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Gonadotropin Releasing Hormones (GnRHs) Analogs

Section: Injections
Effective Date: February 01, 2020
Revised Date: January 27, 2020
Last Reviewed: January 22, 2020

Description

Leuprolide acetate (Lupron®, Lupron Depot ®, Lupron Depot-Ped ®, Eligard®) is a synthetic analog of gonadotropin releasing hormone (GnRH). Although leuprolide acetate has potent GnRH agonist properties during short-term or intermittent therapy, the principal effect of the drug during long-term administration is inhibition of gonadotropin secretion and suppression of ovarian and testicular steroidogenesis.

Leuprolide and norethindrone (Lupaneta®) is a combination medicine used to treat symptoms of endometriosis.

Triptorelin extended-release (Triptodur®) and triptorelin pamoate (Trelstar®) are synthetic decapeptide agonist analogs of GnRH that reversibly inhibits gonadotropin secretion when administered in continuous doses.

Histrelin (Vantas®, Supprelin LA®) is a synthetic nonapeptide analog of GnRH. Contained in an implant, histrelin (Vantas, Supprelin LA) is released via a diffusion-controlled hydrogel polymer reservoir. Histrelin (Vantas, Supprelin LA) functions as a GnRH agonist, and is a potent inhibitor of gonadotropin secretion when administered in continuous doses.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

The use of leuprolide acetate (Lupron) may be considered medically necessary for the following conditions:

Food and Drug Administration (FDA) Indications:

Prostate Cancer

  • The palliative treatment of advanced prostate cancer; or

Central Precocious Puberty

  • The treatment of children with central precocious puberty; or

Endometriosis

  • The management of endometriosis, including pain relief and reduction of endometriotic lesions:
    • Duration of initial treatment or retreatment not to exceed 6 months; or

Anemia due to Uterine Fibroids

  • The preoperative treatment of anemia due to uterine fibroids in combination with iron supplementation when iron therapy alone fails to correct the anemia:
    • Duration of therapy not to exceed 3 months.

National Comprehensive Cancer Network (NCCN) Recommendations:

Salivary Gland Tumors

  • Treatment for androgen receptor positive recurrent disease with distant metastases in individuals with a performance status (PS) of 0-3; or

Prostate Cancer

  • As adjuvant androgen deprivation therapy (ADT) as a single agent if life expectancy is less than or equal to 5 years and asymptomatic in EITHER of the following:
    • In selected individuals with high or very high-risk disease where complications such as hydronephrosis or metastasis can be expected within 5 years; or
    • In individuals with regional or metastatic disease; or
  • As adjuvant ADT as a single agent with or without external beam radiation (EBRT) if lymph node metastasis found during pelvic lymph node dissection (PLND) for:
    • Individuals in the very low risk group and greater than or equal to 20 year expected survival; or
    • Individuals in the low or intermediate risk groups and greater than or equal to 10 year expected survival; or
    • Individuals in the high or very high-risk groups and greater than 5 year expected survival; or
  • Initial ADT as a single agent or in combination with a first-generation antiandrogen (e.g. bicalutamide, nilutamide, flutamide, etc.) if life expectancy greater than 5 years or symptomatic:
    • For 4-6 months in combination with EBRT with or without brachytherapy for individuals in the unfavorable intermediate risk group; or
    • For 2-3 years in combination with EBRT for individuals in the high or very high-risk group; or
    • For 2-3 years in combination with EBRT followed by docetaxel and concurrent steroid after completion of radiation in selected individuals in the high or very high-risk group who are fit for chemotherapy; or
    • For 1-3 years in combination with EBRT and brachytherapy for individuals in the high or very high-risk group; or
    • For 2-3 years in combination with EBRT for individuals in the regional risk group with or without:
      • Abiraterone and prednisone; or
      • Abiraterone and methylprednisolone or
  • Initial ADT as a single agent for individuals in the regional risk group if life expectancy is greater than 5 years or symptomatic with or without:
    • Abiraterone and prednisone; or
    • Abiraterone and methylprednisolone; or
  • Single agent treatment for individuals who progressed on observation of localized disease; or
  • ADT for Prostate-Specific Antigen (PSA) persistence/recurrence:
    • As a single agent* or in combination with a first-generation antiandrogen following radical prostatectomy in combination with EBRT for disease without distant mestases: or
    • As a single agent* following radical prostatectomy in combination with or without EBRT fir distant regional metastatic disease with:
      • A first-generation antiandrogen; or
      • Abiraterone and prednisone; or
      • Abiraterone and methylprednisolone; or
    • For positive digital rectal exam (DRE) following EBRT if biopsy negative and no distant metastases as single agent* therapy or in combination with a first-generation antiandrogen; or
    • For positive DRE following EBRT in individuals who are not candidates for local therapy (especially if positive bone scan) as single agent* therapy or in combination with a first-generation antiandrogen; or
    • For positive DRE following EBRT in individuals who are not candidates for local therapy and have a positive bone scan as single agent* therapy or with:
      • Abiraterone and prednisone; or
      • Abiraterone and methylprednisolone; or
  • For castration-naïve disease:
    • As a single agent* for M0 or M1 disease; or
    • In combination with a first-generation antiandrogen for M0 or M1 disease; or
    • In combination with ONE of the following for M1 disease:
      • Docetaxel and concurrent steroid with or without a first-generation antiandrogen; or
      • Abiraterone and prednisone; or
      • Abiraterone and methylprednisolone; or
  • For M0 or M1 castration resistant disease as ADT to maintain castrate serum testosterone levels to less than 50 ng/dL.

The use of leuprolide/leuprolide acetate (Lupron) in the treatment of conditions other than the above is considered not medically necessary.

Procedure Code

J1950 J9218

The use of leuprolide acetate for depot suspension (Lupron Depot) may be considered medically necessary for ANY of the following conditions:

FDA Indications:

Endometriosis

  • The management of endometriosis, including pain relief and reduction of endometriotic lesions:
    • Duration of initial treatment or retreatment not to exceed 6 months; or
  • As initial management of painful symptoms of endometriosis and for management of recurrence of symptoms in combination with norethindrone acetate 5 mg tablet taken once daily as add-back therapy:
    • Duration of initial treatment or retreatment not to exceed 6 months.

Anemia due to Uterine Fibroids

  • The preoperative treatment of anemia due to uterine fibroids in combination with iron supplementation when iron therapy alone fails to correct the anemia:
    • Duration of therapy not to exceed 3 months and limited to one injection.

Prostate Cancer

  • The palliative treatment of advanced prostatic cancer.

NCCN Recommendations:

Invasive Breast Cancer

  • For the treatment of premenopausal women* with hormone receptor-positive disease in combination with:
    • Adjuvant endocrine therapy; or
    • Endocrine therapy for recurrent or metastatic disease; or

*Men with breast cancer should be treated similarly to postmenopausal women, except that use of an aromatase inhibitor is ineffective without concomitant suppression of testicular steroidogenesis.

Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer- Epithelial Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer

  •  For hormonal therapy as a single agent for persistent disease or recurrence; or

 Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer- Low-Grade Serous/Grade 1 Endometrioid Epithelial Carcinoma

  •  For hormone therapy as a single agent for low-grade serous/grade 1 endometrioid epithelial carcinoma or borderline epithelial tumors with invasive implants as:
    • Primary adjuvant treatment for pathologic stage IC-IV disease; or
    • Maintenance treatment following adjuvant chemotherapy for pathologic stage II-IV disease; or

Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer-Malignant Sex Cord-Stromal Tumors

  •  As a single agent for clinical relapse in individuals with stage II-IV granulosa cell tumors.

The use of leuprolide acetate for depot suspension (Lupron Depot) in the treatment of conditions other than the above is considered not medically necessary.

Procedure Codes

J1950 J9217

The use of leuprolide acetate for depot suspension (Lupron Depot Ped) may be considered medically necessary for the treatment of children with central precocious puberty.

The use of leuprolide acetate for depot suspension (Lupron Depot Ped) for any other indication is considered not medically necessary.

Procedure Codes

J9217 J1950

Leuprolide and norethindrone (Lupaneta Pack) may be considered medically necessary for women 18 years of age and older for:

  • The initial management of the painful symptoms of endometriosis; or
  • The management of recurrence of symptoms.

Initial treatment course is limited to 6 months and use is not recommended longer than a total of 12 months due to concerns about adverse impact on bone mineral density.

The use of Leuprolide and norethindrone (Lupaneta Pack) for any other indications is considered not medically necessary.

Procedure Codes

J3490

The use of leuprolide acetate (Eligard) may be considered medically necessary for the following conditions:

FDA Indications:

Prostate Cancer

The palliative treatment of advanced prostate cancer.

NCCN Recommendations:

The use of leuprolide acetate (Lupron) may be considered medically necessary for the following conditions:

Salivary Gland Tumors

  • Treatment for androgen receptor positive recurrent disease with distant metastases in individuals with a PS of 0-3; or

Prostate Cancer

  • As adjuvant ADT as a single agent if life expectancy is less than or equal to 5 years and asymptomatic in EITHER of the following:
    • In selected individuals with high or very high risk disease where complications such as hydronephrosis or metastasis can be expected within 5 years; or
    • In individuals with regional or metastatic disease; or
  • As adjuvant ADT as a single agent with or without EBRT if lymph node mestastsis found during PLND for:
    • Individuals in the very low risk group and greater than or equal to 20 year expected survival; or
    • Individuals in the low or intermediate risk groups and greater than or equal to 10 year expected survival; or
    • Individuals in the high or very high risk groups and greater than 5 year expected survival; or
  • Initial ADT as a single agent or in combination with a first-generation antiandrogen (e.g. bicalutamide, nilutamide, flutamide, etc.) if life expectancy greater than 5 years or symptomatic:
    • For 4-6 months in combination with EBRT with or without brachytherapy for individuals in the unfavorable intermediate risk group; or
    • For 2-3 years in combination with EBRT for individuals in the high or very high risk group; or
    • For 2-3 years in combination with EBRT followed by docetaxel and concurrent steroid after completion of radiation in selected individuals in the high or very high risk group who are fit for chemotherapy; or
    • For 1-3 years in combination with EBRT and brachytherapy for individuals in the high or very high risk group; or
    • For 2-3 years in combination with EBRT for individuals in the regional risk group with or without:
      • Abiraterone and prednisone; or
      • Abiraterone and methylprednisolone; or
  • Initial ADT as a single agent for individuals in the regional risk group if life expectancy is greater than 5 years or symptomatic with or without:
    • Abiraterone and prednisone; or
    • Abiraterone and methylprednisolone; or
  • Single agent treatment for individuals who progressed on observation of localized disease; or
  • ADT for PSA persistence/recurrence:
    • As a single agent* or in combination with a first-generation antiandrogen following radical prostatectomy in combination with EBRT for disease without distant mestases: or
    • As a single agent* following radical prostatectomy in combination with or without EBRT fir distant regional metastatic disease with:
      • A first generation antiandrogen; or
      • Abiraterone and prednisone; or
      • Abiraterone and methylprednisolone; or
    • For DRE following EBRT if biopsy negative and no distant metastases as single agent* therapy or in combination with a first generation antiandrogen; or
    • For positive DRE following EBRT in individuals who are not candidates for local therapy (especially if positive bone scan) as single agent* therapy or in combination with a first generation antiandrogen; or
    • For positive DRE following EBRT in individuals who are not candidates for local therapy and have a positive bone scan as single agent* therapy or with:
      • Abiraterone and prednisone; or
      • Abiraterone and methylprednisolone; or
  • For castration-naïve disease:
    • As a single agent* for M0 or M1 disease;or
    • In combination with a first generation antiandrogen for M0 or M1 disease; or
    • In combination with ONE of the following for M1 disease:
      • Docetaxel and concurrent steroid with or without a first-generation antiandrogen; or
      • Abiraterone and prednisone; or
      • Abiraterone and methylprednisolone; or
  • For M0 or M1 castration-resistant disease as ADT to maintain castrate testosterone serum levels less than 50 ng.

The use of leuprolide acetate (Eligard) for any other indication is considered not medically necessary.

Procedure Codes

J9217

The use of triptorelin extended-release (Triptodur) may be considered medically necessary for the following conditions:

FDA Indications

Central Precocious Puberty

  • The treatment of pediatric individuals 2 years and older with central precocious puberty.

The use of triptorelin extended-release (Triptodur) for any other indication is considered not medically necessary.

Procedure Codes

J3316

The use of triptorelin pamoate (Trelstar) may be considered medically necessary for the following conditions:

FDA Indications

 Prostate Cancer

  • The palliative treatment of advanced prostate cancer.

NCCN Recommendations

Prostate Cancer

  • ADT as a single agent if life expectancy is less than or equal to 5 years and asymptomatic:
    • In selected individuals with high or very high risk disease where complications such as hydronephrosis or metastasis can be expected within 5 years; or
    • In individuals with regional or metastatic disease; or
  • ADT as a single agent with or without EBRT if lymph node metastasis found during PLND:
    • For individuals in the very low risk group with greater than or equal to 20 year expected survival; or
    • For individuals in the low or intermediate risk groups and greater than or equal to 10 year expected survival; or
    • For individuals in the high or very high risk groups with greater than 5 year expected survival; or
  • Initial ADT as a single agent or in combination with a first-generation antiandrogen (e.g. bicalutamide, nilutamide, flutamide, etc.) if life expectancy greater than 5 years or symptomatic:
    • For 4-6 months in combination with EBRT with or without brachytherapy for individuals in the unfavorable intermediate risk group; or
    • For 2-3 years in combination with EBRT for individuals in the high or very high risk group; or
    • For 2-3 years in combination with EBRT followed by docetaxel and concurrent steroid after completion of radiation in selected individuals in the high or very high risk group who are fit for chemotherapy; or
    • For 1-3 years in combination with EBRT and brachytherapy for patients in the high or very high risk group; or
    • For 2-3 years in combination with EBRT for individuals in the regional risk group with or without:
      • Abiraterone and prednisone; or
      • Abiraterone and methylprednisolone; or
  • Initial ADT as single agent for individuals in the regional risk group if life expectancy greater than 5 years or symptomatic with or without:
    • Abiraterone and prednisone; or
    • Abiraterone and methylprednisolone; or
  • Single agent treatment for individuals with progressed on observation of localized disease; or
  • ADT for PSA persistence/recurrence:
    • As a single agent* or in combination with a first-generation antiandrogen following radical prostatectomy in combination with EBRT for disease without distant mestases: or
    • As a single agent* following radical prostatectomy in combination with or without EBRT for distant regional metastatic disease with:
      • A first generation antiandrogen; or
      • Abiraterone and prednisone; or
      • Abiraterone and methylprednisolone; or
    • For positive DRE following EBRT if biopsy negative and no distant metastases as single agent* therapy or in combination with a first generation antiandrogen; or
    • For positive DRE following EBRT in individuals who are not candidates for local therapy (especially if positive bone scan) as single agent* therapy or in combination with a first generation antiandrogen; or
    • For positive DRE following EBRT in individuals who are not candidates for local therapy and have a positive bone scan as single agent* therapy or with:
      • Abiraterone and prednisone; or
      • Abiraterone and methylprednisolone; or
  • For castration-naïve disease:
    • As a single agent* for M0 or M1 disease; or
    • In combination with a first generation antiandrogen for M0 or M1 disease; or
    • In combination with ONE of the following for M1 disease:
      • Docetaxel and concurrent steroid with or without a first-generation antiandrogen; or
      • Abiraterone and prednisone; or
      • Abiraterone and methylprednisolone; or
  • For M0 or M1 castration-resistant disease as ADT to maintain castrate testosterone serum levels less than 50 ng/dL; or

Other Medically Accepted Non-FDA Approved Indications, Class IIb or Higher Grade Recommendation

The use of triptorelin pamoate (Trelstar) may be considered medically necessary for the following conditions:

Breast Cancer

  • For the treatment of premenopausal women with hormone-sensitive advanced breast cancer; or

 Endometriosis

  • For the treatment of endometriosis:
    • Note: clinical guidelines suggest the addition of hormonal add-back therapy to triptorelin pamoate (Trelstar) as an effective means of reducing the bone mineral loss that occurs with triptorelin therapy alone; or
  • For the treatment of endometrial hyperplasia.

The use of triptorelin pamoate (Trelstar) for any other indication is considered not medically necessary.

Procedure Codes

J3315

The use of histrelin acetate subcutaneous implant (Vantas) may be considered medically necessary for the following conditions:

FDA Indications

Prostate Cancer

  • For the palliative treatment of advanced prostate cancer.

NCCN Indications

Prostate Cancer

  • ADT as single agent if life expectancy less than or equal to 5 years and asymptomatic:
    • In selected individuals with high or very high risk disease where complications such as hydronephrosis or metastasis can be expected within 5 years; or
    • In individuals with regional or metastatic disease; or
  • ADT as single agent with or without EBRT if lymph node metastasis found during PLND:
    • For individuals in the very low risk group and greater than or equal to 20 year expected survival; or
    • For individuals in the low or intermediate risk groups and greater than or equal to 10 year expected survival; or
    • For individuals in the high or very high risk groups and greater than 5 year expected survival; or
  • Initial ADT as a single agent or in combination with a first-generation antiandrogen (e.g. bicalutamide, nilutamide, flutamide, etc.) if life expectancy greater than 5 years or symptomatic:
    • For 4-6 months in combination with EBRT with or without brachytherapy for individuals in the unfavorable intermediate risk group; or
    • For 2-3 years in combination with EBRT for individuals in the high or very high risk group; or
    • For 2-3 years in combination with EBRT followed by docetaxel and concurrent steroid after completion of radiation in selected individuals in the high or very high risk group who are fit for chemotherapy; or
    • For 1-3 years in combination with EBRT and brachytherapy for patients in the high or very high risk group; or
    • For 2-3 years in combination with EBRT for individuals in the regional risk group with or without:
      • Abiraterone and prednisone; or
      • Abiraterone and methylprednisolone; or
  • Initial ADT as single agent for individuals in the regional risk group if life expectancy greater than 5 years or symptomatic with or without:
    • Abiraterone and prednisone; or
    • Abiraterone and methylprednisolone; or
  • Single agent treatment for individuals with progressed on observation of localized disease; or
  • ADT for PSA persistence/recurrence:
    • As a single agent* or in combination with a first-generation antiandrogen following radical prostatectomy in combination with EBRT for disease without distant mestases: or
    • As a single agent* following radical prostatectomy in combination with or without EBRT for distant regional metastatic disease with:
      • A first generation antiandrogen; or
      • Abiraterone and prednisone; or
      • Abiraterone and methylprednisolone; or
    • For positive DRE following EBRT if biopsy negative and no distant metastases as single agent* therapy or in combination with a first generation antiandrogen; or
    • For positive DRE following EBRT in individuals who are not candidates for local therapy (especially if positive bone scan) as single agent* therapy or in combination with a first generation antiandrogen; or
    • For positive DRE following EBRT in individuals who are not candidates for local therapy and have a positive bone scan as single agent* therapy or with:
      • Abiraterone and prednisone; or
      • Abiraterone and methylprednisolone; or
  • For castration-naïve disease:
    • As a single agent* for M0 or M1 disease; or
    • In combination with a first generation antiandrogen for M0 or M1 disease; or
    • In combination with ONE of the following for M1 disease:
      • Docetaxel and concurrent steroid with or without a first-generation antiandrogen; or
      • Abiraterone and prednisone; or
      • Abiraterone and methylprednisolone; or
  • For M0 or M1 castration-resistant disease as ADT to maintain castrate testosterone serum levels less than 50 ng/dL; or

The use of histrelin acetate subcutaneous implant (Vantas) for any other indication is considered not medically necessary.

Procedure Codes

J9225

The use of histrelin acetate subcutaneous implant (Supprelin LA) may be considered medically necessary for the following conditions:

FDA Indications

Central Precocious Puberty

  • For treatment of children with central precocious puberty.

The use of histrelin acetate subcutaneous implant (Supprelin LA) for any other indication is considered not medically necessary.

Procedure Codes

J9226

Other Medically Accepted Non-FDA Approved Indications

The use of histrelin acetate (Supprelin LA, Vantas), leuprolide acetate (Lupron Depot, Lupron Depot-Ped), or triptorelin (Triptodur, Trelstar) may be considered medically necessary for puberty suppression in individuals with gender dysphoria when ALL of the following criteria are met:

The adolescent has demonstrated a long-lasting and intense pattern of gender non-conformity or gender dysphoria (whether suppressed or expressed); and

  • Gender dysphoria emerged or worsened with the onset of puberty; and
  • Any co-existing psychological, medical, or social problems that could interfere with treatment (e.g., that may compromise treatment adherence) have been addressed, such that the adolescent’s situation and functioning are stable enough to start treatment; and
  • The adolescent has given informed consent and, particularly when the adolescent has not reached the age of medical consent, the parents or other caretakers or guardians have consented to the treatment and are involved in supporting the adolescent throughout the treatment process.

The use of histrelin acetate (Supprelin LA, Vantas), leuprolide acetate (Lupron Depot, Lupron Depot-Ped), or triptorelin (Triptodur, Trelstar) for any other indication is considered not medically necessary.

Procedure Codes

J1950J9217J9225J9226J3315J3316

Note*: First generation antiandrogen must be given for 7 or more days to prevent testosterone flare if metastases are present in weight-bearing bone.

Note: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

Covered Diagnosis Codes for Procedure Codes J1950 and J9217

C07C08.0C08.1C08.9C48.1C48.2C48.8
C50.011C50.012C50.019C50.021C50.022C50.029C50.111
C50.112C50.119C50.121C50.122C50.129C50.211C50.212
C50.219C50.221C50.222C50.229C50.311C50.312C50.319
C50.321C50.322C50.329C50.411C50.412C50.419C50.421
C50.422C50.429C50.511C50.512C50.519C50.521C50.522
C50.529C50.611C50.612C50.619C50.621C50.622C50.629
C50.811C50.812C50.819C50.821C50.822C50.829C50.911
C50.912C50.919C50.921C50.922C50.929C56.1C56.2
C56.9C57.00C57.01C57.02C57.10C57.11C57.12
C57.20C57.21C57.22C57.3C57.4C57.7C57.8
C57.9C61D25.0D25.1D25.2D25.9D50.0
D50.9E22.8F64.0F64.1F64.2F64.8F64.9
Z87.890N80.0N80.1N80.2N80.3N80.4N80.5
N80.6N80.8N80.9Z85.43Z85.46

Covered Diagnosis Codes for Procedure Code J9218

C07C08.0C08.1C08.9C61D25.0D25.1
D25.2D25.9E22.8N80.0N80.1N80.2N80.3
N80.4N80.5N80.6N80.8N80.9Z85.46

Covered Diagnosis Codes for Procedure Code J3315

C61C50.011C50.012C50.019C50.021C50.022C50.029
C50.111C50.112C50.119C50.121C50.122C50.129C50.211
C50.212C50.219C50.221C50.222C50.229C50.311C50.312
C50.319C50.321C50.322C50.329C50.411C50.412C50.419
C50.421C50.422C50.429C50.511C50.512C50.519C50.521
C50.522C50.529C50.611C50.612C50.619C50.621C50.622
C50.629C50.811C50.812C50.819C50.821C50.822C50.829
C50.911C50.912C50.919C50.921C50.922C50.929F64.0
F64.1F64.2F64.8F64.9Z87.890N80.0N80.1
N80.2N80.3N80.4N80.5N80.6N80.7N80.8
N80.9Z85.46

Covered Diagnosis Codes for Procedure Code J3316

E22.8F64.0F64.1F64.2F64.8F64.9Z87.890

Covered Diagnosis Codes for Procedure Code J9225

C61Z85.46F64.0F64.1F64.2F64.8F64.9
Z87.890

Covered Diagnosis Codes for Procedure Code J9226

E22.8F64.0F64.1F64.2F64.8F64.9Z87.890

Professional Statements and Societal Positions Guidelines

NA

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