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New Waivers and Rules to Allow Hospitals to Respond to the COVID-19 Crisis

April 1, 2020

President Trump, through an emergency declaration and rulemaking, has announced temporary changes, in effect for the duration of the emergency, which will allow health systems and their hospitals to have the capacity they require to absorb and manage surges in COVID-19 patients. See, 
https://www.cms.gov/files/document/covid-hospitals.pdf.  The following actions for hospitals may be taken immediately:

  1. Increase in Hospital Capacity via Temporary Sites.  CMS’ “Hospital Without Walls Initiative” allows hospital services to be provided in other healthcare facilities or sites so that COVID-19 patients are isolated to help efforts around infection control and preservation of PPE.  This means that hospitals can set up temporary expansion sites to help address the urgent need to expand capacity to care for patients at remote locations that are not considered part of the facility, such as hotels or community facilities.
     
  2. Relaxing of Conditions of Participation.  CMS is relaxing CoPs allowing hospitals to focus on patient care and enroll ambulatory surgery centers and freestanding emergency departments to enroll as hospitals to address hospital capacity issues on a temporary basis.  Information for ASCs to bill as hospitals can be found at: https://www.cms.gov/files/document/provider-enrollment-relief-faqs-covid-19.pdf
     
  3. Offsite Patient Screening.  CMS is waiving certain EMTALA requirements to allow hospitals, psychiatric hospitals and critical access hospitals to screen patients at a location offsite from the hospital’s campus to prevent the spread of COVID-19 as long as not inconsistent with the state emergency preparedness plan.
     
  4. Paperwork Requirements.  CMS is waiving specific paperwork requirements with respect to: (i) timeframes in providing a copy of a medical record (see 42 CFR §482.13(d)(2)); (ii) patient visitation, including the requirement to have written policies and procedures on visitation of patients who are in COVID-19 isolation and quarantine processes (see 42 CFR §482.13(h)); and (iii)  seclusion (see 42 CFR §482.13(e)(1)(ii)).
     
  5. Physical Environment.  CMS will permit non-hospital buildings/space to be used for patient care and quarantine sites, provided that the location is approved by the State.
     
  6. Temporary Expansion Sites.  CMS is waiving the provider-based rules per 42 CFR §413.65 to allow hospitals to establish and operate as part of the hospital at any location meeting the conditions of participation for hospitals in operation.  This waiver also allows hospitals to change the status of their current provider-based department locations to the extent necessary to address the needs of hospital patients as part of the State or local pandemic plan.
     
  7. Workforce
  • Sterile Compounding.  CMS is waiving hospital sterile compounding requirements 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 to conserve scarce face mask supplies.
     
  • Medical Staff Requirements.  CMS is waiving the Medical Staff requirements at 42 CFR §482.22(a)(1)-(4) 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 to address workforce concerns related to COVID-19.
     
  • Physician Services.  CMS is waiving 42 CFR §482.12(c), which requires that Medicare patients be under the care of a physician.  This allows hospitals to use other practitioners, such as physician assistants and nurse practitioners to the fullest extent possible.
  • Anesthesia Services.  CMS is waiving the requirements at 42 CFR §482.52(a)(5),42 CFR §485.639(c)(2), and 42 CFR §416.42 (b)(2) that a certified registered nurse anesthetist (CRNA) is under the supervision of a physician. CRNA supervision will be at the discretion of the hospital or Ambulatory Surgical Center (ASC), and state law. This waiver applies to hospitals, CAHs, and ASCs.  These waivers will allow CRNAs to function to the fullest extent of their licensure, and should be implemented so long as they are not inconsistent with a State emergency plan.
  • Respiratory Care Services.  CMS is waiving the requirement at 42 CFR §482.57(b)(1) 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.  CMS is waiving the minimum personnel qualifications for clinical nurse specialists, nurse practitioners, and physician assistants described at 42 CFR §485.604 (a)(2), 42 CFR §485.604 (b)(1-3), and 42 CFR §485.604 (c)(1-3). Clinical Nurse Specialists, Nurse Practitioners, and Physician Assistants will still have to meet state requirements for licensure and scope of practice, but not additional Federal requirements that may exceed State requirements.
  • CAH Staff Licensure.  CMS is deferring to staff licensure, certification, or registration to State law by waiving the requirement at 42 CFR §485.608(d) that staff of the CAH be licensed, certified, or registered in accordance with applicable Federal, State, and local laws and regulations.  The CAH and its staff must still be in compliance with applicable Federal, State and Local laws and regulations, and all patient care must be furnished in compliance with State and local laws and regulations.
  1. Critical Access Hospital Length of Stay.  CMS is waiving Medicare rules that the number of beds can be no more than 25 and that the length of stay is no more than 96 hours.  See, 42 CFR §413.620.
  2. CAH Status and Location.  CMS is waiving the requirement at 485.610(b) that the CAH be located in a rural area or an area being treated as rural, allowing the CAHs flexibility in the establishment of surge site locations.  Waiving the requirement at 485.610(e) regarding off-campus and co-location requirements allows the CAH flexibility in establishing off-site locations.
  3. Housing Acute Care Patients in Excluded Distinct Part Units.  CMS is waiving requirements to allow acute care hospitals to house acute care inpatients in excluded distinct part units, where the distinct part unit’s beds are appropriate for acute care inpatients. The Inpatient Prospective Payment System hospital should bill for the care and annotate the patient’s medical record to indicate that the patient is an acute care inpatient being housed in the excluded unit because of capacity issues related to the disaster or emergency.
  4. Care for Excluded Inpatient Psychiatric Unit Patients in the Acute Care Unit of a Hospital.  CMS is waiving requirements to allow acute care hospitals with excluded distinct part inpatient psychiatric units to relocate inpatients from the excluded distinct part psychiatric unit to an acute care bed and unit.  The hospital should continue to bill for inpatient psychiatric services (i.e., IPF PPS) and annotate the medical record to indicate that the patient is a psychiatric inpatient being cared for in an acute care bed because of capacity or other exigent circumstances related to COVID-19.  This waiver may be utilized where the hospital’s acute care beds are appropriate for psychiatric patients and the staff and environment are conducive to safe care.
  5. Care for Excluded Inpatient Rehabilitation Unit Patients in the Acute Care Unit of a Hospital.  CMS is waiving requirements to allow acute care hospitals with excluded distinct part inpatient rehabilitation units to relocate inpatients from the excluded distinct part rehabilitation unit to an acute care bed and unit.  The hospital should continue to bill for inpatient rehabilitation services (i.e., IRF PPS) and annotate the medical record to indicate that the patient is a rehabilitation inpatient being cared for in an acute care bed because of capacity or other exigent circumstances; provided that the hospital’s acute care beds are appropriate for providing care to rehabilitation patients.
  6. Telemedicine.  CMS is waiving the provisions related to telemedicine for hospitals and CAHs at 42 CFR §482.12(a)(8)-(9) and 42 CFR §485.616(c), making it easier for telemedicine services to be furnished to the hospital’s patients through an agreement with an off-site hospital.  This allows for increased access to necessary care for hospital and CAH patients, including access to specialty care.
  7. Verbal Orders.  CMS is waiving the requirements of 42 CFR §482.23, §482.24 and §485.635(d)(3) to allow for additional flexibilities related to verbal orders where read-back verification is still required but authentication may occur later than 48 hours.
  8. Reporting Requirements.  CMS is waiving reporting requirements at 42 CFR §482.13(g) (1)(i)-(ii) which require hospitals to report patients in an intensive care unit whose death is caused by their disease process but who required soft wrist restraints to prevent pulling tubes/IVs, may be reported later than close of business next business day, provided any death where the restraint may have contributed is continued to be reported within standard time limits.
  9. Limit Discharge Planning for Hospitals and CAHs.  CMS is waiving detailed regulatory requirements to provide information regarding discharge planning, as outlined in 42 CFR §482.43(a)(8), §482.61(e), and 485.642(a)(8).  During this public health emergency, a hospital may not be able to assist patients in using quality measures and data to select a nursing home or home health agency, but must still work with families to ensure that the patient discharge is to a post-acute care provider that is able to meet the patient’s care needs.
  10. Modify Discharge Planning for Hospitals.  Patients must continue to be discharged to an appropriate setting with the necessary medical information and goals of care.  However, CMS is waiving certain requirements related to hospital discharge planning for post-acute care services at 42 CFR §482.43(c).  For example, a patient may not be able to receive a comprehensive list of nursing homes in the geographic area, but must still be discharged to a nursing home that is available to provide the care that is needed by the patient.
  11. Medical Records.  CMS is waiving 42 CFR §482.24(a) through (c), which cover the subjects of the organization and staffing of the medical records department, requirements for the form and content of the medical record, and record retention requirements.  CMS is also waiving requirements under 42 CFR §482.24(c)(4)(viii) and §485.638(a)(4)(iii) related to medical records to allow flexibility in completion of medical records within 30 days following discharge and for CAHs that all medical records must be promptly completed.
  12. Flexibility in Patient Self Determination Act Requirements (Advance Directives).  CMS is waiving the requirements at sections 1902(a)(58) and 1902(w)(1)(A) for Medicaid, 1852(i) (for Medicare Advantage), and 1866(f) and 42 CFR §489.102 for Medicare, which require hospitals and CAHs to provide information about its advance directive policies to patients.
  13. Extension for Inpatient Prospective Payment System (IPPS) Wage Index Occupational Mix Survey Submission.  CMS collects data every 3 years on the occupational mix of employees for each short-term, acute care hospital participating in the Medicare program.  CMS is currently granting an extension for data submission for hospitals nationwide affected by COVID-19 until August 3, 2020, or longer as warranted.
  14. Utilization Review.  CMS is waiving these requirements at 42 CFR §482.1(a)(3) and 42 CFR §482.30, that a hospital must have a utilization review (UR) plan with a UR committee that provides for review of services furnished to Medicare and Medicaid beneficiaries to evaluate the medical necessity of the admission, duration of stay, and services provided.
  15. Quality Assessment and Performance Improvement Program.  CMS is waiving 42 CFR §482.21(a)-(d) and (f), and 42 CFR §485.641(a), (b), and (d), which provide details on the scope of the quality assessment and performance improvement (QAPI) program, the incorporation, and setting priorities for the QAPI program’s performance improvement activities, and integrated QAPI programs (for hospitals that are a part of a hospital system).  While this waiver decreases burden associated with the development of a hospital or CAH QAPI program, the requirement that hospitals and CAHs maintain an effective, ongoing, hospital-wide, data driven QAPI program will remain.
  16. Nursing Services.  CMS is waiving the provisions at 42 CFR §482.23(b)(4), 42 CFR §482.23(b)(7), and §485.635(d)(4), which require the nursing staff to develop and keep current a nursing care plan for each patient, and the provision that requires the hospital to have policies and procedures in place establishing which outpatient departments are not required to have a registered nurse present.
  17. Food and Dietetic Services.  CMS is waiving the requirement at 42 CFR §482.28(b)(3) to have a current therapeutic diet manual approved by the dietitian and medical staff readily available to all medical, nursing, and food service personnel.
  18. Written Policies and Procedures for Appraisal of Emergencies at Off Campus Hospital Departments.  CMS is waiving 42 CFR §482.12(f)(3) related to emergency services, with respect to the surge facility(ies) only, such that written policies and procedures for staff to use when evaluating emergencies are not required for surge facilities so long as they are not inconsistent with a state’s emergency preparedness or pandemic plan.
  19. Emergency Preparedness Policies and Procedures.  CMS is waiving 42 CFR §482.15(b) and 42 CFR §485.625(b), which requires the hospital and CAH to develop and implement emergency preparedness policies and procedures, and 42 CFR §482.15(c)(1)-(5) and 42 CFR §485.625(c)(1)-(5) which requires that the emergency preparedness communication plans for hospitals and CAHs to contain specified elements with respect to the surge site.
  20. Signature Requirements.  CMS is waiving signature and proof of delivery requirements for Part B drugs and durable medical equipment when a signature cannot be obtained because of the inability to collect signatures.  Suppliers should document in the medical record the date of delivery and that a signature was not able to be obtained because of COVID-19.
  21. Accelerated/Advance Payments.  In order to increase cash flow to providers impacted by COVID-19, CMS has expanded its current Accelerated and Advance Payment Program to provide necessary funds during the public health emergency to any Medicare provider/supplier who submits a request to the appropriate Medicare Administrative Contractor (MAC).  CMS has extended the repayment of these accelerated/advance payments to begin 120 days after the date of issuance of the payment.  See, www.cms.gov/files/document/Accelerated-and-Advanced-Payments-Fact-Sheet.pdf.
  22. Cost Reporting.  CMS is delaying the filing deadline of certain cost report due dates due 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.
  23. Provider Enrollment.  CMS has established toll-free hotlines for all providers as well as the following flexibilities for provider enrollment:
  • Waive certain screening requirements.
  • Postpone all revalidation actions.
  • Expedite any pending or new applications from providers.
  1. Medicare Appeals in Fee for Service, Medicare Advantage (MA) and Part D.
  • CMS is allowing Medicare Administrative Contractors (MACs) and Qualified Independent Contractor (QICs) in the FFS program 42 CFR §405.942 and 42 CFR §405.962 and MA and Part D plans, as well as the Part C and Part D Independent Review Entity (IREs), 42 CFR §562, 42 CFR §423.562, 42 CFR §422.582 and 42 CFR §423.582 to allow extensions to file an appeal;
  • CMS is allowing MACs and QICs in the FFS program 42 CFR §405.950 and 42 CFR §405.966 and the Part C and Part D IREs to waive requirements for timeliness for requests for additional information to adjudicate appeals; MA plans may extend the timeframe to adjudicate organization determinations and reconsiderations for medical items and services (but not Part B drugs) by up to 14 calendar days if: the enrollee requests the extension; the extension is justified and in the enrollee’s interest due to the need for additional medical evidence from a noncontract provider that may change an MA organization’s decision to deny an item or service; or, the extension is justified due to extraordinary, exigent, or other non-routine circumstances and is in the enrollee’s interest 42 CFR §422.568(b)(1)(i), §422.572(b)(1) and §422.590(f)(1);
  • CMS is allowing MACs and QICs in the FFS program 42 CFR 405.910 and MA and Part D plans, as well as the Part C and Part D IREs to process an appeal even with incomplete Appointment of Representation forms 42 CFR §422.561, 42 CFR §423.560.  However, any communications will only be sent to the beneficiary;
  • CMS is allowing MACs and QICs in the FFS program 42 §CFR 405.950 and 42 CFR §405.966 and MA and Part D plans, as well as the Part C and Part D IREs to process requests for appeal that do not meet the required elements using information that is available 42 CFR §422.562, 42 CFR §423.562; and
  • CMS is allowing MACs and QICs in the FFS program 42 CFR §405.950 and 42 CFR §405.966 and MA and Part D plans, as well as the Part C and Part D IREs, 42 CFR §422.562, 42 CFR §423.562 to utilize all flexibilities available in the appeal process as if good cause requirements are satisfied.
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