Evidence Based Studies for Strategic Discussions/Battles Dr. Juan F. Quintana DNP, MHS, CRNA

Why? Challenges Supervision Efforts Barriers to practice AAs Lack of Identification Attempts to transfer regulation to Medical Boards

21st century studies 1. Lewin Group/Hogan – Cost Effectiveness of Anesthesia Providers (2010) 2. Research Triangle Institute (RTI)/Cromwell - No Harm Found Study 3. Lewin Group/Negrusa – Scope of Practice Barriers (2016) 4. Geographic Imbalance Anesthesia Providers/ Liao, Quraishi, Jordan (2015) 5. Dexter and Epstein

Lewin Group – Cost Effectiveness Anesthesia Cost Effectiveness of Anesthesia Providers May/June 2010 Journal of Nursing Economic$ http://www.aana.com/newsandjournal/News/Pages/062110-Study-Sh ows-CRNA-Only-Anesthesia-Delivery-Most-Cost-Effective-.aspx

Lewin Group – Cost Effectiveness Anesthesia The study assesses the cost effectiveness of CRNAs and Anesthesiologists with regard to Cost of Education, Quality of Care, Cost Effectiveness of Anesthesia Practice Models and Access to Care.

Lewin Group – Cost Effectiveness Anesthesia Evaluated Literature and Data for both CRNA and MDAs Education Direct Costs, Opportunity Costs, Value of Services Quality Claims – Nationwide Inpatient Sample, Ingenix Database, National Ambulatory Surgery Sample Anesthesia Practice Models MDA, CRNA, ACT model, Supervision model Access CRNA vs MDA location by US Counties

Lewin Group Cost Effectiveness Summary Education To educate a CRNA ~ $200k /MDA ~ $1.2M Quality Data = no difference in Quality/Safety by anesthesia provider or model Anesthesia Practice Models CRNA-only anesthesia most cost effective CRNA collaboration 2nd most cost effective Access CRNA provide greater access to rural communities

Lewin Group - ASA response 1. Invalid because the AANA paid for it. a. Lewin group acts independently using their data b. Peer Reviewed Article c. IF the AANA didn’t pay for it then who would put up the $$$ 2. CRNAs are not more cost effective, CMS pays us the same a. While CMS pays the same, but most commercial insurance companies do not. b. The salaries of MDAs are 2x CRNA, the hospital must then absorb the cost of MDAs out of its own pocket = more cost to the system

Research Triangle Institute – No Harm Found No Harm Found When Nurse Anesthetists Work Without Supervision by Physicians Health Affairs, Brian Dulisse and Jerry Cromwell, 2010(29):1469-1475. https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2008.0966

Research Triangle Institute – No Harm Found This article explores whether the change in CMS policy toward anesthesia supervision had a negative impact on patient outcomes. We begin by examining the absolute level and time trends of adverse patient outcomes within the states that opted out and those that did not. Focus on Mortality and Complications

Research Triangle Institute – No Harm Found Additional notes: Examined whether there was a material change in the provision of anesthesia services away from anesthesiologists in favor of certified registered nurse anesthetists. Whether there is evidence of different outcomes associated with the two types of anesthetists. Whether case-mix complexity differed between opt-out and non-opt-out states and by anesthetist training.

Research Triangle Institute – No Harm Found For the nerds: 5 percent Medicare Inpatient (Part A) and Carrier (Part B) Medicare limited data set files for 1999–2005 Provides three full years of post-opt-out data for six of fourteen opt-out states and at least two full years of data for eleven opt-out states. Inpatient only using base units as a measure of complexity T-tests to measure differences in adjusted mortality rates between opt-out and non-opt-out states within each stratum. Estimated logistic regressions using indicators for state opt-out status before/ after opt-out and for anesthesia provider, to determine the effects of these variables on the probability of mortality and complications.

RTI - No Harm Found Evaluated MDA only (AA), CRNA only (QZ) and ACT (QK/AD/QX) Pass Through facilities surgical procedures included 500,000 cases reviewed from 1999-2005 Compared Opt Out vs Non Opt Out States

RTI - No Harm Found Results from 1999 – 2005 Change in providers Opt out Non Opt Out CRNA 21% ⬆ 9.7% ⬆ MDA 42% ⬆ 44.5% ⬇ ACT 37% ⬇ 45.8% - Creating obvious concerns for our MDA colleagues in ACTs.

RTI - No Harm Found Results from 1999 – 2005 Complexity of cases Opt out Non Opt Out CRNA 7.2% 7.2% MDA 8.3% 8.4% ACT 7.6% 7.6% Cases w/ higher base units done most frequently by MDAs.

RTI - No Harm Found Results from 1999 – 2005 Mortality (averaged) Opt out Non Opt Out CRNA 2.27% 3.04% MDA 2.88% 3.34% ACT 2.04% 2.86% Note the ACT had the lowest mortality. Question which provider resulted in the reduction of mortality?

RTI - No Harm Found Mortality Complications Non Opt Out Opt Out Opt Out Non Opt Out Opt Out Opt Out Before After Before After MDA 1.00 0.797 0.788 1.00 0824 0.818 CRNA 0.899 0.651 0.689 0.992 0.798 0.813 Team 0.959 0.708 0.565 1.067 0.927 0.903

RTI - No Harm Found Summary Analysis found no evidence to suggest that there is an increase in patient risk associated with anesthesia provided by unsupervised certified registered nurse anesthetists. We conclude that patient safety was not compromised by the opt-out policy. Opting Out would lead to more-cost-effective care as the solo practice of certified registered nurse anesthetists increases.

RTI – ASA response 1. Invalid because the AANA paid for it. a. RTI group acts independently using their data b. Peer Reviewed Article c. IF the AANA didn’t pay for it then who would put up the $$$ 2. Inaccurate study because many ACT groups use the QZ modifier to bill for services. a. ACTs fail to meet TERFRA rules/ fear fraud. b. Using QZ admits MDAs are depending on CRNA independent judgement. 3. Underpowered study

Lewin Group/Negrusa – Scope of Practice Scope of Practice Laws and Anesthesia Complications: No Measurable Impact of CRNA expanded Scope of practice on Anesthesia-related Complications Medical Care, Negrusa, Brighita PhD; Hogan, Paul F. MS; Warner, John T. PhD; Schroeder, Caryl H. BA; Pang, Bo MS, October 2016 - Volume 54 - Issue 10 - p 913–920. http://journals.lww.com/lww-medicalcare/Citation/2016/10000/Scope_of_Practice_Laws_and_Anesthesia.4.aspx

Lewin Group – Scope of Practice Talking Points 5.7 million anesthesia cases x5 larger than the largest sample ever used in previous anesthesia outcomes studies First to focus on effects of state SOP laws and anesthesia delivery models on patient safety No evidence that the odds of a complication differ by SOP or delivery model.

Lewin Group – Scope of Practice Interesting additional findings 8 /10k anesthesia procedures had a complication Complications 4x more likely inpatient vs outpatient Complications increased depending on characteristics, comorbidities and the procedure. Complications higher in OB services Complications higher in Gyn services

Lewin Group – Scope of Practice ASA response Invalid because the AANA paid for it. Lewin group acts independently using their data Peer Reviewed Article IF the AANA didn’t pay for it then who would put up the $$$ Inaccurate study because many ACT groups use the QZ modifier to bill for services.

Epstein & Dexter – MDA Supervision on First Starts and Critical Portions of Anesthesia Influence of Supervision Ratios by Anesthesiologists on First-case Starts and Critical Portions Richard H. Epstein, M.D., C.P.H.I, M.S.,* Franklin Dexter, M.D., Ph.D https://www.aana.com/advocacy/federalgovernmentaffairs/Documents/Influence_of_Supervision_Ratios_by%2028.pdf

Epstein & Dexter – MDA Supervision on First Starts and Critical Portions of Anesthesia Background: Anesthesia groups may wish to decrease the supervision ratio for nontrainee providers. The number of operating rooms that an anesthesiologist can supervise concurrently is determined by the probability of multiple simultaneous critical portions of cases (i.e., requiring presence) and the availability of cross-coverage. A simulation study showed peak occurrence of critical portions during first cases, and frequent supervision lapses. These predictions were tested using real data from an anesthesia information management system.

Epstein & Dexter – MDA Supervision on First Starts and Critical Portions of Anesthesia Talking points Written by MDAs based on a French study. 15,656 cases reviewed over 1 year @ Thomas Jefferson Univ. 1:2 ratio MDA:CRNA successful ~ 65% of the time resulting in 22.2 min delays in start 1:3 ration MDA:CRNA successful ~ 1% of the time MDAs by their own studies show they are not meeting TEFRA supervision /medical direction rules IF they can’t meet TEFRA rules for CRNAs who CAN function independently, how can they meet them for AAs.

Epstein & Dexter – MDA Supervision on First Starts and Critical Portions of Anesthesia ASA talking points – none Oped by a couple of MDAs. Epstein /Dexter response http://anesthesiology.pubs.asahq.org/article.aspx?articleid=1934228 Concluded: “Anesthesiologists have led the development of the science of OR management. Hopefully they will also play a large role in its application at their facilities. We stand by the appropriateness of the methodology and the conclusions of our paper.2 “

Geographic Imbalance - Liao, Quraishi, and Jordan Geographical Imbalance of Anesthesia Providers and Its Impact on the Uninsured and Vulnerable Populations Nursing Economic$, C. Jason Liao, Jihan A. Quraishi, and Lorraine M. Jordan, 2015 October https://www.aana.com/docs/default-source/research-aana.com-web-documents-(all)/liao-quraishi-jordan-nursing-economics-2015.pdf?sfvrsn=d0cb4bb1_4

Geographic Imbalance - Liao, Quraishi, and Jordan The purpose of this study was to determine if there is a relationship between socioeconomic factors related to geography and insurance type and the distribution of anesthesia provider type.

Geographical Imbalance of Anesthesia Providers Provider-to-population ratio was calculated as the number of anesthesia providers (CRNAs or MDA respectively) per 10,000 people. Compared to MDAs, CRNAs are more likely to be found in counties where populations have lower median incomes but also where unemployment, the uninsured, and Medicaid are more densely populated.

Geographical Imbalance of Anesthesia Providers Lessening restrictions on CRNA practice would improve the opportunity for CRNAs to better serve the 47 million uninsured and vulnerable populations

Geographical Imbalance of Anesthesia Providers ASA talking points NONE

Needleman & Minnick – Anesthesia Provider Model and Maternal Outcomes Needleman, J., & Minnick, A.F. (2009). Anesthesia provider model, hospital resources, and maternal outcomes. Health Services Research, 44(2 Pt 1), 464-482. doi: 10.1111/j.1475-6773. 2008.00919.x

Needleman & Minnick – Anesthesia Provider Model and Maternal Outcomes Talking points 1,141,641 OB patients from 369 hospitals in six representative states Hospitals using only CRNAs, or CRNAs and MDAs, do not have systematically poorer maternal outcomes compared with hospitals using anesthesiologist-only models

Silber study Study of 5,972 medicare patients post Chole/TURP Did NOT mention CRNAs at all did not evaluate anesthesia. Evaluated Failure to save from post op complications CMS (HCFA: 2001) After eliminating the supervision rule, response: In the rule, HCFA found that there was “no compelling scientific evidence that an across-the-board federal physician supervision requirement for CRNAs leads to better outcomes.” Medicare and Medicaid programs; hospital conditions of participation: anesthesia services. Fed Regist. January 18, 2001; 66(12):4674-4684.

Famous MDA quotes Stoelting response to Abstein study …the participation of certified registered nurse anesthetists (CRNAs) in delivery of anesthesia care would have ceased many years ago if there was evidence that this participation resulted in a less favorable outcome compared with anesthesia personally administered by an anesthesiologist.” [Robert K. Stoelting, MD, Department of Anesthesia, Indiana Uni- versity School of Medicine, Indianapolis; Anesthesia & Analgesia. December 1996, 82:1347, Letters to the Editor.]

Evidence Based Studies for Strategic Discussions/Battles THANK YOU!! Dr. Juan F. Quintana DNP, MHS, CRNA