A Light in the Storm: Section 1135(b) Waivers During Disaster or Emergency

By Sara Avakian
Attorney, Polsinelli
By Elizabeth Tucker
Attorney, Polsinelli

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Original Publish Date: April 9, 2019

Disasters such as the California wildfires, the North Dakota flooding, H1N1 pandemic, and Hurricanes Michael, Harvey, and Irma have had a tremendous impact on health care providers. When disaster strikes, resources are often stretched thin – and delivering quality care to patients while juggling an understaffed facility due to displaced employees and federal regulatory requirements can present significant challenges. Section 1135 of the Social Security Act provides relief to health care providers by authorizing the Secretary of the Department of Health and Human Services (“the Secretary”) to grant waivers from compliance with Medicare, Medicaid, and Children’s Health Insurance Program requirements after either the President has declared an emergency or disaster or the Secretary has declared a Public Health emergency.¹ These Section 1135(b) waivers relieve health care providers from the added burdens of technical compliance with federal health care programs during declared emergencies; but, they do not affect state law requirements.²

Section 1135 of the Social Security Act allows the Secretary to temporarily waive or modify the application of certain certification requirements of subchapters XVIII, XIX, or XXI, or any regulation thereunder.³ Specifically, the Secretary may grant waivers during an emergency period for the following categories:

Conditions of participation and other certification and program participation requirements;
Pre-approval requirements;
Requirements that health care professionals be licensed in the State in which they practice, as 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);
Sanctions under Emergency Medical Treatment and Labor Act (“EMTALA”) for redirecting a patient to an alternate provider and sanctions under Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (note, HIPAA and EMTALA waivers are subject to special time limitations: a 72-hour period beginning upon implementation of the hospital’s disaster protocol);
Sanctions for self-referrals under Stark law;
Performance deadlines and timetables (these requirements may be delayed, but not waived altogether); and
Limitations on payment for Medicare enrollees to obtain services from out of network providers.⁴

In determining whether to grant an 1135(b) waiver request, the Centers for Medicare and Medicaid Services (“CMS”), at the direction of the Secretary, considers whether the waiver or modifications will allow the requesting provider the opportunity to provide care while responding to the emergency or disaster. To make this determination, CMS may grant waivers in different capacities and scopes. Some waivers may be granted for specific providers in specific geographic areas.⁵ Alternatively, CMS may also apply a “blanket” waiver, where CMS determines that all providers are similarly situated and may require similar waivers. For example, in the past, CMS has issued a blanket waiver for all hospitals in an affected region waiving the transfer requirements under EMTALA, or granting temporary requests for increases in the number of certified beds.⁶

There are a multitude of providers that may request an 1135(b) waiver: hospitals, including acute care, critical access hospitals, long term care hospitals, and inpatient rehabilitation facilities; skilled nursing facilities; durable medical equipment, prosthetics, orthotics and supplies (“DMEPOS”) providers; home health providers; Intermediate Care Facilities for the Developmentally Disabled; rural health clinics and federally qualified health clinics; End Stage Renal Disease (ESRD) facilities; ambulance providers; and physicians. In addition, waivers may be granted to beneficiaries, such as an extension to file an appeal.

Due to the broad range of public health emergencies, the specific type of relief sought may vary widely depending on the type of provider requesting an 1135(b) waiver.

A few examples of relief sought by provider type include:

Hospital or Skilled Nursing Facilities requesting to increase their certified bed capacity;
Hospitals requesting to screen or triage patients at an offsite location;
Hospitals requesting to transfer a patient who has not been stabilized;
Critical Access Hospitals requesting an extension to the 25 bed and 96 hour length of stay limit;
Skilled Nursing Facilities requesting exception to three-day prior hospitalization;
Intermediate Care Facilities for the Developmentally Disabled or Skilled Nursing Facilities requesting payment for services provided to beneficiaries in alternative physical settings, such as shelters; and
DMEPOS requesting waiver of the face-to-face requirement for certain DMEPOS.

There is no specific form or format that is required, but the request for waiver should clearly state the scope of the issue, the impact and the relief the entity is seeking. The waiver request should include the following: provider name and type; full address; Medicare provider number (CCN); contact person with contact information; a brief summary of why the waiver is needed; the type of relief sought; and the specific regulatory requirements that the facility is seeking to be waived.⁷

The waiver request should be submitted to the state department of health (“State Agency”) and the appropriate CMS Regional Office. Applicants may want to seek legal counsel regarding their particular situation when preparing waiver requests.

Overall, it is recommended that providers be familiar with the 1135(b) waiver process especially given that emergencies are unexpected and can develop quickly. In addition, providers should consider updating their emergency plan to include guidance on the 1135(b) process.

About the Authors:

Sara Avakian is a health care attorney with Polsinelli who focuses on the regulatory, compliance and operational issues facing health care providers, including long-term care providers, senior housing entities and hospitals. She also counsels health care professionals on licensure and disciplinary matters. Contact Sara at savakian@polsinelli.com or 312.873.2993.

Elizabeth (Ellie) Tucker is a health care attorney with Polsinelli whose practice focuses on senior-housing and long term care providers, as well as acute and post-acute care providers. Her work includes legal advice for an array of regulatory, operational, and compliance issues facing these providers. Contact Ellie at etucker@polsinelli.com or 314.622.6661.

Notes

¹ 42 U.S.C.A. § 1320b-5(g)(1).
² Additional Emergency and Disaster-Related Policies and Procedures That May Be Implemented Only With a § 1135 Waiver, CTRS. FOR MEDICARE & MEDICAID SERVS., 5 (Sept. 14, 2018) https://www.cms.gov/about-cms/agency-information/emergency/downloads/medicareffs-emergencyqsas1135waiver.pdf
³ 42 U.S.C.A. § 1320b-5(b).
⁴ 42 U.S.C.A. § 1320b-5(b)(1)-(7).
⁵ See generally 1135 Waiver At A Glance, CTRS. FOR MEDICARE & MEDICAID SERVS., (last visited Mar. 4, 2019), https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/Downloads/1135-Waivers-At-A-Glance.pdf
⁶ Id. at 3-4.
⁷ 1135 Waiver Request Communication Method – Best Practice, CTRS. FOR MEDICARE & MEDICAID SERVS., 5 (last visited Mar. 4, 2019) https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/Downloads/What-Information-to-Provide-for-an-1135-Waiver-Request.pdf