Influenza Pandemic Emergency Preparedness – Waiver of Certain Medicare Requirements

Provisions for temporarily waiving EMTALA duty under a disaster scenario (as opposed to H1N1) were included in the Pandemic and All Hazards Preparedness Act of 2006 (P.L. 109-417) and are addressed in the first question.

Question: What is HHS’s process for approving and issuing Emergency Medical Treatment and Labor Act (EMTALA) waivers for hospitals that have implemented hospital disaster protocols in response to an emergency?

Answer: There are 4 prerequisites for a hospital waiver of EMTALA sanctions under HHS’s authority under Section 1135 of the Social Security Act. They are as follows:

1. the President has declared an emergency or disaster under the Stafford Act or the National Emergencies Act,
2. the Secretary of HHS has declared a Public Health Emergency (PHE) under Section 319 of the Public Health Service Act,
3. the Secretary of HHS has invoked his authority under Section 1135 of the Social Security Act and authorized CMS to waive sanctions for certain EMTALA violations that arise as a result of the circumstances of the emergency, and
4. the hospital in the affected area has implemented its hospital disaster protocol

Question: It was my understanding that only the HHS Secretary had the authority to issue 1135 waivers (which could be requested by States), but a 12/7/07 CMS memo (Waiver of Emergency Medical Treatment and Labor Act (EMTALA) Sanctions in Hospitals Located in Areas Covered by a Public Health Emergency Declaration) indicates that the Regional Office (RO) "may issue an advisory notice that hospitals with dedicated emergency departments in the emergency area will not, during the emergency period, be subject to" certain EMTALA sanctions, if both the President and Secretary declare emergencies. Does the issuance of an advisory notice by the RO carry the same weight as an 1135 waiver

Answer: No. The December 7, 2007 CMS memorandum referenced in the question is part of the standard operating procedure describing how CMS will implement the EMTALA provisions of a Section 1135 waiver issued by the Secretary. The RO’s issuance of an "advisory notice" occurs only after the Secretary has invoked his 1135 waiver authority delegating the specifics to the CMS Administrator, and after the Administrator of CMS has waived certain EMTALA sanctions for 72 hours for the hospital(s) in the affected area with dedicated emergency departments that have implemented their hospital disaster protocol. Furthermore, in a refinement to the process described in the December 7 memorandum, CMS now requires hospitals in the affected area to notify CMS, through the appropriate State Survey Agency, when they implement a hospital disaster protocol.

Question: What is HHS’s procedure for addressing requests from States to waive EMTALA? How frequent are such requests?

Answer: We currently handle these matters on a case-by-case basis. In any local, regional or national disaster - tornado, hurricane, wildfires, etc, --States, providers, trade groups and other stakeholders can and do communicate regularly with CMS and the State survey agencies to inform CMS about local conditions that may require unique consideration. State survey agencies are responsible for reporting the status of health care providers affected by the emergency to their CMS Regional Office. CMS makes recommendations to the Secretary, based on the status information. Because our recommendations are informed by the specific circumstances, we do not believe that a formal procedure is necessary at this time.