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Oklahoma Prepared to Enforce Patient Right to Pharmacy Care Act Amid COVID-19 Concerns

In May 2019, Oklahoma passed the Patient Right to Pharmacy Care Act ("Act"). The Act takes aim at unfair pharmacy benefit manager (“PBM”) practices by expanding network access for independent pharmacies, prohibiting PBMs from requiring patients to use pharmacies that are owned or affiliated with PBMs, prohibiting PBMs from providing higher reimbursement to PBM-owned pharmacies, and charging post-point-of-sale fees after claims have already been paid. These are crucial protections to...

FDA Guidance on Conduct of Clinical Trials During the COVID-19 Pandemic

COVID-19 is having a profound effect on clinical trials for medical products, including drugs, devices and biological products. Site closures, travel restrictions, quarantines, infections among participants and trial personnel, and investigational product supply chain issues are just a few of the concerns facing sponsors that may impact protocol-specified procedures. On March 18, 2020 the Food and Drug Administration (“FDA”) issued (and updated on April 2, 2020) a Guidance entitled Conduct...

HHS Provider Relief Funds, Round Two, $20 Billion in Funds – Most Providers Required to Submit Net Revenue and Loss Estimates

Last week, the U.S. Department of Health and Human Services ("HHS") announced that all Medicare-participating providers with COVID-19 related losses are eligible for a second round of funding, totaling $20 billion, from the CARES Act-authorized Public Health and Social Services Emergency Fund (the “Funds”). Of a total of $100 billion of Funds authorized by Congress for payments to healthcare providers, $30 billion was released to all Medicare Part A and...

COVID-19 Business Interruption Insurance: Preserve Your Claims

COVID-19 has caused significant financial impact on Providers, including the suspension or complete shutdown of some types of medical practices and surgery centers. Many states and municipal authorities have issued Executive Orders mandating non-essential business closures, including the suspension of elective and non-urgent medical procedures. For many Providers, this can mean the end of their business. Providers are now looking to their insurance companies to compensate for loss of business...

Temporary Exceptions to DEA Regulations Permitting Flexibility in Distributing and Dispensing Controlled Substances in Wake of COVID-19

In an effort to facilitate continuity of patient care and to respond appropriately to the circumstances that have arisen during the COVID-19 pandemic, the Drug Enforcement Administration (“DEA”) has recently announced three exceptions to DEA regulations for DEA-registered hospitals and clinics that will remain effective until the end of public health emergency crisis. Given the urgency of the situation, the DEA is providing DEA-registered hospital/clinics with the flexibility to utilize...