Procedure Site of Care Durable Form

Page 1 of 9 Procedure Site of Care Policy Last Reviewed / Revised: 4/24/2025 (date to be updated, as appropriate) ALOHACARE Policy Number: MP-32

Policy Name: Procedure Site of Care Policy

Line of Business: Medicare Advantage, QUEST Integration (Medicaid)

Original Effective Date: 8/13/2025

Review/Revision Dates: N/A

Attachment(s): No

I. PURPOSE:

The purpose of this policy is to outline the criteria for determining the appropriate site of care for surgical procedures, based on clinical effectiveness, safety, and best practices.

II. SCOPE

These guidelines address site of care for select outpatient surgical services that are commonly performed outside of a hospital setting. Specifically, the guideline addresses the medical necessity of performing an outpatient surgical procedure at a hospital outpatient department (HOPD) where a higher level of support may be available. The appropriate place of care is defined as the facility (HOPD or freestanding) with the proper equipment and level of support to perform select outpatient surgical services that meet applicable clinical guidelines for appropriate use.
This guideline does not evaluate the clinical appropriateness of individual procedures but focuses solely on the selection of optimal site of care where the service is rendered. Some procedures may also be subject to clinical appropriateness review; in which case, a separate clinical guideline or policy may be applied to adjudicate clinical appropriateness. This guideline does not address the availability of alternative non-hospital sites for performing an individual procedure. The purpose of this guideline is to outline the clinical scenarios in which hospital-based care is medically necessary and, by exclusion, when it is clinically reasonable to provide services in a non-hospital setting.

Page 2 of 9 Procedure Site of Care Policy Last Reviewed / Revised: 4/24/2025 (date to be updated, as appropriate) The guideline does not cover the qualification or credentialing of providers (or ancillary staff) to perform any procedure, nor does it seek to define the adequacy of facilities or equipment used in rendering procedures. While the accreditation and licensing of surgical facilities are not discussed in this document, it is assumed that facilities where services are rendered meet all required state and national requirements. Please refer to AlohaCare’s prior authorization lookup tool for the current applicable code list. III. DEFINITIONS:

Hospital outpatient department (HOPD): Hospital department at which services are rendered to outpatients.

Nonhospital: Freestanding surgical facility or provider office that is not owned/operated by a hospital.

Surgical procedure: For purposes of this guideline, this term encompasses procedures (see appendix for codes) that can be safely rendered outside the hospital outpatient setting, including traditional surgical procedures (e.g., cataract extraction) and both diagnostic and therapeutic endoscopic procedures. The term excludes procedures that routinely require post-procedure admission to the hospital.

Acute coronary syndrome: Acute myocardial infarction (either ST elevation or non-ST elevation) or unstable angina pectoris.

Asthma – moderate or severe: When any of the following are present, the patient can be considered to have moderate or severe asthma: A. Daytime symptoms every day. B. Nocturnal symptoms at least once per week. C. At least daily use of “rescue” inhaler to relieve symptoms. D. FEV1 < 80% of predicted despite medical management.

Chronic obstructive airways disease (COPD) – moderate or severe: Forced expiratory volume in 1 second/Forced vital capacity (FEV1/FVC) ratio of ≤ 0.7 and FEV1 < 80% of predicted.

Diabetes – poorly controlled: Diabetes with hemoglobin A1c > 9 for more than one year, hospitalization for management of diabetic ketoacidosis within the past 6 months or requiring treatment for hypoglycemia within the past month.

Hypertension – treatment resistant: Persistent hypertension in a patient taking three or more antihypertensive medications.

Increased bleeding risk: Prior history of abnormal bleeding, established diagnosis of a condition which predisposes to bleeding (e.g., thrombocytopenia, hemophilia, prolonged INR despite treatment with vitamin K, need to continue anticoagulants or antiplatelet agents through to perioperative period), anticipated need for blood transfusion, blood products or other

Page 3 of 9 Procedure Site of Care Policy Last Reviewed / Revised: 4/24/2025 (date to be updated, as appropriate) substances to control bleeding risk.

New York Heart Association (NYHA) Functional Classification: Symptom-based classification of the severity of heart failure as outlined below: A. Class I. Individuals with cardiac disease but without resulting limitation of physical activity; ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain; symptoms only occur on severe exertion. B. Class II. Individuals with cardiac disease resulting in slight limitation of physical activity; they are comfortable at rest; ordinary physical activity (e.g., moderate physical exertion, such as carrying shopping bags up several flights of stairs) results in fatigue, palpitation, dyspnea, or anginal pain. C. Class III. Individuals with cardiac disease resulting in marked limitation of physical activity; they are comfortable at rest; less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain. D. Class IV. Individuals with cardiac disease resulting in inability to carry on any physical activity without discomfort; symptoms of heart failure or the anginal syndrome may be present even at rest; if any physical activity is undertaken, discomfort is increased.

Obstructive sleep apnea (OSA) – moderate or severe: OSA diagnosed by either polysomnography or home sleep testing with Apnea Hypopnea Index (AHI) or Respiratory Disturbance Index (RDI) ≥ 15.

Renal disease – end-stage: Patient is on regular hemodialysis or has glomerular filtration rate of < 15 mL/min per 1.73 m2.

IV. CLINICAL INDICATIONS

A hospital outpatient department (HOPD) is considered medically necessary for requests that meet applicable medical necessity criteria for the service being performed in ANY of the following scenarios: A. Procedures that require ancillary resources that are not available outside of a HOPD related to ANY of the following:

1. Duration of surgical procedure is expected to exceed 3 hours.
2. Anticipated difficulty with establishment or maintenance of an airway based on preoperative airway assessment, such as prior history of difficult intubation, craniofacial abnormalities, limitation of neck extension, etc.
3. Prior unanticipated surgical or anesthetic complication resulting in instability requiring unplanned admission or additional care beyond what is routinely

Page 4 of 9 Procedure Site of Care Policy Last Reviewed / Revised: 4/24/2025 (date to be updated, as appropriate) rendered for that procedure (e.g., resuscitation, management of hemodynamic instability, prolonged observation, transfusion, etc.). B. Clinical comorbidities and/or complexities that require access to services and/or higher acuity resources that are not available outside of a HOPD due to ANY of the following:

1. Age ≤ 18 or ≥ 75 years.
2. Pregnant.
3. Increased bleeding risk.
4. Intellectual disability or cognitive impairment.
5. Coronary artery disease (CAD)/peripheral vascular disease (PVD) [ongoing cardiac ischemia requiring medical management or recently placed (within 1 year) drug eluting stent].
6. Individuals with drug eluting stents (DES) placed within one year or bare metal stents (BMS) or plain angioplasty within 90 days unless acetylsalicylic acid and antiplatelet drugs will be continued by agreement of surgeon, cardiologist, and anesthesia.
7. Ongoing evidence of myocardial ischemia.
8. Severe valvular heart disease.
9. Uncontrolled diabetes with recurrent diabetic ketoacidosis (DKA) or severe hypoglycemia.
10. Presence of an ASA class 3 or above comorbidity, such as: ▪ Body mass index (BMI) ≥ 40. ▪ Treatment resistant hypertension. ▪ Poorly controlled diabetes. ▪ End-stage renal disease. ▪ Documented history of stroke or transient ischemic attack (TIA). ▪ Documented history of myocardial infarction to acute coronary syndrome. ▪ Established diagnosis of severe valvular heart disease. ▪ Sustained, symptomatic cardiac arrhythmia despite treatment. ▪ NYHA Class III or IV congestive heart failure. ▪ Moderate or severe asthma. ▪ Moderate or severe COPD. ▪ Moderate or severe OSA. ▪ Liver cirrhosis (with MELD score > 8). C. Advanced surgical planning determines an individual requires overnight recovery and care following a surgical procedure. D. When performing a procedure outside the HOPD would reasonably be expected to create clinically significant delays in care. E. Absence of a geographically accessible alternative non-HOPD facility capable of performing the requested procedure.

Page 5 of 9 Procedure Site of Care Policy Last Reviewed / Revised: 4/24/2025 (date to be updated, as appropriate)

V. RATIONALE

Over the past several decades, procedures that were previously rendered exclusively in hospital settings have become available at non-hospital locations, such as freestanding facilities and physician offices. This shift in site of care, particularly for surgical and endoscopic procedures, has been driven by the development of less invasive surgical approaches, improvement in anesthetic techniques, and availability of equipment outside of the hospital setting. Concurrently, patient demand has similarly grown for the convenience of neighborhood services, ease of scheduling outside of the hospital, and an increasing focus on patient experience. The lower cost of non-hospital services and the economic advantage of global billing (from a provider perspective) have also contributed to the increased availability of non-hospital sites of care. There is growing literature demonstrating which patients and procedures can safely be moved from an inpatient to an outpatient setting, high quality, prospective; however, randomized controlled studies are lacking to answer the clinical question of which patients can safely receive the same services outside of a hospital setting all together. Current evidence indicates comparable safety profiles for a variety of outpatient procedures performed in and out of the hospital, ranging from endoscopies to orthopedic procedures. These findings, however, likely rely on careful patient selection, which has largely been derived retrospectively. Therefore, many of the criteria outlined in this guideline reflect clinical scenarios with demonstrated safety in the outpatient setting, with additional considerations made for performance outside of the hospital. This guideline aims to apply to a subset of outpatient procedures routinely performed outside of a hospital setting with an expected same-day discharge plan that includes post-discharge home care and pain control that meets the clinical needs of the procedure performed. The criteria outlined in this guideline provide a clinical framework in which the use of a HOPD is considered medically necessary. These criteria do not require any service to be performed within a HOPD and many patients included in the outlined scenarios routinely receive care outside of a HOPD.

VI. IMPORTANT REMINDER The purpose of this Medical Policy is to provide a guide to coverage. This Medical Policy is not intended to dictate to providers how to practice medicine. Nothing in this Medical Policy is intended to discourage or prohibit providing other medical advice or treatment deemed appropriate by the treating physician. Benefit determinations are subject to applicable member contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control. This Medical Policy has been developed through consideration of the medical necessity criteria under Hawaii’s Patients’ Bill of Rights and Responsibilities Act (Hawaii Revised Statutes §432E- 1.4) or for QUEST members under Hawaii Administrative Rules (HAR 1700.1-42),

Page 6 of 9 Procedure Site of Care Policy Last Reviewed / Revised: 4/24/2025 (date to be updated, as appropriate) generally accepted standards of medical practice and review of medical literature and government approval status. AlohaCare has determined that services not covered under this Medical Policy will not be medically necessary under Hawaii law in most cases. If a treating physician disagrees with AlohaCare’s determination as to medical necessity in a given case, the physician may request that AlohaCare reconsider the application of the medical necessity criteria to the case at issue in light of any supporting documentation.

VII. RESOURCES AND REFERENCE DOCUMENTS

1. Agency for Healthcare Research and Quality. Surgeries in Hospital-Owned Outpatient Facilities, 2012. Statistical Brief #188 Healthcare Cost and Utilization Project (HCUP). Rockville, MD: Agency for Healthcare Research and Quality; 2016. p. 14.
2. Agostoni M, Fanti L, Gemma M, et al. Adverse events during monitored anesthesia care for GI endoscopy: an 8-year experience. Gastrointest Endosc. 2011;74(2):266-75.
3. American College of Surgeons. Statement on Patient Safety Principles for Office-Based Surgery Utilizing Moderate Sedation/Analgesia. Chicago (IL): American College of Surgeons;
4. p. 2.
5. American Society of Anesthesiologists (ASA). Guidelines for Ambulatory Anesthesia and Surgery. Schaumburg (IL): American Society of Anesthesiologists; 2018. p. 2.
6. American Society of Anesthesiologists (ASA). Guidelines for Patient Care in Anesthesiology. Schaumburg (IL): American Society of Anesthesiologists; 2016. p. 4.
7. American Society of Anesthesiologists (ASA). Practice Guidelines for Moderate Procedural Sedation and Analgesia 2018: A Report by the American Society of Anesthesiologists Task Force on Moderate Procedural Sedation and Analgesia, the American Association of Oral and Maxillofacial Surgeons, American College of Radiology, American Dental Association, American Society of Dentist Anesthesiologists, and Society of Interventional Radiology. Anesthesiology. 2018;128(3):437-79.
8. Bettelli G. High risk patients in day surgery. Minerva Anestesiol. 2009;75(5):259-68.
9. Bilimoria KY, Liu Y, Paruch JL, et al. Development and evaluation of the universal ACS NSQIP surgical risk calculator: a decision aid and informed consent tool for patients and surgeons. J Am Coll Surg. 2013;217(5):833-42.e1-3.
10. Bryson GL, Chung F, Cox RG, et al. Patient selection in ambulatory anesthesia – an evidence- based review: part II. Can J Anaesth. 2004;51(8):782-94.
11. Bryson GL, Chung F, Finegan BA, et al. Patient selection in ambulatory anesthesia – an evidence-based review: part I. Can J Anaesth. 2004;51(8):768-81.

Page 7 of 9 Procedure Site of Care Policy Last Reviewed / Revised: 4/24/2025 (date to be updated, as appropriate)

11. Carey K, Burgess JF Jr, Young GJ. Hospital competition and financial performance: the effects of ambulatory surgery centers. Health Econ. 2011;20(5):571-81.
12. Chukmaitov AS, Menachemi N, Brown LS, et al. A comparative study of quality outcomes in freestanding ambulatory surgery centers and hospital-based outpatient departments: 1997-
13. Health Serv Res. 2008;43(5 Pt 1):1485-504.
14. Cullen KA, Hall MJ, Golosinskiy A. Ambulatory surgery in the United States, 2006. Natl Health Stat Report. 2009(11):1-25.
15. Doyle DJ, Goyal A, Bansal P, et al. American Society of Anesthesiologists Classification (ASA Class). StatPearls. Treasure Island (FL): StatPearls Publishing LLC.; 2020.
16. ASGE Standards of Practice Committee; Early DS, Lightdale JR, Vargo JJ 2nd, et al. Guidelines for sedation and anesthesia in GI endoscopy. Gastrointest Endosc. 2018;87(2):327-
18. Enestvedt BK, Eisen GM, Holub J, et al. Is the American Society of Anesthesiologists classification useful in risk stratification for endoscopic procedures? Gastrointest Endosc. 2013;77(3):464-71.
19. Epstein LJ, Kristo D, Strollo PJ Jr, et al. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009;5(3):263-76.
20. Fleisher LA, Fleischmann KE, Auerbach AD, et al. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines. J Am Coll Cardiol. 2014;64(22):e77-137.
21. Fleisher LA, Pasternak LR, Herbert R, et al. Inpatient hospital admission and death after outpatient surgery in elderly patients: importance of patient and system characteristics and location of care. Arch Surg. 2004;139(1):67-72.
22. Fleisher LA, Pasternak LR, Lyles A. A novel index of elevated risk of inpatient hospital admission immediately following outpatient surgery. Arch Surg. 2007;142(3):263-8.
23. Fox JP, Burkardt DD, Ranasinghe I, et al. Hospital-based acute care after outpatient colonoscopy: implications for quality measurement in the ambulatory setting. Med Care. 2014;52(9):801-8.
24. Fox JP, Vashi AA, Ross JS, et al. Hospital-based, acute care after ambulatory surgery center discharge. Surgery. 2014;155(5):743-53.
25. Friedman LS. Surgery in the patient with liver disease. Trans Am Clin Climatol Assoc. 2010;121:192-204; discussion 5.
26. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease 2019 Report. Fontana, WI (USA): Global Initiative for Chronic Obstructive Lung Disease, Inc.; 2019. p. 155.

Page 8 of 9 Procedure Site of Care Policy Last Reviewed / Revised: 4/24/2025 (date to be updated, as appropriate)

25. Grisel J, Arjmand E. Comparing quality at an ambulatory surgery center and a hospital-based facility: preliminary findings. Otolaryngol Head Neck Surg. 2009;141(6):701-9.
26. Gupta A. Preoperative screening and risk assessment in the ambulatory surgery patient. Curr Opin Anaesthesiol. 2009;22(6):705-11.
27. Hackett NJ, De Oliveira GS, Jain UK, et al. ASA class is a reliable independent predictor of medical complications and mortality following surgery. Int J Surg. 2015;18:184-90.
28. Hurwitz EE, Simon M, Vinta SR, et al. Adding Examples to the ASA-Physical Status Classification Improves Correct Assignment to Patients. Anesthesiology. 2017;126(4):614-22.
29. Imran JB, Madni TD, Taveras LR, et al. Analysis of operating room efficiency between a hospital-owned ambulatory surgical center and hospital outpatient department. Am J Surg. 2019;218(5):809-12.
30. Jones WS, Mi X, Qualls LG, et al. Trends in settings for peripheral vascular intervention and the effect of changes in the outpatient prospective payment system. J Am Coll Cardiol. 2015;65(9):920-7.
31. Joshi GP, Ahmad S, Riad W, et al. Selection of obese patients undergoing ambulatory surgery: a systematic review of the literature. Anesth Analg. 2013;117(5):1082-91.
32. Joshi GP, Ankichetty SP, Gan TJ, et al. Society for Ambulatory Anesthesia consensus statement on preoperative selection of adult patients with obstructive sleep apnea scheduled for ambulatory surgery. Anesth Analg. 2012;115(5):1060-8.
33. Joshi GP, Chung F, Vann MA, et al. Society for Ambulatory Anesthesia consensus statement on perioperative blood glucose management in diabetic patients undergoing ambulatory surgery. Anesth Analg. 2010;111(6):1378-87.
34. Kruse FM, Groenewoud S, Atsma F, et al. Do independent treatment centers offer more value than general hospitals? The case of cataract care. Health Serv Res. 2019;54(6):1357-65.
35. Lermitte J, Chung F. Patient selection in ambulatory surgery. Curr Opin Anaesthesiol. 2005;18(6):598-602.
36. Malik AT, Xie J, Retchin SM, et al. Primary single-level lumbar microdisectomy/decompression at a free-standing ambulatory surgical center vs a hospital- owned outpatient department-an analysis of 90-day outcomes and costs. Spine J. 2020;20(6):882-7.
37. Massachusetts Medical Society. Office-Based Surgery Guidelines. Waltham, MA: Massachusetts Medical Society; 2011. p. 60.
38. Mathis MR, Naughton NN, Shanks AM, et al. Patient selection for day case-eligible surgery: identifying those at high risk for major complications. Anesthesiology. 2013;119(6):1310-21.

Page 9 of 9 Procedure Site of Care Policy Last Reviewed / Revised: 4/24/2025 (date to be updated, as appropriate)

39. Mayo Foundation for Medical Education and Research. Post-operative Mortality Risk in Patients with Cirrhosis. Medical Professionals Transplant Medicine Calculators. Rochester, MN: Mayo Foundation for Medical Education and Research; 2020. p. 3.
40. Munnich EL, Parente ST. Returns to specialization: Evidence from the outpatient surgery market. J Health Econ. 2018;57:147-67.
41. National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007;120(5 Suppl):S94-138.
42. Pannucci CJ, Shanks A, Moote MJ, et al. Identifying patients at high risk for venous thromboembolism requiring treatment after outpatient surgery. Ann Surg. 2012;255(6):1093-9.
43. Paquette IM, Smink D, Finlayson SR. Outpatient cholecystectomy at hospitals versus freestanding ambulatory surgical centers. J Am Coll Surg. 2008;206(2):301-5.
44. Qin C, Helfrich MM, Curtis DM, et al. The effect of surgical setting on anterior cruciate ligament reconstruction outcomes. Phys Sportsmed. 2019;47(4):411-5. 4
45. Sankar A, Johnson SR, Beattie WS, et al. Reliability of the American Society of Anesthesiologists physical status scale in clinical practice. Brit J Anaesth. 2014;113(3):424-32.
46. Shnaider I, Chung F. Outcomes in day surgery. Curr Opin Anaesthesiol. 2006;19(6):622-9.
47. Steiner CA, Karaca Z, Moore BJ, et al. Surgeries in Hospital-Based Ambulatory Surgery and Hospital Inpatient Settings, 2014: Statistical Brief #223. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Rockville (MD): Agency for Healthcare Research and Quality (US);
49. Tanaka M. Ambulatory Surgery Centers Versus Hospital-based Outpatient Departments: What’s the Difference? AAOS Now. 2019(SEP 2019):4.
50. Trentman TL, Mueller JT, Gray RJ, et al. Outpatient surgery performed in an ambulatory surgery center versus a hospital: comparison of perioperative time intervals. Am J Surg. 2010;200(1):64-7.
51. Vila H, Jr., Soto R, Cantor AB, et al. Comparative outcomes analysis of procedures performed in physician offices and ambulatory surgery centers. Arch Surg. 2003;138(9):991-5.
52. Whippey A, Kostandoff G, Paul J, et al. Predictors of unanticipated admission following ambulatory surgery: a retrospective case-control study. Can J Anaesth. 2013;60(7):675-83.
53. Wynia MK, Classen DC. Improving ambulatory patient safety: learning from the last decade, moving ahead in the next. JAMA. 2011;306(22):2504-5.