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Colorado’s Waiver Process

A waiver is an exception to a rule authorized by CDPHE. Waivers to the scope of practice rules are specifically permitted in statute, as are the imposition of conditions on those waivers by CDPHE.[12]  Waivers to state agency rules are common because a set of regulations cannot address every potential situation that may arise in a regulatory setting. Waivers to the scope of practice regulations are generally issued because the practice of medicine evolves over time to include acts or medications that are not within EMS providers’ scopes of practice as set forth in rule. In these cases, rulemaking is required to add those acts or medications into the regulations, and the rulemaking process may take anywhere from six months to two years.  
 

Waivers to the scope of practice are also important to allow EMS agencies in rural areas that are not able to maintain a staff of advanced level providers to be able to perform or administer certain life-saving acts or medications. The EMPAC monitors all granted waivers for a period of time, and if the data shows the waived acts and medications have been safely and effectively implemented, it may recommend that those waivered acts and medications be put into the providers’ scopes of practice through a rule change. Some examples of previous waived medications that were subsequently adopted into scope after EMPAC recommended them as safe alternatives to opioids for pain management include Acetaminophen (Tylenol) for AEMT, EMT-I and paramedic, and Ketorolac (Toradol) for paramedic.
 

Even if data shows over time that a waivered act or medication has been safely implemented, it may not end up in the scope of practice. Colorado bases its scopes of practice on the National Scope of Practice and National Education Standards. Until these bodies include waivered acts or medications in EMS providers’ scopes of practice and develop relevant standardized education, CDPHE may opt to continue to follow its waiver program to allow the performance of out-of-scope acts or medications under certain circumstances/conditions. Moreover, one of the benefits of waivers is that CDPHE can require EMS agency medical directors who hold the waiver to report additional data (beyond submitting a patient care report (PCR)). These additional data not only allow CDPHE to conduct more thorough analyses and enhanced monitoring of the skill or of the drug’s administration in the prehospital setting, but they also allow CDPHE to assess the overall accuracy, completeness, and reliability of the data.  
 

An EMS medical director commences the process of seeking a waiver by submitting an application to CDPHE. The application and supporting documents must demonstrate that the EMS agency has a need for the waiver. Additionally, the application must include a description of the training platform developed by the medical director to ensure that the EMS providers who will be authorized to perform or administer the waived acts or medications are properly trained on the out-of-scope acts or medications. The waiver application packets are apportioned among the EMPAC members to review prior to the next quarterly EMPAC meeting. At the EMPAC meeting, each waiver application is presented for discussion. The EMPAC members determine whether the EMS medical director has justified a need for the waiver and has submitted proof of the appropriate protocols, training requirements, and quality assurance methods to support approval of the waiver application. If not, the EMPAC will recommend that the waiver application be tabled or denied unless or until these requirements are met. If so, the EMPAC makes a recommendation to CDPHE to approve the waiver. CDPHE reviews EMPAC’s recommendation and may approve, modify, or reject it. If CDPHE approves the recommendation, it issues a formal approval letter to the EMS agency medical director, indicating the term of (typically three years) and conditions of the waiver. 
 

Until July 2021, Colorado authorized waivers to a paramedic’s scope of practice for ketamine administration for pain management, rapid sequence induction (RSI), and, as pertinent here, for the condition of excited delirium and/or extreme or profound agitation.[13] The administration of ketamine for this condition began as a pilot program in Colorado, at least in part to examine whether the use of ketamine for excited delirium and/or extreme or profound agitation patients would reduce the number of in-custody deaths. In 2013, the Denver Health Paramedic Division’s (DHPD) EMS medical director made a presentation to the EMPAC seeking to obtain a waiver for the DHPD paramedics to administer ketamine for this condition. CDPHE approved the pilot program and DHPD reported the data it collected to EMPAC and CDPHE. 
 

Following DHPD’s pilot program, EMPAC recommended, and CDPHE approved, ketamine waivers for excited delirium and/or extreme or profound agitation to additional EMS agency medical directors. All approved waivers for ketamine administration for excited delirium and/or extreme or profound agitation had conditions attached to them, including mandatory data reporting requirements. Originally, EMS medical directors with these waivers were required to submit data to CDPHE annually on each ketamine administration, as well as summary data of all cases upon application for renewal of the waiver (typically, every three years). In August 2020, CDPHE modified its policies; as of August 26, 2020, medical directors were required to notify CDPHE within 7 days from the date of ketamine administration or 24 hours if the ketamine administration resulted in an adverse outcome or in death. Also, a requirement was added that the EMS agency medical director contact CDPHE’s EMTS medical director or EMTS Branch Operations Section Manager if there is an adverse event or death. (A document outlining the changes is included as Appendix D.)
 

However, on July 6, 2021, CDPHE suspended all waivers for excited delirium and/or extreme or profound agitation.[14] On that day, Governor Polis signed into law HB 21-1251, “Concerning the Appropriate Use of Ketamine Upon a Person in a Prehospital Setting.” This new law prohibits the use of ketamine for excited delirium, directly addresses the conditions for which ketamine may be administered, and sets forth new requirements for its administration. CDPHE suspended the ketamine waiver program for excited delirium and/or extreme or profound agitation to comply with HB 21-1251. Once CDPHE has reviewed the legal requirements set forth in the new law, it may resume consideration of compliant ketamine waivers.