On Friday, the President declared a national health emergency for H1N1 flu in order to waive certain federal regulatory requirements.

According to an explanation prepared by the Association of State and Territorial Health Officials, those restrictions that can be waived include:

• Certification requirements for some doctors to be paid byMedicare, Medicaid and SCHIP programs
• Pe-approval requirements for some services
• Requirements that doctors be licensed in the same state they're practicing in order to get federal payments
• •Sanctions under EMTALA for certain procedures
• A handful of other requirements governing how medical
  providers are paid.
   

The U.S. Department of Health & Human Services explains that under a declared emergency, facilities granted a Section 1135 waiver no longer need to obtain a patient's agreement to speak with family members or friends involved in the patient's care, no longer need to distribute a notice of their privacy practices and no longer need to honor the patient's right to request privacy restrictions or confidential communications.

"For example," an HHS document on HIPAA explains, "an individual may request that her health care provider call her at her office, rather than her home. A health care provider must accommodate
an individual's reasonable request for such confidential communications."

With a Section 1135 waiver granted by the CMS in a declared emergency, however, the provider need not accommodate the request in the example of calling the patient at her office.

EMTALA Q & A

On October 14, 2009, CMS issued the following information in apparent anticipation of the emergency declaration:

Question:

Evacuees from States affected by the public health emergency may arrive at hospital emergency departments merely to obtain refills of prescriptions that they lost when they evacuated during a disaster or public health emergency. Must these individuals be given an EMTALA medical screening examination when they come to the emergency department?

Answer:

"Even under non-emergency circumstances, the Emergency Medical Treatment and Labor Act (EMTALA) regulations make it clear that individuals seeking examination or treatment for a
medical condition (e.g. prescription refills) need not be given a complete medical screening examination, but rather, one that is appropriate for the request that they make in order to determine
that an EMD does not exist. Hospitals may wish to develop specific protocols that include a streamlined screening examination for individuals seeking prescription refills, consistent with the EMTALA regulations at 42 CFR § 489.24."

[PUBLISHER'S CAUTION NOTE:  Previous CMS citations for violations in cases involving prescription requests indicate that a contact record must be made and retained, and that it supports the fact that prudent inquiries were made to assure that the patient is not currently experiencing any symptoms associated with or precipitating the request for RX refill.  In a surge situation, the record might only include a triage tag and in other situations, a triage sheet.  Some record of name, presenting condition, and disposition has been required by CMS in all emergency situations I have discussed with CMS. The extent of the record expectation has varied by the severity of the emergency/surge situation.]

Question:

Is it permissible for a hospital to triage individuals with suspected cases of an infectious disease (including particularly an H1N1 flu virus infection) to an alternative site for evaluation under EMTALA? If so, how do we bill for these services?

Answer:

"Under current Emergency Medical Treatment and Labor Act (EMTALA) law and regulations, hospitals are permitted to move individuals out of their dedicated emergency departments to another part of the hospital (on the hospital’s same campus) in order to provide the required medical screening examination (MSE) and then, if an emergency medical condition is found to exist, to provide stabilizing treatment or arrange for an appropriate transfer. Sometimes hospitals refer to these as “fast-track clinics” and use them either all year round or during surge in demand for emergency department services during the seasonal cold and flu season. The medical screening examination provided in the “clinic” must be performed consistent with the requirements of the EMTALA provision, by qualified medical personnel who can perform an MSE that is appropriate to the individual’s presenting signs and symptoms." 

"If, prior to directing the individual elsewhere in the hospital, qualified medical personnel in the emergency department completed an appropriate MSE and determined that the individual does not
have an emergency medical condition, then the hospital has no further EMTALA obligation to that individual and the issue of moving the individual to an alternate site, either on or off the
hospital’s campus, would be moot from an EMTALA perspective."

[PUBLISHER'S CAUTION NOTE:  As always, an Emergency Medical Condition under EMTALA can be more broad than the concept of "Medical Emergency" until adequate history, exam, and testing has been completed TO RULE OUT these broader types of risks.  In an emergency declaration situation, your emergency plan may provide for variations from your normal triage catagories and transfer protocols.  CMS is likely to enforce compliance (after the fact) with your State and institution emergency plan provisions, so adequate training is recommended for all personnel, so that they are prepared to shit to the emergency protocols with a minimum of confusion.]

"For services rendered to Medicare fee-for-service (FFS) beneficiaries, standard Medicare FFS billing rules apply.  Hospitals should work with their other payers to determine if special billing rules may apply."

Question:

What is CMS’s procedure for addressing requests to waive EMTALA?

Answer:

"Because each emergency or disaster presents a unique set of circumstances, especially as they relate to the demand for emergency treatment, CMS calibrates its response to EMTALA-related issues to coincide with the nature of each emergency. But, in general, CMS handles these matters on a case-by-case basis. In an emergency or disaster, CMS, both centrally and through its Regional Offices, will open communications with affected State governments (especially the State Survey Agencies) and with providers, trade groups, and other stakeholders to learn about local conditions. In addition,
the State survey agencies are responsible for reporting the status of health care providers affected by the emergency to their CMS Regional Office and CMS relies upon that information to make recommendations to the Secretary regarding the need for EMTALA waivers."

[PUBLISHER'S CAUTION NOTE:  For all of my encounters with strange and unpredictable CMS applications of EMTALA, I can honestly say that I have never been aware of CMS strictly applying EMTALA to a hospital that had gone to disaster status except in one case, and that citation was dropped when a post-Katrina declaration of national emergency was issued.  Nevertheless, I would not expect them to ignore actions that deviate from your emergency protocols, standards of care, and EMTALA compliance principles unless  they are reasonably necessary to protect the patient, providers and the facility from the consequences of disaster.]

Question:

Has HHS issued any § 1135 waivers in the past that specifically address EMTALA?

Answer:

"Since § 143 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 amended § 1135 of the Social Security Act to add the waiver authority, § 1135 waivers have been issued for Hurricanes Katrina, Rita, Gustav and Ike, for the flooding in Iowa and Indiana during CY 2008, and for the flooding in North Dakota and Minnesota in CY 2009."

"In each emergency event, sanctions for certain types of EMTALA violations were waived for 72 hours after implementation of an affected hospital’s disaster protocol. However, if a public health emergency were to involve a pandemic infectious disease, the Secretary could invoke his or her waiver authority under § 1135 to waive certain EMTALA sanctions and such an EMTALA waiver would continue in effect until the termination of the applicable public health emergency declaration (in accordance with § 1135(e)(1)(B) of the Act)"

WHAT TO DO COMMENTS FROM THE PUBLISHER:

Under the present declaration, a Section 135 waiver has been issued, which implies that CMS will be issuing notifications and details to hospitals as specific issues arise.

Essentially, EMTALA waivers simply allow hospitals to follow their state emergency plans for where to assess patients, where to funnel patients, and how to do that.  Hospitals that follow these
directions are unlikely to encounter EMTALA issues.

Hospitals, however, should be very cautious of how they communicate any procedural changes to staff and on-call providers, as there may be a tendency to over-apply the waiver in an attack of wishful
thinking.  Denial of care for financial reasons or movement of trauma or surgical patients without proper transfer compliance are not likely to avoid citations even during this waiver period.