Section 1135 Waivers in a Declared Emergency: What They Actually Suspend

A Section 1135 waiver is the mechanism CMS uses to temporarily suspend or modify specific Medicare/Medicaid conditions of participation, certification requirements, and sanctions during a declared emergency, so that providers can respond to the actual conditions on the ground without immediately falling out of compliance. For a patient-safety officer, infection preventionist, or quality director, the practical question is narrower than the legal one: which specific requirements actually change, for how long, and what has to be documented once normal enforcement resumes.

The two declarations that have to exist first

Section 1135 authority does not activate on its own. The statute requires both of the following to be in effect at the same time:

• A Presidential declaration of an emergency or disaster under the National Emergencies Act or the Robert T. Stafford Disaster Relief and Emergency Assistance Act, and
• A public health emergency (PHE) declaration by the HHS Secretary under Section 319 of the Public Health Service Act.

Only once both declarations exist can the Secretary invoke Section 1135. In practice this means a hospital’s emergency management team should track two separate declaration streams, not one — a Stafford Act disaster declaration for a hurricane or wildfire does not, by itself, produce 1135 relief; the Secretary’s PHE declaration has to follow (or already be in place) before any 1135 waiver is legally available. The Secretary must give Congress at least two days’ advance written notice before exercising 1135 authority, specifying the geographic emergency area and the classes of providers affected — waivers are scoped to that declared area, not applied nationwide by default.

What Section 1135 actually lets CMS suspend

The statute enumerates specific categories. CMS does not get open-ended authority to waive anything Medicare-related — only what is listed:

Conditions of participation, certification, and program-participation requirements

The Secretary may waive or modify conditions of participation, other certification requirements, and program-participation requirements for an individual provider or a class of providers. This is the broadest category and the one most directly relevant to survey readiness — it is also the category referenced by name inside 42 CFR 482.15(b), which requires a hospital’s emergency preparedness policies to address the hospital’s role under an 1135 waiver in providing treatment at an alternate care site. That is a standing regulatory expectation, not something a hospital only thinks about once an emergency starts.

Pre-approval and licensure requirements

Pre-approval requirements can be waived, and out-of-state licensure requirements can be waived for a provider who holds an equivalent license in another state and is not excluded from practice under Medicare, Medicaid, or CHIP. This is the provision that allows credentialed clinicians from an unaffected state to practice at a receiving hospital during a surge without each holding an in-state license first — medical staff offices still need to verify the out-of-state license and exclusion status; the waiver removes the licensure-jurisdiction barrier, not the verification step.

EMTALA sanctions for transfers, and screening-location flexibility

Section 1135 lets the Secretary waive sanctions under EMTALA for a transfer of an individual who has not been stabilized, where the transfer is necessitated by the circumstances of the declared emergency. It does not waive EMTALA’s underlying duty to provide a medical screening examination and, where an emergency medical condition exists, to stabilize the patient — those obligations continue. What has historically moved, through the blanket waivers CMS issues under this authority during major declared emergencies, is where that screening can happen without triggering a sanction: permitting screening to occur at an alternate, off-campus location that has been designated by the state as part of its emergency response, rather than only at the hospital’s dedicated emergency department. Confirm this specific relief is actually part of the currently active blanket waiver for any given declared emergency before relying on it — blanket waiver contents vary by event and are not standing law.

Physician self-referral (Stark law) sanctions

Sanctions under the physician self-referral prohibition can be waived for referrals and arrangements directly related to the emergency response — this is narrower than a general waiver of Stark; the relationship still has to be tied to the emergency, and legal/compliance should confirm scope before treating an arrangement as covered.

Deadlines and timetables — modified, not waived

The statute is explicit that deadlines and timetables for required activities may only be modified, never fully waived. A reporting or documentation deadline can move; it cannot disappear. This distinction matters for a quality director tracking what is genuinely excused versus what has simply been given more time.

HIPAA privacy sanctions, telehealth, and other narrower categories

The remaining categories are narrower: certain HIPAA privacy sanctions related to specific notice and consent requirements, Medicare Advantage out-of-network payment restrictions, the requirements governing certain telehealth services, and requirements for ground ambulance services furnished under emergency circumstances. None of these amounts to a blanket suspension of HIPAA or of Medicare Advantage network rules generally — each is a specific, named provision.

What an 1135 waiver does not do

The framing that causes the most operational confusion is treating 1135 as a general “emergency mode” switch. It is not. It waives or modifies only the specific items listed above. It does not suspend EMTALA’s screening-and-stabilization duty itself, does not waive HIPAA’s Security Rule, does not suspend general quality and safety Conditions of Participation that are not specifically targeted by CMS’s declaration, and does not relieve a hospital of documenting what it actually did differently. A hospital operating under an active 1135 waiver is still expected to be able to show, after the fact, exactly which waived provision it relied on and why the emergency circumstances required it.

Blanket waivers versus an individual facility request

Once the two triggering declarations are in place, CMS typically issues a set of blanket waivers that apply automatically, without a separate application, to providers in the declared emergency area — this is how most 1135 relief actually reaches hospitals during a large-scale event. A blanket waiver’s specific contents (which CoPs, which EMTALA relief, which duration) are published by CMS for that event and are not identical from one declared emergency to the next; a hospital should check the current, event-specific waiver list rather than assume a prior emergency’s blanket waivers still apply. Where a facility needs relief that is not covered by the standing blanket waivers — a circumstance specific to that hospital rather than the region generally — it can request an individual 1135 waiver through its CMS Regional Office.

How long a waiver lasts, and how it ends

An 1135 waiver terminates at the earliest of three points: the end of the underlying Presidential emergency/disaster declaration, the end of the Secretary’s public health emergency declaration, or 60 days from the date the waiver was first published — whichever comes first. The Secretary can extend a waiver for additional 60-day periods, but an extension cannot outlast either underlying declaration. This has a direct operational consequence that is easy to miss in the middle of an active response: normal Condition of Participation enforcement resumes the moment the waiver ends, with no grace period built into the statute. A hospital that adjusted its EMTALA screening location or relied on out-of-state licensure relief needs a plan for reverting those practices on the waiver’s actual end date, not on the assumption that the emergency “feeling over” extends the legal relief.

What this means for patient-safety and quality staff specifically

• Build waiver tracking into the emergency operations plan itself. 42 CFR 482.15(b) already requires a policy addressing the hospital’s role under an 1135 waiver at an alternate care site — treat the current blanket-waiver list as a standing item reviewed alongside the hazard vulnerability analysis, not a one-time lookup during an active event.
• Verify, do not assume, licensure relief. An out-of-state clinician still needs their license and exclusion status checked against the waived jurisdictional requirement before they treat a patient — the waiver removes a legal barrier, it does not substitute for the medical staff office’s verification step.
• Document every deviation contemporaneously. If patients are screened at an alternate site, or a transfer decision relies on the EMTALA sanction waiver, log which specific waived provision applied and why, at the time it happens. That record is what a surveyor will ask for once normal enforcement resumes — reconstructing it after the fact is far harder than logging it in real time.
• Coordinate the Stark-waiver scope with legal/compliance separately from the clinical waivers. Because Stark relief only covers arrangements directly related to the emergency response, an arrangement entered into during the emergency is not automatically covered just because the emergency is active.

Frequently asked questions

Does a Section 1135 waiver suspend EMTALA?

No. It can waive sanctions for an unstabilized transfer necessitated by the emergency, and blanket waivers have historically extended flexibility on where screening can occur, but the underlying duty to screen and, where an emergency medical condition exists, to stabilize the patient is not suspended.

How is a public health emergency declaration different from an 1135 waiver?

The PHE declaration (under Section 319 of the Public Health Service Act) is one of the two preconditions that must exist before the Secretary can invoke Section 1135 at all. The PHE declaration itself does not waive any Medicare or Medicaid requirement; the 1135 waiver is the separate, subsequent action that does.

How long does an 1135 waiver last?

It ends at the earliest of the emergency/disaster declaration ending, the PHE declaration ending, or 60 days from when the waiver was first published, whichever comes first — with the option for the Secretary to extend in further 60-day increments, capped by whichever underlying declaration ends first.

Does a hospital have to apply for 1135 relief?

Not for the items covered by CMS’s blanket waivers, which apply automatically across the declared emergency area. A facility only needs to make an individual request through its CMS Regional Office for relief specific to its own circumstances that the blanket waivers do not already cover.

What happens to Condition of Participation compliance once the waiver ends?

Normal enforcement resumes immediately — the statute builds in no grace period. Any practice adopted under the waiver (an alternate screening location, relaxed licensure verification) needs to revert on the waiver’s actual end date, and the hospital should be able to show which waived provision covered each deviation while it was in effect.

Does Section 1135 waive HIPAA?

Only in a narrow way — certain sanctions tied to specific notice and patient-consent requirements can be waived. It is not a general suspension of the HIPAA Privacy Rule and does not touch the Security Rule at all.

Related reading

• Patient Safety & Infection Prevention — cluster hub
• EMTALA: Screening, Stabilization, and Transfer Rules — the underlying duty an 1135 waiver only partially modifies
• Hazard Vulnerability Analysis and the CMS Emergency Preparedness Rule — the 42 CFR 482.15 Condition of Participation this page’s waiver-tracking requirement comes from
• Hospital Incident Command System (HICS) — the command structure that actually decides when to invoke waived provisions during an event