Hospitals, Psychiatric Hospitals, and Critical Access Hospitals (CAHs), including Cancer Centers and Long-Term Care Hospitals (LTCHs)

Title

Regulation or Statute

Provisions

Emergency Medical Treatment & Labor Act (EMTALA)

42 U.S.C. 1395dd(a)

Waives enforcement of 42 U.S.C. 1395dd(a), which requires emergency departments to screen patients in the emergency department to determine if an emergency condition exists. The waiver allows this screening to take place offsite.

Verbal Orders.

42 CFR §482.23(c)(3)(i)

Waives requirement that verbal orders for drugs be used “infrequently.”

Verbal Orders.

42 CFR §482.24(c)(2)

Waives requirement under 42 CFR §482.24(c)(2) that that the ordering practitioner promptly authenticate and document all orders, including verbal orders. Essentially, waiver goes beyond verbal orders to all orders.

Verbal Orders.

42 CFR §482.24(c)(3)

Waives the following requirements for pre-printed and standing orders, specifically that the hospital (i) establish that the orders have been approved by medical, pharmacy, and nursing leadership; (ii) demonstrate that such orders are consistent with nationally recognized and evidence-based guidelines; (iii) ensure that the orders are periodically reviewed; and (iv) ensures that such orders and protocols are dated, timed, and authenticated promptly.

Verbal Orders.

42 CFR §485.635(d)(3)

Waives the requirement that medication administration by nurses be based on written, signed orders, though retains requirement that a practitioner responsible for the care of the patient must authenticate the order in writing as soon as possible after the fact.

Reporting Requirements

42 CFR §482.13(g) (1)(i)-(ii)

Waives requirement that hospitals report patients in an intensive care unit whose death is caused by their disease, but who required soft wrist restraints to prevent pulling tubes/IVs, no later than the close of business on the next business day. Retains the requirement, however that hospitals report where the patient’s restraints may have contributed to the patient’s death.

Patient Rights.

42 CFR §482.13(d)(2); 42 CFR

§482.13(h); 42 CFR §482.13(e)(1)(ii)

For hospitals located in a state which has 51 or more COVID-19 cases only, waives requirement that hospital (i) must provide patient access to medical records within a “reasonable” time frame; (ii) must have a visitation policy (waived for COVID-19 patients only); (iii) may only seclude patients for “management of violent or self-destructive behavior.”

Sterile Compounding.

42 CFR §482.25(b)(1) and 42 CFR

§485.635(a)(3)

Waives requirements regarding the compounding area in order 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.

Detailed Information Sharing for Discharge Planning for Hospitals and CAHs; Limiting Detailed Discharge Planning for Hospitals.

42 CFR §482.43(a)(8), 42 CFR

§482.61(e), and 42 CFR

§485.642(a)(8)

Waives the more onerous requirements of the specified regs such that the relevant standard for discharge planning is broadly that a patient is discharged to an appropriate setting with the necessary medical information and goals of care as described in 42 CFR

§482.43(a)(1)-(7) and (b).

Medical Staff

42 CFR §482.22(a)(1)-(4)

Waives requirements relating to credentialing for physicians in order to allow increase the population of available physicians.

Medical Records

42 CFR §482.24(a)-(c);

Waives form and staffing requirements relating to medical records in order to reduce the time burden for records and increase staffing flexibility. Note that while the particulars are waived, records will still need to be maintained under 42 CFR §482.24.

Flexibility in Patient Self Determination Act Requirements (Advance Directives)

42 USC 1396(a)(58); 42 U.S.C.

1396a(w)(1)(A); 42 U.S.C. 1395w–

22(i); 42 U.S.C. 1395cc(f); 42 CFR

§489.102

Waives requirement to provide information about advance directive policies to patients under Medicare, Medicaid, and Medicare Advantage regs and statutes.

Physical Environment

42 CFR §482.41; 42 CFR §485.623

Allows non-hospital buildings and spaces to be used for patient care and quarantine provided that the location is approved by the state. Essentially, waives the federal approval requirements.

Telemedicine.

42 CFR §482.12(a) (8) – (9); 42 CFR

§485.616(c)

Waives certain contractual requirements as relates to the provision of telemedicine by distant site hospitals, more specifically waiving the requirement that the distant site certifies in a written agreement they comply with the rest of 42 CFR §482.12 (a)(1) – (7). Technically, written telemedicine requirement of 485.12 and 285.616 waived entirely.

Physician Services.

42 CFR §482.12(c)(1)– (2), (4)

Waives requirement that all Medicare patients be under the care of a physician, so long as waiver is not inconsistent with a state’s emergency preparedness or pandemic plan.

Anesthesia Services.

42 CFR §482.52(a)(5); 42 CFR

§485.639(c)(2); 42 CFR §416.42 (b)(2)

Waives requirement that CRNA’s must be under the supervision of a physician to administer anesthesia. CRNA supervision will be at the discretion of the hospital and state law.

Utilization Review.

42 CFR §482.1(a)(3); 42 CFR

§482.30

Waives the entire utilization review condition of 42 CFR 482.30.

Written Policies and Procedures for Appraisal of Emergencies at Off Campus Hospital

Departments.

42 CFR §482.12(f)(3)

Waives requirement that written policies are in place before a hospital can utilize an off- campus facility. Waiver applies to surge facilities only (e.g. in a state with 50+ COVID-19 patients).

Emergency Preparedness Policies and Procedures.

42 CFR §482.15(b), (c) (1-5); 42 CFR

§482.625(b), (c)(1-5)

Waives requirement that hospitals and CAHs develop and implement emergency communications and preparedness policies and procedures for surge sites.

Quality Assessment and Performance Improvement Program.

42 CFR §482.21(a)–(d), (f); 42 CFR

§485.641(a), (b), (d)

Waives requirements the hospitals provide details on the scope of the hospital’s Quality Assessment and Performance Improvement Program, the incorporation, and setting priorities for the program’s performance improvement activities, and integrated Quality Assurance & Performance Improvement programs (for hospitals that are part of a hospital system). While certain requirements are waived, hospitals must maintain an effective, ongoing plan.

Nursing Services

42 CFR §482.23(b)(4), (7)

Waives requirement that hospital nursing staff have a nursing care plan for each patient and that the hospital have policies and procedures in place regarding which outpatient departments have an RN present.

Food and Dietetic Services

42 CFR §482.28(b)(3)

Removes requirement that “A current therapeutic diet manual approved by the dietitian and medical staff must be readily available to all medical, nursing, and food service personnel.”

Respiratory Care Services

42 CFR §482.57(b)(1)

Waives requirement that hospitals designate personnel qualified to perform certain respiratory care procedures in writing.

CAH Personnel Qualifications.

42 CFR §485.604(a)(2); 42 CFR

§485.604(b)(1)– (3); 42 CFR

§485.604(c)(1)–(3).

Waives federal minimum personnel qualifications for clinical nurse specialists, nurse practitioners, and physician assistants in CAHs. Individuals must still meet state licensure requirements.

CAH Staff Licensure

42 CFR §485.608(d)

Waives federal minimum personnel qualifications for CAH staff. State and local restrictions would still apply.

CAH Status and Location

42 CFR §485.610(b); 42 CFR

§485.610(e);

Waives CAH site location requirements to allow CAH’s to establish non-rural temporary off-site locations.

CAH Length of Stay

42 CFR §485.620.

Waives requirements that CAHs limit the number of beds to 25, and that the length of stay be limited to 96 hours with regards to inpatients.

Temporary Expansion Locations

42 CFR§ 482.41; 42 CFR §485.623;

42 CFR §413.65

Waives certain requirements to allow hospitals to establish and operate as part of the hospital any location meeting those conditions of participation for hospitals that continue to apply during the duration of the COVID-19 PHE. Further allows hospitals to change the status of current provider-based department locations to address the needs of patients.

Housing Acute Care Patients in the IRF or Inpatient Psychiatric Facility (IPF) Excluded Distinct Part Units

No citation.

Allows 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. Hospital IPSS should be annotated to reflect patient’s status.

Care for Excluded Inpatient Psychiatric Unit Patients in the Acute Care Unit of a Hospital

No citation.

Allows 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 as a result of a disaster or emergency. IPFPSS should be annotated to reflect patient’s status. Must assess acute care beds for suitability for psychiatric patients.

Care for Excluded Inpatient Rehabilitation Unit Patients in the Acute Care Unit of a Hospital

No citation.

Allows acute care hospitals with excluded distinct part inpatient rehabilitation units that, as a result of a disaster or emergency, to relocate inpatients from the excluded distinct part rehabilitation unit to an acute care bed and unit as a result of this PHE. Hospital billing should be annotated to reflect status and beds should be appropriate to allow patients to continue to receive intensive rehabilitation services.

Flexibility for Inpatient Rehabilitation Facilities (“IRF”) Regarding the “60 Percent Rule”

No citation.

Allows IRFs to exclude patients from the freestanding hospital’s or excluded distinct part unit’s inpatient population for purposes of calculating the applicable thresholds associated with the requirements to receive payment as an IRF (commonly referred to as the “60 percent rule”) if an IRF admits a patient solely to respond to the emergency and the patient’s medical record properly identifies the patient as such.

Extension for Inpatient Prospective Payment System (IPPS) Wage Index Occupational Mix Survey Submission

No citation.

Grants an extension for hospitals to report certain surveys until August 3, 2020.

Supporting Care for Patients in Long-Term Care Acute Hospitals

(LTCHs)

No citation.

Allows a LTCH to exclude patient stays where an LTCH admits or discharges patients in order to meet the demands of the emergency from the 25-day average length of stay requirement.

Care for Patients in Extended Neoplastic Disease Care Hospitals

42 U.S.C. 1395ww; 42 CFR

§412.22(i)

Allows neoplastic disease care hospitals to exclude inpatient stays where the hospital admits or discharges patients in order to meet the demands of the emergency from the greater than 20-day average length of stay requirement.

Hospice

Waive Requirement for Hospices to Use Volunteers.

42 CFR §418.78(e)

Waves requirement for hospices to use volunteers.

Comprehensive Assessments.

42 CFR §418.54

Waives the time frames for the comprehensive assessment of patients. Does not waive the assessments themselves, however the timeframe has been extended from 15 to 21 days.

Waive Non-Core Services.

42 CFR §418.72

Waives requirement for hospice to provide physical and occupational therapy as well as speech-language pathology.

Waived Onsite Visits for Hospice Aide Supervision.

42 CFR §418.76(h)

Waives requirements for nurses to conduct an onsite supervisory visit every two weeks.

General Provisions

Practitioner Locations

No citation.

Temporarily waives requirements that out-of-state practitioners be licensed in the state where they are providing services when they are licensed in another state if practitioner:

  1. is enrolled in the Medicare program;

  2. possesses a valid license to practice in the state which relates to his or her Medicare enrollment;

  3. 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 or her professional capacity; and

  4. is not affirmatively excluded from practice in the state or any other state that is part of the 1135 emergency area.


Note that state licensure requirements will still apply unless they are waived by the state.

Provider Enrollment

42 CFR §424.517-518;

Establishes a toll-free hotline for physicians and other qualifying providers to receive temporary Medicare billing privileges. CMS is also waiving certain requirements (Application fee, criminal background check; site visit), and taking certain liberties to increase the number of available physicians (allowing early termination of opt-out status; liberties with telehealth billing.)

Medicare Appeals in Fee for Service (FFS), Medicare Advantage (MA) and Part D

42 CFR §422.561;42 CFR §422.562;

2 CFR §423.560; 42 CFR §423.562;

42 CFR §422.582; 42 CFR §423.582;

42 CFR §405.910; 42 CFR §405.950 and 42 CFR §405.966

Allows certain qualifying entities certain allowances with regards to the appeals process, including waiving deadlines and requests for additional information to process appeals. Generally, allows contractors to utilize all flexibilities available in the appeal process as if good cause requirements are satisfied.

Medicaid and CHIP (as of 3/13/2020)

No citation.

Creates a waiver checklist for states to use to receiver federal waivers and implement flexibilities.

Blanket Waivers of Sanctions under the Physician Self-Referral Law (also known as the “Stark Law”)

2 U.S.C. 1320b–5; 42 U.S.C. 1395nn

Effective March 1, 2020, grants a blanket waiver for Stark Law compliance with regards to payments for certain COVID-19 purposes. For more information, see here: https://www.cms.gov/files/document/covid-19-blanket-waivers-section-1877g.pdf

Blanket Waivers: Stafford Act, Public Health Emergency (PHE) and Section 1135 Waivers

2 U.S.C. 1320b–5

Outlines HHS’s waiver authority: provides procedures to seek additional waivers.