DECISION AND ORDER
This case is decided pursuant to Chapter 410 of the Texas Workers’ Compensation Act and Rules of the Texas Department of Insurance, Division of Workers’ Compensation. For the reasons discussed herein, the Hearing Officer determines that Claimant is not entitled to outpatient repeat manipulation under anesthesia and diagnostic A&A debridement for the compensable injury of April 6, 2014.
STATEMENT OF THE CASE
On May 3, 2016, Virginia Rodriguez-Gomez, a Division hearing officer, held a contested case hearing to decide the following disputed issues:
- Is the preponderance of the evidence contrary to the decision of the IRO that the Claimant is not entitled to outpatient repeat manipulation under anesthesia and diagnostic A&A debridement for the compensable injury of (Date of Injury)?
The record was held open to allow Claimant to obtain a written medical opinion from his surgeon, JF, M.D. The additional exhibit was admitted without objections, and the record was closed on May 27, 2016.
Petitioner/Claimant appeared and was represented by S S, attorney. Respondent/Carrier appeared and was represented by N M, adjuster.
The following exhibits were admitted into evidence:
Hearing Officer’s Exhibits HO-1 and HO-2.
Claimant’s Exhibits C-1 through C-10.
Carrier’s Exhibits CR-A through CR-D.
As a result of his compensable injury to the left shoulder, Claimant underwent surgical intervention in the form of left shoulder arthroscopy, subacromial decompression rotator cuff repair and distal clavicle resection in January 2015. The surgical intervention was followed by a manipulation under anesthesia (MUA) on May 27, 2015. Claimant requested approval for outpatient repeat MUA and diagnostic A&A (arthrotomy and arthroscopic) debridement due to the development of a frozen left shoulder (adhesive capsulitis) as a result of his compensable injury of (Date of Injury). A utilization reviewer agent (URA) denied the request stating that there was no quantitative documentation of abduction range of motion less than 90 degrees for MUA and there was no submission of imaging studies post-MUA and mini open distal clavicle resection performed in May 2015. Claimant requested a reconsideration of that adverse determination. A second URA denied the request, and Claimant submitted his request for review to the Independent Review Organization (IRO). The IRO denied Claimant’s request, and the case was set for a medical contested case hearing.
Texas Labor Code Section 408.021 provides that an employee who sustains a compensable injury is entitled to all health care reasonably required by the nature of the injury as and when needed. Health care reasonably required is further defined in Texas Labor Code Section 401.011 (22a) as health care that is clinically appropriate and considered effective for the injured employee's injury and provided in accordance with best practices consistent with evidence based medicine or, if evidence based medicine is not available, then generally accepted standards of medical practice recognized in the medical community. Health care under the Texas Workers' Compensation system must be consistent with evidence based medicine if that evidence is available. Evidence based medicine is further defined in Texas Labor Code Section 401.011 (18a) to be the use of the current best quality scientific and medical evidence formulated from credible scientific studies, including peer-reviewed medical literature and other current scientifically based texts and treatment and practice guidelines in making decisions about the care of individual patients. The Commissioner of the Division of Workers' Compensation is required to adopt treatment guidelines that are evidence-based, scientifically valid, outcome-focused and designed to reduce excessive or inappropriate medical care while safeguarding necessary medical care. Texas Labor Code Section 413.011(e). Medical services consistent with the medical policies and fee guidelines adopted by the commissioner are presumed reasonable in accordance with Texas Labor Code Section 413.017(1).
In accordance with the above statutory guidance, the Division of Workers' Compensation has adopted treatment guidelines by Division Rule 137.100. This rule directs health care providers to provide treatment in accordance with the current edition of the Official Disability Guidelines (ODG), and such treatment is presumed to be health care reasonably required as defined in the Texas Labor Code. Thus, the focus of any health care dispute starts with the health care set out in the ODG. Also, in accordance with Division Rule 133.308 (s), "A decision issued by an IRO is not considered an agency decision and neither the Department nor the Division are (sic) considered a party to an appeal. In a division Contested Case Hearing (CCH), the party appealing the IRO decision has the burden of overcoming the decision issued by an IRO by a preponderance of evidence based medical evidence."
- The ODG recommendations for Arthroscopic Debridement:
Recommended as an alternative to shoulder arthroplasty for limited indications below. While the evidence base is not high quality, it is positive, with weak evidence for limited benefit from a relatively non-invasive surgery that might result in delay or avoidance of something much more invasive, specifically a shoulder replacement or reverse shoulder, and this can be especially appealing in a younger patient due to the limited life of shoulder replacement. High quality evidence is lacking for a number of arthroscopic procedures for OA from simple debridement to more extensive forms of chondroplasty, loose body and osteophyte removal, capsular releases, subacromial decompression, biceps tenodesis and axillary neurolysis. The largest meta-analysis to date includes 32 studies and 1229 patients but consists only of case series. Comparing results of arthroscopic debridement (AD) with total shoulder and hemiarthroplasty revealed fewer complications, better motion and similar re-operation rates for AD. The authors concluded that AD is an efficacious and particularly safe alternative in the short term for young patients with concern about arthroplasty. (Sayegh, 2014) A smaller systematic review of five case series also noted similar improvement and functional outcomes with a small (13%) conversion to arthroplasty by 3 years. (Namdari, 2013) AD has been shown to most likely benefit patients with mild glenohumeral OA, small lesions and involvement of only one side of the joint. (Denard, 2011) (Kerr, 2008) Arthroscopic debridement combined with capsular releases has resulted in significant patient dissatisfaction and cannot be recommended. (Skelley, 2014) In contrast, another case series of 30 patients with advanced OA who underwent comprehensive arthroscopic management including 6-8 interventions (including releases) showed reasonable short-term improvement at 2 years with 85% survivorship. No comparison to simple debridement was attempted nor do results of this significantly more aggressive arthroscopic approach appear to be an improvement over simple debridement alone. (Millett, 2013) AAOS Clinical Practice Guidelines on the Treatment of Glenohumeral Arthritis determined that evidence remains inconclusive regarding all arthroscopic treatments for these arthritic conditions. Arthroscopic debridement for irreparable rotator cuff tears with or without OA has been similarly understudied. (AAOS, 2009) See also Arthroplasty (shoulder); Reverse shoulder arthroplasty. Note: In the Knee Chapter, Arthroscopic surgery for osteoarthritis is Not recommended because arthroscopic lavage and debridement in patients with osteoarthritis of the knee is no better than placebo surgery, and arthroscopic surgery provides no additional benefit compared to optimized physical and medical therapy.
Risk vs. benefit: Outpatient arthroscopic shoulder surgery involves less medical risk for carefully selected patients than the alternative of shoulder arthroplasty. While the benefit of major clinical improvement may be limited or temporary by comparison, many patients would opt to consider the less invasive procedure, but expectations should be tempered. Failed arthroscopic outcomes do not preclude later joint replacement, which has its own inherent risks of stiffness, infection, loosening and need for revision.
ODG Indications for Surgery -- Shoulder Arthroscopic Debridement for Arthritis:
Glenohumeral joint osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis with all of the following:
(1) More likely benefit under age 60 (contraindicated over 60 with humeral head deformity, large osteophytes and/or significant motion loss unless mechanical locking due to loose body);
(2) Moderate to severe pain (preventing a good night's sleep) or functional disability that interferes with activities of daily living or work;
(3) Positive imaging findings of shoulder joint degeneration with small lesions, preferably involving only one side of joint;
(4) Conservative therapies (including NSAIDs, intra-articular steroid injections, and physical therapy) have been tried and failed for at least 6 months;
(5) If rheumatoid arthritis, tried and failed anti-cytokine agents or disease modifying anti-rheumatic drugs.
The ODG recommendation for diagnostic arthroscopy:
Recommended as indicated below. Criteria for diagnostic arthroscopy (shoulder arthroscopy for diagnostic purposes): Most orthopedic surgeons can generally determine the diagnosis through examination and imaging studies alone. Diagnostic arthroscopy should be limited to cases where imaging is inconclusive and acute pain or functional limitation continues despite conservative care. Shoulder arthroscopy should be performed in the outpatient setting. If a rotator cuff tear is shown to be present following a diagnostic arthroscopy, follow the guidelines for either a full or partial thickness rotator cuff tear. (Washington, 2002) (de Jager, 2004) (Kaplan, 2004).
The ODG recommendations for Manipulation under Anesthesia:
Under study as an option in adhesive capsulitis. In cases that are refractory to conservative therapy lasting at least 3-6 months where range-of-motion remains significantly restricted (abduction less than 90°), manipulation under anesthesia may be considered. There is some support for manipulation under anesthesia in adhesive capsulitis, based on consistent positive results from multiple studies, although these studies are not high quality. (Colorado, 1998) (Kivimaki, 2001) (Hamdan, 2003) Manipulation under anesthesia (MUA) for frozen shoulder may be an effective way of shortening the course of this apparently self-limiting disease and should be considered when conservative treatment has failed. MUA may be recommended as an option in primary frozen shoulder to restore early range of movement and to improve early function in this often protracted and frustrating condition. (Andersen, 1998) (Dodenhoff, 2000) (Cohen, 2000) (Othman, 2002) (Castellarin, 2004) Even though manipulation under anesthesia is effective in terms of joint mobilization, the method can cause iatrogenic intraarticular damage. (Loew, 2005) When performed by chiropractors, manipulation under anesthesia may not be allowed under a state's Medical Practice Act, since the regulations typically do not authorize a chiropractor to administer anesthesia and prohibit the use of any drug or medicine in the practice of chiropractic. (Sams, 2005) This case series concluded that MUA combined with early physical therapy alleviates pain and facilitates recovery of function in patients with frozen shoulder syndrome. (Ng, 2009) This study concluded that manipulation under anaesthesia is a very simple and noninvasive procedure for shortening the course of frozen shoulder, an apparently self-limiting disease, and can improve shoulder function and symptoms within a short period of time, but there was less improvement in post-surgery frozen shoulders. (Wang, 2007) Two lower quality studies have recently provided some support for the procedure. In this study manipulation under suprascapular nerve block and intra-articular local anesthesia shortened the course of frozen shoulder (FS), although it is an apparently self-limiting disease. (Khan, 2009) In this study manipulation under anesthsia combined with arthroscopy was effective for primary frozen shoulder. (Sun, 2011) Frozen shoulder has a greater incidence, more severe course, and resistance to treatment in patients with diabetes mellitus compared with the general population, but outcomes for diabetic patients with frozen shoulder undergoing treatment with manipulation under general anaesthesia (MUA) are the same as patients without diabetes. (Jenkins, 2012) In this case series, treatment of frozen shoulder by MUA led to improvement in shoulder motion and function at a mean 23 years after the procedure. (Vastamäki, 2012) The latest UK Health Technology Assessment on management of frozen shoulder concludes that there was very little evidence available for MUA and most of the studies identified had limitations. The single adequate study found no evidence of benefit of MUA over home exercise alone. Generalizability is somewhat unclear because of the limited information about previous interventions that participants had received and stage of frozen shoulder. (Maund, 2012) The fastest improvement occurs following the first month after MUA, but 6 months after MUA, shoulder active range of motion remains lower than the uninvolved extremity. (Sokk, 2012) In this study, six months after MUA, endurance time and net impulse remained impaired for the involved shoulder. (Sokk, 2013) According to an Indian study, the efficacy of MUA, injection, and PT are comparable for adhesive capsulitis. (Ghosh, 2012) It is currently unclear as to whether there is a difference in the clinical effectiveness of an arthroscopic capsular release compared to MUA in patients with recalcitrant idiopathic adhesive capsulitis. The quality of evidence available is low and the data available demonstrate little benefit. A high quality study is required to definitively evaluate the relative benefits of these procedures. (Grant, 2013) According to a systematic review of frozen shoulder treatments, outcomes with MUA are equivocal when compared to other treatment approaches. (Uppal, 2015) This study concluded that the best time for MUA, if non-operative treatment has failed to alleviate pain or limitation of shoulder motion is too cumbersome, might be between 6 and 9 months from the onset of the symptoms. (Vastamäki, 2015) See also Surgery for adhesive capsulitis. In other chapters, see the Low Back Chapter, where MUA is not recommended in the absence of vertebral fracture or dislocation; and the Knee Chapter, where MUA is recommended as an option for treatment of arthrofibrosis and/or after total knee arthroplasty, only after a trial (six weeks or more) of conservative treatment, and a single treatment session would then be recommended, not serial treatment sessions.
The IRO provided its reasoning for the denial of the requested procedures and stated “there was no quantitative documentation of range of motion to include abduction less than 90 degrees for a manipulation under anesthesia. There were no submitted imaging studies after the date of the most recent procedure, May of 2015. Therefore, the request was non-certified”.
With regard to the request for MUA, Claimant provided medical records that substantiated left shoulder abduction less than 90 degrees that existed but were not provided to the IRO. Claimant presented a narrative report from his surgeon, JF, M.D., which stated that Claimant had less than 90 degrees of abduction in his left shoulder. With regard to the A&A debridement, Dr. Followwill stated in his narrative report that the ODG recommendation on diagnostic arthroscopy “should be limited to cases where imaging was inconclusive and acute pain or functional limitation continued despite conservative care”. Dr. Followwill referenced an April 28, 2015 arthrogram of Claimant’s left shoulder, which he stated was negative for recurrent tear, but, despite the imaging finding, he suspected that there may be rotator cuff pathology. As noted by the URAs and the IRO, Dr. Followwill did not present imaging studies after the last MUA performed in May 2015, but instead, relied upon the arthrogram performed before the last MUA. He did not address why another MUA would render a different result than the one performed in May 2015 after the January 2015 procedure. Other than to state that he suspected there may be rotator cuff pathology, Dr. Followwill did not present imaging studies to show there was an “inconclusive imaging study”. In fact, the arthrogram was negative for a recurrent tear. Claimant failed to present persuasive evidence-based medical evidence to overcome the IRO’s decision that he is not entitled to outpatient repeat manipulation under anesthesia and diagnostic A&A debridement.
The Hearing Officer considered all of the evidence admitted. The Findings of Fact and Conclusions of Law are based on an assessment of all of the evidence whether or not the evidence is specifically discussed in this Decision and Order.
FINDINGS OF FACT
The parties stipulated to the following facts:
- A.Venue is proper in the (City) Satellite Office of the Texas Department of Insurance, Division of Workers’ Compensation.
- On (Date of Injury), Claimant was the employee of (Employer), Employer and sustained a compensable injury.
- C.On (Date of Injury), Employer provided workers’ compensation insurance with (Carrier), Carrier.
Carrier delivered to Claimant a single document stating the true corporate name of Carrier, and the name and street address of Carrier’s registered agent, which document was admitted into evidence as Hearing Officer’s Exhibit Number 2.
Claimant failed to present persuasive evidence-based medical evidence to overcome the IRO’s decision that Claimant is not entitled to outpatient repeat manipulation under anesthesia and diagnostic A&A debridement.
Outpatient repeat manipulation under anesthesia and diagnostic A&A debridement is not health care reasonably required for the compensable injury of (Date of Injury).
CONCLUSIONS OF LAW
- The Texas Department of Insurance, Division of Workers’ Compensation, has jurisdiction to hear this case.
2. Venue is proper in the (City) Satellite Office.
- The preponderance of the evidence is not contrary to the decision of the IRO that outpatient repeat manipulation under anesthesia and diagnostic A&A debridement is not health care reasonably required for the compensable injury of (Date of Injury).
Claimant is not entitled to outpatient repeat manipulation under anesthesia and diagnostic A&A debridement for the compensable injury of (Date of Injury).
Carrier is not liable for the benefits at issue in this hearing. Claimant remains entitled to medical benefits for the compensable injury in accordance with §408.021.
The true corporate name of the insurance carrier is (Carrier), and the name and address of its registered agent for service of process is
CORPORATION SERVICE COMPANY
211 EAST 7TH STREET, SUITE 620
AUSTIN, TEXAS 78701-3218
Signed this 27th day of May, 2016.