advanced procedure handbook
TRANSCRIPT
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Advanced Procedure Handbook
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Table of Contents
Procedure: Chapter: Page: Neuromodulation 1 Spinal Cord Stimulation (SCS) 3 Dorsal Root Ganglion (DRG) Stimulation 6 Peripheral Nerve Stimulation: Nalu 8 Peripheral Nerve Stimulation: SPRINT 12
Peripheral Nerve Stimulation: Axonic 15
Regenerative Medicine 2 Regenerative Medicine: Platelet Rich Plasma 18 Regenerative Medicine: Placental/Amino Derived Products 19
Advanced Spinal Procedures 3 Kyphoplasty 19 Minimally Invasive Spinal Decompression (MILD) 21
Vertiflex 23
Sacroiliac Joint Fusion 4 25
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CHAPTER ONE: NEUROMODULATION
Spinal Cord Stimulation (SCS)
Vendor: Nevro Rep: Ashley Darling Email: [email protected] Cell: 775-313-3490 Vendor: Abbott Rep: Alex Palma Email: [email protected] Cell: (915)491-2085 Vendor: Medtronic Rep: Haley Fields Email: [email protected] Cell: 602-448-5060 Vendor: Boston Scientific Rep: Brandon Chambers Email: [email protected] Cell: 480-749-5522
OVERVIEW AND INDICATIONS 1. Overview of Procedure: Spinal cord stimulation (SCS) is a neuromodulation device
that is best suited to treat neuropathic pain that is chronic and intractable in nature. SCS works by delivering small electrical pulses to the pain sensing pathways of the spinal cord altering the pain signals traveling to the brain. It is typically prescribed for the treatment of pain of the back, trunk, or limbs. The procedure is performed in two stages, with a trial completed with temporary lead attached to an external generator, followed by implantation with permanent leads and generator if successful.
• It is important to discuss with the attending physician which vendor is most appropriate for patient presentation.
2. Indications: Treatment of chronic, intractable pain of the back, trunk, or limbs that has failed to respond to conservative care.
3. Applicable diagnosis codes (This is not an exhaustive list, rather focused on most applicable to our practice. Please refer to the SCS LCD for a complete list):
Chronic pain due to trauma G89.21 Other chronic post-procedural pain G89.28 Other chronic pain G89.29 Chronic pain syndrome G89.4 Cervical radiculopathy M54.12 Cervicothoracic radiculopathy M54.13 Thoracic radiculopathy M54.13 Thoracolumbar radiculopathy M54.14 Lumbar radiculopathy M54.16 Lumbosacral radiculopathy M54.17
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Sacral and sacrococcygeal radiculopathy M54.18 Cervicalgia M54.2 Low back pain M54.5 Pain in thoracic spine M54.6 Sciatica, unspecified side M54.30 Dorsalgia, unspecified M54.9 Postlaminectomy syndrome, not classified elsewhere
M96.1
Other intervertebral disc degeneration, thoracic region
M51.34
Other intervertebral disc degeneration, thoracolumbar region
M51.35
Other intervertebral disc degeneration, lumbar region
M51.36
Other intervertebral disc degeneration, lumbosacral region
M51.37
4. Photos of device/procedure:
DOCUMENTATION/IMAGING REQUIRED
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• Recent (within one year) MRI of thoracic and lumbar regions (for thoracic lead placement) or recent MRI of cervical and thoracic region (for cervical lead placement)
• Documentation of chronic, intractable pain that has failed to respond to conservative care, with SCS being used as a late or last resort for treatment
• Successful stimulation trial with greater than or equal to 50% reduction in pain intensity before permanent implantation
PRE-OPERATIVE GUIDELINES • Psychiatric evaluation:
o Straight Medicare plans & BCBS AZ/BCBS IL, patient can complete BBHI. All others (Including Medicare replacement plans) patient will need to complete psychiatric evaluation
• Preoperative testing (for implant): (To be completed within 60 days of surgery date) o EKG o CBC o BMP o PT-INR/PTT (if on Coumadin, must have PT-INR/PTT completed within 24 hours
of scheduled surgery) o Surgical clearance from PCP and/or cardiac clearance if indicated based upon
patient health history o Order lumbar brace
• Prescribe for preoperative use (for implant): o Mupirocin 2% topical ointment – apply to each nostril TID x 5 days prior to
surgery (do not order nasal ointment) o Hibiclens 4% topical liquid- wash surgical site in shower QD x 5 days prior to
surgery. • Prescribe for postoperative use (for implant, optional based on physician
preference): o 3-to-5-day course of antibiotics o Short-term course of opioids (or temporary increase of current opioid doses)
POST-OPERATIVE CARE • For Trial:
o Patient should adhere to following activity limitations for duration of trial: Avoid any sudden or jerking movements that may dislodge the
electrodes, such as bending, twisting, pulling or pushing Do not lift greater than 5 pounds
o Patient should not remove their dressing or take a shower/bath until seen at follow up appointment
o Duration of trial is generally 5 to 7 days • For Implant:
o Occlusive dressing for 24 to 48 hours o Postoperative appointment at day 3 to 5, with close wound surveillance
throughout the postoperative period o Staples should be removed at postoperative day 10 to 12
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Dorsal Root Ganglion (DRG) Stimulation
Vendor: Abbott Rep: Alex Palma Email: [email protected] Cell: (915)491-2085
OVERVIEW AND INDICATIONS 1. Overview of Procedure: DRG stimulation offers targeted stimulation to distinct areas
of the body by modulating focal areas of the spinal cord rather than an indiscriminate approach inherent to leads placed over the dorsal columns (as is done with SCS). This provides the ability to treat areas that are traditionally difficult to treat with SCS, such as the hand, chest, abdomen, foot, knee, and groin.
2. Indications: Treatment of severe and chronic neuropathic pain of the trunk or limbs resulting from actual damage to the peripheral nerves that has failed to respond to conservative therapy.
3. Applicable diagnosis codes (This is not an exhaustive list, rather focused on most applicable to our practice and the DRG application. Please refer to the SCS LCD for a complete list):
Chronic pain due to trauma G89.21 Chronic pain syndrome G89.4 Causalgia codes G57.71-G57.72 CRPS codes G90.522-G90.529 Shoulder pain M25.511-M25.512 Hip pain M25.551-M25.552 Arm pain M79.601-M79.602 Leg pain M79.604-M79.605 Phantom limb syndrome G54.6
4. Photos of device/procedure:
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DOCUMENTATION/IMAGING REQUIRED
• Recent (within one year) MRI of thoracic (thoracic generally not required for lumbar/sacral placement) and lumbar areas to determine if a patient’s spinal canal, lateral recess, foramen and epidural anatomy are suitable for needle, introducer and lead placement at each target level. Target foramen must not be critically stenotic. If MRI is contraindicated, CT myelography is a valid alternative for assessing anatomy.
• Documentation demonstrating the patient has severe and chronic neuropathic pain of the trunk or limbs.
• Documentation that the treatment is used only as a last resort, and the patient has tried other standard, conservative treatment modalities and were not effective or contraindicated.
• To proceed with implant, at least 50% reduction in pain during a minimum 3-day trial of temporary dorsal root ganglion neurostimulation.
PRE-OPERATIVE GUIDELINES • Psychiatric evaluation:
o Straight Medicare plans & BCBS AZ/BCBS IL, patient can complete BBHI. All others (including Medicare replacement plans), patient will need to complete psychiatric evaluation.
• Preoperative testing (for implant): (To be completed within 60 days of surgery date) o EKG
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o CBC o BMP o PT-INR/PTT (if on Coumadin, must have PT-INR/PTT completed within 24 hours
of scheduled surgery) o Surgical clearance from PCP and/or cardiac clearance if indicated based upon
patient health history o Order lumbar brace
• Prescribe for use preoperatively (for implant): o Mupirocin 2% topical ointment – apply to each nostril TID x 5 days prior to
surgery (do not order nasal ointment) o Hibiclens 4% topical liquid- wash surgical site in shower QD x 5 days prior to
surgery • Prescribe for use postoperatively (for implant), optional based on physician
preference: o 3-to-5-day course of antibiotics o Short-term course of opioids (or temporary increase of current opioid doses)
POST-OPERATIVE CARE • For Trial:
o Patient should adhere to following activity limitations for duration of trial: Avoid any sudden or jerking movements that may dislodge the
electrodes, such as bending, twisting, pulling or pushing Do not lift greater than 5 pounds
o Patient should not remove their dressing or take a shower/bath until seen at follow up appointment
o Duration of trial is generally 5 to 7 days • For Implant:
o Occlusive dressing for 24 to 48 hours o Postoperative appointment at day 3 to 5, with close wound surveillance
throughout the postoperative period o Staples should be removed at postoperative day 10 to 12
Peripheral Nerve Stimulation: Nalu
Vendor: Nalu Rep: Luke Caswell Email: [email protected] Cell: 480-980-3581
OVERVIEW AND INDICATIONS 1. Overview of Procedure: NALU is a neuromodulation that can be utilized for either
spinal cord stimulation (SCS) or peripheral nerve stimulation (PNS). It differs from traditional SCS systems in that it is battery-free and has a micro-implantable pulse generator, and is controlled by an external therapy disc.
2. Indications: For SCS, treatment of chronic, severe, and intractable pain of the trunk or limbs that has failed to respond to conservative care. For PNS, treatment of chronic,
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severe, and intractable pain of peripheral nerve origin, that has failed to respond to conservative care. PNS is NOT indicated for treatment of the following:
o Fibromyalgia o Phantom limb pain o Diffuse polyneuropathy o Angina pectoris
3. Applicable diagnosis codes: For SCS (This is not an exhaustive list, rather focused on most applicable to our practice. Please refer to the SCS LCD for a complete list):
Chronic pain due to trauma G89.21 Other chronic post-procedural pain G89.28 Other chronic pain G89.29 Chronic pain syndrome G89.4 Cervical radiculopathy M54.12 Cervicothoracic radiculopathy M54.13 Thoracic radiculopathy M54.13 Thoracolumbar radiculopathy M54.14 Lumbar radiculopathy M54.16 Lumbosacral radiculopathy M54.17 Sacral and sacrococcygeal radiculopathy M54.18 Cervicalgia M54.2 Low back pain M54.5 Pain in thoracic spine M54.6 Sciatica, unspecified side M54.30 Dorsalgia, unspecified M54.9 Postlaminectomy syndrome, not classified elsewhere
M96.1
Other intervertebral disc degeneration, thoracic region
M51.34
Other intervertebral disc degeneration, thoracolumbar region
M51.35
Other intervertebral disc degeneration, lumbar region
M51.36
Other intervertebral disc degeneration, lumbosacral region
M51.37
For PNS:
Zoster encephalitis B02.0 Postherpetic trigeminal neuralgia B02.22 Postherpetic polyneuropathy B02.23 Other postherpetic nervous system involvement
B02.29
Diabetic neuropathy codes E08.41, E09.41, E10.41, E11.41, E13.41
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Migraine codes G43.011, G43.019, G43.011, G43.A1, G43.B1, G43.C1, G43.D1, G43.811, G43.819,
Headache codes G44.021, G44.029, G44.321, G44.329, G44.59
Trigeminal neuralgia G50.0 Lumbosacral plexus disorders G54.1 Cervical root disorders G54.2 Thoracic root disorders G54.3 Lumbosacral root disorders G54.4 Other nerve root and plexus disorders G54.8 Nerve root and plexus disorders, unspecified
G54.9
Nerve root and plexus compressions in disease classified elsewhere
G55
Causalgia codes G56.41, G56.42, G56.43, G57.71, G57.72, G57.73
Other specified mononeuropathies G58.8 Mononeuropathy, unspecified G58.9 Mononeuropathy in diseases classified elsewhere
G59
Chronic post-thoracotomy pain G89.22 CRPS codes G90.50, G90.511, G90.512, G90.513,
G90.521, G90.522, G90.523, G90.59 Occipital neuralgia M54.81
4. Photos of device/procedure:
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DOCUMENTATION/IMAGING REQUIRED
For SCS: 1. Recent (within one year) MRI of thoracic and lumbar regions (for thoracic lead
placement) or recent MRI of cervical and thoracic region (for cervical lead placement) 2. Documentation of chronic, intractable pain that has failed to respond to conservative
care, with SCS being used as a late or last resort for treatment 3. Successful stimulation trial with greater than or equal to 50% reduction in pain
intensity before permanent implantation
For PNS: • Documented chronic and severe pain for at least three months • Documented failure of less invasive treatment modalities and medications • Successful stimulation trial with greater than or equal to 50% reduction in pain
intensity before permanent implantation PRE-OPERATIVE GUIDELINES
• Psychiatric evaluation: o Straight Medicare plans & BCBS AZ/BCBS IL, patient can complete BBHI. All
others (including Medicare replacement plans) patient will need to complete psychiatric evaluation
• Preoperative testing (for implant): (To be completed within 60 days of surgery date) o EKG
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o CBC o BMP o PT-INR/PTT (if on Coumadin, must have PT-INR/PTT completed within 24 hours
of scheduled surgery) o Surgical clearance from PCP and/or cardiac clearance if indicated based upon
patient health history o Order lumbar brace for SCS application
• Prescribe for preoperative use (for implant): o Mupirocin 2% topical ointment – apply to each nostril TID x 5 days prior to
surgery (do not order nasal ointment) o Hibiclens 4% topical liquid- wash surgical site in shower QD x 5 days prior to
surgery. • Prescribe for use postoperatively (for implant, optional based on physician
preference): o 3-to-5-day course of antibiotics o Short-term course of opioids (or temporary increase of current opioid doses)
POST-OPERATIVE CARE • For Trial:
o Patient should adhere to following activity limitations for duration of trial: Avoid any sudden or jerking movements that may dislodge the
electrodes, such as bending, twisting, pulling or pushing Do not lift greater than 5 pounds
o Patient should not remove their dressing or take a shower/bath until seen at follow up appointment
o Duration of trial is generally 5 to 7 days • For Implant:
o Occlusive dressing for 24 to 48 hours o Postoperative appointment at day 3 to 5, with close wound surveillance
throughout the postoperative period o Staples should be removed at postoperative day 10 to 12
Peripheral Nerve Simulation: SPRINT
Vendor: SPR Therapeutics Rep: David Jones Email: [email protected] Cell: 480-364-6876
OVERVIEW AND INDICATIONS 1. Overview of Procedure: The SPRINT system is a neuromodulation device designed for
temporary (up to 60 days) treatment of back or extremity pain and works by selectively stimulating targeted peripheral nerve fibers. It consists of an implanted MircoLead (thin, thread-like wire) that is attached to an external pulse generator, controlled with a hand-held remote. While the device is temporary, studies have
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indicated it has the ability to provide sustained relief (even after device is removed), by modulating central plasticity of the nerve fibers.
2. Indications: The SPRINT system is indicated for the temporary (up to 60 days) treatment of chronic, intractable pain or acute post-surgical or post-traumatic pain in the back or extremities that has failed to respond to conservative care. PNS is NOT indicated for treatment of the following:
o Fibromyalgia o Phantom limb pain o Diffuse polyneuropathy o Angina pectoris
3. Applicable diagnosis codes: Zoster encephalitis B02.0 Postherpetic trigeminal neuralgia B02.22 Postherpetic polyneuropathy B02.23 Other postherpetic nervous system involvement
B02.29
Diabetic neuropathy codes E08.41, E09.41, E10.41, E11.41, E13.41 Migraine codes G43.011, G43.019, G43.011, G43.A1,
G43.B1, G43.C1, G43.D1, G43.811, G43.819,
Headache codes G44.021, G44.029, G44.321, G44.329, G44.59
Trigeminal neuralgia G50.0 Lumbosacral plexus disorders G54.1 Cervical root disorders G54.2 Thoracic root disorders G54.3 Lumbosacral root disorders G54.4 Other nerve root and plexus disorders G54.8 Nerve root and plexus disorders, unspecified
G54.9
Nerve root and plexus compressions in disease classified elsewhere
G55
Causalgia codes G56.41, G56.42, G56.43, G57.71, G57.72, G57.73
Other specified mononeuropathies G58.8 Mononeuropathy, unspecified G58.9 Mononeuropathy in diseases classified elsewhere
G59
Chronic post-thoracotomy pain G89.22 CRPS codes G90.50, G90.511, G90.512, G90.513,
G90.521, G90.522, G90.523, G90.59 Occipital neuralgia M54.81
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4. Photos of device/procedure:
DOCUMENTATION/IMAGING REQUIRED
• Documented chronic and severe pain for at least three months • Documented failure of less invasive treatment modalities and medications
Patient Selection
• General: o Healthy nerve target and/or ability to stimulate proximal to an injured
nerve or region of pain o Little to no history/evidence of psychological problems or disorders o No opioid use or low-dose opioid use (<90 MME) o No history of recurrent skin infections and no increased risk for skin
infection o Patient has caregiver and/or can adequately maintain and care for system
(cleaning, charging, operating remote) and bandages o No history of allergy to bandages or skin adhesives
• Specific to post-amputation pain: o Level of amputation does not obstruct lead placement (e.g., total hip
disarticulation) o Prosthesis does not obstruct or cover intended lead exit/bandage site o No radicular pain or CNS injuries or disorders (spinal cord injury, multiple
sclerosis, etc.) • Specific to postoperative pain:
o Location of lead will not interfere with surgery or surgical site o Medical care related to surgery (surgical prep, monitoring equipment,
electrocautery) and recovery (physical therapy, water therapy, etc.) does not interfere with SPRINT system or lead
• Other general criteria that may improve likelihood for successful outcome:
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o Low body mass index (ideally < 30 BMI) o No confounding pain (e.g., significant pain in another area of the body, or
pain of another cause in the same area) o No prior surgeries that may have altered anatomy and/or impeded lead
placement or use of system o No recent anesthetic injections which may interfere with stimulation o No ablation of target nerve
PRE-OPERATIVE GUIDELINES • Follow same pre-operative instructions as basic interventional pain procedure
POST-OPERATIVE CARE • Limit strenuous physical activity and motion (twisting, bending, lifting, climbing) for at
least one week. Avoid excessive stress (tugging, pressure, heat) that may damage the stimulation system.
• Patient will be provided with detailed instructions regarding the use, care, and cleaning of the system by the device representative.
Peripheral Nerve Stimulation: Axonics
Vendor: Axonics Rep: Sonny Morocco Email: [email protected] Cell: (480)238-5008
OVERVIEW AND INDICATIONS 1. Overview of Procedure: Axonics is a sacral neuromodulation device used for the
treatment of overactive bladder, urinary retention, and fecal incontinence. It is similar to SCS, with a stimulation lead placed at S3 or S4 that is connected to small, implantable, and rechargeable generator. The procedure is performed in two steps, with a trial followed by permanent implant if successful. There are two different types of trials that can be pursued:
a. Trial with temporary leads i. Two temporary leads are placed during this trial
ii. Duration of trial is generally 3 to 5 days b. Trial with permanent lead
i. One permanent lead is placed during this trial ii. Duration of trial is generally 1 to 2 weeks
iii. Permanent lead trial is highly recommended for patients with urinary retention and fecal incontinence
2. Indications: The Axonics System is indicated for the treatment of the symptoms of overactive bladder (to include: urinary urge incontinence, urinary urgency/frequency, in combination or alone, and nocturia) non-obstructive urinary retention, and fecal (bowel) incontinence. The therapy is not indicated for treatment of mechanical urinary obstruction.
3. Applicable diagnosis codes: Overactive bladder N32.81
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Urge incontinence N39.41 Other retention of urine R33.8 Retention of urine, unspecified R33.9 Frequency of micturition R35.0 Feeling of incomplete bladder emptying R39.14 Full incontinence of feces R15.9
4. Photos of device/procedure:
DOCUMENTATION/IMAGING REQUIRED
Urinary Incontinence • Patient has been symptomatic for 6 months not related to a neurologic condition
(such as diabetes with peripheral nerve involvement) • Diagnostics to assess for underlining pathology, such as
o Post void residual (PVR) o Urodynamic studies
• Patient has tried and failed conservative therapy including o Behavioral modification/lifestyle changes, such as:
Fluid intake management and avoidance of bladder irritants (caffeine, alcohol, carbonated beverages)
Pelvic floor exercises Bladder training
o Pharmaceutical treatment Antimuscarinic agents (i.e., Oxybutynin) Beta 3-recepor agonist (i.e., Myrbetriq)
• For permanent implantation, evidence that the patient experienced relief of incontinence symptoms in the trial period, usually at least 50%, as demonstrated with voiding diaries
Fecal Incontinence
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• Patient has experienced chronic fecal incontinence (2 times per week for 6 months or 12 months following childbirth) not related to a neurological condition
• Diagnostics to assess for underlining pathology, such as o Lower gastrointestinal endoscopy o CT scan
• Patient has tried and failed conservative therapy including o Behavioral modification/lifestyle changes, such as:
Diet changes Pelvic floor and sphincter exercises
o Pharmaceutical treatment OTC anti-diarrheal medications
o Pessary • Patient cannot tolerate conservative treatments due to severity impacting ability
to work or participate in activities outside the home • For permanent implantation, evidence that the patient experienced relief of
incontinence symptoms in the trial period, usually at least 50%, as demonstrated by bowel diaries
PRE-OPERATIVE GUIDELINES For Implant
• Preoperative testing: (To be completed within 60 days of surgery date) o EKG o CBC o BMP o PT-INR/PTT (if on Coumadin, must have PT-INR/PTT completed within 24 hours
of scheduled surgery) o Surgical clearance from PCP and/or cardiac clearance if indicated based upon
patient health history • Prescribe for use preoperatively:
o Mupirocin 2% topical ointment – apply to each nostril TID x 5 days prior to surgery (do not order nasal ointment)
o Hibiclens 4% topical liquid- wash surgical site in shower QD x 5 days prior to surgery
• Prescribe for use postoperatively, optional based on physician preference: o 3-to-5-day course of antibiotics o Short-term course of opioids (or temporary increase of current opioid doses)
POST-OPERATIVE CARE • For Trial:
o Patient should adhere to following activity limitations for duration of trial: Avoid any sudden or jerking movements that may dislodge the
electrodes, such as bending, twisting, pulling or pushing Do not lift greater than 5 pounds
o Patient should not remove their dressing or take a shower/bath until seen at follow up appointment
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o Duration of temporary lead trial is generally 3 to 5 days o Durations of permanent lead trial is generally 1 to 2 weeks o Patient will need to keep a bladder/bowl diary for the duration of the trial
• For Implant: o Occlusive dressing for 24 to 48 hours o Postoperative appointment at day 3 to 5, with close wound surveillance
throughout the postoperative period o Staples should be removed at postoperative day 10 to 12
CHAPTER TWO: REGENERATIVE MEDICINE
Platelet Rich Plasma
Vendor: Desert Mountain Medical
OVERVIEW AND INDICATIONS 1. Overview of Procedure:
• Regenerative medicine involves the use of cellular therapy to repair tissues and structures that have been damaged by disease, trauma, and the normal aging process. The products used in regenerative medicine include both autologous (harvested from your own body) and allogenic (harvested from amniotic and placental sources during normal childbirth).
• Platelet Rich Plasma is an autologous product, which involves harvesting your own plasma from a blood draw.
• While the method for procuring and processing these products is approved by the Food and Drug Administration (FDA), the indications for usage in the treatment of chronic pain are not approved. However, it has been used safely and successfully on many patients.
2. Indications: For the treatment of chronic pain, regenerative medicine products may be injected into joints, tendons, ligaments, muscles, spinal facets, epidural spaces, intradiscal and others.
DOCUMENTATION/IMAGING REQUIRED • Self-pay procedure, not applicable
PRE-OPERATIVE GUIDELINES • Follow same pre-operative instructions as basic interventional pain procedure • Patient will have blood drawn in pre-operative area, then it will be spun down and
prepared for injection • Patient will be required to sign Consent and Authorization for Regenerative Medicine
Procedure form • Order bracing
POST-OPERATIVE CARE • Follow same post-operative instructions as basic interventional pain procedure
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Placental/Amino Derived Products
Vendor: TeleGen West Product: SurgiGRAFT
OVERVIEW AND INDICATIONS 1. Overview of Procedure:
• Regenerative medicine involves the use of cellular therapy to repair tissues and structures that have been damaged by disease, trauma, and the normal aging process. The products used in regenerative medicine include both autologous (harvested from your own body) and allogenic (harvested from amniotic and placental sources during normal childbirth).
• SurgiGRAFT is an allogenic, placental-derived product that is harvested during a routine c-section and processed for injectable use. Of note, this product does NOT contain stem cells.
• While the method for procuring and processing these products is approved by the Food and Drug Administration (FDA), the indications for usage in the treatment of chronic pain are not approved. However, it has been used safely and successfully on many patients.
2. Indications: For the treatment of chronic pain, regenerative medicine products may be injected into joints, tendons, ligaments, muscles, spinal facets, epidural spaces, intradiscal and others.
DOCUMENTATION/IMAGING REQUIRED • Self-pay procedure, not applicable
PRE-OPERATIVE GUIDELINES • Follow same pre-operative instructions as basic interventional pain procedure • Patient will be required to sign Consent and Authorization for Regenerative Medicine
Procedure form • Order bracing
POST-OPERATIVE CARE • Follow same post-operative instructions as basic interventional pain procedure
CHAPTER THREE: ADVANCED SPINAL PROCEDURES
Kyphoplasty
Vendor: Stryker Rep: Bo Boamah-Wiafe Email: [email protected] Cell: 602-574-9531
OVERVIEW AND INDICATIONS 1. Overview of Procedure: Kyphoplasty is a treatment option for symptomatic
osteoporotic vertebral compression fracture. It involves the placement of a balloon tamponade within the fractured vertebral body to create a low-pressure cavity, followed by injection of bone cement under image guidance. The treatment is designed to immobilize the fracture, reduce pain, and improve alignment.
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2. Indications: Treatment of symptomatic, acute (<6 weeks) or subacute (6 to 12 weeks) osteoporotic vertebral compression fracture located between T5 and L5.
3. Applicable diagnosis codes: Age-related osteoporosis with current pathological fracture, vertebra(e), initial encounter for fracture
M80.08XA
Age-related osteoporosis with current pathological fracture, vertebra(e), sequela
M80.08XS
Other osteoporosis with current pathological fracture, vertebra(e), initial encounter for fracture
M80.88XA
Other osteoporosis with current pathological fracture, vertebra(e), sequela
M80.88XS
4. Photos of device/procedure:
DOCUMENTATION/IMAGING REQUIRED 1. Inclusion criteria (ALL are required):
• Acute (< 6 weeks) or subacute (6-12 weeks) osteoporotic vertebral compression fracture (T5 – L5) by recent (within 30 days) MRI
• Symptomatic (ONE): o Non-hospitalized with moderate to severe pain (NRS or VAS ≥5) despite
optimal non-surgical management o Hospitalized with severe pain (NRS or VAS ≥ 8)
• Multidisciplinary team consensus (ALL are required) o Referring physician (e.g., rheumatologist, endocrinologist)
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o Treating physician (i.e., performing the procedure) o Radiologist o Neurologist
• Exclusion criteria (can have NONE of the following): o Absolute contraindication
Current back pain is not primarily due to the identified acute VCF(s) Osteomyelitis, discitis, or active systemic infection Pregnancy Greater than three vertebral fractures
o Relative contraindication Allergy to bone cement or opacification agents Coagulopathy Spinal instability Myelopathy from the fracture Neurologic deficit Neural impingement Fracture retropulsion/canal compromise
PRE-OPERATIVE GUIDELINES • Follow same pre-operative instructions as basic interventional pain procedure • Order lumbar brace
POST-OPERATIVE CARE • Patient will be required to lay flat in the post-operative area for 30 minutes to 1 hour
to allow cement to set • Follow same post-operative instructions as basic interventional pain procedure
Minimally Invasive Lumbar Decompression (MILD) Vendor: Vertos Medical Rep: Amber Crowder Email: [email protected] Cell: (480)233-3277
OVERVIEW AND INDICATIONS 1. Overview of Procedure: Minimally invasive lumbar decompression is a procedure
designed to debulk hypertrophied ligamentum flavum with a goal of relieving neural compression causing symptoms of neurogenic claudication. MILD selectively removes small portions of ligament and leaves no implants behind. The procedure is performed percutaneously through a 5.1-mm port with specially designed, minimally invasive instruments. The procedure can be done unilaterally or bilaterally, and at multiple symptomatic levels.
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2. Indications: Treatment of lumbar spinal stenosis with neurogenic claudication,
presenting commonly as gluteal or leg pain with walking or standing that is alleviated with sitting.
3. Applicable diagnosis codes: Spinal stenosis, lumbar region with neurogenic claudication
M48.062
DOCUMENTATION/IMAGING REQUIRED • Symptomatic lumbar spinal stenosis with neurogenic claudication • Confirmation of stenosis on imaging with MRI or CT scan • Ligamentum flavum hypertrophy (LF ≥2.5 mm) • The following contraindications must be accounted for before the procedure is
performed on the patient: o Absolute contraindications:
Prior spine surgery at the intended level of treatment Presence of localized site of infection at the site of procedure.
o Relative contraindications: Presence of higher than grade II spondylolisthesis Presence of bleeding diatheses/coagulation disorder Presence of systemic infection
PRE-OPERATIVE GUIDELINES • Preoperative testing: (To be completed within 60 days of surgery date)
o EKG o CBC o BMP o PT-INR/PTT (if on Coumadin, must have PT-INR/PTT completed within 24 hours
of scheduled surgery) o Surgical clearance from PCP and/or cardiac clearance if indicated based upon
patient health history o Order lumbar brace
• Prescribe for use preoperatively:
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o Mupirocin 2% topical ointment – apply to each nostril TID x 5 days prior to surgery (do not order nasal ointment)
o Hibiclens 4% topical liquid- wash surgical site in shower QD x 5 days prior to surgery
• Prescribe for use postoperatively, optional based on physician preference: o 3-to-5-day course of antibiotics o Short-term course of opioids (or temporary increase of current opioid doses)
POST-OPERATIVE CARE • Following treatment, patients typically resume normal activity within 24 hours with
no restrictions. • Postoperative appointment at day 3 to 5, with close wound surveillance throughout
the postoperative period • Remove the outer dressings 3 days after the procedure. Adhesive strips will cover the
incision and should begin to fall off within 7-10 days after the procedure. If they have not fallen off after 14 days, the patient may remove them.
• The patient may begin to shower 3 days after the procedure. Do not sit in a bath or rub the incision. Do not apply lotion, medication, or cream to the incision site.
Vertiflex
Vendor: Boston Scientific Rep: Liz Ludwig Email: [email protected] C: 602-803-7586
OVERVIEW AND INDICATIONS 1. Overview of Procedure: The Vertiflex procedure uses a small implant (the Superion
Indirect Decompression System) that is placed between the spinous processes to help prevent reduction of the canal space when standing or walking, for the treatment of lumbar spinal stenosis with neurogenic claudication. This provides relief by lifting pressure off the nerves to alleviate leg and back pain symptoms that often accompany the condition. The device can be placed at up to two adjacent levels from L1-L5.
4. Indications: Treatment of lumbar spinal stenosis with neurogenic claudication, presenting commonly as gluteal or leg pain with walking or standing that is alleviated with sitting, that has failed to respond to conservative care.
2. Applicable diagnosis codes: Spinal stenosis, lumbar region with neurogenic claudication
M48.062
3. Photos of device/procedure:
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DOCUMENTATION/IMAGING REQUIRED
• Symptomatic lumbar spinal stenosis with neurogenic claudication • Documentation must include evidence of six months of non-operative treatment to
include: o medications o corticosteroid injection therapy o rest or restricted activity o devices designed to help stabilize the spine such as back braces/corsets o physical therapy/exercises to help stabilize the spine and help to build
endurance/increase flexibility. • The diagnosis of lumbar stenosis must be confirmed by radiological evidence (CT scan,
MRI, or myelogram).
PRE-OPERATIVE GUIDELINES • Preoperative testing: (To be completed within 60 days of surgery date)
o EKG o CBC o BMP o PT-INR/PTT (if on Coumadin, must have PT-INR/PTT completed within 24 hours
of scheduled surgery) o Surgical clearance from PCP and/or cardiac clearance if indicated based upon
patient health history o Order lumbar brace
• Prescribe for preoperative use: o Mupirocin 2% topical ointment – apply to each nostril TID x 5 days prior to
surgery (do not order nasal ointment) o Hibiclens 4% topical liquid- wash surgical site in shower QD x 5 days prior to
surgery • Prescribe for postoperative use, optional based on physician preference:
o 3-to-5-day course of antibiotics o Short-term course of opioids (or temporary increase of current opioid doses)
POST-OPERATIVE CARE • Occlusive dressing for 24 to 48 hours
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• Postoperative appointment at day 3 to 5, with close wound surveillance throughout the postoperative period
• Staples should be removed at postoperative day 10 to 12 • For 6 weeks, limit all lifting, bending and strenuous activity including:
• Lifting any weight over 10-15 lbs. • Any large bending of the spine, especially twisting.
CHAPTER FOUR: SACROILIAC JOINT FUSION
Vendor: CornerLoc (Optima Surgical) Rep: Jennifer Kern Email: [email protected] C: (480)217-4802 Vendor: PsiF (Omnia) Rep: Cheryl Jean Email: [email protected] Cell: 480-415-7851 Vendor: LinQ (PainTEQ) Rep: Coby Larson Email: [email protected] Cell: 480-645-2555
OVERVIEW AND INDICATIONS 1. Overview of Procedure: Minimally invasive sacroiliac joint fusion (stabilization)
designed to treat sacroiliac joint instability. a. Specific to CornerLoc and PsiF: two cortical bone allograft and DBM sponge
grafts are placed orthogonally within the sacroiliac joint, via a posterior approach.
b. Specific to LinQ: A single bone allograft is placed within the sacroiliac joint, via a posterior approach.
2. Indications: SI joint fusion should be considered after non-surgical interventions have failed to provide a patient with an enduring solution to their pain. Fusing the SI joint, thereby eliminating pain-generating instability, can provide enduring pain relief.
• SI Fusion is not indicated if: o Systemic arthropathy (ankylosing spondylitis or rheumatoid arthritis) o Somatoform disorder or fibromyalgia o Infection, tumor, or fracture o Acute, traumatic instability of SI joint o Neural compression as seen on MRI/CT that correlates with symptoms.
3. Applicable Diagnosis Codes: Sacroiliitis M46.1 Other intervertebral disc degeneration, lumbar region
M51.36
Other intervertebral disc degeneration, lumbosacral region
M51.37
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Low back pain M54.5 Fusion of spine, lumbosacral region M43.27 Fusion of spine, sacral and sacrococcygeal region
M43.28
Sacrococcygeal disorders M53.3 Post-laminectomy syndrome M96.1 Unspecified osteoarthritis M19.90 Primary osteoarthritis M19.91 Post-traumatic osteoarthritis M19.92 Age-related osteoporosis without current pathological fracture
M81.0
4. Photos of device/procedure:
CornerLoc
PsiF
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LinQ
DOCUMENTATION/IMAGING REQUIRED • Minimum of 6 months of conservative care to include: NSAIDS (if able), physical
therapy or chiropractic care, optimization of medication and bracing • SI joint exam • 3 of 5 positive provocative test (Distraction, thigh thrust, Faber, compression,
Gaenslen’s) • MRI of lumbar spine • 2 diagnostic intraarticular injections of the SI joint, on two separate dates of service,
with 75% or greater relief • X-ray of SI joint including hip to rule out other pathologies such as tumor or fracture
PRE-OPERATIVE GUIDELINES
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• Preoperative testing: (To be completed within 60 days of surgery date) o EKG o CBC o BMP o PT-INR/PTT (if on Coumadin, must have PT-INR/PTT completed within 24 hours
of scheduled surgery) o Surgical clearance from PCP and/or cardiac clearance if indicated based upon
patient health history • Prescribe for preoperative use:
o Mupirocin 2% topical ointment – apply to each nostril TID x 5 days prior to surgery (do not order nasal ointment)
o Hibiclens 4% topical liquid- wash surgical site in shower QD x 5 days prior to surgery
• Prescribe for postoperative use, optional based on physician preference: o 3-to-5-day course of antibiotics o Short-term course of opioids (or temporary increase of current opioid doses)
• Order lumbar brace and walker for post-operative use POST-OPERATIVE CARE
• Occlusive dressing for 24 to 48 hours • Postoperative appointment at day 3 to 5, with close wound surveillance throughout
the postoperative period • Staples should be removed at postoperative day 10 to 12 • Up to 2 weeks postoperatively: avoid driving, sponge bath or brief shower (no
immersion), keep surgical dressing in place. • Up to 6 weeks postoperatively: avoid lifting 10 pounds or more, avoid NSAIDS to
ensure desired inflammatory response. • Up to 12 weeks postoperatively: avoid running or jumping. • Other considerations: walk only as tolerated, maintain regular diet, take pain
medication as prescribed. • Patient should be provided with a walker for 1 week post-operatively to limit weight
bearing on the SI joint.