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PHARMACY ALERT: HHS Issues Guidance on PREP Act Preemption of State and Local Laws that Prohibit Licensed Pharmacists From Ordering and Administering FDA-approved COVID-19 Tests

On May 19, 2020, the Department of Health and Human Services (HHS) issued guidance clarifying whether the Public Readiness and Emergency Preparedness (PREP) Act preempts State licensing laws that restrict pharmacists and pharmacies from ordering and administering FDA-approved COVID-19 tests.  As we discussed in an earlier article, the Office of the Assistant Secretary of Health and Human Services (“OASH”) issued guidance on April 8, 2020 that authorized licensed pharmacists to...

MANUFACTURER ALERT: CARES Act Clears Path for Over-the-Counter Expansion

The rising cost of healthcare and the renewed focus on personal hygiene related to the COVID-19 pandemic has brought a marked increase in the use of over-the-counter (OTC) medications such as cold remedies, antihistamines, pain relievers and hand sanitizers. Nonprescription drug products play an increasingly important role in the United States health care system. OTC drugs are defined as those that are safe and effective for use by the general...

DHHS Provider Relief Funds- New Funding Round for Medicaid Providers Excluded from First Rounds of Funding

On June 9, 2020 the U.S. Department Health and Human Services (“DHHS”) announced that it was allocating a total of $15 Billion in Provider Relief Fund payments to Medicaid or Children’s Health Insurance Program (CHIP) providers who have been impacted by the COVID-19 crisis. These funds are specifically for providers who are not enrolled Medicare providers, and thus were ineligible for the first two rounds of the Provider Relief Fund...

The Impact of COVID-19 on PBM Contracts

Plan Sponsors, ranging from self-insured employers to government entities, have taken steps to relax requirements so that patients have access to healthcare and life saving drugs. However, some PBMs have taken the opportunity to syphon money out of Plan Sponsors, at the expense of both Plans and patients. We will discuss three areas of concern for Plan Sponsors during COVID-19. Price Guaranty Provision. PBM contracts often contain force majeure provisions...

CMS Doubles Down On Value Based Care (“VBC”), Taking Additional Comprehensive Measures to Ensure COVID-19 Does Not Disrupt the Continuous and Rapid Transition from Volume Based Care to VBC

If there were ever any doubts about the seriousness of CMS’ commitment to transitioning the nation’s healthcare system from one based on volume-based to value-based compensation models, those doubts were squashed by a recent CMS blog post and bulletin, announcing the implementation of very significant temporary “flexibilities and adjustments” to various VBC programs in an effort to ensure that providers participating in those programs are able to weather the chaos...