CMS 1135 Waiver for National Disaster and Emergency
What are Section 1135 waivers?
Section 1135 waivers provide a temporary relaxation of certain, healthcare regulatory requirements in the event of a declared disaster or emergency. In the past, the waivers have been issued for natural disasters and pandemics, such as Hurricane Katrina and H1N1 influenza, and focused on specific concerns related to those events and their impact on the healthcare system and provision of care. Section 1135 Waivers are useful in addressing any Medicare/Medicaid provider enrollment-related issues and flexibilities questions or concerns. They are meant to allow sufficient health care items and services to be available to meet the needs of Medicare, Medicaid and CHIP beneficiaries and allow health care providers that provide such services in good faith can be reimbursed for them and not subjected to sanctions for noncompliance, absent any fraud or abuse.
What Medicare and Medicaid flexibilities can states seek through a Section 1135 waiver request?
See the flexibilities below (these are federal flexibilities and not regarding state licensure):
- Provider Locations: Temporary waiver of the requirement that out-of-state providers be licensed in the state where they provide services when they are licensed in another state. This temporary waiver applies to Medicare and Medicaid reimbursement requirements but not to CHIP or state licensing requirements.
- Provider Enrollment: Establishment of a toll-free hotline for non-certified Part B suppliers, physicians and non-physician practitioners to enroll and receive temporary Medicare billing privileges. Waiver of the application fee, finger-based criminal background checks and site visit are typically part of the screening requirements. Postponement of all revalidation actions. Ability for licensed providers to render services outside of their state of enrollment, and expedited handling of any pending or new applications from providers.
- Medicare Appeals in Fee-for-Service, Medicare Advantage and Part D: Extension of time to file an appeal and waiver of timeliness for requests for additional information to adjudicate the appeal. Appeals will be processed even with incomplete Appointment of Representation forms, but communicating only to the beneficiary. Requests for appeal that do not meet the required elements will be processed using information that is available. All flexibilities available will be used in the appeal process as if good cause requirements are satisfied.
- Skilled Nursing Facilities (SNFs): Waiver of the three-day prior hospitalization requirement for coverage of an SNF stay. Beneficiaries may be transferred because of the emergency without a prior qualifying hospital stay, and certain beneficiaries’ SNF coverage, once benefits are exhausted, may be renewed. CMS also waived the timeframe requirements for Minimum Data Set assessments and transmission.
- Critical Access Hospitals (CAHs): Waiver of the 25-bed limit requirement for CAHs and waiver of 96-hour limit on length of stays.
- Housing Acute Care Patients in Excluded Distinct Part Units: Waiver to allow acute care hospitals to house acute care inpatients in excluded distinct part units. The Inpatient Prospective Payment System hospital is instructed to annotate in the medical record that the patient is an acute care inpatient being housed in the excluded unit because of capacity issues related to the emergency.
- Durable Medical Equipment (DMEPOS): Authorization for contractors to waive the face-to-face visit, new physician’s order or medical necessity requirements for replacement of DMEPOS when the DMEPOS is lost, destroyed, irreparably damaged, or otherwise rendered unusable or unavailable as a result of the emergency.
- Care for Excluded Inpatient Psychiatric Unit Patients in the Acute Care Unit of a Hospital: Ability for acute care hospitals to relocate inpatients from excluded distinct part psychiatric units to acute care beds and units if necessary. The affected hospital is instructed to annotate the medical record to indicate the patient is a psychiatric inpatient being cared for in an acute care bed because of capacity or exigent circumstances related to the emergency.
- Care for Excluded Inpatient Rehabilitation Unit Patients in the Acute Care Unit of a Hospital: Ability for acute care hospitals to relocate inpatients from excluded distinct part rehabilitation units to acute care beds and units if necessary. The affected hospital is instructed annotate the medical record to indicate the patient is a rehabilitation inpatient being cared for in an acute care bed because of capacity or exigent circumstances related to the emergency.
- Supporting Care for Patients in Long-Term Care Acute Hospitals (LTCHs): Ability for LTCHs to exclude patient stays where an LTCH admits or discharges patients in order to meet the demands of the emergency from the 25-day average length of stay requirement otherwise applicable to LTCHs.
- Home Health Agencies (HHAs): Relief to HHAs regarding the timeframes related to OASIS Transmission and allowing Medicare Administrative Contractors to extend the auto-cancellation date of Requests for Anticipated Payment during emergencies (note that this is an extension of time and not a waiver of completion).
- Part B Prescription Refills: Medicare payment may be permitted for replacement prescription fills (for a quantity up to the amount originally dispensed) of covered Part B drugs in circumstances where dispensed medication has been lost or otherwise rendered unusable or unavailable due to the emergency.
Do Section 1135 waivers affect State laws or regulations?
Under section 1135, only certain Federal requirements relating to Medicare, Medicaid, CHIP, and HIPAA may be waived or modified. An 1135 waiver does not affect State laws or regulations.
Is there a list of states who have applied for Section 1135 waivers?
The Centers for Medicare and Medicaid Services has an up to date list of states who have applied for these waivers. This can be found on the CMS Current Emergencies web page. In addition, Kaiser Family Foundation has posted a list of state data and state health care policy actions regarding coronavirus. See State Data and Policy Actions to Address Coronavirus.
What brought about Section 1135 Waivers?
On January 31, 2020, the Secretary of Health and Human Services (HHS) declared a public health emergency under section 319 of the Public Health Service Act (42 U.S.C. 247d), in response to COVID-19. On March 13, President Trump declared a national emergency due to COV-19. As a result of these declarations, the Secretary of HHS may exercise the authority under section 1135 of the Social Security Act to temporarily waive or modify certain requirements of the Medicare, Medicaid, and State Children’s Health Insurance programs and of the Health Insurance Portability and Accountability Act Privacy Rule throughout the duration of the public health emergency declared in response to the COVID-19 outbreak.
How can CMS implement these waivers?
CMS may implement Section 1135 waivers in several ways, although all require that CMS determine that a provider has been affected by the disaster or emergency that prompted the issuance of the waivers. CMS has the option to issue Section 1135 waivers that require providers to request and receive approval for relief on a case-by-case basis, or CMS can implement “blanket” waivers. Blanket waivers may be issued when CMS has determined that all similarly situated providers in an identified emergency area need such a waiver or modification. Often, as with natural disasters, the “emergency area” is limited. In other cases, such as pandemics, the emergency area may be much more expansive. CMS considers several factors when determining whether to provide a specific or blanket waiver or modification, including the scope and severity of the emergency, the expected duration, feedback from the state survey agency and state and federal emergency response officials, and supporting data gathered by state provider associations. Any waivers or modifications issued by CMS pertain only to federal requirements, and providers must ensure that any steps they take in accordance with the waivers also comport with state law.
Did CMS release guidance on how these waivers affect CRNA practice?
The current CMS guidance does not focus on specific areas that affect CRNA anesthesia practice such as working in ICUs ORs and triaging incoming COVID-19 patients. However, the agency releases guidance almost daily and the AANA is tracking the CMS coronavirus web page to see if there is information that can be added to this FAQ.
Approximately how long will the process take for approving/denying a waiver request?
CMS will review and validate the 1135 waiver requests utilizing a cross regional Waiver Validation Team. The cross-regional Waiver Validation Team will review waiver requests to ensure they are justified and supportable. HHS anticipates that requests to operate under 1135 Waiver flexibilities should be responded to within three business days of receipt.
What do the Section 1135 waivers not do?
1135 waivers are not a grant or financial assistance program. They do not allow for reimbursement for services otherwise not covered. They do not allow individuals to be eligible for Medicare who otherwise would not be eligible. And they do not last forever - they last 30-60 days or the duration of the emergency.
How does a state apply for a Section 1135 waiver?
There is no specific form or format that is required to submit the request for a Section 1135 waiver, but the state should clearly state the scope of the issue and the impact. States and territories may submit a Section 1135 waiver request to email@example.com.
CMS Temporary Supervision Removal
What does the Centers for Medicare & Medicaid Services’ action to waive the requirement for supervision mean for CRNAs?
The Centers for Medicare & Medicaid Services (CMS) Conditions of Participation, or CoPs, are federal regulations with which particular healthcare facilities must comply in order to participate – that is, receive funding from – the Medicare and Medicaid programs, the largest payors for healthcare in the U.S. As part of the CoPs, CMS requires that CRNA anesthesia services be under the supervision of a physician. This waiver temporarily removes this CoP, which is a federal requirement. State laws in place regarding supervision or other physician involvement will still remain in effect, meaning that CRNA services may still need to be under the supervision of a physician. CRNAs will not have to be under the supervision of a physician in states without any supervision requirements. State law requirements concerning supervision are available on the AANA's Opt Out Toolkit. (requires member login).
When does this waiver become effective and how long will it apply?
This waiver becomes effective immediately. Waivers such as this one typically end no later than the termination of the emergency period, or 60 days from the date the waiver or modification is first published. The waiver would then end unless the Secretary of Health and Human Services extends the waiver by notice for additional periods of up to 60 days, up to the end of the emergency period.
Does this only remove supervision for Medicare patients/cases?
No. This waiver of supervision requirements applies to all patients/cases within Medicare-certified facilities, regardless of payor. Please note, however, that this CMS waiver does not affect existing requirements that may imposed by private payors, e.g., Aetna, Blue Cross, etc.
How does this affect Medicaid?
This applies to Medicaid to the extent that the Part A facility conditions of participation also apply to Medicaid. However, Medicaid is a federal/state hybrid program, and Medicaid requirements under state law will still apply. This CMS waiver also does not affect participation or direct reimbursement to healthcare providers under Medicaid.
How does this affect CRNA ability to bill QZ?
Billing under Part B, including modifiers like QZ, etc., are not affected by this CMS waiver.
Medicare Reimbursement Critical Care During the COVID-19 Pandemic
Can CRNAs be paid for providing critical care services during the Covid-19 pandemic?
Under current Medicare reimbursement policy there is nothing that expressly precludes CRNAs from being paid under Medicare Part B for critical care services provided in the intensive care unit (ICU) setting. In CMS’ recent guidance, COVID-19 FAQs, the agency did not address the issue of paying specialty clinicians (e.g. CRNAs) for critical care services. This is also true regarding the CMS’ recent telehealth waiver, which includes critical care telehealth codes.
CMS’ general policy regarding payment for Critical Care is available in the Medicare Claims Processing Manual for codes (codes 99291 - 9292) can be found at: Section 30.6.12 – Critical Care Visits and Neonatal Intensive Care. It is important to note that although Medicare may technically pay Part B claims for critical care services, actual reimbursement will depend on your Medicare Administrative Contractor’s (MAC) local coverage determinations (LCDs) AND whether your state’s scope of practice laws supports CRNAs providing critical care outside of the perioperative setting.
As CMS provides updates to its COVID-19 FAQs, we will post links and update this document on AANA’s Covid-19 webpage. For specific questions regarding CMS policy, please contact AANA’s Federal Government Affairs (FGA) at firstname.lastname@example.org or (202) 484-8400 and for questions regarding state scope of practice please contact AANA’s State Government Affairs (SGA) at email@example.com or (847) 655-1130.
I am interested in finding out what am I allowed to do as a CRNA under my state’s Scope of Practice (SOP) laws?
Under Medicare Part B regulations (42 C.F.R. §410.69 (b)) Medicare will pay for reasonable and necessary medical or surgical services furnished by CRNAs if they are legally authorized to perform these services in the State in which the services are furnished. State scope of practice laws will vary in its support for CRNAs providing critical care services outside of the perioperative setting. AANA’s Professional Practice Division has prepared a Scope of Nurse Anesthesia Practice document that provides an overview of issues that include but are not limited to: education, licensure, certification, accountability and clinical anesthesia practice.
In addition, AANA’s SGA Division has prepared various SOP summaries based on each state’s statutes and regulations obtained from its regulatory agencies and AANA’s legislative and regulatory tracking services. The SGA Division works diligently at keeping these documents current; however, SGA cannot guarantee their accuracy and therefore these summaries do not constitute legal advice. For legal advice, please consult an experienced healthcare attorney.
I am interested in finding information on my Medicare Administrative Contractor’s (MAC) local coverage determinations (LCDs) regarding reimbursement for critical care services. Where may I find this information?
Medicare contracts its administrative functions out to entities known as Medicare Administrative Contractors or (MACs) for processing claims. Each MAC is given wide latitude to administer the Medicare program for its designated region. The MACs also have discretionary authority to establish which services are reasonable and necessary and therefore considered a covered Medicare benefit. These covered benefits are documented in policy documents know as Local Coverage Determinations (LCDs). Find the MAC for your region here. Each MAC’s LCDs may be accessed through the MAC’s website under its medical policy page. For other questions please contact AANA’s FGA Division at firstname.lastname@example.org or (202) 484-8400.
As a CRNA, how will I be reimbursed for providing critical care services?
CRNAs should be utilized as advanced care providers to expand the Nation’s critical care workforce, see Medicare Reimbursement for CRNAs Serving as Advanced Practice Providers in Critical Care Settings.
Medicare Telehealth Services and How They Impact CRNA Services
Note: Telehealth services provided must be within state scope of practice. Ability to provide services via telehealth does not authorize scope of practice elements or prescriptive authority that are not already included in state scope of practice.
How has the Centers for Medicare and Medicaid Services (CMS) expanded telehealth services for providers?
The use of Telehealth under Medicare has been historically low because it was limited to rural areas, but due to the coronavirus crisis, CMS is expanding this benefit on a temporary and emergency basis under the Section 1135 waiver authority and the Coronavirus Preparedness and Response Supplemental Appropriations Act (HR 6704). Under this new waiver, Medicare can pay for office, hospital and other visits furnished via telehealth across the US and including patient’s homes starting on March 6, 2020. CRNAs have been eligible to be telehealth providers prior to this expansion, but this wavier expands the circumstances for CRNAs to provide telehealth. Before this waiver, Medicare would only pay for telehealth on a limited basis such as when the person receiving the service lives in a rural area and then they leave their home to go to a clinic, hospital or certain other types of medical facilities for that service.
Are CRNA telehealth services covered?
Under the CMS 1135 Waiver, CRNAs are included in the list of providers that can care for patients using telehealth services. Reimbursement is dependent on your Medicare Administrative Contactor (MAC) and their Local Coverage Determinations (LCDs), on state scope of practice laws, and existing Medicare policy.
What are the five types of telehealth services can be provided to Medicare beneficiaries?
There are five types of telehealth services physicians and other professionals (including CRNAs) can provide: Medicare telehealth visits, virtual check-ins, e-consults, remote patient monitoring and e-visits. There are now 171 new telehealth codes that can be billed for under the Medicare Physician Fee Schedule. To the extent that a National Coverage Determination (NCD) or Local Coverage Determination (LCD) would otherwise require a face-to-face visit for evaluations and assessments, clinicians would not have to meet those requirements during the public health emergency.
What are the common telehealth services and codes CRNAs can use to treat patients?
Please see the document released by CMS on March 30, 2020 entitled Physicians and Other Clinicians: CMS Flexibilities to Fight COVID-19, which lists in great detail the services that providers can now provide under the five categories of telehealth services so that clinicians can take care of their patients while mitigating the risk of the spread of the virus. These codes include services such as critical care services, emergency department visits, initial hospital care and hospital discharge day management and initial and continuing intensive care services. Under
the public health emergency, all beneficiaries across the country can receive Medicare telehealth and other communications technology-based services wherever they are located. Providers can provide these services to new or established patients. In addition, providers can waive Medicare copayments for these telehealth services for beneficiaries in Medicare.
Where can telehealth services be provided?
Telehealth services can be provided to both new and existing beneficiaries in any location, in both urban and rural areas, including a private home. This applies to all existing Medicare telehealth services. The visits can be via telephone call and also the visits do not have to contain both an audio and a visual component as was previously required.
What is the frequency of certain telehealth services that can be provided?
The following services no longer have limitations on the number of times they can be provided by Medicare telehealth: a subsequent inpatient visit can be furnished via Medicare telehealth, without the limitation that the telehealth visit is once every three days; a subsequent skilled nursing facility visit can be furnished via Medicare telehealth, without the limitation that the telehealth visit is once every 30 days; and critical care consult codes may be furnished to a Medicare beneficiary by telehealth beyond the once per day limitation.
How can I find out if I can offer my services in another state?
With the 1135 waivers, governors have been making state licensure and telehealth requirements more flexible by allowing out of state providers to treat patients across state lines. The requirements that are waived are at federal level and not at the state level.
Providers must look at each state law and executive orders to see what the state licensure requirements are. Check state boards of nursing for these requirements also, because each state is unique and may have different licensure requirements.
What technology can I use to provide telehealth services, if I don’t have dedicated audio/visual equipment?
Telehealth visits can be conducted over the phone and do not need to include both an audio and a video component. Furthermore, the OIG is providing flexibility for providers to reduce cost sharing for telehealth. Also, physicians and other practitioners will not be subject to administrative sanctions for reducing or waiving any cost-sharing obligations Federal health care program beneficiaries may owe for telehealth services furnished consistent with then applicable coverage and payment rules. See OIG Policy Statement Regarding Physicians and Other Practitioners That Reduce or Waive Amounts Owed by Federal Health Care Program Beneficiaries for Telehealth Services During the 2019 Novel Coronavirus (COVID-19).
Could I be subject to penalties under HIPAA for using devices like smartphones to provide telehealth services?
The Office of Civil Rights (OCR) will exercise its enforcement discretion and will not impose penalties for noncompliance with the regulatory requirements under the HIPAA Rules against covered health care providers in connection with the good faith provision of telehealth during the COVID-19 nationwide public health emergency. A covered health care provider that wants to use audio or video communication technology to provide telehealth to patients during the COVID-19 nationwide public health emergency can use any non-public facing remote communication product that is available to communicate with patients (e.g. Apple Face Time or Facebook Messenger). See Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency.
Can certain medications be prescribed to patients evaluated using telehealth?
DEA registered practitioners may issue prescriptions for controlled substance to patients for who they have not conducted an in-person meeting with. Here is the press release.
DEA-registered practitioners may continue this telemedicine practice for as long as the designation is in effect, if all required conditions are met:
- The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice
- The telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system.
- The practitioner is acting in accordance with applicable Federal and State law.
Will traditional malpractice insurance cover me if I offer telehealth consultation services during COVID-19?
Consult your malpractice insurance carrier. Traditional Medical malpractice insurance coverage depends on your carrier.
Have commercial insurance plans expanded their benefits to cover COVID-19 related services?
Yes, we have heard that commercial health plans are expanding their benefits and/or relaxing requirements to cover services such as testing, cost sharing, prior authorization requirements, expanding access to telehealth and nurse/provider hotlines.
Can providers be reimbursed under CMS while they are physically in the home (under quarantine)?
CMS doesn't limit where providers can practice. They can add their own home address to their Medicare Enrollment by reaching out to their Medicare Administrative Contractor (MAC). It would be effective immediately so providers can provide care without a disruption. See 42 CFR 424.516 for more information. If a CRNA reassigns his/her billing rights to a clinic or group practice that clinic or group practice must add the individuals home address to their Medicare enrollment by reaching out to their MAC.