National Medical Policy

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1 National Medical Policy Subject: Policy Number: Outpatient Joint Replacement NMP531 Effective Date*: April 2014 Updated: April 2016 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State s Medicaid manual(s), publication(s), citation(s), and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link National Coverage Determination (NCD) National Coverage Manual Citation Local Coverage Determination (LCD)* Article (Local)* XX Other Medicare Inpatient Only List (2015) None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. Outpatient Joint Replacement Apr 16 1

2 If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Note: This policy only addresses the place of service and does not address medical necessity of the joint replacement itself Current Policy Statement: Minimally invasive knee and hip joint replacement may be performed in an outpatient setting in specific facilities that have been contractually approved by Health Net's ancillary contracting department to perform these procedures in the outpatient setting. This approval is based on the facilities ability to select appropriate patients, capability to provide 24 hour observation and the existence of an agreement with a hospital to transfer and accept complications as necessary. Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets. ICD-9 Codes N/A ICD-10 Codes N/A CPT Codes N/A HCPCS Code N/A Scientific Rationale Initial Knee and hip arthroplasty two of the most commonly performed orthopedic procedures in the United States. Among older patients, the per capita number of primary total knee replacements doubled from 1991 to 2010 (from 31 to 62 per 10,000 Medicare enrollees annually). The number is expected to grow by 673 percent, from 600,000 in 2010 to 3.48 million procedures by According to the Agency for Healthcare Research and Quality, more than 285,000 total hip replacements are performed each year in the United States and rates are expected to continue to 174% or 527,000 procedures by Joint replacements have traditionally been performed in the acute care hospital setting and patients have been admitted postoperatively because of patient and physician concerns about uncontrolled pain, decreased mobility, and the possibility of perioperative complication. Over the past 20 years, however, the mean duration of hospitalization for patients who undergo total knee and hip arthroplasty in the United Outpatient Joint Replacement Apr 16 2

3 States has decreased from approximately 9 to 3.5 days. This has been attributed to multiple factors, including minimally invasive surgical techniques with less soft tissue damage, regional anesthesia, improved pain management, early mobilization, changes in rehabilitation techniques, and discharges to inpatient rehabilitation. There has been recent interest in performing these procedures on an outpatient basis and Medicare (2013) is considering removing total knee joint replacement from the Inpatient Only list. As of March 2014,these procedures still remain as inpatient only. A parapatellar arthrotomy has been utilized (i.e., median parapatellar, midvastus, subvastus, or lateral) to access the knee joint and perform the arthroplasty with incision sizes that range from 4 to 10 inches. Minimally invasive approaches are generally more complex for the surgeon but allow for a decrease in the size of the incision and less disturbance of surrounding muscle and tissue. In newer surgical techniques, such as the minimally-invasive quadriceps-sparing total knee replacement, the incision is typically even shorter at 3 4 inches, allowing the surgeon to insert knee replacement, avoiding trauma to the quadriceps muscle. The less-traumatic nature of the surgical approach also may decrease post-operative pain and diminish the need for extensive rehabilitation and therapy compared to more traditional approaches. Berger et al (2009) evaluated 111 patients post elective unicompartmental (UKA) or total knee arthroplasty (TKA) to determine if same day surgery would result in a higher perioperative complication rates than standard-length hospitalization. Patient age ranged from 48 years to 85 years with an average weight of pounds, and Body Mass Index (BMI) ranged from 18.7 to Preoperatively, 102 patients were diagnosed with osteoarthritis, 1 with osteonecrosis, 3 with rheumatoid arthritis, and 5 with posttraumatic injuries. A comprehensive perioperative clinical pathway was followed, including preoperative teaching, regional anesthesia, preemptive oral analgesia, preemptive antiemetics, and a rapid rehabilitation protocol. In the 111 patients, the knee arthroplasty was completed by noon and the patients agreed to be followed prospectively. Of the 111 patients, 104 (94%, 24 with UKA and 80 with TKA) met discharge criteria (stable vital signs, tolerated regular diet and adequate pain control on oral medications) and were discharged directly to home the day of surgery. Nausea requiring additional treatment before discharge was the most common reason for a delay in discharge. There were four (3.6%) readmissions (all with TKA) and one emergency room visit without readmission (in a patient with a TKA) within the first week after surgery, while there were four subsequent readmissions (3.6%) and one additional emergency room visit without readmission within three months of surgery, all among patients undergoing TKA. There were no deaths, cardiac events, or pulmonary complications during this study. Potential limitations of this study include the relatively small sample size and as a result the potential for a Type II error. The absence of reported differences in data between the patients with UKA and TKA may reflect such error. This study was also conducted at a medical center that has been using rapid rehabilitation protocols, minimally invasive techniques, and same-day discharge for many THA patients for several years. It should also be noted that only one surgeon was involved. The authors concluded that outpatient knee arthroplasty surgery is feasible for patients who are able to participate in the clinical pathway and noted that the 3.6% incidence of readmission within the first week may have been reduced by a prolonged hospital stay. The authors also stated that our high percentage of same-day discharge may also reflect..the expertise developed by our team in remedying problems that inevitably arise in the perioperative period. Outpatient Joint Replacement Apr 16 3

4 Kolisek (2009) compared the results of two selected matched cohorts of 64 patients who underwent total knee arthroplasty during the same time period. One cohort of patients, who had no severe medical conditions, lived within one hour of the office, and had help at home, followed an accelerated pathway in which they were discharged within 23 hours of surgery, and the other cohort followed a standard inpatient protocol, with a mean hospital stay of 2.3 days (range, 2-4 days). There were no perioperative complications in either cohort, and none of the patients who followed the outpatient protocol returned to the hospital for any reason. At a mean follow-up of 24 months (range, months), the mean Knee Society knee scores of the outpatient and inpatient cohorts were 96 points (range, points) and 95 points (range, points), respectively. (The Knee Society Scoring System (KSS) consists of a two parts, one is completed by the surgeon and includes information on pain walking on level ground and on stairs or inclines, as well as an assessment of alignment, ligament stability, and ROM, along with deductions for flexion contracture or extensor lag. The second component is a survey completed by the patient is related to function which evaluates features such as standard activities of daily living, patient-specific sports and recreational activities, patient satisfaction, and patient expectations. ) The mean Knee Society function scores were 89 points (range, points) and 90 points (range, points), respectively. The authors noted several study limitations including that there was no randomization, no matching of comorbidities and a short follow up time period. They did conclude that an outpatient TKA protocol may be safe for selected patients, with no major perioperative complications, and this pathway may be associated with excellent short-term results that are comparable to conventional inpatient protocols. In addition, this protocol has been successfully utilized by more than one surgeon. Further study is indicated to refine the indications for this protocol, as well as to examine the immediate and long-term patient clinical outcomes. Lovald et al (2013) published a cost and outcome analysis of outpatient total knee arthroplasty to determine the differences in cost, complications and mortality between patients who stay the standard three to four nights in a hospital versus those that elect for either an outpatient procedure or a shortened stay. The Medicare 5% limited data sets (LDS) sample was used to identify patients with a total knee arthroplasty (TKA) procedure between TKA patients were separated into the groups treated in the following hospital settings: outpatient, one day inpatient, two days inpatient, three to four days inpatient or five-plus days inpatient. Results considered average annual payments adjusted to Jan-2011, mortality, readmission, revision and common complications. Differences in costs and risk ratios for each outcome were adjusted using logistic regression for age, sex, race, buy-in status, region and Charlson (for complications) score. The results were compared at 90 days, one year and two years after surgery. There were 23,534 fiveplus day, 73,498 three to four day, 6,756 two day, 1,374 one day and 2,883 outpatient patients included in the study. At one year, the outpatient group had less pain (HR=0.86, p=0.0001) and stiffness (HR=0.82, p=0.0167) in comparison to the traditional stay group, but had higher 90-day infection (HR=1.44, p=0.0397), dislocation (HR=1.77, p=0.0468) readmission (HR=1.57, p=0.042) and mortality (HR=2.13, p=0.0005) risks. The one day group had less pain (HR=0.83, p=0.0022), but a higher risk of mortality (HR=1.62, p=0.0198) and revision (HR=1.93, p=0.0018) at one year. The two day Outpatient Joint Replacement Apr 16 4

5 group had a higher risk for dislocation (HR=1.37, p=0.0436), implant loosening (HR=1.92, p=0.005), mortality (HR=1.26, p=0.0385) and revision (HR=1.31, p=0.0231) at one year. The authors noted limitations in the study such as the Medicare data do not capture all the risk factors for poor outcomes, many of which may have been more prevalent in patients with longer hospital stays. They concluded that despite sizeable cost reductions, there was an increased revision and mortality risk for the outpatient and short stay TKA groups relative to the traditional stay group. The shorter stay groups did show an improvement in associated pain and stiffness. The five-plus stay group suffered the highest costs and hazard risks for mortality, revision and many of the complications analyzed. Minimally invasive total hip arthroplasty (MIS-THA) actually is not a single approach but a collective term that encompasses multiple distinct minimally invasive surgical (MIS) approaches. Basic approaches currently employed for MIS-THA include the direct anterior, anterolateral, direct lateral, posterior and the two-incision but the approach and size of the incision is usually determined by surgeon preference. For example, the surgeon may use a single mini-incision, which is usually shorter than 10 cm, or may prefer to use 2 incisions, each of which is shorter than 5 cm Berger et al (2009) reported his experience with 150 consecutive THA patients. Of the 150 patients enrolled in this study, 38 were women (25.3%) and 112 were men (74.7%). The average age of the patients was 58 years (range, years). Thirty-six patients were over 65 years of age (24%), 75 patients were between 50 and 65 years of age (50%), and 39 patients were under 50 years of age (26%). The average weight of the women was 158 pounds (range, pounds) and the average weight of the men was 212 pounds (range, pounds). The BMI averaged 30.4 for the men (range, ) and 28 for the women (range, ). The preoperative diagnosis was osteoarthritis in 142 patients (94.7%), developmental dysplasia of the hip in five patients (3.3%), and osteonecrosis in three patients (2%). A comprehensive perioperative perioperative anesthesia and rehabilitation protocol including preoperative teaching, regional anesthesia, and preemptive oral analgesia and antiemetic therapy was implemented around a minimally invasive surgical technique. A rapid rehabilitation pathway was started immediately after surgery and patients had the option of being discharged to home the day of surgery if standard discharge criteria were met. All 150 patients were discharged to home the day of surgery, at which time 131 patients were able to walk without assistive devices. Thirty-eight patients required some additional intervention outside the pathway to resolve nausea, hypotension, or sedation prior to discharge. There were no readmissions for pain, nausea, or hypotension yet there was one readmission for fracture and nine emergency room evaluations in the three month perioperative period. The authors noted a number of limitations in this study, most notably that the follow-up was limited to three months and no outcomes past that time period were obtained. They concluded that patient selection and implementation of specialized clinical pathways not only can decrease the length of stay but decrease complications. However, they note that more research needs to be performed to Outpatient Joint Replacement Apr 16 5

6 determine patient selection criteria and if outpatient procedures should only be performed at select institutions with extensive experience and dedicated resources. Chen (2013) reported that hip replacement can be performed as outpatient surgery using the surgical technique of THA through a modified abductor-sparing Watson- Jones (anterolateral) approach, along with a comprehensive clinical pathway. One hundred thirteen sequential patients were treated with primary THA completed by noon by a single surgeon from January to August Eighty-seven of the 113 patients agreed to be placed in an outpatient protocol, and 26 were treated with an in-patient protocol. Eighty-six of the 87 patients (98.9%) in the outpatient group were successfully discharged home the day of surgery. The remaining patient was discharged home the next morning (postoperative day 1). No patients had significant medical complications, and there were no readmissions within the acute 2-week postoperative period. A deep hip infection developed in one patient at 3 weeks postoperatively. That patient was readmitted to the hospital and treated with a onestage reimplantation procedure. This study confirmed that outpatient THA can be successfully and safely performed through a modified, minimally invasive Watson- Jones (anterolateral) approach coupled with a comprehensive clinical pathway. Dorr et al (2010) surveyed patients younger than 65 years determine what percentage of patients would enroll in a study of outpatient total hip arthroplasty, its safety, and benefits of the program. Of 192 eligible patients, 69 (36%) enrolled, and 53 (77%) of these went home the same day of surgery. Of 53, 44 maintained a diary for the first 3, weeks and 52 completed a satisfaction questionnaire at 6 weeks. Patients were followed for 6 months for occurrence of complications. There were no medical readmissions. Of 52 patients who completed a 6 week questionnaire, 50 (96%) were satisfied with the decision to have outpatient total hip arthroplasty. There were no objective physical benefits identified. This study reports the distribution of acceptance and completion of same day discharge for patients with total hip arthroplasty in a metropolitan population. Review History April 2014 Medical Advisory Council, initial review April 2015 Update no revisions April 2016 Update no revisions. References Update April Anderson Orthopedic Clinic. Discussion on Outpatient Total Knee Replacement with Dr. Nitin Goyal. March 23, den Hartog YM, Mathijssen NMC, Vehmeijer SBW. Total hip arthroplasty in an outpatient setting in 27 selected patients. Acta Orthop. November, 2015; 86(6): References Update April Lovald S, Ong K, Lau E, et al. Patient selection in outpatient and short-stay total knee arthroplasty. J Surg Orthop Adv Spring;23(1):2-8. References Initial 1. Berend KR, Lombardi AV, Jr. Liberal indications for minimally invasive oxford unicondylar arthroplasty provide rapid functional recovery and pain relief. Surg Technol Int. 2007;16: Outpatient Joint Replacement Apr 16 6

7 2. Berger RA. A comprehensive approach to outpatient total hip arthroplasty. Am J Orthop. 2007;36: Berger RA, Sanders S, D Ambrogio E, Buchheit K, et al. Minimally invasive quadriceps-sparing TKA: results of a comprehensive pathway for outpatient TKA. J Knee Surg. 2006;19: Berger RA, Sanders S, Gerlinger T, et al. Outpatient total knee arthroplasty with a minimally invasive technique. J Arthroplasty. 2005;20: Bertin KC. Minimally invasive outpatient total hip arthroplasty: a financial analysis. Clin Orthop Relat Res. 2005;435: Isaac D, Falode T, Liu P, et al. Accelerated rehabilitation after total knee replacement. Knee. 2005;12: Teeny SM, York SC, Benson C, Perdue ST. Does shortened length of hospital stay affect total knee arthroplasty rehabilitation outcomes? J Arthroplasty. 2005;20: Scuderi GR, Noble PC, Benjamin JB, et al. New Knee Society Knee Scoring System Clin Orthop Relat Res. Jan 2012; 470(1): HCPUnet, Healthcare Cost and Utilization Project. Agency for Healthcare Research and Quality. (Accessed on December 20, 2012). 10. Cram P, Lu X, Kates SL, et al. Total knee arthroplasty volume, utilization, and outcomes among Medicare beneficiaries, JAMA 2012; 308: Kurtz S, Ong K, Lau E, et al. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to J Bone Joint Surg Am 2007; 89: Cram P, Lu X, Kaboli PJ, et al. Clinical Characteristics and Outcomes of Medicare Patients Undergoing Total Hip Arthroplasty, JAMA. 2011;305(15): Berger RA. A comprehensive approach to outpatient total hip arthroplasty. Am J Orthop. 2007;36(9 Suppl): Berger RA, Jacobs JJ, Meneghini RM, et al. Rapid rehabilitation and recovery with min- imally invasive total hip arthroplasty. Clin Orthop Relat Res. 2004;429: Healy WL, Ayers ME, Iorio R, et al. Impact of a clinical pathway and implant standardization on total hip arthroplasty: a clinical and economic study of shortterm patient outcome. J Arthroplasty. 1998;13: Healy WL, Iorio R, Ko J, et al. Impact of cost reduction programs on short-term patient outcome and hospital cost of total knee arthroplasty. J Bone Joint Surg Am. 2002;84: Kim S, Losina E, Solomon DH, Wright J, Katz JN. Effectiveness of clinical pathways for total knee and total hip arthroplasty: literature review. J Arthroplasty. 2003;18: Dorr, LD (2010) Outpatient total hip arthroplasty. J Arthroplasty 25(4): Chen, D. (2013) Outpatient minimally invasive total hip arthroplasty via a modified Watson-Jones approach: technique and results Instr Course Lect; 62: Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, Outpatient Joint Replacement Apr 16 7

8 including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. The Policies do not replace or amend the Member s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code requires health care service plans to cover reconstructive surgery. Reconstructive surgery means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Outpatient Joint Replacement Apr 16 8

9 Reconstructive surgery does not mean cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Outpatient Joint Replacement Apr 16 9