1. Karen M. Fuller Centers for Medicare & Medicaid Services
WCDSC Manager-SF CLIA, State Operations and WCDSC Emergency Coordinator
San Francisco Regional Office

2. Authority for 1135 Waivers Presidential Declaration
National Emergencies Act (e.g., H1N1); or
Robert T. Stafford Act (Gov. asks Pres. to make Declaration (e.g., San Diego fires)
Secretarial Declaration of a Public Health Emergency under Section 319 of PHS Act (definition of “emergency area” and “time period”
State emergency declarations are not relevant

3. 1135 of the Social Security Act Waivers
Section 1135 of the Social Security Act authorizes the Secretary to waive or modify certain Medicare, Medicaid or CHIP requirements in certain kinds of emergencies
Federal Requirements only, not state licensure
Scope
Allow reimbursement during an emergency or disaster even if providers can’t comply with certain requirements that would under normal circumstances bar Medicare, Medicaid or CHIP payment
Generally speaking, coverage rules, payment rules, and rules applicable to beneficiaries may NOT be waived or modified under this authority
Purpose
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. (72 hour limit refer to EMTALA)
Duration

4. Examples of Modifications under 1135 Waiver Authority
MDS – Refer to CMS Q&A’s for details.
Mandatory Reporting Requirements
42 CFR (a) and (b)
Limit CAHs to 25-beds & 96 hour length of stay
42 CFR (b)(2) - IHR
Inpatient Rehabilitation Rules & 3 day hospital qualifying stay

5. EMTALA Waiver
Preconditions
Presidential Declaration under Stafford or National Emergencies Act and HHS Secretary Declaration of Public Health Emergency
Duration
72 Hours after activation of hospital disaster plan or
Indefinite during pandemic infections disease
Allows
Direction or relocation (e.g., 2011 N.D. ED) to alternate off-campus site
Transfers of individuals with unstable emergency medical conditions (as necessary)

6. 1135 Waiver Review Process Is there an actual need?
Within defined Emergency Area?
Is there an actual need?
Will Regulatory relief requested actually address stated need?
Can this be resolved within current regulations?
Should we consider individual or blanket (rare) waiver issued)?
What is the expected duration?

7. Waiver Review Inputs CMS State Emergency and Licensure Staff
Facility
State Emergency and Licensure Staff
HHS Regional Emergency Coordinators
Provider Associations
CMS

8. Expectations of Waived Providers
Request
Provide sufficient information to justify actual need & what law or regulation is being waived, why, and for how long.
Law does not allow anticipatory waivers—must be actual event/need.
Waived
Providers and suppliers will be required to keep careful records of beneficiaries to whom they provide services, in order to ensure that proper payment may be made.
Will receive verbal, or written letter approval by CMS.
Normal Ops
Providers must resume compliance with normal rules and regulations as soon as they are able to do so

9. Options without an 1135 Waiver (subject to State licensure)
Bed Increases
Excluded Unit increases (42 CFR (b)(3))
Bed changes
42 CFR (SPDFs)
Not to exceed 8 months for SPDFs
Initial Certification of Providers &
Special Purpose Dialysis Facilities (SPDFs)
Subject to case by case determination
Modification of Enforcement Activities

10. EMTALA-No Waiver Alternate Screening Site On Campus
Hospital Owned-Operated Property
May be re-directed to alternate site
Tent in Parking lot, auditorium
Off-Campus Hospital Controlled Sites
For initial presentation. Cannot re-direct from ED to off-campus site
ILI Screening Center
Community Screening Clinics
Public notice of location and services
May be staffed by personnel from hospital, but not billing on behalf of the hospital for services

11. Summary 1135 Waivers dependent on situation and national Declarations.
Waivers reviewed on case-by-case basis using national guidelines and inputs (most common CAH bed increase/los waivers, temporary relocation of residents to other facilities with non-waived bed increases granted, short term relocation of emergency departments of hospitals).
Reimbursement questions can be coordinated with S&C but Medicare and Medicaid Divisions and contractors provide determinations and instructions.
Patient and individual safety is always our first consideration.
Action in response and recovery requires collaborative timely action – we have and will continue to do this together.

12. Selected References http://www.cms.hhs.gov/SurveyCertEmergPrep/

13. Karen Fuller 415 744-3741 Karen.Fuller@cms.hhs.gov
Thank you
Karen Fuller