La. Admin. Code tit. 40 § I-2113

Current through Register Vol. 50, No. 11, November 20, 2024

Section I-2113 - Therapeutic Procedures-Operative

A. When considering operative intervention in chronic pain management, the treating physician must carefully consider the inherent risk and benefit of the procedure. All operative intervention should be based on a positive correlation with clinical findings, the clinical course, and diagnostic tests. A comprehensive assessment of these factors should have led to a specific diagnosis with positive identification of the pathologic condition. Operative treatment is indicated when the natural history of surgically treated lesions is better than the natural history for non-operatively treated lesions.

1. Surgical procedures are seldom meant to be curative and should be employed in conjunction with other treatment modalities for maximum functional benefit. Functional benefit should be objectively measured and includes the following:

a. return-to-work or maintaining work status;

b. fewer restrictions at work or performing activities of daily living (ADLs);

c. decrease in usage of medications prescribed for the work-related injury;

d. measurable functional gains, such as increased range-of-motion or documented increase in strength;

e. education of the patient should include the proposed goals of the surgery, expected gains, risks or complications, and alternative treatment

2. Education of the patient should include the proposed goals of the surgery, expected gains, risks or complications, and alternative treatment.

a. Description - Neurostimulation is the delivery of low-voltage electrical stimulation to the spinal cord or peripheral nerves to inhibit or block the sensation of pain. This is a generally accepted procedure that has limited use. May be most effective in patients with chronic, intractable limb pain who have not achieved relief with oral medications, rehabilitation therapy, or therapeutic nerve blocks, and in whom the pain has persisted for longer than six months. Particular technical expertise is required to perform this procedure and is available in some neurosurgical, rehabilitation, and anesthesiology training programs and fellowships. Physicians performing this procedure must be trained in neurostimulation implantation and participate in ongoing injection training workshops, such as those sponsored by the Internal Society for Injection Studies or as sponsored by implant manufacturers.

b. Complications - May include paraplegia, epidural hematoma, epidural hemorrhage, undesirable change in stimulation, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or equipment migration, pain at implantation site, loss of pain relief, chest wall stimulation, and other surgical risks.

c. Surgical Indications - Failure of conservative therapy including active and/or passive therapy, medication management, or therapeutic injections. Preauthorization is required. Habituation to narcotic analgesics in the absence of a history of addictive behavior does not preclude the use of neurostimulation. Only patients who meet the following criteria should be considered candidates for neurostimulation:

i. A diagnosis of a specific physical condition known to be chronically painful has been made on the basis of objective findings; and

ii. All reasonable surgical and non-surgical treatment has been exhausted; and

iii. Pre-surgical psychiatric or psychological evaluation has been performed and has demonstrated motivation and long-term commitment without issues of secondary gain; and

iv. There is no evidence of addictive behavior. (Tolerance and dependence to narcotic analgesics are not addictive behaviors and do not preclude implantation.); and

v. The topography of pain and its underlying pathophysiology are amenable to stimulation coverage (the entire painful area has been covered); and

vi. A successful neurostimulation screening test of two-three days. A screening test is considered successful if the patient (a) experiences a 50 percent decrease in pain, which may be confirmed by visual analogue scale (VAS), and (b) demonstrates objective functional gains or decreased utilization of pain medications. Functional gains may be evaluated by an occupational therapist and/or physical therapist prior to and before discontinuation of the trial.

vii. For spinal cord stimulation, a temporary lead is implanted at the level of pain and attached to an external source to validate therapy effectiveness. (For peripheral nerve screening, a nerve block is performed to define the specific nerve branch but if multiple branches are involved, a screening test for spinal cord stimulation may be indicated.) Long-term functional improvement is anticipated when objective functional improvement has been observed during time of neurostimulation screen exam.

d. Contraindications - Unsuccessful neurostimulation test either inability to obtain functional improvement or reduction of pain, those with cardiac pacemakers, patient unable to properly operate the system. It should not be used if future MRI is planned.

e. Operative Treatment Implantation of stimulating leads connected by extensions to either an implanted neurostimulator or an implanted receiver powered by an external transmitter. The procedure may be performed either as an open or a percutaneous procedure, depending on the presence of epidural fibrosis and the anatomical placement required for optimal efficacy.

f. Post-Operative Considerations MRI is contraindicated after placement of neurostimulators.

g. Post-Operative Therapy Active and/or passive therapy should be employed to improve function. Implantable stimulators will require frequent monitoring such as adjustment of the unit and replacement of batteries.

3. Smoking may affect soft tissue healing through tissue hypoxia. Patients should be strongly encouraged to stop smoking and be provided with appropriate counseling by the physician. If a treating physician recommends a specific smoking cessation program peri-operatively, this should be covered by the insurer. Physicians may monitor smoking cessation with laboratory tests such as cotinine levels. The surgeon will make the final determination as to whether smoking cessation is required prior to surgery. Similarly, patients with uncontrolled diabetes are at increased risk of post-operative infection and poor wound healing. It is recommended that routine lab work prior to any surgical intervention include a hemoglobin A1c. If it is higher than the recommended range, the surgery should be postponed until optimization of blood sugars has been achieved.

4. Prior to surgical intervention, the patient and treating physician should identify functional operative goals and the likelihood of achieving improved ability to perform activities of daily living or work activities, and the patient should agree to comply with the pre- and post-operative treatment plan including home exercise. The provider should be especially careful to make sure the patient understands the amount of post-operative therapy required and the length of partial- and full-disability expected post-operatively.

5. Monitored anesthesia care is acceptable for diagnostic and therapeutic procedures.

6. Neurostimulation

a. Description-Spinal cord stimulation (SCS) is the delivery of low-voltage electrical stimulation to the spinal cord or peripheral nerves to inhibit or block the sensation of pain. The system uses implanted electrical leads and a battery powered implanted pulse generator (IPG).

b. There is some evidence that SCS is superior to reoperation in the setting of persistent radicular pain after lumbosacral spine surgery, and there is some evidence that SCS is superior to conventional medical management in the same setting. Success was defined as achieving 50 percent or more pain relief. However, the study could not demonstrate increased return to work. Some functional gains have been demonstrated. These findings may persist at three years of follow-up in patients who had an excellent initial response and who are highly motivated.

c. There is some evidence that a higher-frequency, 500Hz to 10 KHz spinal cord stimulator is more effective than a traditional low frequency 50 Hz stimulator in reducing both back pain and leg pain in patients who have had a successful trial of an external stimulator. Two-thirds of the patients had radiculopathy and one-half had predominant back pain. The higher frequency device appears to lead to greater patient satisfaction than the low frequency device, which is likely to be related to the fact that the higher frequency device does not produce paresthesias in order to produce a pain response. In contrast to the low frequency stimulator, which requires recharging about twice per month, the higher frequency stimulator is recommended for every one to three days recharging for 0.5 to 3 hours. A United Kingdom study of cost effectiveness for high frequency spinal cord stimulators found high cost effectiveness compared to traditional non-rechargeable or rechargeable stimulators, re-operation, or medical management.

d. Some evidence shows that SCS is superior to re-operation and conventional medical management for severely disabled patients who have failed conventional treatment and have Complex Regional Pain Syndrome (CRPS I) or failed back surgery with persistent radicular neuropathic pain.

e. A recent randomized trial found that patients with spinal cord stimulators for CRPS preferred different types and levels of stimulation for pain relief. No difference was found between 40,500Hz, 1200 Hz, and 10KHz levels or burst stimulation.

f. SCS can be used for patients who have CRPS II. Spinal cord stimulation for spinal axial pain has traditionally not been very successful. Recent technological advances such as higher frequency and burst stimulation have demonstrated better results for axial spine pain. These technologically superior spinal cord stimulators are recommended for axial spine pain.

g. SCS may be most effective in patients with CRPS I or II who have not achieved relief with oral medications, rehabilitation therapy, or therapeutic nerve blocks, and in whom the pain has persisted for longer than six months.

h. It is particularly important that patients meet all of the indications before a permanent neurostimulator is placed because several studies have shown that workers compensation patients are less likely to gain significant relief than other patients. As of the time of this guideline writing, spinal cord stimulation devices have been FDA approved as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral and bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain, leg pain and arm pain.

i. Particular technical expertise is required to perform this procedure and is available in some neurosurgical, rehabilitation, and anesthesiology training programs and fellowships. Physicians performing this procedure must be trained in neurostimulation implantation and participate in ongoing training workshops on this subject, such as those sponsored by the American Society of Interventional Pain Practitioners (ASIPP), North American Neuromodulation Society (NANS), or as sponsored by implant manufacturers. Permanent electrical lead and IPG placement should be performed by surgeons (orthopedic or neurosurgery) with fellowship training in spine based surgical interventions or other physicians who have completed an Accreditation Council for Graduate Medical Education (ACGME) accredited pain medicine fellowship or training and have completed the required number of supervised implantations during fellowship or training.

j. Complications-Serious, less common complications include spinal cord compression, paraplegia, epidural hematoma, epidural hemorrhage, undesirable change in stimulation, seroma, CSF leakage, infection, erosion, allergic response. Other complications consist of dural puncture, hardware malfunction or equipment migration, pain at implantation site, loss of pain relief, chest wall stimulation, and other surgical risks. In recent studies, device complication rates have been reported to be 25 percent at six months, 32 percent at 12 months, and 45 percent at 24 months. The most frequent complications are reported to be electrode migration (14 percent) and loss of paresthesia (12 percent), up to 24 percent required additional surgery. In a recent review of spinal stimulation, 34.6 percent of all patients reported a complication, most of them being technical equipment-related issues or undesirable stimulation.

k. Surgical Indications-Patients with established CRPS I or II, or radicular or trunk pain, or a failed spinal surgery with persistent functionally limiting radicular pain greater than axial pain, who have failed conservative therapy including active and/or passive therapy, pre-stimulator trial psychiatric evaluation and treatment, medication management, or therapeutic injections. Traditional SCS is not recommended for patients with the major limiting factor of persistent axial spine pain. Higher frequency stimulators may be used for patients with predominantly axial back pain or trunk pain. Traditional or other SCS may be indicated in a subset of patients who have a clear neuropathic radicular pain (radiculitis) with or without previous surgery. The extremity pain should account for at least 50 percent or greater of the overall back and leg pain experienced by the patient. Prior authorization is required. Habituation to opioid analgesics in the absence of a history of addictive behavior does not preclude the use of SCS. Patients with severe psychiatric disorders, issues of secondary gain, and one or more primary risk factors are not candidates for the procedure. The prognosis worsens as the number of secondary risk factors increases. Approximately, one third to one half of patients who qualify for SCS can expect a substantial long-lasting pain relief; however, it may not influence allodynia and hypesthesia. Patients expectations need to be realistic, and therefore, patients should understand that the SCS intervention is not a cure for their pain but rather a masking of their symptomatology which might regress over time. There appears to be a likely benefit of up to three years, although some practitioners have seen benefits persist for longer periods.

i. Prior to surgical intervention, the patient and treating physician should identify functional operative goals and the likelihood of achieving improved ability to perform activities of daily living or work, as well as possible complications. The patient should agree to comply with the pre- and post-operative treatment plan including home exercise. The provider should be especially careful to make sure the patient understands the amount of post-operative therapy required and the length of partial- and full-disability expected post-operatively.

ii. Informed decision making should be documented for all invasive procedures. This must include a thorough discussion of the pros and cons of the procedure and the possible complications as well as the natural history of the identified diagnosis. Since many patients with the most common conditions will improve significantly over time, without invasive interventions, patients must be able to make well-informed decisions regarding their treatment.

iii. Smoking may affect soft tissue healing through tissue hypoxia. Patients should be strongly encouraged to stop smoking and be provided with appropriate counseling by the physician. If a treating physician recommends a specific smoking cessation program perioperative, this should be covered by the insurer. Typically the patient should show some progress toward cessation at about six weeks. Physicians may monitor smoking cessation with laboratory tests such as cotinine levels. The surgeon will make the final determination as to whether smoking cessation is required prior to surgery. Patients with demonstrated success may continue the program up to three months or longer if needed based on the operative procedure. Smoking cessation should continue throughout the post-operative period. Refer to Smoking Cessation Medications and Treatment for further details.

iv. Patients must meet the following criteria in order to be considered candidates for neurostimulation:

(a). Traditional or other SCS may be indicated in a subset of patients who have a clear neuropathic or radicular pain (radiculitis) or trunk pain; are not candidates for surgical intervention on the spine; have burning pain in a distribution amenable to stimulation coverage and have pain at night not relieved by position. The extremity pain should account for at least 50 percent or greater of the overall arm or leg and back pain experienced by the patient. Higher frequency stimulators may be used for patients with predominantly axial back pain.

(b). Prior to the stimulator trial, a comprehensive psychiatric or psychological evaluation, and a chronic pain evaluation. Refer to Personality/Psychological Evaluation for Pain Management, for more information. This evaluation should include a standardized detailed personality inventory with validity scales (e.g., MMPI-2, MMPI-2-RF, or PAI); pain inventory with validity measures (e.g., BHI 2, MBMD); clinical interview and complete review of the medical records. The psychologist or psychiatrist performing these evaluations should not be an employee of the physician performing the implantation. This evaluation must be completed, with favorable findings, before the screening trial is scheduled. Before proceeding to a spinal stimulator trial, the evaluation should find the following:

(i). no indication of falsifying information;

(ii). no indication of invalid results on testing; and

(iii). no primary psychiatric risk factors or "red flags" (e.g., psychosis, active suicidality, severe depression, or addiction). (Note that tolerance and dependence to opioid analgesics are not addictive behaviors and do not preclude implantation); and

(iv). a level of secondary risk actors or "yellow flags" (e.g., moderate depression, job dissatisfaction, dysfunctional pain conditions) judged to be below the threshold for compromising the patients ability to benefit from neurostimulation;

(v). the patient is cognitively capable of understanding and operating the neurostimulation control device; and

(vi). the patient is cognitively capable of understanding and appreciating the risks and benefits of the procedure; and

(vii). the patient is familiar with the implications of having an implant, can accept the complications, potential disfigurement, and effort it takes to maintain the device; and

(viii). the patient is cognitively capable of understanding the course of injury both with and without neurostimulation; and

(ix). the patient has demonstrated a history of motivation in and adherence to prescribed treatments; and

(x). the patient understands the work related restrictions that may occur with placement of the stimulator. All reasonable surgical and non-surgical treatment has been exhausted; and

(xi). the topography of pain and its underlying pathophysiology are amenable to stimulation coverage (the entire painful area has been covered); and

(xii). a successful neurostimulation screening test of at least three to seven days for a percutaneous trial or 7 to 10 days for an open surgically implanted trial lead.

(c). For a spinal cord neurostimulation screening test, a temporary lead is either implanted surgically with an incision or percutaneously attached to the skin and attached to an external source to validate therapy effectiveness. A screening test is considered successful if the patient meets both of the following criteria:

(a) experiences a 50 percent decrease radicular or CRPS in pain, which may be confirmed by visual analogue scale (VAS) or Numerical Rating Scale (NRS), and

(b) demonstrates objective functional gains or decreased utilization of pain medications.

(i). Objective, measurable, functional gains must be evaluated by the primary treating physician prior to and before discontinuation of the trial. If the trial is with a surgically implanted lead below the skin, then the trial is from 7 to 10 days. If the trial is percutaneous, then the trial is three to seven days. Functional gains may include: standing, walking, positional tolerance, upper extremity activities, increased social participation, or decreased medication use.

l. Contraindications

i. unsuccessful SCS test-inability to obtain objective, documented, functional improvement or reduction of pain;

ii. those with cardiac pacemakers should be evaluated on an individual basis as some may qualify for surgery;

iii. patients who are unable to properly operate the system;

iv. patients who are anti-coagulated and cannot be without anticoagulation for a few days (e.g., patients with artificial heart valves);

v. patients with frequent severe infections;

vi. patients for whom a future MRI is planned unless the manufacturer has approval for the body part that will be the subject of the MRI.

m. Operative Treatment-Implantation of stimulating lead or leads connected by extensions to either an implanted neurostimulator or an implanted receiver powered by an external transmitter. The procedure may be performed either as an open or a percutaneous procedure, depending on the presence of epidural fibrosis and the anatomical placement required for optimal efficacy. During the final procedure for non-high frequency devices or for those without surgically implanted trial leads, the patient must be awakened to establish full coverage from the placement of the lead. One of the most common failures is misplaced leads. Functional improvement is anticipated for up to three years or longer when objective functional improvement has been observed during the time of neurostimulation screening exam.

n. Post-Operative Considerations

i. MRI may be contraindicated depending on the model and implant location.

ii. Work restrictions postplacement include no driving when active paresthesias are present. This does not apply to higher frequency stimulators as no paresthesia is present. Thus, use of potentially dangerous or heavy equipment while the lower frequency simulator is active is prohibited. The physician may also limit heavy physical labor to prevent lead dislodgement.

o. Post-Operative Therapy-Active and/or passive therapy should be employed to improve function. Implantable stimulators will require frequent monitoring such as adjustment of the unit and replacement of implanted batteries. Estimated battery life of SCS implantable devices is usually 5 to 10 years depending on the manufacturer.

7. Dorsal Root Ganglion Stimulator (See Neurostimulation)

8. Peripheral Nerve Stimulation-This modality should only be employed with a clear nerve injury or when the majority of pain is clearly in a nerve distribution in patients who have completed six months of other appropriate therapy including the same pre-trial psychosocial evaluation and treatment as are recommended for spinal cord stimulation. A screening trial should take place over three to seven days and is considered successful if the patient meets both of the following criteria:

a. experiences a 50 percent decrease in pain, which may be confirmed by Visual Analogue Scale (VAS) or Numerical Rating Scale (NRS); and

b. demonstrates objective functional gains or decreased utilization of pain medications. It may be used for proven occipital, ulnar, median, and other isolated nerve injuries.

9. Intrathecal drug delivery-recommended in patients in whom other conservative measures have failed or in those requiring high dose oral opiates or experiencing side effects to control pain or in cases of spasticity or uncontrolled muscle spasms. Oral pain medication would not be appropriate for chronic pain in conjunction with an Intrathecal pain pump, except for up to the initial ten days after implant for purpose of postop incisional pain or weaning and stopping oral opiates. Treatment for concomitant acute pain separate from chronic pain can combine oral opiates and pump medication at reduced doses orally. Pumps require refilling every one to six months for the life of the patient. More than one medication may be needed in the pump. Once implanted the managing physician must arrange for continuity of care for refills and or pump adjustments. Oral opiates should be stopped 7-10 days after implantation or pump and Intrathecal catheter and pump should be titrated to control chronic pain. A PTM (Patient therapy manager) may be used for breakthrough pain. Acute pain may be treated concomitantly with short courses or oral opiates. Intrathecal pumps may be considered when dystonia and spasticity are dominant features or when pain is not able to be managed using any other non-operative treatment or in cases inadequate opiate management by other routes. Specific brands of infusion systems have been FDA approved for the following: chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, chronic infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, and chronic intrathecal infusion of baclofen for the management of severe spasticity. Other medications commonly used and acceptable in the pump as defined in the The Polyanalgesic Consensus Conference (PACC) Recommendations on Intrathecal Drug Infusion Systems Best Practices and Guidelines 2017 Tim Deer et al "Neuromodulation: Technology at the Neural Interface".

a. Due to lack of proven efficacy and safety, the following medications are not recommended: magnesium, benzodiazepines, neostigmine, tramadol, and ketamine.

b. Description. This mode of therapy delivers small doses of medications directly into the cerebrospinal fluid.

c. Complications. Intrathecal delivery is associated with significant complications, such as infection, catheter disconnects, CSF leak, arachnoiditis, pump failure, nerve injury, and paralysis.

i. Typical adverse events reported with opioids (i.e., respiratory depression, tolerance, and dependence) or spinal catheter-tip granulomas that might arise during intrathecal morphine or hydromorphone treatment have not currently been recorded for ziconotide. The most common presentation of an intraspinal mass is a sudden increase in dosage required for pain relief, with new neurologic defects secondary to a mass effect. Technical errors can lead to drug overdose which can be life-threatening. Withdrawal or death can occur if pump refill is denied or prevented.

ii. Surveys have shown technical problems requiring surgical correction in 18 percent to 40 percent of patients. CSF leakage may occur with multiple dural punctures since the needle is larger than the spinal catheter. Follow PACC guidelines on efficacy. The function of the pump depends on its electronic power source, which may be disrupted by the magnet of an MRI; therefore, after the patient has an MRI, the pump should be checked immediately after the MRI to ensure that it does not need to be restarted. The delivery rate can be affected by atmospheric pressure and body temperature. Some pumps are recommended to be emptied before the MRI and refilled immediately after the MRI.

d. Indications. Clinical studies are conflicting, regarding long-term, effective pain relief in patients with non-malignant pain. This treatment must be have preauthorization and the recommendation of at least one physician experienced in chronic pain management. The procedure should be performed by physicians with documented experience.

i. Prior to surgical intervention, the patient and treating physician should identify the possible functional operative goals and the likelihood of achieving improved ability to perform activities of daily living or work, as well as possible complications. The patient should agree to comply with the pre- and post-operative treatment plan including home exercise. The provider should be especially careful to make sure the patient understands the amount of post-operative therapy required and the length of partial- and full-disability expected post-operatively.

ii. Informed decision-making should be documented for all invasive procedures. This must include a thorough discussion of the pros and cons of the procedure and the possible complications as well as the natural history of the identified diagnosis. Since many patients with the most common conditions will improve significantly over time, without invasive interventions, patients must be able to make well-informed decisions regarding their treatment.

e. This small eligible sub-group of patients must meet all of the following indications:

i. a diagnosis of a specific physical condition known to be chronically painful has been made on the basis of objective findings; and

ii. all reasonable surgical and non-surgical treatment has been exhausted including failure of conservative therapy including active and/or passive therapy, medication management, or therapeutic injections; and

iii. pre-trial psychiatric or psychological evaluation has been performed (same as for SCS); and

iv. there is no evidence of current addictive behavior. (Tolerance and dependence to opioid analgesics are not addictive behaviors and do not preclude implantation.); and

v. it is recommended that patients be tapered off of opioids before the trial or keep on same dose and wean and stop within two weeks post implant or wean and stop two to three weeks before trial per PACC Guidelines for Trialing; and

vi. a successful trial of continuous infusion by a percutaneous spinal infusion pump for a minimum of 24 hours or by bolus infusion. A screening test is considered successful if the patient (a) experiences a 50 percent decrease in pain, which may be confirmed by VAS, and (b) demonstrates objective functional gains or decreased utilization of other pain medications.

f. Contraindications. Infection, body size insufficient to support the size and weight of the implanted device. Patients with other implanted programmable devices should be given these pumps with caution since interference between devices may cause unintended changes in infusion rates.

10. Dorsal Nerve Root Resection: This procedure is not recommended. There exists the possibility of complications including unintended extensive nerve damage causing significant motor or sensibility changes from larger than anticipated lesioning of the ganglia at the dorsal ganglia level. For radio-frequency ablation refer to Radio Frequency Ablation-Dorsal Nerve Root Ganglion.

La. Admin. Code tit. 40, § I-2113

Promulgated by the Louisiana Workforce Commission, Office of Workers Compensation Administration, LR 37:1711 (June 2011), Amended LR 46246 (2/1/2020), Repromulgated LR 46397 (3/1/2020), Amended LR 50693 (5/1/2024).

AUTHORITY NOTE: Promulgated in accordance with R.S. 23:1203.1.