil Kim.Continue Reading Assessing Data Assets in Healthcare: A Discussion with Arti Bedi Pullins

On July 3, District Judge Ada Brown of the Northern District of Texas issued an order enjoining the Federal Trade Commission (“FTC”) from enforcing its “Final Rule” against plaintiffs Ryan, LLC (“Ryan”) and the U.S. Chamber of Commerce (the “Chamber”). If implemented, the Final Rule would effectively render nearly all non-compete agreements unlawful. Accordingly, this opinion was one of the most highly anticipated judicial decisions in antitrust and labor and employment law in recent memory.Continue Reading Not So “Final”? Texas Federal Court Enjoins Enforcement of FTC’s Noncompete Ban, Leaving Future of Commission’s Rule in Doubt

On Wednesday, a federal court in Texas stayed provisions of the Centers for Medicare & Medicaid Services’ (“CMS”) contract year 2025 Final Rule that amended the longstanding Medicare Advantage (“MA”) and Part D agent and broker compensation methodology and prohibited certain terms in contracts with third party marketing organizations (“TPMOs”). This decision follows two lawsuits filed against CMS and the Department of Health and Human Services (“HHS”) arguing that the Final Rule exceeds CMS’s statutory authority, is arbitrary and capricious, and was promulgated without complying with procedural requirements.[1] The Texas federal judge stayed the effective date of the “Fixed Fee” and “Contract-Terms Restriction” (i.e., 42 C.F.R. § 422.2274(a), (c), (d), (e) and § 423.2274(a), (c), (d), (e)) of the Final Rule during the pendency of the lawsuits, and chose not to remand to the agency, instead promising an expeditious ruling on the merits at the parties’ request.Continue Reading Texas Court Stays CMS CY2025 Final Rule on Agent and Broker Compensation and Contract Term Restrictions

On June 10, 2024, the U.S. Supreme Court granted certiorari in Advocate Christ Medical Center v. Becerra[1] for the October 2024 – 2025 term to review a D.C. Circuit Court of Appeals ruling potentially affecting up to $4 billion in federal funding for hospitals.[2] The Supreme Court will determine whether the federal Department of Health and Human Services (“HHS”) properly reimbursed hospitals for providing care to patients receiving financial aid from the Supplemental Security Income Program (the “SSI Program”).[3] Hospitals benefiting from Medicare reimbursement adjustments for treating low-income patients should closely monitor this case, as a favorable ruling for the plaintiffs may impact how hospitals are reimbursed for similar claims in the future.Continue Reading SCOTUS to Review Case Impacting Medicare Reimbursement for Hospitals Treating Low-Income Patients

This week, in a significant win for the American Hospital Association plaintiff, the U.S. District Court for the Northern District of Texas issued an opinion vacating the Department of Health and Human Services’ (“HHS”) guidance on the use of online tracking technologies under HIPAA. At the heart of the dispute was the guidance released by HHS in December of 2022 and then updated again in March of 2024 (collectively, the “Guidance”), which suggested that information collected from unauthenticated website visitors could be considered protected health information (“PHI”) under HIPAA. The Guidance was challenged by hospitals and healthcare providers who argued it exceeded HHS’ statutory authority under HIPAA and imposed unreasonable compliance burdens.Continue Reading HIPAA Web Tracking Guidance Vacated

In a decision joined by all nine justices, the Supreme Court preserved the Food and Drug Administration’s (“FDA’s”) regulatory approval of mifepristone, ensuring continued access to the widely-used abortion medication across the country. Food and Drug Administration, et al. v. Alliance for Hippocratic Medicine et al., No. 23-235 and Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine, et al., No. 23-236. The Court ultimately decided the case on procedural grounds, holding that the plaintiffs lacked standing to bring suit.Continue Reading Supreme Court Unanimously Preserves Access to Mifepristone

Only two months after California’s cost and market impact review (CMIR) regime began to require notice of certain healthcare-related transactions, the Office of Health Care Affordability (OHCA) has already proposed several amendments (Amendments) to the regulations. To recap, the CMIR regulations as currently in effect require that health care entities (HCEs) notify OHCA of transactions meeting certain materiality thresholds at least ninety days prior to closing, as discussed in depth in our previous blog series.[1] Public comments to the Amendments will be accepted until June 20, 2024 and the Amendments are scheduled for discussion at an OHCA board meeting on June 26, 2024. OHCA has not yet announced when the Amendments would take effect, if passed.Continue Reading OHCA Proposes Amendments to its Cost and Market Impact Review Program

On June 6, 2024, California Attorney General Rob Bonta announced that he led a multistate coalition of eleven (11) state attorneys general in in submitting a comment letter (the “Comment Letter”) in response to the Federal Trade Commission, the U.S. Department of Justice, and the U.S. Department of Health and Human Services’ (together the “Agencies”) request for information regarding consolidation in healthcare by private equity. On March 5, 2024, the Agencies issued a “Request for Information on Consolidation in Healthcare Markets,” on the same day the Agencies hosted a public workshop regarding the impact of private equity investment in the healthcare system. Continue Reading California Attorney General Advocates for Greater Antitrust Enforcement in Private Equity in Healthcare

On May 17, 2024, Colorado Governor signed into law, Senate Bill 24-205, the Colorado Artificial Intelligence (AI) Act (the “Act”). The law will take effect on February 1, 2026 and the Colorado Attorney General will have exclusive enforcement authority. As previewed in our prior blog post, the Act focuses on consumer protection issues when companies develop AI tools and imposes obligations on developers (i.e., creators) and deployers (i.e., users) of “high risk” AI systems. “High-Risk” AI systems (“HRAIS”) are defined as any AI system that “makes, or is a substantial factor in making, a consequential decision.” A substantial factor means one that (1) “assists in making a consequential decision”; (2) “is capable of altering the outcome of a consequential decision”; and (3) “is generated by an artificial intelligence system.” A consequential decision is a decision that has a material legal or similarly significant effect on matters related to education, employment, financial lending services, an essential government service, healthcare services, housing, insurance, or legal services. This article specifically reviews the impact the Act has on healthcare services.Continue Reading Colorado’s Artificial Intelligence Act Impact on Healthcare Decisions

At last week’s America’s Physician Groups Spring conference in San Diego, California, we listened as physicians and health system leaders described the ways in which they are responding to short and long term challenges to the sustainability of America’s healthcare system in its current form. It now stands at a critical juncture, facing challenges such as provider shortages and burnout, increasing concerns around access and cost for pharmaceutical products and other supplies, the increasing burden of managing chronic diseases, rising demand for services across the spectrum from an aging population, and balancing the transition to value-based care models in a predominantly fee-for-service environment.Continue Reading Acting Now to Sustain and Improve America’s Healthcare System: Advice from Innovative Physicians and Health System Leaders

At last week’s America’s Physician Group Spring conference in San Diego, California, our team heard firsthand how physicians are leading efforts to integrate Artificial Intelligence (AI) applications in ambulatory and inpatient settings in major healthcare systems across the nation. Physician and IT leaders described in detail their organizations’ efforts to identify safe, cost-effective, desirable ways to leverage AI to enhance the efficiency and quality of patient care and reduce physicians’ administrative workload. Here, we highlight key approaches that have generated early success for various health systems and physician groups, as well as key pitfalls that participants looking to adopt these technologies need to account for in their planning.Continue Reading How Physicians are Pioneering Use of AI Applications in Ambulatory and Inpatient Care