LCD Reference Article Billing and Coding Article

Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs

A52453

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Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

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Source Article ID
N/A
Article ID
A52453
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
01/01/2023
Revision Ending Date
N/A
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Article Text

This article contains billing and coding guidelines that complement the Local Coverage Determination (LCD) Drugs and Biologicals, Coverage of, for Label and Off-Label Uses.

Abstract:

Synthetic luteinizing hormone-releasing hormone (LHRH) analogs (also called LHRH agonists) available in the United States include leuprolide acetate (Lupron®, Eligard®, Viadur™, Lutrate), goserelin acetate (Zoladex®), triptorelin (Trelstar® Depot, Trelstar™LA, Triptodur®), and histrelin acetate (Vantas™). These drugs may be administered by injection or placed as small implants under the skin monthly, or every 3, 4, 6, or 12 months, depending on the preparation. The FDA approved indications and recognized off-label uses (which meet criteria in LCD L33394) vary by product. Leuprolide mesylate (Cancevi®) has been added effective for dates of service on or after 05/26/2021.

Specific coding guidelines for this drug:

Once yearly implants (J9219 and J9225) will not be reimbursed more often than once in a 12-month period and will be denied when submitted with a diagnosis that is not covered. In addition, once yearly implant therapy is not reasonable unless the physician expects the life expectancy of the patient to be longer than one year.

Leuprolide Acetate

HCPCS code J9218 (leuprolide acetate, per 1 mg.) describes a usually self-administered form of leuprolide acetate and is not covered under Medicare Part A/B. Please refer to the Self-Administered Drug Exclusion List – Medical Policy Articles (A53021 for J-K MAC and A53022 for J6 MAC).

Claims for leuprolide acetate billed for prostate cancer at dosages (i.e. J1950 for 3.75 mg of leuprolide acetate) which are medically indicated for other diagnoses will be subject to review and possible denial.

The 10.8 mg implant is not labeled for use in women (AHFS, 2007) and is considered contraindicated in women (Drugdex, 2009).

Camcevi® (leuprolide mesylate) is a ready-to-use, 6-month depot formulation of the approved gonadotropin releasing hormone (GnRH) agonist leuprolide.

Lutrate (leuprolide acetate for depot suspension) a gonadotropin-releasing hormone (GnRH) agonist- 22.5 mg for 3 months administration.

Documentation Requirements:

The medical record documentation for patients receiving a once-yearly implant should support ongoing follow-up visits at least every three (3) to four (4) months. This documentation must be submitted upon request. Claims submitted without requested supporting evidence in the medical record will be denied as being not medically necessary.

Utilization Guidelines:

Drugs may be designed to deliver their respective agents at a controlled rate for a specified therapeutic period of time (e.g., those formulated in depot or implant form). Eligard®, for example, (packaged as 22.5 mg /vial) is designed to deliver the 22.5 mg of leuprolide acetate at a controlled rate over a 3-month therapeutic period; Vantas® (packaged as a 50 mg implant) is formulated to deliver histrelin continuously for 12 months. We would expect, therefore, to see the billing frequency for these drugs to match the particular drug formulation administered. For example, the Vantas® 50 mg implant would only be billed once per 12 months.

The leuprolide acetate and histrelin implants are designed to deliver their respective agents for 12 months at a controlled rate. Therefore, payment for these agents is usually limited to once in a 12-month period.

Surgical implant forms of leuprolide acetate and histrelin acetate hormonal therapy must be removed after twelve months. When a surgical implant is removed, another surgical implant may be inserted to continue therapy.

Coverage of leuprolide acetate and histrelin acetate, administered every 12 months in the surgical implant form for treatment of prostate cancer, is considered medically appropriate only for patients having a reasonable expectation of surviving at least 12 months.

GnRH analogs are covered for the indicated diagnosis, with frequency of administration governed by the duration of action of the previously administered GnRH analog. Drugs administered at intervals exceeding these frequencies, and the associated administration services will be denied.

FDA and Compendia Review:

AHFS Drug Information 2009. Available at http://www.ahfsdruginformation.com/. Accessed 01/28/2009.

Clinical Pharmacology Web site. http://www.clinicalpharmacology.com/. Accessed 11/30/2022.

FDA Web site: https://www.accessdata.fda.gov/scripts/cder/daf/

Lexi-Drugs Web site. http://online.lexi.com. Accessed 11/30/2022

Manufacturer’s drug inserts.

Micromedex DrugDex®. Thomson Web site. http://www.thomsonhc.com/home/dispatch. Accessed 11/30/2022

National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium®. Available at http://www.nccn.org/professionals/drug_compendium/content/contents.asp Accessed 11/30/2022

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Group 1

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ICD-10-CM Codes that Support Medical Necessity

Group 1

(172 Codes)
Group 1 Paragraph

J1950 [Injection, leuprolide acetate (for depot suspension), per 3.75 mg]

Group 1 Codes
Code Description
C48.1 Malignant neoplasm of specified parts of peritoneum
C48.8 Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum
C50.011 Malignant neoplasm of nipple and areola, right female breast
C50.012 Malignant neoplasm of nipple and areola, left female breast
C50.021 Malignant neoplasm of nipple and areola, right male breast
C50.022 Malignant neoplasm of nipple and areola, left male breast
C50.111 Malignant neoplasm of central portion of right female breast
C50.112 Malignant neoplasm of central portion of left female breast
C50.121 Malignant neoplasm of central portion of right male breast
C50.122 Malignant neoplasm of central portion of left male breast
C50.211 Malignant neoplasm of upper-inner quadrant of right female breast
C50.212 Malignant neoplasm of upper-inner quadrant of left female breast
C50.221 Malignant neoplasm of upper-inner quadrant of right male breast
C50.222 Malignant neoplasm of upper-inner quadrant of left male breast
C50.311 Malignant neoplasm of lower-inner quadrant of right female breast
C50.312 Malignant neoplasm of lower-inner quadrant of left female breast
C50.321 Malignant neoplasm of lower-inner quadrant of right male breast
C50.322 Malignant neoplasm of lower-inner quadrant of left male breast
C50.411 Malignant neoplasm of upper-outer quadrant of right female breast
C50.412 Malignant neoplasm of upper-outer quadrant of left female breast
C50.421 Malignant neoplasm of upper-outer quadrant of right male breast
C50.422 Malignant neoplasm of upper-outer quadrant of left male breast
C50.511 Malignant neoplasm of lower-outer quadrant of right female breast
C50.512 Malignant neoplasm of lower-outer quadrant of left female breast
C50.521 Malignant neoplasm of lower-outer quadrant of right male breast
C50.522 Malignant neoplasm of lower-outer quadrant of left male breast
C50.611 Malignant neoplasm of axillary tail of right female breast
C50.612 Malignant neoplasm of axillary tail of left female breast
C50.621 Malignant neoplasm of axillary tail of right male breast
C50.622 Malignant neoplasm of axillary tail of left male breast
C50.811 Malignant neoplasm of overlapping sites of right female breast
C50.812 Malignant neoplasm of overlapping sites of left female breast
C50.821 Malignant neoplasm of overlapping sites of right male breast
C50.822 Malignant neoplasm of overlapping sites of left male breast
C50.911 Malignant neoplasm of unspecified site of right female breast
C50.912 Malignant neoplasm of unspecified site of left female breast
C50.921 Malignant neoplasm of unspecified site of right male breast
C50.922 Malignant neoplasm of unspecified site of left male breast
C56.1 Malignant neoplasm of right ovary
C56.2 Malignant neoplasm of left ovary
C56.3 Malignant neoplasm of bilateral ovaries
C57.01 - C57.02 Malignant neoplasm of right fallopian tube - Malignant neoplasm of left fallopian tube
C57.11 - C57.12 Malignant neoplasm of right broad ligament - Malignant neoplasm of left broad ligament
C57.21 - C57.22 Malignant neoplasm of right round ligament - Malignant neoplasm of left round ligament
C57.3 Malignant neoplasm of parametrium
C57.4 Malignant neoplasm of uterine adnexa, unspecified
C57.7 - C57.8 Malignant neoplasm of other specified female genital organs - Malignant neoplasm of overlapping sites of female genital organs
D25.0 Submucous leiomyoma of uterus
D25.1 Intramural leiomyoma of uterus
D25.2 Subserosal leiomyoma of uterus
D25.9 Leiomyoma of uterus, unspecified
N80.01 Superficial endometriosis of the uterus
N80.02 Deep endometriosis of the uterus
N80.03 Adenomyosis of the uterus
N80.101 Endometriosis of right ovary, unspecified depth
N80.102 Endometriosis of left ovary, unspecified depth
N80.103 Endometriosis of bilateral ovaries, unspecified depth
N80.109 Endometriosis of ovary, unspecified side, unspecified depth
N80.111 Superficial endometriosis of right ovary
N80.112 Superficial endometriosis of left ovary
N80.113 Superficial endometriosis of bilateral ovaries
N80.121 Deep endometriosis of right ovary
N80.122 Deep endometriosis of left ovary
N80.123 Deep endometriosis of bilateral ovaries
N80.201 Endometriosis of right fallopian tube, unspecified depth
N80.202 Endometriosis of left fallopian tube, unspecified depth
N80.203 Endometriosis of bilateral fallopian tubes, unspecified depth
N80.211 Superficial endometriosis of right fallopian tube
N80.212 Superficial endometriosis of left fallopian tube
N80.213 Superficial endometriosis of bilateral fallopian tubes
N80.221 Deep endometriosis of right fallopian tube
N80.222 Deep endometriosis of left fallopian tube
N80.223 Deep endometriosis of bilateral fallopian tubes
N80.311 Superficial endometriosis of the anterior cul-de-sac
N80.312 Deep endometriosis of the anterior cul-de-sac
N80.319 Endometriosis of the anterior cul-de-sac, unspecified depth
N80.321 Superficial endometriosis of the posterior cul-de-sac
N80.322 Deep endometriosis of the posterior cul-de-sac
N80.329 Endometriosis of the posterior cul-de-sac, unspecified depth
N80.331 Superficial endometriosis of the right pelvic sidewall
N80.332 Superficial endometriosis of the left pelvic sidewall
N80.333 Superficial endometriosis of bilateral pelvic sidewall
N80.341 Deep endometriosis of the right pelvic sidewall
N80.342 Deep endometriosis of the left pelvic sidewall
N80.343 Deep endometriosis of the bilateral pelvic sidewall
N80.351 Endometriosis of the right pelvic sidewall, unspecified depth
N80.352 Endometriosis of the left pelvic sidewall, unspecified depth
N80.353 Endometriosis of bilateral pelvic sidewall, unspecified depth
N80.361 Superficial endometriosis of the right pelvic brim
N80.362 Superficial endometriosis of the left pelvic brim
N80.363 Superficial endometriosis of bilateral pelvic brim
N80.371 Deep endometriosis of the right pelvic brim
N80.372 Deep endometriosis of the left pelvic brim
N80.373 Deep endometriosis of bilateral pelvic brim
N80.381 Endometriosis of the right pelvic brim, unspecified depth
N80.382 Endometriosis of the left pelvic brim, unspecified depth
N80.383 Endometriosis of bilateral pelvic brim, unspecified depth
N80.3A1 Superficial endometriosis of the right uterosacral ligament
N80.3A2 Superficial endometriosis of the left uterosacral ligament
N80.3A3 Superficial endometriosis of the bilateral uterosacral ligament(s)
N80.3B1 Deep endometriosis of the right uterosacral ligament
N80.3B2 Deep endometriosis of the left uterosacral ligament
N80.3B3 Deep endometriosis of bilateral uterosacral ligament(s)
N80.3C1 Endometriosis of the right uterosacral ligament, unspecified depth
N80.3C2 Endometriosis of the left uterosacral ligament, unspecified depth
N80.3C3 Endometriosis of bilateral uterosacral ligament(s), unspecified depth
N80.391 Superficial endometriosis of the pelvic peritoneum, other specified sites
N80.392 Deep endometriosis of the pelvic peritoneum, other specified sites
N80.399 Endometriosis of the pelvic peritoneum, other specified sites, unspecified depth
N80.41 Endometriosis of rectovaginal septum without involvement of vagina
N80.42 Endometriosis of rectovaginal septum with involvement of vagina
N80.511 Superficial endometriosis of the rectum
N80.512 Deep endometriosis of the rectum
N80.519 Endometriosis of the rectum, unspecified depth
N80.521 Superficial endometriosis of the sigmoid colon
N80.522 Deep endometriosis of the sigmoid colon
N80.529 Endometriosis of the sigmoid colon, unspecified depth
N80.531 Superficial endometriosis of the cecum
N80.532 Deep endometriosis of the cecum
N80.539 Endometriosis of the cecum, unspecified depth
N80.541 Superficial endometriosis of the appendix
N80.542 Deep endometriosis of the appendix
N80.549 Endometriosis of the appendix, unspecified depth
N80.551 Superficial endometriosis of other parts of the colon
N80.552 Deep endometriosis of other parts of the colon
N80.559 Endometriosis of other parts of the colon, unspecified depth
N80.561 Superficial endometriosis of the small intestine
N80.562 Deep endometriosis of the small intestine
N80.569 Endometriosis of the small intestine, unspecified depth
N80.6 Endometriosis in cutaneous scar
N80.A0 Endometriosis of bladder, unspecified depth
N80.A1 Superficial endometriosis of bladder
N80.A2 Deep endometriosis of bladder
N80.A41 Superficial endometriosis of right ureter
N80.A42 Superficial endometriosis of left ureter
N80.A43 Superficial endometriosis of bilateral ureters
N80.A51 Deep endometriosis of right ureter
N80.A52 Deep endometriosis of left ureter
N80.A53 Deep endometriosis of bilateral ureters
N80.A61 Endometriosis of right ureter, unspecified depth
N80.A62 Endometriosis of left ureter, unspecified depth
N80.A63 Endometriosis of bilateral ureters, unspecified depth
N80.B1 Endometriosis of pleura
N80.B2 Endometriosis of lung
N80.B31 Superficial endometriosis of diaphragm
N80.B32 Deep endometriosis of diaphragm
N80.B39 Endometriosis of diaphragm, unspecified depth
N80.B4 Endometriosis of the pericardial space
N80.B5 Endometriosis of the mediastinal space
N80.B6 Endometriosis of cardiothoracic space
N80.C10 Endometriosis of the anterior abdominal wall, subcutaneous tissue
N80.C11 Endometriosis of the anterior abdominal wall, fascia and muscular layers
N80.C19 Endometriosis of the anterior abdominal wall, unspecified depth
N80.C2 Endometriosis of the umbilicus
N80.C3 Endometriosis of the inguinal canal
N80.C4 Endometriosis of extra-pelvic abdominal peritoneum
N80.C9 Endometriosis of other site of abdomen
N80.D1 Endometriosis of the sacral splanchnic nerves
N80.D2 Endometriosis of the sacral nerve roots
N80.D3 Endometriosis of the obturator nerve
N80.D4 Endometriosis of the sciatic nerve
N80.D5 Endometriosis of the pudendal nerve
N80.D6 Endometriosis of the femoral nerve
N80.D9 Endometriosis of other pelvic nerve
N80.8 Other endometriosis
N80.9 Endometriosis, unspecified
R10.2 Pelvic and perineal pain
Z85.3 Personal history of malignant neoplasm of breast

Group 2

(12 Codes)
Group 2 Paragraph

J3315 (Injection, triptorelin pamoate, 3.75 mg)

Primary ICD-10-CM codes: (these diagnoses can be billed as a single diagnosis or in conjunction with the secondary ICD-10-CM codes listed below)


Group 2 Codes
Code Description
C61 Malignant neoplasm of prostate
D07.5 Carcinoma in situ of prostate
D25.0 Submucous leiomyoma of uterus
D25.1 Intramural leiomyoma of uterus
D25.2 Subserosal leiomyoma of uterus
N60.11 Diffuse cystic mastopathy of right breast
N60.12 Diffuse cystic mastopathy of left breast
N80.01 Superficial endometriosis of the uterus
N80.02 Deep endometriosis of the uterus
N80.03 Adenomyosis of the uterus
N85.01 Benign endometrial hyperplasia
Z85.46 Personal history of malignant neoplasm of prostate

Group 3

(13 Codes)
Group 3 Paragraph

The ICD-10-CM codes listed below are considered secondary codes. When these codes are reported for J3315, the claim must also include a diagnosis from the primary diagnosis list above.

Group 3 Codes
Code Description
C77.2 Secondary and unspecified malignant neoplasm of intra-abdominal lymph nodes
C77.4 Secondary and unspecified malignant neoplasm of inguinal and lower limb lymph nodes
C77.8 Secondary and unspecified malignant neoplasm of lymph nodes of multiple regions
C77.9 Secondary and unspecified malignant neoplasm of lymph node, unspecified
C78.00 Secondary malignant neoplasm of unspecified lung
C78.01 Secondary malignant neoplasm of right lung
C78.02 Secondary malignant neoplasm of left lung
C78.6 Secondary malignant neoplasm of retroperitoneum and peritoneum
C78.7 Secondary malignant neoplasm of liver and intrahepatic bile duct
C79.2 Secondary malignant neoplasm of skin
C79.31 Secondary malignant neoplasm of brain
C79.51 Secondary malignant neoplasm of bone
C79.52 Secondary malignant neoplasm of bone marrow

Group 4

(163 Codes)
Group 4 Paragraph

J9202 (Goserelin acetate implant, per 3.6 mg)

Primary ICD-10-CM codes: (these diagnoses can be billed as a single diagnosis or in conjunction with the secondary ICD-10-CM codes listed below)


Group 4 Codes
Code Description
C50.011 Malignant neoplasm of nipple and areola, right female breast
C50.012 Malignant neoplasm of nipple and areola, left female breast
C50.021 Malignant neoplasm of nipple and areola, right male breast
C50.022 Malignant neoplasm of nipple and areola, left male breast
C50.111 Malignant neoplasm of central portion of right female breast
C50.112 Malignant neoplasm of central portion of left female breast
C50.121 Malignant neoplasm of central portion of right male breast
C50.122 Malignant neoplasm of central portion of left male breast
C50.211 Malignant neoplasm of upper-inner quadrant of right female breast
C50.212 Malignant neoplasm of upper-inner quadrant of left female breast
C50.221 Malignant neoplasm of upper-inner quadrant of right male breast
C50.222 Malignant neoplasm of upper-inner quadrant of left male breast
C50.311 Malignant neoplasm of lower-inner quadrant of right female breast
C50.312 Malignant neoplasm of lower-inner quadrant of left female breast
C50.321 Malignant neoplasm of lower-inner quadrant of right male breast
C50.322 Malignant neoplasm of lower-inner quadrant of left male breast
C50.411 Malignant neoplasm of upper-outer quadrant of right female breast
C50.412 Malignant neoplasm of upper-outer quadrant of left female breast
C50.421 Malignant neoplasm of upper-outer quadrant of right male breast
C50.422 Malignant neoplasm of upper-outer quadrant of left male breast
C50.511 Malignant neoplasm of lower-outer quadrant of right female breast
C50.512 Malignant neoplasm of lower-outer quadrant of left female breast
C50.521 Malignant neoplasm of lower-outer quadrant of right male breast
C50.522 Malignant neoplasm of lower-outer quadrant of left male breast
C50.611 Malignant neoplasm of axillary tail of right female breast
C50.612 Malignant neoplasm of axillary tail of left female breast
C50.621 Malignant neoplasm of axillary tail of right male breast
C50.622 Malignant neoplasm of axillary tail of left male breast
C50.811 Malignant neoplasm of overlapping sites of right female breast
C50.812 Malignant neoplasm of overlapping sites of left female breast
C50.821 Malignant neoplasm of overlapping sites of right male breast
C50.822 Malignant neoplasm of overlapping sites of left male breast
C50.911 Malignant neoplasm of unspecified site of right female breast
C50.912 Malignant neoplasm of unspecified site of left female breast
C50.921 Malignant neoplasm of unspecified site of right male breast
C50.922 Malignant neoplasm of unspecified site of left male breast
C61 Malignant neoplasm of prostate
D07.5 Carcinoma in situ of prostate
D25.0 Submucous leiomyoma of uterus
D25.1 Intramural leiomyoma of uterus
D25.2 Subserosal leiomyoma of uterus
D25.9 Leiomyoma of uterus, unspecified
E30.1 Precocious puberty
N80.01 Superficial endometriosis of the uterus
N80.02 Deep endometriosis of the uterus
N80.03 Adenomyosis of the uterus
N80.101 Endometriosis of right ovary, unspecified depth
N80.102 Endometriosis of left ovary, unspecified depth
N80.103 Endometriosis of bilateral ovaries, unspecified depth
N80.109 Endometriosis of ovary, unspecified side, unspecified depth
N80.111 Superficial endometriosis of right ovary
N80.112 Superficial endometriosis of left ovary
N80.113 Superficial endometriosis of bilateral ovaries
N80.121 Deep endometriosis of right ovary
N80.122 Deep endometriosis of left ovary
N80.123 Deep endometriosis of bilateral ovaries
N80.201 Endometriosis of right fallopian tube, unspecified depth
N80.202 Endometriosis of left fallopian tube, unspecified depth
N80.203 Endometriosis of bilateral fallopian tubes, unspecified depth
N80.211 Superficial endometriosis of right fallopian tube
N80.212 Superficial endometriosis of left fallopian tube
N80.213 Superficial endometriosis of bilateral fallopian tubes
N80.221 Deep endometriosis of right fallopian tube
N80.222 Deep endometriosis of left fallopian tube
N80.223 Deep endometriosis of bilateral fallopian tubes
N80.311 Superficial endometriosis of the anterior cul-de-sac
N80.312 Deep endometriosis of the anterior cul-de-sac
N80.319 Endometriosis of the anterior cul-de-sac, unspecified depth
N80.321 Superficial endometriosis of the posterior cul-de-sac
N80.322 Deep endometriosis of the posterior cul-de-sac
N80.329 Endometriosis of the posterior cul-de-sac, unspecified depth
N80.331 Superficial endometriosis of the right pelvic sidewall
N80.332 Superficial endometriosis of the left pelvic sidewall
N80.333 Superficial endometriosis of bilateral pelvic sidewall
N80.341 Deep endometriosis of the right pelvic sidewall
N80.342 Deep endometriosis of the left pelvic sidewall
N80.343 Deep endometriosis of the bilateral pelvic sidewall
N80.351 Endometriosis of the right pelvic sidewall, unspecified depth
N80.352 Endometriosis of the left pelvic sidewall, unspecified depth
N80.353 Endometriosis of bilateral pelvic sidewall, unspecified depth
N80.361 Superficial endometriosis of the right pelvic brim
N80.362 Superficial endometriosis of the left pelvic brim
N80.363 Superficial endometriosis of bilateral pelvic brim
N80.371 Deep endometriosis of the right pelvic brim
N80.372 Deep endometriosis of the left pelvic brim
N80.373 Deep endometriosis of bilateral pelvic brim
N80.381 Endometriosis of the right pelvic brim, unspecified depth
N80.382 Endometriosis of the left pelvic brim, unspecified depth
N80.383 Endometriosis of bilateral pelvic brim, unspecified depth
N80.3A1 Superficial endometriosis of the right uterosacral ligament
N80.3A2 Superficial endometriosis of the left uterosacral ligament
N80.3A3 Superficial endometriosis of the bilateral uterosacral ligament(s)
N80.3B1 Deep endometriosis of the right uterosacral ligament
N80.3B2 Deep endometriosis of the left uterosacral ligament
N80.3B3 Deep endometriosis of bilateral uterosacral ligament(s)
N80.3C1 Endometriosis of the right uterosacral ligament, unspecified depth
N80.3C2 Endometriosis of the left uterosacral ligament, unspecified depth
N80.3C3 Endometriosis of bilateral uterosacral ligament(s), unspecified depth
N80.391 Superficial endometriosis of the pelvic peritoneum, other specified sites
N80.392 Deep endometriosis of the pelvic peritoneum, other specified sites
N80.399 Endometriosis of the pelvic peritoneum, other specified sites, unspecified depth
N80.41 Endometriosis of rectovaginal septum without involvement of vagina
N80.42 Endometriosis of rectovaginal septum with involvement of vagina
N80.511 Superficial endometriosis of the rectum
N80.512 Deep endometriosis of the rectum
N80.519 Endometriosis of the rectum, unspecified depth
N80.521 Superficial endometriosis of the sigmoid colon
N80.522 Deep endometriosis of the sigmoid colon
N80.529 Endometriosis of the sigmoid colon, unspecified depth
N80.531 Superficial endometriosis of the cecum
N80.532 Deep endometriosis of the cecum
N80.539 Endometriosis of the cecum, unspecified depth
N80.541 Superficial endometriosis of the appendix
N80.542 Deep endometriosis of the appendix
N80.549 Endometriosis of the appendix, unspecified depth
N80.551 Superficial endometriosis of other parts of the colon
N80.552 Deep endometriosis of other parts of the colon
N80.559 Endometriosis of other parts of the colon, unspecified depth
N80.561 Superficial endometriosis of the small intestine
N80.562 Deep endometriosis of the small intestine
N80.569 Endometriosis of the small intestine, unspecified depth
N80.6 Endometriosis in cutaneous scar
N80.A0 Endometriosis of bladder, unspecified depth
N80.A1 Superficial endometriosis of bladder
N80.A2 Deep endometriosis of bladder
N80.A41 Superficial endometriosis of right ureter
N80.A42 Superficial endometriosis of left ureter
N80.A43 Superficial endometriosis of bilateral ureters
N80.A51 Deep endometriosis of right ureter
N80.A52 Deep endometriosis of left ureter
N80.A53 Deep endometriosis of bilateral ureters
N80.A61 Endometriosis of right ureter, unspecified depth
N80.A62 Endometriosis of left ureter, unspecified depth
N80.A63 Endometriosis of bilateral ureters, unspecified depth
N80.B1 Endometriosis of pleura
N80.B2 Endometriosis of lung
N80.B31 Superficial endometriosis of diaphragm
N80.B32 Deep endometriosis of diaphragm
N80.B39 Endometriosis of diaphragm, unspecified depth
N80.B4 Endometriosis of the pericardial space
N80.B5 Endometriosis of the mediastinal space
N80.B6 Endometriosis of cardiothoracic space
N80.C10 Endometriosis of the anterior abdominal wall, subcutaneous tissue
N80.C11 Endometriosis of the anterior abdominal wall, fascia and muscular layers
N80.C19 Endometriosis of the anterior abdominal wall, unspecified depth
N80.C2 Endometriosis of the umbilicus
N80.C3 Endometriosis of the inguinal canal
N80.C4 Endometriosis of extra-pelvic abdominal peritoneum
N80.C9 Endometriosis of other site of abdomen
N80.D1 Endometriosis of the sacral splanchnic nerves
N80.D2 Endometriosis of the sacral nerve roots
N80.D3 Endometriosis of the obturator nerve
N80.D4 Endometriosis of the sciatic nerve
N80.D5 Endometriosis of the pudendal nerve
N80.D6 Endometriosis of the femoral nerve
N80.D9 Endometriosis of other pelvic nerve
N80.8 Other endometriosis
N80.9 Endometriosis, unspecified
N89.7 Hematocolpos
N92.5 Other specified irregular menstruation
N93.8 Other specified abnormal uterine and vaginal bleeding
Z85.3 Personal history of malignant neoplasm of breast
Z85.46 Personal history of malignant neoplasm of prostate

Group 5

(13 Codes)
Group 5 Paragraph

The ICD-10-CM codes listed below are considered secondary codes. When these codes are reported for J9202, the claim must also include a diagnosis from the primary diagnosis list above.

Group 5 Codes
Code Description
C77.2 Secondary and unspecified malignant neoplasm of intra-abdominal lymph nodes
C77.4 Secondary and unspecified malignant neoplasm of inguinal and lower limb lymph nodes
C77.8 Secondary and unspecified malignant neoplasm of lymph nodes of multiple regions
C77.9 Secondary and unspecified malignant neoplasm of lymph node, unspecified
C78.00 Secondary malignant neoplasm of unspecified lung
C78.01 Secondary malignant neoplasm of right lung
C78.02 Secondary malignant neoplasm of left lung
C78.6 Secondary malignant neoplasm of retroperitoneum and peritoneum
C78.7 Secondary malignant neoplasm of liver and intrahepatic bile duct
C79.2 Secondary malignant neoplasm of skin
C79.31 Secondary malignant neoplasm of brain
C79.51 Secondary malignant neoplasm of bone
C79.52 Secondary malignant neoplasm of bone marrow

Group 6

(60 Codes)
Group 6 Paragraph

J9217 [Leuprolide acetate (for depot suspension), per 7.5 mg]

Primary ICD-10-CM codes (these diagnoses can be billed as a single diagnosis or in conjunction with the secondary ICD-10-CM codes listed below)


Group 6 Codes
Code Description
C07 Malignant neoplasm of parotid gland
C08.0 Malignant neoplasm of submandibular gland
C08.1 Malignant neoplasm of sublingual gland
C50.011 Malignant neoplasm of nipple and areola, right female breast
C50.012 Malignant neoplasm of nipple and areola, left female breast
C50.021 Malignant neoplasm of nipple and areola, right male breast
C50.022 Malignant neoplasm of nipple and areola, left male breast
C50.111 Malignant neoplasm of central portion of right female breast
C50.112 Malignant neoplasm of central portion of left female breast
C50.121 Malignant neoplasm of central portion of right male breast
C50.122 Malignant neoplasm of central portion of left male breast
C50.211 Malignant neoplasm of upper-inner quadrant of right female breast
C50.212 Malignant neoplasm of upper-inner quadrant of left female breast
C50.221 Malignant neoplasm of upper-inner quadrant of right male breast
C50.222 Malignant neoplasm of upper-inner quadrant of left male breast
C50.311 Malignant neoplasm of lower-inner quadrant of right female breast
C50.312 Malignant neoplasm of lower-inner quadrant of left female breast
C50.321 Malignant neoplasm of lower-inner quadrant of right male breast
C50.322 Malignant neoplasm of lower-inner quadrant of left male breast
C50.411 Malignant neoplasm of upper-outer quadrant of right female breast
C50.412 Malignant neoplasm of upper-outer quadrant of left female breast
C50.421 Malignant neoplasm of upper-outer quadrant of right male breast
C50.422 Malignant neoplasm of upper-outer quadrant of left male breast
C50.511 Malignant neoplasm of lower-outer quadrant of right female breast
C50.512 Malignant neoplasm of lower-outer quadrant of left female breast
C50.521 Malignant neoplasm of lower-outer quadrant of right male breast
C50.522 Malignant neoplasm of lower-outer quadrant of left male breast
C50.611 Malignant neoplasm of axillary tail of right female breast
C50.612 Malignant neoplasm of axillary tail of left female breast
C50.621 Malignant neoplasm of axillary tail of right male breast
C50.622 Malignant neoplasm of axillary tail of left male breast
C50.811 Malignant neoplasm of overlapping sites of right female breast
C50.812 Malignant neoplasm of overlapping sites of left female breast
C50.821 Malignant neoplasm of overlapping sites of right male breast
C50.822 Malignant neoplasm of overlapping sites of left male breast
C50.911 Malignant neoplasm of unspecified site of right female breast
C50.912 Malignant neoplasm of unspecified site of left female breast
C50.921 Malignant neoplasm of unspecified site of right male breast
C50.922 Malignant neoplasm of unspecified site of left male breast
C56.1 Malignant neoplasm of right ovary
C56.2 Malignant neoplasm of left ovary
C56.3 Malignant neoplasm of bilateral ovaries
C56.9 Malignant neoplasm of unspecified ovary
C57.01 - C57.02 Malignant neoplasm of right fallopian tube - Malignant neoplasm of left fallopian tube
C57.11 - C57.12 Malignant neoplasm of right broad ligament - Malignant neoplasm of left broad ligament
C57.21 - C57.22 Malignant neoplasm of right round ligament - Malignant neoplasm of left round ligament
C57.3 Malignant neoplasm of parametrium
C57.4 Malignant neoplasm of uterine adnexa, unspecified
C57.7 - C57.8 Malignant neoplasm of other specified female genital organs - Malignant neoplasm of overlapping sites of female genital organs
C61 Malignant neoplasm of prostate
D07.5 Carcinoma in situ of prostate
D25.0 Submucous leiomyoma of uterus
D25.1 Intramural leiomyoma of uterus
D25.2 Subserosal leiomyoma of uterus
Z85.3 Personal history of malignant neoplasm of breast
Z85.46 Personal history of malignant neoplasm of prostate

Group 7

(13 Codes)
Group 7 Paragraph

The ICD-10-CM codes listed below are considered secondary codes. When these codes are reported for J9217, the claim must also include a diagnosis from the primary diagnosis list above.

Group 7 Codes
Code Description
C77.2 Secondary and unspecified malignant neoplasm of intra-abdominal lymph nodes
C77.4 Secondary and unspecified malignant neoplasm of inguinal and lower limb lymph nodes
C77.8 Secondary and unspecified malignant neoplasm of lymph nodes of multiple regions
C77.9 Secondary and unspecified malignant neoplasm of lymph node, unspecified
C78.00 Secondary malignant neoplasm of unspecified lung
C78.01 Secondary malignant neoplasm of right lung
C78.02 Secondary malignant neoplasm of left lung
C78.6 Secondary malignant neoplasm of retroperitoneum and peritoneum
C78.7 Secondary malignant neoplasm of liver and intrahepatic bile duct
C79.2 Secondary malignant neoplasm of skin
C79.31 Secondary malignant neoplasm of brain
C79.51 Secondary malignant neoplasm of bone
C79.52 Secondary malignant neoplasm of bone marrow

Group 8

(3 Codes)
Group 8 Paragraph

J9219 (Leuprolide acetate implant, 65 mg), surgical implant

Primary ICD-10-CM codes (these diagnoses can be billed as a single diagnosis or in conjunction with the secondary ICD-10-CM codes listed below)

Group 8 Codes
Code Description
C61 Malignant neoplasm of prostate
D07.5 Carcinoma in situ of prostate
Z85.46 Personal history of malignant neoplasm of prostate

Group 9

(13 Codes)
Group 9 Paragraph

The ICD-10-CM codes listed below are considered secondary codes. When these codes are reported for J9219, the claim must also include a diagnosis from the primary diagnosis list above.

Group 9 Codes
Code Description
C77.2 Secondary and unspecified malignant neoplasm of intra-abdominal lymph nodes
C77.4 Secondary and unspecified malignant neoplasm of inguinal and lower limb lymph nodes
C77.8 Secondary and unspecified malignant neoplasm of lymph nodes of multiple regions
C77.9 Secondary and unspecified malignant neoplasm of lymph node, unspecified
C78.00 Secondary malignant neoplasm of unspecified lung
C78.01 Secondary malignant neoplasm of right lung
C78.02 Secondary malignant neoplasm of left lung
C78.6 Secondary malignant neoplasm of retroperitoneum and peritoneum
C78.7 Secondary malignant neoplasm of liver and intrahepatic bile duct
C79.2 Secondary malignant neoplasm of skin
C79.31 Secondary malignant neoplasm of brain
C79.51 Secondary malignant neoplasm of bone
C79.52 Secondary malignant neoplasm of bone marrow

Group 10

(5 Codes)
Group 10 Paragraph

J9225 (Histrelin implant, 50 mg), surgical implant

ICD-10-CM code E30.1 for children with disability who are covered under Medicare.

Primary ICD-10-CM codes (these diagnoses can be billed as a single diagnosis or in conjunction with the secondary ICD-10-CM codes listed below)

Group 10 Codes
Code Description
C61 Malignant neoplasm of prostate
D07.5 Carcinoma in situ of prostate
E30.1 Precocious puberty
E30.8 Other disorders of puberty
Z85.46 Personal history of malignant neoplasm of prostate

Group 11

(13 Codes)
Group 11 Paragraph

The ICD-10-CM codes listed below are considered secondary codes. When these codes are reported J9225, the claim must also include a diagnosis from the primary diagnosis list above.

Group 11 Codes
Code Description
C77.2 Secondary and unspecified malignant neoplasm of intra-abdominal lymph nodes
C77.4 Secondary and unspecified malignant neoplasm of inguinal and lower limb lymph nodes
C77.8 Secondary and unspecified malignant neoplasm of lymph nodes of multiple regions
C77.9 Secondary and unspecified malignant neoplasm of lymph node, unspecified
C78.00 Secondary malignant neoplasm of unspecified lung
C78.01 Secondary malignant neoplasm of right lung
C78.02 Secondary malignant neoplasm of left lung
C78.6 Secondary malignant neoplasm of retroperitoneum and peritoneum
C78.7 Secondary malignant neoplasm of liver and intrahepatic bile duct
C79.2 Secondary malignant neoplasm of skin
C79.31 Secondary malignant neoplasm of brain
C79.51 Secondary malignant neoplasm of bone
C79.52 Secondary malignant neoplasm of bone marrow

Group 12

(3 Codes)
Group 12 Paragraph

J3316 [Injection, triptorelin, extended-release, 3.75 mg]

Group 12 Codes
Code Description
E22.8 Other hyperfunction of pituitary gland
E30.1 Precocious puberty
E30.8 Other disorders of puberty

Group 13

(2 Codes)
Group 13 Paragraph

Effective for dates of service on or after 01/01/2022, leuprolide mesylate (Camcevi®) should be reported with HCPCS code J1952.

Effective for dates of service 5/26/2021 through 12/31/2021, leuprolide mesylate (Camcevi®) should be reported with HCPCS code J3590.

Group 13 Codes
Code Description
C61 Malignant neoplasm of prostate
Z85.46 Personal history of malignant neoplasm of prostate

Group 14

(2 Codes)
Group 14 Paragraph

Effective for dates of service on or after 01/01/2023, leuprolide acetate for depot suspension (Lutrate) should be reported with HCPCS code J1954.

Group 14 Codes
Code Description
C61 Malignant neoplasm of prostate
Z85.46 Personal history of malignant neoplasm of prostate
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ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

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Group 1 Codes

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ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

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Additional ICD-10 Information

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Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

Code Description

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N/A

Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

Code Description

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Other Coding Information

Group 1

Group 1 Paragraph

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Group 1 Codes

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Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A N/A
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Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
01/01/2023 R12

Updated to indicate the article is an LCD Reference Article

01/01/2023 R11

Based on Transmittal 11738 (CR 12998) January 2023 Integrated Outpatient Code Editor (I/OCE) Specifications Version 24.0, HCPCS code J1954-Lutrate (leuprolide acetate for depot suspension) has been added to the CPT/HCPCS section of the article and Group 14 has been added to the ICD-10 code lists. Reference to this drug has been added throughout the article.

10/01/2022 R10

Based on the annual ICD-10 code update, ICD-10 codes N80.0, N80.1, N80.2, N80.3, N80.4 and N80.5 have been deleted and replaced with N80.01, N80.02, N80.03, N80.101, N80.102, N80.103, N80.109, N80.111, N80.112, N80.113, N80.121, N80.122, N80.123, N80.201, N80.202, N80.203, N80.211, N80.212, N80.213, N80.221, N80.222, N80.223, N80.311, N8.0312, N80.319, N80.321, N80.322, N80.329, N80.331, N80.332, N80.333, N80.341, N80.342, N80.343, N80.351, N80.352, N80.353, N80.361, N80.362, N80.363, N80.371, N80.372, N80.373, N80.381, N80.382, N80.383, N80.391, N80.392, N80.399, N80.3A1, N80.3A2, N80.3A3, N80.3B1, N80.3B2, N80.3B3, N80.3C1, N80.3C2, N803.C3, N80.41, N80.42, N80.511, N80.512, N80.519, N80.521, N8.0522, N80.529, N80.531, N80.532, N80.539, N80.541, N80.542, N80.549, N80.551, N80.552, N80.559, N80.561, N80.562, N80.569, N80.A0, N80.A1, N80.A2, N80.A41, N80.A42, N80.A43, N80.A51, N80.A52, N80.A53, N80.A61, N80.A62, N80.A63, N80.B1, N80.B2, N80.B31, N80.B32, N80.B39, N80.B4, N80.B5, N80.B6, N80.C10, N80.C11, N80.C19, N80.C2, N80.C3, N80.C4, N80.C9, N80.D1, N80.D2, N80.D3, N80.D4, N80.D5, N80.D6, and N80.D9 in Group 1 and 4 of the ICD-10 code lists. ICD-10 code N80.0 has been deleted from the Group 2 ICD-10 code list and has been replaced with N80.01, N80.02, N80.03.

01/01/2022 R9

Based on the annual CPT/HCPCS update, the description for CPT code 11981 has been revised. HCPCS code J1952 has been added to the "CPT/HCPCS Codes" section of the article. Information regarding leuprolide mesylate (Cancevi®) has been added throughout the article. Group 13 has been added to the “ICD-10-CM Codes that Support Medical Necessity” section of the article for leuprolide mesylate (Cancevi®).

10/01/2021 R8

Based on the annual ICD-10 code update, ICD-10 code C56.3 has been added to Group 1 and Group 6. Based on compendia review, ICD-10 codes C57.01, C57.02, C57.11, C57.12, C57.21, C57.22, C57.3, C57.4, C57.7 and C57.8 have been added to Group 6 effective for dates of service on or after 10/01/2021.

05/01/2020 R7

Based on compendia review, ICD-10-CM codes D25.0, D25.1, D25.2, N60.11, N60.12, N80.0 and N85.01 have been added for HCPCS code J3315 (Group 2), ICD-10-CM code E30.1 has been added for HCPCS code J9202 (Group 4) and ICD-10-CM codes D25.0, D25.1 and D25.2 have been added for HCPCS code J9217 (Group 6) effective for dates of service on or after 05/01/2020.

11/07/2019 R6

This article was converted to the new Billing and Coding Article format. The Article Text section has been revised to remove the indications which can be found on the FDA Web site and in the approved compendia. The “Sources of Information” has been revised to “FDA and Compendia Review.” Sources of information other than the FDA and compendia have been moved to a PDF file attached to LCD L33394. The Bill type codes have been removed from this article. Guidance on these codes is available in the Bill type code section.

01/01/2019 R5

Based on the 2019 annual HCPCS update, HCPCS code J3316 has been added to the "CPT/HCPCS Codes" section of the article. An indication for central precocious puberty for triptorelin extended-release (Triptodur®) has been added in the “Indications” section of the article and Group 12 (payable diagnoses) has been added in the “Covered ICD-10 Code” section of the article.

05/10/2018 R4

The following indications have been added for luprolide acetate (HCPC codes J1950 and J1270):

  • Ovarian cancer/fallopian tube cancer/primary peritoneal cancer - epithelial ovarian cancer - malignant sex cord-stromal tumors (J1950)
  • Head and Neck cancers-salivary gland tumors (J9217)

The following ICD-10-CM codes have been added to the Group 1 code list: C48.1, C48.8, C56.1, C56.2, C57.01-C57.02, C57.11-C57.12, C57.21 – C57.22, C57.3, C57.4 and C57.7-C57.8 and the following ICD-10-CM codes have been added to the Group 6 code list: C07, C08.0 and C08.1 effective for dates of service on or after 05/10/2018.

08/01/2016 R3 Based on a reconsideration request, coverage for suspected endometriosis causing chronic pelvic pain has been added for leuprolide acetate, J1950, effective for dates of service on or after 08/01/2016. ICD-10-CM code R10.2 has been added to the Group 1 ICD-10 code list. Lexi-Drugs compendium has been added to the “Abstract” section of the article and Lexi-Drugs Web site has been added to the “Sources of Information” section.
10/01/2015 R2 The place of service guidelines for the Part B MAC have been removed.
10/01/2015 R1 Updated to include revisions made since April 2014. The following ICD-10-CM codes have been added to the Group 6 Covered ICD-10 Codes: C50.011, C50.012, C50.021, C50.022, C50.111, C50.112, C50.121, C50.122, C50.211, C50.212, C50.221, C50.222, C50.311, C50.312, C50.321, C50.322, C50.411, C50.412, C50.421, C50.422, C50.511, C50.512, C50.521, C50.522, C50.611, C50.612, C50.621, C50.622, C50.811, C50.812, C50.821, C50.822, C50.911, C50.912, C50.921 and C50.922.
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