Billing chart: Blue Cross highlights medical, benefit policy changes

00170,** 41899** **Unlisted procedure code

Dental anesthesia

The safety and efficacy of general anesthesia or intravenous sedation for specified dental procedures have been established. They are useful therapeutic options for patients meeting the appropriate patient selection criteria.

Inclusionary and exclusionary criteria have been updated, effective March 2023.

Inclusions:

This policy addresses general anesthesia provided for rendering dental services. General anesthesia services for rendering a dental procedure can be eligible for separate reimbursement if the anesthesia is rendered by a provider other than the dental services provider (such as an anesthesiologist or certified registered nurse anesthetist, or CRNA). All facility charges incurred in association with the anesthesia charges are covered under the medical/surgical benefit if any one of the following criteria are met:

• For children younger than age 7 (i.e., through the end of the sixth year)
• For older patients (age 7 and older), consider the extent of the procedures required. At a minimum, the patient should require one of the following:
• A total of six or more teeth to be extracted
• Procedures that must be performed in two or more quadrants of the mouth on the same date of service

In addition, for patients ages 7 and older, one of the following conditions must exist:

• A concurrent hazardous medical or behavioral condition that creates a documented medical necessity for performing the procedure in an accredited facility using general anesthesia or sedation. These conditions may include, but are not limited to, labile hypertension, significant cardiac arrhythmias (more than five premature ventricular contractions per minute on EKG), severe cerebral palsy or spasticity, morbid obesity, severe autism, movement disorders, chronic respiratory disease, hemophilia, uncontrolled diabetes, etc. Note: A history of chronic diabetes mellitus isn’t considered a concurrent hazardous medical condition under the above criteria.
• A statement from the member’s primary physician supporting that the member has medical conditions too serious to undergo dental treatment in the dental office setting.
• Significant cellulitis or swelling and associated trismus (a sustained spasm of the jaw muscles, characteristic of the early stages of tetanus) that doesn’t allow the use of local anesthesia.
• Extensive orofacial or dental trauma for which treatment under local anesthesia would be ineffective or compromised.

Exclusions:

• Patients with situational anxiety or stable chronic medical conditions don’t satisfy the above criteria.
• All other anesthesia modalities used to perform dental services in the dental provider’s office.

15271-15278, 15777, A2001, A2002, A2004-A2018, A4100, A6010, A6011, A6021-A6023, Q4101-Q4108, Q4110, Q4113, Q4114, Q4116-Q4118, Q4121, Q4122, Q4124, Q4127, Q4128, Q4130, Q4135, Q4136, Q4147, Q4149, Q4158, Q4161, Q4164-Q4166, Q4182, Q4195, Q4196, Q4203

Experimental:

Q4111, Q4112, Q4115, Q4123, Q4125, Q4126, Q4134, Q4141-Q4143, Q4146, Q4152, Q4167, Q4175-Q4180, Q4193, Q4197, Q4202, Q4200, Q4220, Q4222, Q4226, Q4238

Basic benefit and medical policy

Skin and tissue substitutes

The safety and effectiveness of skin and tissue substitutes approved by the U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services have been established for patients meeting specified selection criteria. They may be useful therapeutic options when indicated.

Human tissue products are subject to the rules and regulations of banked human tissue by the American Association of Tissue Banks, or AATB, and have been established for patients meeting specified selection criteria. They may be useful therapeutic options when indicated.

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

Inclusions:

The following skin and tissue substitutes are considered established when used according to FDA approval. This list may not be all-inclusive:

• Apligraft^®
• Apis^®
• Atlas Wound Matrix
• Biobrane^®
• Bio-conneKt^® Wound Care Matrix
• BTM Wound Dressing (aka NovoSorb^® BTM)
• Cytal^® Burn Matrix
• Cytal^® MicroMatrix™
• Cytal™ Wound Matrix (formerly MatriStem)
• Cytal^® Wound Sheet
• Derma-Gide (aka Geistlich Derma-Gide™)
• Dermagraft^®
• Endoform Dermal Template™
• Epicel^® has FDA Humanitarian Device Approval
• E-Z Derm™
• Helicoll™
• Hyalomatrix^®
• InnovaMatrix™ (also known as InnovaMatrix AC)
• InnovaMatrix™ FS
• Integra^® Bilayer Matrix
• Integra^® Dermal Regeneration Template
• Integra^® Flowable Wound Matrix
• Intregra^® Matrix Wound Dressing (formerly known as Avagen)
• Keratec Wound Dressings (Kermatrix^®):
• Keratec Keragel
• Keraderm
• Kerafoam
• Kerecis™ Omega3 Wound (formerly known as MeriGen)
• MediSkin^®
• Microlyte^® Ag
• MicroMatrix^®
• Mirragen™
• Oasis^® Burn Matrix
• Oasis^® Ultra Tri-Layer Wound Matrix
• Oasis^® Wound Matrix
• Ologen™ Collagen Matrix
• Omeza^® Collagen Matrix
• OrCel^®
• PELNAC™ Bilayer Wound Matrix
• Permacol™ (Covidien)
• PermeaDerm B
• PermeaDerm C
• PermeaDerm Glove
• Phoenix™ Wound Matrix
• PriMatrix™ Dermal Repair Scaffold
• Puracol^® and Puracol^® Plus Collagen Wound Dressings
• PuraPly Wound Matrix (formerly known as FortaDerm)
• PuraPly Antimicrobial Wound Matrix (formerly known as FortaDerm AM)
• Restrata^®
• Strattice™
• Suprathel^®
• SupraSDRM Biodegradable Matrix Wound Dressing
• SurgiMend^®
• Symphony™
• Talymed™
• TenoGlide™
• TransCyte^®
• XCelliStem^® Wound Powder

Breast reconstructive surgery using allogeneic acellular dermal matrix products^a (including each of the following: AlloDerm^®, AlloMend^®, Cortiva^®, [AlloMax™], DermACELL™, DermaMatrix™, FlexHD^®, FlexHD^® Pliable™, Graftjacket^®) are considered established when one of the following are met:

• There is insufficient tissue expander or implant coverage by the pectoralis major muscle and additional coverage is required.
• There is viable but compromised or thin postmastectomy skin flaps that are at risk of dehiscence or necrosis.
• The inframammary fold and lateral mammary folds have been undermined during mastectomy and reestablishment of these landmarks is needed.

Note: Various acellular dermal matrix products used in breast reconstruction have similar efficacy. The products listed are those that have been identified for use in breast reconstruction. Additional acellular dermal matrix products may become available for this indication.

Treatment of chronic, noninfected, full-thickness diabetic lower extremity ulcers is established when using the following tissue engineered skin substitutes:

• AlloPatch^®a
• Apligraft^®b
• Dermagraft^®b
• GraftJacket^® Regenerative Tissue Matrix-Ulcer Repair
• Integra^®, Omnigraft™ Dermal Regeneration Matrix (also known as Omnigraft™) and Integra Flowable Wound Matrix
• Theraskin^®

Treatment of chronic, noninfected, partial- or full-thickness lower-extremity skin ulcers due to venous insufficiency, which haven’t adequately responded following a one-month period of conventional user therapy is established when using the following tissue-engineered skin substitutes:

• Aplifraf^®b
• Oasis™ Wound Matrix^c
• Theraskin^®

OrCel™ is considered established when all the following criteria are met:

• Used for the treatment of dystrophic epidermolysis bullosa
• Used for the treatment of mitten-hand deformity
• Standard would therapy has failed
• Provided in accordance with the humanitarian device exemption, or HDE, specifications of the U.S. Food and Drug Administration

The following skin and tissue products and substitutes are considered established for use in the treatment of second- and third-degree burns:

• Alloderm
• Epicel^® (for the treatment of deep dermal or full-thickness burns comprising a total body surface area ≥30% when provided in accordance with the HDE specifications of the FDA)^d
• Integra^® Dermal Regeneration Template^b

^aBanked human tissue
^bFDA premarket approval
^cFDA 510(k) clearance
^dFDA-approved under an HDE

Exclusions:

All other uses of bioengineered skin and soft tissue substitutes listed above unless they meet one of the following criteria:

• FDA approval and provided in accordance with the FDA guidelines
• Covered by Centers for Medicare & Medicaid Services

All other skin and soft tissue substitutes including, but not limited to:

• ACell^® UBM Hydrated/Lyophilized Wound Dressing
• AlloSkin™
• AlloSkin™ RT
• Aongen™ Collagen Matrix
• Architect^® ECM, PX, FX
• ArthroFlex™ (Flex Graft)
• AxoGuard^® Nerve Protector (AxoGen)
• BellaCell HD or SureDerm^®
• CollaCare^®
• CollaCare^® Dental
• Collagen Wound Dressing (Oasis Research)
• CollaGUARD^®
• CollaMend™
• CollaWound™
• Coll-e-Derm
• Collexa^®
• Collieva^®
• Conexa™
• Coreleader Colla-Pad
• CorMatrix^®
• Cymetra™ (Micronized AlloDerm™)
• Dermadapt™ Wound Dressing
• DermaPure™
• DermaSpan™
• DressSkin
• Durepair Regeneration Matrix^®
• ENDURAGen™
• Excellagen
• ExpressGraft™
• FlexiGraft^®
• FlowerDerm^®
• GammaGraft
• hMatrix^®
• InteguPly^®
• Keroxx™
• MatriDerm^®
• Matrix HD™
• MemoDerm™
• Microderm^® biologic wound matrix
• Miroderm^®
• MyOwn Skin™
• NeoForm™
• Progenamatrix™
• Puros^® Dermis
• RegenePro™
• Repliform^®
• Repriza™
• SkinTE™
• SimpliDerm^®
• StrataGraft^®
• TenSIX™ Acellular Dermal Matrix
• TissueMend
• TheraForm™ Standard/Sheet
• TruSkin™
• Veritas^® Collagen Matrix
• XCM Biologic^® Tissue Matrix
• XenMatrix™ AB

20974, 20975, E0748, E0749

Basic benefit and medical policy

Bone growth stimulation of the spine

The safety and effectiveness of invasive or noninvasive methods of electrical bone growth stimulation of the spine have been established. They are useful therapeutic options for patients meeting patient selection criteria.

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

Inclusions:

• Invasive or noninvasive methods of electrical bone growth stimulation are medically necessary for use as an adjunct to lumbar or cervical spinal fusion surgery in patients at high risk for fusion failure, defined as any one of the following criteria:
• One or more previous failed spinal fusions
• Grade III or worse spondylolisthesis
• Fusion to be performed at more than one level
• Current tobacco use
• Diabetes
• Renal disease
• Alcoholism
• Immunocompromise
• Systemic vascular disease
• History of long term use of corticosteroids
• Metabolic bone disease (including osteoporosis, osteopenia and bone disease secondary to renal disease, nutritional deficiency, or conditions in which bone healing is likely to be compromised)
• Noninvasive electrical bone stimulation may be considered medically necessary as a treatment of patients with failed lumbar or cervical spinal fusion. Failed spinal fusion is defined as a spinal fusion that hasn’t healed at a minimum of six months after the original surgery, as evidenced by serial X-rays over a course of three months.

• Semi-invasive electrical stimulation

55530, 58321, 58322, 58323, 58540,
58672, 58752, 58760, 58970, 58974,
58976, 76857, 76948, 89250, 89253^a,
89254, 89255, 89257, 89258, 89259, 89260, 89261, 89264, 89268, 89272, 89280^b, 89281^b, 89290^c, 89291^c, 89322, 89335^d, 89337^a, 89342, 89343, 89344^d, 89346^a, 89352, 89353, 89354^d, 89356^a, S4011, S4013, S4014, S4015, S4016, S4021, S4022, S4027, S4028, S4035, S4037, S4040, S4042, J0725             

^aOnly when inclusion criteria are met
^bOnly for diagnosis of male factor infertility
^cRefer to policy “Genetic Testing – Preimplantation”
^dOnly for adult men diagnosed with azoospermia, as part of the intracytoplasmic sperm injection procedure.

Not covered:

Basic benefit and medical policy

Assisted reproductive techniques

Selected assisted reproductive techniques, or ART, are established and may be considered useful therapeutic options in the treatment of infertility.

When infertility is due to an underlying medical condition (e.g., chronic infection, uterine fibroids, etc.), the treatment of that disorder is medically necessary and is covered under basic medical-surgical benefits.** When no medically correctable underlying medical condition is found (e.g., low sperm count, anovulation), other options may be pursued. One option is ART – specific services that may be used to establish pregnancy. Assisted reproductive techniques are only available to members when the employer group has chosen to offer the services as additional or extra benefits, through certificate benefit language or riders.

The focus of this policy is the use of ART in individuals who are diagnosed with infertility. Assisted reproductive techniques for individuals who are not diagnosed with infertility is based on benefit coverage (the certificate of coverage or rider) and is beyond the scope of this medical policy. Exclusionary criteria have been updated, effective March 1, 2023. 

**See the medical policy “Infertility Diagnosis.”

Basic benefit policy group variations:

Assisted reproductive techniques, or ARTs, aren’t general medical or surgical benefits. While the procedures listed in the inclusions are considered established, these services are available only as additional benefits offered by a group or employer. The covered services and limitations are defined by the group or employer. The benefit plan, including the certificate of coverage or rider, determines the available coverage.

Inclusions:

• Artificial insemination
• Assisted reproductive technologies:
• In vitro fertilization, or IVF
• Gamete intrafallopian transfer, or GIFT
• Transuterine fallopian transfer, or TUFT
• Natural oocyte retrieval with intravaginal fertilization, or NORIF
• Pronuclear state tubal transfer, or PROST
• Tubal embryo transfer, or TET
• Zygote intrafallopian transfer, or ZIFT
• Embryo transfer
• Blastocyst transfer
• Intracytoplasmic sperm injection, or ICSI, for male factor infertility only
• Cryopreservation of embryos and sperm
• Storage of embryos and sperm
• Thawing of embryos and sperm
• Mature oocytes: Cryopreservation, with storage and thawing for up to three months following cryopreservation, when both of the following criteria are met:
• It’s a covered IVF cycle using fresh oocytes
• Inability to obtain viable sperm for oocyte fertilization at the time of oocyte retrieval
• Assisted embryo hatching when one of the following criteria is met:
• The individual is age 38 or older
• There have been two or more IVF failures related to failed implantation
• Elective single-embryo transfer, or eSET

Exclusions:

• Co-culture of embryos
• Cryopreservation of ovarian tissue, immature oocytes, or testicular tissue**
• Storage of ovarian tissue or testicular tissue**
• Thawing of ovarian tissue or testicular tissue**
• All services related to gestational surrogacy, gestational parent or gestational carrier
• Time lapse monitoring or imaging of embryos (e.g., EmbryoScope^®)
• Endometrial receptivity testing (e.g., ERA^® [Endometrial Receptivity Analysis])
• ART services are excluded when there has been a voluntary sterilization procedure (e.g., tubal ligation, vasectomy), including when there has been surgical reversal of the sterilization procedure, as this isn’t considered treatment of disease
• Reversal of prior sterilization procedure is excluded

**Cryopreservation, storage and thawing of testicular tissue is only covered in adult men with azoospermia, as these procedures are part of intracytoplasmic sperm injection.

77046, 77047, 77048, 77049

Basic benefit and medical policy

MRI for breast cancer

The safety and effectiveness of magnetic resonance imaging of the breast have been established. It may be considered a useful diagnostic option for patients meeting criteria.

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

Payment policy:

The PPO Radiology Management program applies to these procedures and they may be subject to vendor preauthorization.

Inclusions:

Note: All the following policy statements refer to performing MRI of the breast with a breast coil and the use of contrast. MRI of the breast without the use of a breast coil, regardless of the clinical indication, is considered experimental.

1. MRI of the breast may be considered established for screening for breast cancer in individuals at a high risk of breast cancer.

High-risk considerations
 
There is no standardized method for determining a woman’s risk of breast cancer that incorporates all possible risk factors. There are validated risk prediction models, but they are based primarily on family history.

The following list includes individual factors known to indicate a high risk of breast cancer:

• An individual diagnosed with lobular carcinoma in situ, or LCIS, atypical lobular hyperplasia, or ALH/atypical ductal hyperplasia, known as ADH
• An individual with a known BRCA1 or BRCA2 variant or a first-degree relative of an individual with either of these gene mutations
• An individual with another gene variant associated with high risk: ATM, BARD 1, CDH1, CHEK2, NF1, PALB2, PTEN, RAD51C, RAD51D, STK11, TP53 or a first-degree relative of an individual with any of these gene mutations
• An individual with a lifetime risk of 20% or greater of developing breast cancer as identified by models that are largely defined by family history. This includes individuals that carry genetic mutations in the following genes: TP53 (Li-Fraumeni syndrome), PTEN (Cowden syndrome, Bannayan-Riley-Ruvalcaba syndrome) and STK11 (Peutz-Jeghers syndrome).
• An individual who received radiotherapy to the chest between 10 and 30 years of age

A number of factors may increase the risk of breast cancer but don’t by themselves indicate high risk. It is possible that combinations of these factors may be indicative of high risk, but it’s not possible to give quantitative estimates of risk. As a result, it may be necessary to individualize the estimate of risk, whereby one would need to take into account the numerous risk factors. A number of risk factors, not individually indicating high risk, are included in the National Cancer Institute Breast Cancer Risk Assessment Tool (also called the Gail model). Risk factors in the model can be accessed online bcrisktool.cancer.gov.

2. MRI of the breast is considered established for the following indications:

Suspected cancer:

• Single follow-up MRI at six months following a breast MRI with BI-RADS category 3 findings
• Differentiation of palpable mass from surgical scar tissue
• Lesion/abnormality characterization when other imaging (e.g., ultrasound, mammography) and physical examination are inconclusive, and inability to localize the lesion prevents a biopsy from being performed
• Metastatic cancer of unknown primary and suspected to be of breast origin or axillary adenopathy and no mammographic or physical findings of primary breast carcinoma
• Evaluation of pathologic nipple discharge after nondiagnostic mammography and ultrasound
• Suspected breast implant-associated anaplastic large cell lymphoma in patients with textured implants when ultrasound is nondiagnostic
• Evaluation of a documented abnormality of the breast prior to obtaining an MRI-guided biopsy when there is documentation that other methods, such as palpation or ultrasound, are not able to localize the lesion for biopsy

Diagnostic workup and management:

• To determine the extent of disease in biopsy-proven breast cancer in either of the following:
• Ductal carcinoma in situ, or DCIS, when the lesion is greater than 2 cm
• Invasive carcinoma
• To define the relationship of the tumor to the fascia and its extension into the pectoralis major, serratus anterior or intercostal muscles prior to surgery
• Preoperative tumor mapping of the involved breast to evaluate the presence of multicentric disease in patients with clinically localized breast cancer who are candidates for breast-conservation therapy
• Presurgical planning in patients with locally advanced breast cancer (before and after completion of neoadjuvant chemotherapy) to permit tumor localization and characterization
• Suspected recurrence in patients with tissue transfer flaps (rectus, latissimus dorsi and gluteal) post-reconstruction
• Suspected recurrence in patients with a prior history of breast cancer when clinical, mammographic or sonographic findings are inconclusive
• Post-lumpectomy with close or positive margins to evaluate for residual disease

Surveillance:

• In patients with a personal history of breast cancer after breast conserving therapy or unilateral mastectomy who meet criteria for MRI breast screening (see Inclusion A)

Exclusions:

• Screening technique in average-risk patients
• Screening technique for the detection of breast cancer when the sensitivity of mammography is limited (i.e., dense breasts)
• Diagnosis of low-suspicion findings on conventional testing, immediate biopsy isn’t indicated, and the patient is referred for short-interval follow-up
• Diagnosis of a suspicious breast lesion to avoid biopsy

81170, 81206, 81207, 81208, 81401, 81450, 81455, 0016U, 0040U

Basic benefit and medical policy

Genetic testing – BCR/ABL1 testing in CML and ALL

The safety and effectiveness of genetic testing for BCR/ABL1 in individuals undergoing evaluation for or diagnosed with chronic myelogenous leukemia, or CML or acute lymphoblastic leukemia, or ALL, have been established. It may be considered a useful tool when indicated.

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

Inclusions:

Chronic myelogenous leukemia
BCR-ABL1 qualitative testing for the presence of the fusion gene is established for the diagnosis of chronic myeloid leukemia.

BCR-ABL1 testing for messenger RNA transcript levels by quantitative real-time reverse transcription-polymerase chain reaction at baseline before initiation of treatment and at appropriate intervals is established for monitoring of chronic myeloid leukemia treatment response and remission.

Evaluation of ABL kinase domain, or KD, single nucleotide variants to assess individuals for tyrosine kinase inhibitor resistance is established when there is an inadequate initial response to treatment or any sign of loss of response, or when there is a progression of the disease to the accelerated or blast phase.

Acute lymphoblastic leukemia
BCR-ABL1 testing for messenger RNA transcript levels by quantitative real-time reverse transcription-polymerase chain reaction at baseline before initiation of treatment and at appropriate intervals during therapy is established for monitoring of Philadelphia chromosome-positive acute lymphoblastic leukemia treatment response and remission.

Evaluation of ABL KD single nucleotide variants to assess individuals for tyrosine kinase inhibitor resistance is established when there is an inadequate initial response to treatment or any sign of loss of response.

Testing:

Next-generation sequencing, or NG, with a multiple-gene panel test (e.g., CPT code *81450 or *81455), 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 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 (most laboratories are able to process these)
• Proprietary laboratory analyses, or PLA, tests (processed by one specific independent laboratory). Most PLA tests have billing codes that end in “U.”

Exclusions:

BCR/ABL1 testing and Kinase domain mutation testing are considered experimental for all other indications.

81420, 81507, 81599,** 81479***

Experimental:
81422, 0060U, 0327U

**If the codes above don’t apply and the test involves multianalyte assays and an algorithmic analysis

***If the codes above don’t apply and the test does not involve an algorithmic analysis

Basic benefit and medical policy

Noninvasive prenatal screening for fetal aneuploidies

The safety and effectiveness of noninvasive prenatal screening for fetal aneuploidies using cell-free fetal DNA have been established. It may be considered a useful diagnostic option when indicated.

The peer-reviewed medical literature hasn’t demonstrated the clinical utility of noninvasive prenatal screening for microdeletions and single gene disorders using cell-free fetal DNA. Therefore, this service is considered experimental.

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

Inclusions:

• Nucleic acid sequencing-based testing of maternal plasma to screen for trisomy 21 in women with singleton and twin pregnancies. (Karyotyping would be necessary to exclude the possibility of a false positive nucleic acid sequencing-based test.)
• Concurrent nucleic acid sequencing-based testing of maternal plasma for trisomy 13 or 18 in women who are eligible for and are undergoing nucleic acid sequencing-based testing of maternal plasma for trisomy 21.  
• Nucleic acid sequencing-based testing of maternal plasma for fetal sex or fetal sex chromosome aneuploidy only when certain fetal abnormalities are noted on ultrasound, such as cases of ambiguous genitalia or cystic hygroma when the determination of fetal sex is necessary to help guide medical management.

Exclusions:

• Nucleic acid sequencing-based testing of maternal plasma for trisomy 21 in women with pregnancies of multiple gestations of three or more fetuses
• Nucleic acid sequencing-based testing of maternal plasma for trisomy 13 or 18, other than in the situations specified above
• Nucleic acid sequencing-based testing of maternal plasma for fetal sex determination or fetal sex chromosome aneuploidies other than the situation specified above
• Nucleic acid sequencing-based testing of maternal plasma for microdeletions
• Nucleic acid sequencing-based testing of maternal plasma for twin zygosity.
• Vanadis^® NIPT of maternal plasma to screen for trisomy 21, 18 and 13
• Vistara NIPT of maternal plasma to screen for single-gene disorders
• For other aneuploidies or genetic disorders not specified above

97129, 97130

Basic benefit and medical policy

Cognitive rehabilitation

The safety and effectiveness of cognitive rehabilitation (as a distinct and definable component of the rehabilitation process) have been established. It may be considered a useful therapeutic option in the rehabilitation of patients meeting specific selection criteria.

Exclusionary criteria have been updated to exclude SARS-CoV-2 infection, effective March 1, 2023.

Inclusions:

Cognitive rehabilitation is an established procedure when used an as adjunctive treatment of cognitive deficits (e.g., attention, language, memory, reasoning, executive functions, problem solving and visual processing) when all the following criteria are met:

1. The cognitive deficits have been acquired as a result of neurologic impairment due to traumatic brain injury or stroke.
2. Services must be provided by a qualified licensed professional and must be prescribed by the attending physician as part of the written care plan.
3. There must be documentation of potential for improvements based on the patient’s pre-injury function.
4. Patients must be able to actively participate in the program. The patient must have sufficient cognitive function to understand and participate in the program as well as adequate language expression and comprehension (e.g., the patient shouldn’t have severe aphasia).
5. The member is expected to make significant cognitive improvement (e.g., member isn’t in a vegetative or custodial state).

Exclusions:

Excluded diagnoses include, but are not limited to:

• Mental retardation
• Multiple sclerosis
• Cerebral palsy
• Encephalopathy
• S/P brain surgery
• Dementia (e.g., from Alzheimer’s disease, HIV-infection or Parkinson’s disease)
• Cognitive decline chronic obstructive pulmonary disease
• Behavioral or psychiatric disorders such as attention-deficit/hyperactivity disorder and schizophrenia
• Pervasive developmental disorders
• Post-acute cognitive sequelae of SARS-CoV-2 infection

J3490

Basic benefit and medical policy

Elucirem (gadopiclenol)

Elucirem (gadopiclenol) is considered established, effective Sept. 21, 2022. 

Elucirem is a gadolinium-based contrast agent indicated in adult and pediatric patients age 2 and older for use with magnetic resonance imaging to detect and visualize lesions with abnormal vascularity in the following:

• The central nervous system (brain, spine and associated tissues)
• The body (head and neck, thorax, abdomen, pelvis and musculoskeletal system)

Dosage and administration:

The recommended dose for adult and pediatric patients age 2 and older is 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at approximately 2 mL/sec.
 
Dosage forms and strengths:

Injection: 0.5 mmol/mL of gadopiclenol in single-dose vials, single-dose prefilled syringes and pharmacy bulk packages.

J3490

Basic benefit and medical policy

Testosterone cypionate IM (testosterone cypionate)

Effective June 2, 2022, testosterone cypionate IM (testosterone cypionate) is covered for the following FDA-approved indications:

Testosterone cypionate injection is an androgen indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

Limitations of use:

• Safety and efficacy of testosterone cypionate injection in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) haven’t been established.
• Safety and effectiveness in pediatric patients below the age of 12 years haven’t been established.

Dosage and administration:

• Injectable testosterone products may have different doses, strengths or administration instructions and they aren’t substitutable on a milligram-per-milligram basis. Administer testosterone cypionate injection by deep gluteal intramuscular injection only.
• Prior to initiating testosterone cypionate injection, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum concentrations are below the normal range.
• Recommended dosage is 50 mg to 400 mg administered every two to four weeks as a deep intramuscular injection in the gluteal muscle. Individualize the dose and schedule based on the patient’s age, diagnosis, response to treatment and the appearance of adverse reactions.

Dosage forms and strengths:

Injection: 200 mg/mL in a single-dose vial

J9173

Basic benefit and medical policy

Imfinzi (durvalumab)

The FDA has updated the payable indications for Imfinzi (durvalumab), effective Sept. 2, 2022. The payable indications include the following:

In combination with gemcitabine and cisplatin, as treatment of adult patients with locally advanced or metastatic biliary tract cancer