Billing chart: Blue Cross highlights medical, benefit policy changes

93702

Basic benefit and medical policy

Bioimpedance for lymphedema

Devices using bioimpedance (bioelectrical impedance
spectroscopy) in the diagnosis, surveillance of cancer-
related extremity asymptomatic sub-clinical lymphedema is considered established when criteria is met. This policy was effective Sept. 1, 2023.

Payment policy:
 
Modifiers 26 and TC don’t apply to this procedure.

Inclusions:
 
Individuals meeting one of the following criteria:

• Regional (axillary or inguinal) lymph node dissection or sentinel lymph node biopsy with > 6 nodes removed
• Regional node irradiation
• Taxane-based chemotherapy

Note: L-Dex measurements should be performed as (1) A baseline before surgery/treatment. (2) Quarterly for the first year post-operatively. (3) Everly six months on years 2 and 3 post-operatively. (4) Yearly for years 4 and 5 post-operatively.

Exclusions:

• Symptomatic lymphedema

11920, 11921, 11922, 17380, 17999,** 19318, 19325, 19350, 21120, 21121, 21122, 21123, 21125, 21127, 21137, 21138, 21139, 21209, 30400, 30410, 30420, 31599,** 31899,** 54520, 55970, 55980, 56805, 57291, 57292, 57335, 58150, 58152, 58180, 58260, 58262, 58275, 58291, 58541, 58542, 58543, 58544, 58550, 58552, 58553, 58554

Experimental
11950, 11951, 11952, 11954, 15769, 15771, 15772, 15773, 15774, 15820, 15821, 15822, 15823, 15824, 15825, 15826, 15828, 15830, 15832, 15833, 15834, 15835, 15836, 15837, 15838, 15839, 15876, 15877, 15878, 15879, 19316, 21208, 30430, 30435, 30450, 69300, Q2026, Q2028

Basic benefit and medical policy

Lung and lobar lung transplants

Gender affirming services

The safety and effectiveness of select medical and surgical treatments for gender dysphoria have been established. The established treatments for gender dysphoria include:

• Puberty suppression in adolescents
• Hormone therapy (for masculinization or feminization) for adolescents and adults who meet criteria.
• Medically necessary gender-affirming surgery:
• Genitalia reconstruction
• Mastectomy — defined in this policy as surgical removal of the breast
• Augmentation mammoplasty (implants)
• Thyroid reduction chondroplasty (tracheal shave)
• Facial feminization
• Facial masculinization

Note: Surgery can’t be used to reverse effects of hormone therapy used to affirm an individual’s gender identity/expression.

To ensure appropriate preventive medical care, any anatomical structure present that warrants screening should continue to be screened, regardless of gender identity. Examples include:

• Breast cancer screening in transgender and gender-diverse people with breasts formed during natal puberty who haven’t undergone gender-affirming chest surgery and for transgender and gender-diverse people who have received estrogens, taking into account the length of time of hormone use, dosing, current age and age at which the hormones were initiated
• Prostate cancer screening for transgender and gender diverse people who have retained their prostate
• Cervical screening for transgender and gender-diverse people who currently have or previously had a cervix following local guidelines for individuals assigned female at birth.
• Obstetric services for transgender and gender diverse people when they are pregnant.

The medical policy statement, and inclusionary and exclusionary criteria have been updated, effective Jan. 1, 2024.

Inclusions:

While the following procedures are considered established for this policy, the specific coverage for each member is based on the benefit, which is defined by the group or employer.

Assessment, diagnosis and treatment should be provided through a multidisciplinary gender services clinic or program affiliated with a major medical center. If this level of service is unavailable, there should be documentation that reflects a coordinated approach to care by specialists involved (mental health specialists, physicians, surgeons, etc.).

Puberty suppression**

Health care professionals taking care of transgender and gender diverse adolescents with gender dysphoria should involve relevant disciplines, including mental health and medical professionals, to reach a decision about whether puberty suppression or hormone initiation for these adolescents are appropriate and remain indicated throughout the course of treatment until the transition is made to adult care. Puberty suppression hormones for adolescents may be indicated for members who meet all the following inclusionary criteria:

Inclusions:

• Meets diagnostic criteria for gender dysphoria (see description and background above for diagnostic criteria).
• Gender dysphoria is marked and sustained.
• Demonstrates emotional and cognitive maturity required to provide informed consent for the treatment and, particularly when the adolescent hasn’t reached the age of medical consent, the parents, guardians or other legally authorized caretakers have consented to the treatment and are involved in supporting the adolescent throughout the treatment process.
• Mental health concerns (if any) that may interfere with diagnostic clarity, capacity to consent and gender-affirming medical treatments have been addressed — sufficiently so that gender-affirming medical treatment can be provided optimally.
• Onset of puberty to at least Tanner stage 2 has been reached.
• Contraindications to therapy are absent in the judgment of the managing physician.

**Medications for puberty suppression may be managed under the member’s pharmacy benefit.

Hormone therapy**

Hormone therapy may be indicated for members who meet all the following inclusionary criteria.

Inclusions for adolescents, defined as from the start of puberty until the legal age of majority (18 years of age):

• Meets diagnostic criteria for gender dysphoria (see description and background above for diagnostic criteria).
• Gender dysphoria is marked and sustained.
• Other possible causes of apparent gender incongruence have been identified and excluded.
• Demonstrates emotional and cognitive maturity required to provide informed consent for the treatment and, particularly when the adolescent hasn’t reached the age of medical consent, the parents, guardians or other legally authorized caretakers have consented to the treatment and are involved in supporting the adolescent throughout the treatment process.
• Mental health concerns (if any) that may interfere with diagnostic clarity, capacity to consent and gender-affirming medical treatments have been addressed — sufficiently so that gender-affirming medical treatment can be provided optimally.
• Onset of puberty to at least Tanner stage 2 has been reached.
• Contraindications to therapy are absent in the judgment of the managing physician.
• Mental health and physical conditions that could negatively impact the outcome of gender-affirming medical treatments have been assessed, with the risks and benefits discussed, before a decision is made regarding treatment.
• One letter of assessment as indicated below.***
• Medications will be prescribed by or in consultation with a pediatric endocrinologist who has collaborated on care with a mental health care provider.

Inclusions for adults:

• 18 years of age or older (age of majority).
• Meets diagnostic criteria for gender dysphoria (see description and background above for diagnostic criteria).
• Gender dysphoria is marked and sustained.
• Other possible causes of apparent gender incongruence have been identified and excluded.
• Demonstrates capacity to make a fully informed decision and to consent for gender-affirming hormone treatment.
• Contraindications to therapy are absent in the judgment of the managing physician.  
• Mental health and physical conditions that could negatively impact the outcome of gender-affirming medical treatments have been assessed, with the risks and benefits discussed, before a decision is made regarding treatment.

**Medications for hormone therapy may be managed under the member’s pharmacy benefit.

Hair removal

• If gender-affirming surgery is approved for a transgender or gender diverse person, hair removal (e.g., electrolysis, laser hair removal) may be considered established following medical review only for the types of tissue described below: 
• When the scrotal and surrounding tissues are used in the surgical construction of the vagina.
• When free flap or other donor tissues are used for phalloplasty performed in conjunction with vaginectomy and full-length urethroplasty.

Gender-affirming surgery

Inclusions:

Gender-affirming surgery may be indicated for members who meet all the following inclusionary criteria:

1. Chest surgery**
1. Mastectomy (surgical removal of the breast) is considered reconstructive when all the following criteria has been met:
• The individual is at least 18 years of age.
• The individual has been diagnosed with gender dysphoria (see the description and background section for diagnostic criteria).
• Gender dysphoria is marked and sustained.
• The individual has the capacity to make fully informed decisions and consent for treatment.
• One letter of assessment as indicated below.***
• Other possible causes of apparent gender incongruence have been identified and excluded.
• Mental health and physical conditions that could negatively impact the outcome of gender-affirming medical treatments have been assessed, with the risks and benefits discussed, before a decision is made regarding treatment.
• Hormone therapy prior to mastectomy isn’t required as the aim of hormone therapy prior to facial surgery or gonadectomy is primarily to introduce a period of reversible testosterone or estrogen suppression before the individual undergoes irreversible surgical intervention.
• Living in a gender role congruent with gender identity for 12 continuous months isn’t required prior to a mastectomy.
• Pre-operative and post-operative care that addresses both surgical results and possible behavioral health impacts is highly recommended.
• Nipple reconstruction, including tattooing, following a gender-affirming mastectomy that meets the reconstructive criteria above is considered reconstructive.
2. Breast augmentation is considered reconstructive when all the following criteria has been met:
• The individual is at least 18 years of age.
• The individual has been diagnosed with gender dysphoria (see the description and background section for diagnostic criteria).
• Gender dysphoria is marked and sustained.
• The individual has the capacity to make fully informed decisions and consent for treatment.
• One letter of assessment as indicated below.***
• Other possible causes of apparent gender incongruence have been identified and excluded.
• Mental health and physical conditions that could negatively impact the outcome of gender-affirming medical treatments have been assessed, with the risks and benefits discussed, before a decision is made regarding treatment.
• The individual is stable on their gender-affirming hormonal treatment regime for at least 12 months, unless a rationale is provided by the health care practitioner that indicates that hormone treatment is either contraindicated or not necessary for the individual’s clinical situation.
• Living in a gender role congruent with gender identity for 12 continuous months isn’t required prior to breast augmentation.
• Existing chest appearance demonstrates significant variation from expected appearance for the individual’s gender identity.
• Pre-operative and post-operative care that addresses both surgical results and possible behavioral health impacts is highly recommended.

**The procedures needed to reconstruct a feminine/masculine appearance can only be performed once per lifetime.  

2. Facial surgery**^† is considered reconstructive when all the following criteria has been met:  
• The individual is at least 18 years of age.
• The individual has been diagnosed with gender dysphoria (see the description and background section for diagnostic criteria).
• Gender dysphoria is marked and sustained.
• The individual has the capacity to make fully informed decisions and consent for treatment.
• Other possible causes of apparent gender incongruence have been identified and excluded.
• One letter of assessment as indicated below.***
• Mental health and physical conditions that could negatively impact the outcome of gender-affirming medical treatments have been assessed, with the risks and benefits discussed, before a decision is made regarding treatment.
• The individual is stable on their gender-affirming hormonal treatment regime for at least 12 months, unless a rationale is provided by the health care practitioner that indicates that hormone treatment is either contraindicated or not necessary for the individual’s clinical situation.
• The gender identity should be present for at least 12 months.
• The member has a consistent stable gender identity that is well documented by their treating providers and, when possible, lives as their affirmed gender in places where it is safe to do so.
• Existing facial appearance demonstrates significant variation from expected appearance for the individuals gender identity (photographic evidence must be maintained as part of the medical record).
• The procedure directly addresses variation from expected appearance for the experienced gender. (Note: Each procedure requested should be considered separately as some procedures may be cosmetic and others may be reconstructive.)
• Pre-operative and post-operative care that addresses both surgical results and possible behavioral health impacts is highly recommended.   

**The procedures needed to reconstruct a feminine/masculine appearance can only be performed once per lifetime.   

^†Procedures included in this group that aren’t considered cosmetic when used to treat gender dysphoria are:

• Thyroid reduction chondroplasty (tracheal shave)
• Genioplasty (repositioning or reshaping of the chin) Mandible augmentation (jawline contouring/reconstruction)
• Facial bone reduction
• Forehead reduction/contouring
• Rhinoplasty (reshaping/contouring of the nose).

3. Genital surgery is considered medically necessary when all the following criteria have been met: 
• The individual is at least 18 years of age.
• The individual has been diagnosed with gender dysphoria (see the description and background section for diagnostic criteria).
• Gender dysphoria is marked and sustained.
• The individual has the capacity to make fully informed decisions and consent for treatment.
• Other possible causes of apparent gender incongruence have been identified and excluded.
• One letter of assessment as indicated below.***
• Mental health and physical conditions that could negatively impact the outcome of gender-affirming medical treatments have been assessed, with the risks and benefits discussed, before a decision is made regarding treatment.
• The individual is stable on their gender-affirming hormonal treatment regime for at least 12 months, unless a rationale is provided by the health care practitioner that indicates that hormone treatment is either contraindicated or not necessary for the individual’s clinical situation.
• The gender identity should be present for at least 12 months.
• The member has a consistent stable gender identity that is well documented by their treating providers and, when possible, lives as their affirmed gender in places where it is safe to do so. 
• Pre-operative and post-operative care that addresses both surgical results and possible behavioral health impacts is highly recommended.

These criteria don’t apply to patients who are having these surgical procedures for medical indications other than gender dysphoria.

***Letter requirements:

1. Required for hormone therapy for adolescents
2. Required for facial, pelvic, gonadal or genital surgery for adults

Adolescents

One letter of assessment from the multidisciplinary team (or in situations where a multidisciplinary team is not available, a professional from one of the multiple disciplines who are experts in transgender health and in the management of the care required for transgender and gender diverse adolescents who is taking care of the individual) is required for adolescents receiving gender-affirming medical treatment. This letter needs to reflect the assessment and opinion from the team, which involves both medical health care practitioners and mental health professionals, and support that the individual meets the criteria for gender dysphoria. Health care professionals working with gender-diverse adolescents should undertake a comprehensive biopsychosocial assessment of adolescents who present with gender identity-related concerns and seek medical related care, and accomplish this in a collaborative and supportive manner. The detailed assessment must have been performed within 12 months of the first requested treatment. 

The health care professional assessing and working with the adolescent should meet all the following criteria:

1. Are licensed by their professional body and hold a postgraduate degree or its equivalent in a clinical field related to transgender health granted by a nationally accredited institution.
2. Receive theoretical and evidenced-based training and develop expertise in general child, adolescent and family mental health across the developmental spectrum.
3. Receive training and have expertise in gender identity development, gender diversity in children and adolescents, have the ability to assess capacity to assent/consent and possess general knowledge of gender diversity across the lifespan.
4. Continue engaging in professional development in all areas relevant to gender-diverse children, adolescents and families.
5. Receive training and develop expertise in autism spectrum disorders and other neurodevelopmental presentations or collaborate with a developmental disability expert when working with autistic/neurodivergent gender diverse adolescents.

Adults

One letter of assessment from a health care professional who has competencies in the assessment of transgender and gender diverse people, documenting that the individual meets the criteria for gender dysphoria, is required for transgender and gender-diverse adults for gender-affirming surgical treatments. The detailed assessment must have been performed within 12 months of the initial requested procedure. 

The health care professional should meet all the following criteria:

1. Are licensed by their professional body and hold, at a minimum, a master’s degree or equivalent training in a clinical field related to transgender health or equivalent further clinical training in this area that’s granted by a nationally accredited institution
2. Should be competent using the latest edition of the Diagnostic and Statistical Manual of Mental Disorders for diagnosis
3. Are able to identify co-existing mental health or other psychosocial concerns and distinguish these from gender dysphoria, incongruence and diversity
4. Are able to assess capacity to consent for treatment
5. Have experience or be qualified to assess clinical aspects of gender dysphoria, incongruence and diversity
6. Undergo continuing education in health care relating to gender dysphoria, incongruence and diversity

Exclusions:

• Gender-affirming services aren’t covered if contract or certificate language contains specific exclusion of these services.
• Reversal of physical or functional outcomes due to gender-affirming services.
• Reversal of surgical procedures performed for gender affirming services. 
• All procedures that are primarily cosmetic and not reconstructive or not medically necessary including, but not limited to:
• Abdominoplasty
• Blepharoplasty
• Brow lift
• Calf implants
• Cheek/malar implants
• Chin/nose implants
• Collagen injections
• Drugs for hair loss or growth
• Forehead lift
• Hair removal (for exception: see Inclusions, electrolysis)
• Hair transplantation
• Injectable dermal fillers (e.g., Sculptra, Radiesse)
• Lip reduction
• Liposuction
• Mastopexy
• Neck tightening
• Otoplasty
• Pectoral implants
• Removal of redundant skin
• Rhytidectomy
• Speech language therapy
• Non-covered services

19318

Basic benefit and medical policy

Breast reduction services

The safety and effectiveness of breast reduction have been established. It may be considered a useful therapeutic option (and not considered cosmetic) when one of the following is met:

• Individual selection guidelines in this policy are met.
• Performed in conjunction with medically necessary breast reconstruction for the purposes of attaining breast symmetry.**

**Refer to the medical policy “Reconstructive Breast Surgery/Management of Implants.” 

The medical policy statement was updated, effective Jan. 1, 2024.

Inclusions:

Patient selection guidelines

Patients under the age of 18 years can’t give legal consent for surgery. The parent or legal guardian must support and authorize a reduction mammaplasty (breast reduction).

Emancipated minors may be extended individual consideration.

Inclusions:

Must meet A, or must meet both B and C

1. Must meet both 1 and 2:
1. Patient’s breasts are fully grown (i.e., breast size stable for approximately one year)
2. Removal of more than 500 grams of tissue from each breast
2. One of the following (1, 2 or 3) must be met:
1. Pain (both of the following)
1. Documented pain in the neck and/or shoulders or postural backache which must be of long-standing duration.
2. Failure of conservative therapy (e.g., an appropriate support bra, exercises, heat/cold treatments, non-steroidal anti-inflammatory agents or muscle relaxants).
2. Shoulder grooving
3. Recurrent intertrigo between the breasts and the chest wall
3. Both of the following criteria must be met:
1. Breasts are fully grown (i.e., breast size stable for approximately one year).
2. The amount of tissue to be removed from each breast must be greater than or equal to the 22nd percentile on the Schnur Scale.**

**If one breast meets the tissue amount based on the Schnur Scale (even if the other breast doesn’t), this criterion is met.

If one breast meets the Schnur scale criteria, and all other criteria for breast reduction are met, the breast tissue may be removed from the other breast to achieve symmetry.

The Schnur Sliding Scale (see below) is used by physicians to evaluate individuals being considered for breast reduction surgery.

Body surface area, along with average weight of breast tissue removed is incorporated into the chart. If the individual's body surface area and weight of breast tissue removed fall below the 22nd percentile, then the surgery isn’t medically necessary. If the individual's body surface area and weight of breast tissue removed is above the 22nd percentile, then the surgery is considered medically necessary if other applicable criteria are met.

Calculation of body surface area

Body surface area = the square root of height (cm) times weight (kg) divided by 3600.

• To convert pounds to kilograms, multiply pounds by 0.45.
• To convert inches to meters, multiply inches by .0254.        

To calculate body surface area, click here.

  
Exclusions:

Breast reduction isn’t covered for either of the following indications because it’s considered cosmetic in nature and not medically necessary:

• Surgery is being performed to treat psychological symptomatology or psychosocial complaints, in the absence of significant physical, objective signs.
• Surgery is being performed for the sole purpose of improving appearance.

29800, 29805, 29830, 29840, 29860, 29870, 29900, 29999**

Basic benefit and medical policy

In-office arthroscopy

In-office needle arthroscopy using the mi-eye 2™, mi-eye 3 needlescope™ with cannula and VisionScope^® is experimental. Its use hasn’t been scientifically demonstrated to improve patient clinical outcomes.

The medical policy statement has been updated, effective Jan. 1, 2024.

Inclusionary and exclusionary guidelines:

Not applicable

33945, 50360, 50365

Basic benefit and medical policy

Heart-kidney transplant

The safety and effectiveness of a heart-kidney transplant have been established. It may be considered a useful therapeutic option for carefully selected patients with end-stage heart and kidney disease.

Inclusionary criteria have been updated, effective Jan. 1, 2024.

Inclusions:

Indications for combined heart-kidney transplant include, but aren’t limited to, progressive chronic heart and kidney disease unresponsive to other medical and surgical therapy. In general, patients are selected for a combined heart-kidney transplant if one or more of the following apply:

• End-stage heart and kidney disease not amenable to any other form of therapy
• End-stage heart disease and estimated glomerular filtration rate, or eGFR, is 33 mL/minute or less, or preoperative evaluation of the kidney indicates the likelihood that the rate of progression of renal injury or dysfunction after single organ transplant is high
• End-stage heart disease not amenable to any other form of therapy and associated with a life expectancy of 6 to 12 months
• The consideration for risk-reducing procedure (e.g., CABG) performed at the same time as the organ transplant is a consideration based on medical consultation review

Exclusions:

• Significant systemic or multisystemic disease (other than cardiorenal failure)
• Pulmonary hypertension that is fixed as evidenced by pulmonary vascular resistance, or PVR, greater than 5 Woods units, or trans-pulmonary gradient, or TPG, greater than or equal to 16 mm/Hg.
• Severe pulmonary disease despite optimal medical therapy, not expected to improve with heart transplantation alone.

Potential contraindications for transplant/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 heart or kidney 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

All transplants must be prior authorized through the Human Organ Transplant Program.

Note: There are individual heart and kidney transplant policies that contain more detailed information.

47133, 47135, 47140, 47141, 47142, 47143, 47144, 47145, 47146, 47147, 32850, 32853, 32854, 32855, 32856

Basic benefit and medical policy

Lung/double-lung and liver transplant

Combined double-lung and liver transplants have been established as clinically safe and effective for carefully selected individuals with end-stage lung and liver disease when transplantation of a single organ is precluded by severe disease in the other organ system, such that the individual’s prognosis after combined transplantation is felt to be better than with sequential transplantation.

The inclusionary and exclusionary criteria have been updated, effective Jan. 1, 2024.

Inclusions:

Indications for combined lung-double lung and liver transplant include, but aren’t limited to, progressive chronic lung and liver disease unresponsive to other medical and surgical therapy. In general, patients are selected for combined lung-liver transplant if one or more of the following apply:

• A lung transplant is typically required for irreversible, chronic lung diseases for which there is no further medical or surgical therapy available and survival is limited.
• Bilateral lung transplantation is typically required when chronic lung infection disease is present, e.g., associated with cystic fibrosis and bronchiectasis. Some but not all cases of pulmonary hypertension will require bilateral lung transplantation.
• A liver transplant is typically required for irreversibly damaged livers for which there is no further medical or surgical therapy available, prognosis is poor and end stage liver disease (e.g., alcoholic liver disease, viral hepatitis, autoimmune hepatitis, protoporphyria, biliary cirrhosis, vascular disease, trauma or toxic reactions, etc.).
• End-stage lung disease and end-stage liver disease not amenable to any other form of therapy.

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.

Exclusions:

• Patients with coronary artery disease not amenable to percutaneous intervention or bypass grafting or associated with significant impairment of left ventricular function.
• Patients colonized with highly resistant or highly virulent bacteria, fungi or mycobacteria.
• 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.)

Potential contraindications for transplant/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 or lung 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 for alcohol-related hepatitis

• Patients who are being considered for approval for a liver transplant who have liver disease related to alcohol use disorder must be evaluated for ongoing alcohol use.
• To determine candidacy for liver transplant in the setting of alcohol related hepatitis, guidelines such as the Dallas consensus criteria and the SALT criteria must be met.

All transplants must be prior authorized through the Human Organ Transplant Program.

Note: There are individual transplant policies for each of these organs (Lung Transplant, Liver Transplant) that contain more detailed information.

66179, 66180, 66183, 66184, 66185,
0449T, 0450T, 0474T, 0671T, 66999

Note: The above procedures may be billed with cataract removal codes 66982-66984, 66987-66989, 66991

Experimental/not covered:
66999,** 0253T

Basic benefit and medical policy

Aqueous shunts and stents for glaucoma

The safety and effectiveness of the insertion of U.S. Food and Drug Administration-approved aqueous shunts and stents have been established. They are useful therapeutic options for reducing intraocular pressure in individuals with glaucoma in whom medical therapy has failed to adequately control intraocular pressure.

Insertion of ab externo aqueous shunts approved by the FDA is established as a method to reduce intraocular pressure in individuals with glaucoma in whom medical therapy has failed to adequately control intraocular pressure.

Use of an ab externo aqueous shunt for all other conditions, including in individuals with glaucoma when intraocular pressure is adequately controlled by medications, is considered experimental.

Insertion of ab interno aqueous stents approved by the FDA as a method to reduce intraocular pressure in individuals with glaucoma in whom medical therapy has failed to adequately control intraocular pressure, is considered established.

Implantation of one or two FDA-approved microstents in conjunction with cataract surgery may be considered established in individuals with mild to moderate open-angle glaucoma currently treated with ocular hypotensive medication.

The use of ab interno stents for all other conditions is considered experimental.

Inclusionary criteria have been updated, effective Jan. 1, 2024.

Inclusions:

Insertion of FDA-approved aqueous shunts is considered established as a method to reduce intraocular pressure in patients with mild to moderate open-angle glaucoma when conventional pharmacologic treatments have failed to control intraocular pressure adequately. 

Currently available FDA-approved shunts include:

• Ahmed™ glaucoma implant
• Baerveldt^® seton
• Ex-PRESS^® mini glaucoma shunt
• Glaucoma pressure regulator
• Krupin-Denver valve implant
• Molteno^® implant
• Schocket shunt
• Xen Gel Stent
• CyPass^® Micro-Stent^a (recalled)
• iStent^{® a}
• iStent Inject^{® ab}
• iStent Infinate^®
• Hydrus™ ^®

^aThese stents are indicated for use in conjunction with cataract surgery for the reduction of IOP in adult patients with mild to moderate primary open-angle glaucoma.

^abThe iStent Inject^® comes pre-loaded with two stents.

Exclusions:

• The use of an aqueous shunt for all other conditions, including patients with glaucoma when intraocular pressure, is controlled by medications.
• Insertion of aqueous shunts that aren’t FDA approved.
• For the Trabecular Micro-Bypass iStent and the iStent Inject, patients with the following conditions aren’t appropriate candidates and the insertion of this stent would be considered experimental:
• Quick or sudden increase in eye pressure
• Inflammation of the eye tissue (uvea)
• Neovascular glaucoma
• Noticeable birth irregularities on the front of the eye
• Orbital tumor
• Thyroid eye disease
• Sturge-Weber syndrome
• Any other type of condition that may cause elevated pressure in the veins of the eye
• For the Hydrus Microstent, patients with the following conditions aren’t appropriate candidates and the insertion of this stent would be considered experimental:
• When the colored part of the eye (iris) is pushed up against the drainage pathway or when other material blocks the drainage pathway
• Traumatic glaucoma, malignant glaucoma or inflammation of the eye tissue
• Glaucoma associated with the growth of abnormal blood vessels in the eye
• Noticeable birth irregularities of the anterior chamber angle

81210, 81445, 81455, 81456, 0037U, 0239U, 0239U, 0242U, 0326U

Basic benefit and medical policy

GT – BRAF mutation in melanoma targeted therapy

Testing for BRAF V600 variants in tumor tissue of individuals with unresectable or metastatic melanoma or with resected stage III melanoma is established to select individuals for treatment with FDA-approved BRAF inhibitors, MEK inhibitors or immunotherapy.

Testing for BRAF V600 variants for all other individuals with melanoma is considered experimental.

Testing for genetic mutations using a panel with 5-50 genes may also be considered appropriate for cutaneous melanoma (stage 3 and stage 4).

Testing for genetic mutations using a panel with 51 or more genes may also be considered appropriate for cutaneous melanoma (stage 3 and stage 4).

Molecular testing on peripheral blood (i.e., liquid biopsy, ctDNA) may be established when criteria are met.

The medical policy statement and inclusionary and exclusionary criteria have been updated, effective Jan. 1, 2024.

Inclusionary and exclusionary guidelines:

Inclusions:

Refer to the pharmacy Genetic Testing of Drugs policy (Atezolizumab, Binimetinib, Dabrafenib, Encorafenib, Entrectinib, Larotrectinib, Pembrolizumab, Vemurafenib, Trametinib and Cobimetinib) for patient selection.

Circulating tumor DNA (liquid biopsy)

The clinical utility of circulating tumor DNA and circulating tumor cells for management of advanced solid cancers has been established when all the following criteria is met.

• May be considered established for guidance in the selection of appropriate targeted FDA therapeutic options for any of the following conditions:
• Metastatic cancers
• Inoperable locally advanced cancers
• Refractory cancers
• Recurrent cancers
• Advanced cancer (stages 3 or 4)
• Individual hasn’t been previously tested using the same liquid biopsy panel, unless a new primary cancer diagnosis is made, and further cancer treatment is being considered or the individual is experiencing a relapse.
• There is clinical documentation that tissue-based testing can’t be performed (e.g., insufficient sample, inaccessible tumor or where there may be a delay in obtaining tumor sample) or tissue-based testing isn’t required when there is an FDA-approved companion diagnostic device that is a circulating tumor test (liquid biopsy panel).

FDA-approved companion diagnostics

A companion diagnostic is an FDA-approved medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product. The test helps a health care professional determine whether, for a specific patient, a particular therapeutic product’s benefits outweigh any potential serious side effects or risks.

Companion diagnostics can:

• Identify patients who are most likely to benefit from a particular therapeutic product.
• Identify patients likely to be at increased risk for serious side effects as a result of treatment with a particular therapeutic product.
• Monitor response to treatment with a particular therapeutic product for the purpose of adjusting treatment to achieve improved safety or effectiveness.

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.”

Proprietary laboratory analyses testing

A PLA test is considered established when the following criteria is met:

• Biomarker confirmation is required by an FDA-approved or cleared test before 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.

Information regarding FDA-approved companion diagnostic tests should be obtained from the FDA’s List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) webpage.

For accuracy, please access the information directly from the FDA site as the website is updated frequently.

Exclusions:

• The use of circulating tumor DNA and circulating tumor cells is considered experimental when the criteria above aren’t met.
• The use of circulating tumor DNA and circulating tumor cell testing is considered experimental for all other indications related to solid tumors, including measurable residual disease, or MRD, testing and cancer screening (e.g., Galleri).

81445, 81450, 81455, 0239U, 0242U, 0326U

Experimental

Basic benefit and medical policy

Circulating tumor DNA (liquid biopsy)

The clinical utility of circulating tumor DNA and circulating tumor cells for selecting targeted therapy for advanced solid cancers has been established when criteria is met. 

The use of circulating tumor DNA and circulating tumor cell testing is considered experimental for all other indications related to solid tumors, including measurable residual disease, or MRD, testing and cancer screening (e.g., Galleri).

The medical policy statement, and inclusionary and exclusionary criteria have been updated, effective Jan. 1, 2024.

Inclusionary and exclusionary guidelines:

Inclusions:

The clinical utility of circulating tumor DNA and circulating tumor cells for selecting targeted therapy for advanced solid cancers has been established when all the following criteria is met.

• May be considered established for guidance in the selection of appropriate targeted FDA therapeutic options for any of the following conditions:
• Metastatic cancers
• Inoperable locally advanced cancers
• Refractory cancers
• Recurrent cancers
• Advanced cancer (stages III or IV)
• Individual hasn’t been previously tested using the same liquid biopsy panel, unless a new primary cancer diagnosis is made, and further cancer treatment is being considered or the individual is experiencing a relapse.
• There is clinical documentation that tissue-based testing can’t be performed (e.g., insufficient sample, inaccessible tumor or where there may be a delay in obtaining tumor sample) or tissue-based testing isn’t required when there is an FDA-approved companion diagnostic device that is a circulating tumor test (liquid biopsy).

U.S. Food and Drug Administration companion diagnostics

A companion diagnostic is an FDA-approved medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product. The test helps a health care professional determine whether, for a specific patient, a particular therapeutic product’s benefits outweigh any potential serious side effects or risks.

Companion diagnostics can:

• Identify patients who are most likely to benefit from a particular therapeutic product.
• Identify patients likely to be at increased risk for serious side effects as a result of treatment with a particular therapeutic product.
• Monitor response to treatment with a particular therapeutic product for the purpose of adjusting treatment to achieve improved safety or effectiveness.

FDA-approved companion diagnostic tests

FDA-approved companion diagnostic tests include:

• Tests 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.”

Proprietary laboratory analyses testing

A PLA test is considered established when the following criteria is 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.

Information regarding FDA-approved companion diagnostic tests should be obtained from the FDA’s List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) webpage.

For accuracy, access the information directly from the FDA site, which is updated frequently.

Exclusions:

• The use of circulating tumor DNA and circulating tumor cells is considered experimental when criteria above aren’t met.
• The use of circulating tumor DNA and circulating tumor cell testing is considered experimental for all other indications related to solid tumors, including measurable residual disease, or MRD,  testing and cancer screening (e.g., Galleri).

97039,** 64999**

Basic benefit and medical policy

PENS, PNT and restorative neurostimulation therapy

Percutaneous electrical nerve stimulation, or PENS, percutaneous neuromodulation therapy, known as PNT, and restorative neurostimulation therapy are considered experimental for chronic pain. The effectiveness of these therapies hasn’t been clinically proven. This policy statement has been updated, effective Jan. 1, 2024.

C9399
J3490
J3590

Basic benefit and medical policy

Prevymis (letermovir)

The FDA updated the indications for Prevymis (letermovir). This was effective June 5, 2023.

• Prophylaxis of CMV disease in adult kidney transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative [D+/R-]).

Dosage and administration:

Kidney transplant: 480 mg administered once daily orally or as an IV infusion over one hour through 200 days post-transplant.

E0650, E0651, E0652, E0655, E0656, E0657, E0660, E0665, E0666, E0667, E0668, E0669, E0670, E0671, E0672, E0673, E0676

Basic benefit and medical policy

Postsurgical home use of limb compression devices

The safety and effectiveness of postsurgical home limb compression devices for venous thromboembolism prophylaxis have been established. It may be considered a useful therapeutic option when clinical criteria are met.

Inclusionary and exclusionary criteria have been updated, effective Jan. 1, 2024.

Inclusions:

Postsurgical home use of limb compression devices for venous thromboembolism, or VTE, prophylaxis is indicated when one of the following criteria are met:

• After major orthopedic procedures^a in individuals with a contraindication^b to anticoagulant and antiplatelet agents (e.g., at high-risk for bleeding)
• After major non-orthopedic or other orthopedic procedures in individuals who are at moderate or high risk of venous thromboembolism (see Tables IE 1 and 2) with a contraindication^b to anticoagulant and antiplatelet agents (e.g., at high-risk for bleeding)
• After major orthopedic^a or major non-orthopedic procedures^c, as an adjunct to anticoagulant or antiplatelet therapy, in individuals who are at extremely high risk^d for venous thromboembolism.

Exclusions:

• Individuals who are at low risk of venous thromboembolism
• Home use of limb compression devices for venous thromboembolism prophylaxis for periods longer than 30 days post-surgery

^aExamples include major orthopedic surgery includes total hip arthroplasty, total knee arthroplasty or hip fracture surgery.

^bThe main contraindication to anticoagulants is a high risk of bleeding. However, there is no absolute threshold at which anticoagulants cannot be used. Rather, there is a risk-benefit continuum that takes into account the benefits of treatment and risks of bleeding. There may also be intolerance to specific agents, although uncommon. Intolerance may result from allergic reactions or adverse events. Finally, when heparin preparations are used, serum antibodies and heparin-induced thrombocytopenia can develop, precluding further use of heparin products.

^cExamples of major non-orthopedic surgery may include urological, abdominal, pelvic, neurological and extensive trauma procedures.

^dIndividuals older than 60 years plus prior VTE, cancer or molecular hypercoagulable state.

J3490
J3590

Basic benefit and medical policy

Rystiggo (rozanolixizumab-noli)

Rystiggo (rozanolixizumab-noli) is considered established when criteria are met, effective June 27, 2023.

Coverage of Rystiggo (rozanolixizumab-noli) is provided when all the following are met:

• FDA-approved indication
• FDA-approved age
• Documented anti-acetylcholine receptor, or AChR, antibody positive myasthenia gravis, or MG, identified by both of the following:
• Lab record or chart notes identifying the patient is positive for anti-AChR antibodies
• One of the following confirmatory tests:
• Positive edrophonium test
• History of clinical response to oral cholinesterase inhibitors (for example, pyridostigmine)
• Electrophysiological evidence of abnormal neuromuscular transmission by repetitive nerve stimulation, or RNS, or single-fiber electromyography, or SFEMG

Or

• Documented anti-muscle-specific tyrosine kinase, or MuSK, antibody positive MG identified by both of the following:
• Lab record or chart notes identifying the patient is positive for anti-MuSK antibodies.
• Electrophysiological evidence of abnormal neuromuscular transmission by repetitive nerve stimulation, or RNS, or single-fiber electromyography, or SFEMG.

• Patients must not have a history of:
• Thymectomy within six months
• Current thymoma
• Other neoplasms of the thymus

• Previous treatment courses of at least 12 weeks with one of the following standards of care have been ineffective: methotrexate, azathioprine, cyclophosphamide, cyclosporine, mycophenolate mofetil, or tacrolimus unless all are contraindicated or not tolerated.
• Patient is currently receiving, and will continue to receive, a stable standard of care regimen.
• Must not be used with other biologic therapies for myasthenia gravis or immunoglobulin therapy.
• Trial and failure, intolerance or a contraindication to the preferred products as specified in the Blue Cross Blue Shield of Michigan and Blue Care Network medical utilization management drug list.

Quantity limitations, authorization period and renewal criteria:

• Quantity limits: Align with FDA-recommended dosing.
• Authorization period: One year at a time
• Renewal criteria: Clinical documentation must be provided to confirm that current criteria are met and that the medication is providing clinical benefit.

Rystiggo (rozanolixizumab-noli) isn’t a benefit for URMBT.

J3490
J3590

Basic benefit and medical policy

Tyruko (natalizumab-sztn)

Effective Aug. 24, 2023, Tyruko (natalizumab-sztn) is covered for its FDA-approved indications.

Coverage of Tyruko (natalizumab-sztn) is provided when all the following are met:

• Diagnosis of multiple sclerosis:
• FDA-approved age
• FDA-approved indication
• Won’t be used in combination with other disease-modifying treatments of multiple sclerosis
• Diagnosis of Crohn’s disease
• Coverage will be provided for biosimilar products for FDA-labeled indications of the innovator product when criteria are met.
• Trial and failure, contraindication or intolerance to the preferred drugs as listed in Blue Cross Blue Shield of Michigan and Blue Care Network’s utilization management medical drug list.

Quantity limitations, authorization period and renewal criteria:
 

• Quantity limits: Align with FDA-recommended dosing.
• Authorization period: One year at a time
• Renewal criteria: Clinical documentation must be provided to confirm that current criteria are met and that the medication is providing clinical benefit.

This drug isn’t a benefit for URMBT.

J9217

Basic benefit and medical policy

Eligard (leuprolide acetate for depot suspension)

Effective July 20, 2023, Eligard (leuprolide acetate for depot suspension) is covered for the following FDA-approved indications:

Eligard (leuprolide acetate for depot suspension) is a gonadotropin releasing hormone, or GnRH, agonist indicated for the treatment of advanced prostate cancer.

J9355
Q5112
Q5113
Q5114
Q5116
Q5117

Basic benefit and medical policy

Off-label use approved

Blue Cross Blue Shield of Michigan has approved payment for the off-label use of Herceptin (trastuzumab), Ontruzant (trastuzumab-dttb), Herzuma (trastuzumab-pkrb), Ogivri (trastuzumab-dkst), Trazimera (trastuzumab-qyyp) and Kanjinti (trastuzumab-anns) for the treatment of malignant neoplasm of the endometrium.

URMBT is excluded from this change.