It was a popular healthcare reform slogan: “Don’t let the government come between me and my doctor!” But as physicians, we are all aware that both governmental and insurance regulations play a large role in the practice of medicine.
The Center for Medicare and Medicaid Services (CMS), a part of the larger Department for Health and Human Services, administers a $750 billion budget, paying for the medical expenses of a substantial proportion of all Americans. To receive reimbursement for the services provided to Medicare and Medicaid patients, hospitals must meet the CMS Conditions of Participation (CoPs). Since the passage of the Social Security Amendments of 1965, a partnership has existed between CMS and The Joint Commission (JCAHO) whereby hospitals may be surveyed by CMS or The Joint Commission for the purposes of deeming compliance with the CoPs.
The CoPs are broad regulations for hospital operations, covering many areas of the hospital(including Emergency Services), and CMS frequently issues "interpretive guidelines" to guide surveyors in interpreting and applying the Conditions. The hospital must adhere to these guidelines in their treatment of all patients, not just Medicare or Medicaid patients, in order to be deemed in compliance.
In February 2010, CMS issued updated Interpretive Guidelines on Anesthesia Services, which had the potential to restrict the use of procedural sedation in the emergency department by interpreting the administration of any amount of propofol as deep sedation and then requiring all the criteria for anesthesia to be met. Emergency physicians reviewing the guidelines were highly concerned about an adverse impact on patient care. When patients come to the emergency department requiring joint reductions and cardioversions, how could we provide prompt and adequate analgesia and sedation to perform these procedures without performing procedural sedation with the use of agents such as propofol?
In March 2010, the presidents of ACEP, AAEM, and ENA (Emergency Nurses Association) composed a letter to CMS requesting clarification on their new guidelines. A team of physicians and ACEP Federal Affairs Director, Barbara Tomar, worked together to review the literature on the safety of procedural sedation—particularly using propofol in the emergency department. Many studies in the US and Canada have shown an excellent safety profile and rapid recovery time with the use of propofol for emergency department procedural sedation.
In April 2010, I was spending the month in ACEP’s Governmental Affairs office in Washington D.C. as the ACEP-EMRA Health Policy Mini-Fellow. As part of my work, I assisted with the literature review and was invited to attend a meeting with CMS officials regarding the guidelines. With ACEP President Angela Gardner, AAEM President Harold Blumstein, and ENA President Diane Gurney on speakerphone, Barbara Tomar and I met with CMS staff in Baltimore and discussed the issues surrounding procedural sedation in the emergency department.
We provided relevant medical literature, as well as information on the comprehensive training that emergency medicine residents receive in the use of sedating agents and proper airway and cardiovascular monitoring. This training makes us uniquely qualified amongst non-anethesiolgists to perform “rescue” for sedations that become deeper than expected, given our skills in airway management and cardiovascular resuscitation.
In January, a revision of the Interpretive Guidelines was released, and all of our concerns were addressed. The new guidelines continue to state that each hospital must determine clinical privileges for anesthesia administration. But they also acknowledge that the particular environment of the emergency department and the specialized training of emergency physicians means that we may determine our own guidelines on the use of procedural sedation in our clinical environment. Appropriate nationally recognized guidelines, including the ACEP Clinical Policy on procedural sedation, can now be used to govern the use of sedation in emergency departments.
With this change, emergency physicians will be able to continue to provide comprehensive care to our patients using the most appropriate sedating agent as guided by the clinical situation. Clearly, accomplishing this revision required advocacy efforts, but this was not the most familiar lobby-your-congressman advocacy. Regulatory advocacy has always been a necessity—requiring frequent interaction with federal employees in HHS, CMS, and other national agencies to ensure that as laws are applied, the perspectives of emergency physicians and emergency patients are considered.
The passage of the Patient Protection and Affordable Care Act (PPACA) initially required legislative advocacy, but now that the law has passed, it has created a mountain of new legislation requiring interpretation. Our regulatory advocacy efforts are more crucial than ever. With this concern in mind, ACEP has just created the Emergency Medicine Action Fund (EMAF) to allow various groups of EPs to work together to positively impact the regulatory implementation of the PPACA. This will be a group to watch in the coming months and years, particularly as new payment methods for physicians like bundled payments and accountable care organizations (ACOs) are put into place.
To learn more about current advocacy issues, be sure to attend the ACEP Leadership and Advocacy Conference in Washington, D.C. this May 22-25! Also consider applying to be the next ACEP-EMRA Mini-Fellow. Applications are due July 15th, and more information is available at EMRA.org. Read more about the EMAF and the CMS guidelines on sedation on at ACEP.org.