Medicare Advantage Medical Policy Updates 092223

Medicare Advantage Medical Policy: Alzheimer’s Disease Anti-Amyloid Therapies

Policy statement:

1. A. Universal Prerequisites - All Products and All Indications
   1. Diagnosis consistent with Alzheimer’s disease with initiation at mild cognitive impairment (MCI) due to AD or mild dementia stage. Supporting source: FDA §Indications and Usage; Gold
   2. Confirm presence of amyloid beta pathology prior to first dose (amyloid PET or CSF biomarkers). Supporting source: FDA §Dosage and Administration; Gold
   3. Obtain and review a recent baseline brain MRI prior to initiating therapy; ensure site access to MRI for Supporting source: FDA §Dosage and Administration; FDA §Warnings and Precautions 5.1; Gold
   4. ongoing safety monitoring.
   5. Product-specific MRI surveillance per label during early treatment: Leqembi - obtain MRI within ~1 week prior to the 3rd, 5th, 7th, and 14th infusions; Kisunla - obtain

1. MRI prior to the 2nd, 3rd, 4th, and 7th infusions. If symptoms suggest ARIA, perform clinical evaluation and MRI. Supporting source: FDA §Dosage and Administration; FDA §Warnings and Precautions 5.1; Gold
2. ApoE ε4 genotyping performed prior to initiation with documented clinician-patient (or caregiver) counseling on ARIA risk by genotype; treatment may proceed without testing if patient declines after counseling. Supporting source: FDA §Boxed Warning; FDA §Warnings and Precautions 5.1; Gold
3. No known serious hypersensitivity to the requested agent or its excipients. Supporting source: FDA §Contraindications; Gold
4. Prescribed by, or in consultation with, a specialist experienced in cognitive disorders (e.g., Neurology, Geriatrics, Psychiatry/Neuropsychiatry). Supporting source: -; Silver
5. Baseline MRI does not demonstrate high-risk findings for ARIA or hemorrhage consistent with clinical trial exclusions (e.g., >4 cerebral microhemorrhages, prior lobar intracerebral hemorrhage >1 cm, superficial siderosis, vasogenic edema, major territorial Supporting source: FDA §Warnings and Precautions 5.1; Silver
6. stroke, multiple lacunar infarcts, significant vascular malformations, or other unstable intracranial pathology).
7. Provider attests to ARIA management plan consistent with label (dose interruption and MRI follow-up for ARIA-E/ARIA-H per severity; clinical judgment regarding resumption or discontinuation). Supporting source: FDA §Dosage and Administration; FDA §Warnings and Precautions 5.1; Gold

B. Coverage Exclusions, Hard Stops, and Discontinuation Rules

1. Serious hypersensitivity to the requested agent or excipients (absolute contraindication).
2. Initiation without documented amyloid beta pathology confirmation.
3. Initiation without a recent baseline brain MRI and a plan for on-treatment MRI surveillance per product label.
4. ARIA management across class: Suspend dosing and manage per label when ARIA-E or ARIA-H is detected; resume or permanently discontinue based on type, severity, symptoms, and radiographic resolution/stabilization. For intracerebral hemorrhage >1 cm, suspend; use clinical judgment on continuation after stabilization.
5. Kisunla - consideration to stop upon minimal amyloid: Consider stopping dosing when amyloid plaques are reduced to minimal levels on amyloid PET, consistent with product labeling.

Drug Names - Originator Products and Biosimilars

Medicare Advantage Medical Policy: Breyanzi (Lisocabtagene Maraleucel)

Effective: 10/15/2026
Preauthorization Required: Yes

A. Universal Prerequisites - All Products and All Indications

1. Adult patients (≥18 years). Supporting source: FDA §Indications and Usage
2. Administer only at facilities certified and enrolled in the Breyanzi REMS program with immediate on-site access to tocilizumab and resuscitative equipment; confirm availability of tocilizumab prior to infusion. Supporting source: FDA §Boxed Warning; FDA §Dosage and Administration
3. Use lymphodepleting chemotherapy (fludarabine 30 mg/m2/day IV and cyclophosphamide 300 mg/m2/day IV for 3 days) prior to infusion unless contraindicated; infuse 2-7 days after completion. Supporting source: FDA §Dosage and Administration
4. Do not administer to patients with active infection or active inflammatory disorders; delay infusion for unresolved serious toxicities from prior therapy, active uncontrolled infection, or active GVHD. Supporting source: FDA §Boxed Warning; FDA §Dosage and Administration; FDA §Warnings and Precautions
5. Premedicate with acetaminophen and an H1-antihistamine 30-60 minutes before infusion; avoid prophylactic systemic corticosteroids. Supporting source: FDA §Dosage and Administration
6. Post-infusion monitoring: monitor patients daily for at least 7 days for cytokine release syndrome and neurologic toxicities; continue to monitor for at least 2 weeks after infusion. Supporting source: FDA §Warnings and Precautions 5.1; FDA §Warnings and Precautions 5.2
7. CAR-T coverage is governed by CMS NCD 110.24 for FDA- approved or CMS-compendia-supported autologous CAR-T use. CMS covers CAR-T when used for a medically accepted indication; non-FDA-approved autologous CAR-T is nationally non-covered. Supporting source: CMS NCD 110.24
8. CAR-T treatment centers will complete required manufacturer, FDA post-marketing, or cellular therapy registry follow-up, when applicable. CIBMTR collects CAR-T data through cellular therapy data forms Supporting source: CIBMTR

B. Coverage Exclusions, Hard Stops, and Discontinuation Rules

1. Primary central nervous system lymphoma (Limitation of Use).
2. Pediatric patients (<18 years) - safety and efficacy not established.
3. Active uncontrolled infection or active inflammatory disorders at time of infusion (delay infusion until resolved).

Drug Names - Originator Products and Biosimilars

Medicare Advantage Medical Policy: Bioengineered Skin and Soft Tissue Substitutes

Effective: 10/15/2026
Preauthorization Required: Yes

A. Universal Prerequisites - All Products and All Indications

1. Correct pre-existing hypocalcemia before the first dose. Maintain calcium of at least 1,000 mg per day and vitamin D of at least 400 IU per day during therapy.
2. For patients with advanced chronic kidney disease, including an estimated glomerular filtration rate below 30 mL/min/1.73 m2 or dialysis, evaluate for chronic kidney disease-mineral and bone disorder before initiation.
   1. a. The evaluation should include intact parathyroid hormone, serum calcium, 25-hydroxyvitamin D, and 1,25-dihydroxyvitamin D, as clinically appropriate.
   2. b. The treating site must be able to monitor calcium weekly for one month and monthly thereafter.
3. Perform pregnancy testing before initiation in females of reproductive potential. Avoid use during pregnancy.
4. Obtain baseline calcium and repeat calcium 10 to 14 days after injection in patients predisposed to hypocalcemia, including patients with malabsorption or hypoparathyroidism.
5. Complete a dental or oral evaluation and optimize oral hygiene before initiation in patients with risk factors for osteonecrosis of the jaw.
   1. a. Avoid elective invasive dental procedures during therapy when possible.
6.  Do not administer more than one denosumab product concomitantly, including Prolia, Xgeva, or any biosimilar.

B. Step Therapy and Continuation Requirements

1. Prolia and Prolia-referenced biosimilars - Osteoporosis and Cancer-Treatment-Induced Bone Loss
   1. a. The request must satisfy Step 1A or Step 1B before proceeding to Step 2, unless the prerequisite is clinically inappropriate.
      
      1. i. STEP 1A: Trial of intravenous zoledronic acid (J3489) with documented inadequate response, contraindication, or intolerance.
      2. ii. STEP 1B: OR trial of an oral bisphosphonate, such as alendronate, risedronate, or ibandronate, for at least 12 months with documented inadequate response, contraindication, or intolerance.
   2. b. Inadequate response may include one or more of the following:
      
      1. i. A new or worsening fragility fracture while adherent to treatment.
      2. ii. Clinically significant bone mineral density loss, generally greater than 3% to 5% by DXA, despite adherence.
      3. iii. Inability to tolerate therapy after an attempted re-challenge.
      4. iv. A contraindication such as an estimated glomerular filtration rate below 30 to 35 mL/min/1.73 m2 or esophageal stricture.
   3. c. STEP 2 (effective February 15, 2026): Trial of at least one of the following preferred denosumab biosimilar product families, using the Prolia-referenced product that is appropriate for the requested indication: Bilprevda/Bildyos, Jubbonti/Wyost, or Stoboclo/Osenvelt, unless contraindicated or unavailable.
      
      1. i. The selected preferred biosimilar must be administered according to labeled dosing for at least one dose.
      2. ii. A request to transition to Prolia or another non-preferred denosumab product must include the clinical reason for the transition.
   4. d. STEP 3: Prolia may be approved when the prior steps are completed or clinically inappropriate.
      
      1. i. Documentation must explain the reason for bypass, such as severe renal impairment, severe esophageal disease, intolerance to each clinically appropriate preferred denosumab biosimilar, or product unavailability.
   5. e. Applicable diagnosis codes include M81.0, M81.8, M80.0X-, M80.8X-, Z79.811, and Z79.818.
2. 2. Prolia and Prolia-referenced biosimilars - Glucocorticoid-Induced Osteoporosis
   
   1. a. STEP 1A: Trial of intravenous zoledronic acid (J3489) with inadequate response, contraindication, or intolerance in the context of systemic glucocorticoids expected to continue for at least six months.
   2. b. STEP 1B: OR trial of an oral bisphosphonate for at least 12 months with inadequate response, contraindication, or intolerance.
   3. c. STEP 2 (effective February 15, 2026): Trial of at least one of the following preferred denosumab biosimilar product families, using the Prolia-referenced product that is appropriate for the requested indication: Bilprevda/Bildyos, Jubbonti/Wyost, or Stoboclo/Osenvelt, unless clinically inappropriate.
   4. d. STEP 3: Prolia may be approved when the prior steps are completed or clinically inappropriate and the rationale for originator use is documented.
   5. e. Applicable diagnosis codes include M81.4 and Z79.52.
3. 3. Xgeva and Xgeva-referenced biosimilars - Prevention of Skeletal-Related Events in Multiple Myeloma or Bone Metastases from Solid Tumors
   
   1. a. STEP 1: Trial of zoledronic acid or an oral bisphosphonate when clinically appropriate for the indication, with documented inadequate response, contraindication, or intolerance. Pamidronate may also satisfy the prerequisite for an applicable oncology indication.
      
      1. i. Documentation may include at least one intravenous bisphosphonate dose followed by a skeletal-related event, persistent uncontrolled bone pain or skeletal-related-event risk, or a contraindication such as renal impairment.
   2. b. STEP 2 (effective February 15, 2026): Trial of at least one of the following preferred denosumab biosimilar product families, using the Xgeva-referenced product that is appropriate for the requested indication: Bilprevda/Bildyos, Jubbonti/Wyost, or Stoboclo/Osenvelt, unless contraindicated or unavailable.
      
      1. i. Administer the biosimilar according to labeled dosing, generally 120 mg subcutaneously every four weeks, for at least one cycle.
   3. c. STEP 3: Xgeva may be approved when the prior steps are completed or clinically inappropriate and the rationale is documented.
   4. d. Applicable diagnosis codes include C90.00-C90.02 and C79.51.
4. 4. Xgeva and Xgeva-referenced biosimilars - Hypercalcemia of Malignancy Refractory to Bisphosphonate Therapy
   
   1. a. STEP 1: Document persistent or recurrent hypercalcemia despite prior intravenous bisphosphonate therapy.
   2. b. STEP 2 (effective February 15, 2026): Trial of at least one of the following preferred denosumab biosimilar product families, using the Xgeva-referenced product that is appropriate for the requested indication and the labeled loading schedule: Bilprevda/Bildyos, Jubbonti/Wyost, or Stoboclo/Osenvelt.
      
      1. i. The labeled schedule includes administration on Days 1, 8, and 15 of the first month, followed by every four weeks.
   3. c. STEP 3: Xgeva may be approved when the biosimilar is clinically inappropriate or unavailable and the rationale is documented.
   4. d. The applicable diagnosis code is E83.52.
5. 5. Continuation Requests
   
   1. a. The provider must attest that the member meets all applicable prior authorization continuation criteria.
   2. b. The patient must have had an adequate response or significant improvement while receiving treatment.
   3. c. When the response or improvement is not adequate, the provider must submit the clinical rationale for continuing treatment.
   4. d. Increased bone density should be documented by DXA at least every two years when applicable to the treated indication.
   5. e. The continuation dose, frequency, route, and product must remain consistent with the FDA label or a covered off-label regimen.
      
      1. i. Requests exceeding standard label-based dosing require clinical rationale, current weight, response history, and a safety monitoring plan.
6. C. Approval Duration
   
   1. 1. New-start approval: 12 months.
   2. 2. Continuation-of-care approval: 12 months.
7. D. Coverage Exclusions, Hard Stops, and Discontinuation Rules
   
   1. 1. Pregnancy is a contraindication for Prolia-referenced products. Verify a negative pregnancy test before initiation when applicable.
   2. 2. Active hypocalcemia must be corrected before initiation.
   3. 3. Known hypersensitivity to denosumab or any product component is not covered.
   4. 4. Concomitant use of more than one denosumab product, such as Prolia with Xgeva, is not covered.
   5. 5. Abrupt discontinuation of Prolia-referenced therapy is associated with rebound bone turnover and multiple vertebral fractures.
      
      1. a.  When Prolia-referenced therapy is stopped, transition to a potent antiresorptive therapy, such as intravenous zoledronic acid, is required according to applicable local coverage guidance to mitigate rebound risk.

Drug Names - Originator Products and Biosimilars

Originator (Reference) Products

Medicare Advantage Medical Policy: Immune Globulin (IVIG/SCIG)

Effective: 10/15/2026
Preauthorization Required: YES

Policy Statement:

1. A. Universal Prerequisites - All Products and All Indications
   1. 1. Use immune globulin only for FDA-labeled or CMS-compendia-supported indications. Administer the product by the FDA-labeled route (IV or SC) and follow labeled dosing and infusion-rate guidance.
   2. 2. Screen for contraindications and high-risk conditions before each course.
      
      1. a. History of severe hypersensitivity or anaphylaxis to human immune globulin.
      2. b. IgA deficiency with anti-IgA antibodies and prior hypersensitivity.
      3. c. Risk factors for thrombosis or acute renal dysfunction.
      4. i. Ensure adequate hydration in at-risk patients.
      5. ii. Use the minimum practicable dose and infusion rate in at-risk patients.
   3. 3. Defer live attenuated virus vaccines as directed by the product label because immune globulin may interfere with the immune response. Coordinate vaccination timing with the prescriber.
   4. 4. Document an accurate current weight in kilograms before dosing because most regimens are weight-based.
2. B. Step Therapy and Continuation Requirements
   
   1. 1. IVIG preferred-agent requirements
      
      1. a. STEP 1A preferred IVIG agents:
         
         1. i. Gammagard Liquid (J1569).
         2. ii. Gammaked or Gammoned-C (J1561).
      2. b. STEP 1B preferred IVIG agents:
         
         1. i. Octagam (J1568).
         2. ii. Privigen (J1459).
      3. c. Documentation must show one of the following for the applicable preferred agent:
         
         1. i. A prior adequate therapeutic trial.
         2. ii. Current stable therapy.
         3. iii. Contraindication or intolerance.
         4. iv. Lack of availability or a product shortage.
      4. d. The preferred-product step may be bypassed for a documented medical exception, such as specific brand intolerance, clinical urgency, or product shortage.
   2. 2. SCIG preferred-agent requirements
      
      1. a. STEP 2A preferred SCIG agents:
         
         1. i. Gammagard Liquid ERC (J1569).
         2. ii. Hizentra (J1559).
         3. iii. Cutaquig (J1551).
      2. b. STEP 2B preferred SCIG agent:
         
         1. i. HyQvia (J1575).
      3. c. Documentation must show one of the following for the applicable preferred agent:
         
         1. i. A prior adequate therapeutic trial.
         2. ii. Current stable therapy.
         3. iii. Contraindication or intolerance.
         4. iv. Lack of availability or a product shortage.
      4. d. The preferred-product step may be bypassed for a documented medical exception, such as line-access issues, brand intolerance, clinical urgency, or product shortage.
   3. 3. Continuation requests
      
      1. a. The provider must attest that the member meets all required prior authorization continuation criteria.
      2. b. The patient must have had an adequate response or significant improvement while receiving the medication.
      3. c. When the response or improvement is not adequate, the provider must submit the clinical rationale for continuing treatment.
      4. d. Clinical documentation must support continued benefit, such as reduced infection frequency or severity; stable or improved IgG trough levels when relevant; platelet response for ITP; improved or stable neurologic function for CIDP, MMN, GBS, or MG; reduced disease activity for autoimmune indications; or prevention of relapse when maintenance therapy is requested.
      5. e. The continuation dose, frequency, route, and product must remain consistent with the FDA label or a covered off-label regimen.
         
         1. i. Requests exceeding standard label-based dosing require clinical rationale, current weight, response history, and a safety monitoring plan.
3. C. Approval Duration
   
   1. 1. New-start approval: 6 months.
   2. 2. Continuation-of-care approval: 12 months.
4. D. Coverage Exclusions, Hard Stops, and Discontinuation Rules
   
   1. 1. History of anaphylaxis or severe systemic reaction to human immune globulin (absolute contraindication).
   2. 2. IgA deficiency with antibodies to IgA and a history of hypersensitivity reaction (contraindication per label).
   3. 3. Use solely for routine prophylaxis of common viral illnesses without an FDA-labeled or compendia-supported indication.

Drug Names - Originator Products and Biosimilars

 

Medicare Advantage Medical Policy: Kymriah (Tisagenlecleucel) 

Effective: 10/15/2026
Preauthorization Required: Yes

Policy Statement:

1. A. Universal Prerequisites - All Products and All Indications
   
   1. 1. Treatment must occur at a KYMRIAH REMS-certified center; confirm availability of at least two doses of tocilizumab on site prior to infusion; pre-medicate with acetaminophen and an H1-antihistamine; verify patient identity; product is for autologous use only. Supporting source: FDA §Dosage and Administration; FDA §Warnings and Precautions 5.1
   2. 2. Do not administer in patients with active infection or inflammatory disorders; delay infusion for unresolved serious adverse reactions from prior therapy, active uncontrolled infection, active GVHD, or worsening disease after lymphodepleting chemotherapy. Supporting source: FDA Boxed Warning; FDA §Warnings and Precautions 5.1; FDA §Dosage and Administration 2.2
   3. 3. Baseline evaluation: ECOG Performance Status; confirm B-cell lineage disease with CD19 expression per institutional standard; baseline imaging (CT/MRI/PET as applicable) for response assessment; baseline labs (CBC with differential, CMP, LFTs); pregnancy test for females of reproductive potential. Supporting source: NCCN Guidelines v1.2025; FDA §Use in Specific Populations 8.3
   4. 4. Infection risk management: Screen for HBV (HBsAg, anti-HBc with reflex HBV DNA as indicated) and manage per guideline before systemic anticancer therapy; do not delay urgent treatment for pending results when clinically necessary. Supporting source: ASCO 2020
   5. 5. Post-infusion monitoring: Monitor daily for signs/symptoms of CRS during the first week and for at least 2 weeks after treatment; monitor for neurologic toxicities and manage per institutional algorithm. Supporting source: FDA §Warnings and Precautions 5.1; FDA §Warnings and Precautions 5.2
   6. 6. Off label oncology uses require support in a CMS-recognized compendium (e.g., NCCN Drugs & Biologics Compendium, AHFS DI, Lexi- Drugs, Clinical Pharmacology, Micromedex DrugDex). Supporting source: NCCN Compendium; AHFS DI
   7. 7. CAR-T coverage is governed by CMS NCD 110.24 for FDA-approved or CMS-compendia-supported autologous CAR-T use. CMS covers CAR-T when used for a medically accepted indication; non-FDA-approved autologous CAR-T is nationally non-covered.
   8. 8. CAR-T treatment centers will complete required manufacturer, FDA post-marketing, or cellular therapy registry follow-up, when applicable. CIBMTR collects CAR-T data through cellular therapy data forms
2. B. Coverage Exclusions, Hard Stops, and Discontinuation Rules
   
   1. 1. Primary central nervous system lymphoma (limitation of use for large B-cell lymphoma indication)
   2. 2. Active uncontrolled infection or inflammatory disorder at time of planned infusion
   3. 3. Administration at a non-REMS-certified center
   4. 4. Pregnancy - treatment not recommended; verify pregnancy status prior to therapy
   5. . Hold/delay infusion criteria: Delay infusion for unresolved serious adverse reactions from preceding chemotherapy (pulmonary or cardiac reactions, hypotension), active uncontrolled infection, active GVHD, or worsening disease burden after lymphodepleting chemotherapy.

Drug Names - Originator Products and Biosimilars

Medicare Advantage Medical Policy: Tecartus (Brexucabtagene Autoleucel)

Effective: 10/15/2026
Preauthorization Required: Yes

Policy Statement:

1. A. Universal Prerequisites - All Products and All Indications
   
   1. 1. Age ≥18 years at the time of leukapheresis and infusion Supporting source: FDA §Indications and Usage
   2. 2. Confirm immediate availability of tocilizumab (minimum 2 doses per patient) and emergency equipment prior to infusion; monitor closely for CRS and neurologic toxicity Supporting source: FDA §Dosage and Administration; FDA §Warnings and Precautions 5.1; FDA §Warnings and Precautions 5.2
   3. 3. No clinically significant active systemic infection or inflammatory disorder at the time of infusion Supporting source: FDA §Boxed Warning; FDA §Warnings and Precautions 5.5
   4. 4. Administer lymphodepleting chemotherapy per FDA label prior to infusion unless clinically contraindicated; premedicate with acetaminophen and an H1-antihistamine 30-60 minutes before infusion; avoid prophylactic systemic corticosteroids Supporting source: FDA §Dosage and Administration
   5. 5. Autologous use only with patient identity verification matching the cassette and infusion bag at preparation and infusion Supporting source: FDA §Dosage and Administration
   6. 6. CAR-T coverage is governed by CMS NCD 110.24 for FDA- approved or CMS-compendia-supported autologous CAR-T use. CMS covers CAR-T when used for a medically accepted indication; non-FDA-approved autologous CAR-T is nationally non-covered. Supporting source: CMS NCD 110.24
   7. 7. CAR-T treatment centers will complete required manufacturer, FDA post-marketing, or cellular therapy registry follow-up, when applicable. CIBMTR collects CAR-T data through cellular therapy data forms Supporting source: CIBMTR

B. Coverage Exclusions, Hard Stops, and Discontinuation Rules

1. 1. Clinically significant active systemic infection or active inflammatory disorder at the time of planned infusion

Drug Names - Originator Products and Biosimilars

Medicare Advantage Medical Policy: Multiple Myeloma Anti-Neoplastics

Effective: 10/15/2026
Preauthorization Required: Yes

Policy Statement

1. Dynamic posturography is considered experimental/investigational. The evidence is insufficient to determine whether dynamic posturography improves health outcomes in patients with balance disorders.
   
   

Medicare Advantage Medical Policy: Implantable Bone Conduction and Bone Anchored Hearin Aid

Effective: 01/01/2024
Preauthorization Required: Yes

Policy Statement

1. Unilateral fully or partially implantable bone-conduction, percutaneous or transcutaneous (bone-anchored) hearing aid(s) may be considered medically necessary as an alternative to an air-conduction hearing aid in patients 5 years of age and older with conductive or mixed sensorineural/conductive hearing loss, when the following criteria is met:
   1. Must meet ONE of the following medical criteria:
      1. Congenital or surgically induced malformations (eg, atresia) of the external ear canal or middle ear; OR
      2. Chronic external otitis or otitis media; OR
      3. Tumors of the external canal and/or tympanic cavity; OR
      4. Dermatitis of the external canal. AND
   2. A pure-tone average bone-conduction threshold measured at 0.5, 1, 2, and 3 kHz of better than or equal to 45 dB (OBC and BP100 devices), 55 dB (Intenso device), or 65 dB (Cordele II device).
2. For Bilateral implantable bone-conduction, percutaneous or transcutanous bone anchored hearing aids for symmetrically conductive or mixed hearing loss may be considered medically necessary in patients 5 years of age and older patients meeting the above audiologic criteria (A and B) with loss as defined by a difference between left- and right-side bone-conduction threshold of < 10 dB on average measured at 0.5, 1, 2, and 3 kHz (4 kHz for OBC and Ponto Pro), or < 15 dB at individual frequencies.
3. For Unilateral Sensorineural deafness with normal hearing in the other ear an implantable bone-conduction, percutaneous or transcutaneous (bone-anchored) hearing aid may be considered medically necessary in patients 5 years of age and older patients when the pure-tone average air-conduction threshold of the normal ear is >20 dB measured at 0.5, 1, 2, and 3 kHz.
4. Other uses of implantable bone-conduction (bone-anchored) hearing aids, including use in patients with bilateral sensorineural deafness, are considered investigational.

Medicare Advantage Medical Policy: Myoelectric Upper-Limb Prosthetic

Effective: 01/01/2024
Preauthorization Required: Yes

Policy Statement

1. Myoelectric upper-limb prosthetic components may be considered medically necessary when the ALL the following conditions are met:
   
   1. The prosthetic device is ordered or provided by a physician or under the direction of a physician, AND
   2. Amputee is evaluated by an independent qualified professional (prosthetist/orthoptist) to determine the most appropriate prosthetic components and control mechanism (e.g., body-powered, myoelectric, or combination of body-powered and myoelectric), AND
   3. The patient has an amputation or missing limb at the wrist or above (e.g., forearm, elbow) due to trauma or congenital absence, AND
   4. Standard body-powered prosthetic devices cannot be used or are insufficient to meet the functional needs of the individual in performing activities of daily living AND use of the limb for employment/school environment or extracurricular activities is not sufficient evidence for prescription of this device over standard prosthetic application, AND
   5. The remaining musculature of the arm(s) contains the minimum microvolt threshold to allow operation of a myoelectric prosthetic device, AND
   6. The patient has demonstrated sufficient neurologic and cognitive function to operate the prosthesis effectively, AND
   7. The patient is free of comorbidities that could interfere with function of the prosthesis (e.g., neuromuscular disease), AND
   8. Functional evaluation indicates that with training, use of a myoelectric prosthesis is likely to meet the functional needs of the individual (e.g., gripping, releasing, holding, coordinating movement of the prosthesis) when performing activities of daily living. This evaluation should consider the patient’s needs for control, durability (maintenance), function (speed, work capability), and usability.
2.  Myoelectric prostheses are contraindicated, and therefore considered not medically necessary for:
   
   1. ADLs that require frequent lifting of heavy objects (16lbs or greater), OR
   2. Environments involve frequent contact with dirt, dust, grease, water, and solvent, OR
   3. When neuromas and/or phantom limb pain are exacerbated with the use of the prosthesis.
3. High-definition silicone used to make a prosthesis resemble a patient’s skin is considered not medically necessary and cosmetic.
4. Upper-limb prosthetic components investigational under all other conditions because their effectiveness has not been established, including but not limited to:
   
   1. Advanced upper-limb prosthetic components with both sensor and myoelectric control (e.g., LUKE Arm).
   2. A prosthesis with individually powered digits, including but not limited to a partial hand prosthesis (e.g., ProDigits).
   3. Myoelectric controlled upper-limb orthoses.
   4. Implantable myoelectric sensors for upper limb prostheses and hand prostheses.
   5. Transcranial direct current stimulation for enhancing performance of myoelectric prostheses.
   6. Adjustable click systems (e.g., Revo and Boa click systems).
   7. Targeted muscle re-innervation for improved control of myoelectric upper limb prostheses and treatment of painful post-amputation neuroma.
   8. Myo-electric hand prostheses.
5. The following supplies or accessories may be medically necessary for effective functioning of allowed equipment:
   
   1. Prosthetic sheaths/socks, including a gel cushion layer (prosthetic gel stockings; 12 in 12 months).
   2. No more than 2 socket inserts per individual prosthesis in 12 months. Any additional would be reviewed for medical necessity.
   3. No more than two replacement liners per prosthesis in 12 months.
6. One myoelectric prosthesis per limb per 5 (five) years is covered when medically indicated. Coverage will not be provided if the prosthesis is functioning properly and in good general condition.
7. Evaluation of the member, measurement and/or casting, and fitting/adjustments of the prosthesis are included in the allowance for the prosthesis. There is no separate payment for these services. There is no separate payment if CAD-CAM technology is used to fabricate a prosthesis. Reimbursement is included in the allowance of the codes for a prosthesis.
8. Additional warranties and guarantees beyond the included base warranty or manufacturer warranty, are considered convenience items and are not medically necessary.
9. Items billed for replacement that are still under manufacturer warranty are considered not medically necessary.
10. Custom fabricated socket inserts L6696 and L6697 are for atypical congenital or atypical traumatic amputations. These codes are for use only with the initial issue of a custom fabricated socket insert. Additional inserts (either custom fabricated or prefabricated) provided at the time of initial issue or replacement socket inserts are coded L6694, or L6695 whichever is applicable. There must be adequate documentation by the prosthetist of functional and/or physiological need for custom socket inserts. The simple entry of atypical amputation in those records is not sufficient.
11. There is no separate payment for batteries (L7360, L7364, L7367, and L8505) and/or battery chargers (L7362, l7366, L7368) billed concurrently with a powered base item or associated add-ons.

Medicare Advantage Medical Policy: Percutaneous Disc Procedures

Effective: 01/01/2024
Preauthorization Required: Yes

Policy Statement

1. Intradiscal electrothermal therapy (IDET) is considered investigational.
2.  Endoscopic discectomy is considered investigational as a technique of intervertebral disc decompression in patients with back pain and/or radiculopathy related to disc herniation in the lumbar, thoracic, or cervical spine.
3. Percutaneous intradiscal radiofrequency thermocoagulation, percutaneous laser disc decompression, and percutaneous spinal discectomy are investigational for all indications

Medicare Advantage Medical Policy: Multimarker Algorithmic Testing for Ovarian Cancer

Effective: 01/01/2024
Preauthorization Required: Yes
Policy Statement

Ovarian Cancer Diagnostic Algorithmic Tests

1. Ovarian cancer diagnostic algorithmic tests (i.e., OVA1, Overa, ROMA, and OvaWatch) (0003U, 81500, 81503, 0375U) may be considered investigational for all indications, including but not limited to:
   1. Preoperative evaluation of adnexal masses to triage for malignancy.
   2. Screening for ovarian cancer
   3. Selecting patients for surgery for an adnexal mass
   4. Evaluation of patients with clinical or radiologic evidence of malignancy
   5. Evaluation of patients with nonspecific signs or symptoms suggesting possible malignancy
   6. Postoperative testing and monitoring to assess surgical outcome and/or to detect recurrent malignant disease following treatment.