Prior Authorization List (PAL) and Documentation Guidelines:

CMS’s WISeR model in Texas

Overview

Starting January 5, 2026, Cohere Health® will manage select prior authorizations in partnership with Novitas, the Medicare Administrative Contractor for Texas. Our goal for this partnership is to streamline the prior authorization process for the select services listed below. Utilizing National Coverage Determinations (NCD) and Local Coverage Determinations (LCD) from CMS and Novitas, we aim to enhance provider workflows and support informed clinical decision-making.

Please refer to the tables below for the applicable services, procedure codes, and documentation guidelines to ensure that all required information is included when submitting a prior authorization request.

Services and Procedure Codes

Service	Procedure Codes
Arthroscopic Lavage and Arthroscopic Debridement for the Osteoarthritic Knee	29877
Application of Bioengineered Skin Substitutes to Lower Extremity Chronic Non-Healing Wounds	15271, 15272, 15273, 15274, 15275, 15276, 15277, 15278
Cervical Fusion	22554
Diagnosis and Treatment of Impotence	54400, 54401, 54405
Epidural Steroid Injections for Pain Management	62321, 62323, 64479, 64480, 64483, 64484
Electrical Nerve Stimulators	63655
Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea	64582
Incontinence Control Devices	53445, 53451, 53452, 53440, 57288
Induced Lesions of Nerve Tracts	64605, 64610
Percutaneous Vertebral Augmentation (PVA) for Vertebral Compression Fracture (VCF)	22510, 22511, 22512, 22513, 22514, 22515
Phrenic Nerve Stimulator	33276, 33277
Sacral Nerve Stimulation For Urinary Incontinence	64561, 64581
Vagus Nerve Stimulation (VNS)	64568

Documentation Requirements

Epidural Steroid Injections for Pain Management Procedure codes: 62321, 62323, 64479, 64480, 64483, 64484 Local Coverage Determination (LCD): ESI for Pain Management, L36920	Epidural Steroid Injections for Pain Management Procedure codes: 62321, 62323, 64479, 64480, 64483, 64484 Local Coverage Determination (LCD): ESI for Pain Management, L36920
Please include the following documentation in your request:	Please include the following documentation in your request:
Most recent office visit note(s) that supports relevant pre-procedure documentation related to indication for injection (i.e., relevant medical history, duration, pain/disability severity, assessment/physical examination, progress notes, pertinent testing/procedure results, conservative treatment(s), etc.) *Note: The scales used to measure of pain and/or disability must be documented in the medical record Include spine level/s and laterality (right, left or bilateral) when applicable	Most recent office visit note(s) that supports relevant pre-procedure documentation related to indication for injection (i.e., relevant medical history, duration, pain/disability severity, assessment/physical examination, progress notes, pertinent testing/procedure results, conservative treatment(s), etc.) *Note: The scales used to measure of pain and/or disability must be documented in the medical record Include spine level/s and laterality (right, left or bilateral) when applicable
Details and duration of noninvasive conservative care (e.g. medications, physical therapy, home exercise program)	Details and duration of noninvasive conservative care (e.g. medications, physical therapy, home exercise program)
Outcome of prior treatments If applicable, the percent (%) of relief from previous injections and duration of relief	Outcome of prior treatments If applicable, the percent (%) of relief from previous injections and duration of relief
Imaging reports ( e.g. MRI, CT scan)	Imaging reports ( e.g. MRI, CT scan)
Please note: Frequent continuation of epidural steroid injections over 12 months may trigger a focused medical review. Use beyond twelve months requires the following: Pain is severe enough to cause a significant degree of functional disability or vocational disability. ESI provides at least 50% sustained improvement of pain and/or 50% objective improvement in function (using the same scale as baseline). Rationale for the continuation of ESIs including but not limited to patient is high-risk surgical candidates, the patient does not desire surgery, recurrence of pain in the same location relieved with ESIs for at least three months The primary care provider must be notified regarding continuation of procedures and prolonged repeat steroid use.	Please note: Frequent continuation of epidural steroid injections over 12 months may trigger a focused medical review. Use beyond twelve months requires the following: Pain is severe enough to cause a significant degree of functional disability or vocational disability. ESI provides at least 50% sustained improvement of pain and/or 50% objective improvement in function (using the same scale as baseline). Rationale for the continuation of ESIs including but not limited to patient is high-risk surgical candidates, the patient does not desire surgery, recurrence of pain in the same location relieved with ESIs for at least three months The primary care provider must be notified regarding continuation of procedures and prolonged repeat steroid use.
Additional Resources: Click here for Novitas service documentation requirements checklist. Click here to view additional LCD requirements	Additional Resources: Click here for Novitas service documentation requirements checklist. Click here to view additional LCD requirements
Common non-affirmations for ESI requests: Missing pain severity and/or disability severity as measured on a scale Missing % of relief and duration of benefit from prior injection Missing conservative care details and duration documentation Missing documentation requirements for use beyond 12 months	Common non-affirmations for ESI requests: Missing pain severity and/or disability severity as measured on a scale Missing % of relief and duration of benefit from prior injection Missing conservative care details and duration documentation Missing documentation requirements for use beyond 12 months

Electrical Nerve Stimulators Procedure code: 63655 National Coverage Determination (NCD): Electrical Nerve Stimulators, 160.7	Electrical Nerve Stimulators Procedure code: 63655 National Coverage Determination (NCD): Electrical Nerve Stimulators, 160.7
Please include the following documentation in your request:	Please include the following documentation in your request:
Most recent office visit note(s) that support relevant pre-procedure documentation related to spinal cord stimulator implant CPT 63655 (i.e., chronic intractable pain condition, relevant medical history, duration, pain/disability severity, assessment/physical examination, progress notes, pertinent testing/procedure results, conservative treatment(s), etc.)	Most recent office visit note(s) that support relevant pre-procedure documentation related to spinal cord stimulator implant CPT 63655 (i.e., chronic intractable pain condition, relevant medical history, duration, pain/disability severity, assessment/physical examination, progress notes, pertinent testing/procedure results, conservative treatment(s), etc.)
Documentation that stimulation is being used only as a late resort (if not a last resort) for patients with chronic intractable pain, including but not limited to at least one treatment tried and failed (or documentation that they were contraindicated): Medications Physical therapy Injections Spine surgery Cognitive behavioral therapy	Documentation that stimulation is being used only as a late resort (if not a last resort) for patients with chronic intractable pain, including but not limited to at least one treatment tried and failed (or documentation that they were contraindicated): Medications Physical therapy Injections Spine surgery Cognitive behavioral therapy
Documentation showing that the patient was evaluated by a multidisciplinary team (including psychological, surgical, medical and physical therapy)	Documentation showing that the patient was evaluated by a multidisciplinary team (including psychological, surgical, medical and physical therapy)
Documentation showing that the patient achieved a reduction in pain AND evidence of functional restoration with a temporarily implanted electrode	Documentation showing that the patient achieved a reduction in pain AND evidence of functional restoration with a temporarily implanted electrode
Documentation that the patient is not a candidate for percutaneously placed leads (e.g., previous instrumentation, challenging anatomy, high BMI, other technical challenges)	Documentation that the patient is not a candidate for percutaneously placed leads (e.g., previous instrumentation, challenging anatomy, high BMI, other technical challenges)
Additional Resources: CMS Provider and Supplier Operational Guide Click here to view additional CMS requirements.	Additional Resources: CMS Provider and Supplier Operational Guide Click here to view additional CMS requirements.
Common non-affirmations for Spinal Cord Stimulator requests: Missing evidence of previous failed treatments to confirm that the spinal cord stimulator is being used only after other options have been exhausted Failure to submit results of temporarily implanted electrode stimulator trial that demonstrate significant pain relief	Common non-affirmations for Spinal Cord Stimulator requests: Missing evidence of previous failed treatments to confirm that the spinal cord stimulator is being used only after other options have been exhausted Failure to submit results of temporarily implanted electrode stimulator trial that demonstrate significant pain relief

Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea Procedure code: 64582 Local Coverage Determination (LCD): HGNS for the Treatment of Obstructive Sleep Apnea, L38385	Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea Procedure code: 64582 Local Coverage Determination (LCD): HGNS for the Treatment of Obstructive Sleep Apnea, L38385
Please include the following documentation in your request:	Please include the following documentation in your request:
Results of polysomnography performed within 24 months of first consultation of HGNS implant (include date of first consultation of HGNS implant and date of polysomnography test) showing: Predominantly obstructive events (defined as central and mixed apneas less than 25% of the total apnea-hypopnea index (AHI) AND AHI is 15 to 65 events per hour	Results of polysomnography performed within 24 months of first consultation of HGNS implant (include date of first consultation of HGNS implant and date of polysomnography test) showing: Predominantly obstructive events (defined as central and mixed apneas less than 25% of the total apnea-hypopnea index (AHI) AND AHI is 15 to 65 events per hour
Documentation demonstrating one of the following: Continuous positive airway pressure (CPAP) failure (defined as AHI greater than 15 events per hour, despite CPAP usage) OR CPAP intolerance (defined as less than 4 hours per night, 5 nights per week or CPAP has been returned) including shared decision making that the patient was intolerant of CPAP despite consultation with a sleep expert	Documentation demonstrating one of the following: Continuous positive airway pressure (CPAP) failure (defined as AHI greater than 15 events per hour, despite CPAP usage) OR CPAP intolerance (defined as less than 4 hours per night, 5 nights per week or CPAP has been returned) including shared decision making that the patient was intolerant of CPAP despite consultation with a sleep expert
Drug-induced sleep endoscopy (DISE) procedure showing absence of complete concentric collapse at the soft palate level.	Drug-induced sleep endoscopy (DISE) procedure showing absence of complete concentric collapse at the soft palate level.
Documentation of any other anatomical findings that would compromise performance of device, e.g., tonsil size 4 per standardized tonsillar hypertrophy grading scale, laryngeal abnormalities that would cause a fixed obstruction (e.g., supraglottic stenosis, post-radiation fibrosis, laryngoceles, etc.), anterior cervical osteophytes impinging or pushing on the posterior pharynx.	Documentation of any other anatomical findings that would compromise performance of device, e.g., tonsil size 4 per standardized tonsillar hypertrophy grading scale, laryngeal abnormalities that would cause a fixed obstruction (e.g., supraglottic stenosis, post-radiation fibrosis, laryngoceles, etc.), anterior cervical osteophytes impinging or pushing on the posterior pharynx.
Documentation of counseling regarding future MRI utilization (depending on model implanted)	Documentation of counseling regarding future MRI utilization (depending on model implanted)
Assessment and documentation of none of the following contraindications: Central and mixed apneas compromising more than one-quarter of the total AHI Another implantable device that could result in an unintended interaction with the HGNS implant system (e.g., pacemakers, implantable cardioverter-defibrillators, other nerve stimulators) BMI equal to or greater than 35 kg/m2 Neuromuscular disease Hypoglossal-nerve palsy Severe restrictive or obstructive pulmonary disease. Moderate-to-severe pulmonary arterial hypertension Severe valvular heart disease New York Heart Association class III or IV heart failure Recent myocardial infarction or severe cardiac arrhythmias (within the past 6 months) Persistent uncontrolled hypertension despite medication use An active, serious mental illness that reduces the ability to carry out Activities of Daily Living and would interfere with the patient’s ability to operate the HGNS device and report problems to the attending provider Coexisting non-respiratory sleep disorders that would confound functional sleep assessment Patient is or plans to become pregnant Patient is unable or does not have the necessary assistance to operate the sleep remote Patient has a condition or procedure that has compromised neurological control of the upper airway	Assessment and documentation of none of the following contraindications: Central and mixed apneas compromising more than one-quarter of the total AHI Another implantable device that could result in an unintended interaction with the HGNS implant system (e.g., pacemakers, implantable cardioverter-defibrillators, other nerve stimulators) BMI equal to or greater than 35 kg/m2 Neuromuscular disease Hypoglossal-nerve palsy Severe restrictive or obstructive pulmonary disease. Moderate-to-severe pulmonary arterial hypertension Severe valvular heart disease New York Heart Association class III or IV heart failure Recent myocardial infarction or severe cardiac arrhythmias (within the past 6 months) Persistent uncontrolled hypertension despite medication use An active, serious mental illness that reduces the ability to carry out Activities of Daily Living and would interfere with the patient’s ability to operate the HGNS device and report problems to the attending provider Coexisting non-respiratory sleep disorders that would confound functional sleep assessment Patient is or plans to become pregnant Patient is unable or does not have the necessary assistance to operate the sleep remote Patient has a condition or procedure that has compromised neurological control of the upper airway
Additional resources: CMS Provider and Supplier Operational Guide Click here to view additional CMS requirements.	Additional resources: CMS Provider and Supplier Operational Guide Click here to view additional CMS requirements.
Common Non-affirmations for sleep requests: Documented results of tests and procedures not included in request (see above). Non-FDA-approved hypoglossal nerve neurostimulation is considered not medically reasonable and necessary for the treatment of adult obstructive sleep apnea due to insufficient evidence of being safe and effective. Submitted information contains a contraindication, such as BMI over 35.	Common Non-affirmations for sleep requests: Documented results of tests and procedures not included in request (see above). Non-FDA-approved hypoglossal nerve neurostimulation is considered not medically reasonable and necessary for the treatment of adult obstructive sleep apnea due to insufficient evidence of being safe and effective. Submitted information contains a contraindication, such as BMI over 35.

Cervical Fusion Procedure codes: 22554 Local Coverage Determination (LCD): Cervical Fusion, L39793	Cervical Fusion Procedure codes: 22554 Local Coverage Determination (LCD): Cervical Fusion, L39793
Please include the following documentation in your request:	Please include the following documentation in your request:
Clear indication of what is being requested	Clear indication of what is being requested
Relevant medical history, or general background information	Relevant medical history, or general background information
Physical examination findings	Physical examination findings
Pertinent imaging reports, procedure reports, and/or progress notes Include advanced imaging that corresponds to the documented signs and symptoms.	Pertinent imaging reports, procedure reports, and/or progress notes Include advanced imaging that corresponds to the documented signs and symptoms.
Additional documentation that supports medical necessity for each indication Duration/character/location of pain, or myelopathy, or cervical spine deformities/instability Documentation of activities of daily living (ADL) limitations (when applicable) Failure to respond to multimodal conservative management (when applicable)	Additional documentation that supports medical necessity for each indication Duration/character/location of pain, or myelopathy, or cervical spine deformities/instability Documentation of activities of daily living (ADL) limitations (when applicable) Failure to respond to multimodal conservative management (when applicable)
Documentation of pain with VAS score	Documentation of pain with VAS score
Failure to respond to multimodal conservative treatment or documentation of class III myelopathy or progression or neurological deficit during conservative treatment.	Failure to respond to multimodal conservative treatment or documentation of class III myelopathy or progression or neurological deficit during conservative treatment.
Additional resources: Click here to view LCD requirements. Click here to view Novitas best practices.	Additional resources: Click here to view LCD requirements. Click here to view Novitas best practices.
Common non-affirmations for Cervical Fusion requests: Clinical notes and advanced imaging not attached. Omission of documentation of history and exam findings, pain score (VAS), impact on ADL, or conservative treatment. Exam findings do not correspond to advanced imaging. Please note: This procedure is not considered appropriate for axial cervical pain or asymptomatic myelopathy.	Common non-affirmations for Cervical Fusion requests: Clinical notes and advanced imaging not attached. Omission of documentation of history and exam findings, pain score (VAS), impact on ADL, or conservative treatment. Exam findings do not correspond to advanced imaging. Please note: This procedure is not considered appropriate for axial cervical pain or asymptomatic myelopathy.

Percutaneous Vertebral Augmentation (PVA) for Vertebral Compression Fracture (VCF) Procedure codes: 22510, 22511, 22512, 22513, 22514, 22515 Local Coverage Determination (LCD): PVA for VCF, L35130	Percutaneous Vertebral Augmentation (PVA) for Vertebral Compression Fracture (VCF) Procedure codes: 22510, 22511, 22512, 22513, 22514, 22515 Local Coverage Determination (LCD): PVA for VCF, L35130
Please include the following documentation in your request:	Please include the following documentation in your request:
For painful, debilitating, osteoporotic, vertebral, collapse/compression fractures, the following requirements should be met: Acute (less than 6 weeks) or subacute (6 to 12 weeks) osteoporotic VCF (T1 – L5) based on symptom onset, and documented by advanced imaging (bone marrow edema on MRI or bone-scan/SPECT/CT uptake) Symptomatic VCF Hospitalized with severe pain, defined as a Numeric Rating Scale (NRS) or Visual Analog Scale (VAS) pain score greater than or equal to 8 OR Non-hospitalized with moderate to severe pain, defined as a NRS or VAS pain score greater than or equal to 5, despite optimal non-surgical management (e.g., narcotic and/or non-narcotic medication, physical therapy modalities), with and without methods of immobility (e.g., rest, bracing). For non-hospitalized patients, one of the following must be documented: Worsening pain OR Stable to improved pain (but NRS or VAS score remains greater than or equal to 5), with at least 2 of the following: Progression of vertebral body height loss More than 25% vertebral body height reduction Kyphotic deformity Severe impact of VCF on daily functioning, indicated by a Roland Morris Disability Questionnaire (RDQ) score greater than 17 Continuum of Care Documentation of referral for evaluation of bone mineral density and osteoporosis education for subsequent treatment as indicated Documentation of participation in an osteoporosis prevention/treatment program	For painful, debilitating, osteoporotic, vertebral, collapse/compression fractures, the following requirements should be met: Acute (less than 6 weeks) or subacute (6 to 12 weeks) osteoporotic VCF (T1 – L5) based on symptom onset, and documented by advanced imaging (bone marrow edema on MRI or bone-scan/SPECT/CT uptake) Symptomatic VCF Hospitalized with severe pain, defined as a Numeric Rating Scale (NRS) or Visual Analog Scale (VAS) pain score greater than or equal to 8 OR Non-hospitalized with moderate to severe pain, defined as a NRS or VAS pain score greater than or equal to 5, despite optimal non-surgical management (e.g., narcotic and/or non-narcotic medication, physical therapy modalities), with and without methods of immobility (e.g., rest, bracing). For non-hospitalized patients, one of the following must be documented: Worsening pain OR Stable to improved pain (but NRS or VAS score remains greater than or equal to 5), with at least 2 of the following: Progression of vertebral body height loss More than 25% vertebral body height reduction Kyphotic deformity Severe impact of VCF on daily functioning, indicated by a Roland Morris Disability Questionnaire (RDQ) score greater than 17 Continuum of Care Documentation of referral for evaluation of bone mineral density and osteoporosis education for subsequent treatment as indicated Documentation of participation in an osteoporosis prevention/treatment program
For malignant vertebral fracture, documentation that the patient has an osteolytic vertebral, metastasis, or myeloma with severe back pain related to a destruction of the vertebral body, not involving the major part of the cortical bone.	For malignant vertebral fracture, documentation that the patient has an osteolytic vertebral, metastasis, or myeloma with severe back pain related to a destruction of the vertebral body, not involving the major part of the cortical bone.
Assessment and documentation of none of the following: Current back pain is not primarily due to the identified acute or subacute VCF(s) Osteomyelitis, discitis or active systemic or surgical site infection Pregnancy	Assessment and documentation of none of the following: Current back pain is not primarily due to the identified acute or subacute VCF(s) Osteomyelitis, discitis or active systemic or surgical site infection Pregnancy
Assessment of the following relative contraindications and rationale for proceeding with PVA if one or more of the following exists: Greater than three vertebral fractures per procedure Allergy to bone cement or opacification agents Uncorrected coagulopathy Spinal instability Myelopathy from the fracture Neurologic deficit Neural impingement Fracture retropulsion/canal compromise	Assessment of the following relative contraindications and rationale for proceeding with PVA if one or more of the following exists: Greater than three vertebral fractures per procedure Allergy to bone cement or opacification agents Uncorrected coagulopathy Spinal instability Myelopathy from the fracture Neurologic deficit Neural impingement Fracture retropulsion/canal compromise
Additional resources: CMS Provider and Supplier Operational Guide Click here to view additional CMS requirements.	Additional resources: CMS Provider and Supplier Operational Guide Click here to view additional CMS requirements.
Common non-affirmations for PVA for VCF requests: Requested at spinal levels other than T1-L5 Advanced imaging does not demonstrate bone marrow edema consistent with an acute osteoporotic fracture Chronic osteoperotic fracture (> 12 weeks from symptom onset) Missing Pan scare (VAS or NRS) Missing documentation of non surgical management in non-hospitalised patients. Missing Roland Morris Disability Questionnaire score	Common non-affirmations for PVA for VCF requests: Requested at spinal levels other than T1-L5 Advanced imaging does not demonstrate bone marrow edema consistent with an acute osteoporotic fracture Chronic osteoperotic fracture (> 12 weeks from symptom onset) Missing Pan scare (VAS or NRS) Missing documentation of non surgical management in non-hospitalised patients. Missing Roland Morris Disability Questionnaire score

Diagnosis and Treatment of Impotence Procedure codes: 54400, 54401, 54405 National Coverage Determination (NCD): Diagnosis and Treatment of Impotence, 230.4	Diagnosis and Treatment of Impotence Procedure codes: 54400, 54401, 54405 National Coverage Determination (NCD): Diagnosis and Treatment of Impotence, 230.4
Please include the following documentation in your request:	Please include the following documentation in your request:
Documentation of evaluation and diagnosis of erectile dysfunction (e.g., testosterone level if a patient has signs or symptoms concerning for hypogonadism)	Documentation of evaluation and diagnosis of erectile dysfunction (e.g., testosterone level if a patient has signs or symptoms concerning for hypogonadism)
Treatments tried and failed (or contraindicated), including but not limited to addressing reversible etiologies and other interventions: Oral medications, e.g., phosphodiesterase-5 (PDE-5) inhibitors Intracavernosal injection Vacuum-assisted erection device Psychotherapy (for psychogenic erectile dysfunction) Testosterone replacement therapy (for patients with testosterone deficiency)	Treatments tried and failed (or contraindicated), including but not limited to addressing reversible etiologies and other interventions: Oral medications, e.g., phosphodiesterase-5 (PDE-5) inhibitors Intracavernosal injection Vacuum-assisted erection device Psychotherapy (for psychogenic erectile dysfunction) Testosterone replacement therapy (for patients with testosterone deficiency)
Absence of systemic infection, active urogenital infection and/or active skin infection in the region of surgery	Absence of systemic infection, active urogenital infection and/or active skin infection in the region of surgery
Additional resources: CMS Provider and Supplier Operational Guide Click here to view additional CMS requirements.	Additional resources: CMS Provider and Supplier Operational Guide Click here to view additional CMS requirements.
Common non-affirmations for Diagnosis & Treatment of Impotence requests: Missing conservative (non-invasive) treatment methods tried. Missing or incomplete evaluation for reversible causes of erectile dysfunction.	Common non-affirmations for Diagnosis & Treatment of Impotence requests: Missing conservative (non-invasive) treatment methods tried. Missing or incomplete evaluation for reversible causes of erectile dysfunction.

Incontinence Control Devices Procedure codes: 53445, 53451, 53452, 53440, 57288 National Coverage Determination (NCD): Incontinence Control Devices, 230.10	Incontinence Control Devices Procedure codes: 53445, 53451, 53452, 53440, 57288 National Coverage Determination (NCD): Incontinence Control Devices, 230.10
Please include the following documentation in your request:	Please include the following documentation in your request:
Documentation of evaluation and diagnosis of SUI, including but not limited to: Relevant history, in particular, elements that may impact placement of an incontinence control device such as prior prostate or pelvic surgery, pelvic radiation therapy, or urethral trauma (resulting in damage to the urethral sphincter), if applicable Physical examination, including pelvic or rectal exam, if applicable Urinalysis – Patients with an abnormal urinalysis, such as unexplained hematuria or pyuria, should undergo additional evaluation if being considered for surgical intervention. Result of a cough or bladder stress test or an objective demonstration of urinary incontinence with a comfortably full bladder Additional testing, if applicable Voiding diary (at least 24-hours of symptoms) Cystoscopy where there is a concern for urinary tract abnormalities Urodynamic testing for complicated or mixed symptoms (e.g., patients with mixed incontinence in whom the predominant contributor is unclear) Assessment and exclusion of other etiologies of urinary incontinence (e.g., known or suspected urinary tract infection, high post-void residual volume concerning for overflow incontinence, high-grade pelvic organ prolapse if SUI is not demonstrated by pelvic organ prolapse reduction)	Documentation of evaluation and diagnosis of SUI, including but not limited to: Relevant history, in particular, elements that may impact placement of an incontinence control device such as prior prostate or pelvic surgery, pelvic radiation therapy, or urethral trauma (resulting in damage to the urethral sphincter), if applicable Physical examination, including pelvic or rectal exam, if applicable Urinalysis – Patients with an abnormal urinalysis, such as unexplained hematuria or pyuria, should undergo additional evaluation if being considered for surgical intervention. Result of a cough or bladder stress test or an objective demonstration of urinary incontinence with a comfortably full bladder Additional testing, if applicable Voiding diary (at least 24-hours of symptoms) Cystoscopy where there is a concern for urinary tract abnormalities Urodynamic testing for complicated or mixed symptoms (e.g., patients with mixed incontinence in whom the predominant contributor is unclear) Assessment and exclusion of other etiologies of urinary incontinence (e.g., known or suspected urinary tract infection, high post-void residual volume concerning for overflow incontinence, high-grade pelvic organ prolapse if SUI is not demonstrated by pelvic organ prolapse reduction)
Documentation of adjunctive measures and treatments tried and failed (or contraindicated), including at least one but not limited to: Lifestyle modifications (e.g., addressing contributory medical conditions, limiting alcohol and caffeine consumption, weight reduction if overweight, modifying fluid intake) Pelvic floor muscle training (± biofeedback) Low-dose vaginal estrogen for patients with genitourinary syndrome of menopause (GSM) or evidence of hypoestrogenism by history or exam Support devices (e.g., continence pessaries, vaginal inserts, penile clamps) Prior surgery for SUI	Documentation of adjunctive measures and treatments tried and failed (or contraindicated), including at least one but not limited to: Lifestyle modifications (e.g., addressing contributory medical conditions, limiting alcohol and caffeine consumption, weight reduction if overweight, modifying fluid intake) Pelvic floor muscle training (± biofeedback) Low-dose vaginal estrogen for patients with genitourinary syndrome of menopause (GSM) or evidence of hypoestrogenism by history or exam Support devices (e.g., continence pessaries, vaginal inserts, penile clamps) Prior surgery for SUI
Documentation for any planned concomitant procedures that may affect outcomes associated with placement of an incontinence control device (e.g., patients should not undergo concomitant urethral diverticulectomy, repair of urethrovaginal fistula, or urethral mesh excision and stress incontinence surgery with the exception of placement of autologous slings)	Documentation for any planned concomitant procedures that may affect outcomes associated with placement of an incontinence control device (e.g., patients should not undergo concomitant urethral diverticulectomy, repair of urethrovaginal fistula, or urethral mesh excision and stress incontinence surgery with the exception of placement of autologous slings)
Additional resources: CMS Provider and Supplier Operational Guide Click here to view additional CMS requirements.	Additional resources: CMS Provider and Supplier Operational Guide Click here to view additional CMS requirements.
Common non-affirmations for Incontinence Control Device requests: Missing conservative (non-invasive) treatment methods tried (e.g. pelvic floor exercises, biofeedback, lifestyle modification, support devices). Missing or incomplete diagnostic evaluation such as voiding diary (for at least 24 hours), cystography, post-void residual, urodynamic testing.	Common non-affirmations for Incontinence Control Device requests: Missing conservative (non-invasive) treatment methods tried (e.g. pelvic floor exercises, biofeedback, lifestyle modification, support devices). Missing or incomplete diagnostic evaluation such as voiding diary (for at least 24 hours), cystography, post-void residual, urodynamic testing.

Arthroscopic Lavage and Arthroscopic Debridement for the Osteoarthritic Knee Procedure code: 29877 National Coverage Determination (NCD): Arthroscopic Lavage and Arthroscopic Debridement for the Osteoarthritic Knee, 150.9	Arthroscopic Lavage and Arthroscopic Debridement for the Osteoarthritic Knee Procedure code: 29877 National Coverage Determination (NCD): Arthroscopic Lavage and Arthroscopic Debridement for the Osteoarthritic Knee, 150.9
Please include the following documentation in your request:	Please include the following documentation in your request:
Documentation of Imaging that documents degree of osteoarthritis, including Outerbridge classification or grade I-IV including standing X-rays	Documentation of Imaging that documents degree of osteoarthritis, including Outerbridge classification or grade I-IV including standing X-rays
Include documentation that the patient has less severe and/or early degenerative arthritis and is presenting with symptoms other than pain alone: Mechanical symptoms that include, but are not limited to, catching, locking, snapping, or popping. Limb and knee joint alignment Less severe and/or early degenerative arthritis, remain at local contractor discretion.	Include documentation that the patient has less severe and/or early degenerative arthritis and is presenting with symptoms other than pain alone: Mechanical symptoms that include, but are not limited to, catching, locking, snapping, or popping. Limb and knee joint alignment Less severe and/or early degenerative arthritis, remain at local contractor discretion.
Documentation to support the patient’s knee condition including but not limited to: Reports of standing X-rays MRI results Arthroscopy results (in the event of pre-payment review)	Documentation to support the patient’s knee condition including but not limited to: Reports of standing X-rays MRI results Arthroscopy results (in the event of pre-payment review)
Additional Resources: CMS Provider and Supplier Operational Guide Click here to view additional CMS requirements.	Additional Resources: CMS Provider and Supplier Operational Guide Click here to view additional CMS requirements.
Common non-affirmations for Orthopedic Surgery requests: Missing standing X-rays Outerbridge III and IV or Grade III and IV osteoarthritis Lavage used alone for the osteoarthritic knee Osteoarthritic patients presenting with knee pain only	Common non-affirmations for Orthopedic Surgery requests: Missing standing X-rays Outerbridge III and IV or Grade III and IV osteoarthritis Lavage used alone for the osteoarthritic knee Osteoarthritic patients presenting with knee pain only

Sacral Nerve Stimulation For Urinary Incontinence Procedure codes: 64561, 64581 National Coverage Determination (NCD): Sacral Nerve Stimulation For Urinary Incontinence, 230.18	Sacral Nerve Stimulation For Urinary Incontinence Procedure codes: 64561, 64581 National Coverage Determination (NCD): Sacral Nerve Stimulation For Urinary Incontinence, 230.18
Please include the following documentation in your request:	Please include the following documentation in your request:
Documentation of the diagnosis (e.g., urge incontinence, urgency-frequency syndrome, or urinary retention) and associated lower urinary tract symptoms, including: Urinary voiding dysfunction is not a secondary manifestation of specific neurologic diseases (e.g. diabetes with peripheral nerve involvement), stress incontinence, or urinary (e.g. bladder outlet) obstruction.	Documentation of the diagnosis (e.g., urge incontinence, urgency-frequency syndrome, or urinary retention) and associated lower urinary tract symptoms, including: Urinary voiding dysfunction is not a secondary manifestation of specific neurologic diseases (e.g. diabetes with peripheral nerve involvement), stress incontinence, or urinary (e.g. bladder outlet) obstruction.
Documentation of treatments tried and failed (or contraindications), including at least one but not limited to: Behavioral therapy (e.g., bladder training, pelvic floor rehabilitation) Pharmacologic therapy Surgical corrective therapy (e.g., augmentation cystoplasty)	Documentation of treatments tried and failed (or contraindications), including at least one but not limited to: Behavioral therapy (e.g., bladder training, pelvic floor rehabilitation) Pharmacologic therapy Surgical corrective therapy (e.g., augmentation cystoplasty)
Documentation that the patient is capable of operating the sacral nerve stimulating device and recording voiding diary data such that the clinical results of the implant procedure can be properly evaluated.	Documentation that the patient is capable of operating the sacral nerve stimulating device and recording voiding diary data such that the clinical results of the implant procedure can be properly evaluated.
Documentation that the patient had a successful test stimulation, as demonstrated by 50% or greater improvement (as measured through voiding diaries).	Documentation that the patient had a successful test stimulation, as demonstrated by 50% or greater improvement (as measured through voiding diaries).
Additional Resources: CMS Provider and Supplier Operational Guide Click here to view additional CMS requirements	Additional Resources: CMS Provider and Supplier Operational Guide Click here to view additional CMS requirements
Common non-affirmations for Neurology/Urology requests: The request is for fecal incontinence. The request is for stress incontinence or urinary obstruction Missing conservative (non-invasive) treatment methods tried and failed (e.g. pelvic floor exercises, biofeedback, lifestyle modification, support devices). Missing or incomplete diagnostic evaluation such as voiding diary, cystography, post-void residual, urodynamic testing. Missing documentation of trial stimulation showing 50% improvement per voiding diary.	Common non-affirmations for Neurology/Urology requests: The request is for fecal incontinence. The request is for stress incontinence or urinary obstruction Missing conservative (non-invasive) treatment methods tried and failed (e.g. pelvic floor exercises, biofeedback, lifestyle modification, support devices). Missing or incomplete diagnostic evaluation such as voiding diary, cystography, post-void residual, urodynamic testing. Missing documentation of trial stimulation showing 50% improvement per voiding diary.

Application of Bioengineered Skin Substitutes to Lower Extremity Chronic Non-Healing Wounds Procedure codes: 15271, 15272, 15273, 15274, 15275, 15276, 15277, 15278 Local Coverage Determination (LCD): Application of Bioengineered Skin Substitutes to Lower Extremity Chronic Non-Healing Wounds, L35041	Application of Bioengineered Skin Substitutes to Lower Extremity Chronic Non-Healing Wounds Procedure codes: 15271, 15272, 15273, 15274, 15275, 15276, 15277, 15278 Local Coverage Determination (LCD): Application of Bioengineered Skin Substitutes to Lower Extremity Chronic Non-Healing Wounds, L35041
Please include the following documentation in your request:	Please include the following documentation in your request:
Description of the wound or ulcer at baseline (prior to beginning conservative treatment) relative to size, location, stage, duration, and presence of infection as well as progression throughout treatments tried.	Description of the wound or ulcer at baseline (prior to beginning conservative treatment) relative to size, location, stage, duration, and presence of infection as well as progression throughout treatments tried.
Documentation of the following related to the wound or ulcer: Partial- or full-thickness ulcers, not involving tendon, muscle, joint capsule or exhibiting exposed bone or sinus tracts, have a clean granular base unless the CTP package label indicates the CTP is approved for use involving tendon, muscle, joint capsule or exhibiting exposed bone or sinus tracts, with a clean granular base Skin deficit at least 1.0 square cm in size Clean and free of necrotic debris or exudate Adequate circulation/oxygenation to support tissue growth/wound healing, as evidenced by physical examination (e.g., Ankle-Brachial Index (ABI) of no less than 0.60, toe pressure > 30mm Hg) For diabetic foot ulcers, a diagnosis of Type 1 or Type 2 Diabetes along with medical management for this condition	Documentation of the following related to the wound or ulcer: Partial- or full-thickness ulcers, not involving tendon, muscle, joint capsule or exhibiting exposed bone or sinus tracts, have a clean granular base unless the CTP package label indicates the CTP is approved for use involving tendon, muscle, joint capsule or exhibiting exposed bone or sinus tracts, with a clean granular base Skin deficit at least 1.0 square cm in size Clean and free of necrotic debris or exudate Adequate circulation/oxygenation to support tissue growth/wound healing, as evidenced by physical examination (e.g., Ankle-Brachial Index (ABI) of no less than 0.60, toe pressure > 30mm Hg) For diabetic foot ulcers, a diagnosis of Type 1 or Type 2 Diabetes along with medical management for this condition
Documentation addressing the circumstances why the wound or ulcer has had a “failed response," defined as having failed to respond to documented appropriate wound-care measures, having increased in size or depth, or having not changed in baseline size or depth with no indication that improvement is likely (such as granulation, epithelization, or progress towards closing), including but not limited to: Interventions that failed Updated medication history Review of pertinent medical problems that may have occurred since previous wound or ulcer evaluations For a neuropathic diabetic foot ulcer, documentation of failure to respond to conservative wound care measures of greater than four weeks, during which the patient is compliant with recommendations, and without evidence of underlying osteomyelitis or nidus of infection For a venous stasis ulcer present for at least 3 months, documentation of failure to respond to appropriate wound care for at least 30 days with documented compliance For a full thickness skin loss ulcer that is the result of abscess, injury or trauma, documentation of failure to respond to appropriate control of infection, foreign body, tumor resection, or other disease process for a period of 4 weeks or longer	Documentation addressing the circumstances why the wound or ulcer has had a “failed response," defined as having failed to respond to documented appropriate wound-care measures, having increased in size or depth, or having not changed in baseline size or depth with no indication that improvement is likely (such as granulation, epithelization, or progress towards closing), including but not limited to: Interventions that failed Updated medication history Review of pertinent medical problems that may have occurred since previous wound or ulcer evaluations For a neuropathic diabetic foot ulcer, documentation of failure to respond to conservative wound care measures of greater than four weeks, during which the patient is compliant with recommendations, and without evidence of underlying osteomyelitis or nidus of infection For a venous stasis ulcer present for at least 3 months, documentation of failure to respond to appropriate wound care for at least 30 days with documented compliance For a full thickness skin loss ulcer that is the result of abscess, injury or trauma, documentation of failure to respond to appropriate control of infection, foreign body, tumor resection, or other disease process for a period of 4 weeks or longer
Documentation that therapy has resolved any infection and/or underlying osteomyelitis with documentation of the conditions that have been treated and resolved, as applicable: Control of edema, venous hypertension or lymphedema Control of any nidus of infection or colonization with bacterial or fungal elements Elimination of underlying cellulitis, osteomyelitis, foreign body, or malignant process Appropriate debridement of necrotic tissue or foreign body (exposed bone or tendon) For diabetic foot ulcers, appropriate non-weight bearing or off-loading pressure For venous stasis ulcers, compression therapy provided with documented diligent use of multilayer dressings, compression stockings of greater than 20mmHg pressure, or pneumatic compression Provision of wound environment to promote healing (protection from trauma and contaminants, elimination of inciting or aggravating processes)	Documentation that therapy has resolved any infection and/or underlying osteomyelitis with documentation of the conditions that have been treated and resolved, as applicable: Control of edema, venous hypertension or lymphedema Control of any nidus of infection or colonization with bacterial or fungal elements Elimination of underlying cellulitis, osteomyelitis, foreign body, or malignant process Appropriate debridement of necrotic tissue or foreign body (exposed bone or tendon) For diabetic foot ulcers, appropriate non-weight bearing or off-loading pressure For venous stasis ulcers, compression therapy provided with documented diligent use of multilayer dressings, compression stockings of greater than 20mmHg pressure, or pneumatic compression Provision of wound environment to promote healing (protection from trauma and contaminants, elimination of inciting or aggravating processes)
Documentation of smoking history, and that the patient has received counseling on the effects of smoking on outcomes and treatment for smoking cessation (if applicable)	Documentation of smoking history, and that the patient has received counseling on the effects of smoking on outcomes and treatment for smoking cessation (if applicable)
Documentation of choice of skin substitute graft product	Documentation of choice of skin substitute graft product
Documentation of expected number of applications over a 12‐week period. Of note, simultaneous use of more than one product for the episode of wound is not covered. Product change within the episode of wound is allowed, not to exceed the 10 application limit per wound per 12‐week period of care	Documentation of expected number of applications over a 12‐week period. Of note, simultaneous use of more than one product for the episode of wound is not covered. Product change within the episode of wound is allowed, not to exceed the 10 application limit per wound per 12‐week period of care
Assessment and documentation of none of the following: Partial thickness loss with the retention of epithelial appendages is not a candidate for grafting or replacement, as epithelium will repopulate the deficit from the appendages, negating the benefit of overgrafting. Prior utilization of skin substitute grafts when a previous full course of applications was unsuccessful within 1 year. Unsuccessful treatment is defined as: Increase in size or depth of an ulcer or no change in baseline size or depth AND No sign of improvement or indication that improvement is likely (such as granulation, epithelialization or progress towards closing) for a period of 4 weeks past start of therapy Retreatment of healed ulcers (those showing greater than 75% size reduction and smaller than 0.5 square cm) Patient has inadequate control of underlying conditions or exacerbating factors (e.g., uncontrolled diabetes, active infection, and active Charcot arthropathy of the ulcer extremity, vasculitis or continued tobacco smoking without physician attempt to address smoking cessation) Known hypersensitivity to any component of the specific skin substitute graft (e.g., allergy to avian, bovine, porcine, equine products)	Assessment and documentation of none of the following: Partial thickness loss with the retention of epithelial appendages is not a candidate for grafting or replacement, as epithelium will repopulate the deficit from the appendages, negating the benefit of overgrafting. Prior utilization of skin substitute grafts when a previous full course of applications was unsuccessful within 1 year. Unsuccessful treatment is defined as: Increase in size or depth of an ulcer or no change in baseline size or depth AND No sign of improvement or indication that improvement is likely (such as granulation, epithelialization or progress towards closing) for a period of 4 weeks past start of therapy Retreatment of healed ulcers (those showing greater than 75% size reduction and smaller than 0.5 square cm) Patient has inadequate control of underlying conditions or exacerbating factors (e.g., uncontrolled diabetes, active infection, and active Charcot arthropathy of the ulcer extremity, vasculitis or continued tobacco smoking without physician attempt to address smoking cessation) Known hypersensitivity to any component of the specific skin substitute graft (e.g., allergy to avian, bovine, porcine, equine products)
Additional Resources: CMS Provider and Supplier Operational Guide Click here to view additional CMS requirements	Additional Resources: CMS Provider and Supplier Operational Guide Click here to view additional CMS requirements
Common non-affirmations for Skin Substitute requests: Request is for more than 4 units for the initial request. Request is for more than 10 units within 12 weeks. Request is for additional treatment after 4 applications but no evidence of wound healing is documented. Uncontrolled underlying conditions (e.g., uncontrolled diabetes, active infection, and active Charcot arthropathy of the ulcer extremity, vasculitis or continued tobacco smoking without physician attempt to affect smoking cessation). Simultaneous use of more than one wound product for the episode. Request is for a patient with a known hypersensitivity to a component of the skin substitute graft. Request for re-treatment within one year for a venous stasis ulcer or diabetic neuropathic foot ulcer	Common non-affirmations for Skin Substitute requests: Request is for more than 4 units for the initial request. Request is for more than 10 units within 12 weeks. Request is for additional treatment after 4 applications but no evidence of wound healing is documented. Uncontrolled underlying conditions (e.g., uncontrolled diabetes, active infection, and active Charcot arthropathy of the ulcer extremity, vasculitis or continued tobacco smoking without physician attempt to affect smoking cessation). Simultaneous use of more than one wound product for the episode. Request is for a patient with a known hypersensitivity to a component of the skin substitute graft. Request for re-treatment within one year for a venous stasis ulcer or diabetic neuropathic foot ulcer

Induced Lesions of Nerve Tracts Procedure codes: 64605, 64610 National Coverage Determination (NCD): Induced Lesions of Nerve Tracts, 160.1	Induced Lesions of Nerve Tracts Procedure codes: 64605, 64610 National Coverage Determination (NCD): Induced Lesions of Nerve Tracts, 160.1
Please include the following documentation in your request:	Please include the following documentation in your request:
Documentation of diagnosis and evaluation of trigeminal neuralgia, including history (of compatible clinical features and impact on daily function) and imaging, as applicable Documentation of failure of or intolerance to at least two conventional medications (e.g., carbamazepine, oxcarbazepine, gabapentin) Documentation of the clinical rationale (e.g., patient cannot tolerate open surgery, patient does not have signs of neurovascular compromise) supporting the selection of rhizotomy or neurolysis over other surgical options (e.g., microvascular decompression, stereotactic radiosurgery)	Documentation of diagnosis and evaluation of trigeminal neuralgia, including history (of compatible clinical features and impact on daily function) and imaging, as applicable Documentation of failure of or intolerance to at least two conventional medications (e.g., carbamazepine, oxcarbazepine, gabapentin) Documentation of the clinical rationale (e.g., patient cannot tolerate open surgery, patient does not have signs of neurovascular compromise) supporting the selection of rhizotomy or neurolysis over other surgical options (e.g., microvascular decompression, stereotactic radiosurgery)
Additional Resources: CMS Provider and Supplier Operational Guide Click here to view additional CMS requirements	Additional Resources: CMS Provider and Supplier Operational Guide Click here to view additional CMS requirements
Common non-affirmations for Non-Spinal Pain Management requests: Missing documentation of conservative treatment with at least two conventional medications (e.g., carbamazepine, oxcarbazepine, gabapentin) Missing documentation supporting the selection of rhizotomy or neurolysis over other surgical options (e.g., microvascular decompression, stereotactic radiosurgery)	Common non-affirmations for Non-Spinal Pain Management requests: Missing documentation of conservative treatment with at least two conventional medications (e.g., carbamazepine, oxcarbazepine, gabapentin) Missing documentation supporting the selection of rhizotomy or neurolysis over other surgical options (e.g., microvascular decompression, stereotactic radiosurgery)

Phrenic Nerve Stimulator Procedure codes: 33276, 33277 National Coverage Determination (NCD): Phrenic Nerve Stimulator, 160.19	Phrenic Nerve Stimulator Procedure codes: 33276, 33277 National Coverage Determination (NCD): Phrenic Nerve Stimulator, 160.19
Please include the following documentation in your request:	Please include the following documentation in your request:
For hypoventilation caused by respiratory paralysis resulting from lesions of the brainstem and cervical spinal cord (interruption of neuronal conduction at or above the C3 vertebral level), congenital central hypoventilation syndrome, and other disorders with ventilatory insufficiency (in which there is dependence on intermittent or permanent use of a mechanical ventilation as well as maintenance of a permanent tracheotomy stoma), the following requirements should be met: Documentation of the etiology of ventilatory insufficiency as well as evaluation (e.g., of diaphragmatic function) and management to date, including the use of mechanical ventilation Documentation of intact phrenic nerve function, e.g., through a percutaneous nerve conduction study Documentation of absence of severe underlying primary pulmonary disease through history and exam, prior and current chest imaging, and pulmonary function testing (when feasible) Documentation of normal chest wall movement Documentation of cognitive function that would enable them to participate in and complete the training and rehabilitation associated with the use of the device	For hypoventilation caused by respiratory paralysis resulting from lesions of the brainstem and cervical spinal cord (interruption of neuronal conduction at or above the C3 vertebral level), congenital central hypoventilation syndrome, and other disorders with ventilatory insufficiency (in which there is dependence on intermittent or permanent use of a mechanical ventilation as well as maintenance of a permanent tracheotomy stoma), the following requirements should be met: Documentation of the etiology of ventilatory insufficiency as well as evaluation (e.g., of diaphragmatic function) and management to date, including the use of mechanical ventilation Documentation of intact phrenic nerve function, e.g., through a percutaneous nerve conduction study Documentation of absence of severe underlying primary pulmonary disease through history and exam, prior and current chest imaging, and pulmonary function testing (when feasible) Documentation of normal chest wall movement Documentation of cognitive function that would enable them to participate in and complete the training and rehabilitation associated with the use of the device
For central sleep apnea (CSA), the following requirements should be met: Documentation of etiology of CSA as idiopathic/primary or heart-failure–related CSA (not opioid- or medication-induced) Documentation of moderate to severe CSA confirmed by polysomnography: AHI greater than 15 events per hour Documentation of failure, intolerance, or contraindication to at least one of the following: Continuous positive airway pressure (CPAP) Bilevel positive airway pressure (BiPAP) Adaptive servo-ventilation (ASV) Oxygen (for patients who have hypoxemia while sleeping) For patients with heart failure (HF): documentation of New York Heart Association (NYHA) class, left ventricular ejection fraction (LVEF), and stable, optimized guideline‐directed medical therapy (GDMT) for 30 days or more If implantable cardioverter-defibrillator/cardiac resynchronization therapy/pacemaker present, documentation of a plan for device interaction testing Assessment and documentation of none of the following contraindications: Active infection NYHA IV HF Recent stroke/transient ischemic attack (TIA) Severe renal disease Phrenic nerve palsy/anatomic barriers Opioid or other medication-induced CSA	For central sleep apnea (CSA), the following requirements should be met: Documentation of etiology of CSA as idiopathic/primary or heart-failure–related CSA (not opioid- or medication-induced) Documentation of moderate to severe CSA confirmed by polysomnography: AHI greater than 15 events per hour Documentation of failure, intolerance, or contraindication to at least one of the following: Continuous positive airway pressure (CPAP) Bilevel positive airway pressure (BiPAP) Adaptive servo-ventilation (ASV) Oxygen (for patients who have hypoxemia while sleeping) For patients with heart failure (HF): documentation of New York Heart Association (NYHA) class, left ventricular ejection fraction (LVEF), and stable, optimized guideline‐directed medical therapy (GDMT) for 30 days or more If implantable cardioverter-defibrillator/cardiac resynchronization therapy/pacemaker present, documentation of a plan for device interaction testing Assessment and documentation of none of the following contraindications: Active infection NYHA IV HF Recent stroke/transient ischemic attack (TIA) Severe renal disease Phrenic nerve palsy/anatomic barriers Opioid or other medication-induced CSA
Additional Resources: CMS Provider and Supplier Operational Guide Click here to view additional CMS requirements	Additional Resources: CMS Provider and Supplier Operational Guide Click here to view additional CMS requirements
Common non-affirmations for Phrenic Nerve Stimulator requests: Missing sleep testing and/or pulmonary function tests that confirm a qualifying diagnosis. Lack of documentation of failure of positive pressure ventilation or mechanical ventilation. Missing documentation of intact phrenic nerve function, e.g., through a percutaneous nerve conduction study. Missing documentation of absence of contraindications (e.g. opioid use)	Common non-affirmations for Phrenic Nerve Stimulator requests: Missing sleep testing and/or pulmonary function tests that confirm a qualifying diagnosis. Lack of documentation of failure of positive pressure ventilation or mechanical ventilation. Missing documentation of intact phrenic nerve function, e.g., through a percutaneous nerve conduction study. Missing documentation of absence of contraindications (e.g. opioid use)

Vagus Nerve Stimulation (VNS) Procedure code: 64568 National Coverage Determination (NCD): Vagus Nerve Stimulation (VNS), 160.18	Vagus Nerve Stimulation (VNS) Procedure code: 64568 National Coverage Determination (NCD): Vagus Nerve Stimulation (VNS), 160.18
Please include the following documentation in your request:	Please include the following documentation in your request:
For the treatment of medically refractory partial onset seizures: Documentation of medically refractory partial onset seizures with failure of or intolerance to at least two trials of single or combination antiepileptic therapy Documentation with rationale that the patient is not a candidate for epilepsy surgery, has failed epilepsy surgery, or refuses epilepsy surgery after shared decision making discussion Documentation patient has no history of left or bilateral cervical vagotomy	For the treatment of medically refractory partial onset seizures: Documentation of medically refractory partial onset seizures with failure of or intolerance to at least two trials of single or combination antiepileptic therapy Documentation with rationale that the patient is not a candidate for epilepsy surgery, has failed epilepsy surgery, or refuses epilepsy surgery after shared decision making discussion Documentation patient has no history of left or bilateral cervical vagotomy
For treatment-resistant depression through CMS’ Coverage with Evidence Development (CED): Enrollment in an active CMS-approved trial associated with this NCD/CED Documentation of major depressive disorder (MDD) episode for at least two years or at least four episodes of MDD, including a current episode Documentation of a minimum criterion of four prior failed treatments of adequate dose and duration as measured by a tool designed for this purpose Documentation of a major depressive episode (MDE) as measured by a guideline recommended depression scale assessment tool on two visits, within a 45-day span prior to implantation of the VNS device Documentation of a stable medication regimen for at least four weeks before device implantation Documentation that none of the following criteria are present: Current or lifetime history of psychotic features in any MDE Current or lifetime history of schizophrenia or schizoaffective disorder Current or lifetime history of any other psychotic disorder Current or lifetime history of rapid cycling bipolar disorder Current secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder Current suicidal intent Treatment with another investigational device or investigational drugs History of left or bilateral cervical vagotomy	For treatment-resistant depression through CMS’ Coverage with Evidence Development (CED): Enrollment in an active CMS-approved trial associated with this NCD/CED Documentation of major depressive disorder (MDD) episode for at least two years or at least four episodes of MDD, including a current episode Documentation of a minimum criterion of four prior failed treatments of adequate dose and duration as measured by a tool designed for this purpose Documentation of a major depressive episode (MDE) as measured by a guideline recommended depression scale assessment tool on two visits, within a 45-day span prior to implantation of the VNS device Documentation of a stable medication regimen for at least four weeks before device implantation Documentation that none of the following criteria are present: Current or lifetime history of psychotic features in any MDE Current or lifetime history of schizophrenia or schizoaffective disorder Current or lifetime history of any other psychotic disorder Current or lifetime history of rapid cycling bipolar disorder Current secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder Current suicidal intent Treatment with another investigational device or investigational drugs History of left or bilateral cervical vagotomy
Additional Resources: CMS Provider and Supplier Operational Guide Click here to view additional CMS requirements	Additional Resources: CMS Provider and Supplier Operational Guide Click here to view additional CMS requirements
Common non-affirmations for VNS requests: Request is for a patient with a seizure disorder Lack of information regarding previous medication trials (confirming treatment-refractory epilepsy). Missing documentation of enrollment in an active CMS-approved trial associated with this NCD/CED for major depressive disorder. Lack of submission of a depression scale assessment tool covering two visits within a 45 day span prior to request.	Common non-affirmations for VNS requests: Request is for a patient with a seizure disorder Lack of information regarding previous medication trials (confirming treatment-refractory epilepsy). Missing documentation of enrollment in an active CMS-approved trial associated with this NCD/CED for major depressive disorder. Lack of submission of a depression scale assessment tool covering two visits within a 45 day span prior to request.

Review Criteria: Home Health

Geisinger Health Plan Prior Authorization List

Medical Mutual (MMO) Prior Authorization List

Oak Street Health (Humana): Prior Authorization List (PAL) Codes Under Management

Oak Street Health (Aetna): Prior Authorization List (PAL) Codes Under Management

Medicare - Novitas: Prior Authorization List (PAL) Codes Under Management

Services and Procedure Codes

Documentation Requirements