Billing chart: Blue Cross highlights medical, benefit policy changes

20930, 20939, 20999,** 0565T, 0566T, 0489T, 0489T

Basic benefit and medical policy

Orthopedic applications of stem-cell therapy

Mesenchymal stem cell therapy is considered experimental for all orthopedic applications, including use in repair or regeneration of musculoskeletal tissue.

Allograft bone products containing viable stem cells, including, but not limited to, demineralized bone matrix, or DBM, with stem cells, are considered experimental for all orthopedic applications.

Allograft or synthetic bone graft substitutes that must be combined with autologous blood or bone marrow are considered experimental for all orthopedic applications.

These therapies haven’t been scientifically demonstrated to improve patient clinical outcomes.

The medical policy statement has been updated, effective July 1, 2023.

Inclusionary and exclusionary guidelines:

Not applicable

43644, 43645, 43770, 43771, 43772, 43773, 43774, 43775, 43843, 43845, 43846, 43847, 43848, 43886, 43887, 43888, 43999, 44130, 96130, 96131, 96136, 96137, 96138, 96139, S2083

Experimental
43999,** 96146, 43290, 43291, 43842

**When used to indicate any of the following procedures:

• Loop gastric bypass gastroplasty, also known as mini-gastric bypass
• Stomach stapling
• SADI-S
• SIPS
• Endoscopic procedures to treat weight gain after bariatric surgery
• Natural Orifice Transluminal Endoscopic Surgery, known as NOTES™

Basic benefit and medical policy

Bariatric surgery

The safety and effectiveness of laparoscopic and open gastric restrictive procedures including, but not limited to, Roux-en-Y gastric bypass, sleeve gastrectomy, biliopancreatic diversion with duodenal switch and adjustable gastric band have been established. They may be considered useful therapeutic options when specified criteria are met.

Inclusionary and exclusionary criteria have been updated, effective July 1, 2023.

Inclusions:

Surgical procedures are considered established treatment options if all the following criteria are met:

• The individual has one of the following:
• A BMI of >40
• A BMI of >35 with one or more co-morbid conditions including, but not limited to:
• Degenerative joint disease (including degenerative disc disease)
• Hypertension
• Hyperlipidemia, coronary artery disease
• Presence of other atherosclerotic diseases
• Sleep apnea
• Congestive heart failure

                        or

• A BMI of > 30 with Type 2 diabetes
• All individuals 18 to 60 years of age with conditions above 
• Individuals older than 60 years of age may be considered if it’s documented in the medical record that the individual’s physiologic age and co-morbid conditions result in a positive risk/benefit ratio.
• Criteria for bariatric surgery for individuals younger than 18 years of age are similar: 1) BMI ≥40 kg/m2 (or 140% of the 95th percentile for age and sex, whichever is lower); 2) BMI ≥35 kg/m2 (or 120% of the 95th percentile for age and sex, whichever is lower) with clinically significant comorbidities; and should include documentation that the primary care provider has addressed the risk of surgery on future growth, the patient's maturity level and the patient’s ability to understand the procedure and comply with postoperative instructions, as well as the adequacy of family support.
• The individual has undergone multidisciplinary evaluation by an established bariatric treatment program to include medical, nutritional and mental health evaluations to determine ultimate candidacy for bariatric surgery. Such an evaluation should include an assessment of the patient’s likely ability and willingness to cooperate effectively with a rigorous post-operative program. This should include documentation of past participation in a non-surgical weight-loss program. Documentation of a non-surgical weight-loss program is waived for super morbidly obese individuals who have a BMI of ≥50.
• The non-surgical program participation and multidisciplinary evaluation must have occurred within four years of the date of surgery. 
• A psychological evaluation must be performed as a pre-surgical assessment by a contracted mental health professional to establish the patient’s emotional stability, ability to comprehend the risk of surgery and to give informed consent, and ability to cope with expected post-surgical lifestyle changes and limitations. Such psychological consultations may include one unit total of psychological testing for purposes of personality assessment (e.g., the MMPI-2 or adolescent version, the MMPI-A).
• In cases where a revision of the original procedure is planned because of failure due to anatomic or technical reasons (e.g., obstruction, staple dehiscence, etc.), or excessive weight loss of 20% or more below ideal body weight, the revision is determined to be medically appropriate without consideration of the initial preoperative criteria. The medical records should include documentation of:
• The date and type of the previous procedure
• The factors that precipitated the failure or the nature of the complications from the previous procedure that mandate (necessitate) the takedown
• If the indication for the revision is a weight gain or a failure of the patient to lose a desired amount of weight due to patient non-adherence, then the patient must re-qualify for the subsequent procedure and meet all the initial preoperative criteria.

Exclusions:

The following surgical procedures are considered experimental because their safety or effectiveness hasn’t been proven:

• Loop gastric bypass gastroplasty using a Billroth II type of anastomosis, also known as mini-gastric bypass
• Biliopancreatic bypass without duodenal switch
• Long-limb gastric bypass procedure (i.e., >150 cm)
• Stomach stapling (vertical banded gastroplasty)
• Endoscopic and endoluminal procedures (including but not limited to insertion of the StomaphyX™ device, use of the Overstitch device, insertion of a gastric balloon, endoscopic gastroplasty, intragastric balloons, aspiration therapy device) or use of an endoscopically placed duodenojejunal sleeve) as a primary bariatric procedure or as a revision procedure, (i.e., to treat weight gain after bariatric surgery to remedy large gastric stoma or large gastric pouches).
• Any bariatric surgery for individuals with Type 2 diabetes who have a BMI of less than 30
• Laparoscopic gastric plication
• Vagus nerve blocking (see the separate policy, “Vagus Nerve Blocking for Morbid Obesity.”)
• Single anastomosis duodenoileal bypass with sleeve gastrectomy, or SADI-S
• Stomach intestine pylorus sparing surgery, or SIPS
• Bariatric surgery for pre-adolescents
• Natural orifice transluminal endoscopic surgery, or NOTES™
• Two-stage bariatric surgery procedures (e.g., SG as the initial procedure followed by BPD at a later time)

81235, 81275, 81404, 81405, 81406, 81445, 81479, 0037U

Basic benefit and medical policy

Somatic biomarker testing for targeted treatment of NSCLC

The medical policy statements regarding medically necessary testing of somatic variants used to determine treatment of non-small cell lung cancer have been updated, effective July 1, 2023.

EGFR testing

• The safety and effectiveness of analysis of somatic variants in exons 18 (such as G719X), 19 (such as L858R, T790M), 20 (such as S678I) or 21 (such as L861Q) within the EGFR gene have been established to predict treatment response to an FDA-approved therapy (e.g., erlotinib [Tarceva^®], gefitinib [Iressa^®] or afatinib [Gilotrif^®]), or osimertinib (Tagrisso) in individuals with advanced lung adenocarcinoma, large cell carcinoma, advanced squamous cell NSCLC and NSCLC not otherwise specified, if the individual doesn’t have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label
• Analysis of tumor tissue for somatic variants in exon 20 (e.g., insertion variants) within the EGFR gene, may be considered established to predict treatment response to an FDA-approved therapy (e.g., mobocertinib [Exkivity] or amivantamab [Rybrevant]) in individuals with NSCLC, if the individual doesn’t have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label
• At diagnosis, analysis of plasma for somatic variants in exons 19 through 21 (e.g., exon 19 deletions, L858R, T790M) within the EGFR gene, using the cobas EGFR Variant Test v2, Guardant360 CDx test, FoundationOne Liquid CDx, OncoBEAM test or InVisionFirst-Lung test to detect circulating tumor DNA (ctDNA) may be considered established as an alternative to tissue biopsy to predict treatment response to an FDA-approved therapy in individuals with advanced lung adenocarcinoma, large cell carcinoma, advanced squamous cell NSCLC and NSCLC not otherwise specified if the individual doesn’t have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label
• At progression, analysis of plasma for the EGFR T790M resistance variant for targeted therapy with osimertinib using the cobas EGFR Variant Test v2, Guardant360 CDx test, OncoBEAM test, or InVisionFirst-Lung test to detect ctDNA, may be considered established in individuals with advanced lung adenocarcinoma, large cell carcinoma, advanced squamous cell NSCLC and NSCLC not otherwise specified, when tissue biopsy to obtain new tissue isn’t feasible (e.g., in those who don’t have enough tissue for standard molecular testing using formalin-fixed paraffin-embedded tissue, don’t have a biopsy-amenable lesion or can’t undergo biopsy), and when the individual doesn’t have any FDA-labeled contraindications to osimertinib and it’s intended to be used consistently with the FDA-approved label
• Analysis of plasma for somatic variants in exon 20 (e.g., insertion variants) within the EGFR gene using an FDA-approved companion diagnostic plasma test to detect ctDNA may be considered established as an alternative to tissue biopsy to predict treatment response to an FDA-approved therapy in individuals in NSCLC (e.g., amivantamab [Rybrevant]), if the individual doesn’t have any FDA-labeled contraindications to the requested agent and both the agent and ctDNA test are intended to be used consistently with their FDA-approved labels
• The analysis for other EGFR variants within exons 22-24, or other applications related to NSCLC, is considered experimental. The peer-reviewed medical literature hasn’t yet demonstrated the clinical utility of this testing for this indication.

ALK testing

• The safety and effectiveness of analysis of somatic rearrangement variants of the ALK gene in tissue have been established. It’s an effective diagnostic option for predicting treatment response to crizotinib (Xalkori^®), ceritinib (Zykadia™, alectinib [Alecensa], brigatinib [Alunbrig]) or lorlatinib [Lorbrena] in patients with advanced lung adenocarcinoma and large cell carcinoma or for patients in whom an adenocarcinoma component can’t be excluded, if the individual doesn’t have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label
• Analysis of plasma for somatic rearrangement variants of the ALK gene using an FDA-approved companion diagnostic plasma tests to detect ctDNA is considered established as an alternative to tissue biopsy to predict treatment response to an FDA-approved ALK inhibitor therapy in individuals with NSCLC (e.g., alectinib [Alcensa]), if the individual doesn’t have any FDA-labeled contraindications to the requested agent and both the agent and ctDNA test are intended to be used consistently with their FDA-approved labels
• Analysis of somatic rearrangement variants of the ALK gene in tissue or plasma is considered experimental in all other situations.

BRAF V600E testing

• Analysis of the BRAF V600E variant is established to predict treatment response to FDA-approved BRAF or MEK inhibitor therapy (e.g., dabrafenib [Tafinlar] and trametinib [Mekinist^®]), in individuals with advanced lung adenocarcinoma or in whom an adenocarcinoma component can’t be excluded, if the individual doesn’t have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label.
• Analysis of tumor tissue for the somatic BRAF V600E variant is considered experimental in all other situations.
• Analysis of plasma for the somatic BRAF V600E variant to detect ctDNA is considered experimental as an alternative to tissue biopsy to predict treatment response to BRAF or MEK inhibitor therapy in patients with NSCLC.

ROS1 testing

• Analysis of somatic rearrangement variants of the ROS1 gene is established to predict treatment response to FDA-approved ROS1 inhibitor therapy (crizotinib [Xalkori]) in individuals with advanced lung adenocarcinoma or in whom an adenocarcinoma component can’t be excluded. If the individual doesn’t have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label
• Analysis of tumor tissue for somatic rearrangement variants of the ROS1 gene is considered experimental in all other situations
• Analysis of plasma for somatic rearrangement variants of the ROS1 gene using plasma specimens to detect ctDNA is considered experimental as an alternative to tissue biopsy to predict treatment response to ROS1inhibitortherapy (e.g., crizotinib [Xalkori] or entrectinib [Rozlytrek]) in patients with NSCLC

KRAS testing
 

• Analysis of somatic variants of the KRAS gene is established as a technique to predict treatment nonresponse to sotorasib (Lumakras) in individuals with advanced lung adenocarcinoma or in whom an adenocarcinoma component can’t be excluded, if the individual doesn’t have an FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA approved label
• Analysis of plasma for somatic variants of the KRAS gene (e.g., G12C) using an FDA-approved companion diagnostic plasma test to detect ctDNA is considered established as an alternative to tissue biopsy to predict treatment response to sotorasib (Lumakras) in patients with advanced lung adenocarcinoma or in whom an adenocarcinoma component can’t be excluded.
• All other uses of analysis of somatic variants of the KRAS gene in tissue or plasma are considered experimental.

HER2 testing

• Analysis of tumor tissue for somatic alterations in the HER2 (ERBB2) gene is considered established to predict treatment response to an FDA-approved therapy (e.g., fam-trastuzumab deruxtecan-nxki [Enhertu]) in individuals with unresectable or metastatic NSCLC, if the individual doesn’t have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label. 
• Analysis of plasma for somatic alterations in the HER2 (ERBB2) gene using an FDA-approved companion diagnostic plasma to detect ctDNA is considered established as an alternative to tissue biopsy to predict treatment response to an FDA-approved therapy (e.g., fam-trastuzumab deruxtecan-nxki [Enhertu]) in individuals with unresectable or metastatic NSCLC, if the individual doesn’t have any FDA-labeled contraindications to the requested agent and both the agent and ctDNA test are intended to be used consistently with their FDA-approved labels.
• All other uses of analysis of somatic variants of the HER2 (ERBB2) gene in tissue or plasma are considered experimental.

NTRK gene fusion testing

• Larotrectinib and entrectinib are considered established when all the following are met:
• Individual has a confirmatory diagnosis of a solid tumor that is metastatic or when surgical resection is likely to result in severe morbidity.
• The tumor has an NTRK gene fusion without a known acquired resistance variant.
• Individual has progressed following standard of care or failed standard of care for the given solid tumor.
• Must be prescribed by an oncologist or hematologist.
• Individual doesn’t have any FDA-labeled contraindications to the requested agent and is intended to be used consistently with the FDA-approved label.
• Larotrectinib and entrectinib are considered experimental in all other situations.

RET rearrangement testing

• Analysis of tumor tissue for somatic alterations in the RET gene may be considered established to predict treatment response to pralsetinib or selpercatinib in individuals with metastatic NSCLC if the individual doesn’t have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label.
• Analysis of tumor tissue for somatic alterations in the RET gene is considered experimental in all other situations.
• Analysis of plasma for somatic alterations of the RET gene using plasma specimens to detect ctDNA is considered experimental as an alternative to tissue biopsy to predict treatment response to RET inhibitor therapy (e.g., selpercatinib [Retevmo], pralsetinib [Gavreto]) in individuals with NSCLC.

MET exon 14 skipping alteration

• Analysis of tumor tissue for somatic alterations in tissue that leads to MET exon 14 skipping may be considered established to predict treatment response to capmatinib in individuals with metastatic NSCLC, if the individual doesn’t have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label. 
• Analysis of plasma for somatic alteration that leads to MET exon 14 skipping using an FDA-approved companion diagnostic plasma tests to detect ctDNA is considered established as an alternative to tissue biopsy to predict treatment response to MET inhibitor therapy (e.g., capmatinib [Tabrecta]) in patients with NSCLC, if the individual doesn’t have any FDA-labeled contraindications to the requested agent and both the agent and ctDNA test are intended to be used consistently with their FDA-approved labels.
• Analysis of somatic alterations of the MET gene in tissue or plasma is considered experimental in all other situations.

PD-L1 testing

• PD-L1 testing may be considered established to predict treatment response to an FDA-approved therapy (e.g., atezolizumab,nivolumab in combination with ipilimumab or pembrolizumab [Keytruda], or cemiplimab-rwlc [libtayo]) in individuals with NSCLC if the individual doesn’t have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label.
• PD-L1 testing is considered experimental in all other situations.

Tumor mutational burden testing

• May be established for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options (for example, Keytruda). 

Plasma testing when tissue is insufficient

Plasma tests for oncogenic driver variants deemed medically necessary on tissue biopsy may be considered established to predict treatment response to targeted therapy for individuals meeting all the following criteria:

• Individual doesn’t have sufficient tissue for standard molecular testing using formalin-fixed paraffin-embedded tissue.
• Follow-up tissue-based analysis is planned should no driver variant be identified via plasma testing.

Guidelines:

Testing

Next-generation sequencing, or NGS, with a multiple-gene panel test may be considered established when used for diagnostic and prognostic purposes or for guidance in the selection of appropriate FDA-approved therapeutic options.

Proprietary laboratory analyses, or PLA, testing

A PLA test as an FDA-approved companion diagnostic to determine the appropriate therapeutic drug is considered established when all the following criteria are met:

• Biomarker confirmation is required by an FDA-approved or FDA-cleared test prior to initiating treatment (as described in the FDA prescribing label of the therapeutic in the section “Indications and Usage”).
• The test is an FDA-approved companion diagnostic.
• The FDA hasn’t identified a non-PLA test (e.g., an FDA companion diagnostic that is billed by a CPT code) for the same therapeutic indication.

FDA-approved companion diagnostic tests

FDA-approved companion diagnostic tests include:

• Tests that are billed with CPT codes (Note: Most laboratories are able to process these.)
• Proprietary laboratory analyses tests (processed by one specific independent laboratory). Most PLA tests have billing codes that end in “U.”

81401, 81405, 81406     

Experimental procedures:
S3852, 0346U

Basic benefit and medical policy

Genetic testing for Alzheimer’s

Genetic testing for a known familial variant in the presenilin genes, or PSEN, or amyloid-beta precursor protein, or APP, gene associated with autosomal dominant early-onset Alzheimer’s disease in an asymptomatic individual to determine future risk of disease is considered established only for those individuals meeting patient selection criteria and who are seeking preconception genetic counseling.

Genetic testing for variants in presenilin genes or amyloid-beta precursor protein gene associated with autosomal dominant Alzheimer’s disease in an asymptomatic individual to determine future risk of disease is established for individuals who meet patient selection criteria and who are seeking preconception genetic counseling

Genetic testing for confirming a diagnosis of Alzheimer’s disease or determining the risk assessment of developing Alzheimer’s when family planning isn’t an issue is considered experimental.

Exclusionary criteria have been updated, effective July 1, 2023.

Inclusions:

• Targeted genetic testing for known familial variant in the presenilin genes or amyloid-beta precursor protein gene associated with autosomal dominant early-onset Alzheimer’s disease is established when all the following criteria are met:
• The individual has a close relative (first- or second-degree relative) with a known familial variant associated with autosomal dominant early-onset Alzheimer’s disease.
• Results of testing will inform reproductive decision-making.
• Genetic testing for variants in presenilin genes or amyloid-beta precursor protein gene associated with autosomal dominant early-onset Alzheimer’s disease is established in an asymptomatic individual to determine future risk of disease when the following criteria are met:
• The individual has a family history of dementia consistent with autosomal dominant Alzheimer’s disease for whom the genetic status of the affected family members is unavailable.
• Results of testing will inform reproductive decision-making

Genetic counseling by appropriately trained individuals is strongly encouraged to be done in conjunction with the genetic testing for Alzheimer’s disease when the above criteria are met.

Exclusions:

Genetic testing for the risk assessment of Alzheimer’s disease in asymptomatic individuals is considered experimental in all other situations. Genetic testing includes, but isn’t limited to, testing for the apolipoprotein E ε4 allele, or APOE, or triggering receptor expressed on myeloid cells 2, or TREM2.

Genetic testing to guide the initiation or management of a U.S. Food and Drug Administration-approved amyloid-beta targeting therapy (e.g., aducanumab) is considered experimental. Genetic testing includes, but isn’t limited to, testing for the APOE epsilon 4 allele.

92507, 92508, 92521, 92522, 92523, 92524, 92526, 92610

Basic benefit and medical policy

Speech and language pathology rehab

The effectiveness of speech and language pathology services (including voice therapy, swallowing and feeding therapy) has been established. It’s a useful therapeutic option for patients meeting patient selection criteria, effective July 1, 2023.

Inclusionary and exclusionary guidelines:

• Speech and language pathology
• Rehabilitative therapy

Inclusions (must meet all):

Outpatient speech and language rehabilitation is covered when:

• The speech therapy is ordered for the treatment of an organic medical condition resulting from illness, injury, surgery or congenital abnormality, or for the immediate postoperative or convalescent state of the patient’s illness.
• Based on a plan of care, the therapy sessions achieve a specific diagnosis-related goal for an individual who has a reasonable expectation of achieving measurable significant functional improvement in a reasonable and predictable period of time and the therapy sessions provide specific, effective and reasonable treatment for the individual’s diagnosis and physical condition and require the judgment, knowledge and skills of a qualified provider of SLP services due to the complexity and sophistication of the therapy and the medical condition of the individual.
• The treatment is provided or supervised by a licensed speech-language pathologist that is properly contracted with Blue Cross Blue Shield of Michigan.
• Coverage is also available for treatment of an acute exacerbation of a chronic condition that is subject to significant improvement.

Conditions for which rehabilitative speech and language pathology services may be covered include, but aren’t limited to:

• Intensive treatment of a physical disease, trauma, congenital anomalies, therapeutic surgical interventions (e.g., surgery to the neck or throat) or medical interventions (e.g., post- radiation therapy that affects voice, speech, language, fluency, swallowing or cognition).
• Treatment of apraxia or dyspraxia of speech
• Rehabilitation following stroke or transient ischemic attacks
• Rehabilitation post cochlear implantation (aural, speech, language and voice rehabilitation)
• Voice therapy for the pre-surgical or nonsurgical treatment of vocal cord nodules or polyps, vocal cord paresis/paralysis and muscle tension dysphonia
• Speech and language therapy for a documented diagnosis of autism as part of a comprehensive treatment program for autism. (Note: Michigan mandates treatment coverage for the diagnosis and treatment of autism spectrum disorders, including therapeutic care, e.g., services provided by a licensed or certified speech and language pathologist.)
• Speech and language therapy for developmental conditions, including syntactic, semantic or articulation disorders when it’s determined that the condition is severe and not likely to be “self-correcting.”

The following criteria help to identify severe developmental conditions.

Severity criteria for developmental conditions

• The child’s communicative abilities are scored within the severe range on a standardized test of communicative dysfunction.
• The child’s communicative abilities are scored within the severe range on a subtest of a standardized test of communicative dysfunction.
• The child is essentially nonverbal and has a communication deficit that is too severe for standardized testing.
• The child tests at more than one year behind norms for receptive language skills on a standardized test of communicative dysfunction.
• The child tests at more than one year behind for expressive language skills on a standardized test of communicative dysfunction.
• The child tests at more than one year behind norms for articulation proficiency on a standardized test of communicative dysfunction.

If a child’s severity status changes as a consequence of treatment while therapy is in progress, coverage will continue for the remainder of the 60 calendar days or 60 treatments, depending on the member’s benefit.

The medical chart must demonstrate specific treatment goals based on the original and ongoing assessment of the child’s speech or language disorder. Measurement of progress to goals must be documented.

Exclusions:

Check individual certificates relating to exclusions for the diagnosis of developmental disorders. If developmental disorders aren’t specifically listed as excluded conditions in the certificate or contract, then speech therapy may be considered for coverage for this diagnosis if criteria regarding severity are met.

• Longstanding chronic conditions where improvement is unlikely
• Therapy for conditions that are self-correcting with no history of a medical problem such as:
• Language therapy for very young children
• Mild developmental articulation errors that are self-correcting
• Developmental disorders not felt to be severe
• The expectation doesn’t exist that the speech therapy will result in a practical improvement in the level of functioning within a reasonable and predictable time period
• Summer speech therapy programs normally provided by the school system during the regular school year
• Self-correcting conditions, including hoarseness when no medical problem is identified
• Services that don’t require the skills of a qualified provider of SLP services including, but not limited to, the following:
• Treatments that maintain function using routine, repetitious or reinforced procedures that are neither diagnostic nor therapeutic (for example, practicing word drills for developmental articulation errors)
• Procedures that may be carried out effectively by the individual, family or caregivers
• Treatments that aren’t supported in peer-reviewed literature
• Voice therapy associated with gender-affirming services

Habilitative therapy

Inclusions (must meet all of the following):

• The therapy is intended to maintain, develop or improve speech, voice, language or swallowing impairment skills that haven’t (but normally would have) developed or that are at risk of being lost as a result of illness,** injury, loss of a body part or congenital abnormality. An individual would either not be expected to develop the function or would be expected to permanently lose the function without the habilitative service (not merely fluctuate).
• The therapy documentation objectively verifies that, at a minimum, functional status is maintained.
• The services require the judgment, knowledge and skills of a qualified SLP due to the complexity and sophistication of the therapy and the medical condition of the individual.

**Note: Illness includes a wide range of conditions. For purposes of clarity, illness includes, but isn’t limited to, autism spectrum disorder.

Exclusions:

• The therapy is aimed at developing, improving or maintaining functions, which would normally develop with no intervention.
• The therapy is aimed at a function that would be permanently lost as a result of illness, injury, loss of a body part or congenital abnormality whether or not therapy was provided.
• The therapy is considered primarily educational.
• The expectation doesn’t exist that the speech therapy will result in a practical improvement in the level of functioning within a reasonable and predictable period of time or an assessment of progress to goals doesn’t demonstrate “maintenance” of status or capabilities.
• Services that don’t require the skills of a qualified provider of SLP include, but aren’t limited to, the following:
• Treatments that maintain function using routine, repetitious or reinforced procedures that are neither diagnostic nor therapeutic (e.g., practicing word drills for developmental articulation errors)
• Procedures that may be carried out effectively by the individual, family or caregivers
• Routine reevaluations not meeting the above criteria
• Treatments that aren’t supported in peer-reviewed literature
• Duplicate habilitative therapy
• Longstanding chronic conditions 

Swallowing therapy

Inclusions:

• Infants who have a history of being fed through a feeding tube and have never learned to swallow properly
• Patients who are status post neurological injury (e.g., stroke, traumatic brain injury, post-surgery) or radiation who have been noted to have swallowing difficulties
• Patients with congenital (i.e., present at birth) anatomic defects that affect swallowing where functional improvement is predicted (e.g., craniofacial impairments such as cleft palate and cleft lip)
• Patients with chronic conditions (e.g., Parkinson’s disease, amyotrophic lateral sclerosis, etc.) with new onset swallowing difficulties as evidenced by coughing and choking with meals, drooling, etc., may benefit from short-term swallowing therapy.

Exclusions:

• Blue Cross doesn’t cover swallowing/feeding therapy for food aversions because this is considered a behavioral problem. Treatment for behavioral problems isn’t covered under the speech/swallowing therapy benefit.
• Blue Cross doesn’t separately cover neuromuscular stimulation to the muscles of the throat to stimulate inactive swallowing muscles commonly found in patients with dysphagia (known as vital stimulation or VitalStim therapy) and similar non-specific electrical stimulation methods for the treatment of dysphagia unless included in a standard program of dysphagia rehabilitation.
• Blue Cross doesn’t cover deep pharyngeal neuromuscular stimulation, or DPNS.
• Any therapy involving digital stimulation of the mouth, tongue or pharynx in patients not having a specifically diagnosed neuromuscular disorder specifically and adversely effecting swallowing
• Swallowing therapy for deviant swallow or tongue thrust

98975, 98976, 98977, 98980, 98981, 99453, 99454, 99457, 99458, 99091

Basic benefit and medical policy

Remote patient and therapeutic monitoring

The use of remote patient monitoring, or RPM, to collect physiological or psychological data in the medical management of patients is considered established when policy guidelines criteria are met.

The use of RTM in the medical management of an individual’s respiratory or musculoskeletal treatment plan is considered established when criteria are met.

Medical policy criteria have been updated, effective July 1, 2023.

RPM isn’t intended to be an ongoing modality; it’s intended to be an intervention in response to a complication, decompensation or instability of a medical condition. It may be used during the stabilization period, while a patient returns to the baseline of their condition or establishes a new baseline. Once baseline is achieved, RPM is no longer an integral part of a plan of care.

When Blue Cross Blue Shield of Michigan has an existing medical policy that is specific to the technology or device being considered for RPM, that policy supersedes the information in this policy.

Inclusions:

RPM is approved when both of the following are met:

• A physician or qualified health care practitioner has determined that the patient’s condition is one of the following: 
• High risk for decompensation or complication that may lead to hospitalization or another acute intervention
• Requires monitoring for a current or new treatment plan
• There is an order written by a physician or qualified health care practitioner that specifies the medical condition and the length of time for RPM, up to 90 days.

Remote patient monitoring policy guidelines

RPM data

• Data may include common physiological parameters such as heart rate, blood pressure, temperature, respiratory rate, weight, oxygen saturation, peak flow, blood glucose levels, well-being information, etc.

RPM device guidance**

• The device used for data collection must be a medical device, as defined by the FDA.
• The device is non-invasive and has the potential to be connected to a wireless network through Bluetooth, Wi-Fi, or cellular connection.
• The device transmits a patient’s measurements directly to their health care provider or to a monitoring company affiliated with the health care provider.
• Some devices may have the potential to apply algorithms to the data, which result in notifications of parameters that are outside the ideal range for that patient.
• The device used must provide secure, HIPAA-compliant transmission of the data.

**Examples: Devices may include wearable, hand-held, stationary in-home units and digital interfaces. A device may be a clinical electronic thermometer, electrocardiograph, cardiac monitor, pulse oximeter, non-invasive blood pressure monitor, etc.

Services included in RPM

• Initial setup and patient instruction of the monitoring device
• RPM for up to 90 days
• Each 30-day billing cycle must include at least 16 days of monitoring.
• Remote patient monitoring should include daily monitoring or programmed alert transmissions.
• Remote patient monitoring programs can be offered by health plans, hospital systems, medical specialty groups or clinical practices.
• Reimbursement for remote patient monitoring is driven by current Blue Cross payment policy.
• Physician interpretation of the physiological or psychological data.

For RPM services beyond 90 days (all of the following)
 

• There is a physician or qualified health care practitioner order for the continuation of RPM.
• The medical record contains documentation that supports the medical necessity for continued RPM and reflects that the results of the monitoring are used in clinical decision-making and intervention.
• RPM (after the first 90 days) is billed with modifier KX (the provider attests that requirements specified in the medical policy have been met).

Note: Patients with complex, chronic conditions who are at elevated risk for intermittent exacerbations and poor long-term clinical outcomes may benefit from longer-term RPM within the context of a Provider-Delivered Care Management, health plan-administered care management program or an approved provider-organization or vendor-managed care management program.

RPM exclusions:

• RPM isn’t separately billable if performed during a 90-day global payment period (e.g., following surgery).
• The RPM device itself (including any additional apps, software, digital interfaces, etc.) isn’t covered.

Remote therapeutic monitoring, or RTM

Remote therapeutic monitoring services (e.g., musculoskeletal system status, respiratory system status, therapy adherence, therapy response) represent the review and monitoring of data related to signs, symptoms, and a function of therapeutic response. These data may represent objective device generated integrated data or subjective inputs reported by an individual. These data are reflective of therapeutic responses that provide a functionally integrative representative of patient status.   

When Blue Cross Blue Shield of Michigan has an existing medical policy that is specific to the technology or device being considered for RTM, that policy supersedes the information in this policy.

Inclusions:

RTM is approved when there is an order written by a physician or qualified health care practitioner that specifies the medical condition and the length of time for RTM, up to 90 days.

Policy guidelines

RTM data

• Data may be self-reported by the individual or may be electronically captured by a device.
• Data is for a respiratory or musculoskeletal condition.

 
RTM device guidance (when a device is used)**

• The device used for data collection must be a medical device, as defined by the FDA.
• The device used must provide secure, HIPAA-compliant transmission of the data.

**Examples: Devices may include wearable, hand-held and digital interfaces.

Services included in RTM

• Initial set-up and patient instruction of the monitoring device.
• RTM for up to 90 days.
• Each 30-day billing cycle must include at least 16 days of monitoring.
• Reimbursement for remote therapeutic monitoring is driven by current Blue Cross payment policy.

For RTM services beyond 90 days (all the following)

• There is a physician or qualified health care practitioner order for the continuation of RTM.
• The medical record contains documentation that supports the medical necessity for continued RTM and reflects that the results of the monitoring are used in clinical decision-making and intervention.
• RTM after the first 90 days is billed with modifier KX (the provider attests that requirements specified in the medical policy have been met).

Note: Patients with complex, chronic conditions who are at elevated risk for intermittent exacerbations and poor long-term clinical outcomes may benefit from longer-term RPM within the context of a Provider-Delivered Care Management, health plan-administered care management program or an approved provider-organization or vendor-managed care management program.

RTM exclusions:

The RTM device itself (including any additional apps, software, digital interfaces, etc.) isn’t covered

C9399, J3490, J3590

Basic benefit and medical policy

Precedex (dexmedetomidine hydrochloride)

Effective Dec. 16, 2022, Precedex (dexmedetomidine hydrochloride) is covered for the following FDA-approved indications:

• Precedex (dexmedetomidine hydrochloride) is an alpha2-adrenergic receptor agonist indicated for the sedation of non-intubated pediatric patients aged 1 month to younger than 18 years prior to and during non-invasive procedures.

Dosage and administration:

For sedation of pediatric patients during non-invasive procedures: Patients 1 month to younger than 2 years old initiate at 1.5 mcg/kg over 10 minutes followed by a maintenance infusion of 1.5 mcg/kg/hour and titrated to achieve the desired clinical effect with the dosage ranging from 0.5 to 1.5 mcg/kg/hour; patients 2 to younger than 18 years old initiate at 2.0 mcg/kg over 10 minutes followed by a maintenance infusion of 1.5 mcg/kg/hour and titrated to achieve the desired clinical effect with the dosage ranging from 0.5 to 1.5 mcg/kg/hour.

J0714

Basic benefit and medical policy

Avycaz (ceftazidime and avibactam)

Avycaz (ceftazidime and avibactam) is considered established when criteria are met, effective Dec. 20, 2022. Avycaz (ceftazidime and avibactam) has been approved for the following updated indications:

Avycaz is a combination of ceftazidime, a cephalosporin, and avibactam, a beta-lactamase inhibitor, indicated for the treatment of infections caused by designated susceptible Gram-negative microorganisms in adult and pediatric patients age 3 months and older.

Dosage and administration:

Dosage of Avycaz in pediatric patients aged 2 years to less than 18 years with estimated glomerular filtration rate, or eGFR, greater than 50 mL/min/1.73 m2 and 3 months to less than 2 years without renal impairment infection: cIAI, cUTI including pyelonephritis and HABP/VABP       

Age range: 2 years to less than 18 years     
Dose: Avycaz 62.5 mg/kg to a maximum of 2.5 grams (ceftazidime 50 mg/kg and avibactam 12.5 mg/kg to a maximum dose of ceftazidime 2 grams and avibactam 0.5 grams)
           
Age range: 6 months to less than 2 years    
Dose: Avycaz 62.5 mg/kg (ceftazidime 50 mg/kg and avibactam 12.5 mg)
           
Age range: 3 months to less than 6 months 
Dose: Avycaz 50 mg/kg (ceftazidime 40 mg/kg and avibactam 10 mg/kg)

Infusion time/frequency:

Two hours/every eight hours

J3490

Basic benefit and medical policy

Lamzede (velmanase alfa-tycv)

Effective Feb. 16, 2023, Lamzede (velmanase alfa-tycv) is covered for the following FDA-approved indications:

• Lamzede is recombinant human lysosomal alpha-mannosidase indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients.

Dosage and administration:

• For females of reproductive potential, verify that the patient isn’t pregnant prior to initiating treatment.
• Consider pretreating with antihistamines, antipyretics or corticosteroids prior to Lamzede administration.
• Recommended Lamzede dosage is 1 mg/kg (actual body weight) administered once every week as an intravenous infusion.

Dosage forms and strengths:

For injection: 10 mg of velmanase alfa-tycv as a lyophilized powder in a single-dose vial for reconstitution.

Lamzede (velmanase alfa-tycv) isn’t a benefit for URMBT.

J3490

Basic benefit and medical policy

Rykindo (risperidone injection)

Rykindo (risperidone injection) is considered established when criteria are met, effective Jan. 13, 2023.

Rykindo is an atypical antipsychotic indicated:

• For the treatment of schizophrenia in adults.
• As monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.

      Dosage and administration:

• Establish tolerability with oral risperidone before initiating treatment with Rykindo.
• Administer Rykindo by intramuscular, or IM, injection in the gluteal muscle by a health care provider. Don’t administer by any other route.
• Recommended dosage of Rykindo is 25 mg intramuscular every two weeks. Patients not responding to 25 mg may benefit from 37.5 mg or 50 mg. Dosage titration shouldn’t be made more frequently than every four weeks. The maximum recommended dosage should not exceed 50 mg every two weeks.
• Administer the first dose of Rykindo along with seven days of oral risperidone. 
• Renal or hepatic impairment: Titrate with oral risperidone up to at least 2 mg before initiating treatment with Rykindo. A starting dose of 12.5 mg may be appropriate for some patients.

Dosage forms and strengths:

For extended-release injectable suspension: 12.5 mg, 25 mg, 37.5 mg, and 50 mg.

Rykindo (risperidone injection) isn’t a benefit for URMBT.

J9271

Basic benefit and medical policy

Keytruda (pembrolizumab)

Blue Cross Blue Shield of Michigan has approved payment for the off-label use of Keytruda (pembrolizumab) for the treatment of malignant neoplasm of the retroperitoneum.

URMBT is excluded from this change.

J9304

Basic benefit and medical policy

Pemfexy (pemetrexed)

Effective Dec. 14, 2022, Pemfexy (pemetrexed) is payable for the following FDA-approved usage related to metastatic non-squamous non-small cell lung cancer, or NSCLC:

In combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no estimated glomerular filtration rate, or eGFR, or anaplastic lymphoma kinase, or ALK, genomic tumor aberrations

S2202, 36465, 36466, 36470, 36471,
36475, 36476, 36478, 36479, 36482,
36483, 37500, 37700, 37718, 37722,
37735, 37760, 37761, 37765, 37766,
37780, 37785, 76942     

Not covered:

Basic benefit and medical policy

Treatment of varicose veins/venous insufficiency

The treatment of the great or small saphenous veins by surgery (ligation and stripping), endovenous thermal ablation (radiofrequency or laser), microfoam sclerotherapy or cyanoacrylate adhesive is considered established when criteria are met.

The treatment of accessory saphenous veins by surgery (ligation and stripping), endovenous radiofrequency or laser ablation, microfoam sclerotherapy or cyanoacrylate adhesive is considered established when criteria have been met.

The treatment of symptomatic varicose tributaries is considered established when criteria are met.

Surgical ligation (including subfascial endoscopic perforator surgery), endovenous radiofrequency or laser ablation of incompetent perforator veins is considered established as a treatment of leg ulcers associated with chronic venous insufficiency when criteria are met.

Endovenous ablation of varicose veins by mechanochemical (ClariVein^®) is experimental. This procedure hasn’t been scientifically demonstrated to be as safe and effective as conventional treatment.

Endovenous cryoablation of any vein is experimental. This procedure hasn’t been scientifically demonstrated to be as safe and effective as conventional treatment.

Inclusionary and exclusionary criteria have been updated, effective July 1, 2023.

Inclusions:

Great or small saphenous veins

Treatment of the great or small saphenous veins by surgery (ligation and stripping), endovenous thermal ablation (radiofrequency or laser), microfoam sclerotherapy or cyanoacrylate adhesive criteria (must meet both):

• There is demonstrated saphenous reflux and CEAP, known as Clinical, Etiology, Anatomy, Pathophysiology, class C2 or greater.
• There is documentation of one or more of the following indications:
• Ulceration secondary to venous stasis
• Recurrent superficial thrombophlebitis
• Hemorrhage or recurrent bleeding episodes from a ruptured superficial varicosity
• Persistent pain, swelling, itching, burning or other symptoms are associated with saphenous reflux and the symptoms significantly interfere with activities of daily living and conservative management including compression therapy for at least three months hasn’t improved the symptoms.
• Conservative management must include a trial of compression therapy garments.
• Medical reason for compression therapy exemption is documented (e.g., existing chronic limb ischemia, severe musculoskeletal disability, morbid obesity, unusual leg anatomy) .

Accessory saphenous veins

Treatment of accessory saphenous veins by surgery (ligation and stripping), endovenous radiofrequency or laser ablation, microfoam sclerotherapy or cyanoacrylate adhesive criteria (must meet all):

• Incompetence of the accessory saphenous vein is isolated.
• There is demonstrated accessory saphenous reflux.
• There is documentation of one or more of the following indications:
• Ulceration secondary to venous stasis
• Recurrent superficial thrombophlebitis
• Hemorrhage or recurrent bleeding episodes from a ruptured superficial varicosity
• Persistent pain, swelling, itching, burning, or other symptoms are associated with saphenous reflux, and the symptoms significantly interfere with activities of daily living, and conservative management including compression therapy for at least three months has not improved the symptoms.
• Conservative management must include a trial of compression therapy garments,
• Medical reason for compression therapy exemption is documented (e.g., existing chronic limb ischemia, severe musculoskeletal disability, morbid obesity, unusual leg anatomy)

Concurrent treatment of the accessory saphenous veins along with the great or small saphenous veins is considered established when criteria are met for each vein and there is documentation of anatomy showing that the accessory saphenous vein discharged directly into the common femoral vein.

Note: Radiofrequency or laser treatment of varicose veins will be covered for two treatments per lower extremity per patient per lifetime. Any additional claims should be submitted using an NOC code to facilitate evaluation for reimbursement. An unusual situation, such as a demonstrated recanalized vessel, would be considered for reimbursement on an individual case-by-case basis.

Symptomatic varicose tributaries

The following treatments are considered established in the treatment of symptomatic varicose tributaries** of the saphenous veins (none of these techniques has been shown to be superior to another):

• Stab avulsion
• Hook phlebectomy
• Sclerotherapy
• Transilluminated powered phlebectomy

**When performed either at the same time or following prior treatment (surgical, radiofrequency or laser).

Perforator veins

Surgical ligation (including subfascial endoscopic perforator surgery), endovenous radiofrequency or laser ablation of incompetent perforator veins as a treatment of leg ulcers associated with chronic venous insufficiency criteria (must meet all):

• There is demonstrated perforator reflux.
• The superficial saphenous veins (great, small, or accessory saphenous and symptomatic varicose tributaries) have been previously eliminated.
• Ulcers have not resolved following combined superficial vein treatment and compression therapy for at least three months.
• The venous insufficiency isn’t secondary to deep venous thromboembolism.

Telangiectasia

Treatment of telangiectasia, such as spider veins, angiomata and hemangiomata, is considered cosmetic and not covered.

Exclusions:

Techniques for conditions not specifically listed above are considered experimental, including, but not limited to:

• Sclerotherapy techniques, other than microfoam sclerotherapy, of great, small or accessory saphenous veins
• Sclerotherapy of perforator veins
• Sclerotherapy of isolated tributary veins without prior or concurrent treatment of saphenous veins
• Stab avulsion, hook phlebectomy or transilluminated powered phlebectomy of perforator, great or small saphenous, or accessory saphenous veins
• Endovenous radiofrequency or laser ablation of tributary veins
• Mechanochemical ablation of any vein
• Endovenous cryoablation of any vein
• Ligation or ablation of incompetent perforator veins performed concurrently with superficial venous surgery isn’t covered.