Permission to Get It Done: CMS Issues Sweeping Regulatory Waivers to Promote Action

CMS issued a series of new temporary blanket waivers offering our healthcare system some badly needed flexibility to address COVID-19.  These waivers apply automatically to all applicable providers and suppliers. Highlights of the key new blanket waivers for hospitals and physicians/other practitioners follow below. Please note that this list is not exhaustive of all possible waivers.

As a reminder, providers do not need to apply for an individual waiver if a blanket waiver has been issued by CMS.  Please contact Advis for assistance regarding requests not covered by a blanket waiver.

CMS also issued blanket waivers for other provider types, including: ambulances; teaching hospitals/physicians; long term care facilities; home health agencies; hospices; inpatient rehabilitation facilities; long term care hospitals and extended neoplastic disease care hospitals; rural health clinics and federally qualified health centers; laboratories; end stage renal disease facilities; durable medical equipment; participants in the Medicare Diabetes Prevention program; and Medicare Advantage and Part D plans. 

  • Temporary Expansion Sites: Hospitals may provide hospital services in other healthcare facilities and sites not currently considered to be part of a healthcare facility, or set up temporary expansion sites to help address the need for increased capacity to care for patients.
    • Remote locations may include hotels or other community facilities.
    • Hospitals may provide inpatient and outpatient services at temporary expansion sites.
    • Non-hospital buildings/space used for patient care and quarantine must be approved by the state – certain physical environment Conditions of Participation (“CoPs”) are waived.
  • Medicare Enrollment of Other Institutional Providers as a Hospital
    • Ambulatory Surgery Centers (“ASCs”) that are currently enrolled in Medicare will be permitted to temporarily enroll as hospitals and to provide hospital services.
    • Other entities (e.g., freestanding emergency departments) can enroll as an ASC and then convert their enrollment to hospital status.
    • ASCs should contact the COVID-19 Provider Enrollment Hotline to enroll and receive hospital billing privileges.
  • EMTALA: CMS is waiving enforcement of the EMTALA medical screening requirement. Hospitals will be permitted to screen patients at an offsite location to prevent the spread of COVID-19 (as long as it is not inconsistent with the state emergency preparedness or pandemic plan).
  • Patient’s Rights/Paperwork: Hospitals located in a state that has widespread confirmed COVID-19 cases (i.e., 51 or more confirmed cases) are not required to meet paperwork requirements under the following:
    • 42 CFR 482.13(d)(2) – Timeframes for providing a copy of a medical record.
    • 42 CFR 482.13(h) – Patient visitation rights, including the requirement to have written policies and procedures on visitation of patients who are in COVID-19 isolation and quarantine processes.
    • 42 CFR 482.13(e)(1)(ii) – Related to seclusion of patients.
  • Provider-based Regulations: The provider-based regulations at 42 CFR 413.65 are waived to allow hospitals to establish and operate as part of the hospital in any location meeting the CoPs for hospitals in operation during the public health emergency. Hospitals may change the status of their current provider-based departments to address patient need.
  • Telemedicine: Requirements for hospitals at 42 CFR 482.12(a)(8)-(9) and 42 CFR 485.616(c) are waived. These requirements relate to hospital agreements with distant-site hospitals/telemedicine entities and agreements for credentialing and privileging of telemedicine physicians and practitioners.
  • CAH Status and Location: Requirement that CAH be located in a rural area or area being treated as rural is waived. CAH off-campus and co-location requirements are also waived.  This allows flexibility in establishing surge and off-site locations.
  • Verbal Orders: Requirements of CoPs for nursing services and medical record services related to verbal orders are waived, where read-back verification is still required but authentication may occur later than 48 hours.
  • Reporting Requirements: Waiver of certain CMS reporting requirements related to death of a patient caused by their disease but who required soft wrist restraints to prevent pulling tubes/IVs. Such information may be reported later than the close of business the next day.  However, any death where the restraint may have contributed is continued to be reported within standard time limits.
  • Limit Discharge Planning for Hospital and CAHs: Discharge planning will focus on ensuring patients are discharged to an appropriate setting with necessary medical information and goals of care. Hospitals may not be able to assist patients in using quality measures and data to identify a nursing home or home health agency, but they must still work with families to ensure that discharge is to a post-acute care venue able to meet the patient’s needs.
  • Modify Discharge Planning for Hospitals: Certain discharge planning requirements are waived for patients discharged and referred for home health agency services, or transferred to a SNF, IRF, or LTACH. Patients may not be able to receive a comprehensive list of post-acute venues in the geographic area, but must still be discharged to the venue that is available to provide the needed care.
  • Medical Records: CMS is waiving requirements related to organization and staffing of the medical records department, and requirements for medical record content and retention.
  • Advance Directive Flexibility: Requirement of hospitals to provide information to patients about its advance directive policies to patients is waived.
  • Utilization Review: The entire utilization review CoP, requiring hospitals to have a utilization review plan with a utilization review committee to evaluate the medical necessity of the admission, duration of stay, and services, is waived.
  • QAPI: Certain requirements of the CoPs for QAPI are waived, including details related to the scope of the program, incorporation, setting priorities for QAPI activities, and integration within a hospital system. Improvements to the plan should focus on COVID-19 and the public health emergency.  While the waiver reduces administrative burdens, hospitals are still required to maintain an effective, ongoing, hospital-wide, data-driven QAPI program.
  • Nursing Services: The requirements for nurses to develop and keep current a nursing care plan for each patient is waived. The provision requiring hospitals to have policies and procedures for establishing which outpatient departments are not required to have a registered nurse present is waived.
  • Food and Dietetic Service: The requirement to have a current therapeutic diet manual approved by the dietitian and medical staff readily available to all medical, nursing, and food service personnel is waived. Surge capacity sites would not need to maintain such manuals.
  • Policies and Procedures for Appraisal of Emergencies at Off-Campus Hospital Departments: Policies and procedures for staff to use when evaluating emergencies are not required for surge facilities.
  • Emergency Preparedness Policies and Procedures: The requirement for hospitals to develop and implement emergency preparedness policies and procedures is waived for surge sites.
  • Signature Requirements: CMS is waiving signature and proof of delivery requirements for Part B drugs and DME when a signature cannot be obtained because of inability to collect signature. Suppliers should document in the medical record the date of delivery and that signature was not able to be obtained due to COVID-19.
  • Cost Reporting
    • Filing deadline of fiscal year end 10/31/19 cost reports due March 31, 2020 and fiscal year end 11/30/19 cost reports due April 30, 2020 has been extended to June 30, 2020.
    • Filing deadline of fiscal year end 12/31/19 cost reports due May 31, 2020 has been extended to July 31, 2020.

All waivers allow for qualified professionals to operate to the fullest extent of their state license.

  • Sterile Compounding: Sterile compounding requirements waived 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.
  • Medical Staff Requirements: Various medical staff CoPs waived:
    • Physicians whose privileges will expire may continue practicing at the hospital.
    • New physicians will be able to practice in the hospital before full medical staff/governing body review and approval.
  • Physician Services: Requirement that Medicare patients be under the care of a physician is waived. Other practitioners (e.g., physician’s assistants and nurse practitioners) may be used if not inconsistent with the state’s emergency preparedness or pandemic plan.
  • Anesthesia Services: Waiver of requirements related to supervision of certified registered nurse anesthetists (“CRNAs”). CRNA supervision will be at the discretion of the hospital or ASC and state law.
  • Respiratory Care Services: Requirement that hospitals designate, in writing, personnel qualified to perform specific respiratory care procedures and required supervision is waived (so long as not inconsistent with the state’s emergency preparedness or pandemic plan).
  • CAH Staff Licensure: Staff licensure, certification, or registration is deferred to state law.
  • CAH Personnel Qualifications: Personnel qualifications for clinical nurse specialists, nurse practitioners, and physician assistants are waived (state license requirements are still in place).
  • More than 80 Additional Services to be Furnished by Telehealth: Clinicians can now provide the following additional services by telehealth:
    • Emergency Department Visits, Levels 1-5 (CPT codes 99281-99285)
    • Initial and Subsequent Observation and Observation Discharge Day Management (CPT codes 99217- 99220; CPT codes 99224- 99226; CPT codes 99234- 99236)
    • Initial hospital care and hospital discharge day management (CPT codes 99221-99223; CPT codes 99238- 99239)
    • Initial nursing facility visits, All levels (Low, Moderate, and High Complexity) and nursing facility discharge day management (CPT codes 99304-99306; CPT codes 99315-99316)
    • Critical Care Services (CPT codes 99291-99292) Domiciliary, Rest Home, or Custodial Care services, New and Established patients (CPT codes 99327- 99328; CPT codes 99334-99337)
    • Home Visits, New and Established Patient, All levels (CPT codes 99341- 99345; CPT codes 99347- 99350)
    • Inpatient Neonatal and Pediatric Critical Care, Initial and Subsequent (CPT codes 99468- 99473; CPT codes 99475- 99476)
    • Initial and Continuing Intensive Care Services (CPT code 99477- 994780)
    • Care Planning for Patients with Cognitive Impairment (CPT code 99483)
    • Psychological and Neuropsychological Testing (CPT codes 96130- 96133; CPT codes 96136- 96139)
    • Therapy Services, Physical and Occupational Therapy, All levels (CPT codes 97161- 97168; CPT codes 97110, 97112, 97116, 97535, 97750, 97755, 97760, 97761, 92521- 92524, 92507)
    • Radiation Treatment Management Services (CPT codes 77427)
  • Additional Provider Services to be Paid for as Medicare Telehealth Services: The additional provider services include:
    • Licensed clinical social worker services
    • Clinical psychologist services
    • Physical therapy services
    • Occupational therapist services
    • Speech language pathology services
  • Virtual Check-Ins and E-Visits
    • Clinicians can now provide virtual check-in services to new and established patients (previously limited to established patients) (HCPCS codes G2010, G2012).
    • Licensed clinical social workers, clinical psychologists, physical therapists, occupational therapists, and speech language pathologists can provide e-visits (HCPCS codes G2061-G2063).
    • Physicians and other clinicians can provide certain services by telephone to their established patients (CPT codes 98966-98968; 99441-99443).
  • Remote Patient Monitoring
    • Remote patient monitoring is available to both new and established patients.
    • Service can be provided for acute and chronic conditions and for patients with only one disease.
  • Removal of Frequency Limitations on Medicare Telehealth: The following services have no limitations on the number of times they can be provided by Medicare telehealth:
    • Subsequent inpatient visit can be furnished by telehealth, without the limitation that the telehealth visit is once every three days (CPT codes 99231-99233).
    • Subsequent skilled nursing facility visit can be furnished via telehealth, without the limitation that the telehealth visit is once every 30 days (CPT codes 99307-99310).
    • Critical care consult codes may be furnished to a Medicare beneficiary by telehealth beyond the once per day limitation (CPT codes G0508-G0509).
  • Other Medicare Telehealth
    • If a National Coverage Determination or Local Coverage Determine requires a face-to-face visit for evaluations and assessments, clinicians would not have to meet those requirements during the public health emergency.
    • Beneficiary consent should not interfere with the provision of telehealth services. Annual consent may be obtained at the same time, and not necessarily before, the time that services are furnished.
  • Waives Medicare and Medicaid’s requirements that physicians and non-physician practitioners be licensed in the state where they are providing services (state requirements still apply). The following conditions must be met:
    • Must be enrolled as a physician/non-physician practitioner in the Medicare program;
    • Must possess a valid license to practice in the state which relates to his or her Medicare enrollment;
    • Is furnishing services, whether in person or via telehealth, in a state in which the emergency is occurring and they can provide relief; and
    • Is not affirmatively excluded from practice in the state or any other state that is part of the 1135 emergency area.
  • Toll-free hotlines have been established for physicians, non-physician practitioners, and Part A providers/suppliers establishing isolation facilities to enroll and receive temporary Medicare billing privileges. CMS is providing flexibilities for provider enrollment:
    • Waive certain screening requirements.
    • Postpone all revalidation actions.
    • Allow licensed physicians and other practitioners to bill Medicare for services provided outside of their state of enrollment.
    • Expedite any pending or new applications from providers.
    • Allow practitioners to render telehealth services from their home without reporting their home address on their Medicare enrollment while continuing to bill from your currently enrolled location.
    • Allow opted-out practitioners to terminate their opt-out status early and enroll in Medicare to provide care to more patients.