Health Law Advisor

On March 9, 2020, the Office of the National Coordinator for Health Information Technology (“ONC”) and the Center for Medicare and Medicaid Services (“CMS”) published their long-awaited final rules that seeks to promote interoperability. Market participants waited longer than usual for this rule due to the Department of Health and Human Services (“HHS”) extending the comment period at the request of a variety of stakeholders.

The ONC’s rule (the “Final Rule”) supports interoperability by prohibiting “information blocking”.  Affected organizations (see below) will want to be considering the impact on contracts and developing compliance policies that reflect the requirements of the Final Rule. One aspect of needed compliance relates to the Final Rule’s exceptions to information blocking including a newly-added “content and manner” exception.

Generally, information blocking is defined as an action by an actor interfering with, preventing, or materially discouraging access, exchange, or use of electronic health information[1]  (“EHI”). Actors include health care providers, health IT developers, health information exchanges, or health information network. In the proposed rule, the ONC proposed seven exceptions to conduct that might otherwise be deemed information blocking. However, in the Final Rule, ONC created eight exceptions. Further, the ONC defined two categories of exceptions: (1) Exceptions that involve not fulfilling requests to access, exchange, or use EHI and (2) Exceptions that involve procedures for fulfilling requests to access, exchange, or use EHI. Each of the eight enumerated exceptions are categorized as follows:

On March 16, 2020, FDA finalized its guidance titled Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Policy”). The Policy includes information and recommendations to assist laboratories and commercial manufacturers in development of diagnostic tests for the novel coronavirus (“COVID-19”) during the ongoing pandemic.

During the first week of implementation, questions arose regarding the extent to which the Emergency Use Authorization (“EUA”) pathway to market, as described by the Policy, covers at-home ...

On March 22, 2020, the U.S. Food and Drug Administration (“FDA”) issued guidance, for immediate implementation, that aims to increase the availability of ventilators and other respiratory devices needed to address the COVID-19 pandemic.  While FDA urges health care facilities to use, wherever possible, FDA-cleared standard full-featured ventilators to treat COVID-19 patients (as well as other patients requiring ventilatory support), FDA will allow a more flexible approach to modifications to these devices to help boost manufacturing capacity and supply.  FDA also took the opportunity to lay out guidelines that encourage submission of Emergency Use Authorization (“EUA”) applications for devices not marketed in the United States, continuing an unprecedented Agency response to the pandemic.

Guidance Scope

Specifically, FDA will allow manufacturers of certain FDA-cleared ventilator/respiratory devices (as detailed in the table below) to make modifications to the indications, claims, functionality, or to the hardware, software, or materials of the device without making a new 510(k) submission to FDA, so long as the modification will not create undue risk in light of the public health emergency.  Such changes, which would normally require a new 510(k), could include a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.

Notwithstanding numerous restrictions limiting access to many resources during the ongoing coronavirus (COVID-19) pandemic, marijuana users in states where medicinal and adult use is legal may still have access to cannabinoid supplies. Even as states, counties, and municipalities increasingly restrict or shut down business activities to stem the spread of the virus, many jurisdictions will keep medical marijuana dispensaries open as “essential” businesses like pharmacies and grocery stores.

Medical Marijuana Dispensaries Deemed “Essential” Businesses

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.

On March 16, 2020, U.S. Attorney General Barr directed in a memorandum to U.S. Attorneys that “[e]very U.S. Attorney's Office is thus hereby directed to prioritize the detection, investigation, and prosecution of all criminal conduct” related to the COVID-19 outbreak.[3] Attorney General Barr advised, “the pandemic is dangerous enough without wrongdoers seeking to profit from public panic,” and therefore, such criminal conduct will not be tolerated.

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.

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:

1. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 CFR Part 117);
2. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507); and
3. Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (21 CFR Part 1 Subpart L).

The Agency has stated that this temporary guidance will become effective immediately, without comment from the public, due to the exigent circumstances surrounding this ongoing public health threat.

On March 17, 2020 the Department of Health and Human Services, Office for Civil Rights (“OCR”) announced that it would “exercise its enforcement discretion and will waive any potential penalties for HIPAA violations” for health care providers who are serving patients using “everyday communications technologies.”  The OCR issued this guidance to ensure providers could make use of available technologies and communication apps in order to facilitate virtual visits with patients.

Specifically, the guidance provides (emphasis added):

A covered health care provider ...

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.

Greater utilization of telehealth during the COVID-19 outbreak will reduce providers’ and patients’ exposure to the virus in health care facilities. Telehealth is especially useful for mild cases of illness that can be managed at the patient’s home, thereby decreasing the volume of individuals seeking care in facilities. To further facilitate the increased utilization of telehealth, the Centers for Disease Control’s interim guidance for healthcare facilities notes that healthcare providers can communicate with patients by telephone if formal telehealth systems are not available. This allows providers to have greater flexibility when telehealth technology providers lack the bandwidth to accommodate this increase in telehealth utilization or are otherwise unavailable.

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.

The Senate has spoken to this issue via the Families First Act which prohibits cost sharing and imposing prior authorizations for COVID-19 related testing under Medicare, CHIP, and individual and small/large self-funded group plans. See Division F-Health Provisions, § 6001, Coverage of Testing for COVID-19. While some payors have recognized and acknowledged the difficulties posed by COVID-19 and have made exceptions to the standard requirements, those exceptions have been limited. For example, the Blue Cross Blue Shield Association has indicated that its network of 36 BCBS companies will waive prior authorizations for diagnostic tests and covered services that are medically necessary for members diagnosed with COVID-19. Similarly, Wellmark and Anthem, Inc., have waived prior authorizations for covered services related to COVID-19. While these limited pre-authorization waivers are a start, they do not resolve the dilemma faced by those providers treating patients who are not suffering from COVID-19.