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Policy & Medicine 05/26/2020 05:00
On May 8, 2020, the Second District Court of Appeal in California issued a decision that may reinstate potentially hundreds of lawsuits against Johnson & Johnson for its product Risperdal. Readers may recall the Risperdal cases that are pending across the country, with a segment of cases in California, Pennsylvania, Missouri, and South Carolina. Men, […]
Policy & Medicine 05/22/2020 05:03
Recently, the US Food and Drug Administration (“FDA”) Center for Devices and Radiological Health (“CDRH”) published guidance describing how medical device manufacturers should notify CDRH of shortages during the pandemic. This is a new reporting requirement for medical device manufacturers, as they are generally not required to report shortages. However, the Coronavirus Aid, Relief and […]
Policy & Medicine 05/19/2020 05:02
While news reports of overwhelmed and exhausted front-line healthcare workers have been getting a lot of attention in the media, other healthcare workers are suffering from pay cuts, furloughs and redeployments as a result of the COVID-19 pandemic. This is yet another area where the pandemic is causing disruptions to the healthcare system, and the […]
Policy & Medicine 05/18/2020 05:02
Recently, the Centers for Medicare & Medicaid Services (CMS) announced that clinicians participating in the Quality Payment Program (QPP) can earn credit in the Merit-based Incentive payment system (MIPS) by attesting to a new COVID-19 Clinical Trials improvement activity based on participation in a clinical trial and reporting information.
Policy & Medicine 05/15/2020 05:02
In response to rapidly changing conditions due to the COVID-19 pandemic, the US Food and Drug Administration (“FDA”) published a revised guidance on postmarket adverse event reporting requirements. The revised guidance applies to drugs, biologics, medical devices, combination products and dietary supplements. The revised guidance addresses the following areas: Information on Pandemic Preparedness: The guidance […]
Policy & Medicine 05/13/2020 05:01
On Thursday, May 7, 2020, the United States Centers for Medicare and Medicaid Services (CMS) released the 2021 Notice of Benefit and Payment Parameters final rule. This rule finalizes the CMS’ proposed modification of existing policy relating to how pharmaceutical manufacturer direct assistance (i.e., coupons) accrues with respect to health plan enrollees’ annual limit on […]
Policy & Medicine 05/12/2020 05:02
The Centers for Medicare and Medicaid Services (“CMS”) recently announced the new Part D Senior Savings Model, which is intended to lower the Medicare beneficiaries’ out-of-pocket costs for insulin to a maximum $35 copay per thirty-day supply. The Savings Model will ensure predictable monthly copays for beneficiaries and applies to a wide-variety of insulin formulations, […]
Policy & Medicine 05/07/2020 04:58
Earlier this year, Teva agreed to pay $54 million to settle an Anti-Kickback Statute (AKS) and False Claims Act (FCA) claim that it used speaker programs to pay physician speakers to induce prescriptions for two of its drugs, Copaxone and Azilect. Background Charles Arnstein and Hossam Senousy, former sales representatives of Teva Neuroscience, filed the […]
Policy & Medicine 05/05/2020 05:02
Recently, the Food and Drug Administration (FDA) detailed a new “special emergency program” for accelerating research and development of potential treatments for coronavirus disease (COVID-19). Under the coronavirus treatment acceleration program (CTAP), FDA says it is responding to requests from researchers and industry as rapidly as possible and by providing “ultra-rapid, interactive input on most […]
Policy & Medicine 05/04/2020 05:02
On April 13, 2020, Global Health Care LLC presented a webinar entitled, Managing Pharma and Medical Device Ethics and Compliance Function Remotely, the second in a series of webinars addressing compliance issues created by the COVID-19 pandemic. In this webinar, panelists discussed some of the challenges they are facing, as well as suggestions for how […]
Policy & Medicine 04/30/2020 05:05
Recent changes from the Administration have helped physicians see more patients through telehealth services. This has been welcome news for many physicians and their patients. In this story, we outline some of the most recent changes, but also the many challenges that remain related to telehealth administration. Recent Changes We have previously covered the telehealth […]

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