COVID ARCHIVE
With the end of the COVID-19 public health emergency, this content is not regularly updated. The information here may be outdated and links may no longer function.

 

Waiver Tracker
Coronavirus (COVID-19)

Trained healthcare professionals are standing by to answer questions about coronavirus. The call is free. NJ residents should call the 24-Hour Public Hotline, called "The NJ Poison Control and Coronavirus Hotline," at 1-800-962-1253.

The NJ Poison Control Center and 211 have partnered with the State to provide information to the public on COVID-19:

Call: 2-1-1 | Text: NJCOVID to 898-211 | Visit: https://covid19.nj.gov/ for additional information

In a highly regulated field like healthcare, temporary waivers of certain regulations allow healthcare facilities to adjust and respond more quickly during a public health emergency. This Waiver Tracker provides status updates on federal and state waivers sought by NJHA. For the September 2022 update, we have incorporated all of CMS’ information from the fact sheets issued at https://www.cms.gov/coronavirus-waivers as well as the NJ Department of Health updates at https://www.state.nj.us/health/legal/covid19/. The status of each waiver is color coded: green print for “in effect,” yellow for “in effect but with exceptions” and red for “expired or will expire when federal PHE ends.”

Main COVID-19 Page Hospital Visitation Codes COVID BigShot Site Coronavirus Briefings Key for locked members only page.

UPDATED on May 11, 2023

N.J. Department of Health - Hospitals

WaiverStatus
EMS Crewmember Requirements
Senate Bill 3241 extends the temporary waiver for crewmember requirements for nonemergency basic life support vehicles and specialty care transport units. The waiver was set to expire January 1, 2023 and is now extended to January 1, 2024.
In effect until Jan. 2024
Acute Care Hospital At Home
On July 21, 2021, the NJ DOH issued a blanket waiver for the requirement at N.J.A.C. 8:43G-2.5 that a licensed general hospital only provide services within the hospital’s licensed space and to permit hospitals to apply for entry into CMS’ Acute Care Hospital at Home Program and provide the services permitted under the program by CMS, if approved. To institute the Hospital at Home Program, CMS issued an individual waiver requirement for standards at 42 CFR 482.23(b) and (b) 1 that required nursing services to be provided in a hospital 24 hours a day, 7 days a week with a registered nurse immediately available for the care of any patient. The Hospital at Home program identified 60 acute care conditions that can be treated at home with proper monitoring and treatment protocols. NJ hospitals that have been granted a waiver by CMS to participate in the Hospital at Home Program must — prior to providing any services under the program – send to the NJDOH (Eugene.brenycz@doh.nj.gov): A copy of the hospital’s CMS waiver approval The date the hospital will begin providing acute care hospital at home program services The name, phone number and email address of the hospital’s contact for NJDOH to contact about the program. After the conclusion of the CMS waiver, hospitals will be required to resume compliance with the temporarily waived NJDOH standards noted above.
Extended by Congress through Dec. 31, 2024.
Pre-employment Requirements
https://www.state.nj.us/health/healthfacilities/documents/CN/temp_waivers/03-13-2020_Memo-Licensed%20Inpatient%20Facility%20Administrators_Temp_Operational_Waiver.pdf
The Department of Health will not require prior Department approval of temporary waivers for the following requirements from licensed facilities:
  • Exceeding licensed bed capacity
  • Bed additions requiring prior CN approval
  • Physical space requirements
Staff qualifications requirements Facilities will have to provide a written report to DOH detailing which, if any, actions were implemented, the duration and any adverse outcomes that result
Will expire on Aug. 13, 2023
Permits acute care hospitals to substitute the credentialing standards of their accrediting body instead of DOH requirements https://www.state.nj.us/health/legal/covid19/3-26-2020%20Waiver%20of%20Credentialing%20Standards.pdf Will expire on Aug. 13, 2023
Emergency Medical Services Waivers for EMTs, Paramedics, BLS, ALS BLS

https://www.state.nj.us/health/legal/documents/covid19/EO%20103%20Waiver%20DOH%20Various%20Revocations.pdf
Expired July 18, 2022
Hospital Nursing Ratios
https://www.state.nj.us/health/legal/covid19/4-7-2020_Hospital_Temp_Waivers_during_COVID-19_StateofEmergency.pdf
In effect only during the period of Public Health Emergency declared by Governor Philip D. Murphy in Executive Order No.1 03 issued on March 9, 2020. Once the Public Health Emergency is mitigated, hospitals will be required to return to operate in accordance with all licensure standards. Still shown as in effect on DOH web page.
Discharge Planning Requirements
https://www.state.nj.us/health/legal/covid19/4-7-2020_Hospital_Temp_Waivers_during_COVID-19_StateofEmergency.pdf
In effect only during the period of Public Health Emergency declared by Governor Philip D. Murphy in Executive Order No.1 03 issued on March 9, 2020. Once the Public Health Emergency is mitigated, hospitals will be required to return to operate in accordance with all licensure standards. Still shown as in effect on DOH web page.
However, CMS has terminated this waiver at 42 CFR 482.43(c) with the conclusion of the federal PHE on May 11, 2023.
Dialysis Staffing Waiver
https://www.state.nj.us/health/legal/covid19/4-17-2020_WaiverDialysisStaffing.pdf
Expiration Date: Concurrent with end of EO 103. Still shown as in effect on DOH web page.
Waiver of APN/Anesthesia and CRNA requirements at N.J.A.C. 8:43A
https://www.state.nj.us/health/legal/covid19/4-17-2020_WaiverAPN_Anesthesia_CRNA.pdf
In effect for the duration of the Public Health Emergency. Does not specify state or federal PHE. Still shown as in effect on DOH web page
Guidance for a Remotely Conducted 2022 Hospital Annual Meeting — The permission to hold the required annual meeting remotely will remain in place for 2022. Acute Care Annual Public Meeting may be held remotely if certain requirements are met. In effect, new memo issued Jan. 10, 2023
ED 20-037 Authorization for Members of the Healthcare Provider Community to Conduct COVID-19 Vaccination Administration (Revised December 31, 2021) In effect unless otherwise modified, supplemented or rescinded and/or extended by statute or legislative resolution consistent with P.L. 2021 c.103
ED 21-002 Authorization for General Hospitals and Ambulatory Care Facilities Licensed for Primary Care to Conduct COVID-19 Vaccination Administration Outside of the Licensed Site (April 14, 2021) Remains in effect until it is determined by DOH that the emergency no longer exists.
Waiver of Utilization Requirements for Invasive Cardiac Diagnostic Facilities, Cardiac Surgical Centers, Physicians Practicing at Centers
https://www.state.nj.us/health/legal/covid19/03-04-21_N.J.A.C.8-33RuleWaivers.pdf
Expiration Date: Concurrent with the End of Public Health Emergency. Does not specify state or federal PHE. Still shown as in effect on DOH web page
Support Persons for Patients with Disabilities
https://www.state.nj.us/health/legal/covid19/5-12-2020_SupportPersons_forPatientsWithDisabilities.pdf
No specified end date; shown as in effect on DOH web page
ED 21-011 Protocols for COVID-19 Testing and Vaccination Reporting for Covered Settings Pursuant to Executive Order Nos. 252, 253, and 264 (Revised Sept. 2, 2022) In effect under EOs 252, 283, 290, 292, 294, 302 and/or until otherwise modified, supplemented, rescinded or NJ State of Emergency ends, whichever is sooner
In effect

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N.J. Department of Health - Nursing Homes, Assisted Living, CPCH, Dementia Care Homes, PACE, PMDC/ADHS

WaiverStatus
CNA Reciprocity – ED-20-004 (Revised July 2022)
https://www.state.nj.us/health/legal/documents/covid19/final%20revised%2020-004%20cna%20reciprocity%20and%20TNA.pdf
Remains in effect
Authorization for ALF, CPCH to Hire Out of State CNAs - ED-20-005
https://www.state.nj.us/health/legal/covid19/20-005%20ED%20-%20ALF,%20ALP,%20CPCH%20to%20Hire%20Out-Of-State%20CNAs%202020-03-31.pdf
Remains in effect
Pre-employment Requirements
https://www.state.nj.us/health/healthfacilities/documents/CN/temp_waivers/03-13-2020_Memo-Licensed%20Inpatient%20Facility%20Administrators_Temp_Operational_Waiver.pdf
The Department of Health will not require prior Department approval of temporary waivers for the following requirements from licensed facilities:
  • Exceeding licensed bed capacity
  • Bed additions requiring prior CN approval
  • Physical space requirements
Staff qualifications requirements Facilities will have to provide a written report to DOH detailing which, if any, actions were implemented, the duration and any adverse outcomes that result
Will expire Aug. 13, 2023
Waivers associated with expiration of CNA, CMA certification Expired
Temporary Nurse Aides
https://www.state.nj.us/health/legal/covid19/4-15-2020_NurseAideCompetency.pdf

Expired CNA Certifications; Student Nurses
https://www.state.nj.us/health/legal/covid19/4-29-20_WaiverRequirements_forNurseAideCertification.pdf
Expired May 11, 2023
ED 21-011 Protocols for COVID-19 Testing and Vaccination Reporting for Covered Settings Pursuant to Executive Order Nos. 252, 253, and 264 (Revised Sept. 2, 2022) In effect under EOs 252, 283, 290, 292, 294, 302 and/or until otherwise modified, supplemented, rescinded or NJ State of Emergency ends, whichever is sooner
ED 21-012 Directive for the Resumption of Services in all Long-Term Care Facilities licensed pursuant to N.J.A.C 8:43, N.J.A.C 8:36, N.J.A.C 8:39, and N.J.A.C 8:37 (Revised Dec. 2022) In effect until revoked or modified by DOH or until the NJ State of Emergency ends, whichever is sooner
ED 22-001 COVID-19 Related Health and Safety Requirements For the Reopening of New Jersey Pediatric Medical Day Care Facilities (Revised April 6, 2022) In effect under EO 292 or unless modified, superseded, supplemented and/or rescinded.
ED 21-006 Expansion of Attendance at Programs of All-Inclusive Care for the Elderly (PACE) (Revised February 17, 2023) In effect unless modified, superseded or rescinded
ED 21-007 COVID-19 Related Health and Safety Requirements for the Reopening of New Jersey Adult Day Health Services Facilities (Revised February 17, 2023) In effect unless modified, superseded or rescinded
In effect

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N.J. Department of Banking & Insurance

WaiverStatus
COVID-19 and Health Insurance FAQ Removed
Telehealth FAQ Removed
Coverage of COVID-19 Testing

https://www.state.nj.us/dobi/bulletins/blt22_03.pdf

https://www.state.nj.us/dobi/bulletins/blt20_24.pdf

https://www.state.nj.us/dobi/bulletins/blt20_03.pdf

The Department of Banking and Insurance (“Department”) is expanding the requirements in Bulletin 20-03 to require carriers to cover, without cost-sharing, without prior authorization or other medical management requirements, any SARS-COV-2 molecular test authorized pursuant to the DOH standing order. This requirement includes such testing, regardless of site as authorized by the DOH Standing Order, including tests administered at any in or out-of-network community-based, county testing, or private testing site, (including, but not limited to, in and out-of-network hospitals, provider offices, urgent care centers, and pharmacies), and includes items and services furnished to an individual during such visits that result in an order for or administration of a SARS-COV-2 molecular test. Carriers must treat any such test authorized pursuant to the DOH standing order as medically appropriate for the individual. Carriers must not impose cost-sharing for SARSCOV-2 molecular tests provided by in-network or out-of-network laboratories.
In effect
USE OF TELEMEDICINE AND TELEHEALTH TO RESPOND TO THE COVID-19 PANDEMIC In effect

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N.J. Division of Consumer Affairs

WaiverStatus
All Temporary Emergency Graduate Licensure (TEGL) programs will be continued until further notice. Individuals currently holding TEGLs will remain authorized to practice under the TEGL, subject to the requirements set forth in AO 2020-05 and 2020-12. The Division will continue to accept applications for TEGLs from recent graduates until further notice. Please visit the TEGL program page here for more information. In effect
DISCONTINUATION OF TEMPORARY EMERGENCY RECIPROCITY LICENSURE PROGRAMS

SUPERSEDING ALL PRIOR NOTICES
EFFECTIVE DATE: July 15, 2022


The Division of Consumer Affairs discontinued the Temporary Emergency Reciprocity Licensure Program on August 1, 2022, for all classes of Group 2 health care practitioners, with the sole exception of respiratory care therapists.

All practitioners holding a TERL on August 1, 2022 will remain eligible to continue practicing under the TERL through August 31, 2022. Effective September 1, 2022, TERL holders (except for respiratory care therapists - please see below) must refrain from engaging in any further practice in the State of New Jersey, unless participating in the "bridge program" described below.

DCA has authorized a "bridge program" to plenary licensure available to all TERL holders. Any TERL holder who files a complete application for a plenary license in New Jersey (using the electronic application process available on the board websites) by 11:59 p.m. on August 31, 2022 will qualify for the "bridge program," and will be authorized to continue practicing in New Jersey under the TERL until the earliest of:
  • The date of issuance of a New Jersey license;
  • The date of notification of denial of an application for a plenary license in New Jersey; or
  • The end of the day on March 31, 2023.
You will be considered to have filed a complete application for licensure in New Jersey provided that you submit a complete application and pay the required application fee on or before August 31, 2022.

Your TERL will automatically expire if you receive a plenary license, if your application for a plenary license is denied, or on April 1, 2023—whichever comes first.
  • Please click here to apply to the Temporary Emergency Reciprocity License (TERL).
  • To verify a Temporary Emergency Reciprocity License (TERL), click here.
Expired, except for respiratory therapists or those who completed bridge program requirements as of Aug. 31, 2022.
TEMPORARY EMERGENCY RECIPROCITY LICENSURE
INFORMATION FOR RESPIRATORY CARE THERAPISTS SUPERSEDING ALL PRIOR NOTICES

The TERL program for respiratory care therapists will remain in place, without change, through May 31, 2023, or until the end of New Jersey's State of Emergency if that occurs prior to May 31, 2023. Respiratory care therapists currently holding a TERL will remain authorized to practice in New Jersey under the TERL through May 31, 2023.

The Division will continue to accept applications for TERLs from respiratory care therapists through May 31, 2023.

The Division urges respiratory care therapists who wish to continue providing respiratory care services in New Jersey after May 31, 2023 to file an application for a plenary license in New Jersey as soon as possible to avoid any gap between the expiration of the TERL and the State Board of Respiratory Care's decision regarding their application for a plenary license.

Please click here to apply to the Temporary Emergency Reciprocity License (TERL).

To verify a Temporary Emergency Reciprocity License (TERL), click here.
Effective March 22, 2023 through May 31, 2023 or until the end of NJ’s state of emergency, whichever occurs first
Telehealth FAQs
https://www.njconsumeraffairs.gov/COVID19/Documents/FAQ-Telehealth.pdf
 
Office Practices
DCA issued an administrative order modifying AO 2021-11, which governed the provision of health care services in office settings in light of the COVID-19 pandemic. The AO, DCA-AO-2022-01, now requires health care professionals who provide care in office settings to monitor and adhere to any guidance issued by the Centers for Disease Control and Prevention, the New Jersey Department of Health, the Occupational Safety and Health Administration, and local health departments.
New guidelines in effect
DCA has temporarily waived on-site supervision requirements for audiology and speech-language pathology temporary licensees, certain licensed occupational therapy assistants, and licensed physical therapy assistants. To learn more, click here. In effect
Suspension of Certain Restrictions Advanced Practice Nurses and Physician Assistants
Governor Murphy’s Executive Order No. 112 and the Division’s corresponding Administrative Order suspend certain restrictions on the scope of practice for Advanced Practice Nurses (APNs) and Physician Assistants (PAs) during the state of emergency and public health emergency.

Please click here to read Acting Director Paul R. Rodríguez’s letter to APNs, PAs, and physicians.

Temporary Removal of Supervision Requirements for Advanced Practice Nurses and Physician Assistants
DCA has temporarily lifted supervisory requirements for APNs and PAs. To learn more, click here.

Executive Order #112 | Administrative Order #2020-02
In effect
In-Person Requirement Waiver for Health Care Service Firms
DCA has temporarily waived the requirement that plan-of-care evaluations by nursing supervisors be completed in patients' homes.
In effect
In-Person Continuing Education Waiver
An emergency waiver has temporarily lifted rules for 16 professional boards requiring continuing education to be completed in person. Boards not listed here do not have in-person CE requirements.
  1. Acupuncture Examining Board
  2. Alcohol and Drug Counselor Committee
  3. Art Therapists Advisory Committee
  4. Board of Chiropractic Examiners
  5. Board of Dentistry
  6. Electrologists Advisory Committee
  7. Elevator, Escalator, and Moving Walkway Mechanics Licensing Board
  8. Fire Alarm, Burglar Alarm and Locksmith Advisory Committee
  9. Home Inspection Advisory Committee
  10. Board of Marriage and Family Therapy Examiners
  11. Board of Massage and Bodywork Therapy
  12. Board of Mortuary Science
  13. Board of Optometrists
  14. Perfusionists Advisory Committee
  15. Board of Pharmacy
  16. Board of Psychological Examiners
In effect
Telehealth Prescribing
DCA has waived rules to allow healthcare providers who have existing CDS prescribing authority to use telemedicine encounters to meet CDS prescribing requirements. For more information, click here.

DCA-AO-2020-15 and DCA-W-2020-14
In effect
Schedule II Medications

The New Jersey Board of Pharmacy (Board) is providing this guidance for the pharmacy community concerning Administrative Order 2020-18 and Waiver 2020-16 (DCA-AO-2020-18, DCA-W-2020-16).

Oral Authorization of Schedule II medications: Pursuant to this Administrative Order, a pharmacist may now dispense up to a 30-day supply of Schedule II CDS upon the oral order of a prescriber. In addition, consistent with waivers issued by the United States Drug Enforcement Administration, follow up paper prescriptions may be submitted within 15 days, and may be submitted via facsimile. This waiver does NOT apply to "initial" opioid prescriptions for pain; it is only applicable for patients being treated for "chronic" pain.

The pharmacist must use his or her professional judgment when dispensing pursuant to the oral order of a prescriber. The pharmacist should only dispense the amount adequate to treat the patient during the emergency period, but in no case more than a 30-day supply. The pharmacist shall reduce the prescription to writing, with all information required to be included for a valid prescription, other than the signature of the prescribing practitioner. The follow up paper prescription should be included in the patient profile when received.
In effect

Vaccinators

All DCA waivers and flexibilities related to which health care team members are permitted to administer immunizations can be found here:
https://www.njconsumeraffairs.gov/COVID19/Pages/C19-Waivers-of-Licensing-Rules.aspx
In effect

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Centers for Medicare & Medicaid Services — Acute Care Hospitals, Teaching Hospitals, InPatient Rehabilitation Hospitals, Long Term Acute Care Hospitals, InPatient Psychiatric Hospitals

WaiverStatus
Emergency Medical Treatment & Labor Act (EMTALA). CMS has been partially waiving the enforcement of section 1867(a) of the Social Security Act (the Emergency Medical Treatment and Active Labor Act, or EMTALA). This has allowed hospitals, psychiatric hospitals, and critical access hospitals (CAHs) to screen patients at a location offsite from the hospital’s campus to prevent the spread of COVID-19, while remaining consistent with the state emergency preparedness or pandemic plan. Expired
"Stark Law" Waivers: On March 30, 2020, CMS issued blanket waivers of certain provisions of the Stark Law. These blanket waivers applied to financial relationships and referrals that are related to the COVID-19 emergency. During the PHE, CMS permitted certain referrals and the submission of related claims that would otherwise violate the Stark Law, if all requirements of the waivers were met. Expired
Increased IPPS Payments for COVID Patients: Hospitals have received a 20% increase in Medicare payments through the IPPS for patients diagnosed with COVID-19 Expired
Verbal Orders. CMS has been 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 readback verification is still required but authentication may occur later than 48 hours. This has allowed for more efficient treatment of patients in a surge situation. Specifically, the following requirements are waived:
  • §482.23(c)(3)(i) -If verbal orders are used for the use of drugs and biologicals (except immunizations), they are to be used infrequently.
  • §482.24(c)(2) -All orders, including verbal orders, must be dated, timed, and authenticated promptly by the ordering practitioner or by another practitioner who is responsible for the care of the patient.
  • §482.24(c)(3) -Hospitals may use pre-printed and electronic standing orders, order sets, and protocols for patient orders. This would include all subparts at §482.24(c)(3).
  • )§485.635(d)(3) -Although the regulation requires that medication administration be based on a written, signed order, this does not preclude the CAH from using verbal orders. A practitioner responsible for the care of the patient must authenticate the order in writing as soon as possible after the fact.
Expired
Signature Requirements: CMS is not enforcing 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 appropriate date of delivery and that a signature was not able to be obtained because of COVID-19. Expired
Reporting Requirements. CMS has been waiving reporting requirements at §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. Due to current hospital surge, we are waiving this requirement to ensure that hospitals are focusing on increased care demands and patient care. Expired
Patient Rights. CMS is waiving requirements under 42 CFR §482.13 only for hospitals that are considered to be impacted by a widespread outbreak of COVID-19. Hospitals that are located in a state which has widespread confirmed cases (i.e., 51 or more confirmed cases*) as updated on the CDC website, CDC States Reporting Cases of COVID-19, at ttps://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html, would not be required to meet the following requirements:
  • §482.13(d)(2) -With respect to timeframes in providing a copy of a medical record.
  • §482.13(h) -Related to patient visitation, including the requirement to have written policies and procedures on visitation of patients who are in COVID-19 isolation and quarantine processes.
  • §482.13(e)(1)(ii) -Regarding seclusion.
Expired
Telehealth

Hospital Outpatient Services Accompanying Professional Services Furnished Via Telehealth:When a physician or nonphysician practitioner, who typically furnishes professional services in the hospital outpatient department, furnishes telehealth services to the patient’s home during the COVID-19 PHE as a “distant site” practitioner, they bill with a hospital outpatient place of service, since that is likely where the services would have been furnished if not for the COVID19 PHE. The physician or practitioner is paid for the service under the PFS at the facility rate, which does not include payment for resources, such as clinical staff, supplies, or office overhead, since those things are usually supplied by the hospital outpatient department. The hospital may bill under the OPPS for the originating site facility fee associated with the telehealth service.
Certain telehealth flexibilities were extended by Congress until Dec. 31, 2024
https://telehealth.hhs.gov/providers/policy-changes-during-the-covid-19-public-health-emergency/medicare-and-medicaid-policies/
Other Telehealth Medicare Flexibilities The Consolidated Appropriations Act of 2022 extended certain telehealth flexibilities for Medicare patients for 151 days after the official end of the federal PHE. If there are no permanent changes made to Medicare coverage, most Medicare beneficiaries will lost access to coverage of nearly all telehealth services, unless they reside in a rural area or are enrolled in Medicare Advantage. Certain telehealth flexibilities were extended by Congress until Dec. 31, 2024
https://telehealth.hhs.gov/providers/policy-changes-during-the-covid-19-public-health-emergency/medicare-and-medicaid-policies/
Hospitals Able to Provide Care in Temporary Expansion Sites: As part of the CMS Hospital Without Walls initiative during the PHE, hospitals could provide hospital services in other hospitals and sites that otherwise would not have been considered part of a healthcare facility, or could set up temporary expansion sites to help address the urgent need to increase capacity to care for patients. During the PHE, CMS provided additional flexibilities for hospitals to create surge capacity by allowing them to provide room and board, nursing, and other hospital services at remote locations, such as hotels or community facilities. During the PHE, hospitals are expected to control and oversee the services provided at an alternative location. Expired
Ambulatory Surgical Centers Temporary Enrollment as Hospitals. CMS permitted ambulatory surgical centers (ASCs) to temporarily reenroll as hospitals and to provide hospital services to help address the urgent need to increase hospital capacity to take care of patients. Other interested entities, such as independent, freestanding, emergency departments (IFEDs), could pursue temporarily enrolling as a hospital during the PHE. Expired
Sterile Compounding. CMS has been waiving hospital sterile compounding requirements at 42CFR §482.25(b)(1) and §485.635(a)(3) 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. This conserves scarce face mask supplies. CMS has not been reviewing the use and storage of facemasks under these requirements. Expired
Modify Discharge Planning for Hospitals: Patients must continue to be discharged to an appropriate setting with the necessary medical information and goals of care. To address the COVID-19 pandemic, CMS has been waiving certain, more detailed, requirements related to hospital discharge planning for post-acute care services at 42 CFR §482.43(c), so as to expedite the safe discharge and movement of patients among care settings, and to be responsive to fluid situations in various areas of the country. CMS has been waiving certain requirements for those patients discharged home and referred for HHA services, or for those patients transferred to a SNF for post-hospital extended care services, or transferred to an IRF or LTCH for specialized hospital services. Expired
Patient Rights Paperwork Requirements: CMS has been waiving certain specific paperwork requirements that are considered to be impacted by a widespread outbreak of COVID-19. Hospitals that are located in a state that has widespread confirmed cases have not been required to meet the following requirements.
  • 42 CFR §482.13(d)(2) with respect to timeframes in providing a copy of a medical record.
  • 42 CFR §482.13(h) related to patient visitation, 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) regarding seclusion.
Expired
Physical Environment: CMS has been waiving certain physical environment requirements at 42 CFR §482.41 and 42 CFR §485.623 to allow for increased flexibilities for surge capacity and patient quarantine at hospitals and psychiatric hospitals. CMS will permit facility and non-facility space that is not normally used for patient care to be utilized for patient care or quarantine, provided the location is approved by the state and is consistent with the state’s emergency preparedness or pandemic plan. States are still subject to obligations under the integration mandate of the Americans with Disabilities Act, to avoid subjecting persons with disabilities to unjustified institutionalization or segregation Expired
Specific Life Safety Code (LSC) for Hospitals: CMS has been modifying these requirements as follows:
  • Alcohol-based Hand-Rub (ABHR) Dispensers: We are waiving the prescriptive requirements for the placement of alcohol-based hand rub (ABHR) dispensers for use by staff and others due to the need for the increased use of ABHR in infection control. However, ABHRs contain ethyl alcohol, which is considered a flammable liquid, and there are restrictions on the storage and location of the containers. This includes restricting access by certain patient/resident population to prevent accidental ingestion. Due to the increased fire risk for bulk containers (over five gallons) those will still need to be stored in a protected hazardous materials area. Refer to: 2012 LSC, sections 18/19.3.2.6. In addition, facilities should continue to protect ABHR dispensers against inappropriate use as required by 42 CFR §482.41(b)(7) for hospitals and §485.623(c)(5) for CAHs.
  • Fire Drills: Due to the inadvisability of quarterly fire drills that move and mass staff together, we will instead permit a documented orientation training program related to the current fire plan, which considers current facility conditions. The training will instruct employees, including existing, new or temporary employees, on their current duties, life safety procedures and the fire protection devices in their assigned area. Refer to: 2012 LSC, sections 18/19.7.1.6.
  • Temporary Construction: CMS is waiving requirements that would otherwise not permit temporary walls and barriers between patients. Refer to: 2012 LSC, sections18/19.3.3.2.
Expired
Hospital Outpatient: Use of Provider-Based Departments as Temporary Expansion Sites: For the duration of the PHE related to COVID-19, CMS has been waiving certain requirements under the Medicare conditions of participation at 42 CFR §482.41 and §485.623 and the provider-based department requirements at 42 CFR §413.65 to allow hospitals to expand capacity by creating new, or relocating existing, provider-based departments. These waivers were intended to enable hospitals to meet the needs of Medicare beneficiaries in alignment with the state or local pandemic plan. Expired
Hospital-Only Remote Outpatient Therapy and Education Services: Consistent with the CMS Hospitals without Walls Initiative, during the PHE, hospitals may provide behavioral health and education services furnished by hospital-employed counselors or other professionals who cannot bill Medicare directly for their professional services. This includes partial hospitalization services. These services may be furnished to a beneficiary in their home when the beneficiary is registered as an outpatient of the hospital and the hospital considers the beneficiary’s home to be a provider-based department of the hospital. Certain telehealth flexibilities were extended by Congress until Dec. 31, 2024
https://telehealth.hhs.gov/providers/policy-changes-during-the-covid-19-public-health-emergency/medicare-and-medicaid-policies/
Medical Staff Requirements: CMS has been waiving the Medical Staff requirements at 42 CFR §482.22(a)(1)-(4) to allow for physicians, whose privileges would have expired, 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. CMS has been waiving §482.22(a) (1)-(4) regarding details of the credentialing and privileging process. Expired
Physician Services: CMS has been waiving 482.12(c)(1)–(2) and §482.12(c)(4), which requires that Medicare patients be under the care of a physician. This allows hospitals to use other practitioners, such as physician’s assistant and nurse practitioners to the fullest extent possible. This waiver has been implemented while remaining consistent with a state’s emergency preparedness or pandemic plan. Expired
Anesthesia Services: CMS has been 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 has been at the discretion of the hospital or Ambulatory Surgical Center (ASC) and state law. This waiver applies to hospitals, CAHs, and ASCs. These waivers allow CRNAs to function to the fullest extent of their licensure and has been implemented while remaining consistent with a state or pandemic/emergency plan. Expired
Respiratory Care Services: CMS has been 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. Not being required to designate these professionals in writing allows qualified professionals to operate to the fullest extent of their licensure and training in providing patient care for respiratory illnesses. Expired
Nursing Services: CMS has been waiving the provision at 42 CFR 482.23(b)(4), 42 CFR 482.23(b)(7), and 485.635(d)(4), which requires 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. Expired
Food and Dietetic Service: CMS has been 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. Expired
Emergency Preparedness Policies and Procedures: CMS has been waiving 482.15(b), which requires the hospital to develop and implement emergency preparedness policies and procedures, and 482.15(c)(1)-(5) which require that the emergency preparedness communication plans for hospitals to contain specified elements with respect to the surge site. Expired
Medical Records: CCMS has been 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 has been waiving requirements under 42 CFR §482.24(c)(4)(viii) related to medical records to allow flexibility in completion of medical records within 30 days following discharge. Expired
Flexibility in Patient Self Determination Act Requirements (Advance Directives). CMS has been waiving the requirements at section 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 to provide information about its advance directive policies to patients. Expired
Utilization Review: CMS has been waiving the requirements at 42 CFR §482.1(a)(3) and 42 C.F.R §482.30, that require that hospitals participating in Medicare and Medicaid to have a utilization review plan that meets specified requirements. CMS has been waiving the entire Utilization Review CoP at §482.30, which requires 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. Expired
Quality Assessment and Performance Improvement Program: CMS has been waiving 482.21(a)-(d) and (f), and 485.641(a), (b), and (d), which provide details on the scope of the program, the incorporation, and setting priorities for the 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 QAPI program, the requirement that hospitals maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program remains. Expired
State Licensure: During the PHE, CMS allowed licensed physicians and other practitioners to bill Medicare for services provided outside of their state of enrollment. CMS has determined that, when the PHE ends, CMS regulations will continue to allow for a total deferral to state law. There is no CMS-based requirement that a provider must be licensed in its state of enrollment.
Requirement for Hospitals and CAHs to Report Data for COVID-19 and Acute Respiratory Illness, including Seasonal Influenza Virus, Influenza-like Illness, and Severe Acute Respiratory Infection: Hospitals are required to report information in accordance with a frequency, and in a standardized format, as specified by the Secretary during the PHE for COVID-19. More information is available at https://www.hhs.gov/sites/default/files/covid-19-faqs-hospitals-hospital-laboratory-acute-care-facility-data-reporting.pdf Beginning after the PHE ends and continuing until April 30, 2024, unless the Secretary determines an earlier end date, hospitals are required to report data for COVID-19 and seasonal influenza in a standardized format and frequency as specified by the Secretary. CMS will notify regulated entities, stakeholders, and the public of the start date of necessary reporting, reporting frequency, and other requirements via subregulatory guidance, following a model similar to that which we used to inform regulated entities at the beginning of the COVID-19 PHE.
https://www.hhs.gov/sites/default/files/covid-19-faqs-hospitals-hospital-laboratory-acute-care-facility-data-reporting.pdf
Application of Teaching Physician Regulations: Under current rules, Medicare payment is made for services furnished by a teaching physician involving residents only if the physician is physically present for the key portion of the service or procedure, and immediately available to furnish services during the entire procedure, where applicable. During the COVID-19 PHE, teaching physicians may use audio/video real time communications technology to interact with the resident through virtual means, which would meet the requirement that they be present for the key portion of the service, including when the teaching physician involves the resident in furnishing Medicare Telehealth services. These flexibilities do not apply in the case of surgical, high risk, interventional, or other complex procedures, services performed through an endoscope, and anesthesia services.

Teaching physicians involving residents in providing care at certain primary care centers can provide the necessary direction, management and review for services furnished by up to four residents at a time using audio/video real time communications technology.

During the PHE, teaching physicians can oversee and bill for an expanded scope of care furnished by up to four residents at a time in certain primary care centers, including all levels of an office/outpatient evaluation and management (E/M) visit, telephone E/M, care management, and communication technology-based services
Expired
Resident Moonlighting: Under permanent policy, Medicare considers the services of residents that are not related to their approved graduate medical education programs and performed in the outpatient department or the emergency department of a hospital as the resident’s separately billable physicians’ services. Medicare also considers the services of residents that are not related to their approved GME programs and furnished to inpatients of a hospital in which they have their training program as separately billable physicians’ services. This is unchanged and will continue after the PHE.
Counting of Resident Time at Alternate Locations: Existing regulations have specific rules on when a hospital may count a resident for purposes of Medicare direct graduate medical education (DGME) payments or indirect medical education (IME) payments. Normally, if the resident is performing activities within the scope of his/her approved program in his/her own home, or a patient’s home, the hospital may not count the resident. During the COVID-19 PHE, a hospital that is paying the resident’s salary and fringe benefits for the time that the resident is at home or in a patient’s home, but performing duties within the scope of the approved residency program and meets appropriate physician supervision requirements could claim that resident for IME and DGME purposes. Expired
Graduate Medical Education (GME) Residents Training in Other Hospitals: During the COVID-19 PHE, a teaching hospital that sends residents to other hospitals has been able to continue to claim those residents in the teaching hospital’s IME and DGME FTE resident counts, if certain requirements are met. Those requirements include that 1) the teaching hospital sends the resident to the other hospital in response to the COVID-19 pandemic; 2) the time spent by the resident training at the other hospital is in lieu of time that would have been spent training at the sending hospital; and 3) the time that the resident spent training immediately prior to and/or subsequent to the time frame that the COVID-19 PHE has been in effect has been included in the FTE count for the sending hospital. Moreover, the presence of residents in non-teaching hospitals has not triggered establishment of IME and/or DGME FTE resident caps at those non-teaching hospitals. Specifically, for DGME, the presence of residents in non-teaching hospitals has not triggered establishment of PRAs at those non-teaching hospitals. Expired
IME Payments Held Harmless for Temporary Increase in Beds: During the COVID-19 PHE, CMS has held teaching hospitals harmless from a reduction in IME payments due to beds temporarily added during the COVID-19 PHE, by not considering such beds when determining IME payments. Any added beds will be considered in determining the hospital's IME payments.
Price Transparency for COVID-19 Testing: CMS implemented the CARES Act requirement that providers of a diagnostic test for COVID-19 are to make public the cash price for such tests on their websites. Providers without websites have been required to provide price information in writing, within two business days upon request, and on a sign posted prominently at the location where the provider performs the COVID-19 diagnostic test, if such location is accessible to the public. Noncompliance may result in civil monetary penalties up to $300 per day. This special price transparency requirement has ended. Price transparency requirements under other laws and regulations will continue to apply.
Enhanced Medicare Payments for New COVID-19 Treatments: Hospital Inpatient Stays: Effective for discharges occurring on or after November 2, 2020, and through the end of the FY in which the COVID-19 PHE ends, the Medicare program has provided an enhanced payment for eligible inpatient cases that involve use of certain new products authorized or approved to treat COVID-19 (86 FR 45162). The enhanced payment is equal to the lesser of: 1) 65% of the operating outlier threshold for the claim; or 2) 65% of the costs of the case beyond the operating Medicare payment (including the 20% add-on payment under section 3710 of the CARES Act) for eligible cases. Will remain in place through the end of the fiscal year in which the COVID-19 PHE ends, which would be Sept. 30, 2023.
Separate Medicare Payment for New COVID-19 Treatments: Hospital Outpatient Departments: CMS has excluded FDA-authorized or approved drugs and biologicals (including blood products) authorized or approved to treat COVID-19 (and for which the FDA authorization or approval does not limit use to the inpatient setting) from being packaged into the Comprehensive Ambulatory Payment Classification (C-APC) payment when these treatments are billed on the same claim as a primary C-APC service. Instead, Medicare has been paying for these drugs and biologicals separately for the duration of the PHE. Payment for these treatments will be packaged into the payment for a C-APC when these services are billed on the same outpatient claim.
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: CMS has been waiving the requirements at 42 CFR 482.58, special requirements for hospital providers of long-term care services (swing beds), subsections (a)(1)-(4) Eligibility, to allow hospitals to establish SNF swing beds, payable under the SNF prospective payment system (PPS), to provide additional options for hospitals with patients who no longer require acute care, but are unable to find placement in a SNF. Expired
Housing Acute Care Patients in Excluded Distinct Part Units: During the PHE, CMS has been 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 (IPPS) hospital should bill for the care and annotate the patient’s medical record to indicate the patient is an acute care inpatient being housed in the excluded unit because of capacity issues related to the disaster or emergency. Expired
Care for Excluded Inpatient Psychiatric Unit Patients in the Acute Care Unit of a Hospital: During the PHE, CMS has been waiving requirements to allow acute care hospitals with excluded distinct part inpatient psychiatric units that, as a result of a disaster or emergency, need 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 under the Inpatient Psychiatric Facility Prospective Payment System (IPF PPS) for such patients and annotate the medical record to indicate the patient is a psychiatric inpatient being cared for in an acute care bed, because of capacity or other exigent circumstances related to the COVID-19 PHE. This waiver could be utilized where the hospital’s acute care beds are appropriate for psychiatric patients and the staff and environment are conducive to safe care. For psychiatric patients, this includes assessment of the acute care bed and unit location to ensure those patients at risk of harm to self and others are safely cared for. Expired
Care for Excluded Inpatient Rehabilitation Unit Patients in the Acute Care Unit of a Hospital: CMS has been waiving requirements to allow acute care hospitals with excluded distinct part inpatient rehabilitation units that, as a result of a disaster or emergency, need 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 under the Inpatient Rehabilitation Facility Prospective Payment System for such patients and annotate the medical record to indicate the patient is a rehabilitation inpatient being cared for in an acute care bed, because of capacity or other exigent circumstances related to the disaster or emergency. This waiver could be utilized where the hospital’s acute care beds are appropriate for providing care to rehabilitation patients and such patients continue to receive intensive rehabilitation services. When the COVID-19 PHE ends, inpatients receiving rehabilitation services, paid under the IRF PPS and furnished by the excluded distinct part rehabilitation unit of an acute care hospital, cannot be housed in an acute care bed and unit. Expired
Flexibility for Inpatient Rehabilitation Facilities Regarding the 60% Rule: During the PHE, CMS has been allowing 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% 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. In addition, during the applicable waiver time period, this exception has also applied to facilities not yet classified as IRFs, but have attempted to obtain classification as an IRF. Expired
Intensity of Therapy Requirement (“Three-Hour Rule”): The Coronavirus Aid, Relief, and Economic Security (CARES) Act requires the Secretary to waive § 412.622(a)(3)(ii) (commonly referred to as the “three-hour rule”), the criterion that patients treated in inpatient rehabilitation facilities generally receive at least 15 hours of therapy per week. The waiver of this requirement for all beneficiaries treated in a hospital-based or freestanding IRF provides flexibility for IRFs to provide care for patients during the PHE for the COVID-19 pandemic. Expired
Standards to Rehabilitate Patients: Medicare payment regulations require IRFs to meet certain standards to rehabilitate patients, including providing interdisciplinary care, ensuring that admitted patients are stable enough for rehabilitation therapy and need at least two types of therapy, and providing close medical supervision by a rehabilitation physician. During the PHE, these standards do not have to apply to patients who are admitted to freestanding IRFs solely for surge capacity reasons in a state that currently satisfies all of the following, as determined by applicable state and local officials:
  1. All vulnerable individuals continue to shelter in place.
  2. Individuals continue social distancing.
  3. Individuals avoid socializing in groups of more than 10.
  4. Non-essential travel is minimized.
  5. Visits to senior living facilities and hospitals are prohibited.
  6. Schools and organized youth activities remain closed.
The standard IRF requirements would continue to apply to patients who are admitted for the IRFs’ standard rehabilitative services. During the PHE, freestanding IRFs have taken advantage of these flexibilities for some of their beneficiaries (those who are surge patients from inpatient hospitals), while continuing to provide standard IRF-level care for those beneficiaries who would benefit from IRF-level care and would otherwise receive such care in the absence of the PHE.
Expired
LTCH Site Neutral Payment Rate Provisions: As required by section 3711(b) of the CARES Act, during the Public Health Emergency (PHE) due to COVID-19, certain provisions of section 1886(m)(6) of the Social Security Act were waived relating to certain site neutral payment rate provisions for long-term care hospitals (LTCHs).
  • Section 3711(b)(1) of the CARES Act waived the payment adjustment under section 1886(m)(6)(C)(ii) of the Act for LTCHs that do not have a discharge payment percentage (DPP) for the period that is at least 50% during the COVID-19 PHE period. For the purposes of calculating an LTCH’s DPP, all admissions during the COVID-19 PHE period were counted in the numerator of the calculation. In other words, LTCH cases that were admitted during the COVID-19 PHE period were counted as discharges paid the LTCH PPS standard Federal payment rate. At the end of the COVID-19 PHE, the payment adjustment under section 1886(m)(6)(C)(ii) of the Act is applied for LTCHs that do not have a DPP for the period that is at least 50%.
  • Section 3711(b)(2) of the CARES Act provides a waiver of the application of the site neutral payment rate under section 1886(m)(6)(A)(i) of the Act for those LTCH admissions that are in response to the public health emergency and occur during the COVID-19 public health emergency (PHE) period. Under this provision, all LTCH cases admitted during the COVID-19 public health emergency period (that is, admissions occurring on or after January 27, 2020 through the duration of the COVID-19 PHE) were paid the relatively higher LTCH PPS standard Federal rate.
All LTCH admissions, except those that meet the requirements for exclusion from the site neutral rate, are now subject to the site neutral payment rate under section 1886(m)(6)(A)(i) of the Act.
Long-Term Care Acute Hospitals (LTCHs) 25-day ALOS: CMS issued a blanket waiver to long-term care hospitals 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 at § 412.23(e)(2), which allows these hospitals to participate in the LTCH PPS. Hospitals should add the “DR” condition code to applicable claims. Expired
Inpatient Psychiatric Facilities (IPFs) and Inpatient Rehabilitation Facilities (IRFs) Teaching Status Adjustment Payments: To ensure that teaching IPFs and IRFs can alleviate bed capacity issues by taking patients from the inpatient acute care hospitals without being penalized by lower teaching status adjustments, we have been freezing the IPFs’ and IRFs’ teaching status adjustment payments at their values prior to the PHE. For duration of the COVID-19 PHE, a teaching IPF’s and a teaching IRF’s teaching status adjustment payments have been the same as they were on the day before the COVID-19 PHE was declared. Any change to a teaching IPF’s or a teaching IRF’s average daily census will be considered in determining its teaching status adjustment payments.

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Centers for Medicare & Medicaid Services — Skilled Nursing Facilities

WaiverStatus
Physical Environment: Provided that the state has approved the location as one that sufficiently addresses safety and comfort for patients and staff, CMS waived requirements under 42 CFR §483.90 to allow for a non-SNF/NF building to be temporarily certified as, and available for use by, a SNF in the event there are needs for isolation processes for COVID-19 positive residents, which may not be feasible in the existing SNF structure, to ensure care and services during treatment for COVID-19 is available while protecting other vulnerable adults. This waiver terminated on 06-06-2022 per QSO-22-15- NH&NLTC&LSC
3-Day Prior Hospitalization: CMS temporarily waived the requirement for a three-day prior hospitalization for coverage of a skilled nursing facility (SNF) stay. This waiver provides temporary emergency coverage of SNF services without a qualifying hospital stay. In addition, for certain beneficiaries who exhausted their SNF benefits, it authorizes a onetime renewed SNF coverage without first having to start and complete a 60-day “wellness period” (that is, the 60-day period of non-inpatient status that is normally required in order to end the current benefit period and renew SNF benefits). This waiver will apply only for those beneficiaries who have been delayed or prevented by the emergency itself from commencing or completing the 60-day “wellness period” that would have occurred under normal circumstances. By contrast, if the patient has a continued skilled care need (such as a feeding tube) that is unrelated to the COVID-19 emergency, then the beneficiary cannot renew his or her SNF benefits under the Section 1812(f) waiver, as it is this continued skilled care in the SNF rather than the emergency that is preventing the beneficiary from beginning the 60-day “wellness period.” Expired
Waive Pre-Admission Screening and Annual Resident Review (PASRR): CMS has been allowing states and nursing homes to suspend these assessments for new residents for 30 days. After 30 days, new patients admitted to nursing homes with a mental illness (MI) or intellectual disability (ID) should receive the assessment as soon as resources become available. New Jersey ended this waiver in November 2021.
Resident Groups: CMS waived the requirements at §483.10(f)(5) to allow for residents to have the right to participate in-person in resident groups. This waiver only permitted the facility to restrict having in-person meetings during the national emergency given the recommendations of social distancing and limiting gatherings of more than ten people. This waiver was terminated on 05/07/2022 per QSO-22-15-NH&NLTC&LSC
Quality Assurance and Performance Improvement (QAPI). CMS modified certain requirements in 42 CFR §483.75, which required long-term care facilities to develop, implement, evaluate, and maintain an effective, comprehensive, data-driven QAPI program. Specifically, CMS modified §483.75(b)–(d) and (e)(3) to the extent necessary to narrow the scope of the QAPI program to focus on adverse events and infection control. This waiver was terminated on 05/07/2022 per QSO-22-15-NH&NLTC&LSC
Nurse Aide In-Service Training: CMS modified the nurse aide training requirements at §483.95(g)(1) for SNFs and NFs, which requires the nursing assistant to receive at least 12 hours of in-service training annually. In accordance with section 1135(b)(5) of the Act, CMS postponed the deadline for completing this requirement throughout the COVID-19 PHE until the end of the first full quarter after the declaration of the PHE concludes. This waiver was terminated on 06/06/2022 per QSO-22-15-NH&NLTC&LSC
Detailed Information Sharing for Discharge Planning. CMS waived the discharge planning requirement in §483.21(c)(1)(viii), which required LTC facilities to assist residents and their representatives in selecting a post-acute care provider using data, such as standardized patient assessment data, quality measures and resource use. CMS maintained all other discharge planning requirements. (This waiver was terminated on 05-07-2022 per QSO-22-15-NH&NLTC&LSC) This waiver was terminated on 05/07/2022 per QSO-22-15-NH&NLTC&LSC
Clinical Records. CMS modified the requirement at 42 CFR §483.10(g)(2)(ii) which required long-term care (LTC) facilities to provide a resident a copy of their records within two working days (when requested by the resident). Specifically, CMS modified the timeframe requirements to allow LTC facilities ten working days to provide a resident’s record rather than two working days. This waiver was terminated on 05/07/2022 per QSO-22-15-NH&NLTC&LSC
State Licensure: During the PHE, CMS allowed licensed physicians and other practitioners to bill Medicare for services provided outside of their state of enrollment. CMS has determined that, when the PHE ends, CMS regulations will continue to allow for a total deferral to state law. Thus, there is no CMS-based requirement that a provider must be licensed in its state of enrollment.
Required Facility Reporting: Under §483.80(g), long-term care facilities are required to report COVID-19 cases in their facility to the CDC National Health Safety Network (NHSN) on a weekly basis. In COVID-19 Public Health Emergency Interim Final Rule #3 (CMS-3401-IFC), CMS is codifying enforcement actions for facilities noncompliance with this requirement. Failure to report will result in the imposition of a civil money penalty for each occurrence of non-reporting as follows: A civil money penalty of $1,000 for the first occurrence, followed by $500 added to the previously imposed civil money penalty for each subsequent occurrence, not to exceed the maximum amount set forth in § 488.408(d)(1)(iii). Facilities are also required to notify residents, their representatives, and families of residents in facilities of the status of COVID-19 in the facility, which includes any new cases of COVID-19 as they are identified. This action supports CMS’ commitment to transparency so that individuals know important information about their environment, or the environment of a loved one. CMS extended these mandatory COVID-19 reporting requirements beyond the current COVID-19 PHE until December 31, 2024.
Transfers of COVID-19 Patients: A long term care facility can temporarily transfer its COVID-19 positive resident(s) to another facility, such as a COVID-19 isolation and treatment location, with the provision of services “under arrangements.” The transferring LTC facility need not issue a formal discharge in this situation, as it is still considered the provider and should bill Medicare normally for each day of care. The transferring LTC facility is then responsible for reimbursing the other provider that accepted its resident(s) during the emergency period. This is consistent with recent CDC guidance, and helps residents with COVID-19 by placing them into facilities that are prepared to care for them. The SNF should follow the procedures described in 40.3.4 of the Medicare Claims Processing Manual (https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/clm104c06.pdf) to submit a discharge bill to Medicare. The COVID-19 isolation and treatment facility should then bill Medicare appropriately for the type of care it is providing for the beneficiary. If the COVID-19 isolation and treatment facility is not yet an enrolled provider, the facility should enroll through the provider enrollment hotline for the Medicare Administrative Contractor that services their geographic area to establish temporary Medicare billing privileges.  
Inspection, Testing & Maintenance (ITM) under the Physical Environment Conditions of Participation: CMS has been waiving certain physical environment requirements for Hospitals, inpatient hospice, ICF/IIDs, and SNFs/NFs to reduce disruption of patient care and potential exposure/transmission of COVID-19. The physical environment regulations require that facilities and equipment be maintained to ensure an acceptable level of safety and quality. CMS will permit facilities to adjust scheduled inspection, testing and maintenance (ITM) frequencies and activities for facility and medical equipment. Waivers terminated at 418.110(c)(2)(iv) for inpatient hospice, 483.470(j) for ICF/IID and 483.90(a)(1) and (b) for SNFs/NF on 06/06/2022 per QSO-22- 15-NH&NLTC&LSC.
Specific Life Safety Code (LSC) for Multiple Providers. CMS has been waiving and modifying particular waivers under 42 CFR §483.470(j) for ICF/IIDs and §483.90(a) for SNF/NFs. Specifically, CMS modified these requirements as follows:

  • Alcohol-based Hand-Rub (ABHR) Dispensers: We are waiving the prescriptive requirements for the placement of alcohol based hand rub (ABHR) dispensers for use by staff and others due to the need for the increased use of ABHR in infection control. However, ABHRs contain ethyl alcohol, which is considered a flammable liquid, and there are restrictions on the storage and location of the containers. This includes restricting access by certain patient/resident population to prevent accidental ingestion. Due to the increased fire risk for bulk containers (over five gallons) those will still need to be stored in a protected hazardous materials area. Refer to: 2012 LSC, sections 18/19.3.2.6. In addition, facilities should continue to protect ABHR dispensers against inappropriate use as required by 42 CFR §483.470(j)(5)(ii) for ICF/IIDs and §483.90(a)(4) for SNF/NFs.
  • Fire Drills: Due to the inadvisability of quarterly fire drills that move and mass staff together, CMS permited a documented orientation training program related to the current fire plan, which considers current facility conditions. The training will instruct employees, including existing, new or temporary employees, on their current duties, life safety procedures and the fire protection devices in their assigned area. Refer to: 2012 LSC, sections 18/19.7.1.6.
  • Temporary Construction: CMS waived requirements that would otherwise not permit temporary walls and barriers between patients. Refer to: 2012 LSC, sections 18/19.3.3.2.
Expired

Waivers terminated for fire drills at §418.110(d) for inpatient hospice; §483.470(j) for ICF/IIDs; and §483.90(a) for SNF/NFs on 06/06/2022 per QSO-22-15-NH&NLTC&LSC.

Waivers terminated for temporary construction at §418.110(d) for inpatient hospice; §483.470(j) for ICF/IIDs; and §483.90(a) for SNF/NFs on 06/06/2022 per QSO-22-15--NH&NLTC&LSC.
Physician Delegation of Tasks in SNFs: CMS has waived the requirement in § 483.30(e)(4) that prevents a physician from delegating a task when the regulations specify that the physician must perform it personally. This waiver did not include the provision of § 483.30(e)(4) that prohibits a physician from delegating a task when the delegation is prohibited under state law or by the facility’s own policy. This waiver terminated on 05/07/2022 per QSO-22-15-NH&NLTC&LSC.
Physician Visits: CMS waived the requirement at § 483.30(c)(3) that all required physician visits (not already exempted in § 483.30(c)(4) and (f)) must be made by the physician personally. We modified this provision to permit physicians to delegate any required physician visit to a nurse practitioner (NPs), physician assistant, or clinical nurse specialist who is not an employee of the facility, who is working in collaboration with a physician, and who is licensed by the state and performing within the state’s scope of practice laws. This waiver was terminated on 05/07/2022 per QSO-22-15-NH&NLTC&LSC.
Training and Certification of Nurse Aides: CMS waived the requirements at 42 CFR §483.35(d), (except for 42 CFR §483.35(d)(1)(i)), which required that a SNF and NF may not employ anyone for longer than four months unless they met the training and certification requirements under §483.35(d). To ensure the health and safety of nursing home residents, CMS did not waive §483.35(d)(1)(i), which requires facilities to not use any individual working as a nurse aide for more than four months, on a full-time basis, unless that individual is competent to provide nursing and nursing related services. We further note that we did not waive §483.35(c), which requires facilities to ensure that nurse aides are able to demonstrate competency in skills and techniques necessary to care for residents' needs, as identified through resident assessments, and described in the plan of care. Achieving adequate staffing levels may be a concern for SNFs and NFs during the public health emergency. CMS temporarily waived these requirements so they do not present barriers for SNFs and NFs to hire staff; the temporary waiver helped these facilities provide adequate levels of staffing for the duration of the COVID-19 pandemic. This waiver terminated on 06/06/2022 per QSO-22-15-NH&NLTC&LSC.
Paid Feeding Assistants: CMS is modified the requirements at 42 CFR §§ 483.60(h)(1)(i) and 483.160(a) regarding required training of paid feeding assistants. Specifically, CMS modified the minimum timeframe requirements in these sections, which require this training to be a minimum of 8 hours. CMS modified to allow that the training can be a minimum of one hour in length. CMS did not waive any other requirements under 42 CFR §483.60(h) related to paid feeding assistants or the required training content at 42 CFR §483.160(a)(1)-(8), which contains infection control training and other elements. Additionally, CMS did not waive or modify the requirements at 42 CFR §483.60(h)(2)(i), which requires that a feeding assistant must work under the supervision of a registered nurse or licensed practical nurse. This waiver terminated on 06/06/2022 per QSO-22-15-NH&NLTC&LSC
Director of Food and Nutrition Services (New as of 11/26/21): CMS issued a waiver for 42 CFR 483.60(a)(1) and 483.60(a)(2) that requires dietitians hired or contracted with prior to November 28, 2016, to meet the specified requirements no later than five years after November 28, 2016 or as required by state law and to designate a person to serve as the director of food and nutrition services who, for designations prior to November 28, 2016, meets the specified requirements no later than five years after November 28, 2016, or no later than one year after November 28, 2016 for designations after November 28, 2016. The specified requirements involve specialized education or training in food service management and safety resulting in an associate’s or higher degree in hospitality or food service management, a bachelor’s or higher degree granted by a regionally accredited college or university in the United States, a certified dietary manager, or a certified food service manager. These educational and training requirements range in length, at a minimum, of 18 months to four years. It has been unusually challenging for these requirements to be met due to the COVID-19 Public Health Emergency (PHE). Therefore, CMS has been waiving this requirement due to the inability for individuals to enroll in, attend, or complete a certification program due to circumstances related to the COVID-19 PHE. Codified in regulation
Established new requirements for Long Term Care Facilities to Conduct SARS-CoV-2 Testing for Staff and Residents: Under the new 483.80(h) CMS is requiring Long-Term Care (LTC) Facilities to test Staff and Residents. Specifically, facilities are required to test residents and staff, including individuals providing services under arrangement and volunteers, for COVID-19 based on parameters set forth by the Secretary. This rule will enhance efforts to keep COVID-19 from entering and spreading through nursing homes. These regulations are effective on September 2, 2020. These regulations are applicable for the duration of the PHE for COVID–19. Note that section 488.447 is applicable 1 year beyond the expiration of the PHE for COVID–19.

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Centers for Medicare and Medicaid Services — Home Health and Hospice

WaiverStatus
Medicare Telehealth and Telecommunications Technology: Home Health Agencies (HHAs) can provide more services to beneficiaries using telecommunications technology within the 30-day period of care, as long as it’s part of the patient’s plan of care and does not replace needed in-person visits as ordered on the plan of care. Telecommunications technology can include, for example: remote patient monitoring; telephone calls (audio only and TTY); and two-way audio-video technology that allows for real-time interaction between the clinician and patient. However, only in-person visits can be reported on the home health claim.

The required face-to-face encounter for home health can be conducted via telehealth (i.e., 2-way audio-video telecommunications technology that allows for real-time interaction between the physician/allowed practitioner and the patient) when the patient is at home.
This provision is permanent beyond the COVID-19 PHE. Home health services furnished using telecommunication systems are required to be included on the home health claim beginning July 1, 2023.
Medicare Telehealth Hospice: Hospice providers can provide services to a Medicare patient receiving routine home care through telecommunications technology (e.g., remote patient monitoring; telephone calls (audio only and TTY); and two-way audio-video technology), if it is feasible and appropriate to do so. Only in-person visits are to be recorded on the hospice claim.

Face-to-face encounters for purposes of patient recertification for the Medicare hospice benefit can now be conducted via telehealth.
This interim regulatory change will expire at the end of the PHE.



Section 3706 of The CARES Act allowed for face-to-face encounters for purposes of patient recertification for the Medicare hospice benefit can now be conducted via telehealth (i.e., two-way audio-video telecommunications technology that allows for real-time interaction between the hospice physician/hospice nurse practitioner and the patient). This statutory change will expire on December 31, 2024.
"Homebound" Definition: A beneficiary is considered homebound when their physician advises them not to leave the home because of a confirmed or suspected COVID-19 diagnosis or if the patient has a condition that makes them more susceptible to contract COVID-19. As a result, if a beneficiary is homebound due to COVID-19 and needs skilled services, an HHA can provide those services under the Medicare Home Health benefit. This is not a change in the definition of homebound and is irrespective of the COVID-19 PHE
Detailed Information Sharing for Discharge Planning for Home Health Agencies. CMS has been waiving the requirements of 42 CFR §484.58(a) to provide detailed information regarding discharge planning, to patients and their caregivers, or the patient’s representative in selecting a post-acute care provider by using and sharing data that includes, but is not limited to, (another) home health agency (HHA), skilled nursing facility (SNF), inpatient rehabilitation facility (IRF), and long-term care hospital (LTCH) quality measures and resource use measures. CMS is maintaining all other discharge planning requirements. Expired
Plans of Care and Certifying/Recertifying Patient Eligibility: In addition to a physician, section 3708 of the CARES Act allows a Medicare-eligible home health patient to be under the care of a nurse practitioner, clinical nurse specialist, or a physician assistant who is working in accordance with state law. These physicians/practitioners can: 1) order home health services; 2) establish and periodically review a plan of care for home health services (e.g., sign the plan of care); 3) certify and re-certify that the patient is eligible for Medicare home health services. These changes, effective March 1, 2020, provide the flexibility needed for more timely initiation of services for home health patients, while allowing providers and patients to practice social distancing. Specifically, for Medicare, these changes are effective for Medicare claims with a “claim through date” on or after March 1, 2020. This provision has been made permanent beyond the COVID-19 public health emergency and is codified in the regulations at 42 CFR 409.43.
Clinical Records: CMS extended the deadline for completion of the requirement at 42 CFR §484.110(e), which requires HHAs to provide a patient a copy of their medical record at no cost during the next visit or within four business days (when requested by the patient). Specifically, CMS has allowed HHAs ten business days to provide a patient’s clinical record, instead of four. Expired
Training and Assessment of Aides: CMS has been waiving the requirement at 42 CFR §418.76(h)(2) for Hospice and 42 CFR §484.80(h)(1)(iii) for HHAs, which require a registered nurse, or in the case of an HHA a registered nurse or other appropriate skilled professional (physical therapist/occupational therapist, speech language pathologist) to make an annual onsite supervisory visit (direct observation) for each aide that provides services on behalf of the agency. In accordance with section 1135(b)(5) of the Act, we are postponing completion of these visits. All postponed onsite assessments must be completed by these professionals no later than 60 days after the expiration of the PHE. This waiver will expire on July 11, 2023.
12-hour Annual In-Service Training Requirement for Home Health Aides: CMS is modifying the requirement at 42 C.F.R. §484.80(d) that home health agencies must assure that each home health aide receives 12 hours of in-service training in a 12-month period. This flexibility will end on Dec. 31, 2023 and return to pre-PHE requirements at the end of the calendar year that the PHE ends.
Quality Assurance and Performance Improvement (QAPI): CMS has modified the requirements at 42 CFR §418.58 for Hospice and §484.65 for HHAs, which require these providers to develop, implement, evaluate, and maintain an effective, ongoing, hospice/HHA-wide, data-driven QAPI program. Specifically, CMS has modified the requirements at §418.58(a)–(d) and §484.65(a)–(d) to narrow the scope of the QAPI program to concentrate on infection control issues, while retaining the requirement that remaining activities should continue to focus on adverse events. The requirement that HHAs and hospices maintain an effective, ongoing, agency-wide, data-driven quality assessment and performance improvement program will remain. Expired
Waive Onsite Visits for HHA Aide Supervision: CMS has been waiving the requirements at 42 CFR §484.80(h), which require a nurse to conduct an onsite visit every two weeks. This would include waiving the requirements for a nurse or other professional to conduct an onsite visit every two weeks to evaluate if aides are providing care consistent with the care plan, as this may not be physically possible for a period of time. This waiver is also temporarily suspending the two-week aide supervision by a registered nurse for home health agencies requirement at §484.80(h)(1), but virtual supervision is encouraged during the period of the waiver. Postponed visits must be completed by July 10, 2023. CY 2022 Home Health Prospective Payment System Final Rule (CMS 1747-F), CMS finalized the provision for aide supervision for patients receiving skilled care every 14 days to now allow for one virtual visit per 60-day episode per patient and only in rare circumstances. For patients receiving non-skilled care, the registered nurse must make an onsite, in person visit every 60 days to assess the quality of care and services provided by the home health aide and to ensure that services meet the patient’s needs; semi-annually the nurse will make a supervisory direct observation visit for each patient to which the aide is providing services.
OASIS Reporting: CMS is providing relief to HHAs on the timeframes related to OASIS transmission through the following 1) extending the five-day completion requirement for the comprehensive assessment to 30 days; and 2) waiving the 30-day OASIS submission requirement. Delayed submission is permitted during the PHE. We are now allowing 30 days for the completion of the comprehensive assessment. HHAs must submit OASIS data prior to submitting their final claim in order to receive Medicare payment. Expired
Home Health Quality Reporting Program: CMS delayed the compliance dates for collecting and reporting the Transfer of Health Information quality measures and certain standardized patient assessment data elements (SPADEs) adopted for the HH Quality Reporting Program. HHAs are required to begin collecting the Transfer of Health Information quality measures and certain SPADEs on January 1, 2023.
Allow Occupational Therapists (OTs), Physical Therapists (PTs), and Speech Language Pathologists (SLPs) to Perform Initial and Comprehensive Assessment for all Patients: CMS has been waiving the requirements in 42 CFR § 484.55(a)(2) and § 484.55(b)(3) that rehabilitation skilled professionals may only perform the initial and comprehensive assessment when only therapy services are ordered. This temporary blanket allowed any rehabilitation professional (OT, PT, or SLP) to perform the initial and comprehensive assessment for all patients receiving therapy services as part of the plan of care, to the extent permitted under state law, regardless of whether or not the service establishes eligibility for the patient to be receiving home care. As part of the CY 2022 Home Health Prospective Payment System Final Rule (CMS 1747-F), CMS finalized changes to § 484.55(a) and (b)(2) to permanently allow occupational therapists to complete the initial and comprehensive assessments for patients, in accordance with Division CC, section 115 of CAA 2021.
Ordering Medicaid Home Health Services and Equipment: Medicaid home health regulations now allow non-physician practitioners to order medical equipment, supplies and appliances, home health nursing and aide services, and physical therapy, occupational therapy or speech pathology and audiology services, in accordance with state scope of practice laws. Made permanent
"Stark Law" Waivers: The physician self-referral law 1) prohibits a physician from making referrals for certain designated health services payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship, unless the requirements of an applicable exception are satisfied; and 2) prohibits the entity from filing claims with Medicare (or billing another individual, entity, or third party payer) for any improperly referred designated health services. On March 30, 2020, CMS issued blanket waivers of certain provisions of the Stark Law. These blanket waivers applied to financial relationships and referrals that are related to the COVID-19 emergency. The remuneration and referrals described in the blanket waivers must be solely related to COVID-19 purposes, as defined in the blanket waiver document. Expired
Hospice Annual Training. CMS is modifying the requirement at 42 CFR §418.100(g)(3), which requires hospices to annually assess the skills and competence of all individuals furnishing care and provide in-service training and education programs where required. This does not alter the minimum personnel requirements at 42 CFR §418.114. Selected hospice staff must complete training and have their competency evaluated in accordance with unwaived provisions of 42 CFR Part 418. Compliance is required no later than Sept. 30, 2023
Waived Requirement for Hospices to Use Volunteers: CMS has been waiving the requirement at 42 CFR §418.78(e) that hospices are required to use volunteers (including at least 5% of patient care hours). It is anticipated that hospice volunteer availability and use will be reduced related to COVID-19 surge and anticipated quarantine. Compliance is required no later than Dec. 31, 2023
Hospice Comprehensive Assessments: CMS has been waiving certain requirements for Hospice 42 CFR §418.54 related to update of the comprehensive assessments of patients. This waiver applies the timeframes for updates to the comprehensive assessment (§418.54(d)). Hospices must continue to complete the required assessments and updates, however, the timeframes for updating the assessment may be extended from 15 to 21 days. Expired
Waive Non-Core Services: CMS has been waiving the requirement for hospices to provide certain non-core hospice services during the national emergency, including the requirements at 42 CFR §418.72 for physical therapy, occupational therapy, and speech language pathology. Expired
Specific Life Safety Code (LSC) for Hospice: CMS is waiving and modifying particular waivers under 42 CFR §418.110(d) for inpatient hospice. Specifically, CMS is modifying these requirements as follows:
  • Alcohol-based Hand-Rub (ABHR) Dispensers: We are waiving the prescriptive requirements for the placement of alcohol based hand rub (ABHR) dispensers for use by staff and others due to the need for the increased use of ABHR in infection control. However, ABHRs contain ethyl alcohol, which is considered a flammable liquid, and there are restrictions on the storage and location of the containers. This includes restricting access by certain patient/resident population to prevent accidental ingestion. Due to the increased fire risk for bulk containers (over five gallons) those will still need to be stored in a protected hazardous materials area. Refer to: 2012 LSC, sections 18/19.3.2.6. In addition, facilities should continue to protect ABHR dispensers against inappropriate use as required by 42 CFR §418.110(d)(4) for inpatient hospice.
  • Fire Drills: Due to the inadvisability of quarterly fire drills that move and mass staff together, we will instead permit a documented orientation training program related to the current fire plan, which considers current facility conditions. The training will instruct employees, including existing, new or temporary employees, on their current duties, life safety procedures and the fire protection devices in their assigned area. Refer to: 2012 LSC, sections 18/19.7.1.6.
  • Temporary Construction: CMS has been waiving requirements that would otherwise not permit temporary walls and barriers between patients. Refer to: 2012 LSC, sections 18/19.3.3.2.
Expired

Terminated waivers for fire drills at §418.110(d) for inpatient hospice; §483.470(j) for ICF/IIDs; and §483.90(a) for SNF/NFs terminated on 6-6-2022 per QSO-22-15-NH & NLTC & LSC)

Terminated waivers for temporary construction at §418.110(d) for inpatient hospice; §483.470(j) for ICF/IIDs; and §483.90(a) for SNF/NFs on 6-6-2022 per QSO-22-15-NH & NLTC & LSC.

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U.S. Department of Labor, Occupational Health & Safety Administration

Food & Drug Administration — Emergency Use Authorizations

On March 10, the Food and Drug Administration published a notice, without comment period, to provide clarity with respect to the guidance documents that will no longer be effective with the expiration of the federal PHE as well as the guidance documents that FDA is revising to continue in effect for some period of time after the PHE expiration date of May 11, 2023.
https://www.govinfo.gov/content/pkg/FR-2023-03-13/pdf/2023-05094.pdf

General Information:

All FDA guidance documents can be accessed at https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders or https://www.fda.gov/regulatory-information/search-fda-guidance-documents