Editorial Commentary: Denial of Payment Limits Patient Access to Musculoskeletal Procedures: What Can Willie Sutton Teach Us About the Decreasing Incidence of Acromioplasty?

Arthroscopic acromioplasty is one of the most commonly performed orthopedic surgical procedures. The indication for performing an acromioplasty has traditionally been based on the mechanical theory of impingement of the coracoacromial arch on the soft tissues of the rotator cuff footprint. Orthopedic surgeons have recommended surgically decompressing this phenomenon for six decades to eliminate shoulder pain and restore function. Recent high-level studies have cast doubt on the value of acromioplasty compared to other nonoperative treatment modalities. There is also an increased recognition and awareness that rotator cuff disease is as much a degenerative and senescent process as it is a mechanical one. There is now good evidence that the incidence of acromioplasty is falling significantly, especially in treatment scenarios that involve an intact rotator cuff. The cause of this decrease must be understood as multifactorial and related to both the clinical evidence and the economics and reimbursement policy concerning acromioplasty. Like many other high-volume and elective orthopedic surgical procedures, third-party reimbursement policy dictates patient access to treatments. Yet, current and future literature and clinical expertise determine proper indications for acromioplasty. Doctors are in the best position to indicate proper patient care.

The Near-Term Ramifications of Long-Term Trends in Orthopedic Surgical Reimbursement.

BACKGROUND: There has been 25-year trend of decreasing value for orthopedic surgical work based on the Resource-Based Relative Value Scale (RBRVS) for Medicare reimbursement. This study was undertaken to estimate the time that Medicare payment rates for time spent in the office doing cognitive work will equal time dedicated in the operating room to performing procedural work based on long-term negative payment trends. METHODS: The RBRVS Update Committee database was accessed to extract the time elements for 2 procedures, total knee arthroplasty and total hip arthroplasty (27447 and 27130), on the day of surgery. The evaluation and management code mix for 2 mid-sized orthopedic practice was averaged to create an amalgamated rate for the reimbursement of office work on an hourly rate. A graph of the 25-year trend line in Medicare reimbursement for arthroplasty procedures was used to create a trend line. The trend line was then extrapolated to estimate the time in the future that the hourly rate for office work would equal the hourly rate for surgery. RESULTS: Time inputs and the Medicare conversion factor for 2021 were used in this analysis. Total procedural time for both 27447 and 27130 was 204 minutes (3.4 hours) on the day of surgery. An amalgamated hourly office rate of 7.9 relative value unit was calculated from the average of the 2 mid-sized private practices for an overall in office Medicare reimbursement of $318.89/h, with $1083.04 for the 3.4 hours allowed in the RBRVS Update Committee database for a joint replacement. When the trend line for reimbursement was extrapolated to the $1083.04 price point, the year corresponding to the point where hourly office reimbursement would equal hourly surgical work was 2024. CONCLUSION: Policymakers in Washington and practicing orthopedic surgeons need to consider the looming economic parity of surgical and cognitive work for Medicare. Continued negative reimbursement rates are likely to decrease patient access to necessary surgical care and result in de facto rationing of arthroplasty services for Medicare patients. The deployment of the orthopedic workforce is likely to change to accommodate the decreases in the value of surgical work. This trend will have significant impact on the practice of musculoskeletal medicine and patient access to orthopedic services.

Editorial Commentary: A Rigged Game-Surgeon Reimbursement Under the Resource-Based Relative Value Scale, Current Procedural Terminology, and the Affordable Care Act.

The value of surgeon procedural work is currently determined through a fee-setting process controlled by the Centers for Medicare & Medicaid Services. This process relies on the Resource-Based Relative Value Scale (RBRVS) to advise the Centers for Medicare & Medicaid Services concerning surgical work reimbursement. This system and several other government policy decisions over the past 25 years have placed orthopaedic surgeons at great disadvantage in establishing and maintaining the value of orthopaedic surgical work. Continued reliance on the RBRVS will result in further reductions in surgical reimbursements and may affect patient access to orthopaedic services. Orthopaedic surgeons must consider moving away from the RBRVS and Current Procedural Terminology as a way of determining value and instead establish price as the value signal in orthopaedic medicine. Bundled-payment methodologies offer one mechanism for establishing price in the marketplace.

Editorial Commentary: What You See Is What You Get-Is In-Office Needle Arthroscopy Ready for Prime Time?

In-office needle arthroscopy (IONA) has been around for many years, and technological improvements in image fidelity, patient convenience and access to care, and medical economics have resulted in renewed interest in this diagnostic tool. Patients could be well served by an immediate diagnosis of their joint pathology at the initial office encounter. A limitation of the current literature is that for research purposes, studies comparing IONA with diagnostic surgical arthroscopy and/or magnetic resonance imaging have been performed in the operating room-not the office setting. In addition, IONA is limited to intra-articular evaluation. IONA has been shown to be accurate and cost-effective, and future adoption of this modality seems promising.

Patient-Reported Outcomes After Use of a Bioabsorbable Collagen Implant to Treat Partial and Full-Thickness Rotator Cuff Tears.

PURPOSE: To collect outcomes data on patients treated with a bioinductive collagen implant designed to induce rotator cuff healing in partial- and full-thickness cuff tears and to assess the safety and efficacy of the device. METHODS: Fifteen surgeons in 15 centers in the United States enrolled patients between April 2016 and August 2017 and collected standardized outcomes data. Patients 21 years of age and older, able to read and speak English, and with partial- or full-thickness tears of the rotator cuff documented by magnetic resonance imaging were included in the study. Patients were assessed preoperatively with visual analogue scale (VAS), single-assessment numeric evaluation (SANE), Veterans RAND 12-Item (VR-12), American Shoulder and Elbow Surgeons (ASES), and Western Ontario Rotator Cuff (WORC) outcomes measures. Postoperative assessment was made at 2, 6, and 12 weeks, 6 months, and 1 year. Patients underwent a standardized operative procedure with the implant. Patient demographics, comorbidities, tear types, and concomitant operative procedures were recorded. RESULTS: Patients in both groups experienced statistically significant improvement in VAS, SANE, VR-12 PCS, ASES, and WORC scores (mean values 1.1, P < .001; 86.0, P < .001; 49.7, P < .001; 85.6, P < .001; and 84.4, P < .001 for partial tears and 1.2, P < .001; 80.7, P < .001; 45.7, P < .001; 83.8, P < .0001; and 80.1, P < .001 for full-thickness tears, respectively). For the partial tear group, average times for return to driving, work, and nonoverhead athletic activity were 14.6, 37.3, and 65.6 days, and for the full-thickness group, 24.5, 50.7, and 119.2 days, respectively. In the partial-thickness group, 84% and 83% of patients reported improvement in their VAS pain and ASES scores, respectively, that met or exceeded each measure's minimal clinically important difference. In the full-thickness group, 72% and 77% of the patients met or exceeded the minimal clinically important differences for VAS pain and ASES, respectively. CONCLUSION: Outcomes after repair of partial- and full-thickness rotator cuff tears using a bioinductive implant show safety and efficacy at 1-year follow-up. LEVEL OF EVIDENCE: Retrospective case series, level IV evidence.

Editorial Commentary: Are We Running Out of Treatments for Osteoarthritis of the Knee?

A considerable body of literature with high-level evidence has been published in the past 15 years calling into question the value of arthroscopic surgery in treating osteoarthritis of the knee (OAK). This, plus recent guidelines advising against the use of conservative treatments such as hyaluronic viscosupplementation, threatens to limit patient access to treatment for a chronic disease state with no known cure. The disease burden of OAK is considerable and represents one of the largest health care dollar expenditures in the United States and the world. Orthopaedic surgeons are the primary specialty dealing with OAK and manage this disease from inception to the final endpoint of total joint arthroplasty. As the population ages and the incidence of OAK increases, we must find ways to improve our ability to show efficacy in our treatments and also promote innovative modalities and applications to ameliorate the disability and dysfunction associated with OAK. Arthroscopy is recognized as a global leader in the presentation of evidence and debate surrounding all treatments for OAK and plays an important role in improving knowledge and treatment efficacy.

Employment Contracts: The Good, the Bad, and the Ugly.

Recent trends indicate that a greater number of orthopaedic surgeons who complete their residency and/or fellowship training are accepting employment positions at hospitals. Moreover, established orthopaedic surgeons with successful private practices have begun to consider whether aligning with hospitals and larger health systems can be effectively accomplished. A comprehensive evaluation of institution-based employment opportunities is essential for orthopaedic surgeons considering hospital-based employment. Surgeons should be aware of the healthcare, clinical, and administrative opportunities of private practice employment versus hospital-based employment before accepting a clinical position.

Making Sure the Media Gets It Right on Orthopaedic Research.

Patient-centered medicine requires an informed health care consumer. Traditionally, orthopaedic surgeons were the primary source for patients regarding diagnostic and treatment options for musculoskeletal conditions. Now patients get information from a variety of sources including the Internet, social media, and print journalism. Most of these sources are not vetted or peer reviewed and some not even fact checked. Part of the role of the orthopaedic surgeon is to educate patients, and interpreting this type of information is an increasingly demanding but essential task. A recent article in the New York Times titled "Why 'Useless' Surgery Is Still Popular" illustrates the importance of this educational role. Patients deserve the most up-to-date and accurate assessment of medical information. The most appropriate source of that information is their treating physician and surgeon.

Getting Ready for ICD-10 and Meaningful Use Stage 2.

For the past 24 years, most developed countries have used the International Classification of Diseases, Tenth Revision (ICD-10) to report physician services. In the United States, physicians have continued to use the American Medical Association Current Procedural Terminology, Fourth Edition and the Healthcare Common Procedure Coding System. The ICD-10-Clinical Modification (CM) has approximately 4.9 times more codes than the International Classification of Diseases, Ninth Revision. ICD-10-CM allows for more specific descriptors of a procedure and is broken down by category, etiology, anatomic site, severity, and extension. ICD-10-CM is scheduled to be implemented by Medicare and commercial payers on October 1, 2015. In addition to ICD-10 implementation, physicians have to meet the requirements of the Meaningful Use Electronic Health Record Incentive Program. The Meaningful Use program is designed to promote the use of certified electronic health technology by providing eligible professionals with incentive payments if they meet the defined core and menu objectives of each stage of the program. All core measures must be met; however, providers can choose to meet a preset number of menu measures. Meaningful Use Stage 1 required eligible professionals to meet core and menu objectives that focused on data capture and sharing. Meaningful Use Stage 2 requires eligible professionals to meet core and menu objects that focus on advanced clinical processes for a full year in 2015. Stage 3 has been delayed until 2017, and core and menu measures that will focus on improving outcomes have not yet been defined. It is important for orthopaedic surgeons to understand the history of and techniques for the use of ICD-10-CM in clinical practice. Orthopaedic surgeons also should understand the requirements for Meaningful Use Stages 1 and 2, including the core objectives that must be met to achieve satisfactory attestation.

Economic Impact of Orthopedic Adult Reconstruction Office Practice: The Implications of Hospital Employment Models on Local Economies.

The purpose of this study was to evaluate the economic attributes of private practice adult reconstruction (AR) offices. 458 AAHKS surgeons responded; 65% were in private practice (fee-for-service, non-salaried, non-employed AR surgeons). 54% had considered hospital employment in the past two years. The average group employs 13.4 orthopedic surgeons (3.4 AR), and 105 other employees. The average total budget is $12.5 million per year with $4 million in salaries, and $238,000 in tax revenue generated. Co-management joint ventures are a better model than hospital employment for aligning AR surgeons and hospitals and realizing the cost effectiveness and quality improvement goals of PPACA and AARA while preserving the economic impact of AR private practice.

Did the American Academy of Orthopaedic Surgeons osteoarthritis guidelines miss the mark?

The American Academy of Orthopaedic Surgeons (AAOS) 2013 guidelines for knee osteoarthritis recommended against the use of viscosupplementation for failing to meet the criterion of minimum clinically important improvement (MCII). However, the AAOS's methodology contained numerous flaws in obtaining, displaying, and interpreting MCII-based results. The current state of research on MCII allows it to be used only as a supplementary instrument, not a basis for clinical decision making. The AAOS guidelines should reflect this consideration in their recommendations to avoid condemning potentially viable treatments in the context of limited available alternatives.

Evidence-based medicine, appropriate-use criteria, and sports medicine: how best to develop meaningful treatment guidelines.

We propose using appropriate-use criteria (AUC) as the methodology of choice for formulating and disseminating evidence-based medicine guidelines in sports medicine and arthroscopy. AUC provide a structured process for integrating findings from the scientific literature with clinical judgment to produce explicit criteria for determining the appropriateness of specific treatments. The use of AUC will enable surgeons to treat patients in a more consistent manner based on expert clinical consensus and evidence-based medicine. This methodology also will ensure that guidelines represent all stakeholders and available evidence.

Resorbable Bioinductive Collagen Implant Is Cost Effective in the Treatment of Rotator Cuff Tears.

Purpose: This study was conducted to investigate whether the use of resorbable bioinductive collagen implant (RBI) in addition to conventional rotator cuff repair (conventional RCR) is cost-effective when compared to conventional RCR alone, in the treatment of full-thickness rotator cuff tears (FT RCT). Methods: We developed a decision analytic model to compare the expected incremental cost and clinical consequences for a cohort of patients with FT RCT. The probabilities for healing or failure to heal (retear) were estimated from the published literature. Implant and healthcare costs were estimated from a payor's perspective in 2021 U.S. prices. An additional analysis included indirect cost estimations (e.g., productivity losses). Sensitivity analyses explored the effect of tear size, as well as the impact of risk factors. Results: The base case analysis demonstrated that resorbable bioinductive collagen implant + conventional rotator cuff repair results in incremental costs of $232,468 and an additional 18 healed RCTs per 100 treated patients over 1 year. The estimated incremental cost-effectiveness ratio (ICER) is $13,061/healed RCT compared to conventional RCR alone. When return to work was included in the model, RBI + conventional RCR was found to be cost saving. Cost-effectiveness improved with tear size with the largest benefit seen in massive tears compared to large tears, as well as patients at higher risk of retearing. Conclusions: This economic analysis demonstrated that RBI + conventional RCR delivered improved healing rates at a marginal increase in costs when compared to conventional RCR alone and is, therefore, cost-effective in this patient population. Considering indirect costs, RBI + conventional RCR resulted in lower costs compared to conventional RCR alone and is, therefore, deemed to be cost saving. Level of Evidence: Level IV, economic analysis.

Regulatory and Ethical Aspects of Orthobiologic Therapies.

Orthobiologic therapies show significant promise to improve outcomes for patients with musculoskeletal pathology. There are considerable research efforts to develop strategies that seek to modulate the biological environment to promote tissue regeneration and healing and/or provide symptomatic relief. However, the regulatory pathways overseeing the clinical translation of these therapies are complex, with considerable worldwide variation. The introduction of novel biologic treatments into clinical practice raises several ethical dilemmas. In this review, we describe the process for seeking approval for biologic therapies in the United States, Europe, and Japan. We highlight a number of ethical issues raised by the clinical translation of these treatments, including the design of clinical trials, monitoring outcomes, biobanking, "off-label" use, engagement with the public, marketing of unproven therapies, and scientific integrity.

Full-Thickness Rotator Cuff Tears Can Be Safely Treated With a Resorbable Bioinductive Bovine Collagen Implant: One-Year Results of a Prospective, Multicenter Registry.

PURPOSE: The purpose of this study was to prospectively collect safety and efficacy data in a large group of patients undergoing arthroscopic repair of full-thickness rotator cuff tears augmented with a resorbable bioinductive bovine collagen implant designed to promote healing. METHODS: Seventeen centers across the United States enrolled patients in an institutional review board-approved registry to collect outcomes data on the implant. Patients undergoing surgical management of full-thickness rotator cuff tears augmented with the implant were enrolled. Inclusion criteria were age of ≥21 years, willingness to participate and the ability to read and speak English. Exclusion criteria included hypersensitivity to bovine-derived products. Patients were assessed before and after surgery at up to 1 year with outcomes including the single-assessment numeric evaluation (SANE), Veterans RAND 12-Item (VR-12) mental components and physical components (VR-12 PCS), American Shoulder and Elbow Surgeons (ASES), and Western Ontario Rotator Cuff (WORC) outcome measures. Ad hoc analyses were performed to compare these outcomes at all time points depending on tear size (small/medium vs large/massive). Serious complications were collected. RESULTS: Of 210 patients enrolled, 192 had 1-year follow-up data available. The patients experienced statistically significant improvement between baseline and 1 year for mean SANE, VR-12 PCS, ASES, and WORC scores (40.0-82.0, 33.5-47.3, 46.2-87.8, and 36.2-81.0, respectively; P < .001 for all results). Ad-hoc analysis demonstrated that similar results were obtained at 1 year regardless of tear size. Twenty patients (10.4%) experienced serious complications (10.4%), including revision surgery (n = 18), proximal humerus fracture/partial subscapularis tear resulting from multiple falls (n = 1), and adhesive capsulitis (n = 1). CONCLUSIONS: The safety and efficacy of a bioinductive implant in the surgical management of full-thickness rotator cuff tears at 1 year was shown in this study. Implant efficacy appears to be comparable regardless of the underlying tear size. LEVEL OF EVIDENCE: Level IV, therapeutic case series.

Treatment of Partial-Thickness Rotator Cuff Tears With a Resorbable Bioinductive Bovine Collagen Implant: 1-Year Results From a Prospective Multicenter Registry.

BACKGROUND: Surgical treatment of partial-thickness rotator cuff tears remains challenging and controversial, with several traditional options including debridement with acromioplasty, transtendon or in situ repair, and take-down and repair. A resorbable bioinductive bovine collagen implant has shown promise as an alternative treatment option for partial-thickness tears. PURPOSE: Data from a registry were analyzed to further establish that the implant contributes to improved patient-reported outcome (PRO) scores across a large number of patients treated for partial-thickness rotator cuff tears. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: A total of 19 centers in the United States enrolled patients >21 years old with partial-thickness tears of the rotator cuff in a comprehensive prospective multicenter registry. PRO scores were recorded preoperatively and postoperatively at 2 and 6 weeks, 3 and 6 months, and 1 year: American Shoulder and Elbow Surgeons, Single Assessment Numeric Evaluation, Veterans RAND 12-Item Health Survey (physical and mental component scores), and Western Ontario Rotator Cuff scores. Revisions were reported throughout the study. RESULTS: The registry included 272 patients with partial-thickness tears (49 grade 1 tears, 101 grade 2 tears, and 122 grade 3 tears), 241 who underwent isolated bioinductive repair (IBR; collagen implant placed after bursectomy without a traditional rotator cuff repair), and 31 who had take-down and repair with bioinductive augmentation. Patients experienced statistically significant and sustained improvement from baseline for all PRO scores beginning at 3 months. Among patients with grade ≥2 tears, those with take-down and repair had significantly inferior scores at 2 and 6 weeks for most PRO scores as compared with those who underwent IBR, but the difference was no longer significant at 1 year for all but the physical component score of the Veterans RAND 12-Item Health Survey. There were 11 revisions, which occurred at a mean ± SD of 188.7 ± 88.0 days after the index surgery. There were no infections. CONCLUSION: This registry analysis further establishes across a large data set that this resorbable bioinductive bovine collagen implant improves PROs in all grades of partial-thickness tears, whether used as IBR or in conjunction with take-down and repair. IBR may offer improved early clinical outcomes (≤6 weeks) and comparable outcomes at 1 year when compared with a more invasive "take-down and repair" approach.

Risk of Severe Acute Localized Reactions for Different Intraarticular Hyaluronic Acid Knee Injections in a Real-World Setting.

OBJECTIVE: Case reports of severe acute localized reactions (SALR) following intraarticular (IA) hyaluronic acid (HA) injections for knee osteoarthritis (OA) have been described. We compared surrogate SALR measures between patients using hylan G-F 20 and specific non-hylan G-F 20 HA products. DESIGN: Knee OA patients were identified from the Optum Clinformatics dataset (January 2006 to June 2016), stratified into hylan G-F 20 and non-hylan G-F 20 HA users, matched by single or multiple injection products. Occurrences of surrogate SALR measures including inflammation/infection, intraarticular corticosteroid (CS) injections, arthrocentesis/aspiration, arthrotomy/incision and drainage, and arthroscopy were evaluated within 3 days post-HA. RESULTS: Based on 694,404 HA injections, inflammation/infection rate was rare within 3 days of HA (up to 0.03%), with no statistical differences between hylan G-F 20 and non-hylan G-F 20 groups (matched by single or multiple injection products). The risk of knee arthrotomy/incision and drainage, arthroscopy, or arthrocentesis for hylan G-F 20 (2 mL) 3 weekly injection patients was lower than Hyalgan/Supartz and Orthovisc patients, but greater than Euflexxa patients. Overall, we found that Hylan G-F 20 (2 mL) 3 weekly injection had lower SALR rates compared to Hyalgan/Supartz and Orthovisc. However, Hylan G-F 20 (2 mL) 3 weekly injection had slightly higher rates of SALR when compared to Euflexxa. Among the single injection products, Hylan G-F 20 (6 mL) single injection had lower rates of SALR than Monovisc and Gel-One. CONCLUSIONS: This study shows no clear correlation between avian-derived or cross-linked products and SALR and provides evidence against avian-derived products or crosslinking as a source for these reactions.

Biologic Association Annual Summit: 2020 Report.

Interest and research in biologic approaches for tissue healing are exponentially growing for a variety of musculoskeletal conditions. The recent hype concerning musculoskeletal biological therapies (including viscosupplementation, platelet-rich plasma, and cellular therapies, or "stem cells") is driven by several factors, including demand by patients promising regenerative evidence supported by substantial basic and translational work, as well as commercial endeavors that complicate the scientific and lay understanding of biological therapy outcomes. While significant improvements have been made in the field, further basic and preclinical research and well-designed randomized clinical trials are needed to better elucidate the optimal indications, processing techniques, delivery, and outcome assessment. Furthermore, biologic treatments may have potential devastating complications when proper methods or techniques are ignored. For these reasons, an association comprising several scientific societies, named the Biologic Association (BA), was created to foster coordinated efforts and speak with a unified voice, advocating for the responsible use of biologics in the musculoskeletal environment in clinical practice, spearheading the development of standards for treatment and outcomes assessment, and reporting on the safety and efficacy of biologic interventions. This article will introduce the BA and its purpose, provide a summary of the 2020 first annual Biologic Association Summit, and outline the future strategic plan for the BA.