CMS Documentation Requests

As part of the Medical Review process, we request medical records for some services prior to completing claim processing. The Medical Review (MR) mission is to reduce provider billing errors and ensure that claims are paid correctly while maintaining the WISeR integrity

Label Documentation - Highly encouraged voluntary effort to help providers/suppliers validate all requested records are included and to ensure reviewers can easily identify such medical record elements.

For detailed documentation requirements, providers who choose to submit a prior authorization request for a WISeR select item or service should refer to the relevant NCDs and/or their MAC jurisdiction’s LCDs and Local Coverage Articles (LCAs), if available, for guidance. They can be found on the Medicare Coverage Database website.

The following WISeR services have been selected for prior authorization and pre-payment review if performed in a WISeR jurisdiction. The HCPCS/CPT codes associated with these selected items and services are listed in Appendix A.

1.     Percutaneous Image-Guided Lumbar Decompression for Spinal Stenosis (NCD 150.13)

General documentation requirements for PILD for LSS through CMS’ CED7 are as follows:

1.      Enrollment in an active CMS-approved trial associated with this NCD/CED

2.      Documentation of:

2.1 Neurogenic claudication symptoms defined generally as leg/buttock/groin pain and/or paresthesias that are exacerbated with standing and walking and relieved by flexion and/or sitting/laying down

2.2 VAS leg symptom severity greater than 50 (in either leg) during episodes of neurogenic claudication

2.3 Persistence of symptoms for at least 3 months

2.4 Treatments tried and failed including but not limited to:

2.4.1       Medications

2.4.2       Physical therapy

2.4.3       Home exercise program

2.4.4       Injections

3.      Diagnosis of central canal spinal stenosis, with or without mild to moderate lateral recess stenosis, from hypertrophic ligamentum flavum, at one or two levels from L1-L5 with radiologic evidence performed within the last 12 months of baseline visit

4.      Assessment and documentation of none of the following:

4.1 Significant back, buttock or leg pain from causes other than lumbar central canal stenosis, e.g., acute compression fracture, metabolic neuropathy, vascular claudication symptoms

4.2 Axial back pain only

4.3 Severe foraminal stenosis at index level(s) and/or symptomatic foraminal stenosis at any lumbar level

4.4 Severe lateral recesses

4.5 Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention

4.6 Prior PILD or decompressive or fusion surgery at index level(s)

4.7 Epidural steroid or nerve block steroid injection at index level(s) within 8 weeks of baseline assessments

4.8 Spondylolisthesis (anterolisthesis or retrolisthesis) of any Grade

4.9 Spondylolysis (pars fracture)

4.10 Acute traumatic spinal fractures within the last 3 months with related pain       symptoms

4.11 Degenerative lumbar scoliosis with Cobb angle greater than or equal to 30 degrees including index level(s)

4.12 Epidural lipomatosis (if it is deemed to be a significant contributor of canal narrowing by the physician)

4.13 Current spinal cord stimulator or implanted pain pump

2.      Arthroscopic Lavage and Arthroscopic Debridement for the Osteoarthritic Knee (NDC 150.9)

General documentation requirements for arthroscopic lavage and arthroscopic debridement of the osteoarthritic knee are as follows:

1.      Documentation that the patient has less severe and/or early degenerative arthritis and is presenting with symptoms other than pain alone, e.g., mechanical symptoms that include, but are not limited to, catching, locking, snapping, or popping.

2.      Documentation to support the patient’s knee condition including but not limited to:

2.1.  Reports of standing x-rays

2.2.  MRI results

2.3.  Arthroscopy results (in the event of pre-payment review

3.      Induced Lesions of Nerve Tracts (160.1)

For this NCD, WISeR will initially focus on neurolytic destruction of the trigeminal nerve. General documentation requirements are as follows:

1.      Documentation of diagnosis and evaluation of trigeminal neuralgia, including history (of compatible clinical features and impact on daily function) and imaging, as applicable

2.      Documentation of failure of or intolerance to at least two conventional medications (e.g., carbamazepine, oxcarbazepine, gabapentin)

3.      Documentation of 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)

4.      Vagus Nerve Stimulation (NCD 160.18)¹

General documentation requirements for Vagus Nerve Stimulation (VNS) for the treatment of medically refractory partial onset seizures are as follows:

1.      Documentation of medically refractory partial onset seizures with failure of or intolerance to at least two trials of single or combination antiepileptic therapy

2.      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

3.      Documentation patient has no history of left or bilateral cervical vagotomy

General documentation requirements for VNS for treatment-resistant depression through CMS’ Coverage with Evidence Development (CED)² are as follows:

1.      Enrollment in an active CMS-approved trial associated with this NCD/CED

2.      Documentation of major depressive disorder (MDD) episode for at least two years or at least four episodes of MDD, including a current episode

3.      Documentation of a minimum criterion of four prior failed treatments of adequate dose and duration as measured by a tool designed for this purpose

4.      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

5.      Documentation of a stable medication regimen for at least four weeks before device implantation

6.      Documentation that none of the following criteria are present:

6.1.  Current or lifetime history of psychotic features in any MDE

6.2.  Current or lifetime history of schizophrenia or schizoaffective disorder

6.3.  Current or lifetime history of any other psychotic disorder

6.4.  Current or lifetime history of rapid cycling bipolar disorder

6.5.  Current secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder

6.6.  Current suicidal intent

6.7.  Treatment with another investigational device or investigational drugs

6.8.  History of left or bilateral cervical vagotomy

¹ Prior authorization and pre-payment medical review for Vagus Nerve Stimulation will only be implemented for the indications specified in Appendix C.

² Centers for Medicare & Medicaid Services. (2024). Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD)

5. Phrenic Nerve Stimulator (NCD 160.19)

General documentation requirements for the implantation of a phrenic nerve stimulator are as follows – the following requirements should be met:

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:

1.      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

2.      Documentation of intact phrenic nerve function, e.g., through a percutaneous nerve conduction study

3.      Documentation of absence of severe underlying primary pulmonary disease through history and exam, prior and current chest imaging, and pulmonary function testing (when feasible)

4.      Documentation of normal chest wall movement

5.      Documentation of cognitive functions 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:

1.      Documentation of etiology of CSA as idiopathic/primary or heart-failure–related CSA (not opioid- or medication-induced)

2.      Documentation of moderate to severe CSA confirmed by polysomnography: AHI greater than 15 events per hour

3.      Documentation of failure, intolerance, or contraindication to at least one of the following:

3.1.  Continuous positive airway pressure (CPAP)

3.2.  Bilevel positive airway pressure (BiPAP)

3.3.  Adaptive servo-ventilation (ASV)

3.4.  Oxygen (for patients who have hypoxemia while sleeping)

4.      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

5.      If implantable cardioverter-defibrillator/cardiac resynchronization therapy/pacemaker present, documentation of a plan for device interaction testing

6.      Assessment and documentation of none of the following contraindications:

6.1.  Active infection

6.2.  NYHA IV HF

6.3.  Recent stroke/transient ischemic attack (TIA)

6.4.  Severe renal disease

6.5.  Phrenic nerve palsy/anatomic barriers

6.6.  Opioid or other medication-induced CSA

6.      Electrical Nerve Stimulators (160.7)

For this NCD, WISeR will initially focus on spinal cord stimulators but will not overlap with CPT code(s) for spinal neurostimulators in CMS’ Prior Authorization Program for Certain Hospital Outpatient Department (OPD) Services program.

Prior authorization is being implemented for the permanent implantation procedure. A trial procedure should be done, and documentation should be submitted as part of the prior authorization request for permanent implantation of a stimulatory device.

General documentation requirements for laminectomy for the implantation of a spinal cord stimulator for the relief of chronic intractable pain are as follows:

1.      Documentation of condition requiring procedure and applicable physical exam

2.      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):

2.1.  Medications

2.2.  Physical therapy

2.3.  Injections

2.4.  Spine surgery

2.5.  Cognitive behavioral therapy

3.      Documentation showing that the patient was evaluated by a multidisciplinary team (including psychological, surgical, medical and physical therapy)

4.      Documentation showing that the patient achieved demonstrated 50% reduction in pain relief and evidence of functional restoration with a temporarily implanted electrode

5.      Documentation that the patient is not a candidate for percutaneously placed leads (e.g., previous instrumentation, challenging anatomy, high BMI, other technical challenges)

5.

7.      Incontinence Control Devices (NCD 230.10

NCD 230.10 provides Medicare coverage and payment criteria for the use of mechanical/hydraulic incontinence control devices and collagen implants or injections. Given urethral bulking agents no longer contain collagen (as Contigen® has been discontinued), WISeR initially will focus on mechanical/hydraulic incontinence control devices for the purposes of treating Stress Urinary Incontinence (SUI).

General documentation requirements for mechanical/hydraulic incontinence control devices are as follows:

1.      Documentation of evaluation and diagnosis of SUI, including but not limited to:

1.1.  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

1.2.  Physical examination, including pelvic or rectal exam, if applicable

1.3.  Urinalysis – Patients with an abnormal urinalysis, such as unexplained hematuria or pyuria, should undergo additional evaluation if being considered for surgical intervention.

1.4.  Result of a cough or bladder stress test or an objective demonstration of urinary incontinence with a comfortably full bladder

1.5.  Additional testing, if applicable

1.5.1.     Voiding diary (at least 24-hours of symptoms)

1.5.2.     Cystoscopy where there is a concern for urinary tract abnormalities

1.5.3.     Urodynamic testing for complicated or mixed symptoms (e.g., patients with mixed incontinence in whom the predominant contributor is unclear)

1.6.   Assessment and exclusion of other etiologies of urinary incontinence (e.g., known or suspected urinary tract infection, high post-void residual volume concerning overflow incontinence, high-grade pelvic organ prolapse if SUI is not demonstrated by pelvic organ prolapse reduction)

2.      Documentation of adjunctive measures and treatments tried and failed (or contraindicated), including at least one but not limited to:

2.1.  Lifestyle modifications (e.g., addressing contributory medical conditions, limiting alcohol and caffeine consumption, weight reduction if overweight, modifying fluid intake)

2.2.  Pelvic floor muscle training (± biofeedback)

2.3.  Low-dose vaginal estrogen for patients with genitourinary syndrome of menopause (GSM) or evidence of hypoestrogenism by history or exam

2.4.  Support devices (e.g., continence pessaries, vaginal inserts, penile clamps)

2.5.  Prior surgery for SUI

3.      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)

3.

8.      Sacral Nerve Stimulation for Urinary Incontinence (230.18)³

Prior authorization is being implemented for the permanent, not trial, implantation procedure.

General documentation requirements for a permanently implanted sacral nerve stimulator for the treatment of urinary urge incontinence, urgency-frequency syndrome, or urinary retention are as follows:

1.      Documentation of the diagnosis (e.g., urge incontinence, urgency-frequency syndrome, or urinary retention) and associated lower urinary tract symptoms, including:

1.1.  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.

2.      Documentation of treatments tried and failed (or contraindications), including at least one but not limited to:

2.1.  Behavioral therapy (e.g., bladder training, pelvic floor rehabilitation)

2.2.  Pharmacologic therapy

2.3.  Surgical corrective therapy (e.g., augmentation cystoplasty)

3.      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

4.      Documentation that the patient had a successful test stimulation, as demonstrated by 50% or greater improvement (as measured through voiding diaries

³ Prior authorization and pre-payment medical review for Sacral Nerve Stimulation for Urinary Incontinence will only be implemented for the indications specified in Appendix C

9.      Diagnosis and Treatment of Impotence (NCD 230.4)

NCD 230.4 provides Medicare coverage and payment criteria for the diagnosis and treatment of impotence. WISeR initially will implement prior authorization for the insertion of penile prostheses (CPT codes 54400, 54401, and 54405). General documentation requirements include the following:

1.      Documentation of evaluation and diagnosis of erectile dysfunction (e.g., testosterone level if a patient has signs or symptoms concerning for hypogonadism)

2.      Treatments tried and failed (or contraindicated), including but not limited to addressing reversible etiologies and other interventions:

2.1.  Oral medications, e.g., phosphodiesterase-5 (PDE-5) inhibitors

2.2.  Intracavernosal injection

2.3.  Vacuum-assisted erection device

2.4.  Psychotherapy (for psychogenic erectile dysfunction)

2.5.  Testosterone replacement therapy (for patients with testosterone deficiency)

3.      Absence of systemic infection, active urogenital infection and/or active skin infection in the region of surgery

10. Percutaneous Vertebral Augmentation for Vertebral Compression Fracture (L34106, L38201, L35130)

General documentation requirements for Percutaneous Vertebroplasty Augmentation (PVA) (Percutaneous Vertebroplasty (PVP) or Kyphoplasty (PKP)) are as follows:

1.      For painful, debilitating, osteoporotic, vertebral, collapse/compression fractures, the following requirements should be met:

1.1.  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)

1.2.  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:

1.2.1.     Worsening pain OR

1.2.2.     Stable to improved pain (but NRS or VAS score remains greater than or equal to 5), with at least 2 of the following:

1.2.2.1.          Progression of vertebral body height loss

1.2.2.2.          More than 25% vertebral body height reduction

1.2.2.3.          Kyphotic deformity

1.2.2.4.          Severe impact of VCF on daily functioning, indicated by a Roland                                                          Morris Disability Questionnaire (RDQ) score greater than 17

1.3 Documentation of referral for evaluation of bone mineral density and osteoporosis education for subsequent treatment as indicated

1.4 Documentation of participation in an osteoporosis prevention/treatment programs

2.      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

3.      Assessment and documentation of none of the following:

3.1.  Current back pain is not primarily due to the identified acute or subacute VCF(s)

3.2.  Osteomyelitis, discitis or active systemic or surgical site infection

3.3.  Pregnancy

4.      Assessment of the following relative contraindications and rationale for proceeding with PVA if one or more of the following exists:

4.1.  Greater than three vertebral fractures per procedure

4.2.  Allergy to bone cement or opacification agents

4.3.  Uncorrected coagulopathy

4.4.  Spinal instability

4.5.  Myelopathy from the fracture

4.6.  Neurologic deficit

4.7.  Neural impingement

4.8.  Fracture retropulsion/canal compromise

11. Epidural Steroid Injections for Pain Management (L39015, L39240, L36920)

General documentation requirements for epidural steroid injection (ESI) are as follows:

1.      Documentation of history, physical examination, and radiological testing demonstrate one of the following:

1.1.  Lumbar, cervical, or thoracic radiculopathy; radicular pain and/or neurogenic

1.2.  claudication due to disc herniation; osteophyte or osteophyte complexes; severe

1.3.  degenerative disc disease, producing foraminal or central spinal stenosis; OR

1.4.  Post-laminectomy syndrome (persistent or recurrent spinal pain after a prior spine

1.5.  surgery); OR

1.6.  Acute herpes zoster associated pain

2.      Documentation that radiculopathy, radicular pain and/or neurogenic claudication is severe enough to greatly impact quality of life or function, including documentation that an objective pain scale or functional assessment was performed at baseline (prior to interventions) and the same scale was repeated at each follow-up for assessment of response

3.      Documentation of pain duration of at least four weeks, and the inability to tolerate noninvasive conservative care OR medical documentation of failure to respond to four weeks of noninvasive conservative care OR acute herpes zoster refractory to conservative management where a four-week wait is not required

4.      Documentation of anticipated number of ESI sessions (four or less) per spinal region in a rolling 12-month period. For repeat sessions, documentation of at least 50% sustained improvement in pain and/or function from baseline on the same scale for at least 3 months

4.1.  Of note, if the first ESI underperforms, a repeat session after 14 days may be done with a different approach/level/medication and a clear rationale

5.      If applicable: In exceptional and unique cases, documentation establishing the patient-specific need for moderate or deep sedation, general anesthesia, or monitored anesthesia care, as these are generally not required for the procedure

6.      Documentation of the type of image guidance (fluoroscopy or CT with contrast) to be used. If the patient has a documented contrast allergy or pregnancy, ultrasound guidance without contrast may be considered

7.      Documentation of the planned approach, including targeted level(s) and region(s). Of note, transforaminal ESIs (TFESIs) up to 2 levels in one spinal region; interlaminar ESI or caudal ESI up to 1 level in one spinal region; and bilateral TFESI only when clinically indicated (e.g., documented bilateral foraminal stenosis or central herniation affecting both roots) are considered medically reasonable and necessary.

8.      Documentation that the ESI is performed in conjunction with conservative treatments, including but not limited to a combination of:

8.1.  Medication

8.2.  Physical Therapy

8.3.  Spinal manipulation therapy

8.4.  Cognitive behavioral therapy

8.5.  Home exercise program

9.      Documentation that the patient is part of an active rehabilitation program, home exercise program, or functional restoration program

12. Cervical Fusion (L39741, L39758, and L39793)

Select cervical fusion procedure codes are included in CMS’ Prior Authorization Program for Certain Hospital OPD Services.⁴  WISeR will initially focus on CPT codes 22554 and 22585, which are not included in CMS’ Hospital OPD program.

General documentation requirements for cervical fusion for the decompression or stabilization of the cervical spine are as follows:

1.      For traumatic injuries including fractures, dislocations, fracture-dislocations, or traumatic ligamentous disruption, documentation of:

1.1.  Fractures or dislocations which are likely to result in spinal instability without neurological defects, OR

1.2.  Fractures or dislocations associated with neurological defects at the affected level, OR

1.3.  Instability is present

2.      For spinal tumors involving the spine or spinal canal, documentation of:

2.1.  Malignant or benign tumors which have caused instability or neurologic deficit where treatment of the tumor will likely require stabilization of the spine; OR

2.2.  Expected treatment of the tumor whether by chemotherapy or radiation therapy or

2.3.  surgery will likely cause spinal instability or neurologic deficits; OR

2.4.  Instability is present

3.      For infection involving the spine in the form of discitis, osteomyelitis, or epidural abscess, documentation of:

3.1.  Imaging or other studies (MRI, biopsy, bone aspirate) demonstrating infection AND

3.2.  Imaging evidence of vertebral body destruction or documentation that spinal debridement will cause vertebral instability, OR

3.3.  Instability is present

4.      For deformities that include the cervical spine, documentation of:

4.1.  Cervical kyphosis associated with cord compression or atlantoaxial (C1-C2) subluxation or basilar invagination of the odontoid process into the foramen magnum; or sub axial (C2-T1) instability kyphosis, head drop syndrome, post-laminectomy deformity; OR

4.2.  Symptomatic pseudarthrosis (non-union of prior fusion) with radiological (e.g., CT or MRI) demonstration of non-union of prior fusion (lack of bridging bone or abnormal motion at fused segment) after 12 months since fusion surgery or with radiographic evidence of hardware failure (fracture or displacement); OR

4.3.  Spinal instability after laminectomy; OR

4.4.  Rheumatoid arthritis with associated instability; OR

4.5.  Cervical degenerative spondylolisthesis with spinal instability (Anterolisthesis/Posterolisthesis) AND

4.6.  Substantial functional limitation is present such as severe neck pain or difficulty ambulating or decrease ability to perform ADLs or ability to maintain forward gaze OR

4.7.  Progression of deformity

⁴ CPT codes 22551 and 22552 for cervical fusion are included in CMS’ Prior Authorization Program for Certain Hospital Outpatient Department Services. For more information including documentation requirements, please visit Prior Authorization for Certain Hospital Outpatient Department Services webpage.

13. Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea (L38307, L38312, and L38385)

General documentation requirements for the implantation of a hypoglossal nerve stimulator for obstructive sleep apnea are as follows – the following requirements should be met:

1.      Age 22 or older

2.      Body mass index (BMI) is less than 35 kg/m2

3.      Results of polysomnography performed within 24 months of first consultation of HGNS

4.      implant (include date of first consultation of HGNS implant and date of polysomnography test) showing:

4.1.  Predominantly obstructive events (defined as central and mixed apneas less than 25% of the total apnea-hypopnea index (AHI)) AND

4.2.  AHI is 15 to 65 events per hour

5.      Documentation demonstrating one of the following:

5.1.  Continuous positive airway pressure (CPAP) failure (defined as AHI greater than 15 events per hour, despite CPAP usage) OR

5.2.  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

6.      Drug-induced sleep endoscopy (DISE) procedure showing absence of complete concentric collapse at the soft palate level

7.      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

8.      Documentation of counseling regarding future MRI utilization (depending on model implanted)

9.      Assessment and documentation of none of the following contraindications:

9.1.  Central and mixed apneas compromising more than one-quarter of the total AHI

9.2.  Another implantable device that could result in an unintended interaction with the HGNS implant system (e.g., pacemakers, implantable cardioverter-defibrillators, other nerve stimulators)

9.3.  BMI equal to or greater than 35 kg/m2

9.4.  Neuromuscular disease

9.5.  Hypoglossal-nerve palsy

9.6.  Severe restrictive or obstructive pulmonary disease.

9.7.  Moderate-to-severe pulmonary arterial hypertension

9.8.  Severe valvular heart disease

9.9.  New York Heart Association class III or IV heart failure

9.10 Recent myocardial infarction or severe cardiac arrhythmias (within the past 6 months)

9.11 Persistent uncontrolled hypertension despite medication use

9.12 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

10. Coexisting non-respiratory sleep disorders that would confound functional sleep assessment

11. Patient is or plans to become pregnant

12. Patient is unable or does not have the necessary assistance to operate the sleep remote

13. Patient has a condition or procedure that has compromised neurological control of the upper airway

13.

14. Application of Bioengineered Skin Substitutes to Lower Extremity Chronic Non-Healing Wounds (LCD L35041) and Wound Application of CTPs, Lower Extremities (L36690)

General documentation requirements for the application of a skin substitute or cellular and/or tissue product (CTP) in the treatment of diabetic foot ulcer(s) (DFU) and venous leg ulcer(s) (VLU) are as follows:

1.      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

2.      Documentation of the following related to the wound or ulcer:

2.1.  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

2.2.  Skin deficit at least 1.0 square cm in size

2.3.  Clean and free of necrotic debris or exudate

2.4.  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)

2.5.  For diabetic foot ulcers, a diagnosis of Type 1 or Type 2 Diabetes along with medical management for this condition

3.      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:

3.1.  Interventions that failed

3.2.  Updated medication history

3.3.  Review of pertinent medical problems that may have occurred since previous wound or ulcer evaluations

3.4.  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

3.5.  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

3.6.  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

4.      Documentation that therapy has resolved any infection and/or underlying osteomyelitis with documentation of the conditions that have been treated and resolved, as applicable:

4.1.  Control of edema, venous hypertension or lymphedema

4.2.  Control of any nidus of infection or colonization with bacterial or fungal elements

4.3.  Elimination of underlying cellulitis, osteomyelitis, foreign body, or malignant process

4.4.  Appropriate debridement of necrotic tissue or foreign body (exposed bone or tendon)

4.5.  For diabetic foot ulcers, appropriate non-weight bearing or off-loading pressure

4.6.  For venous stasis ulcers, compression therapy provided with documented diligent use of multilayer dressings, compression stockings of greater than 20mmHg pressure, or pneumatic compression

4.7.  Provision of wound environment to promote healing (protection from trauma and contaminants, elimination of inciting or aggravating processes)

5.      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)

6.      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

7.      Assessment and documentation of none of the following:

7.1.  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.

7.2.  Prior utilization of skin substitute grafts when a previous full course of applications was unsuccessful within 1 year. Unsuccessful treatment is defined as:

7.2.1.     Increase in size or depth of an ulcer or no change in baseline size or depth     AND

7.2.2.     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

7.3.  Retreatment of healed ulcers (those showing greater than 75% size reduction and smaller than 0.5 square cm)

7.4.  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 attempting to address smoking cessation)

7.5.  Known hypersensitivity to any component of the specific skin substitute graft (e.g., allergies to avian, bovine, porcine, equine products)

7.5.

Frequently Asked Questions (FAQs)

A.     What is the WISeR Model and why is it being implemented?

The WISeR Model (Wasteful and Inappropriate Services Reduction Model) is a new five-year payment and service-review model created by the Center for Medicare & Medicaid Innovation (CMMI) to bring advanced, technology-supported medical review into Medicare Fee-for-Service (FFS). It is designed to use AI-enabled tools, data analytics, and clinical expertise—supplied by contracted WISeR Participants to improve the accuracy and efficiency of prior authorization and pre-payment medical review for selected items and services.

The model operates in partnership with Medicare Administrative Contractors (MACs) and applies only in selected states. It does not change existing Medicare coverage, payment, or appeals rules. Instead, it changes how certain high-risk services are reviewed before payment is made.

B.     Which services require prior authorization in New Jersey?

Services requiring prior authorization are the WISeR “Select Items and Services.”
These are specific HCPCS/CPT-coded services that CMS has flagged as:

·         high risk for fraud, waste, or abuse

·         clinically unsupported at high rates

·         historically prone to improper payment

New Jersey providers will be required to request prior authorization only for these Select Items and Services.

C.    When does the program begin and end?

The WISeR Model runs for six years, across two consecutive three-year agreement periods.

·         Program Start: January 1, 2026

·         Program End: December 31, 2031

D.    Who is the MAC for New Jersey?

New Jersey is served by Novitas Solutions, Inc., operating as the JL MAC under the WISeR Model.

E.      Are there penalties for non-compliance?

Yes. While WISeR does not impose monetary fines, non-compliance results in claim payment consequences:

·         Claims will be automatically suspended if prior authorization is not submitted for Select Items and Services.

·         Claims will undergo pre-payment medical review by the WISeR Participant.

·         Claims may be denied if documentation does not support Medicare requirements.

·         Providers may experience significant payment delays.