When the White House declared a national emergency in mid-March, it allowed the authorization of waivers of certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements, often referred to as Section 1135 waivers. 

Section 1135 waivers are either “blanket” waivers, which apply to a group of providers, or “case-by-case” or “individual” waivers, which apply to individual providers. With some exceptions (e.g. for EMTALA), these waivers 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 exception is if the Secretary of U.S. Health & Human Services (HHS) extends the waiver by notice for additional periods of up to 60 days, up to the end of the emergency period. 

Notably, Section 1135 waivers apply only to federal requirements and do not apply to state requirements for licensure or conditions of participation. As such, providers must ensure that they take appropriate steps to comply with state law.

Blanket Waivers

For blanket waivers, providers do not take any additional action. Providers may conduct their operations subject to these waivers immediately. That said, Centers for Medicare & Medicaid Services (CMS) previously recommended that while blanket authority for modifications to its regulations 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.

In that same vein, providers should follow prevailing guidance on any modifications to coding and billing practices for services provided under the waiver and providers should maintain careful records of services.

On March 13, 2020, CMS announced a set of Section 1135 blanket waivers and then a subsequent MLN Matters, including waivers for skilled nursing facilities (waiving 3-day hospitalization for coverage), critical access hospitals (waiving 25-bed limit and 96-hour stay limit), and home health agencies (waiving timeframes for OASIS transmissions). 

A few days later, CMS announced an additional blanket waiver to allow Medicare payment for office, hospital, and other visits provided via telehealth. Since, CMS and other divisions within HHS have issued additional waivers, including with respect to EMTALA, HIPAA, the 340B Drug Discount Program, and the Stark law. Providers should continue to monitor this process for purposes of operating under available Section 1135 waivers.

Case-by-Case Waivers

For a case-by-case waiver, providers need to request CMS to issue the waiver. Iowa providers may email their request to the CMS Regional Office (ROCHISC@cms.hhs.gov) with a copy to Iowa Department of Inspections & Appeals (hfdwaivers@dia.iowa.gov). 

In order for the agency to process the request as quickly as possible, the request should contain the following information:

• Provider name/type
• Full address (i.e., county/city/town/state) and CCN (Medicare provider number)
• Contact person, and his or her contact information
• Brief summary of why the waiver is needed
  • e.g.“CAH is 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, i.e. the type of relief being sought or the regulatory requirements or regulatory reference that the requestor to be waived.

For additional information on requesting Section 1135 Waivers, refer to CMS website on Section 1135 Waivers, which includes a outline on Requesting an 1135 Waiver 101 

Iowa Requirements

As noted, Section 1135 waivers apply to federal requirements. With respect to any state requirements that need to be waived or modified in order for a provider to operate in a certain manner during an emergency, a provider may request the applicable state agency to make the waiver or modification. 

In Iowa, the Iowa Department of Inspections & Appeals (DIA) has requested that such state-only waivers be sent by email to the agency (hfdwaivers@dia.iowa.gov) and that such requests should include the following:

• Name, address, and type of facility
• Rule(s) for which the waiver/variance is being requested
• Briefly state why compliance with the rule(s) at this time would pose an undue hardship
• Briefly describe how the variance will not endanger the health, safety, or welfare of any resident or infringe upon the rights of any person

In addition, a state Medicaid agency may request CMS to waive certain Medicaid regulations, e.g. to waive prior authorization or suspend certain provider enrollment. On March 25, 2020 CMS approved Iowa’s waiver request seeking flexibility in its implementation of the Medicaid Program rules during the COVID-19 pandemic. These waivers will allow Iowa to waive copays and premiums for Medicaid members, provide home delivered meals to more Medicaid beneficiaries, and provide additional flexibility for home and community based services providers.  A summary of the Medicaid waivers Iowa requested and received is available at https://dhs.iowa.gov/sites/default/files/DHS_COVID19_MedicaidResponse.pdf?032620201229.  Additional information on Iowa Medicaid rules and responses to COVID-19 is available at https://dhs.iowa.gov/sites/default/files/DHS_COVID19_MedicaidProviderToolkit.pdf?032620201241