​A member asked for information about federal rules that have been temporarily modified or waived to help healthcare facilities and providers respond to the COVID-19 pandemic. In our response, we summarized actions by federal agencies to ease restrictions on federal laws affecting healthcare facility and provider response to the pandemic.

Centers for Medicare and Medicaid Services

Under Section 1135 of the Social Security Act, the Department of Health and Human Services (HHS) secretary is permitted to modify or waive Medicare, Medicaid, and Children's Health Insurance Program requirements if the following circumstances exist (CMS "1135 Waiver"):

• The president has declared a disaster or national emergency under the Stafford Act or National Emergencies Act
• The HHS secretary has declared a public health emergency under Section 319 of the Public Health Service Act

Examples of 1135 waivers include the following (CMS "1135 Waiver"):

• Modifications to the conditions of participation for the Medicare and Medicaid programs
• Modifications to licensing requirements for physicians and other healthcare professionals
• Removal of sanctions under the Emergency Medical Treatment and Labor Act (EMTALA) to give hospitals flexibility in the management of emergency department resources for the screening and treatment of patients affected by the emergency situation (an EMTALA waiver is effective only if the hospital's actions do not discriminate based on an individual's source of payment or ability to pay)

Waivers can vary. Some are called "blanket waivers" and are issued when CMS has determined that all similarly situated providers in an identified emergency area need such a waiver or modification (CMS "1135 Waiver"), as in the case of the COVID-19 pandemic. Other waivers can be issued on a case-by-case basis, such as in response to state requests for waivers from certain Medicaid requirements.

CMS posted a list of blanket waivers applicable during the COVID-19 emergency on its website after issuing an interim final rule on the waivers and announcing its actions in a March 30, 2020, news release. Examples of 1135 waivers applicable to hospitals include the following (CMS "Hospitals"):

• Provisions to allow hospitals to operate temporary expansion sites where inpatient care can be provided, such as in hotels and school dormitories, to separate COVID-19-positive patients from non-COVID-19 patients
• Greater flexibility to admit hospital patients receiving medical care to distinct part units at the hospital (e.g., psychiatry unit, rehabilitation unit), which are typically excluded from Medicare's inpatient prospective payment system
• Provisions for hospitals, laboratories, and other entities to perform COVID-19 testing on people at home and in other community-based settings outside of the hospital
• Permission to direct individuals to an off-site location for COVID-19 testing without incurring EMTALA sanctions, provided the hospital's approach to redirecting individuals for medical screening is consistent with its state's emergency preparedness plan (CMS provided additional guidance on hospitals' EMTALA compliance obligations during the COVID-19 pandemic in a separate memo to state surveyors)
• Easing of critical access hospital limits on permissible number of beds and patient lengths of stay
• Easing of some telehealth requirements (e.g., credentialing and privileging agreements for telehealth physicians and practitioners treating patients in critical access hospitals) to increase patients' access to care
• Waiving of medical staff requirements to allow for physicians whose privileges will expire to continue practicing at the hospital and for new physicians to be able to practice in the hospital before full medical staff/governing body review and approval
• Permission for certified registered nurse anesthetists to practice to the fullest extent of their licensure without the supervision of a physician provided the waiver is consistent with the state's pandemic/emergency plan

CMS also provided lists of blanket waivers for physicians and other practitioners, skilled nursing facilities, home health agencies, inpatient rehabilitation facilities, and more.

Some of the provisions for physicians, home health agencies, hospice programs, and inpatient rehabilitation facilities include greater flexibility for clinicians to use telehealth to conduct face-to-face interactions with patients. Providers can also offer certain services to beneficiaries at home over the phone.

The blanket waivers are in effect from March 1, 2020, through the end of the president's emergency declaration.

HHS Office for Civil Rights

HHS Secretary Alex Azar used HHS's 1135 waiver authority to ease some restrictions to the privacy provisions of the Health Insurance Portability and Accountability Act (HIPAA). The action, effective March 15, 2020, means that the HHS Office for Civil Rights (OCR) will not levy penalties and sanctions against covered hospitals for failure to comply with the following provisions of the HIPAA privacy rule:

• Requirements to obtain a patient's agreement to speak with family members or friends involved in the patient's care (45 CFR § 164.510[b])
• Requirement to honor a request to opt out of the facility directory of individuals in its facility (45 CFR § 164.510[a])
• Requirement to distribute a notice of privacy practices (45 CFR § 164.520)
• Patient's right to request privacy restrictions (45 CFR § 164.522[a])
• Patient's right to request confidential communications (45 CFR § 164.522[b])

OCR also announced on March 17, 2020, that, effective immediately, it was easing some HIPAA privacy restrictions to allow for telehealth consultations that use non-public-facing audio or video communication products, such as FaceTime and Skype, during the COVID-19 pandemic. OCR said it would not impose penalties for HIPAA violations against healthcare providers who use these services "in good faith" for telehealth consults.

HHS Office of Inspector General

To encourage the use of telehealth consults, HHS's Office of Inspector General (OIG) issued a policy statement on March 17, 2020, indicating that physicians and other practitioners will not be subject to sanctions for waiving beneficiary cost-sharing payments for visits paid for by federal healthcare programs. Ordinarily, physicians and other practitioners could be subject to penalties for violating federal antikickback statutes if they waive beneficiaries' coinsurance and deductibles for telehealth visits with the provider.

Occupational Safety and Health Administration

The U.S. Department of Labor's Occupational Safety and Health Administration (OSHA) issued on March 14, 2020, temporary enforcement guidance for its annual fit-testing requirement in its respiratory protection standard for healthcare workers. The guidance recommends that healthcare employers switch to a qualitative or nondestructive fit-testing method from the destructive quantitative method to preserve the supply of N95 respirators or masks. The guidance took effect immediately.

OSHA will not cite employers for violations of the annual fit-testing requirement as long as they adhere to certain practices, such as the following:

• Use only respirators certified by the National Institute for Occupational Safety and Health
• Implement strategies recommended by OSHA and the Centers for Disease Control and Prevention for optimizing and prioritizing N95 respirators
• Perform initial fit tests for each healthcare employee with the same model, style, and size respirator that the employee will be required to wear for protection from coronavirus
• Tell employees that the employer is temporarily suspending the annual fit testing of N95 respirators to preserve the supply for use in situations where they are required to be worn
• Explain to employees the importance of conducting a fit check after putting on a respirator to ensure an adequate seal

The recommendations contained in Ask ECRI do not constitute legal advice. Facilities should consult legal counsel for specific guidance and develop clinical guidance in consultation with their clinical staff.