The Waivers Era Is Over Now That the End of the Public Health Emergency Is Here

In a memorandum issued by the Centers for Medicare and Medicaid Services (CMS) on May 1, 2023, CMS provided guidance to State Survey Agency Directors related to surveys of Long Term Care (LTC) and Acute and Continuing Care (ACC) providers in light of the expiration of the COVID-19 Public Health Emergency (PHE). The memorandum, among other things, outlines compliance timeframes related to the waivers in place for various providers. Some of the ACC-related waivers ended upon the expiration of the PHE on May 11, 2023 are listed below, and the providers are expected to be in compliance after May 11, 2023:

• Ambulatory Surgical Centers (ASCs)
  • ASCs that were enrolled as a hospital during the PHE must have either (i) notified the CMS Survey and Operations Group (SOG) of their intent to convert back to an ASC on or before May 11or (ii) if an ASC wished to convert to a hospital, it must have submitted a form CMS-855A to begin the hospital enrollment process on or before May 11.
    
• Community Mental Health Centers (CMHCs)
  • The waiver of the requirements relating to (i) Quality Assessment and Performance Improvement (42 CFR § 485.917(a)-(d)); (ii) Provision of Services (42 CRF § 485.918(b)(1)(iii)); and (iii) 40 Percent Rule (42 CFR § 485.918(b)(1)(v)).
• End Stage Renal Disease (ESRD) Facilities
  • The waiver of the requirements relating to (i) Training Program and Periodic Audits for operators of the water/dialysate equipment (42 CFR § 494.40(a)); (ii) Maintenance of CPR Certification in relation to ESRD facilities’ Emergency Preparedness (42 CFR § 494.62(d)(1)(iv); (iii) “On-Time” Patient Assessments (42 CFR § 494.80(b)); (iv) Time Period for Initiation of Care Planning and Monthly Physician Visits (42 CFR §494.90(b)(2) and 42 CFR § 494.90(b)(4)); (v) Dialysis Home Visits to Assess Adaptation and Home Dialysis Machine Designation (42 CFR § 494.100(c)(1)(i)); (vi) Special Purpose Renal Dialysis Facilities Designation Expanded (42 CFR § 494.120); (vii) Dialysis Patient Care Technician (PCT) Certification (42 CFR § 494.140(e)(4)); (viii) Furnishing Dialysis Services on the Main Premises (42 CFR § 494.180(d)); and (ix) Transferability of Physician Credentialing (42 CFR § 494.180(c)(1)).
• Home Health Agencies (HHAs)
  • The waivers that (i) allowed HHAs to perform initial assessments of patients remotely or by record review; (ii) allowed various rehabilitation professionals to perform the initial and comprehensive assessment for all patients receiving therapy services as part of the plan of care; (iii) extended the deadline regarding patients’ clinical records requests and OASIS submissions; (iv) waived the requirements relating to Detailed Information Sharing for Discharge Planning (42 CFR § 484.58(a)); and (v) waived the requirements regarding the Onsite Visits for HHA Aide Supervision (42 CFR § 484.80(h)).
• Hospitals/Psychiatric Hospitals/Critical Access Hospitals (CAHs)
  • The waiver of the requirements relating to (i) the enforcement of section 1867(a) of the Emergency Medical Treatment & Labor Act which allowed the facilities to screen patients at a location offsite from the hospital’s campus; (ii) Verbal Orders; (iii) Reporting Requirements (42 CFR § 482.13(g)(1)(i)-(ii)); (iii) Patient Rights (42 CFR § 482.13); (iv) Sterile Compounding (42 CFR § 482.25(b)(1) and § 485.635(a)(3)); (v) Detailed Information Sharing for Discharge Planning for Hospitals and CAHs (42 CFR § 482.43(a)(8), § 482.61(e), and § 485.642(a)(8)); (vi) Limiting Detailed Discharge Planning for Hospitals (42 CFR §482.43(c)); (vii) Medical Staff (42 CFR §482.22(a)(1)-(4)); (viii) Medical Records (42 CFR § 482.24(a) through (c)); (viii) Flexibility in Patient Self Determination Act Requirements (Advance Directives); (xi) Physical Environment (42 CFR §482.41 and 42 CFR § 485.623); (x) Telemedicine (42 CFR § 482.12(a)(8)– (9) and § 485.616(c)); (xi) Physician Services (42 CFR § 482.12(c)(1)– (2) and § 482.12(c)(4)); (xii) Utilization Review (42 CFR § 482.1(a)(3) and 42 CFR § 482.30); (xiii) Written Policies and Procedures for Appraisal of Emergencies at Off Campus Hospital Departments (42 CFR §482.12(f)(3)); (xiv) Emergency Preparedness Policies and Procedures (42 CFR § 482.15(b), § 485.625(b), §482.15(c)(1)–(5) and § 485.625(c)(1)–(5)); (xv) Quality Assessment and Performance Improvement Program (42 CFR § 482.21(a)–(d) and (f), and §485.641(a), (b), and (d)); (xvi) Nursing Services (42 CFR § 482.23(b)(4), §482.23(b)(7), and §485.635(d)(4)); (xvii) Food and Dietetic Services (42 CFR § 482.28(b)(3)); (xviii) Respiratory Care Services (42 CFR § 482.57(b)(1)); (xix) Hospitals Able to Provide Care in Temporary Expansion Sites; (xx) Expanded Ability for Hospitals to Offer Long-term Care Services (“Swing Beds”) for Patients Who Do Not Require Acute Care but Do Meet the Skilled Nursing Facility (SNF) Level of Care Criteria as Set Forth at 42 CFR § 409.31; (xxi) Care for Excluded Inpatient Psychiatric Unit Patients in the Acute Care Unit of a Hospital; (xxii) Care for Excluded Inpatient Rehabilitation Unit Patients in the Acute Care Unit of a Hospital; (xxiii) CAH Personnel Qualifications (42 CFR § 485.604(a)(2), § 485.604(b)(1)– (3), and § 485.604(c)(1)– (3)); (xxiv) CAH Staff Licensure  (42 CFR § 485.608(d)); (xxv) CAH Status and Location (42 CFR § 485.610(b) and § 485.610(e)); (xxvi) CAH Length of Stay (42 CFR § 485.620); (xxvii) Temporary Expansion Locations (42 CFR § 482.41, § 485.623, and § 413.65); and (xxviii) Responsibilities of Physicians in Critical Access Hospitals (CAHs) (42 CFR § 485.631(b)(2)).
• Hospitals/CAHs/ASCs
  • The waiver of the requirements relating to Anesthesia Services and certified registered nurse anesthetist will end upon the conclusion of the PHE.

With respect to Long Term Care facilities, the memorandum also outlines information regarding the remaining regulatory waivers, which were not terminated by CMS in April 2022 (see QSO-22-15-NH & NLTC & LSC). The memorandum includes additional information on (i) 3-Day Prior Hospitalization; (ii) Alcohol-based Hand-Rub (ABHR) Dispensers; (iii) Preadmission Screening and Annual Resident Review (PASARR); (iv) Resident Roommates and Grouping; (v) Resident Transfer and Discharge; (vi) Nurse Aide Training Competency and Evaluation Programs (NATCEP); (vii) Requirements for Reporting related to COVID-19; (viii) Requirements for Educating about and Offering Residents and Staff the COVID-19 Vaccine; (ix) Requirements for COVID-19 Testing; and (x) Focused Infection Control (FIC) Surveys.

Finally, yet importantly, in relation to Staff Vaccination Requirements, the White House announced on May 1, 2023 that, amongst others, CMS-certified facilities, federal employees, and contractors will no longer be subject to COVID-19 vaccination requirements as of May 11, 2023. Although the memorandum mentioned that its vaccine mandate would end soon, it is clear that the mandate was meant to be ended on May 11, 2023. However, it is important to recognize that while the mandate may no longer be in effect and surveyors are not going to be reviewing vaccination status as part of licensing and certification, there may be various reporting requirements related to vaccine status that CMS-certified facilities will continue to have to submit. 

As many of the waivers have ended, it is important for providers to review and ensure compliance with current regulatory requirements.  It is also important to note that some waivers were extended based on congressional and regulatory action to last beyond the PHE (e.g., certain telehealth, DEA-prescribing, etc.).