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Kendall Kohlmeyer

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Kendall Kohlmeyer is an associate in the Corporate Practice Group in the firm's Century City office and is a member of the firm’s Healthcare team.

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A federal judge in D.C. recently ruled in favor of the U.S. Health Resources and Services Administration (“HRSA”), an administrative agency under the U.S. Department of Health and Human Services (“HHS”), by finding that drug manufacturers must obtain pre-approval from HRSA before implementing rebate models under the 340B Program. Specifically, U.S. District Judge Friedrich (“Friedrich”) found that HHS and HRSA did not exceed their authority when they required Eli Lilly & Co., Bristol Myers Squibb Co., Sanofi-Aventis U.S. LLC, Novartis Pharmaceuticals Corp. (“Novartis”) and Kalderos Inc., a health care tech company (together, the “Companies”) to seek pre-approval of the rebate plans they offered.[i]Continue Reading Federal District Court Upholds Authority of HHS to Pre-Approve 340B Rebate Programs; HRSA Submits Proposed 340B Rebate Guidance

Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March 10th, the FDA issued guidance clarifying that 503A and 503B drug compounders must soon cease compounding semaglutide injection products[i] or risk enforcement action.[ii] This has a significant impact on compounding pharmacies as, under the Federal Food, Drug, and Cosmetic Act (the “FD&C”), drug compounders are permitted to compound their own copies of a patented drug if the FDA determines it is in shortage. Due to high demand for the drugs, Wegovy was added to the FDA’s drug shortage list in March 2022, and Ozempic in August 2022.[iii] Wegovy and Ozempic are the only FDA-approved semaglutide injection products.[iv]Continue Reading FDA’s Semaglutide Shortage Resolution: Legal Implications and Risks for Compounding Pharmacies

On July 18, 2024, the Massachusetts Senate passed S. 2871, An Act Enhancing the Health Care Market Review Process (the Bill), to increase oversight of healthcare transactions involving private equity firms, real estate investment trusts, and management services organizations (MSOs). The Bill is another example of the increasing trend towards curbing private equity influence in health care, as highlighted in our previous blog series on California’s Assembly Bill 3129.[1] In Massachusetts, 51% of all healthcare provider transactions in the past decade have involved private equity firms,[2] and the Bill targets such involvement with the goals of expanding care and medication access and improving transparency and affordability, particularly in the primary care space.Continue Reading Massachusetts Senate Passes Bill to Increase Oversight of Private Equity Healthcare Transactions

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

As we previewed last year regarding SB 184 and the establishment of the California Office of Health Care Affordability (OHCA), California now has taken a significant regulatory step aimed at restraining growth in health care costs. On April 24, 2024, OHCA’s board (the “Board”) voted to implement its long anticipated statewide health care cost target, beginning with a 3.5% cap on spending growth in 2025 and decreasing in the following years. As with OHCA’s cost and market impact review (CMIR) reporting regime,[1] this cap will apply to “health care entities,” which include providers such as hospitals, facilities, outpatient clinics, large physician groups and clinical laboratories, payors and fully integrated delivery systems.Continue Reading California is Capping Health Care Cost Increases – Starting at 3.5% in 2025

On April 4, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued the contract year 2025 (CY2025) Medicare Advantage and Part D final rule (the “Final Rule”). In addition to finalizing its CY2025 proposed rule, CMS also addressed several key provisions that remained from the CY2024 proposed rule. According to CMS’ Fact Sheet, the Final Rule builds on existing Biden-Harris Administration policies to strengthen protections and guardrails, promote healthy competition, and ensure Medicare Advantage and Part D plans best meet the needs of enrollees. The Final Rule also promotes access to behavioral health care providers, promote equity in coverage, and improve supplemental benefits.Continue Reading CMS Issues CY2025 Medicare Advantage and Part D Final Rule

“The American people deserve to know that the insurance companies receiving more than $700B annually in taxpayer funds are working to ensure you receive effective, high-quality care. Remember, you have rights and options to ensure you receive the care you deserve.”Continue Reading OIG Sparks Public Excitement about Managed Care and Alludes to Incoming Enforcement Guidance

In the final days of November, the Office of Health Care Affordability (OHCA) published three updates related to its proposed regulations regarding the review of certain healthcare transactions in California:Continue Reading OHCA Published Near-Final Draft of Regulations Requiring Notice and Review of Material Healthcare Transactions in 2024

On November 6, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released the contract year 2025 proposed rule for Medicare Advantage (“MA”) organizations and Part D sponsors (the “Proposed Rule”). The Proposed Rule covers an array of regulatory topics including the Star Ratings program, marketing and communications, agent and broker compensation, health equity, dual eligible special needs plans (“D-SNPs”), utilization management, network adequacy, and access to biosimilars.Continue Reading CMS Promotes Competition, Transparency, Health Equity and More in the CY2025 Medicare Advantage and Part D Proposed Rule

As we anticipated in our previous blog article, the Office of Health Care Affordability (OHCA) made revisions to its proposed regulations following the public workshop hosted by the California Department of Health Care Access and Information (HCAI) in August. On October 9, 2023, HCAI and OHCA published a revised draft of the regulations. Our August blog article outlined the substance of the original draft regulations; this article summarizes the critical takeaways regarding the revisions.Continue Reading OHCA’s Revised Regulations Following Comments from Industry Stakeholders

As we previewed in our previous blog article, the California Department of Health Care Access and Information (HCAI) hosted a live public workshop on August 15, 2023 for in-person and virtual attendees to make comments and pose questions regarding the proposed regulations governing the Office of Health Care Affordability’s (OHCA) review authority for certain healthcare transactions.Continue Reading Public Workshop for OHCA’s Proposed Regulations Sparks Lively Discussion Among Industry Stakeholders