CMS Issues Broad Blanket Waivers to Address COVID-19 Surge at Hospitals and Throughout the Entire Health System

In its continued attempt to address the anticipated surge of COVID-19 patients and strain on the U.S. health care system, the Centers for Medicare & Medicaid Services (CMS), on March 30, 2020, issued sweeping new blanket waivers of federal requirements and payment rule changes. These waivers and rules focus on four areas: (i) increasing hospital capacity; (ii) expanding health care workforce; (iii) reducing paperwork; and (iv) promoting telehealth. Although the waivers and rule changes apply to broad range of Medicare suppliers, providers and practitioners, this article focuses on those that impact hospitals and critical access hospitals (CAHs).

The March 30, 2020 blanket waivers and rule changes add to the several narrower waivers issued by CMS earlier in March. The new blanket waivers also incorporate the hundreds of individual waivers granted by CMS for health care providers, state governments, and state hospital associations. Accordingly, states and providers which have not yet submitted individual waiver requests to CMS need not do so in order to take advantage of the additional flexibilities granted under the March 30, 2020 blanket waivers and rule changes.

A summary of the CMS blanket waivers can be found here. The blanket waivers have a retroactive effective date of March 1, 2020, and will stay in effect through the end of the emergency declaration. Please note that, notwithstanding the increased flexibilities afforded by the CMS blanket waivers and rule changes, certain state law restrictions may still apply. Many states and state agencies with jurisdiction over the topics covered by the CMS blanket waivers are issuing companion waivers of related state administrative regulations. Hospitals and other providers should continue to monitor developments at the state level to understand whether and to what extent related state laws or regulations have been waived or modified.

With respect to hospitals and CAHs specifically, some important CMS waivers and rule changes include, but are not limited to:

• EMTALA. Waiver of certain EMTALA requirements which will allow hospitals and CAHs to screen patients at offsite hospital-owned locations to prevent the spread of COVID-19. Additional CMS guidance pertaining to EMTALA requirements during the COVID-19 outbreak can be found here.
• Temporary Expansion Sites. Waiver of requirements under the Conditions of Participation to establish temporary sites in non-hospital buildings/space to be used for inpatient care and quarantine (i.e., "surge sites") for the duration of the public health emergency, which will allow the hospitals to establish and operate (as part of the hospital) remote locations involving room and board, nursing, and other hospital services at these non-traditional sites. The sites must be approved by the state, pursuant to whatever process the state established. CMS is also waiving the provider-based rule requirements for these sites. Some of the physical building requirements in the Conditions of Participation are explicitly waived, although note that parallel state law facility requirements may still apply.
• Telemedicine. Waiver of requirements pertaining to telemedicine service agreements to make it easier for telemedicine services to be furnished to patients through an agreement with an off-site hospital. CMS also significantly expanded its coverage of telehealth services in an effort to lower exposure risks. For additional information regarding federal flexibilities in telemedicine, please see the March 17, 2020 CMS Fact Sheet and the corresponding Frequently Asked Questions.
• Practitioner Licensing. Waiver of requirement that out-of-state practitioners be licensed in the state where they are providing services when they are licensed in another state. CMS waives the physician or non-physician practitioner licensing requirements when the following conditions are met: (1) the practitioner is enrolled in the Medicare program; (2) the practitioner possesses a valid license to practice in the state which relates to the practitioner's Medicare enrollment; (3) the practitioner is furnishing services—whether in person or via telehealth—in a state in which the emergency is occurring in order to contribute to relief efforts in his/her professional capacity; and (4) the practitioner is not affirmatively excluded from practice in the state or any other state. Please note, as stated above, this waiver does not exempt practitioners from state licensure requirements.
• Verbal Orders. Waiver of requirements pertaining to verbal orders such as the requirement that verbal orders be used infrequently and that they be dated, timed, and authenticated promptly by the ordering practitioner (or another practitioner who is responsible for care). Verbal orders still need to be signed, but signature may occur later than 48 hours.
• Reporting Requirements. Waiver of the requirement that hospitals report, patients in an ICU whose death is caused by their disease, but who required soft wrist restraints, no later than the close of business on the next business day. However, any death where the restraint may have contributed to the cause of death must still be reported within standard time limits (i.e., close of business on the next business day following knowledge of the patient's death).
• Patient Rights. Waiver of certain patient rights for hospitals that are considered to be impacted by a widespread outbreak of COVID-19 (states with 51 or more confirmed cases), including timeframes for providing patients with a copy of their medical records. Under the waiver, hospitals are no longer required to have written policies and procedures addressing visitation of patients who are in COVID-19 isolation or the quarantine process. Finally, the waiver removes certain requirements related to patient seclusion.
• Sterile Compounding. Waiver of requirements pertaining to compounding to allow used face masks to be removed and retained in the compounding area to be re-donned and reused during the same work shift in the compounding area only. CMS will not review the use and storage of face masks under these requirements.
• Detailed Information Sharing for Discharge Planning for Hospitals and CAHs. Waiver of requirements pertaining to hospitals and CAHs assisting patients, their families or the patient's representative in selecting a post-acute care provider by using and sharing data including but not limited to HHA, SNF, IRF, and LTCH quality measures and resource use measures. However, CMS is maintaining the discharge planning requirements that ensure a patient is discharged to an appropriate setting with the necessary medical information and goals of care.
• Limited Detailed Discharge Planning for Hospitals. Waiver of requirements that hospitals include in the discharge plan a list of HHAs, SNFs, IRFs or LTCHs that are available to the patient; that hospitals inform the patient of their freedom to choose among participating providers for post-discharge services; and that hospitals identify in the discharge plan any HHA or SNF for which the patient is referred in which the hospital has a disclosable financial interest.
• Medical Staff. Waiver of privileging and credentialing requirements under 42 CFR 482.22(a)(1)-(4) that require the hospital medical staff to periodically review practitioner privileges. This will allow physicians and other practitioners whose privileges expire to continue practicing at the hospital. This waiver also allows new physicians and practitioners to be able to practice before full medical staff/governing body review and approval.
• Medical Records. Waiver of certain requirements related to the staffing of the medical records department, the form and content of the medical record, and record retention timelines. This also waives the requirement that the medical record is completed within 30 days following discharge.
• Advance Directives. Waiver of requirement that hospitals and CAHs provide information about their advance directive policies to patients.
• Physician Services. Waiver of the requirement that Medicare patients be under the care of a physician.
• Anesthesia Services. Waiver of CRNA supervision requirements. Supervision is now at the discretion of the hospital or CAH and state law.
• Utilization Review. Waiver of the entire utilization review ("UR") condition of participation including the requirement for a UR plan and UR committee.
• Written Policies and Procedures for Appraisal of Emergencies of Off-Campus Hospital Departments. Waiver of requirement for written policies and procedures for staff to use to evaluate emergencies. This waiver only applies to surge facilities to remove the burden on hospitals to develop additional policies and procedures for such facilities.
• Emergency Preparedness Policies and Procedures. Waiver of requirements that hospitals and CAHs develop and implement emergency preparedness policies and procedures and waiver of requirement that the emergency preparedness communication plans for hospitals and CAHs contain specified elements with respect to surge sites.
• Quality Assessment and Performance Improvement Programs. Waiver of requirements pertaining to the scope, incorporation, and setting of priorities for the program's performance improvement activities and integrated Quality Assurance & Perform Improvement programs (for hospitals that are part of a system). However, the requirement that hospitals and CAHs maintain an effective, ongoing, hospital-wide, data-driven quality assessment performance improvement program remains.
• Nursing Services. Waiver of requirement that hospital and CAH nursing staff develop and keep current a nursing care plan for each patient. CMS also waived the requirement that the hospitals and CAHs have nursing-related policies and procedures in place regarding outpatient departments.
• Food and Dietetic Services. Waiver of requirement that providers have a current therapeutic diet manual approved by the dietitian and medical staff readily available to all medical, nursing, and food service personnel. Such manuals do not need to be maintained at surge facilities.
• Respiratory Care Services. Waiver of requirement that hospitals designate in writing the personnel qualified to perform specific respiratory care procedures and the amount of supervision required for personnel to carry out specific procedures.
• CAH Personnel Qualifications. Waiver of the minimum personnel qualifications for clinical nurse specialists, nurse practitioners, and physician assistants to allow CAHs to employ individuals in the roles who meet state licensure requirements and provide maximum staffing flexibility.
• CAH Staff Licensure. Waiver of requirement that CAH staff be licensed, certified, or registered in accordance with applicable federal, state, and local laws. CMS will defer to state law for licensure requirements.
• CAH Status and Location. Waiver of the requirement that CAHs be located in a rural area or an area treated as being rural. Waiver of off-campus and co-location requirements, allowing CAHs the flexibility to establish surge facilities.
• CAH Length of Stay. Waiver of requirement that CAHs limit the number of beds to 25, and that the length of stay be limited to 96 hours.

A few other notable measures taken by CMS that affect hospitals and CAHs include:

• Waivers of Sanctions under the Stark Law: CMS has issued a blanket waiver of the Stark Physician Self-Referral Law. The waiver will make it easier for hospitals and other providers of designated health services to arrange for the staff, space, equipment, and supplies needed for the COVID-19 crisis. Under the blanket waiver, CMS will permit (i.e., waive sanctions regarding) certain financial relationships between entities and physicians which result in referrals and the submission of Medicare claims that would otherwise violate the Stark Law. There are a few qualifiers for the waiver. First, the waiver is available only to "financial relationships and referrals" which are "solely" related to "COVID-19 Purposes," which are further defined in the waiver. Second, there can't be "fraud or abuse" involved. Third, the remuneration must be "directly between the entity and: (1) the physician or the physician organization in whose shoes the physician stands under 42 CFR 411.354(c); or (2) the immediate family member of the physician." Guidance on the waiver found here includes a long list of specific financial relationships covered by the waiver. These waivers may be used without notifying CMS.

  Note that the U.S. Department of Health and Human Services Office of Inspector General (OIG) made a similar announcement, stating on March 30, 2020, that it “will carefully consider the context and intent of the parties when assessing whether to proceed with any enforcement action” for conduct that implicates the Civil Monetary Penalties Law and could be subject to OIG administrative enforcement. Importantly, this only applies during the COVID-19 emergency. Here is the announcement.

• Cost Reporting: CMS is delaying the filing deadlines of certain cost report due dates in response to the COVID-19 outbreak. CMS will delay the filing deadline of FYE 10/31/2019 cost reports (due by March 31, 2020) and FYE 11/30/2019 cost reports (due by April 30, 2020). The extended cost report due dates for these October and November FYEs will be June 30, 2020. CMS will also delay the filing deadline of the FYE 12/31/2019 cost reports due by May 31, 2020. The extended cost report due date for FYE 12/31/2019 will be July 31, 2020.

Our Health Law Team is here to help, and continuously monitoring the COVID-19 landscape. For more information please contact your Quarles & Brady attorney or:

• Jon R. Kammerzelt: (608) 283-2438 / jon.kammerzelt@quarles.com
• Lisa A. Lyons: (414) 277-5679 / lisa.lyons@quarles.com
• Bailey Walden: (602) 229-5432 / bailey.walden@quarles.com