Among the many concerns arising from rampant spread of COVID-19, are provider concerns regarding potential liability for care provided during the pandemic due to limited medical resources. Providers and policy makers have discussed such concerns particularly given the currently limited number of available ventilators and qualified technicians as compared to the numbers of patients who may need access to such equipment.[1] Congress and states have provided varying levels of liability protection, though such protections are themselves limited.

Under the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), Congress provided liability protection to volunteer health care professionals providing health care services during the current public health emergency. [2] Specifically, the CARES Act exempts volunteer health care professionals from liability under federal or state law for any harm caused by an act or omission, unless the harm was caused by willful or criminal misconduct, gross negligence, reckless misconduct, conscious flagrant indifference, or under the influence of alcohol or intoxicating drugs, in providing health care services during the public health emergency with respect to the coronavirus. This provision preempts state or local laws that provide such volunteers with lesser protection from liability.

Notably, Congress chose not to extend liability protection to non-volunteer health care professionals, affording no wide-spread federal protection to those employed or contracted professionals treating patients during the emergency. Certain states, however, have extended liability protection to employed or contracted health care professionals through state orders. For example, Governor Cuomo of New York, through executive order, waived certain state laws to provide immunity from civil liability to certain health care professionals for any injury or death alleged to have been sustained directly as a result of an act or omission by such professional in providing medical services during the pandemic, unless such injury or death was caused by the professional’s gross negligence.[3]

Continue Reading Legal Liability of Healthcare Providers for Care Provided During COVID-19 Pandemic

Numerous media reports concern the shortage of medical resources, personal protective equipment, and qualified professionals during the growing COVID-19 medical emergency.  As a result, providers may ultimately have to make choices regarding resource allocation among hospitalized patients suffering from COVID-19.  Disability rights and other advocacy groups have expressed concern about resource allocation from the point of view of how individuals with pre-existing disabilities and other individuals may have been treated in the past by the medical system.  While bioethicists may work to address the ethical issues involved with treating patients under conditions of resource scarcity, providers rightfully may worry about potential legal liability in distributing scarce resources among those in need.  While both the Trump Administration and Congress have acted to allay some of these worries, concerns remain for both individual practitioners and the facilities with which they work. Continue Reading HHS Office for Civil Rights Bulletin on Civil Rights Issues During the COVID-19 Crisis

On March 13, 2020, President Trump issued a proclamation that the novel coronavirus (“COVID-19”) outbreak in the United States constituted a national emergency. Following this proclamation, pursuant to section 1135(b) of the Social Security Act, the Secretary of the Department of Health and Human Services (“HHS”), Alex Azar, invoked his authority to waive or modify certain requirements of titles of the Act as a result of the consequences of the COVID-19 pandemic, to the extent necessary, as determined by the Centers for Medicare & Medicaid Services (“CMS”), to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in the Medicare, Medicaid, and Children’s Health Insurance Programs (“CHIP”). This authority took effect on March 15, 2020, with a retroactive effective date of March 1, 2020 and will terminate at the conclusion of the public health emergency period.[1] Pursuant to this authority, HHS announced a number of nationwide blanket waivers, including a waiver related to telehealth, in order for providers to respond to the COVID-19 public health emergency.[2]

Separate from and in addition to the blanket waivers, the Secretary’s authority under Section 1135 also allows CMS to grant Section 1135 waivers to states that request CMS to temporarily waive compliance with certain statutes and regulations for its Medicaid programs during the time of the public health emergency. So far, many states have requested these additional flexibilities in order to focus their resources on combatting the outbreak and providing the best possible care to Medicaid enrollees in their states. CMS has been rapidly approving these Section 1135 waiver requests, but it is important to recognize that not all state requests are created equal with respect to utilizing telehealth / telemedicine services during the public health emergency. Based on a review of the publicly available state request letters, it is clear that some states have prioritized use of telehealth in order to respond to COVID-19, while other states have not, or have not yet requested similar flexibilities related to provision of telehealth services. Examples of states that have prioritized greater use of telehealth include:

  • California: The state requested flexibility for telehealth and virtual communications to make it easier for providers to care for people in their homes. Specifically, California requested flexibility to allow telehealth and virtual/telephonic communications for covered State plan benefits, such as behavioral health treatment services, and waiver of face-to-face encounter requirements for Federally Qualified Health Centers and Rural Health Clinics, among others. The state also sought reimbursement of virtual communication and e-consults for certain providers. CMS approved this waiver request on March 23, 2020.
  • Illinois: The Illinois Department of Healthcare and Family Services waiver request, approved on March 23, 2020 by CMS, sought flexibility of documentation requirements, including the lack of documentation of consent for a telehealth consult. Like several other states, Illinois also requested CMS to allow providers to use non-HIPAA compliant telehealth modes from readily available platforms, such as Facetime, WhatsApp, Skype, etc., to facilitate a telehealth visit or check-in at the location of the patient, including the patient’s home.

Continue Reading Some States Are Prioritizing Telehealth Through Section 1135 Waiver Requests

WHO: The Secretary of the Department of Health and Human Services (HHS)

WHAT: Issued nationwide “blanket waivers” of the federal Stark Law (Section 1877 of the Social Security Act) pursuant to his authority Section 1135 of the Social Security Act.

WHEN: Although issued on March 30, 2020, the waivers are retroactively effective as of March 1, 2020.

WHY: HHS is waiving sanctions under the Stark Law and its underlying regulations to ensure that: (1) sufficient health care items and services are available to meet the needs of individuals enrolled in federal healthcare programs, and (2) health care providers that furnish such items and services in good faith, but are unable to comply fully with the Stark Law’s requirements as a result of the consequences of the COVID-19 pandemic, may be reimbursed for such items and services and exempted from sanctions for noncompliance.

HOW: The waiver is available to protect financial relationships that satisfy two criteria: (1) the remuneration and referrals must be solely related to “COVID-19 Purposes”; and (2) the referrals and claims must be related to a defined set of financial relationships, as set forth below.

Continue Reading HHS Issues Blanket Waivers for Certain Financial Relationships Subject to the Stark Law

A post on the Workforce Bulletin blog will be of interest to many of our readers: “The Race to Embrace Remote Online Notarization (“RON”) in Response to the COVID-19 Pandemic,” by attorney  of Epstein Becker Green.

Following is an excerpt:

As employees are required to work remotely and practice social distancing due to the COVID-19 pandemic, the federal government and several state governments (including New York and New Jersey) are moving (New York more quickly than New Jersey) to enable remote online notarization and keep businesses operating.

Read the full post here.

On Friday, March 27, 2020, FDA issued an update to previous guidance titled, “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” (the “Guidance”), adding an Appendix with ten questions and answers for specific topics based on feedback received on the initial March 18th Guidance. To supplement our prior blog post, we identify some key takeaways from the updated Guidance below:

Prioritize Safety of Clinical Trial Participants

  • Ongoing Clinical Trials. Sponsors, investigators, and IRBs should work together to assess whether the participants’ safety is better served by continuing the study as is, discontinuing administration or use of the product, or by ending participation in the trial. The Guidance provides a number of key factors for consideration. FDA also recognizes that there may be an investigational product that is providing benefit to a trial participant, and the sponsor must decide whether to continue administration during the COVID-19 pandemic. This is a context-dependent choice, and sponsors should consider whether there are any reasonable alternative treatments available, the seriousness of the disease or condition, the risks involved in switching treatment, supply chain disruptions, and whether discontinuing administration would pose a substantial risk to the participant.
  • New Clinical Trials. With respect to initiating a new clinical trial, other than one to investigate treatments or vaccines related to COVID-19 infection, FDA advises sponsors to consider the ability to effectively mitigate the risks of a trial in order to preserve safety of the participants and trial integrity. Any new trial must also be designed in a way to comply with the Federal and State public health measures implemented in response to COVID-19.

Continue Reading FDA Issues Update to Guidance for Clinical Trials During the COVID-19 Pandemic

The ongoing pandemic caused by the novel coronavirus has upended the American health care system in many ways. One of the many effects of COVID-19 will likely be substantial disruption in value-based payment arrangements between health plans and providers. Though this is an issue that is not on the top of providers or payors minds as the health care system prepares to respond to the crisis, there are some simple steps that providers can take now to avoid issues in the future.

Any iteration of value-based payments (“VBP”) is likely to be disrupted by COVID-19; be it shared savings, shared risk, or full risk arrangements. Quality targets and reporting deadlines are likely to be missed as providers move many routine and preventative services to telehealth services or suspend them entirely for the time being, as well as turn the bulk of their clinical focus to COVID-19. Cost savings targets are likely to be missed or at least distorted as providers focus on building out their capabilities to address the pandemic. How will these sudden and substantial changes affect the parties participating in value-based arrangements?

CMS has already announced that it will amend its quality reporting requirements from the fourth quarter of 2019 through the end of the second quarter of 2020.[1] The announcement covers a variety of quality reporting requirements and payment programs with the stated purpose of alleviating reporting requirements and disregarding unrepresentative data created during the emergency. States may choose to follow suit for Medicaid programs. How these government steps would flow down into VBP agreements between managed care plans and providers is not clear and requires analysis of the specific agreements.

Continue Reading Value-Based Payment Arrangements During the COVID-19 Pandemic

The coronavirus is having a direct effect – financial and otherwise – on nearly every business.  While the long-term effects of the global pandemic will be significant and far-reaching, the short-term financial consequences to businesses, due to expected cash shortfalls, could make the difference in a company’s survival.  Here are four areas that businesses should review that could impact – and potentially improve – their financial situation:

  • Lease arrangements – Landlords may be willing to accept a temporary reduction in rent rather than risk losing a good, long-term tenant, and otherwise reliable income stream, altogether. This can usually be accomplished by a simple amendment to the lease agreement.
  • Debt covenants – Companies that have credit facilities often are subject to debt covenants in favor of the lender that are tested periodically.  Typical debt covenants that could be violated in times of financial crises include minimum financial tests, or ratios, based on a company’s income, assets, working capital, net worth and equity.  Covenants that consist of operational milestones could be impacted as well.  It’s good practice for companies to approach their lenders and seek amendments (or temporary waivers) to their covenants before those covenants are tripped, rather than afterwards, when the company is in default.

Continue Reading Coronavirus and Cash Shortfalls – What Can You Do to Mitigate the Effects of Coronavirus on Your Organization’s Financial Health?

In response to the growing concerns of the capacity of the health care workforce as a result of the COVID-19 pandemic, on March 24, 2020 the Secretary of Health and Human Services, Alex Azar, issued a letter and associated Guidance to all Governors urging them to take immediate action.  While the federal government, and some states, have admirably waived and relaxed many rules related to the provision of various types of benefits and services, including relaxed telehealth and privacy rules/enforcement, many necessary actions are within the authority of state governments. Presumably, this plea from Secretary Azar is an attempt to “close the gap” between what the federal government has done to remove these barriers and the stringent restrictions of many state licensure laws. Specifically, Azar sets forth eight action items that he is asking Governors and the District of Columbia to consider in order to lift the limits that state rules currently place on licensure, scope of practice, certification, and recertification/relicensure. The action items include:

  1. Waive licensure requirements or restrictions, on a temporary basis, to allow health professionals licensed, registered, or certified in good standing with another state to practice their profession in your state, either in person or through telemedicine.
  2. Waive statutory and regulatory standards to allow the use of telehealth modalities to establish a patient-provider relationship, diagnose and deliver treatment recommendations.
  3. Waive certain scope of practice requirements to temporarily suspend or relax supervision or collaboration requirements and to allow health care professionals to practice in all settings. Encourage State Boards of Medicine, Nursing and other professions to put in place a temporary enforcement moratorium for scope of practice violations.
  4. Remove geographic restrictions and increase the number of health professionals that a physician may supervise and allow supervision using remote or telephonic modalities.
  5. Permit the rapid certification/licensure and Recertification/Relicensure of health care professionals.
  6. Compile a list of state liability protections for in-state and out-of-state health care providers. Work with state insurance commissioners to modify or temporarily rescind provisions in medical malpractice policies that prevent insurance coverage of a health care provider’s work responding to the COVID-19 emergency in another state and work with insurers to waive similar limitations in their policies.
  7. As determined appropriate by state health authorities, modify laws and regulations to utilize medical students to triage, diagnose and treat patients under the supervision of licensed medical staff.
  8. Modify laws or regulations to allow for signature-less pharmaceutical deliveries in order to prevent contact between the recipient and the delivery person.

In setting out these action items, Azar calls on the states to immediately use available statutory and regulatory emergency authority to significantly expand the pool of health care professionals available to treat patients infected with the Corona Virus.

These actions, layered on federal waivers, such as the 1135 waiver of certain requirements applicable to the Medicare, Medicaid and CHIP programs, including prior authorization requirements and state licensure requirements, reflect essential federal/state coordination of COVID-19 responses.

Imagine these scenarios:

  • Your company cannot perform a contract because of the COVID-19 pandemic.
  • A vendor informs you that she cannot provide your company with necessary goods because of supply chain issues caused by a governmental emergency declaration.
  • A subcontractor cannot perform because its employees are self-quarantining.

These are not hypotheticals. Scenarios like these are playing out around the country. The real-world impact of the COVID-19 pandemic is colliding with contractual requirements, and there is new attention to the legal doctrines of “impossibility,” “frustration of purpose,” “impracticability, and “force majeure.”

What do they mean? In a nutshell, traditional contract law says that an unforeseeable event occurring after the contract was formed can excuse contract performance, and determining whether an event was unforeseeable will depend heavily on the specific facts and the language of the contract.

Continue Reading A World Turned Upside Down: Contract Performance During the COVID-19 Pandemic