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Ken is a partner in the Corporate Practice Group in the firm's Los Angeles office and a member of the Healthcare Team.

Now approaching a year-long battle, drug manufacturers and 340B covered entities, which include hospitals and community health centers, participating in the 340B Drug Pricing Discount Program (“340B Participants”) continue to dispute the issue of whether drug manufacturers are required to give 340B Participants discounts on drugs dispensed through contract pharmacies.  The most recent point of contention involves the U.S. Health Resources and Services Administration’s (“HRSA”) May 17, 2021 letters sent to six drug manufacturers stating that the manufacturers’ actions to limit access to 340B Program pricing for 340B Participants who dispense drugs through contract pharmacies is in direct violation of Section 340B of the Public Health Service Act (also referred to as the “340B Statute”).  The letters also included HRSA’s demand that the manufacturers immediately begin offering their drugs at discounted prices to these 340B Participants as well as credit or refund all 340B Participants for overcharges that resulted from the limiting policies, or be subject to civil monetary penalties.  As anticipated, certain drug manufacturers, including Eli Lilly, have filed motions in federal court to stop the HRSA from placing monetary penalties based on their refusal to provide 340B discounts to contract pharmacies.

Continue Reading 340B Drug Pricing Discount Program Update: HRSA Now Demands That Drug Manufacturers Provide 340B Discounts To Contract Pharmacies Amid Ongoing Litigation

In its June 2021 physician supply and demand report, “The Complexities of Physician Supply and Demand: Projections From 2019 to 2034” (the “Report”), the Association of American Medical Colleges (“AAMC”) highlights the ongoing concern of physician shortages in the United States.  According to the Report, the U.S. faces a potential physician shortage of between 37,800 to 124,000 doctors by 2034. While an improvement from AAMC’s June 2020 report, the COVID-19 pandemic highlighted the consequences of failing to address this problem, as medical schools and teaching hospitals were forced to graduate medical students early, and hospitals scrambled to call up retired physicians and to pay steep travel and relocation rates, all to address the public health emergency.
Continue Reading Congressional Action in the Face of Mounting Concerns Regarding Current and Future Physician Shortages

On May 21, 2021, the Centers for Medicare and Medicaid Services (“CMS”) announced that the Next Generation Accountable Care Organization (“ACO”) Model (“NGACO Model” or “Model”), set to end December 31, 2021, will not be extended after receiving a one-year extension due to COVID-19.  The decision comes as a surprise to NGACO participants and other industry groups who have been calling on CMS to revisit its decision and closely consider the Model’s merits and potential as a permanent program option.  Industry stakeholders, such as the National Association of ACOs (“NAACOS”), expressed initial disappointment with CMS’ decision to end the program, but were later able to find some reprieve with CMS’ decision to “allow Next Gen ACOs a limited opportunity to apply for Direct Contracting . . . . starting next year.”

Continue Reading CMS’ Next Generation Accountable Care Organization (NGACO) Model Set To End in December 2021

The Biden Administration’s American Rescue Plan Act of 2021 (H.R. 1319) (the “Act”) could present an opportunity for the growth of utilization of ambulatory surgery centers (“ASCs”), continuing the trend of migration of inpatient procedures to the outpatient setting.  This shift toward the outpatient setting initially began prior to the COVID-19 public health emergency, but was accelerated by the pandemic’s effect on hospitals, likely continuing the substantial increase in investment in the ASC marketplace.
Continue Reading Biden’s American Rescue Plan Follows Trend Toward Outpatient Setting, Increase in ASC Investment

Late last month, the Biden Administration announced the second installment of its recovery plan, dubbed the “American Jobs Plan” (the “Plan”).  The Plan’s $2.3 trillion price tag includes
Continue Reading The American Jobs Plan and the American Rescue Plan: The Biden Administration Bets Big on Home and Community-Based Services

On March 10, 2021, President Biden signed into law the American Rescue Plan Act of 2021 (the “Act”). This $1.9 trillion COVID-19 relief package not only includes a whole host
Continue Reading The American Rescue Plan Act of 2021: A New Lease on Life for the Affordable Care Act?

In a February 10, 2021 ruling (the “Garcia Ruling”) out of the District Court for the Central District of California (the “CDCA Court”) in the case of Gilbert Garcia et al v. Welltower OpCo Group LLC, et. al., 20-02250JVS (C.D. Ca. Feb. 10, 2021), the CDCA Court held that the Public Readiness and Emergency Preparedness Act (42 U.S.C. § 247d–6d) (the “PREP Act”) provides senior living facilities with an exemption from civil liability for actions taken by such facilities to protect facility residents from COVID-19.
Continue Reading Senior Living Communities, Liability for COVID-19 Countermeasures, and the PREP Act: Is the Tide Turning for Providers?

Telehealth services and providers have been in high demand as the world copes with the COVID-19 public health emergency.  Federal and state agencies have amended, and often loosened, regulations in an attempt to facilitate and expand access to telehealth.  However, the honeymoon phase of relaxed oversight may be coming to an end as the world adjusts to a new-normal.
Continue Reading The Honeymoon Phase Is Over: OIG to Audit COVID-19 Part B Telehealth Services

Executive Orders and the Biden Administration’s promises to postpone or withdraw certain last-minute, so-called “midnight rules” promulgated by the Trump Administration are currently grabbing everyone’s attention, especially those in the healthcare space.  But while President Biden may have success in reversing much of his predecessor’s last minute regulatory activity, he is likely to face at least some headwinds as it relates to one of those midnight rules – the “Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions” (the “Final Rule”) – that was published in the Federal Register on January 14, 2021 and became effective on January 12, 2021.
Continue Reading Secret Rules and Hidden Penalties: Biden Executive Order Takes Aim at the Trump Administration’s Efforts to Limit HHS’s Use of Guidance Documents in Civil Enforcement Actions

On April 1, 2021, the California Department of Health Care Services (“DHCS”) will be transitioning all Medi-Cal pharmacy benefits from managed care to fee-for-service (“FFS”).  This
Continue Reading Medi-Cal Rx: California to Transition Medi-Cal Pharmacy Benefits to Fee-For-Service

On December 11, 2020, five hospital groups, including the American Hospital Association (“AHA”), and an organization of hospital pharmacists representing participants in the 340B drug pricing program (“340B Program”), filed a federal lawsuit (the “340B Program Litigation”) against the U.S. Department of Health and Human Services (“HHS”) over HHS’ alleged failure to enforce 340B Program requirements that obligate pharmaceutical manufacturers to provide 340B Program prescription drug discounts to pharmacies contracted by 340B Program-participating hospitals to dispense 340B Program drugs.[1]
Continue Reading Contract Pharmacies and the 340B Drug Discount Program: New Litigation and an Advisory Opinion Point to Ongoing Skirmishes on the 340B Battlefield