On February 4, 2021, the Department of Justice (“DOJ”), Office of Public Affairs, issued a Press Release (the “DOJ Press Release”) announcing that Kelly Wolfe, President of Regency, Inc., a medical billing company located in Florida, pleaded guilty to conspiracy to commit healthcare fraud through a “pernicious telefraud scheme”[1] involving fraudulent Medicare and CHAMPVA (Civilian Health and Medical Program of the Department of Veterans Affairs) claims for medically unnecessary durable medical equipment (“DME”) supplies.  As a result of Wolfe’s criminal plea, Wolfe could face up to 13 years in federal prison. 
Continue Reading OIG Warns Telehealth Industry: “With Great Power Comes Great Responsibility”

In a February 10, 2021 ruling (the “Garcia Ruling”) out of the District Court for the Central District of California (the “CDCA Court”) in the case of Gilbert Garcia et al v. Welltower OpCo Group LLC, et. al., 20-02250JVS (C.D. Ca. Feb. 10, 2021), the CDCA Court held that the Public Readiness and Emergency Preparedness Act (42 U.S.C. § 247d–6d) (the “PREP Act”) provides senior living facilities with an exemption from civil liability for actions taken by such facilities to protect facility residents from COVID-19.
Continue Reading Senior Living Communities, Liability for COVID-19 Countermeasures, and the PREP Act: Is the Tide Turning for Providers?

On February 26, 2021, the Departments of Labor, Health and Human Services (HHS), and the Treasury issued Frequently Asked Questions (FAQs) on the implementation of the Families First Coronavirus Response Act (“FFCRA”), the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), and other health coverage issuesrelated to COVID-19.

Continue Reading New Guidance on Health Plans’ COVID-19 Coverage Obligations

In response to the ongoing COVID-19 public health emergency (the “PHE”) first declared on March 13, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued blanket Section 1135 Waivers to expand, albeit on a temporary basis during the PHE, the range of healthcare professionals who can provide Medicare-covered telehealth services to include physical therapists, occupational therapists, speech language pathologists, and other non-physician practitioners.  (See also, CMS Fact Sheet, “Medicare Telemedicine Health Care Provider Fact Sheet” (March 17, 2020) and CMS’s “COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers” (December 1, 2020)).
Continue Reading The Other Shoe Drops: OIG To Audit COVID-19 Telehealth Home Health Services

On January 15, 2021, the Federal Communications Commission (FCC) announced the initial pilot projects selected for the Connected Care Pilot Program (“Pilot Program”) for telehealth services.  The list includes 14 pilot projects spanning 11 states and more than 150 treatment sites, totaling $26.6 million awarded of the allotted $100 million under the Pilot Program.  We first introduced the Pilot Program on this blog back in April, including a full breakdown of guidance and filing requirements to request funding.
Continue Reading FCC Announces Initial Connected Care Pilot Program Projects For Telehealth

N.B.  Concurrent with the posting of this article, the Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration (“FDA”) has decided to recommend to the FDA that the FDA approve the emergency use authorization applications submitted by Pfizer and BioNTech.  It is being reported that the FDA may formally approve the applications as soon as tomorrow, Friday, December 11, 2020.  More detail regarding the recommendation and the FDA’s decision will be discussed in a follow-up article.

On Monday, December 7, 2020, California Governor Gavin Newsom announced that, “Hope is on the horizon with the [COVID-19] vaccination. We continue to accelerate our planning and preparedness for a safe and equitable vaccine distribution.”  As noted by the Governor, California expects to receive a little more than two million doses of the vaccine this month including 327,000 doses from pharmaceutical company, Pfizer, and 2.6 million doses from biotechnology maker, Moderna.
Continue Reading “Hope Is On The Horizon”: California Governor Gavin Newsom Announces COVID-19 Vaccine Distribution Plan

G force is used to describe the acceleration of an object relative to gravity. The Wright brothers understood that the lift of the airplane had to be greater than the force of gravity.  In much the same way, the pull of gravity that healthcare providers are facing today is COVID-19.
Continue Reading And We Have Lift-Off: Improvements in Healthcare Revenue Cycle Management to Address COVID-19 Challenges

In an effort to provide additional relief to a health care system strained by the COVID-19 pandemic, the Office of the National Coordinator for Health IT (“ONC”) released an Interim Final Rule with Comment Period (“IFC”) on October 29, 2020 that extends the compliance dates under the 21st Century Cures Act Interoperability, Information Blocking, and ONC Health IT Certification Program Final Rule (the “Final Rule”) and offers some technical corrections and clarifications.
Continue Reading Office of the National Coordinator for Health IT Extends Compliance Deadlines under Interoperability Final Rule