What a Federal Emergency Declaration for Opioids Might Look Like for States

October 19, 2017|4:40 p.m.| ASTHO Staff

Earlier this week, President Trump stated that a “major announcement” about the opioid crisis would be coming shortly, probably by next week. There are a few ways the federal government could go about in declaring the opioid crisis an emergency. Below is a brief summary of the measures that could be taken at the federal level and some of the potential impacts on states.  

National Emergencies Act declaration

The National Emergencies Act (NEA) authorizes the president to declare a “national emergency” and activates federal emergency authorities that are specified in the declaration or a subsequent Executive Order. The declaration must be immediately sent to Congress, published in the federal register, and is terminated by presidential proclamation, a joint resolution of Congress, or after one year, unless renewed. The impact on states of a national emergency declaration will depend on the federal statutory emergency authorities activated by the declaration. For example, during the 2009 H1N1 influenza pandemic, President Obama’s NEA declaration, combined with the HHS secretary’s § 319 determination, activated the Social Security Act’s Section 1135 waiver authority (i.e., allowing the HHS secretary to temporarily waive or modify certain Medicare, Medicaid, CHIP, and HIPAA requirements). The 1135 waiver is discussed below.

Stafford Act declaration            

The Robert T. Stafford Disaster Relief and Emergency Assistance Act of 1988 (Stafford Act) authorizes the Federal Emergency Management Agency (FEMA) to coordinate the delivery of federal technical, financial, logistical, and other assistance to states and localities during declared major disasters or emergencies. The governor of an affected state or chief executive of a tribe must first declare an emergency before requesting a federal declaration under the Stafford Act. The president may then declare a "major disaster" (e.g., a severe natural catastrophe or fire, flood, or explosion, regardless of cause) or "emergency” (e.g., any event for which federal assistance is needed to supplement state or local efforts to save lives, protect public health and safety, protect property, or avert the threat of a catastrophe). The president may issue a Stafford Act emergency declaration (but not a major disaster declaration) without a governor or tribal leader’s request for certain emergencies involving federal primary responsibility (such as an emergency affecting a federal facility or subject area).

The declaration enables access to disaster relief assistance and funds as appropriated by Congress.

Funding for assistance under a Stafford Act declaration is usually shared between the federal government (75%) and the state (25%). However, the federal share may be raised by presidential declaration for certain types of assistance. A Stafford Act declaration can also activate other public health emergency response authorities such as the Social Security Act Section 1135 waiver (when combined with a § 319 determination). So far, there is no indication that any state has requested a federal declaration under the Stafford Act for opioids.

Public Health Service Act § 319 public health emergency determinations              

Section 319 of the Public Health Service Act (PHSA) authorizes the HHS secretary to determine that a public health emergency exists. A public health emergency determination under Section 319 is separate and distinct from an NEA or Stafford Act declaration. The determination activates emergency powers that authorize the federal government to engage in activities such as assisting state and local governments, suspending or modifying certain legal requirements, and expending available funds to address the public health emergency.

Once the HHS secretary determines that a public health emergency exists, the secretary is authorized to make grants and contracts, investigate the cause, treatment, or prevention of the disease or disorder underlying the public health emergency, and activate additional emergency powers or modify certain legal requirements to provide states with resources to respond. For example, the secretary can exercise Social Security Act SSA Section 1135 waiver authority if the president has also issued a Stafford Act or NEA declaration (see below), waive certain prescription and dispensing requirements, make temporary personnel appointments,. The secretary may also use funds from the Public Health Emergency Fund when and if those funds are available.

Social Security Act §1135 waivers          

Section 1135 waivers require a presidential emergency declaration under either the NEA or Stafford Act as well as a Section 319 public health emergency determination by the HHS secretary. The HHS secretary can then authorize the temporary modification or waiver of certain Medicare, Medicaid, CHIP, and Health Insurance Portability and Accountability Act (HIPAA) requirements. The purpose of the 1135 waiver authority is to ensure that sufficient healthcare services are available to enrolled individuals when and where an emergency occurs. Service providers who in good faith are unable to comply with certain requirements are reimbursed for the services they provide during an emergency and are exempt from sanctions for noncompliance absent fraud or abuse. 

Section 1135 allows the secretary to waive or modify reimbursement requirements, including conditions of participation and preapproval, licensure requirements, sanctions under the Emergency Medical Treatment and Active Labor Act (EMTALA) up to 72 hours or longer in a pandemic, sanctions related to physician self-referral, deadlines and timetables for performance, out-of-network payments, and sanctions for HIPAA noncompliance. At least two days before formally exercising Section 1135 waiver authority, the secretary must provide a certification and notice to Congress that describes the specific provision to be waived or modified, the healthcare providers to whom the waiver will apply, the geographic area in which the waiver or modification will apply, the period of time the modification will be in effect, and a statement that the waiver or modification is necessary to achieve the purposes of the SSA. The waivers generally expire when the underlying emergency or disaster declaration terminates and the secretary may make a waiver retroactive. Waivers related to the HIPAA privacy rule and non-pandemic-related waivers of EMTALA sanctions are generally limited to 72-hours. A waiver does not affect state laws or regulations, including those for licensure and conditions of participation. The 1135 licensure requirement waiver is only for reimbursement under Medicare, Medicaid, and CHIP. An 1135 waiver would most likely be needed to achieve the recommendation proposed by the president’s Commission on Combating Drug Addiction and the Opioid Crisis to use federal Medicaid funds to reimburse opioid use disorder treatment provided by inpatient facilities with more than 16 beds.

While states are the vanguard in addressing the opioid crisis, a federal emergency declaration for opioids could help by providing needed resources and the temporary suspension of challenging regulatory barriers. Whatever federal action is announced next week, ASTHO will continue to assist state and territorial health agencies in their work.