Understanding Emergency Declarations and Waivers in Healthcare

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 cant 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&As for details. Mandatory Reporting Requirements 42 CFR 485.620(a) and 485.620(b) Limit CAHs to 25-beds & 96 hour length of stay 42 CFR 412.23(b)(2) - IHR Inpatient Rehabilitation Rules & 3 day hospital qualifying stay

5. EMTALA Waiver 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) Duration 72 Hours after activation of hospital disaster plan or Indefinite during pandemic infections disease Preconditions Presidential Declaration under Stafford or National Emergencies Act and HHS Secretary Declaration of Public Health Emergency

6. 1135 Waiver Review Process 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 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 waiversmust 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, email 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 412.25 (b)(3)) Bed changes 42 CFR 405.2164 (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/ http://www/fema.gov/government/grant http://www.oes.ca.gov http://ww.cdc.gov/niosh/topics/flood/ http://www.fda.gov/cdhr/emergency/

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