Category: coronavirus

CMS Announces Enforcement Discretion for Physician Payments Sunshine Act Reporting by Applicable Drug and Device Manufacturers

CMS announced today (with the details found here in its answers to Frequently Asked Questions) that in acknowledgment of the extreme circumstances posed by COVID-19, it will exercise enforcement discretion with respect to any Physician Payments Sunshine Act Open Payments reporting that is submitted after the March 31, 2020 deadline. CMS explained that while it...

HIPAA and COVID-19 Updates: The Office for Civil Rights Provides Additional Guidance on Permitted Disclosures to First Responders

Since the COVID-19 outbreak, many health care providers have had a myriad of HIPAA questions, including questions about whether they can share some types of information and, if so, the type of information they can share with first responders who may have been exposed. Today, the Office for Civil Rights (OCR) published guidance outlining the...

FCC Narrows the TCPA’s Emergency Purpose Exception Amid Pandemic While Greenlighting Certain Emergency Messages by Hospitals, Health Care Providers, and Government

The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s Scott Goldsmith for...

CMS Announces Relief for Participants in Quality Reporting Programs in Response to COVID-19

On March 22, 2020, the Centers for Medicare & Medicaid Services (CMS) announced in a press release that it is granting exceptions from reporting requirements and extensions for upcoming data submission and measure reporting deadlines for Medicare quality reporting programs.  The exceptions and extensions are intended to reduce data collection and reporting burdens for entities...

COVID-19 and EMTALA: Ongoing Requirements and New Waivers

On March 9, 2020, the Centers for Medicare and Medicaid Services (“CMS”) Quality, Safety and Oversight Group (“QSO”) issued a memorandum, QSO-20-15, providing guidance to health care providers related to the Emergency Medical Treatment and Labor Act (“EMTALA”) implications regarding the COVID-19 pandemic. EMTALA is a Federal law that requires all Medicare-participating hospitals (including critical...

Clinical Trials During the COVID-19 Pandemic

In light of the COVID-19 pandemic, the Food and Drug Administration (“FDA”) issued recent non-binding guidance (“Guidance”) on the conduct of ongoing clinical trials of medical products. The FDA acknowledges that the public health emergency may result in unavoidable protocol modifications and/or deviations. Quarantines, site closures, travel limitations, interruptions in the supply chain for the...

COVID-19 and Cross-State Clinician Licensure: Federal and State Regulations, Revisited, and What To Do About Them

The COVID-19 pandemic has dramatically increased the number of patients and providers seeking to implement and use telehealth visits and other digital health solutions – and rapidly, at that.  The challenge of implementing digital health solutions, particularly telehealth, has historically been the patchwork setup of both federal and various state regulations that made it difficult...

Controlled Substance Prescribing Exceptions During Public Health Emergencies

In light of the novel coronavirus pandemic, health care practitioners should be aware of relaxed guidelines for prescribing controlled substance. This blog post describes when practitioners can prescribe controlled substances via telemedicine and exceptions available to opioid treatment programs. Telemedicine Prescribing Typically, an in-person medical evaluation must be conducted before a prescription for a controlled...