To facilitate its response to the H1N1 Influenza outbreak, the federal government has assembled a well-stocked toolbox of legislation, followed by President Obama's presidential declaration of a national emergency with respect to the H1N1 virus. Even before Obama's declaration, the Department of Health and Human Services (HHS) and the Federal Drug Administration (FDA) had a number of tools available that allowed each agency to soften, or even waive, certain regulatory requirements for healthcare providers, specifically the Public Readiness and Emergency Preparedness Act (PREP Act) and Emergency Use Authorizations.

 

The PREP Act authorizes the Secretary of HHS to issue a declaration providing tort liability immunity (except for willful misconduct) to individuals and organizations involved in the development, manufacturing, distribution, administration and use of countermeasures against pandemics, epidemics, diseases and other health threats. On June 25, 2009, Secretary Sebelius extended the PREP Act protections for pandemic vaccines to H1N1 vaccines in order to encourage the widespread development, manufacturing, distribution and administration of the H1N1 vaccine.

 

This declaration provides immunity from tort liability to all of the following groups and individuals: (i) governmental or private organizations that supervise or administer vaccination programs; (ii) healthcare professionals or others authorized under state law to prescribe, administer and dispense vaccines; (iii) individuals or organizations that assist public officials with vaccination programs, even if they are not licensed healthcare professionals (such as local businesses, community groups and volunteer groups); (iv) vaccine manufacturers and distributors; and (v) the United States government. Such individuals cannot be held liable under state or federal law for damages or losses (including death, or physical or mental injury, illness or disability) arising out of any stage of development, manufacturing, distribution, prescribing or administering of the H1N1 vaccine. Patients who would otherwise have a claim against a protected individual or organization may seek compensation from the Countermeasures Injury Compensation Program, a federal program established by the PREP Act to cover liabilities arising out of the use of certain countermeasures — such as vaccines, pharmaceuticals or devices — used to protect against pandemic (not seasonal) influenza.

 

Manufacturers of diagnostic tests, vaccines and pharmaceutical treatment and prophylaxis of the 2009 H1N1 influenza virus can apply to the FDA for an Emergency Use Authorization (EUA), which allows unapproved or uncleared medical products to be legally distributed for the uses specified in the EUA. Specifically in response to the H1N1 outbreak, the FDA has already issued EUAs for the use of two antiviral products (Relenza® and Tamiflu®), N95 respirators, and for the rRT-PCR H1N1 Flu Virus Panel diagnostic test.

 

Section 1135 of the Social Security Act gives the Secretary the ability to waive certain requirements for healthcare facilities under state and federal healthcare programs (i.e., Medicare, Medicaid, and S-CHIP) and under the HIPAA Privacy Rule if (a) the Secretary has declared a public health emergency, and (b) the president has declared a national emergency. On October 24, 2009, with the issuance of a presidential proclamation declaring the H1N1 influenza outbreak a national emergency, President Obama provided HHS with yet another tool by triggering the ability of the Secretary to issue these so-called "1135 waivers."

 

Healthcare facilities may petition for 1135 waivers in response to particular needs. It is possible that any of the following requirements could be waived if the Secretary deems it necessary in order to properly respond to the national emergency: (i) certain conditions of participation or pre-approval requirements to participate in a government healthcare program; (ii) requirements that physicians and healthcare professionals be licensed in the state in which they provide services, as long as they have a valid license in another state; (iii) certain EMTALA requirements; (iv) sanctions under the Stark law; and (v) certain requirements of the HIPAA Privacy Rule. For example, hospitals may request to set up an alternative screening location for patients away from the hospital's main campus, requiring waiver of sanctions for certain directions, relocations or transfers under EMTALA. Also, Critical Access Hospitals may request a waiver of 42 CFR 485.620, which requires a 25-bed limit and average patient stays less than 96 hours in order to accommodate H1N1 patients who require longer stays. The 1135 waivers pertain to federal laws only, however, and do not affect state law requirements.

 

The PREP Act, EUA authority, 1135 waivers, and the president's proclamation of a national emergency are clearly intended to ensure that the necessary medical services and vaccines reach the public in a timely and efficient manner. From the healthcare provider's perspective, such measures will allow services to flow more freely into the market with less government scrutiny.

 

On the other hand, the loosening of governmental restrictions and the offering of immunity for behavior just shy of intentional misconduct may also lead to a decrease in the quality of care provided to patients with little or no accountability by the provider. Bad actors that would otherwise be flushed out under "regular" governmental scrutiny may be able to enter or remain in the market. For example, the FDA has already identified over 140 fraudulent H1N1 products, such as herbal supplements, masks and gloves, and nasal sterilizers. The healthcare community and the public at large need to remain vigilant and continue to demand quality care.

 

The government response to the H1N1 pandemic has resulted in a number of expedient solutions, but it remains to be seen whether such expediency is without consequences.

 

 

 

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