On January 11, 2021, the Centers for Medicare & Medicaid Services (CMS) released a new web portal to more easily permit healthcare providers and other stakeholders to submit requests for specific waivers of certain healthcare regulatory requirements under Section 1135 of the Social Security Act (Section 1135 waivers). Providers now have the ability to submit requests for waivers to CMS and confirm the presence of existing waivers through a centralized web portal.

IN-DEPTH

During the coronavirus (COVID-19) public health emergency, CMS issued a broad variety of Section 1135 waivers on a “blanket” basis applicable to various provider types. CMS also gave providers the ability to request and receive approval for specific relief on a case-by-case basis based on a provider’s specific facts and circumstances. CMS’s instructions to providers regarding how they should request Section 1135 waivers has varied considerably over the course of the pandemic. CMS has now established a standardized form that providers may fill out to request case-by-case Section 1135 waivers and to confirm whether certain waiver types are already in place through prior pronouncements. This information remains relevant to providers, particularly in light of the recent extension of the COVID-19 public health emergency through April 21, 2021.

Background

On March 13, 2020, following the declaration of a national emergency under the National Emergencies Act and an emergency determination under the Stafford Act, CMS began issuing waivers of certain Medicare, Medicaid and Children’s Health Insurance Program (CHIP) requirements, as authorized by Section 1135 of the Social Security Act (collectively, Section 1135 waivers), to assist with the response to the COVID-19 pandemic. Since the first blanket waivers were issued, CMS has regularly published updated and revised blanket waivers and guidance under Section 1135. The blanket Section 1135 waivers do not require providers to submit a request to CMS or notify CMS’s Regional Offices and are applicable nationally to a broad group of providers, reflecting the nationwide effects of the COVID-19 crisis.

Providers and suppliers that have identified the need for additional waiver relief under Section 1135 based on their specific facts and circumstances in relation to the COVID-19 pandemic may also apply for “case-by-case” waivers over and above those provided in the blanket waivers. However, the guidance for how, exactly, a provider should request specific relief has changed over time (including e-mailing a specific CMS inbox and contacting the provider’s CMS Regional Office) and providers have expressed frustration regarding the submission and review of Section 1135 waivers.

Overview of Section 1135 Portal

The new CMS streamlined portal provides a standardized form that providers may fill out to request a case-by-case Section 1135 waiver or to submit an inquiry related to a public health emergency. This portal provides the following standardized fields that a provider will need to complete in order to submit a request for one or more specific Section 1135 waivers:

• Contact information

• Type of organization

• All applicable CMS identification numbers for the organization (i.e., CCN/Provider, Medicare Contract Number or NPI)

Providers can select the appropriate waiver or flexibility type from a drop-down menu, and also have the option to request a new waiver or flexibility request type. CMS also is requesting that providers furnish information on any regulation(s) affected by the waiver or flexibility request in order to understand which aspect of the regulation the provider seeks to have waived. Finally, the provider must provide a summary of why the waiver is needed and the specific relief sought. The portal will permit providers to submit multiple waiver or flexibility requests in the same form submission.

In addition to serving as a mechanism to make requests, CMS designed the portal to assist providers in determining whether an existing waiver or flexibility type may already exist, before the provider submits a narrative description of the waiver or flexibility they seek. CMS has provided links to YouTube videos demonstrating the use of the portal. Additional guidance on the Section 1135 waiver request process is available here.

Importantly, requests for individual waivers of sanctions under the Stark Law may not be submitted through the new CMS portal. Rather, requests for specific Stark Law waivers still must be submitted via e-mail to 1877CallCenter@cms.hhs.gov. Additional information on the process for requesting a specific Stark Law waiver request may be found here.

Key Takeaways

The inconsistencies of using email correspondence as a mechanism to request additional case-by-case waivers under Section 1135 has been frustrating for hospitals and providers. CMS has now established a more streamlined and standardized portal to simplify the process of requesting a Section 1135 waiver based on an individual provider’s specific facts and circumstances, which may prove helpful as the COVID-19 public health emergency remains in effect.