DECISION AND ORDER
This case is decided pursuant to Chapter 410 of the Texas Workers’ Compensation Act and Rules of the Division of Workers’ Compensation (DWC) adopted thereunder. For the reasons discussed herein, the Administrative Law Judge (ALJ) determines that:
Claimant is not entitled to the requested authorization for left shoulder total arthroplasty revision, removal of glenosphere & humeral component, removal of superior screws with inpatient days.
A contested case hearing was held on November 12, 2019, with the record closing on December 6, 2019, to decide the following disputed issue:
Is the preponderance of the evidence contrary to the decision of the IRO that an authorization & coverage for left shoulder total arthroplasty revision, removal of glenosphere & humeral component, removal of superior screws with inpatient days is not reasonably required health care for the compensable injury of (Date of Injury)?
Upon agreement of the parties the issue was revised to:
Is the preponderance of the evidence contrary to the decision of the IRO that an authorization for left shoulder total arthroplasty revision, removal of glenosphere & humeral component, removal of superior screws with inpatient days is not reasonably required health care for the compensable injury of (Date of Injury)?
The record was held open for submission of legal authorities and to resolve an issue regarding the name of Employer. The record was closed on December 6, 2019.
Petitioner/Claimant (Claimant) was present, and assisted by MG, ombudsman. Respondent/Carrier (Carrier) appeared and was represented by RG, attorney.
The following witnesses testified:
For Claimant: (Claimant).
For Carrier: None.
The following exhibits were admitted into evidence:
Administrative Law Judge’s Exhibits: ALJ-1 and ALJ-2.
Claimant’s Exhibits: C-1 through C-14.
Carrier’s Exhibits: CR-A through CR-J.
On (Date of Injury), while working for Employer, Claimant climbed a ladder on a pole to fix an electrical line and the pole broke. Claimant fell approximately 18 feet and sustained a compensable injury to his left shoulder.
Claimant underwent four surgeries. On July 14, 2016, the operative records indicate a procedure of an intramedullary nailing of the left humeral shaft fracture using a Synthes antegrade humeral nail. On January 1, 2017, the procedure performed was a left midshaft humerus open reduction and internal fixation of nonunion; left shoulder removal of retained hardware; and left shoulder bone grafting using right autogenous iliac crest bone graft. On June 21, 2017, the procedure performed was a left shoulder examination under anesthesia, left shoulder complex total shoulder arthroplasty using reverse prosthesis, left shoulder open removal of retained foreign body, left shoulder open subdeltoid inferior capsular contracture release and left shoulder open biceps tenodesis. On August 9, 2017, the procedures performed were a left shoulder examination under anesthesia, left shoulder revision of humeral component of reverse prosthesis, and left shoulder open subdeltoid contracture release.
On January 8, 2019, Claimant underwent a suprascapular nerve block. On February 18, 2019, Dr. TE, Claimant’s surgeon, noted that Claimant had good relief for the first week after the nerve block and then the pain started to return. The report of the nerve block procedure noted findings of a CT visualization of the suprascapular notch which showed possible encroachment by the hardware screws. Blockade of the suprascapular nerve produced a complete relief of Claimant’s shoulder pain.
The medical records in evidence show that on February 18, 2019, Claimant complained of left scapular pain and was diagnosed with subscapular neuralgia. On April 2, 2019, Claimant visited Dr. E who diagnosed Claimant with supra-scapular neuropathy, irreparable rotator cuff tear, and shoulder area pain-etiology unknown.
Dr. GG examined Claimant on May 15, 2019, and wrote that Claimant had persistent pain in the shoulder and that he had had a suprascapular nerve block and had 80% relief in the pain.
Dr. E’s records noted that on June 25, 2019, Claimant desired surgery to remove the glenosphere component, humeral component and take the superior three screws out. Dr. E requested approval of a left shoulder total arthroplasty revision, removal of glenosphere and humeral component, and removal of superior screws with inpatient days.
With a complete date of July 1, 2019, Carrier notified Dr. E of an “adverse determination.” The notice indicated the clinical basis of the denial was unsuccessful peer to peer discussion, and that Official Disability Guidelines (ODG) provided that reverse shoulder arthroplasty may be performed for patients who have failed prior surgical procedures, as well as those who have irreparable rotator cuff tears and intractable pain despite prior conservative management. The ODG also provides that hardware removal is not recommended for routine use but may be recommended for broken hardware, exposed pins, or persistent pain. The notice then stated that the guideline criteria have not been met. The notice continued that, although the patient [Claimant] did have severely restricted range of motion there was no official MRI report submitted for review to confirm the need for revision surgery, there were no official x-ray reports provided, and the provider further noted that x-rays revealed implants were in a good position, and as implants were in a good position there is no evidence of broken hardware, the need for surgery was not established. The reviewer also noted a specific number of inpatient days was not requested and concluded that the requested procedures is not certified.
The denial was appealed and on a complete date of July 10, 2019, Carrier sent an “Appeal Request Denial.” JH MD, an orthopedic surgeon, was the reviewer for the appeal. Dr. H repeated much of the same rationale from the utilization review agent. He noted a peer to peer discussion was not established and he quoted the ODG guidelines for reverse shoulder arthroplasty. He then noted that there continued to be no MRI submitted or documented to confirm the need for revision surgery and that the most recent x-rays indicated the implants were in a good position with no indication of broken hardware. He also noted that no specific number of inpatient days were requested. Finally, he noted that no additional documentation was provided for the review to overturn the prior determination.
Claimant requested an IRO review and DWC appointed Maximus Federal Services Inc. as the Independent Review Organization. The reviewer was a medical doctor., Board Certified in orthopedic surgery. The date of the review was July 20, 2019, and the Reviewer’s report was provided to all parties indicating that the previous adverse determinations should be upheld.
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 (22-a) 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 (18-a) 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. 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 considered parties to an appeal. In a 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 for the requested procedures indicates the following:
ODG Indications for Surgery™ -- Reverse Shoulder Arthroplasty:
Technical considerations include concepts of newer implant designs incorporating lateral offset, 135 degree humeral cup inclination, and larger glenosphere, with or without bone cement.
- Non-functioning irreparable rotator cuff and gleno-humeral arthropathy; or
- Failed hemiarthroplasty or failed total shoulder arthroplasty with irreparable rotator deficiency; or
- Comminuted fractures (3 or 4 part) of the proximal humerus in an older population (65 years of age or older).
- And meet all of the following criteria:
- Limited functional demands; &
- Intractable pain that has not responded to conservative therapy (including NSAIDs, intra-articular steroid injections, and physical therapy for at least 6 months and failed); &
- Adequate deltoid function; &
- Adequate passive range of motion to obtain functional benefit from the prosthesis; &
- Residual bone permits firm fixation of the implant; &
- No evidence of shoulder infection; &
- No severe neurologic deficiency.
- Body Mass Index less than 40, with documented significant weight loss effort for BMI ˃ unless acute fracture; &
- If rheumatoid arthritis, tried and failed anti-cytokine agents or disease modifying anti-rheumatic drugs, unless acute fracture.
Hardware implant removal:
Not recommend the routine removal of hardware implanted for fracture fixation, except in the case of broken hardware or persistent pain, after ruling out other causes of pain such as infection and nonunion. Not recommended solely to protect against allergy, carcinogenesis, or metal detection. Although hardware removal is commonly done, it should not be considered a routine procedure. For more information & references,
Risk versus benefit:
Risk versus benefit: Overall complication rates were 25% (5% major) after primary RSA and 69% after revision RSA. (Saltzman, 2014) RSA compared with TSA patients, had significantly longer length of stay, higher hospital charges that are not completely attributable to increased implant costs alone, and increased rates of perioperative complications. (Jiang, 2014) Early RSA revision has been associated with age less than 65, smoking and obesity, with dislocation being the most common reason. (Werner, 2015) Young age, high pre-operative function, and neurologic dysfunction were associated with poor functional improvement after RSA for massive rotator cuff tears without arthritis. (Hartzler, 2015) Due to higher surgical risks for these more complex conditions, RSA should be carefully considered for strict indications only. Compared to other total joint arthroplasties there is reported to be a steep surgical learning curve as well as relatively poor revision options.
Reverse shoulder arthroplasty (RSA) is most often used for individuals who have shoulder arthritis coupled with an irreparable rotator cuff tear, as well as for very complex shoulder problems including failed previous surgeries. This relatively newer shoulder replacement was initially developed in Europe in the 1980s and then FDA-approved in 2004. The procedure involves insertion of a hemispherical implant into the glenoid and a cup component applied to the humerus, allowing the arm to be more effectively moved by the deltoid instead of the rotator cuff. Initial results were encouraging, but not all shoulder surgeons have gained experience with RSA. The prostheses were originally designed for rotator cuff arthropathy, providing reasonably good results. Over time, indications expanded to include irreparable rotator cuff tears, complex fractures, and rheumatoid arthritis, with results being more variable. There are also fundamental design differences between the original Delta III and later developed RSA prostheses, and there are many studies that simply do not consider these 2 devices separately. (Khan, 2011)
A systematic review (SR) of 35 RSA studies and 2049 patients showed that lateralized prostheses resulted in 18 degrees better external rotation than medialized components. The primary indication for RSA--cuff tear arthropathy--showed more improvement in range-of-motion than other indications, including anatomic prosthetic revision, failed cuff repair, or fracture sequelae. There was high patient satisfaction regardless of indications or prosthetic design. (Samitier, 2015) A related SR of 37 studies and 3150 RSA patients reported that lateralized prostheses had significantly higher glenoid loosening and need for revision than medial, although scapular notching was lower. RSA revision of an anatomic prosthesis had higher risks of reoperation, revision, hematoma, instability, and infection than for other indications. (Alentorn-Geli, 2015) Another SR of 13 RSA studies reported 22 degrees better external rotation and less scapular notching with a lateralized design, but with 7% higher glenoid baseplate loosening than with traditional (medialized). (Lawrence, 2016) A retrospective database review of revision surgeries for lateralized implants reported a 6% overall revision rate (85/1418 patients), but glenoid baseplate failure dropped from 2.5% to 0.3% following newer baseplate modifications. (Stephens, 2016) Another technical consideration, the effect of 135 vs. 155 degree humeral cup inclination was shown in an SR of 65 studies and 3302 patients to result in significantly more external rotation for the 135 degree group, although other motions were similar. (Erickson, 2016) An SR of 41 RSA studies including 1455 cemented and 329 uncemented humeral stems demonstrates equivalent functional outcomes with fewer complications with uncemented, although there are some concerns regarding radiolucent lines and early stem migration. (Phadnis, 2016)
Rotator cuff tears with and without arthropathy: When highly symptomatic large and massive rotator cuff tears can be repaired, they should be. A cost-effectiveness analysis of the U.S. healthcare system determined that both arthroscopic rotator cuff repair and RSA were superior to non-operative care, with incremental cost-effectiveness ratio (ICER)/quality-adjusted life year (QALY) of $15,500/QALY and $37,400/QALY respectively. Arthroscopic cuff repair remains the preferred initial treatment strategy, despite moderately high rates of re-tearing, due to lower costs and slightly better overall clinical outcomes for the majority of patients. (Makhni, 2016) Another cost-effectiveness study of arthroscopic cuff repair for massive rotator cuff tears with pseudo-paralysis but minimal arthritis concluded the same--that arthroscopic repair was favored, with RSA conversion being best used for potential failures, regardless of age. (Dornan, 2017)
For irreparable massive rotator cuff tears, several treatments offer reasonable probabilities for improvement. A cost-effectiveness study showed that physical therapy alone was the most cost-effective with fairly good results (QALY 7.35). For patients seeking further pain relief without functional gains, arthroscopic debridement/biceps tenotomy has a short recovery and is cost-effective. Failing therapy, pain relief and improved function are the potential benefits of RSA, but with moderate risk of complications (QALY 7.69, cost $23,820). (Kang, 2017) An SR of 6 studies and 266 shoulders with irreparable massive rotator cuff tears without osteoarthritis demonstrated a high probability of painless functional improvements following RSA. (Sevivas, 2017)
An SR of 7 studies, lacking prospective randomized trials, of rotator cuff tear arthropathy patients showed that RSA restored pain-free range-of-motion and improved function, but a 17.4% complication rate was noted, mostly heterotopic ossification (6.6%), and revision was needed for 7.3%. (Petrillo, 2017)
Rheumatoid arthritis: 2 SRs have shown that RSA for patients with RA have similar short to medium-term results without higher complications when compared to non-RA massive cuff tears with or without arthropathy. Both studies had 2-year follow-up and resulted in mean active forward flexion of about 125 degrees, abduction 117 degrees, and external rotation 26 degrees. Scapular notching occurred in one/third and complications were reported in 22-31% (mostly minor fracture or infection); and revision was required for 7-9%. (Cho, 2017) (Postacchini, 2016)
Comminuted proximal humerus fractures: RSA is now a reasonable option for surgeons who are highly familiar with the technique for optimum treatment of complex proximal humeral fractures (PHF). (Frombach, 2017) In the past, moderate-high quality evidence indicated that compared with non-surgical treatment, surgery did not result in better outcomes for displaced PHFs. (Handoll, 2015)
While displaced PHFs were historically often treated with hemiarthroplasty (HA) in older adults, this frequently resulted in poor functional outcomes due in-part to associated rotator cuff deficiency. RSA potentially offers improved results for these difficult-to-treat situations. An SR indicates that RSA allows improved forward flexion and functional scores compared with HA for older adults with PHFs. Complications following surgery do not appear to be appreciably higher for RSA, making it a reasonable alternative for treating older adults. (Mata-Fink, 2013) RSA is steadily being used more for acute displaced PHFs. Pain and motion results appear to be significantly better than for HA. Quality healing rates were only 37% for an HA cohort compared with 84% for RSA, with the highest rate of complications also occurring with HA. (Baudi, 2014) In contrast, an SR comparing RSA with HA for PHF showed better RSA forward flexion by 10 degrees, worse external rotation by 10 degrees, but comparable clinical outcomes. RSA had a lower revision rate but somewhat higher complications than HA. (Ferrel, 2015) An SR/MA of 8 studies and 581 patients with minimum 1-year follow-up demonstrated a lower rate of complications, higher functional scores, better active forward elevation, and more healed tuberosities with RSA than HA. (Wang, 2016) Another SR of 10 studies and 256 PHF patients (89% female, mean age 76), while acknowledging a lack of RCTs, concluded nonetheless that RSA effectively restores function and relieves pain in older patients where osteoporosis and cuff dysfunction are common. (Longo, 2016) An effectiveness and safety SR/MA analyzing 34 trials and 2165 displaced PHF patients compared 5 interventions (ORIF, HA, RSA, IM nail, non-operative), concluding that RSA had the highest probability for improving functional outcomes, lowering complications, and avoiding further surgery. (Chen, 2016) An MA of 7 RCTs of 3 or 4-part PHFs in the elderly demonstrated that RSA had the highest functional scores and lowest re-operation rate than other treatment options (HA, ORIF, non-operative), with ORIF being the worst. (Du, 2017) Another SR demonstrated that short and mid-term outcomes have progressively improved for RSA for PHF, especially in patients older than 70. (Gigis, 2017) A cost/effectiveness analysis of arthroplasty for complex PHFs showed that the incremental cost-effectiveness ratio (ICER)/quality-adjusted life year (QALY) of $8100/QALY for RSA was much better than $36,700/QALY for HA, further demonstrating superiority for RSA. (Nwachukwu, 2016)
Complications/revisions: Heterotopic ossification (HO) has been reported in up to 30% of RSA patients, although it is usually non-progressive and without long-term clinical consequences. Grade II HO develops in 11% and has some negative effect on shoulder function. (Verhofste, 2016) Revision to RSA for prior instability of anatomic arthroplasties is problematic, especially for failed hemiarthroplasty and/or BMI > 35, in terms of reported one-in-seven recurrent dislocations, which may be improved with larger glenospheres and increased lateral offset. Even so, there is reasonable implant survivorship (79% at 5 years) without more than otherwise expected complications according to an institutional joint registry analysis. (Hernandez, 2017) Of 34 patients with revision for instability following RSA, most commonly related to deltoid dysfunction or acromial fractures, only 21 remained stable at 2 years. (Abdelfattah, 2017) A retrospective study of 41 morbidly obese (BMI > 40) primary RSAs reported only a 5% revision rate at 3 years and implant survival of 92% at 5 years, with good-excellent reported pain relief. (Statz, 2016) An SR of 9 studies of RSA for fracture sequelae (malunion, nonunion) indicated that this procedure has become the arthroplasty of choice with improved motion and function, at the risk of significant complications including dislocation (17%), infection (7%), fracture (3%), and neurological injury (3%). (Holton, 2017) Sometimes RSA results in persistent painful symptoms which can occur from instability, post-operative fracture, peri-prosthetic infection, and aseptic loosening (humeral more common than glenoid) conditions that can require further revision or resection arthroplasty. (Ekelund, 2017).
The IRO reviewer wrote that there was not enough documentation in the records to justify revision shoulder surgery. There is documentation of normal range of motion and radiographs showing acceptable position of the implants. The reviewer concluded that the medical records did not support the need for revision reverse total shoulder surgery at this time and the established ODG criteria were not met.
An October 9, 2019, opinion/letter from Dr. E was admitted in evidence over the objection of Carrier. Carrier contended that because the document was produced after the review had taken place it was not admissible. Carrier’s cited authority of MCCH docket No. M6-08-10212-01 is not applicable because in that case, the offer was for proof of exhaustion of conservative care events that took place after the review. Dr. E’s statement was not about events or conditions that occurred after the review. Moreover, Dr. E’s statement was a summary or reference to other medical records that were in evidence. Dr. E’s opinion/letter repeated his recommended procedures and noted a CT visualization that shows possible encroachment by the screws and reference of a block of the suprascapular nerve that produced complete relief of the patient’s shoulder pain temporarily. Dr. E did not persuasively explain Claimant’s need for surgery or the evidence-based medical evidence supporting his recommendation. Dr. E was not persuasive that Claimant met all of the ODG criteria for the requested procedures.
Based on the evidence presented, Claimant did not meet his burden of proof to overcome the decision of the IRO by a preponderance of evidence-based medical evidence. Claimant’s evidence presented the recommendation of his surgeon for the proposed surgical procedures; however, Claimant did not present persuasive evidence-based medical evidence to support his position. As a preponderance of the evidence is found not to be contrary to the decision of the IRO that the requested authorization for left shoulder total arthroplasty revision, removal of glenosphere & humeral component, removal of superior screws with inpatient days is not reasonably required health care for the compensable injury of (Date of Injury), Claimant is held not to be entitled to those procedures.
Even though all the evidence presented was not discussed, it was considered. The Findings of Fact and Conclusions of Law are based on all of the evidence presented.
FINDINGS OF FACT
- The parties stipulated to the following facts:
- The Texas Department of Insurance, Division of Workers’ Compensation has jurisdiction to hear this matter.
- Venue is proper in the (City) Field Office of the Texas Department of Insurance, Division of Workers’ Compensation.
- On (Date of Injury), Claimant was the employee of (Employer), Employer.
- On (Date of Injury), Employer provided workers’ compensation insurance coverage through Indemnity Insurance Company of North America, Carrier.
- On (Date of Injury), Claimant sustained a compensable injury.
- Maximus Federal Services Inc. has been certified as an independent review organization and the Texas Department of Insurance has assigned Maximus Federal Services Inc. to this case as the Independent Review Organization (IRO).
- The IRO upheld the URA denial of preauthorization for left shoulder total arthroplasty revision, removal of Glenoshpere & Humeral Component, removal of superior screws with inpatient days-CPT 23474, 23020, 23333.
- The IRO upheld the URA denial of preauthorization for left shoulder total arthroplasty revision, removal of Glenoshpere & Humeral Component, removal of superior screws with inpatient days- CPT 23474, 23020, 23333.
- 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 Administrative Law Judge’s Exhibit Number 2.
- The preponderance of the evidence-based medical evidence is not contrary to the decision of the Independent Review Organization that Claimant is not entitled to the requested authorization for left shoulder total arthroplasty revision, removal of glenosphere & humeral component, removal of superior screws with inpatient days and is not reasonably required health care 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.
- Venue is proper in the (City) Field Office.
- Claimant is not entitled to the requested authorization for left shoulder total arthroplasty revision, removal of glenosphere & humeral component, removal of superior screws with inpatient days.
Claimant is not entitled to the requested authorization for left shoulder total arthroplasty revision, removal of glenosphere & humeral component, removal of Superior screws with inpatient days.
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 Texas Labor Code Section 408.021.
The true corporate name of the insurance carrier is INDEMNITY INSURANCE COMPANY OF NORTH AMERICA and the name and address of its registered agent for service of process is:
C T CORPORATION SYSTEM
1999 BRYAN STREET SUITE 900
DALLAS TX 75201-3136
Signed this 9th day of December, 2019.
Christopher M. Maisel
Administrative Law Judge