Answers To All Your 1135-Waiver Questions

Telemedicine & telehealth services have become an indispensable tool to the healthcare community during the pandemic. They help save lives, promote easy access to healthcare. Virtual services have also aided healthcare-support industries like Medical Coding & Billing and Revenue Cycle Management industries (RCM) service companies. Taking all of this and several other benefits of implementing  a telemedicine system, the government started taking significant steps to truly promote and support telemedicine services during the course of the ongoing pandemic.

The 1135 Waiver authority was issued by the government as part of their emergency response action to aid the people during the pandemic. The waiver authority enables the government body to relax certain restrictions surrounding telemedicine regulations. This has significantly promoted widespread implementation of virtual services. The waiver expanded coverage for all types of telemedicine be it Store & Forward, Remote Patient Monitoring or Real-time telemedicine.

The key details that one needs to be aware of the waiver is that this authorizes the Secretary of Health & Human Services (HHS), Mr. Alex Azar, for the duration of the national emergency to waive or modify certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in Social Security Act programs in the emergency area and time periods and that providers who provide such services in good faith can be reimbursed and exempted from sanctions (absent any determination of fraud or abuse).

• Conditions of participation or other certification requirements
• Program participation and similar requirements
• Pre-Approval requirements
• Requirements that physicians and other healthcare professionals be licensed in the State in which they are providing services, so long as they have equivalent licensing in another State (this waiver is for purposes of Medicare, Medicaid, and CHIP reimbursement only – state law governs whether a non-Federal provider is authorized to provide services in the state without state licensure)
• Emergency Medical Treatment and Labor Act (EMTALA) sanctions for redirection of an individual to receive a medical screening examination in an alternative location pursuant to a state emergency preparedness plan (or in the case of a public health emergency involving pandemic infectious disease, a state pandemic preparedness plan) or transfer of an individual who has not been stabilized if the transfer is necessitated by the circumstances of the declared emergency. A waiver of EMTALA requirements is effective only if actions under the waiver do not discriminate on the basis of a patient’s source of payment or ability to pay.
• Stark self-referral sanctions
• Performance deadlines and timetables may be adjusted (but not waived).
• Limitations on payment to permit Medicare enrollees to use out of network providers in an emergency situation

Now with the enactment and expansion of the waiver, a lot of providers and healthcare professionals still have a lot of questions about what is and isn’t allowed, how are things going to change as a result of this waiver? Till when is this going to be in effect? Is this all under state/federal jurisdiction etc.?

As part of BillingParadise’s initiative to ensure that the right information is conveyed and to do our part to aid the healthcare community during this tumultuous time, we have combed, curated from sources such as, the NHPCO, CMS, Medicare & Medicaid community forums & we have listed some of the most common FAQ pertaining to the 1135 waiver authority. If your question has not been answered here, please comment it below and we will do our best to see that it is answered.

Today. When the President declared a disaster or emergency under the National Emergencies Act and the HHS Secretary declared a public health emergency under Section 319 of the Public Health Service Act, the Secretary of the U.S. Health and Human Services (HHS) was authorized to take certain actions in addition to his regular authorities

An 1135 waiver may temporarily waive or modify or provide flexibility of certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in Social Security Act programs in the emergency area and time periods and that providers who provide such services in good faith can be reimbursed and exempted from sanctions (absent any determination of fraud or abuse).

Once an 1135 Waiver is authorized, in past emergencies, health care providers have submitted requests to operate under that authority to the State Survey Agency or CMS Regional Office. The requests generally have included a justification for the waiver and expected duration of the modification requested. Providers and suppliers have been asked to keep careful records of beneficiaries to whom they provide services, in order to ensure that proper payment may be made. The State Survey Agency and CMS Regional Office have reviewed the provider’s request and make appropriate decisions, usually on a case-by-case basis. CMS has approved specific waivers and modifications only to the extent that the provider in question has been affected by the disaster or emergency. . Providers are expected to come into compliance with any waived requirements prior to the end of the emergency period.

Federally certified/approved providers must operate under normal rules and regulations, unless they have sought and have been granted modifications under the Waiver authority from specific requirements.

With both the national emergency declaration and the PHE are active, the Secretary can use §1135 authority to waive the following:

• Conditions of participation or other certification requirements for individual healthcare providers or types of providers, program participation and similar requirements for individual healthcare providers or types of providers, and pre-approval requirements
• Requirements that physicians and other healthcare professionals be licensed in the state in which they provide services, if they have equivalent licensing in another state and are not affirmatively excluded from practice in that state or in any state that is included, in whole or in part, in the emergency area
• Actions under section 1867 relating to examination and treatment for emergency medical conditions and women in labor (i.e., EMTALA)
• Sanctions under section 1877(g) relating to limitations on physician self-referral
• Deadlines and timetables for performance of required activities, except that such deadlines and timetables may only be modified, not waived
• Limitations on payments under section 1851(i) for healthcare items and services furnished to individuals enrolled in a Medicare Advantage plan by healthcare professionals or facilities not included under such plan
• Sanctions and penalties that arise from noncompliance with certain provisions under HIPAA.

CMS has used the §1135 authority to issue numerous waivers not only to help providers address the emerging challenges of treating patients with COVID-19, but also to ensure providers’ ability to deliver ongoing care to patients in non-COVID-19 situations. Providers and other stakeholders have widely appreciated CMS’s actions. Almost all of these §1135 waivers are tied to the existence of both the PHE and the national emergency declaration. Should one or both of these declarations end, barring other Administrative action, the waiver flexibilities would no longer be in effect.

Waivers end no later than the termination of the emergency period, or 60 days from the date the waiver or modification is first published unless the Secretary of HHS extends the waiver by notice for additional periods of up to 60 days, up to the end of the emergency period.

A specific waiver or modification granted as a result of the emergency may be retroactive to the beginning of the emergency or disaster if warranted

CMS may implement specific waivers or modifications under the 1135 authority on a “blanket” basis, when a determination has been made that all similarly situated providers in the emergency area needed such a waiver or modification.

• The decision to implement a “blanket” waiver or modification of a specific Medicare, Medicaid or CHIP requirement is based on the need and frequency of requests for specific waivers or modifications in response to the disaster or emergency.
• While blanket authority for these modifications may be allowed, the provider should still notify the State Survey Agency and CMS Regional Office if operating under these modifications to ensure proper payment.

You can email and/or mail your request to your CMS Regional Office. The requests must include a justification for the waiver and expected duration of the modification. You should also email your request to 1135waiver@cms.hhs.gov.

Once an 1135 Waiver is authorized, health care providers can submit requests to operate under that authority or for other relief that may be possible outside the authority to the CMS Regional Office with a copy to the State Survey Agency.

The Secretary’s ability to waive telehealth requirements is distinct from the §1135 authority. Congress provided specific telehealth waiver authority through two of the COVID-19 stimulus bills. The Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (the first stimulus bill) gave the Secretary authority to waive two specific requirements for telehealth services under 1834(m): the “originating site” requirements and restrictions on the type of telecommunication used for providing telehealth services.

The CARES Act subsequently expanded the telehealth waiver authority to include all provisions in 1834(m). CARES also authorized the following waivers:

• Allowed Federally Qualified Health Centers and rural health clinics to provide telehealth services to Medicare beneficiaries
• Eliminated the requirement that Medicare beneficiaries with end-stage renal disease receiving home dialysis have a face-to-face clinical assessment at least once every three months
• Allowed Medicare beneficiaries receiving hospice care to have a face-to-face encounter via telehealth with a hospice physician or nurse practitioner to recertify continued eligibility for hospice care
• Required the Secretary of HHS to issue clarifying guidance regarding the use of telecommunications systems for home health services, including remote patient monitoring
• Increased reimbursement to hospitals by providing a 20% add-on payment for inpatient hospital discharges related to COVID-19
• Waived the requirement that patients of an Inpatient Rehabilitation Facility receive at least 15 hours of therapy a week (three hours of therapy per day, five days per week)
• Adjusted transition rules for payment reductions for durable medical equipment
• Required Medicare prescription drug plans and Medicare Advantage drug plans to permit Part D plan enrollees to obtain a 90-day supply of a covered Part D drug (even if the drug is subject to cost and utilization management, medication therapy management or other such programs)
• Expanded the type of hospitals eligible for the Medicare hospital accelerated payment program.

Under these CARES Act provisions, CMS took significant action to increase access to and use of telehealth services, and to provide flexibilities for providers to complete certain administrative requirements virtually. Greater reliance on virtual care and administration is intended to limit patient travel and exposure to COVID-19 and reduce the spread of the virus, in adherence to other federal guidelines. At the same time, telehealth gives providers an opportunity to provide some healthcare services to their patients without a face-to-face encounter, preserving revenue during the crisis.

The two stimulus laws specified that these authorities and waivers are permitted for the duration of the PHE, but they are not tied to the existence of a national emergency declaration. This means that the telehealth waivers, along with the CARES Act policies noted above, could continue to exist if the national declaration ended, as long as the PHE remained in effect.

• Provider Name/Type
• Full Address (including county/city/town/state) CCN (Medicare provider number)
• Contact person and his or her contact information for follow-up questions should the Region need additional clarification.
• Brief summary of why the waiver is needed. For example: CAH is the sole community provider without reasonable transfer options at this point during the specified emergent event (e.g. flooding, tornado, fires, or flu outbreak). CAH needs a waiver to exceed its bed limit by X number of beds for Y days/weeks (be specific).
• Consideration – Type of relief you are seeking or regulatory requirements or regulatory reference that the requestor is seeking to be waived.
• There is no specific form or format that is required to submit the information, but it is helpful to clearly state the scope of the issue and the impact.

If a waiver is requested, the information should come directly from the impacted provider to the appropriate Regional Office mailbox with a copy to the appropriate State Agency for Health Care Administration to make sure the waiver request does not conflict with any State requirements and all concerns are addressed timely.

Some recommended language to include in addition to any specific requests for your organization is as follows:
The blanket waivers issued by CMS did not directly address the critical role performed by hospice providers in delivering compassionate palliative care during this nationwide public health emergency. In addition to clarifying that hospice providers are specifically included in the categories of providers to which the blanket waivers apply, we ask that CMS afford these providers with additional flexibility to confront the challenges caused by COVID-19 through the following waiver requests:

• Suspending all face-to-face visit requirements by hospice physicians and nurse practitioners in favor of permitted telephone and telehealth modalities (42 C.F.R. § 418.22(a)(4))
• Extending the five-day timeframe for hospice providers to submit Notices of Election and Notices of Termination/Revocation (42 C.F.R. § 418.24)
• Encouraging all included hospice services to be provided virtually through telephone and telehealth modalities as determined by the hospice plan of care, including visits from all hospice disciplines, including nursing, social worker, spiritual services, bereavement and other counseling, and any other type of service specified in the plan of care
• Temporarily suspending the requirement of supervision of hospice aides by a registered nurse every 14 days for hospice agencies (42 C.F.R. § 418.76)
• Suspending the requirement that hospices conduct background checks on employees with direct patient contact or access to records before hiring them, such that employees can be onboarded while the background check is processed (42 C.F.R. § 418.113)
• Suspending the volunteer requirements to reflect that many hospice volunteers, who tend to be elderly themselves, are not visiting patients and respecting limitations on social interaction (42 C.F.R. § 418.78(b))
• Limiting the provision of rehabilitative services, including physical therapy, occupational therapy, and speech therapy as these services tend to be limited in hospice care generally, workforce challenges are becoming more acute, and the suspension of these services will serve to respect calls for limited social interaction.
• Delay the implementation of the hospice election statement changes and the hospice election statement addendum, scheduled to begin on October 1, 2020 until two months after the national emergency is concluded.

• ROATLHSQ@cms.hhs.gov (Atlanta RO): Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee
• RODALDSC@cms.hhs.gov (Dallas RO): Arkansas, Louisiana, New Mexico, Oklahoma, Texas
• ROPHIDSC@cms.hhs.gov (Northeast Consortium): Delaware, District of Columbia, Maryland, Pennsylvania, Virginia, West Virginia, New York, New Jersey, Puerto Rico, Virgin Islands, Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont
• ROCHISC@cms.hhs.gov (Midwest Consortium): Illinois, Indiana, Michigan, Minnesota, Ohio, Wisconsin, Iowa, Kansas, Missouri, Nebraska
• ROSFOSO@cms.hhs.gov (Western Consortium): Colorado, Montana, North Dakota, South Dakota, Utah, Wyoming, Alaska, Idaho, Oregon, Washington, Arizona, California, Hawaii, Nevada, Pacific Territories.

No, 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.

Yes, CMS 1135 waiver authority includes the ability to grant state and territorial Medicaid agencies a wider range of flexibilities, and states may now submit Section 1135 waiver requests for CMS approval that will remove administrative burdens and expand access to needed services.