HHS Permits Out-of-State Telehealth Providers to Render Certain Services Nationwide     On December 3, 2020, the Department of Health and Human Services (“HHS”) announced a fourth amendment to its declaration under the Public Readiness and... Read More
Blogs & Articles | COVID-19 Resources | Healthcare | Telehealth and Telemedicine

In an effort made in response to the COVID-19 emergency thus far, as previously discussed in our posts, “What Are the PBMs Doing Amid COVID-19 Crisis: Waivers from Strict Requirements May Exist for Independent Pharmacies,” and “UPDATE: Humana... Read More
Blogs & Articles | COVID-19 Resources | Defending Pharmacies in PBM Audits | Pharmacy Law

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... Read More
Blogs & Articles | COVID-19 Resources | Healthcare | Healthcare Law | Laboratories | Regulatory Compliance, including FDA, DEA and HIPAA

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... Read More
Administrative and Insurance Defense Law | Blogs & Articles | COVID-19 Resources | Healthcare Law | Healthcare Litigation | Pharmacy Law

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... Read More
Blogs & Articles | Chain Pharmacies | Community, Retail Pharmacies | COVID-19 Resources | Life Sciences | Pharmacy Law | Physician Dispensing | Regulatory Compliance, including FDA, DEA and HIPAA | Specialty Pharmacies

Over the last few days, FDA has issued several guidance documents relating to compounding of certain aqueous injectable drugs by outsourcing facilities, State-licensed pharmacies and Federal facilities for duration of the COVID-19 public health... Read More
Blogs & Articles | Chain Pharmacies | Community, Retail Pharmacies | COVID-19 Resources | Healthcare | Hospitals and Healthcare Systems | Life Sciences | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA | Section 340B In-House and Contract Pharmacies

In a March 30th, 2020 proposed Interim Final Rule (“IFR”), CMS declared that it would be applying (and, later, expanding the scope of) its “extreme and uncontrollable circumstances” regulation, 42 C.F.R. 425.502(f), to “mitigate any impact... Read More
Blogs & Articles | COVID-19 Resources | Healthcare Law | Healthcare Litigation | Value Based Care

As Coronavirus (COVID-19) cases continue to plateau and as the nation experiences the benefit of social distancing, the focus has quickly turned to the development of a vaccine.  Promising Vaccines Despite the substantial cost of developing,... Read More
Blogs & Articles | COVID-19 Resources | Healthcare Law | Life Sciences | Manufacturers | Pharmacy Law