After U.S. Attorney General, William P. Barr[1] and the Federal Bureau of Investigation issued warnings this week regarding potential fraudulent schemes that are being perpetrated in the nation’s response to the COVID-19 pandemic, on Sunday, March 22, 2020, the U.S. Department of Justice (DOJ) filed its first enforcement action to shut down COVID-19-related fraud. DOJ attorneys moved in federal court in Austin, Texas for a temporary restraining order against operators of a website, coronavirustestingkit.com, alleged to have engaged in a wire fraud scheme by offering consumers access to “free” World Health Organization (WHO) vaccine kits in exchange for a shipping charge, which required consumers to enter credit card information on the website.[2] The website stated that the kits “only” required water to administer the vaccine and provided testimonials from “recent users.” The government alleged that claims made on the website are false, as the WHO is not offering free vaccine kits and there is not yet a scientifically proven vaccine, and that the intent of the website is to gain access to consumer credit card information.
Healthcare
COVID-19 impact on telehealth services
The Centers for Medicare & Medicaid Services, the Office of Inspector General of the Department of Health and Human Services and the Office for Civil Rights have each issued separate announcements that enhance the ability to furnish telehealth during the COVID-19 public health emergency. These policies will allow flexibility during the coronavirus emergency period to provide telehealth services:
- Without collecting coinsurance and deductible amounts from federal health care program patients. Click here to read more
- Using applications such as FaceTime, Skype, Messenger video, or Google Hangouts even if the applications don’t meet HIPAA standards. Click here to read more
- Using smart phone for telehealth communication and providing services via telehealth even when the patient is at a location (such as his or her home) that does not satisfy Medicare telehealth originating site standards.
Click here to read more
CMS has also issued guidance intended to help states better understand policy options for paying Medicaid providers using telehealth to deliver patient services in combating COVID-19. Click here to read more
The Impact of the Coronavirus on the Provider-Payor Relationship
As the coronavirus spreads throughout the country, hospitals and other health care providers are finding themselves inundated with patients. Those providers who are in-network with payors have and will likely continue to experience difficulty in complying with certain provisions of their contracts. For instance, as payors are also experiencing an unexpected influx of telephone traffic, the wait time for various approvals, including, but not limited to, pre-authorizations are being delayed.
Providers are often contractually obligated to obtain pre-authorizations for certain procedures and services prior to rendering the care. Due to the increased telephone traffic and increased wait times on the payor end, these providers are now faced with a dilemma. A process that as of two weeks ago only took a matter of ten to fifteen minutes now can take up to an hour or more. This creates a serious dilemma for those providers who need to render care to their patients and comply with their contractual obligations to payors.
Overview of changes in the case of international coronavirus epidemic
FDA Issues Temporary Guidance on Food Supplier Verification Audit Requirements
On March 17, 2020, the U.S. Food and Drug Administration (“FDA”) issued a Temporary Policy regarding preventive controls and food supplier verification audit requirements during the COVID-19 public health emergency. This guidance explains the current intent of FDA to not enforce onsite audit requirements in certain circumstances related to the impact of COVID-19. Such onsite audit requirements can be found in three important food regulations:
FDA Issues Guidance for Ongoing Clinical Trials During COVID-19 Pandemic
On Wednesday, March 18, 2020, the Food and Drug Administration (“FDA”) issued a guidance document titled, “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” (the “Guidance”). FDA’s stated purpose in issuing the guidance is to help sponsors to assure the safety of trial participants, maintain compliance with good clinical practice (“GCP”), and minimize risk to the integrity of trials during the ongoing Coronavirus Disease 2019 (“COVID-19”) pandemic.
The Guidance recognizes the impact COVID-19 may have on the conduct of ongoing clinical trials, including quarantines, site closures, travel limitations, interruptions to the supply chain, and other considerations should individuals involved in the studies become infected with COVID-19. FDA acknowledges that these factors may impact a sponsor’s ability to meet protocol-specified procedures, and that protocol modifications may be necessary and deviations unavoidable.
Telehealth Flexibility: Key Regulatory Changes that Providers Should Know
While providers struggle to provide health care to their patients amid the coronavirus contagion concerns, recent regulatory and reimbursement changes will help ease the path to the provision of healthcare via telehealth.
On March 6, 2020, President Donald Trump signed into law an $8.3 billion emergency coronavirus disease 2019 (“COVID-19”) response funding package. In addition to providing funding for the development of treatments and public health funding for prevention, preparedness, and response, the bill authorizes the U.S. Secretary of Health and Human Services, Alex Azar (referred to herein as the “Secretary”), to waive Medicare restrictions on the provision of services via telehealth during this public health emergency.
COVID-19 impact on telehealth services
The Centers for Medicare & Medicaid Services, the Office of Inspector General of the Department of Health and Human Services and the Office for Civil Rights have each issued separate announcements that enhance the ability to furnish telehealth during the COVID-19 public health emergency. These policies will allow flexibility during the coronavirus emergency period to provide telehealth services:
- Without collecting coinsurance and deductible amounts from federal health care program patients.
Click here to read more - Using applications such as FaceTime, Skype, Messenger video, or Google Hangouts even if the applications don’t meet HIPAA standards.
Click here to read more - Using smart phone for telehealth communication and providing services via telehealth even when the patient is at a location (such as his or her home) that does not satisfy Medicare telehealth originating site standards.
Click here to read more
COVID-19 – New York Expands Telehealth Utilization
We hope that everyone is staying safe during the COVID-19 crisis. State health departments are, of course, doing what they can to facilitate management of transmission of COVID-19 by healthcare providers. Some recent actions by the New York Department of Health (“DOH”) to allow or promote telephonic and telehealth services include:
Telephonic Evaluation – Beginning with dates of service of March 13, Medicaid will reimburse telephonic evaluation and management services for established patients where face-to-face visits may not be recommended and it is medically appropriate to evaluate and manage the patient by phone. Additionally, where a patient face-to-face visit is not possible due to the State of Emergency, telephonic visits documented as clinically appropriate by the provider will be considered medically necessary for Medicaid payment purposes.
Congress’s COVID-19 Funding Legislation Expands Access to Telehealth Services for Medicare Beneficiaries
While the world continues to respond to the growing COVID-19 pandemic, the United States Congress recently passed legislation that provides for more than $8 billion in emergency funding to combat COVID-19. Part of this supplemental funding package, signed into law on March 6, 2020, includes the Telehealth Services During Certain Emergency Periods Act of 2020 (the “Act”),[1] which authorizes the Administration to loosen restrictions on telehealth in order to expand access to COVID-19 related telehealth services for Medicare beneficiaries—many of whom are especially vulnerable to this virus and in the event of future emergencies. On March 17, 2020, the Administration announced the implementation of this waiver with a retroactive effective date of March 6, 2020.
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