Billing chart: Blue Cross highlights medical, benefit policy changes

0648T, 0649T

76391, 81596, 76981, 76982, 76983,
87467, 91200, 0002M, 0003M

Not covered
0014M, 76498,** 81599,** 84999**

Basic benefit and medical policy

Evaluation or monitoring of chronic liver disease

The safety and effectiveness of ultrasonic transient elastography (FibroScan^®) for the evaluation or monitoring of individuals with chronic liver disease have been established. It may be considered a useful diagnostic option when indicated.

Magnetic resonance elastography for the diagnosis and management of advanced hepatic fibrosis or cirrhosis has been established. It may be considered a useful option when indicated.

Multiparametric MRI (LiverMultiScan) is considered a useful option for the diagnosis and management of advanced hepatic fibrosis/cirrhosis.

The use of FibroSURE™ multianalyte assays (HCV FibroSURE, ASH FibroSURE, NASH FibroSURE) in chronic liver disease has been established. It may be considered a useful diagnostic option when indicated.

The use of other noninvasive imaging including, but not limited to, acoustic radiation force impulse imaging, known as ARFI, or real-time tissue elastography, is considered experimental for the evaluation or monitoring of patients with chronic liver disease. While these services may be safe, their clinical utility for this clinical indication hasn’t been determined.

The peer-reviewed medical literature hasn’t demonstrated the clinical utility of other multianalyte assays with algorithmic analyses (e.g., FIBROSpect II, Enhanced Liver Fibrosis Test) for the evaluation or monitoring of patients with chronic liver disease. Therefore, these services are experimental.

Multiparametric MRI procedures are covered for members meeting criteria, effective Sept. 1, 2023.

Benefit policy:

*0648T and *0649T may be payable, effective Sept. 1, 2023.

Inclusions:

Noninvasive imaging techniques:

• Ultrasound transient elastography (FibroSCAN^®), using an FDA-approved probe (e.g., S+ M+ or XL+ Probe), may be considered established for the evaluation or monitoring of chronic liver disease.
• Magnetic resonance elastography, or MRE, may be considered established for the diagnosis or management of advanced hepatic fibrosis or cirrhosis for one of the following:
• Individuals with nonalcoholic fatty liver disease who have high risk for cirrhosis due to advanced age, obesity, diabetes or alanine aminotransferase, or ALT, level more than twice the upper limit of normal.
• Individuals with other established chronic liver diseases when ultrasound elastography cannot be performed or is non-diagnostic.

• Multiparametric MRI (LiverMultiScan) is considered a useful option for the diagnosis and management of advanced hepatic fibrosis/cirrhosis when diagnostic testing such as an ultrasound is inconclusive or non-diagnostic.

Multianalyte assays:
 

• A FibroSURE™ multianalyte assay (either HCV FibroSURE™, ASH FibroSURE™ or NASH FibroSURE™) may be considered established for the evaluation or monitoring of chronic liver disease.

Exclusions:

Noninvasive imaging techniques:

• Ultrasound transient elastography in individuals with ascites
• Acoustic radiation force impulse imaging, or ARFI
• Real-time tissue elastography
• Use of ultrasound elastography to differentiate benign from malignant liver lesions

Multianalyte assays:

• Multianalyte assays with algorithmic analyses for the evaluation or monitoring of patients with chronic liver disease not listed above (e.g., Fibrospect, ELF, etc. – this is not a complete list)

32850, 32851, 32852, 32853, 32854, 32855, 32856, S2060, S2061

Basic benefit and medical policy

Lung and lobar lung transplants

The safety and effectiveness of lung or lobar lung transplantation have been established. It may be considered a useful therapeutic option for carefully selected adults, children and adolescents with irreversible, progressively disabling, primary or secondary end-stage pulmonary disease. It’s a useful therapeutic option for individuals meeting selection guidelines.

The safety and effectiveness of lung and lobar lung re-transplantation have been established. It may be considered a useful therapeutic option for carefully selected adults, children and adolescents following an initial failed lung or lobar lung transplantation, and who meet criteria for lung transplantation. It’s a useful therapeutic option for individuals meeting selection guidelines.

Lung or lobar lung transplantation is considered experimental in all other situations.

Inclusionary criteria have been updated, effective Nov. 1, 2023.

Note: Final patient eligibility for transplant is subject to the judgment and discretion of the requesting transplant center.

Inclusions:

Lung specific-background information:

Bilateral lung transplantation is typically required when chronic lung infection disease is present, that is, associated with cystic fibrosis and bronchiectasis. Some, but not all, cases of pulmonary hypertension will require bilateral lung transplantation. Bronchiolitis obliterans is associated with chronic lung transplant rejection, and thus may be the etiology of a request for lung re-transplantation.

Indications for lung and lobar lung transplantation include, but are not limited to, irreversible, chronic lung diseases for which there is no further medical or surgical therapy available, and survival is limited. Lung transplantation is rarely an option for acutely, critically ill patients. The most common illnesses that may result in irreversible, progressively disabling, primary or secondary end-stage pulmonary disease include, but are not limited to:

• Alpha-1 antitrypsin deficiency
• Asbestosis
• Benign hypertensive heart disease without congestive heart failure
• Bilateral bronchiectasis
• Bronchiolitis obliterans
• Bronchopulmonary dysplasia
• Chronic airway obstruction, not elsewhere classified
• Chronic obstructive pulmonary disease
• Chronic respiratory conditions due to fumes and vapors
• Chronic respiratory disease arising in the perinatal period
• Coal workers’ pneumoconiosis
• Congenital bronchiectasis
• Cystic fibrosis with meconium ileus (double lung transplanted)
• Cystic fibrosis without mention of meconium ileus (double lung transplanted)
• Eisenmenger’s syndrome
• Emphysema
• Eosinophilic granuloma
• Idiopathic pulmonary fibrosis
• Idiopathic fibrosing alveolitis
• Interstitial pulmonary fibrosis
• Lung involvement in other diseases classified elsewhere
• Lymphangiomyomatosis
• Neoplasm of uncertain behavior of trachea, bronchus and lung
• Other chronic bronchitis
• Other deficiencies of circulating enzymes
• Other emphysema
• Other specified disorders of metabolism
• Pneumoconiosis due to other inorganic dust
• Pneumoconiosis due to other silica or silicates
• Pneumoconiosis, unspecified
• Pneumonopathy due to inhalation of other dust
• Post inflammatory pulmonary fibrosis
• Primary pulmonary hypertension
• Pulmonary fibrosis
• Pulmonary embolism and infarction
• Pulmonary hypertension due to cardiac disease
• Recurrent pulmonary embolism
• Sarcoidosis
• Scleroderma
• Systemic sclerosis
• Tuberculosis fibrosis of lung
• Ventricular septal defect

General exclusions (contraindications):

Potential contraindications are subject to the judgment of the transplant center:

• Known current malignancy, or history of recent malignancy
• Untreated systemic infection making immunosuppression unsafe, including chronic infection
• Other irreversible end-stage disease not attributed to heart or lung disease
• Stable systemic disease that could be exacerbated by immunosuppression
• Psychosocial conditions or chemical dependency affecting the ability to adhere to therapy as defined by the transplant program

Policy specific (one of the following):

• Coronary artery disease not amenable to percutaneous intervention or bypass grafting, or associated with significant impairment of left ventricular function^a
• Colonization with highly resistant or highly virulent bacteria, fungi or mycobacteria.

^aSome patients may be candidates for combined heart and lung transplantation.

The consideration for risk-reducing procedure (e.g., CABG) performed at the same time as the organ transplant is a consideration based on the medical consultation review.

Patients must meet United Network for Organ Sharing guidelines for a lung allocation score greater than zero.

Exclusions:

Patients not meeting the above inclusionary guidelines.

47133, 47135, 47140, 47141, 47142, 47143, 47144, 47145, 47146, 47147, 47399

Basic benefit and medical policy

Liver transplant

The safety and effectiveness of liver transplantation and retransplantation have been established. It may be considered a useful therapeutic procedure in carefully selected patients with end-stage liver failure due to irreversibly damaged livers.

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

Inclusionary and exclusionary guidelines:

Note: Liver transplants (cadaver or living donor) are covered for the indications listed below when adolescents or adults have met the requesting transplanting center’s selection criteria and one of the following:

1. Model of End-stage Liver Disease, or MELD, score greater than 10 (<10 score may be considered when appropriate)
2. Approval for transplant received from the United Network for Organ Sharing, or UNOS, Regional Review Board.

Inclusions for liver transplant:

1. Patients with end-stage liver disease. Etiologies of end-stage liver disease include, but are not limited to, the following:
1. Hepatocellular diseases
• Alcoholic liver disease
• Viral hepatitis (either A, B, C or non-A, non-B)
• Autoimmune hepatitis
• Alpha-1 antitrypsin deficiency
• Hemochromatosis
• Non-alcoholic steatohepatitis
• Protoporphyria
• Wilson’s disease
2. Cholestatic liver diseases
• Primary biliary cirrhosis
• Primary sclerosing cholangitis with development of secondary biliary cirrhosis
• Biliary atresia
3. Vascular disease
• Budd-Chiari syndrome
4. Neuroendocrine tumors metastatic to the liver (see NET criteria below)
5. Primary hepatocellular carcinoma
6. Inborn errors of metabolism
7. Trauma and toxic reactions
8. Miscellaneous indications
• Familial amyloid polyneuropathy
2. Patients with polycystic disease of the liver who have massive hepatomegaly causing obstruction or functional impairment.
3. Pediatric patients with nonmetastatic hepatoblastoma
4. Patients with unresectable hilar cholangiocarcinoma if additional inclusionary criteria are met (see below).

Cholangiocarcinoma — (Available online at optn.transplant.hrsa.gov/.**

**Blue Cross Blue Shield of Michigan doesn’t own or control this website.
 
Note: The consideration for a risk-reducing procedure (e.g., CABG) performed at the same time as the organ transplant is a consideration based on the medical consultation review.

Criteria for liver transplant patient selection for neuroendocrine tumors, or NET, metastatic to the liver (MELD exception applications for patients with NET):

1. Recipient age <60 years
2. Resection of primary malignancy and extra-hepatic disease without any evidence of recurrence at least six months prior to MELD exception request.
3. Liver-limited neuroendocrine liver metastasis, or NLM, bi-lobar, not amenable to resection. Tumors in the liver should meet the following radiographic characteristics:
1. CT scan: Triple phase contrast
1. Lesions may be seen on only one of the three phases
2. Arterial phase: May demonstrate a strong enhancement
3. Large lesions can become necrotic/calcified
2. MRI appearance:
1. Liver metastasis are hypodense on T1 and hypervascular in T2 wave images
2. Diffusion restriction
3. Majority of lesions are hypervascular on arterial phase with wash-out during portal venous phase IV. Hepatobiliary phase post Gadoxetate Disodium (Eovist): Hypointense lesions are characteristics of NET
4. Consider for exception only those with a NET of gastro-entero-pancreatic, or GEP, origin tumors with portal system drainage. Note: Neuroendocrine tumors whose primary is located in the lower rectum, esophagus, lung, adrenal gland and thyroid aren’t candidates for automatic MELD exception.
5. Lower — intermediate grade following the WHO classification. Only well differentiated (Low grade, G1) and moderately differentiated (intermediate grade G2). Mitotic rate <20 per 10 HPF with less than 20% ki-67 positive markers.
6. Tumor metastatic replacement should not exceed 50% of the total liver volume
7. Negative metastatic workup should include one of the following:
• Positron emission tomography, or PET, scan
• Somatostatin receptor scintigraphy
• Gallium-68 (68Ga) labeled somatostatin analogue 1,4,7,10-tetraazacyclododedecane-N, N′, N″,N′″-tetraacetic acid (DOTA)-D-Phe1-Try3–octreotide (DOTATOC), or other scintigraphy to rule out extra-hepatic disease, especially bone metastasis.

Note: Exploratory laparotomy or laparoscopy isn’t required prior to MELD exception request.

8. No evidence for extra-hepatic tumor recurrence based on metastatic radiologic workup at least three months prior to MELD exception request (submit date).
9. Recheck metastatic workup every three months for MELD exception increase consideration by the Regional Review Board. Occurrence of extra-hepatic progression – for instance lymph-nodal Ga68 positive locations – should indicate de-listing. Patients may come back to the list if any extra-hepatic disease is zeroed and remained so for at least six months.
10. Presence of extra-hepatic solid organ metastases (i.e., lungs, bones) should be a permanent exclusion criteria.

Exclusions for liver transplant:

• Patients with intrahepatic cholangiocarcinoma
• Patients with hepatocellular carcinoma that has extended beyond the liver
• Patients with ongoing alcohol or drug abuse. (Evidence for abstinence may vary among liver transplant programs, but generally, a minimum of three months is required or enrollment in a sanctioned program.)
• Patients with conditions not included in the inclusions section.
• Severe cardiac or pulmonary disease
• AIDS
• Uncontrolled sepsis
• Anatomic abnormality that precludes liver transplantation 
• Hemangiosarcoma
• Persistent noncompliance

Inclusions for liver retransplant:

Liver retransplant is established for patients with:

• Primary graft non-function
• Hepatic artery thrombosis
• Chronic rejection
• Ischemic type biliary lesions after donation after cardiac death
• Recurrent non-neoplastic disease causing late graft failure

Exclusions for liver retransplant:

Patients not meeting above inclusionary criteria for retransplant.

Potential contraindications for transplant or retransplant:

Note: Final patient eligibility for transplant is subject to the judgment and discretion of the requesting transplant center.

Potential contraindications represent situations where proceeding with transplant isn’t advisable in the context of limited organ availability. Contraindications may evolve over time as transplant experience grows in the medical community. Clinical documentation supplied to the health plan should demonstrate that attending staff at the transplant center have considered all contraindications as part of their overall evaluation of potential organ transplant recipients and have decided to proceed.

• Known current malignancy or history of recent malignancy
• Untreated systemic infection making immunosuppression unsafe, including chronic infection
• Other irreversible end-stage disease not attributed to liver disease
• Systemic disease that could be exacerbated by immunosuppression
• Psychosocial conditions or chemical dependency affecting ability to adhere to therapy as defined by the transplant program

Liver-specific guidelines/background information:

Patients with liver disease related to alcohol or drug abuse must be actively involved in a substance abuse treatment program consistent with DALLAS consensus criteria or the Sustained Alcohol Use Post-Liver Transplant, or SALT, criteria/score.

Tobacco consumption is a contraindication.

Patients with polycystic disease of the liver don’t develop liver failure but may require transplantation due to the anatomic complications of a hugely enlarged liver. The MELD/PELD score may not apply to these cases. One of the following complications should be present:

• Enlargement of liver impinging on respiratory function
• Extremely painful enlargement of liver
• Enlargement of liver significantly compressing and interfering with function of other abdominal organs

Patients with familial amyloid polyneuropathy don’t experience liver disease, per se, but develop polyneuropathy and cardiac amyloidosis due to the production of a variant transthyretin molecule by the liver. The MELD/PELD exception criteria and scores may apply to these cases. Candidacy for liver transplant is an individual consideration based on the morbidity of the polyneuropathy. Many patients may not be candidates for liver transplant alone due to coexisting cardiac disease.

Criteria used for patient selection of hepatocellular carcinoma patients eligible for liver transplant include the Milan criteria, which is considered the criterion standard, the University of California, San Francisco, or UCSF, expanded criteria, and UNOS criteria. 

Notes:

Milan criteria: A single tumor 5 cm or less in diameter or 2 to 3 tumors 3 cm or less

UCSF expanded criteria: A single tumor 6.5 cm or less or up to 3 tumors 4.5 cm or less, and a total tumor size of 8 cm or less

UNOS T2 criteria: A single tumor 1 cm or greater and up to 5 cm or less in diameter or 2 to 3 tumors 1 cm or greater and up to 3 cm or less and without extrahepatic spread or macrovascular invasion. UNOS criteria, which were updated in 2013, may prioritize T2 HCC that meet specified staging and imaging criteria by allocating additional points equivalent to a MELD score predicting a 15% probability of death within three months. 

Patients with hepatocellular carcinoma, or HCC, are appropriate candidates for liver transplant only if the disease remains confined to the liver. Therefore, the patient should be periodically monitored while on the waiting list, and if metastatic disease develops, the patient should be removed from the transplant waiting list. In addition, at the time of transplant, a backup candidate should be scheduled. If locally extensive or metastatic cancer is discovered at the time of exploration prior to hepatectomy, the transplant should be aborted, and the backup candidate scheduled for transplant.

Note: Liver transplantation for those with T3 HCC isn’t prohibited by UNOS guidelines, but these patients don’t receive any priority on the waiting list. All patients with HCC awaiting transplantation are reassessed at three-month intervals. Those whose tumors have progressed and are no longer T2 tumors will lose the additional allocation points.

Additionally, nodules identified through imaging of cirrhotic livers are given a class 5 designation. Class 5B and 5T nodules are eligible for automatic priority. Class 5B criteria consist of a single nodule 2 cm or larger and up to 5 cm (T2 stage) that meets specified imaging criteria. Class 5T nodules have undergone subsequent locoregional treatment after being automatically approved on initial application or extension. A single class 5A nodule (>1 cm and <2 cm) corresponds to T1 HCC and doesn’t qualify for automatic priority. However, combinations of class 5A nodules are eligible for automatic priority if they meet stage T2 criteria. Class 5X lesions are outside of stage T2 and aren’t eligible for automatic exception points. Nodules less than 1 cm are considered indeterminate and aren’t considered for additional priority. Therefore, the UNOS allocation system provides strong incentives to use locoregional therapies to downsize tumors to T2 status and to prevent progression while on the waiting list.

HIV-positive patients who meet the following criteria, as stated in the 2001 guidelines of the American Society of Transplantation, could be considered candidates for liver transplantation:

• CD4 count >200 cells per cubic millimeter for >6 months
• Undetectable HIV-1 RNA
• On stable antiretroviral therapy >3 months
• No other complications from AIDS (e.g., opportunistic infection, including aspergillus, tuberculosis, coccidioidomycosis, resistant fungal infections, Kaposi sarcoma, other neoplasm)
• Meeting all other criteria for transplantation

Cholangiocarcinoma:

According to the OPTN policy on liver allocation, candidates with cholangiocarcinoma, or CCA, meeting the following criteria will be eligible for a MELD/PELD exception with a 10% mortality equivalent increase every three months:

• Centers must submit a written protocol for patient care to the OPTN/UNOS Liver and Intestinal Organ Transplantation Committee before requesting a MELD score exception for a candidate with CCA. This protocol should include selection criteria, administration of neoadjuvant therapy before transplantation, and operative staging to exclude patients with regional hepatic lymph node metastases, intrahepatic metastases or extrahepatic disease. The protocol should include data collection as deemed necessary by the OPTN/UNOS Liver and Intestinal Organ Transplantation Committee.
• Candidates must satisfy diagnostic criteria for hilar CCA: malignant-appearing stricture on cholangiography and one of the following: carbohydrate antigen 19-9 100 U/mL, or and biopsy or cytology results demonstrating malignancy, or aneuploidy. The tumor should be considered unresectable on the basis of technical considerations or underlying liver disease (e.g., primary sclerosing cholangitis).
• If cross-sectional imaging studies (computed tomography scan, ultrasound, magnetic resonance imaging) demonstrate a mass, the mass should be less than 3 cm.
• Intra- and extrahepatic metastases should be excluded by cross-sectional imaging studies of the chest and abdomen at the time of initial exception and every three months before score increases.
• Regional hepatic lymph node involvement and peritoneal metastases should be assessed by operative staging after completion of neoadjuvant therapy and before liver transplantation. Endoscopic ultrasound-guided aspiration of regional hepatic lymph nodes may be advisable to exclude patients with obvious metastases before neoadjuvant therapy is initiated.
• Transperitoneal aspiration or biopsy of the primary tumor (either by endoscopic ultrasound, operative, or percutaneous approaches) should be avoided because of the high risk of tumor seeding associated with these procedures.

Donor criteria: Living donor liver transplant

Donor morbidity and mortality are prime concerns in donors undergoing right lobe, left lobe or left lateral segment donor partial hepatectomy as part of living-donor liver transplantation. Partial hepatectomy is a technically demanding surgery, the success of which may be related to the availability of an experienced surgical team. In 2000, the American Society of Transplant Surgeons proposed the following guidelines for living donors:

• Should be healthy individuals who are carefully evaluated and approved by a multidisciplinary team, including hepatologists and surgeons, to ensure that they can tolerate the procedure
• Should undergo an evaluation to ensure that they fully understand the procedure and associated risks
• Should be of legal age and have sufficient intellectual ability to understand the procedures and give informed consent
• Should be emotionally related to the recipients
• Must be excluded if the donor is felt or known to be coerced
• Needs to have the ability and willingness to comply with long-term follow-up

Established

Basic benefit and medical policy

Cochlear implant

The safety and effectiveness of U.S. Food and Drug Administration-approved bilateral and unilateral cochlear implants and associated hybrid cochlear implant devices have been established. The implants may be considered useful therapeutic options when indicated.

Inclusionary criteria have been updated, effective Nov. 1, 2023.

Inclusions:

Unilateral or bilateral cochlear implantation with an FDA-approved cochlear implant is considered an established, safe and effective therapy for individuals who are 9 months or older and who meet one of the following criteria:

• Unilateral or bilateral moderate to profound pre- or post-lingual sensorineural hearing loss
• Limited or no benefit from hearing aids, defined as an aided monosyllabic word score of less than or equal to 50% correct in the ear to be implanted

Replacement of internal or external components in a small subset of members may be considered established when all of the following are met:

• There is an inadequate response to existing components to the point of one of the following:
• Interfering with the individual’s activities of daily living
• The component or components are no longer functional and can’t be repaired

• Copies of original medical records must be submitted either hard copy or electronically to support medical necessity.

Cochlear implant with a hybrid device that includes the hearing aid integrated into the external sound processor of the cochlear implant (e.g., the Nucleus^® Hybrid L24 Cochlear Implant System) may be considered established for patients 18 years and older who meet all the following criteria:

• Bilateral severe-to-profound high-frequency sensorineural hearing loss with residual low-frequency hearing sensitivity
• Receive limited benefit from appropriately fit bilateral hearing aids
• Have all the following hearing thresholds:
• Low-frequency hearing thresholds no poorer than 60 dB hearing level up to and including 500 Hz (averaged over 125, 250, and 500 Hz) in the ear selected for implantation
• Severe to profound mid-to-high frequency hearing loss (threshold average of 2000, 3000, and 4000 Hz ≥75 dB hearing level) in the ear to be implanted
• Moderately severe to profound mid-to-high frequency hearing loss (threshold average of
• 2000, 3000, and 4000 Hz ≤ 60 dB hearing level) in the contralateral ear
• Aided consonant-nucleus-consonant word recognition score from 10% to 60% in the ear to be implanted in the preoperative aided condition and in the contralateral ear will be equal to or better than that of the ear to be implanted but not more than 80% correct.

In certain situations, implantation consideration may be given before 9 months of age. One scenario post meningitis when cochlear ossification may preclude implantation. Another is in cases with a strong family history, because establishing a precise diagnosis is less uncertain. However, these aren’t the only examples where consideration may be given.

Cochlear implantation outside these guidelines may also be considered medically necessary if the patient is diagnosed with auditory neuropathy spectrum disorder with limited or no benefit from hearing aids.

Contraindications to cochlear implantation may include deafness due to lesions of the eighth cranial (acoustic) nerve, central auditory pathway or brainstem; active or chronic infections of the external or middle ear, and mastoid cavity or tympanic membrane perforation. Cochlear ossification may prevent electrode insertion, and the absence of cochlear development as demonstrated on computed tomography scans remains an absolute contraindication.

Exclusions:

• Upgrades of an existing, functioning external system to achieve aesthetic improvement, such as smaller profile components or a switch from a body-worn, external sound processor to a behind-the-ear model
• Replacement of internal or external components solely for the purpose of upgrading to a system with advanced technology or to a next-generation device
• Non-FDA-approved devices or indications

84145

Basic benefit and medical policy

Procalcitonin testing

The safety and effectiveness of procalcitonin testing, or PCT, for confirmation and monitoring of bacterial infections and sepsis in initiating or discontinuing antibiotics in specified patient populations have been established. 

The medical policy statement and inclusionary and exclusionary criteria have been updated, effective Nov. 1, 2023.

Inclusionary and exclusionary guidelines:

Inclusions:

For use in the adult and pediatric population in the inpatient/emergency department setting for the following conditions:

• For use in individuals with lower respiratory tract infections (e.g., pneumonia) for initiating or discontinuing antibiotic therapy
• For use in critically ill individuals with sepsis as a guidance for discontinuation of antibiotic therapy

Exclusions:

The use of procalcitonin testing for the following conditions is experimental because of insufficient evidence of its effectiveness. Note: This isn’t an all-inclusive list.

These indications include the following diagnoses of:

• Surgical infections (including monitoring of the infection)
• Appendicitis
• Chronic renal insufficiency
• Infective endocarditis
• Non-alcoholic fatty liver disease
• Parapneumonic pleural effusions
• Spontaneous bacterial peritonitis
• Pancreatitis
• Pyelonephritis

It’s also considered experimental for:

• Measuring the differentiation of infection from other inflammatory complications following stem cell transplantation
• Predicting outcomes in people with acute coronary syndrome
• Prediction of neurological deficits following carotid endarterectomy

Established
92652, 92653, 95829, 95867, 95868, 95925, 95926, 95927, 95938, 95940, 95955, G0453

Experimental

Basic benefit and medical policy

Intraoperative neurophysiologic monitoring

Intraoperative neurophysiologic monitoring, which includes somatosensory-evoked potentials, motor-evoked potentials using transcranial electrical stimulation, brainstem auditory-evoked potentials, EMG of cranial nerves, EEG and electrocorticography, is established during spinal, intracranial or vascular procedures.

Intraoperative neurophysiologic monitoring of the recurrent laryngeal nerve is established for individuals meeting inclusionary guidelines.

Intraoperative monitoring of visual-evoked potentials is considered experimental.

Intraoperative monitoring of motor-evoked potentials using transcranial magnetic stimulation is considered experimental.

Inclusionary criteria have been updated, effective Nov. 1, 2023.

Inclusions:

The following types of intraoperative monitoring are appropriate when performed during spinal, intracranial or vascular surgeries or procedures:

• Somatosensory-evoked potentials
• Motor-evoked potentials using transcranial electrical stimulation
• Brainstem auditory-evoked potentials
• Electromyogram, or EMG, of cranial nerves
• Electroencephalogram, or EEG
• Electrocorticography, or ECoG

Notes:

• Only qualified people can perform this type of monitoring.
• Train-of-four monitoring is considered integral (not separately payable) to intraoperative procedures to measure the strength of anesthetic neuromuscular blockade.

Intraoperative neurophysiologic monitoring of the recurrent laryngeal nerve is established in individuals undergoing: 

• High-risk thyroid or parathyroid surgery, including:
• Total thyroidectomy
• Repeat thyroid or parathyroid surgery
• Surgery for cancer
• Thyrotoxicosis
• Retrosternal or giant goiter
• Thyroiditis
• Anterior cervical spine surgery associated with any of the following increased risk situations:
• Prior anterior cervical surgery, particularly revision anterior cervical discectomy and fusion, revision surgery through a scarred surgical field, reoperation for pseudarthrosis or revision for failed fusion
• Multilevel anterior cervical discectomy and fusion
• Preexisting recurrent laryngeal nerve pathology, when there is residual function of the recurrent laryngeal nerve

Exclusions:

• Intraoperative monitoring of visual-evoked potentials
• Intraoperative monitoring of motor-evoked potentials using transcranial magnetic stimulation
• Intraoperative EMG and nerve conduction velocity monitoring during surgery on the peripheral nerves
• Intraoperative neurophysiologic monitoring of the recurrent laryngeal nerve during anterior cervical spine surgery not meeting the criteria above or during esophageal surgeries
• Intraoperative monitoring performed during any surgical procedure not specified in the inclusions

A4230, A4232, A4224, A4225, A4226, A9274, E0784, E0787, S1034, S1035, S1036, S1037, 0740T, 0741T

Basic benefit and medical policy

Artificial pancreas devices

The safety and effectiveness of FDA-approved artificial pancreas device systems with a low glucose suspend feature and hybrid closed loop systems may be considered established in patients with insulin-requiring diabetes who meet specified patient selection criteria. It’s a useful therapeutic option for selected patients.

The safety and effectiveness of an FDA-approved closed loop insulin delivery system (e.g., iLet bionic pancreas) may be considered established in individuals with Type 1 diabetes who meet specified patient selection criteria. It’s a useful therapeutic option for selected patients.

The safety and effectiveness of an FDA-approved insulin guidance system (e.g., D-Nav) as an aid in optimizing glycemic control may be considered established for individuals with insulin-dependent Type 2 diabetes. It’s a useful therapeutic option for selected patients.

The medical policy statement and inclusionary and exclusionary criteria have been updated, effective Nov. 1, 2023.

Inclusionary and exclusionary guidelines:

Inclusions:
 
Use of FDA-cleared or approved artificial pancreas device systems with a low-glucose suspend feature may be considered established in patients with insulin-requiring diabetes who meet all of the following criteria:

• Age 6 or older
• Insulin-requiring diabetes
• A history of one level 3 (glucose < 54 mg/dl [3.0mmol/L]) hypoglycemic event characterized by altered mental or physical state requiring third-party assistance for treatment of hypoglycemia (i.e., hypoglycemia unawareness) or recurrent level 2 (glucose < 54 mg/dl [3.0mmol/L]) hypoglycemic events despite multiple attempts to adjust medications or modify the diabetes treatment plan (e.g., nocturnal hypoglycemia)

Use of an FDA-cleared or approved automated insulin delivery system (artificial pancreas device system) designated as hybrid closed loop insulin delivery system (with low glucose suspend and suspend before low features) is considered established in patients with insulin requiring diabetes who meet all of the following criteria:

• Age 6 and older
• Insulin-requiring diabetes
• A history of one level 3 (glucose < 54 mg/dl [3.0mmol/L]) hypoglycemic event characterized by altered mental and/or physical state requiring third-party assistance for treatment of hypoglycemia (i.e., hypoglycemia unawareness or recurrent level 2 (glucose < 54 mg/dl [3.0mmol/L]) hypoglycemic events despite multiple attempts to adjust medications or modify the diabetes treatment plan (e.g., nocturnal hypoglycemia)

Or

• Age 2 to 6 years
• Clinical diagnosis of Type 1 diabetes for three months or more
• Glycated hemoglobin level <10.0%
• Minimum daily insulin requirement (total daily dose) of greater than or equal to 8 units

Use of an FDA-cleared or approved automated insulin delivery system (artificial pancreas device system) designated as a closed-loop insulin delivery system may be considered established in individuals with Type 1 diabetes who meet all of the following criteria:

• Age 6 years and older
• Clinical diagnosis of Type 1 diabetes for 12 months or more
• Using insulin for at least 12 months
• Diabetes managed using the same regimen (either pump or multiple daily injections, with or without continuous glucose monitoring) for three months or longer

Exclusions:

• Use of an artificial pancreas device system is considered experimental in all other situations.
• Use of an artificial pancreas device system not cleared or approved by the FDA is experimental

H0031, H0032, H2014, H2019, S5108, S5111, 0362T, 0373T, 97151, 97152, 97153, 97154, 97155, 97156, 97157, 97158

Basic benefit and medical policy

Autism spectrum disorders

The effectiveness of treatment for autism spectrum disorder has been established. It may be a useful therapeutic option when inclusionary and certificate guidelines are met.

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

Inclusions:

• Full diagnostic criteria for autism spectrum disorder, as published in the most recent edition of the American Psychiatric Association’s Diagnostic and Statistical Manual, are met.
• The maladaptive behavior must affect the individual’s personal safety, the safety of others within the individual’s environment or must significantly interfere with the individual’s ability to function.
• Services in Michigan must be provided or supervised by one of the following:
• A clinician who is a licensed behavior analyst, or LBA
• A psychiatrist who has the appropriate training
• A licensed psychologist who has the appropriate education, training and experience
• A person who holds a license, certificate or registration that authorizes them to perform services included in applied behavior analysis

Services outside of Michigan must be provided by a clinician who meets their state requirements to provide ABA therapy.

• Interventions:
• Are individually centered
• Define target behaviors
• Record objective measures of baseline levels and progress
• Identify and documents specific interventions and techniques
• Document transitional and discharge plans

Exclusions:

• Individuals who don’t meet the diagnostic criteria based on the most recent criteria by the American Psychiatric Association (i.e., most current version of the Diagnostic and Statistical Manual)
• In Michigan, therapy delivered or supervised by clinicians who aren’t licensed behavior analysts or those who don’t meet state requirements to provide ABA therapy
• Outside of Michigan, therapy delivered or supervised by clinicians who don’t meet their state requirements to provide ABA therapy

Autism services allowed via telemedicine synchronous care:

• Specific autism services allowed via telemedicine synchronous care are noted in the CPT section.
• Adaptive behavior interventions (*97153) are allowed if the individual meets appropriateness criteria:
• At a minimum, the individual should exhibit basic skills of joint attention, basic discrimination, basic echoic and basic motor imitation. The individual should be able to follow common one-step instructions, participate in sessions with limited caregiver assistance and sit independently at a computer or tablet for 8 to 10 minutes. Safety concerns and challenging behaviors must be minimal.
• For complete guidelines to consider, see the document titled Guidelines for autism interventions delivered via telemedicine. Autism services provided via telemedicine may not be effective for all individuals. When services are provided via telemedicine and the individual doesn’t show progress, it is expected that the interventions would be modified to face-to-face interactions.

Autism services delivered via telemedicine are synchronous care only; asynchronous care isn’t appropriate for autism services.

J1741

Basic benefit and medical policy

Caldolor (ibuprofen injection)

The FDA has updated the indications for Caldolor (ibuprofen injection). This was effective May 11, 2023.

Caldolor is indicated in adults and pediatric patients aged 3 months and older for the management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics. It’s also approved for the reduction of fever.

Dosage and administration:

Pediatric (pain and fever) aged 3 months to less than 6 months: 10 mg/kg intravenously over 10 minutes up to a maximum single dose of 100 mg

J3490

Basic benefit and medical policy

Cyfendus (anthrax vaccine adsorbed, adjuvanted)

Cyfendus (anthrax vaccine adsorbed, adjuvanted) is considered established, effective July 20, 2023. 

Cyfendus (anthrax vaccine adsorbed, adjuvanted) is a vaccine indicated for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in people ages 18 through 65 when administered in conjunction with recommended antibacterial drugs.

The efficacy of Cyfendus for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax.

Dosage and administration:
 
For intramuscular injection only.
Administer two doses (0.5 mL each) intramuscularly two weeks apart.

Dosage forms and strengths:
 
Suspension for injection; each dose is 0.5 mL.

This drug isn’t a benefit for URMBT.

J3490

Basic benefit and medical policy

Elevidys (delandistrogene moxeparvovec-rokl)

Elevidys (delandistrogene moxeparvovec-rokl) is considered experimental. This policy is effective June 22, 2023.

J9177

Basic benefit and medical policy

Padcev (enfortumab vedotin-ejfv)

Effective April 3, 2023, Padcev (enfortumab vedotin-ejfv), procedure code J9177, is payable for the following indication:

• Padcev (enfortumab vedotin-ejfv) is a Nectin-4-directed antibody and microtubule inhibitor conjugate indicated in combination with pembrolizumab for the treatment of adult patients with locally advanced or metastatic urothelial cancer who aren’t eligible for cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Dosage information:

The recommended dose of Padcev (enfortumab vedotin-ejfv) in combination with pembrolizumab is 1.25 mg/kg (up to a maximum dose of 125 mg) given as an intravenous infusion over 30 minutes on Days 1 and 8 of a 21-day cycle until disease progression or unacceptable toxicity.

J9312
Q5115
Q5119
Q5123

Basic benefit and medical policy

Rituxan (rituximab)

Blue Cross Blue Shield of Michigan has approved payment for the off-label use of Rituxan (rituximab) to treat unspecified nephritic syndrome with diffuse membranous glomerulonephritis.

URMBT groups are excluded from this change.