CMS 1135 waivers allow the U.S. Department of Health and Human Services Secretary to temporarily waive or modify certain Medicare, Medicaid, Children’s Health Insurance Policy (CHIP), and Health Insurance Portability and Accountability Act (HIPAA) requirements to ensure that sufficient health care items and services are available to meet needs during a declared public health emergency. Individual health care providers and associations may trigger additional waivers through feedback and requests to the Assistant Secretary for Preparedness and Response or CMS Regional Offices.

As 1135 waiver authority only applies to federal requirements, state administrations may also waive, suspend or relax health care provider laws and regulations for licensure or state-specific conditions of participation. During the current public health emergency, many state hospital associations are petitioning their state executives and departments of health requesting temporary relief from regulations that are viewed as impediments to their COVID-19 response.

The following is a chronology of Missouri’s waiver process during the 2020 COVID-19 declared emergency:

A. CMS Blanket Waivers: Link On March 13, 2020, CMS granted the following blanket waivers:

Provider Enrollment Flexibilities

• Suspended certain Medicare enrollment screening requirements, including site visits.
• Allow licensed providers to render services outside their state of enrollment.
• Establish a toll-free hotline for providers to enroll and receive temporary Medicare billing privileges.

Flexibility and Relief for State Medicaid Agencies

• Permit out-of-state providers to render services.
• Suspend certain provider enrollment and revalidation requirements.
• Allow providers to provide care in alternative settings.
• Waive prior authorization requirements.
• Suspend certain pre-admission and annual screenings for nursing home residents.

Enforcement Activities

• Suspend non-emergency survey inspections.

B. Duration of CMS Blanket Waivers: The waivers will last for the duration of the declared emergency, unless terminated sooner (42 USC § 1320b-5).

C. CMS Additional 1135 Medicaid Waivers for States: Link CMS has approved state-specific 1135 waivers for the following states:

• Florida (3/17/2020)
• Washington (3/19/2020)
• Alabama (3/23/2020)
• California(3/23/2020)
• Illinois (3/23/2020)
• Louisiana (3/23/2020)
• Mississippi (3/23/2020)
• New Hampshire (3/23/2020)
• New Jersey (3/23/2020)
• New Mexico (3/23/2020)
• North Carolina (3/23/2020)
• Virginia (3/23/2020)

D. Additional Waivers Requested by Missouri Hospital Association to Governor Parsons: In separate letters on 3/16/20 and 3/18/20, MHA has requested that the state suspend or waive the following requirements through executive order to allow for immediate effect:

Hospitals

• Officially adopt all waivers granted by CMS as applicable to the state licensure standards.
• Allow hospitals to exceed the licensed bed capacity stated on their licensure for the duration of the emergency.
• Allow hospitals to place inpatients in non-licensed patient care areas, including sites located off the licensed campus.
• Permit the use of designated beds for any condition requiring inpatient admission, including the use of long-term care units for the care of acute patients.
• Relax discharge provisions to create capacity to treat patients with higher acuities.
• Grant an automatic 6-month extension of any hospital license scheduled to expire during the declared emergency period.
• Extend the licensure expiration date for all health care professions for 6-months including related certifications and registrations, and to call upon licensing boards to process temporary license applications within 2 days.
• Grant authority to deviate from diversion plans to more efficiently move patients to alternative sites of care, including outside the boundaries of the hospital’s written plan.
• Waive certain screenings required to transfer a patient from a hospital to a long-term setting.
• Allow hospitals to disclose and warn first responders when they are dispatched to the home of a Person Under Investigation or suspected of having COVID-19, not just confirmed cases.
• Remove impediments to hospitals to establish alternate child care sites.

Telehealth/Telemedicine

• Allow health care providers to provide telemedicine services in alternate sites and by alternate means.

Advanced Practice Registered Nurses and Physician Assistants

• Allow APRNs and PAs to provide all services within their scope of license despite any limiting provisions in their collaborative practice agreements, and to suspend geographic limitations allowing them to work in any needed area of the state.
• Waive the requirement that a collaborating physician be present and review care provided to acute or chronically ill patients by an APRN, and the requirement that an APRN work continuously with a physician for 1 month allowing immediate work within their scope of practice.

Medicaid Managed Care

• Allow suspension of prior authorization requirements, consistent with state policy.
• Expedite the enrollment of providers.
• Minimize the administrative burden on providers for administrative review processes.

E. Additional Waivers Requested from CMS by the Missouri Department of Social Services: The Division Director for MO HealthNet intends to request waivers of federal Medicaid requirements to:

• Allow provider enrollment functions to streamline participation and reimbursement, including providers located outside the state who treat Missouri Medicaid participants.
• Modify or suspend Missouri’s state plan prior authorization processes or requirements.
• Waiver the requirement that manage care enrollees exhaust the managed care organization review procedures prior to a state level hearing.
• Allow authority to suspend copayment requirements.
• Seek federal authority to waive PASRR screenings entirely to facilitate hospital discharge of patients needing continued long-term care.

F. Executive Order No. 20-04 of the Governor of Missouri: Link On March 18, 2020, the Governor of Missouri ordered, upon approval of the Office of the Governor, the following:

• Authority for the Director of the Department of Health and Senior Services to temporarily waive or suspend any statutes and regulations which would prevent, hinder or delay necessary action by the Department to respond to the COVID-19 health threat, during the period of the emergency and subsequent recovery period.
• Authority for the Director of the Department of Social Services to temporarily waive or suspend any statutes and regulations to best serve the public health and safety, during the period of the emergency and subsequent recovery period.
• Suspends telemedicine laws that prevent physicians from treating patients via telephone or other electronic means without first establishing an in-person physician-patient relationship.

G. Waivers Issued by the Missouri Department of Health and Senior Services: Link On March 20, 2020, the Director of the Department of Health and Senior Services issued waiver and suspension of the following licensing regulations:

Hospitals

• Allow a 6-month extension for any hospital license scheduled to expire during the declared emergency period.
• Allow hospitals to establish alternative screening sites and sites of care away from the licensed premises and place inpatients in non-licensed patient care areas.
• Allow non-licensed remote sites to be considered part of the hospital’s licensed premises for treatment and billing purposes.
• Allow hospitals to exceed their licensed bed capacity.
• Permits the used of medical or surgical beds for intensive care.
• Waive construction standards to all alternative screening and treatment sites.
• Allow the use of a hospital long-term care units for the care of acute inpatients

H. 1135 Waivers Requested from CMS by the Missouri Department of Social Services: Link On March 20, 2020, the Director of MO HealthNet Division requested the following 1135 Waivers from CMS:

Strengthening the Workforce

• To allow additional providers to offer both emergency and non-emergency care to Missouri’s MO HealthNet populations.
• To allow physicians and other healthcare professionals be licensed in Missouri.
• To allow flexibility so that enrolled Home and Community Based Services (HCBS) providers may provide alternative HCBS.
• To allow temporary flexibility in existing protocols between teaching physicians and residents while providing care in teaching hospitals.

Emergency Medical Treatment and Labor Act (EMTALA)

• To suspend EMTALA requirements for a medical screening examination, giving hospitals the ability to triage and divert individuals without obvious emergency medical conditions to alternative COVID-19 screening sites.
• To expand the definition of appropriate transfer to allow for the transfer of patients to a facility offering a lower level of care, so long as the accepting facility has the capacity and capability to treat the patient.
• To allow hospitals to deny transfers unless the accepting facility offers a level of care needed by the patient that cannot be provided by the transferring hospital.

Telehealth

• To allow telehealth visits without an established physician-patient relationship and allow phone visits from the patient’s phone.
• To allow flexibility for licensed and certified home health agencies to provide home health services by telehealth.
• Update: On March 23, 2020, MO HealthNet Division issued the following flexibilities:
  • Allows any licensed provider, enrolled as a MO HealthNet provider, to provide telehealth services within the scope of practice for which they are licensed to any participant. Same standard of care as in-person services.
  • Allows services to be provided to a participant, while at home, using their telephone. The originating site facility fee cannot be billed when the originating site is the participant’s home.

Personal Care Services and Authorized Nurse Visits

• To allow flexibility to deliver services not prior authorized by the state.
• To allow flexibility to deliver personal care services not in accordance with a service plan approved by the state.
• To allow flexibility to conduct authorized nurse visits via telephone as appropriate.
• To allow flexibility to deliver personal care services not in accordance with a service plan approved by the state in a licensed residential care facility I or II.
• To allow flexibility to allow HCBS providers to deliver non-emergency medical transportation at the current HCBS provider rate.

Personal Care Services (Consumer-Directed Model)

• To allow flexibility to deliver services not prior authorized by the state.
• To allow flexibility to deliver personal care services not in accordance with the service plan approved by the state.
• To allow flexibility in required training and orientation of the consumer.
• To allow flexibility in required qualification and training of the attendant.
• To allow flexibility to waive certain compliance requirements of Consumer Directed Service providers.

Community Psychiatric Rehabilitation (CPR) services, Comprehensive Substance Treatment and Rehabilitation (CSTAR) services, and Certified Community Behavioral Health Clinics (CCBHC) services

• To allow flexibility to permit telephonic and other telehealth/electronic means for providing services.
• To allow flexibility to continue prospective payments to CCBHCs and fee-for-service payments to non-CCBHC FFS providers for services delivered via non-face-to-face telehealth methods.
• To allow flexibility to waive client signatures on required documents.
• To allow flexibility to allow community support services to be delivered by all clinical staff with appropriate training.
• To allow flexibility to waive certain training requirements for new community support specialists, peer support specialists, and family support specialists.

Division of Developmental Disabilities (DD) Targeted Case Management services

• To allow flexibility to allow temporary modifications to the individual support plan process with verbal approval through non-face-to-face methods.
• To allow flexibility to allow approval and authorization of ISP changes, via verbal or electronic approval.

Payment Limitations

• To permit the state to lift the restriction of the cost maximums for personal care services.

Provider Enrollment and Revalidation Efforts

• A blanket waiver to allow the state to waive the following screening requirements to provisionally and temporarily enroll providers:
  • Payment of the enrollment application fee;
  • Fingerprint based criminal background checks;
  • Pre-enrollment site visits; and
  • In-state/territory licensure requirements.
• A blanket waiver to allow the state to temporarily cease revalidation of providers.

Prior Authorization Requirements

• To allow waiver of all prior authorization requirements at the state’s discretion.
• To allow waiver of pre-admission screening and annual resident review (PASRR) Level I and II assessment requirements.

Timely Filing Requirements for Billing

• To allow waiver of the timely filing requirements.

Appeals and State Fair Hearings

• To allow flexibility to temporarily delay scheduling of appeals, Medicaid state fair hearings and issuance of fair hearing decisions during the emergency period.
• To allow flexibility to temporarily allow notification of fair hearings rights via telephone.

Public Notice Requirements

• To allow waiver to public notice rules for state plan amendments that only provide or increase beneficiary access to items or services related to COVID19 and would not be a restriction or limitation on payment or services or otherwise burden beneficiaries.

Performance Deadlines

• To allow flexibility in timing and implementation of conducting external quality review and activities and additional quality functions.

Critical Access and Alternative Settings

• A blanket waiver of the number of beds and length of stay requirements for critical access hospitals.
• A blanket waiver to allow facilities to provide services in alternative settings, such as a temporary shelter when a provider’s facility is inaccessible.
• To allow flexibility to deliver HCBS waiver services in alternative settings including a hospital, shelter, or other appropriate setting.

I. The Office for Civil Rights Issues COVID-19 and HIPAA Guidance for Covered Entities: Link On March 24, 2020, the Office for Civil Rights at the US Department of Health and Human Services, which is responsible for HIPAA enforcement, has stated that the HIPAA Privacy Rule permits a covered entity to disclose protected health information (PHI) of an individual who has been infected with, or exposed to, COVID-19, with law enforcement, paramedics, other first responders, and public health authorities without the individual’s HIPAA authorization, in certain circumstances, including the following:

• When the exposure is needed to provide treatment.
• When such notification is required by law.
• To notify a public health authority in order to prevent or control the spread of disease.
• When first responders may be at risk of infection.
• When the disclosure of PHI to first responders is necessary to prevent or lessen a serious and imminent threat to the health and safety of a person or the public.
• When responding to a request for PHI by a correctional institution or law enforcement official having lawful custody of an inmate or other individual, if the facility or official represents that the PHI is needed for:
  • Providing health care to the individual;
  • The health and safety of the individual, other inmates, officers, employees and other present at the correctional institution, or person responsible for the transporting or transferring or inmates;
  • Law enforcement on the premises of the correctional institution; or
  • The administration and maintenance of the safety, security, and good order of the correctional institution.
• General considerations:
  • Except when required by law, or for treatment disclosures, as covered entity must make reasonable efforts to limit the information used or disclosed under any provision listed above to that which is the “minimum necessary” to accomplish the purpose for the disclosure. 45 CFR § 164.502(b).

J. Additional 1135 Waivers Granted by CMS to the Missouri Department of Social Services: Link On March 25, 2020, CMS approved the following waiver and flexibilities related to Medicare, Medicaid, and CHIP, waiver or modification requests that require amendment to the state plan or through a section 1115 demonstration are currently under review:

Provider Enrollment

• Authorized to reimburse out-of-state providers for multiple instances of care to multiple participants, so long as all other applicable criteria is met.
• Authorized to provisionally, temporarily enroll providers who are certified and enrolled with another state Medicaid agency (SMA) or Medicare for the duration of the public health emergency.
• CMS waives the following screening requirements:
  • Payment of the application fee;
  • Criminal background checks associated with fingerprints;
  • Site visits; and
  • In-state/territory licensure.
• Authority to enroll providers who are not currently enrolled with another SMA or Medicare so long as the state meets the following minimum requirements:
  • Must collect minimum data requirements to file and process claims, including, but not limited to NPI; and
  • Must collect Social Security Number, Employer Identification Number, and Taxpayer Identification Number, as applicable, to perform the following screening requirements:
    • OIG exclusion list; and
    • State licensure – provider must be licensed to practice or deliver services for which they file claims, in at least one state/territory.
  • May allow a retroactive effective date for provisional, temporary enrollments no earlier than March 1, 2020.
• Authority to temporarily cease revalidation of Missouri providers.
• Provider enrollment emergency relief efforts apply to CHIP, to the extent possible.
• Authority to temporarily suspend Medicaid fee-for-service prior authorization (pre-approval) requirements.
• Allow for waiver or modification of pre-approval requirements to permit services approved on or after March 1, 2020, to extend through the termination of the public health emergency.
• Allow facilities, including nursing facilities, intermediate care facilities, psychiatric residential treatment facilities, and hospital nursing facilities to be fully reimbursed for services rendered to an unlicensed facility.
• Suspend Pre-Admission Screening and Annual Resident Review (PASRR) level I and II assessments for 30 days. All new admissions can be treated like exempted hospital discharges. After 30 days, new admissions with mental illness or intellectual disability should received a residential review as soon as resources become available.
• Allow enrollees to have more than 90 days, up to an additional 120 days, for an eligibility or fee-for-service appeal to request a state fair hearing.
• Allow modification of the timeline for managed care plans to resolve appeals to 1 day, so that a managed care enrollee may proceed almost immediately to a state fair hearing.
• Allow managed care enrollees an additional 120 days to request a state fair hearing when the initial 120-day deadline would have occurred between March1, 2020, through the end of the public health emergency.
• Allow the state plan amendment (SPA) to temporarily provide or increase beneficiary access to items and services related to COVID-19 (such as cost sharing waivers, payment rate increases, or amendments to alternative benefit plans to add services or providers) and that would not restrict or limit payment or services or otherwise burden beneficiaries and providers.
• Allow the state to waive the public notice requirements for SPA submissions, but only with respect to SPAs that provide or increase beneficiary access to items and services related to COVID-19. Even though CMS is approving this waiver, they encourage Missouri to make all relevant information available to the public, so they are aware of the changes.
• Unless otherwise specified, the 1135 Waivers described are effective March 1, 2020, and will terminate upon termination of the public health emergency, including any extensions.