DECISION AND ORDER
This case is decided pursuant to Chapter 410 of the Texas Workers’ Compensation Act and the Rules of the Texas Department of Insurance, Division of Workers’ Compensation. For the reasons discussed herein, the Hearing Officer determines that Claimant is entitled to one to three day stay for L4-5 anterior posterior fusion with bilateral laminectomy and possible internal bone stimulator for the lumbar spine.
STATEMENT OF THE CASE
On December 14, 2016, Britt Clark, a Division hearing officer, held a contested case hearing to decide the following disputed issue:
- Is the preponderance of the evidence contrary to the IRO’s determination that Claimant is not entitled to one to three day stay for L4-5 anterior posterior fusion with bilateral laminectomy and possible internal bone stimulator for the lumbar spine?
Claimant appeared and was assisted by JH, ombudsman. Carrier appeared and was represented by KM, attorney.
The following witnesses testified:
For Claimant: Claimant and Dr. KJ.
For Carrier: None.
The following exhibits were admitted into evidence:
Hearing Officer’s Exhibits HO-1 and HO-2.
Claimant’s Exhibits C-1 through C-19.
Carrier is Exhibits CR-A through CR-N.
Texas Labor Code Section 408.021 provides that an employee who sustains a compensable injury be 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. 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 addresses the necessity for spinal fusion as follows:
Patient Selection Criteria for Lumbar Spinal Fusion:
(A) Recommended as an option for the following conditions with ongoing symptoms, corroborating physical findings and imaging, and after failure of non-operative treatment (unless contraindicated e.g. acute traumatic unstable fracture, dislocation, spinal cord injury) subject to criteria below:
(1) Spondylolisthesis (isthmic or degenerative) with at least one of these:
(a) instability, and/or
(b) symptomatic radiculopathy, and/or
(c) symptomatic spinal stenosis;
(2) Disc herniation with symptomatic radiculopathy undergoing a third decompression at the same level;
(3) Revision of pseudoarthrosis (single revision attempt);
(4) Unstable fracture;
(6) Acute spinal cord injury (SCI) with post-traumatic instability;
(7) Spinal infections with resultant instability;
(8) Scoliosis with progressive pain, cardiopulmonary or neurologic symptoms, and structural deformity;
(9) Scheuermann's kyphosis;
(B) Not recommended in workers’ compensation patients for the following conditions:
(1) Degenerative disc disease (DDD);
(2) Disc herniation;
(3) Spinal stenosis without degenerative spondylolisthesis or instability;
(4) Nonspecific low back pain.
(C) Instability criteria: Segmental Instability (objectively demonstrable) - Excessive motion, as in isthmic or degenerative spondylolisthesis, surgically induced segmental instability and mechanical intervertebral collapse of the motion segment and advanced degenerative changes after surgical discectomy, with relative angular motion greater than 15 degrees L1-2 through L3-4, 20 degrees L4-5, 25 degrees L5-S1. Spinal instability criteria include lumbar inter-segmental translational movement of more than 4.5 mm. (Andersson, 2000) (Luers, 2007) (Rondinelli, 2008)
(D) After failure of two discectomies on the same disc [(A)(2) above], fusion may be an option at the time of the third discectomy, which should also meet the ODG criteria. (See ODG Indications for Surgery -- Discectomy.)
(E) Revision Surgery for failed previous fusion at the same disc level [(A)(3) above] if there are ongoing symptoms and functional limitations that have not responded to non-operative care; there is imaging confirmation of pseudoarthrosis and/or hardware breakage/malposition; and significant functional gains are reasonably expected. Revision surgery for purposes of pain relief must be approached with extreme caution due to the less than 50% success rate reported in medical literature. Workers compensation and opioid use may be associated with failure to achieve minimum clinically important difference after revision for pseudoarthrosis (Djurasovic, 2011) There is low probability of significant clinical improvement from a second revision at the same fusion level(s), and therefore multiple revision surgeries at the same level(s) are not supported.
(F) Pre-operative clinical surgical indications for spinal fusion should include all of the following:
(1) All physical medicine and manual therapy interventions are completed with documentation of reasonable patient participation with rehabilitation efforts including skilled therapy visits, and performance of home exercise program during and after formal therapy. Physical medicine and manual therapy interventions should include cognitive behavioral advice (e.g. ordinary activities are not harmful to the back, patients should remain active, etc.);
(2) X-rays demonstrating spinal instability and/or myelogram, CT-myelogram, or MRI demonstrating nerve root impingement correlated with symptoms and exam findings;
(3) Spine fusion to be performed at one or two levels;
(4) Psychosocial screen with confounding issues addressed; the evaluating mental health professional should document the presence and/or absence of identified psychological barriers that are known to preclude post-operative recovery;
(5) For any potential fusion surgery, it is recommended that the injured worker refrain from smoking for at least six weeks prior to surgery and during the period of fusion healing; (Colorado, 2001) (BlueCross BlueShield, 2002)
(6) There should be documentation that the surgeon has discussed potential alternatives, benefits and risks of fusion with the patient;
(7) For average hospital LOS after criteria are met, see Hospital length of stay (LOS).
The ODG indicates the following for a laminectomy:
ODG Indications for Surgery™ -- Discectomy/laminectomy --
Required symptoms/findings; imaging studies; and conservative treatments below:
I. Symptoms/Findings which confirm presence of radiculopathy. Objective findings on examination need to be present. Straight leg raising test, crossed straight leg raising and reflex exams should correlate with symptoms and imaging.
Findings require ONE of the following:
A. L3 nerve root compression, requiring ONE of the following:
- Severe unilateral quadriceps weakness/mild atrophy
- Mild-to-moderate unilateral quadriceps weakness
- Unilateral hip/thigh/knee pain
B. L4 nerve root compression, requiring ONE of the following:
- Severe unilateral quadriceps/anterior tibialis weakness/mild atrophy
- Mild-to-moderate unilateral quadriceps/anterior tibialis weakness
- Unilateral hip/thigh/knee/medial pain
C. L5 nerve root compression, requiring ONE of the following:
- Severe unilateral foot/toe/dorsiflexor weakness/mild atrophy
- Mild-to-moderate foot/toe/dorsiflexor weakness
- Unilateral hip/lateral thigh/knee pain
D. S1 nerve root compression, requiring ONE of the following:
- Severe unilateral foot/toe/plantar flexor/hamstring weakness/atrophy
- Moderate unilateral foot/toe/plantar flexor/hamstring weakness
- Unilateral buttock/posterior thigh/calf pain
(EMGs are optional to obtain unequivocal evidence of radiculopathy but not necessary if radiculopathy is already clinically obvious.)
II. Imaging Studies, requiring ONE of the following, for concordance between radicular findings on radiologic evaluation and physical exam findings:
A. Nerve root compression (L3, L4, L5, or S1)
B. Lateral disc rupture
C. Lateral recess stenosis
Diagnostic imaging modalities, requiring ONE of the following:
- MR imaging
- CT scanning
- CT myelography and X-Ray
III. Conservative Treatments, requiring ALL of the following:
A. Activity modification (not bed rest) after patient education (>= 2 months)
B. Drug therapy, requiring at least ONE of the following:
- NSAID drug therapy
- Other analgesic therapy
- Muscle relaxants
- Epidural Steroid Injection (ESI)
C. Support provider referral, requiring at least ONE of the following (in order of priority):
- Physical therapy (teach home exercise/stretching)
- Manual therapy (chiropractor or massage therapist)
- Psychological screening that could affect surgical outcome
- Back school (Fisher, 2004)
For average hospital LOS after criteria are met, see Hospital length of stay (LOS).
Risk versus benefit: The primary tradeoff is whether to undergo the risks of surgery, which are fairly small in this case, to achieve good short-run improvement of symptoms (success rate > 80%) faster than could also be achieved from conservative treatment alone. Minor pain and discomfort may not be worth the risks of surgery and the recovery time from surgery, depending on the patient's tolerance for risk, and there is no downside in delaying surgery. Patients whose pain is controlled in a manner that is acceptable to them may decide to postpone surgery in the hope that it will not be needed, without reducing their chances for complete recovery at 12 months. There is good evidence that discectomy is moderately superior to nonsurgical therapy for improvement in pain and function through 2 to 6 months, but patients on average experience improvement either with or without surgery, and benefits associated with surgery decrease with long-term follow-up. (Chou, 2009) (Chou, 2008) Similar evidence supports the use of surgery for spinal stenosis, but the outcomes look better with surgery out to approximately 2 years. (Malmivaara, 2007) In this trial, early surgery is associated with better short-term outcomes, but at 1 year, disability outcomes of early surgery vs conservative treatment (with eventual surgery if needed) are similar. The median time to recovery was 4.0 weeks for early surgery and 12.1 weeks for prolonged conservative treatment. (Peul, 2007) (Deyo, 2007) Consequently, for patients who don't want surgery no matter how bad their pain is, they will likely improve and they will not have complications from nonoperative treatment, but those patients whose leg pain is severe and is limiting their function, who meet the ODG criteria for discectomy, can do better in the short-term with surgery, and the risks are extremely low. (Weinstein2, 2008) In general, the risk of surgical complications is fairly small, approximately 3% for readmission and reoperation (Pugely, 2014), and 0.10% for death. (HCUP, 2012) For those receiving workers’ compensation, surgery may not be better than non-surgical treatment for most patients, even in the short-run. (Atlas, 2010) (DeBerard, 2008) In workers’ comp it is recommended to screen for presurgical biopsychosocial variables because they are important predictors of discectomy outcomes. (DeBerard, 2011) Obese patients have an increased risk of postoperative complications after lumbar spine surgery, but these are not associated with a greater risk of mortality. (Marquez-Lara, 2014) Smokers have much worse outcomes from lumbar decompression than nonsmokers, with an odds ratio for reoperation over 11. (Bydon, 2015) (Dewing, 2008)
NNH/NNT: Without taking into account specific risk factors, like smoking, obesity, or workers’ comp, the NNH (number needed to harm) is approximately 33, and the NNT (number needed to treat) for short-term improvement is approximately 1.2, but the NNT for long-term improvement is well over 10, compared to conservative treatment.
Surgical discectomy for carefully selected patients with radiculopathy due to lumbar disc prolapse provides faster relief from the acute attack than conservative management, although any positive or negative effects on the lifetime natural history of the underlying disc disease are still unclear. Unequivocal objective findings are required based on neurological examination and testing. (Gibson-Cochrane, 2000) (Malter, 1996) (Stevens, 1997) (Stevenson, 1995) (Buttermann, 2004) (Chou, 2008) For unequivocal evidence of radiculopathy, see AMA Guides. (Andersson, 2000) Standard discectomy and microdiscectomy are of similar efficacy in treatment of herniated disc. (Bigos, 1999) While there is evidence in favor of discectomy for prolonged symptoms of lumbar disc herniation, in patients with a shorter period of symptoms but no absolute indication for surgery, there are only modest short-term benefits. (Osterman, 2006) The SPORT studies concluded that both lumbar discectomy and nonoperative treatment resulted in substantial improvement after 2 years, but those who chose discectomy reported somewhat greater improvements than patients who elected nonoperative care. (Weinstein, 2006) (Weinstein2, 2006) In the treatment of patients with lumbar spinal stenosis, patients improved over the 2-year follow-up regardless of initial treatment, and those undergoing decompressive surgery reported greater improvement regarding leg pain, back pain, and overall disability, but the relative benefit of initial surgical treatment diminished over time while still remaining somewhat favorable at 2 years. (Malmivaara, 2007) Patients undergoing lumbar discectomy are generally satisfied with the surgery, but only half are satisfied with preoperative patient information. (Ronnberg, 2007) If patients are pain free, there appears to be no contraindication to their returning to any type of work after lumbar discectomy. A regimen of stretching and strengthening the abdominal and back muscles is a crucial aspect of the recovery process. (Burnett, 2006) Although both surgery and nonsurgery have similar outcomes after 1 year, early surgery remains a valid treatment option for well-informed patients. (Peul-NEJM, 2007) (Deyo-NEJM, 2007) There is no obvious additional benefit was noted by combining decompression with instrumented fusion. (Hallett, 2007) A British study found that lumbar discectomy improved patients’ self-reported overall physical health more than other elective surgeries. (Guilfoyle, 2007) Microscopic sequestrectomy may be an alternative to standard microdiscectomy. In this RCT, both groups showed dramatic improvement. (Barth, 2008) Discectomy is moderately cost-effective compared with nonsurgical treatment, according to a SPORT study shows. The costs per quality-adjusted life-year gained with surgery compared with nonoperative treatment, including work-related productivity costs, ranges from $34,355 to $69,403, depending on the cost of surgery. It is wise and proper to wait before initiating surgery, but if the patient continues to experience pain and is missing work, then the higher-cost option such as surgery may be worthwhile. (Tosteson, 2008)
Four-year results for the Dartmouth Spine Patient Outcomes Research Trial indicated that patients who underwent standard open discectomy for a lumbar disc herniation achieved significantly greater improvement than non-operatively treated patients (using recommended treatments - active physical therapy, home exercise instruction, and NSAIDs) in all primary and secondary outcomes except work status (78.4% for the surgery group compared with 84.4%). Although patients receiving surgery did better generally, all patients in the study improved. (Weinstein2, 2008) In most patients with low back pain, symptoms resolve without surgical intervention. (Madigan, 2009) This study showed that surgery for disc herniation was not as successful as total hip replacement but was comparable to total knee replacement in success. (Hansson, 2008) Both standard open discectomy and microdiscectomy are moderately superior to nonsurgical therapy for improvement in pain and function through 2 to 3 months, but patients on average experience improvement either with or without surgery, and benefits associated with surgery decrease with long-term follow-up. (Chou, 2009) Use of appropriateness criteria to guide treatment decisions for each clinical situation involving patients with low back pain and/or sciatica, with criteria based upon literature evidence, along with shared decision-making, was observed in one prospective study to improve outcomes in low back surgery. (Danon-Hersch, 2010) An updated SPORT trial analysis confirmed that outcomes of lumbar discectomy were better for patients who have symptoms of a herniated lumbar disc for six months or less prior to treatment. Increased symptom duration was related to worse outcomes following both operative and nonoperative treatment, but the relative increased benefit of surgery compared with nonoperative treatment was not dependent on the duration. (Rihn, 2011) Comparative effectiveness evidence from SPORT shows good value for standard open discectomy after an imaging-confirmed diagnosis of intervertebral disc herniation [as recommended in ODG], compared with nonoperative care over 4 years. (Tosteson, 2011) Carefully selected patients who underwent surgery for a lumbar disc herniation (standard open discectomy) achieved greater improvement than non-operatively treated patients (active physical therapy, education/counseling with home exercise instruction, and NSAIDS), and there was little to no degradation of outcomes in either group (operative and nonoperative) from 4 to 8 years. (Lurie, 2014) Note: Surgical decompression of a lumbar nerve root or roots may include the following procedures: discectomy or microdiscectomy (partial removal of the disc) and laminectomy, hemilaminectomy, laminotomy, or foraminotomy (providing access by partial or total removal of various parts of vertebral bone). Discectomy is the surgical removal of herniated disc material that presses on a nerve root or the spinal cord. A laminectomy is often involved to permit access to the intervertebral disc in a traditional discectomy.
Patient Selection: Microdiscectomy for symptomatic lumbar disc herniations in patients with a preponderance of leg pain who have failed nonoperative treatment demonstrated a high success rate based on validated outcome measures (80% decrease in VAS leg pain score of greater than 2 points), patient satisfaction (85%), and return to work (84%). Patients should be encouraged to return to their preinjury activities as soon as possible with no restrictions at 6 weeks. Overall, patients with sequestered lumbar disc herniations fared better than those with extruded herniations, although both groups consistently had better outcomes than patients with contained herniations. Patients with herniations at the L5-S1 level had significantly better outcomes than did those at the L4-L5 level. (Dewing, 2008) Workers' comp back surgery patients are at greater risk for poor lumbar discectomy outcomes than noncompensation patients. (DeBerard, 2008) (DeBerard, 2011) Overweight and obese patients demonstrated an increased risk of postoperative complications after lumbar spine surgery, but these are not associated with a greater risk of mortality. (Marquez-Lara, 2014)
Spinal Stenosis: For patients with lumbar spinal stenosis, standard posterior decompressive laminectomy alone (without discectomy) offers a significant advantage over nonsurgical treatment. Discectomy should be reserved for those conditions of disc herniation causing radiculopathy. (See Indications below.) Laminectomy may be used for spinal stenosis secondary to degenerative processes exhibiting ligament hypertrophy, facet hypertrophy, and disc protrusion, in addition to anatomical derangements of the spinal column such as tumor, trauma, etc. (Weinstein, 2008) (Katz, 2008) A comparison of surgical and nonoperative outcomes between degenerative spondylolisthesis and spinal stenosis patients from the SPORT trial found that fusion was most appropriate for spondylolisthesis, with or without listhesis, and decompressive laminectomy alone most appropriate for spinal stenosis. (Pearson, 2010) See also Laminectomy.
The proposed treatment was denied at the initial utilization review level and the reconsideration level, and the IRO reviewer agreed with the denial. An initial utilization reviewer, Dr. JR, opined that the Claimant did not have sufficient imaging of neural involvement or indication of instability, though agreed that the length of stay and bone stimulator would be supported if there was a risk of smoking habit. On reconsideration, Dr. GW agreed that there was insufficient evidence of objective focal neurologic deficits, and that Claimant’s pain generators have not been localized to the L4-5 level. The IRO reviewer indicated that there was “no documented instability with lumbar inter-segmental translational movement of more than 4.55 mm” and also was concerned that Claimant had a borderline test result regarding whether she had stopped smoking.
Claimant disputed the denial with the opinion of her treating surgeon and the medical records from her treating providers. A CT Myelogram was read to show a 4mm left paracentral and foraminal disc protrusion at L4-5, which impinged on the proximal left L4 nerve root, as well as severe left foraminal and lateral recess stenosis. It is noted that multiple medical providers have been concerned with the Claimant’s symptoms at the L4-5 level of the spine. Dr. KJ, Claimant’s treating surgeon, opined that Claimant meets the ODG requirements for laminectomy because of Claimant’s L4 radiculopathy symptoms with diminished strength and changes in her reflexes and sensation, which he believed correlated with the CT Myelogram showing damage to the L4-5 disc. He noted that conservative treatment had failed. His testimony, as well as his medical records, showed that Claimant met the ODG requirements for the bilateral laminectomy. Regarding the fusion, though the IRO reviewer opined that Claimant did not have instability in the lumbar spine, Dr. KJ noted that the ODG allows for a fusion if instability would be surgically induced. In this case, his testimony supported that the bilateral laminectomy would cause surgically-induced instability which would necessitate the need for the fusion.
Claimant’s history of smoking was discussed, with Dr. KJ noting that the testing essentially showed that Claimant has stopped smoking given the timeframe it was provided and the reading of the test. It is noted that Claimant credibly testified that she has stopped smoking as of the end of June of 2016. The ODG suggests an injured worker refrain from smoking for at least six weeks prior to surgery and during the period of fusion healing. The six week timeframe has elapsed as of the date of the hearing. Dr. KJ also justified the medical necessity of the bone stimulator, which is suggested if an injured worker has a history of smoking.
The rationale behind the denial was persuasively rebutted by Dr. KJ and the medical evidence as a whole. The preponderance of the medical evidence is contrary to the opinion of the IRO reviewer. Consequently, Claimant is entitled to one to three day stay for L4-5 anterior posterior fusion with bilateral laminectomy and possible internal bone stimulator for the lumbar spine.
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:
- 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 as a self-insured Carrier.
- On (Date of Injury), Claimant sustained a compensable injury.
- 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.
- One to three day stay for L4-5 anterior posterior fusion with bilateral laminectomy and possible internal bone stimulator for the lumbar spine is 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.
- Venue is proper in the (City) Field Office.
- The preponderance of the evidence is contrary to the IRO’s determination that Claimant is not entitled to one to three day stay for L4-5 anterior posterior fusion with bilateral laminectomy and possible internal bone stimulator for the lumbar spine.
Claimant is entitled to one to three day stay for L4-5 anterior posterior fusion with bilateral laminectomy and possible internal bone stimulator for the lumbar spine.
Carrier is ordered to pay benefits in accordance with this decision, the Texas Workers’ Compensation Act, and the Commissioner’s Rules. Accrued but unpaid income benefits, if any, shall be paid in a lump sum together with interest as provided by law.
The true corporate name of the insurance carrier is (Employer), and the name and address of its registered agent for service of process is
213 E. BLACKJACK ST.
DUBLIN, TX 76446
Signed this 21st day of December, 2016.