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Investigate federal waivers to help your H1N1 response


February 1, 2010

Those of you involved with emergency planning for H1N1 should review a series of waivers from the U.S. Department of Health and Human Services (HHS), particularly given predictions that swine flu cases may bounce back over the winter.

The idea behind the waivers is to relax normal patient protections that, during an evolving emergency situation, “may impede the ability of healthcare facilities to fully implement disaster operations plans that enable appropriate care during emergencies,” according to the HHS Web site.

The waivers were initially authorized October 27, 2009, by HHS for some of the Social Security Act’s Section 1135 requirements. Hospitals experiencing an H1N1 patient surge can apply for waivers to get temporary relief from certain rules for the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Emergency Medical Treatment and Active Labor Act of 1986 (EMTALA), Stark Law, Medicare, and the Children’s Health Insurance Program (CHIP). Hospital emergency planners can build these waivers into their flu response plans now, including at what point they will apply for them—which can be done via e-mail or phone (see the box at left for more details).

“In addition to having a limited purpose, Section 1135 waivers only have a limited effect,” Jean Sheil, pandemic coordinator at the Centers for Medicare & Medicaid Services (CMS), said in a November 10 HHS conference call.

The waivers only provide protection from sanctions under CHIP, Medicare, or Medicaid—and only while they’re needed by a facility or when a federally declared emergency period ends, Sheil said.

The Section 1135 waivers typically 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 HHS secretary extends the waiver by notice for additional periods of up to 60 days, up to the end of the emergency period. Note that HIPAA waivers are limited to a 72-hour period beginning upon implementation of a hospital disaster protocol. 


What the HHS waivers cover

Section 1135 waivers lift requirements for preapproval of certain healthcare services (e.g., transporting patients to alternative locations) that normally would not be reimbursed. Specific, up-to-date details of what is covered under the waivers are listed at www.flu.gov under the Health Professional link, and additional information from CMS is available at www.cms.hhs.gov/H1N1. 

As the process moves forward, the agencies will likely update their online FAQs and other guidance.

The piece of the waivers most relevant to emergency planners is the relaxing of CMS licensure requirements. For example, physicians who come to your hospital from another state to assist during a flu surge can perform billable services even if they aren’t licensed in your state, provided they haven’t been barred from practice and are enrolled as Medicare practitioners when required in their home states.

The EMTALA and Stark Law self-referral piece of the waivers allows for the referral or relocation of a patient to another location, as long as it fits in with the state’s emergency preparation or pandemic plan. It also allows for the transfer of patients who have not yet been stabilized if related to a declared public health emergency (i.e., they are H1N1 patients).

However, “with these waivers, all other EMTALA  requirements [still] apply,” Sheil said.


Alternative screening sites don’t need waivers

It is important to note that during extraordinary surges in demand for emergency services, hospitals may set up alternative screening sites on or off campus without obtaining a waiver, said Gay Howard, RN, a risk management and infection control consultant for The Greeley Company, a division of HCPro, Inc., in Marblehead, MA.

Taking that action involves the following provisions:

Individuals may be redirected to alternative screening sites after being logged in at a hospital. The redirection and logging can even take place outside the entrance to the ED.

The person directing should be qualified (e.g., an RN) to recognize individuals who are obviously in need of immediate treatment in the ED.

Medical screening exams must be conducted by qualified personnel, which may include physicians, nurse practitioners, physician assistants, or nurses trained to perform such exams and acting within the scope of their state practice act.

The hospital must provide stabilizing treatment or appropriate transfer to individuals found to have an emergency medical condition, including moving them as needed from the alternative site to another on-campus department.

If the alternative screening site is off campus, the hospital should not advertise the site to the public as a place that provides general care for emergency medical conditions on an urgent, unscheduled basis, Howard said. Hospitals can present the site as an influenza-like illness screening center; however, facilities may not tell individuals who have already come to an ED to go to the off-site location for a medical screening exam.


HIPAA approach is slightly different

The HIPAA waivers don’t need a prior application because they automatically go into effect for 72 hours after a hospital activates its disaster plan, law firm Troutman Sanders, LLP, in Richmond, VA, noted on its pandemic flu Web page (www.troutmansanders.com/panflu). Troutman Sanders allowed Briefings on Hospital Safety to republish information from its Web site.

HHS waives sanctions for the following HIPAA rules:

Obtaining a patient’s agreement to speak with family members or friends

Honoring a patient’s request to opt out of the hospital directory

Distributing the Notice of Privacy Practices

Observing a patient’s right to request privacy restrictions or confidential communications


Because the HIPAA waivers follow activation of a hospital’s disaster response plan, it’s incumbent upon emergency managers to clearly document when they activate their plans, how they change their compliance protocols, and when they return to usual HIPAA compliance, according to Troutman Sanders.

The firm also recommends that hospital planners make sure to stay in compliance with state laws that cover patient rights and check wording of your governor’s flu emergency declaration—if one is in effect—for other potential privacy rules with which your facility must comply.

Similarly, hospitals should double-check how their emergency plans gel with state bed-licensing regulations, David Wright, associate regional administrator of CMS’ Dallas Division of Survey & Certification, reminded emergency preparation managers in the November 10, 2009, conference call.

It’s a potential chink in a disaster plan’s armor: An emergency protocol could expand a facility’s bed count, but the hospital might not be licensed to use them.


Waiver approval has quick turnaround

The application process for the waivers might seem vague—an e-mail or call to your CMS regional office—but it’s designed so hospitals don’t have to worry about forms and detailed processes during an emergency.

At the time of the conference call, Wright said CMS had received 73 waiver requests from organizations in 10 states, five of which had been granted and 64 of which had been withdrawn by the applicants.

Some withdrawals weren’t waiver requests per se, but instead requests for information, Wright said. Also, some hospitals withdrew advance permission to invoke the waivers if a flu surge required a hospital to activate its emergency plan. Those requests don’t get granted.

“We’re asking providers to wait until there’s an actual need,” Wright said. Waivers take about a day to approve, and the approval process typically involves a phone call with the regional office after a hospital applies.


E-mail addresses to request Section 1135 waivers

Check for your state within the following groups:

Atlanta regional office (Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, and Tennessee): ROATLHSQ@cms.hhs.gov 

Dallas regional office (Arkansas, Louisiana, New  Mexico, Oklahoma, and Texas): RODALDSC@cms.hhs.gov

Midwest consortium (Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, Ohio, and Wisconsin): ROCHISC@cms.hhs.gov 

Northeast consortium (Connecticut, Delaware,  Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Puerto Rico, Rhode Island, Vermont, Virgin Islands, Virginia, Washington, DC, and West Virginia): ROPHIDSC@cms.hhs.gov

Western consortium (Alaska, Arizona, California,  Colorado, Hawaii, Idaho, Montana, Nevada, North  Dakota, Oregon, Pacific territories, South Dakota, Utah, Washington, and Wyoming): ROSFOSO@cms.hhs.gov


What needs to happen to  use Section 1135 waivers?

It takes five steps from the federal government before hospitals can use Section 1135 waivers:

The president declares a disaster or emergency under the Stafford Act or National Emergencies Act

The secretary of the U.S. Department of Health and Human Services (HHS) declares a public health emergency under Section 319 of the Public Health Service Act

The secretary declares the availability of Section 1135 waivers

A hospital applies for the waivers (except in the case of the Health Insurance Portability and Accountability Act of 1996, which receives an automatic waiver)

The Centers for Medicare & Medicaid Services grants the waivers


Before the current H1N1 pandemic, the government offered similar Section 1135 waivers for hospitals during hurricanes Katrina (2005), Ike and Gustav (2008), and the North Dakota floods (2009).


Source: HHS.

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