Court Vacates Parts of FFCRA Regulations, Including Healthcare Provider Definition

Healthcare employers who believed they were entirely exempt from the FFCRA’s obligations, including providing certain paid leave, based on the Department of Labor’s March regulations should revisit their position in light of a recent ruling from a New York federal court.  Many healthcare providers believed they were entirely exempt from the FFCRA because of the broad definition of healthcare provider in the Department of Labor’s regulations.   Now, a New York federal district court struck down this regulatory provision.  You can read more about this important decision from our colleagues here.  Healthcare providers with less than 500 employees are encouraged to contact their Jackson Lewis attorney for assistance to assess risks in light of this development.

Affordable Care Act No Longer Interpreted to Prohibit Discrimination Against Transgender Patients

Section 1557 of the Affordable Care Act (“ACA”) contains anti-discrimination provisions, which include prohibitions on sex discrimination, that apply to certain health care providers and insurers receiving federal funding. On June 13, 2020, the Department of Health and Human Services (“HHS”) published a final rule walking back protections for transgender patients, among other changes (“2020 Rule”).

The previous Section 1557 regulations, from 2016 (“2016 Rule”), defined sex as “an individual’s internal sense of gender, which may be male, female, neither, or a combination of male and female, and which may be different from an individual’s sex assigned at birth.” Based on that definition, the 2016 Rule required covered entities (1) not discriminate on the basis of sex in providing access to health programs and activities; (2) “treat individuals consistent with their gender identity”; and (3) prohibited “deny[ing] or limit[ing] health services that are ordinarily or exclusively available to individuals of one sex, to a transgender individual based on the fact that the individual’s sex assigned at birth, gender identity, or gender otherwise recorded is different from the one to which such health services are ordinarily or exclusively available.”

The 2020 Rule eliminated that definition and the above requirements. HHS stated that it

disagrees … that Section 1557 or Title IX encompass gender identity discrimination within their prohibition on sex discrimination…. The biological differences between men and women are not irrelevant to employment law and education, and they are in many ways even more relevant in the health setting…. The Department believes that, unlike stereotypes, reasonable distinctions on the basis of sex, as the biological binary of male and female, may, and often must, play a part in the decision making process – especially in the field of health services. A covered entity such as a healthcare provider is not impermissibly stereotyping biological males (notwithstanding their internal sense of gender) on the basis of sex if it uses pronouns such as “him”; limits access to lactation rooms and gynecological practices to female users and patients; or lists a male’s sex as “male” on medical forms. Similarly, a covered health care entity is not impermissibly stereotyping biological females (notwithstanding their internal sense of gender) on the basis of sex if it uses pronouns such as “her”; warns females that heart-attack symptoms are likely to be quite different than those a man may experience; advises women that certain medications tend to affect women differently than men; or lists a female’s sex as “female” on medical forms. Finally, it is not stereotyping for covered entities to have bathrooms or changing rooms designated by reference to sex, or to group patients in shared hospital rooms by sex. Such practices and actions are not rooted in stereotypes, but in real biological and physiological differences between the sexes. Moreover, none of these examples disadvantages one sex over another, and in fact the failure to take sex into account may in some cases have a disadvantageous effect…. Distinctions based on real differences between men and women do not turn into discrimination merely because an individual objects to those distinctions…. The Department will vigorously enforce Section 1557’s prohibition on sex-based discrimination, but that prohibition cannot be construed as a prohibition on reasonable sex-based distinctions in the health field…. Unprofessional conduct such as inappropriate jokes or questions, excessive precautions, or concealment of treatment options, may be covered under State medical malpractice, tort, or battery laws [but not Section 1557].

Finally, although noting that “[n]othing in this [2020] [R]ule prohibits a healthcare provider from offering or performing sex-reassignment treatments and surgeries, or an insurer from covering such treatments and procedures, either as a general matter or on a case-by-case basis,” (emphasis added), HHS states there is no legal requirement to do so under Section 1557.

The 2020 Rule noted that some comments had urged HHS to defer issuing this Final Rule until the Supreme Court decided a trio of cases and resolved whether Title VII’s sex-discrimination prohibition also prohibits discrimination based on transgender status. HHS explained it opted not to wait because the administration had taken the position in those cases Title VII does not prohibit discrimination based on transgender status, Section 1557 encompasses Title IX’s sex-discrimination provisions (not Title VII), and there are unique medical issues related to “biological” sex implicated in ACA discrimination that would not matter in employment discrimination cases. On June 15, 2020, the Supreme Court decided that Title VII does protect transgender employees.  In doing so, the Supreme Court rejected arguments similar to the HHS statements quoted above.  However, because the Supreme Court’s decision interpreted Title VII and not Title IX, it is unclear what, if any, impact that decision will have on courts’ interpretation of the new HHS rule regarding transgender patients.

OCR’s Relaxed Enforcement of HIPAA During COVID-19 Paves The Way For Increase in Telehealth Services

As the COVID-19 pandemic continues to spread across the country, doctors, dentists, therapists and other healthcare providers have turned to telehealth use with their patients by way of videoconferencing applications such as Zoom, Skype and WebEx. The Office of Civil Rights and the Department of Health and Human Services (“OCR”) defines telehealth as “the use of electronic information and telecommunications technologies to support long-distance clinical health care, patient and professional health-related education, public health and health administration. Technologies include videoconferencing, the internet, store-and-forward imaging, streaming media, and terrestrial and wireless communications.”

There are a number of privacy concerns healthcare providers should consider when utilizing telehealth technology. Generally, healthcare providers providing telehealth services are subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). However, not every videoconferencing application is HIPAA-compliant. HIPAA requires that a healthcare provider who utilizes a vendor to transmit or maintain protected health information, or who utilizes a vendor who has routine access to protected health information (PHI), must have a Business Associate Agreement (BAA) with each vendor.

In light of COVID-19, the OCR recently relaxed its enforcement of HIPAA’s privacy and security rules and issued a notification stating that it will practice “enforcement discretion” regarding HIPAA’s privacy and security rules. The OCR will not impose penalties for noncompliance with HIPAA for healthcare providers’ “good faith provision of telehealth using such non-public facing audio or video communication products during the COVID-19 nationwide public health emergency”, whether the telehealth services are related to a COVID-19 diagnosis and treatment or not, including for example, “a sprained ankle, dental consultation or psychological evaluation, or other conditions.”

The OCR advises healthcare providers to use public facing videoconferencing applications including Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, Zoom, or Skype, to provide telehealth without the risk that the OCR will issue penalties for non-compliance with HIPAA. However, the OCR also specifically disallows the use of certain other public facing video apps such as TikTok, Facebook live, and Twitch to provide telehealth services.

Notwithstanding the OCR’s practice of enforcement discretion, healthcare providers should continue to engage in best practices to safeguard patient data. For example:

1. Consent. Before using video conferencing for medical consultations, request permission from the patient to do so and document their approval in their medical record.

2. BAA. Despite the fact that the OCR will not impose penalties against covered health care providers for the lack of a BAA, the OCR encourages healthcare providers to enter into a BAA with any vendor that provides videoconferencing services, and in its notification provides a list of vendors which represent that they are HIPAA-compliant video conferencing applications that will enter into a HIPAA BAA, including:

  • Skype for Business / Microsoft Teams
  • Updox
  • VSee
  • Zoom for Healthcare
  • Google G Suite Hangouts Meet
  • Cisco Webex Meetings / Webex Teams
  • Amazon Chime
  • GoToMeeting
  • Spruce Health Care Messenger

3. Encryption. Healthcare providers should enable all available encryption and privacy modes when using the videoconferencing technology.

4. Password Protection. Healthcare providers should create a unique meeting ID and a strong password to access a virtual consultation.

5. Monitor. Healthcare providers should monitor all communications containing PHI. Additionally, healthcare providers should check that both employees and patients are accessing via a secure network connection prior to consultations.

According to analysts at Forrester Research, the adoption of telehealth services has increased dramatically, with virtual healthcare interactions projected to exceed 1 billion by year’s end. While the OCR’s relaxed enforcement of HIPAA during COVID-19 likely will end when the pandemic is brought under control, it appears telehealth services may become the “new normal” for healthcare providers.

New York Imposes New COVID-19 Standards on Dental Practices for Reopening

Following Governor Andrew Cuomo’s announcement that dental practices across New York State may reopen to perform all dental care, the New York State Department of Health (DOH) has issued minimum safety and social distancing standards in its “Interim Guidance for Dentistry During the COVID-19 Public Health Emergency.”

The Interim Guidance applies to all dental care, including both emergency and non-emergency or elective care, and will remain in effect until it is rescinded or amended by DOH. All dentists must implement the standards upon reopening and submit an affirmation to DOH stating that they have reviewed the Standards and will implement them.

The Interim Guidance provides:

No dentistry activities can occur without meeting the … Standards, as well as applicable federal requirements, including but not limited to such minimum standards of the Centers for Disease Control and Prevention (CDC), Environmental Protection Agency (EPA), and United States Department of Labor’s Occupational Safety and Health Administration (OSHA).

Recognizing the dynamic and fluid nature of state and federal guidance on preventing the spread of COVID-19, the Interim Guidance notes that the Standards are based on the “best-known public health practices” and cautions all dental practices to understand that such practices — and presumably the Standards themselves — “change frequently.” Therefore, dentists should regularly monitor the DOH website for any updates to the Interim Guidance.

The Standards include practices that are well known to reduce the spread of COVID-19, such as:

  • Requiring physical distancing of at least six feet in every direction in all waiting areas, reception areas, and elevator entrances and other spaces where individuals tend to congregate;
  • Installing physical barriers when adequate distancing is not possible;
  • Limiting elevator density; and
  • Using signage to reduce bi-directional traffic and to otherwise remind all employees, patients, and visitors to engage in best practices (g., social distancing, face coverings and hand washing) to reduce the spread of the disease.

The Standards further require that providers:

  • Limit gatherings in enclosed spaces (g., restrooms and break rooms);
  • Take measures to reduce interpersonal contact and congregation (g., limiting in-person staff present, adequate time between patients, and limiting the number of patients on the schedule); and
  • Limit on-site interactions (g., require employees to remain near their workstations).

On cleaning and disinfection, the Standards require that dental practices “wait at least 15 minutes” after completion of a dental visit to allow potential contagious droplets to fall from the air prior to disinfecting. Inasmuch as dental practices are required to clean and disinfect between each patient visit, this requirement will limit significantly the capacity to service patients.

According to the Standards, dental practices “must ensure that patients and visitors wear face coverings at all times, except when undergoing a dental procedure,” and require all employees to wear appropriate personal protective equipment when providing care in accordance with OSHA standards. For aerosol-generating procedures, the provider’s personnel must wear a properly fit-tested, NIOSH-certified, disposable N95 or higher rated respirator, as well as eye protection, gloves, and gowns.

On screening and testing, dental practices must implement mandatory health screening practices of employees, patients, and visitors, including through remote (e.g., telephone or text) processes. Dental practices must notify the local health department of confirmed positive cases COVID-19 and be prepared to cooperate with the local health department’s contact tracing efforts.

While dental practices are accustomed to taking precautions, they should become familiar with the added DOH requirements by reviewing the Interim Guidance and continuing to monitor for changes to the Standards.

Reopening orders contain extensive requirements creating compliance issues that can vary significantly depending on the specific state or local jurisdiction. Jackson Lewis attorneys are closely monitoring updates and changes to legal requirements and guidance and are available to help employers weed through the complexities involved with state-specific or multistate-compliant plans.

If you have questions or need assistance, please reach out to the Jackson Lewis attorney with whom you regularly work, or any member of our COVID-19 team.

New York State Nursing Home, Adult Care Facility Staff Testing, Certification of COVID-19 Compliance

New York Governor Andrew Cuomo’s Executive Order No. 202.30 (EO 202.30) implements significant changes for nursing homes (NHs) and adult care facilities (ACFs) in the state, including the testing of all personnel for COVID-19 twice a week.

The changes include:

  • NHs and ACFs must test or arrange testing all personnel, including all employees, contract staff, medical staff, operators, and administrators, for COVID-19 twice per week. The facility’s implementation plan must be filed with the Department of Health (DOH) no later than 5:00 p.m. on May 13, 2020. Reportedly, filing may be done by a survey in the Health Electronic Response Data System application on the Health Commerce System.
  • The operator and the administrator of all NHs and ACFs must submit to the DOH a certification of compliance with EO 202.30, all other applicable Executive Orders, and the directives of the Commissioner of Health. This Certification must be filed with the DOH no later than May 15, 2020.
  • Any NH/ACF personnel who refuse to be tested will be considered to have outdated or incomplete health assessments and, therefore, be prohibited from providing services within the NH or ACF.
  • General hospitals must perform a diagnostic test for COVID-19 and obtain a negative result before discharging a patient to a NH and the NH operator or administrator must certify it is able to properly care for such patient before any discharge from a general hospital to a NH.

DOH Guidance

The DOH has issued Dear Administrator Letter (DAL) ACF #20-14 / NH-20-07 to provide additional guidance on the testing and certification requirements.

The DAL requires positive test results be reported to the DOH by 5:00 p.m. the day following the receipt of the test results and the personnel must remain at home in accordance with DOH guidelines and those of the Local Health Department (unless the local requirements are inconsistent with DOH guidelines). The current guidelines provide that asymptomatic employees are ineligible to return to work for 14 days from the date of the first positive test, and symptomatic employees may not return to work until 14 days after the onset of symptoms, provided at least 72 hours have passed since resolution of fever without the use of fever-reducing medications and respiratory symptoms are improving.

The DAL also confirms that a NH/ACF may conduct the testing itself, contract for testing, or direct personnel to community test sites, although if it directs personnel elsewhere, the NH/ACF must implement procedures to obtain the test results to remain in compliance with EO 202.30. The DAL also provides the certification form that must be submitted by May 15th.

The DOH’s FAQ #1, among other things, clarifies that employees working at NH/ACF three days per week or less need only be tested once per week and that the testing requirement does not apply to home health and hospice agency staff serving patients who reside in a NH/ACF. It also points out that employees who have documentation of a positive diagnostic test for COVID-19 or a positive serologic test for IgG against SARS-CoV-2 are exempt from the testing requirement.

Critically, the FAQ states that NHs/ACFs are responsible for providing testing for their employees, including the costs of testing. While the DOH points out that a NH/ACF may be able to make use of community testing sites operated by the state at no charge, this raises administrative, legal and indirect cost issues that may preclude it being a realistic option.

New Jersey Executive Directive Requires Testing Protocols at Certain Healthcare Facilities

The New Jersey Department of Health (DOH) has issued an Executive Directive (ED) requiring all licensed long-term care facilities, assisted living residences, comprehensive personal care homes, residential healthcare facilities, and dementia care homes to implement testing and response protocols by May 19, 2020. Although many facilities likely have already implemented crisis response protocols, the ED mandates the specific contents of any such protocol. Read more.

Class Action Suit Claims ADA Requires Public Accommodation to Prevent Spread of COVID-19 at Facility

Despite significant legal obstacles, a group of plaintiffs filed a class action complaint alleging the Queens Adult Care Center violated Title III of the Americans with Disabilities Act and its precursor, Section 504 of Rehabilitation Act, by failing to provide a level of care to safeguard their health and safety at its assisted living facility during the COVID-19 pandemic. Read more here.

CMS Issues Guidance for Healthcare Services Preparing to Reopen Following COVID-19

As the public health emergency from the COVID-19 pandemic eases and some states begin to open the economy, physician practices and other health care services will begin to prepare to welcome their patients back to their offices to provide non-COVID-19 health care services. In anticipation of the re-opening, the Centers for Medicare and Medicaid Services (CMS) has issued updated guidance for healthcare providers previously restricted from providing non-essential healthcare as reopen and transition to in-person care for non-emergent, non-COVID-19 conditions.

Generally, CMS recommends that providers evaluate their access to and availability of PPE, availability of their workforce, facility readiness, and COVID-19 testing capacity as they strive to protect patients’ safety as they resume the provision of non-essential health care services once state or local restrictions are lifted (referred to herein as the Gating Criteria). Healthcare providers should consider the following key factors as they begin to reopen to the general public to minimize the risk of contagion and assure patients and staff are safe and comfortable while seeking care at the office.

  • Telehealth: Is the practice prepared to provide services through telehealth modalities? Even as the pandemic slows and the economy begins to open, the CMS waivers expanding the authorized use of telehealth remain in effect, permitting practices to offer non-COVID-19 services through telehealth. CMS continues to strongly encourage use of telehealth modalities whenever possible, even as providers resume in-person care and services, to minimize unnecessary possibility of exposure and maximize patient and staff safety.
  • Operational preparedness: Consider triage protocols to determine which patients may or should be seen in person in the office. How many appointments will be scheduled? Continue to operate with waiting rooms, adopt “wait in vehicles” mandates, or bring patients directly to examination rooms? Do waiting rooms need to be re-configured to accommodate social-distancing mandates?
  • Outward-facing protocols: What do patients need to know before they arrive or as a condition of arriving at your office? For instance, will patients be required to take their temperature before arriving for appointments, be COVID-19 symptom-free, wear masks or other PPE upon arrival, or be permitted to bring someone with them?
  • Informed Consent: Although informed consent typically addresses the risks and benefits of a particular treatment or procedure for a medical condition, the COVID-19 pandemic introduces additional risks of seeking that treatment or procedure that are unrelated to the patient’s underlying condition, the procedure, or the treatment therefor. Should informed consent forms include the risk of exposure to COVID-19 as a risk of the treatment or procedure sought for a non-COVID-19 condition where the risk is realized only if the patient seeks in-person care? As the pandemic slows and the declarations of emergency abate, consider your informed consent processes. Will you require patients seeking non-COVID care and treatment to sign a consent for treatment that includes the risk of COVID-19 contagion?
  • Workforce: Consider whether and how employees should be tested for COVID-19 before returning to work or be temperature-checked daily prior to arriving at work. Establish protocols precluding employees with symptoms from reporting to the workplace.
  • Environment of care. Healthcare providers must assure robust protocols for cleaning and disinfecting examination and procedure rooms, equipment, and common areas to assure patient and staff safety. Are there sufficient environmental services staff duly qualified, trained, and available?
  • Surge capacity. Even as the pandemic eases and Gating Criteria are met, as long as no effective vaccine or treatment is available, the risk of capacity surges remains. Healthcare providers need to assure that their supplies of PPE, medication, equipment, and other relevant office supplies remain adequate if there is a need to respond to a potential surge.

Finally, even as in-person health care services become available to the public, healthcare providers are encouraged to develop contingency plans to address further disruptions to non-essential services should the public health emergency needs re-emerge.

Please contact a Jackson Lewis attorney with any questions about the CMS Guidance or other issues.

Guidance Released on Seeking Reimbursement for COVID-19 Testing and Treatment to Uninsured Individuals

The Families First Coronavirus Response Act, enacted on March 18, 2020, appropriated $1 billion to reimburse providers for conducting COVID-19 testing for the uninsured. In addition, part of the $100 billion Provider Relief Fund established by the Coronavirus Aid, Relief, and Economic Security Act, enacted on March 27, 2020, will be used to reimburse hospitals and other health care providers for expenses related to the treatment of uninsured individuals with COVID-19.

The Health Resources & Services Administration (HRSA) released guidance on the claims reimbursement process under the COVID-19 Uninsured Program (Program) and opened the COVID-19 Uninsured Program Portal. The timeline for implementation of the claims process is as follows:

  • April 27 – Sign up period begins for the program
  • April 29 – On Demand training starts
  • May 6 – Begin submitting claims electronically
  • Mid-May – Begin receiving reimbursement

Eligibility Requirements

Eligible claims include qualifying testing for COVID-19 and treatment services with a primary COVID-19 diagnosis, performed on or after February 4, 2020. This includes the following:

  • Specimen collection, diagnostic and antibody testing.
  • Testing-related visits, including in the following settings: office, urgent care, emergency room or via telehealth.
  • Treatment, including office visit (including via telehealth), emergency room, inpatient, outpatient/observation, skilled nursing facility, long-term acute care, acute inpatient rehab, home health, DME (e.g., oxygen, ventilator), emergency ground ambulance transportation, non-emergent patient transfers via ground ambulance, and FDA-approved drugs as they become available for COVID-19 treatment and administered as part of an inpatient stay.
  • FDA-approved vaccine, when available.

For inpatient claims, the date of admittance must be on or after February 4th. Services not covered by traditional Medicare will not be covered under the Program. In addition, the following services are excluded:

  • Any treatment without a COVID-19 primary diagnosis, except for pregnancy when the COVID-19 code may be listed as secondary.
  • Hospice services.
  • Outpatient prescription drugs.

A provider on the U.S. Department of Health and Human Services, Office of the Inspector General list of excluded individuals/entities and/or any provider who has had their Medicare enrollment revoked by the Centers for Medicare & Medicaid Services is ineligible to receive funding, directly or indirectly, from the Program.

Claims Processing

The HRSA has contracted with UnitedHealth Group to administer the Program. Claims must be submitted electronically and will generally be reimbursed at Medicare rates, subject to available funding. The required steps include: enrolling as a provider participant, checking patient eligibility, submitting patient information, submitting claims, and receiving payment via direct deposit. Providers will be required to attest to the following:

  • The provider has checked for health care coverage eligibility and confirmed that the patient is uninsured.
  • The provider will accept the Program reimbursement as payment in full.
  • The provider agrees not to balance bill the patient.
  • The provider agrees to the Program terms and conditions and acknowledges that payment is made subject to potential post-reimbursement audit review.

All claims submitted must be complete and final and no interim bills or corrected claims will be accepted. There will be no adjustments to payment once claims reimbursements are made. Additional information regarding reimbursement rates can be found here.

For additional guidance on this issue, please contact a Jackson Lewis attorney.