ph-0080
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Leuprolide Suspension: Lupron Depot®, Lupron Depot-Ped®, Eligard®, Fensolvi®

Policy Number: PH-0080

Intramuscular/Subcutaneous

 

Last Review Date: 07/01/2021

Date of Origin: 11/28/2011

Dates Reviewed: 12/11, 03/2012, 06/2013, 09/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 5/2016, 8/2016, 11/2016, 2/2017, 5/2017, 8/2017, 11/2017, 02/2018, 05/2018, 04/2019, 04/2020, 06/2020, 04/2021, 07/2021

Precertification requirements do not apply for this policy. Pre-payment claim edits are applied to diagnosis criteria within this policy.

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  1. Length of Authorization
  • Endometriosis: Coverage will be provided for 6 months and is eligible for renewal one time only
  • Uterine leiomyomata (fibroids): Coverage will be provided for 3 months and is not eligible for renewal
  • All other indications: Coverage will be provided for 12 months and is eligible for renewal.
  1. Dosing Limits

A.  Quantity Limit (max daily dose) [NDC Unit]:

B.  Max Units (per dose and over time) [HCPCS Unit]:

Drug Name

Strength

Quantity

Days Supply

Lupron Depot 1-Month

3.75 mg

1 injection

28 days

Lupron Depot 1-Month

7.5 mg

1 injection

28 days

Lupron Depot 3-Month

11.25 mg

1 injection

84 days

Lupron Depot 3-Month

22.5 mg

1 injection

84 days

Lupron Depot 4-Month

30 mg

1 injection

112 days

Lupron Depot 6-Month

45 mg

1 injection

168 days

Lupron Depot-Ped 1-month

7.5 mg

1 injection

28 days

Lupron Depot-Ped 1-month

11.25 mg

1 injection

28 days

Lupron Depot-Ped 3-Month

11.25 mg

1 injection

84 days

Lupron Depot-Ped 1-month

15 mg

1 injection

28 days

Lupron Depot-Ped 3-Month

30 mg

1 injection

84 days

Eligard

7.5 mg

1 injection

28 days

Eligard

22.5 mg

1 injection

84 days

Eligard

30 mg

1 injection

112 days

Eligard

45 mg

1 injection

168 days

Fensolvi

45 mg

1 injection

168 days

Diagnosis

HCPCS

Product(s)

Billable Units

Days Supply

Prostate/Breast/ Ovarian Cancer

Prostate Cancer

J9217

Lupron Depot 1-Month & Eligard 7.5 mg

1

28

Lupron Depot 3-Month & Eligard 22.5 mg

3

84

Lupron Depot 4-Month & Eligard 30 mg

4

112

Lupron Depot 6-Month & Eligard 45 mg

6

168

Salivary Gland Tumors of the Head and Neck

J9217

Lupron Depot 1-month & Eligard 7.5 mg

1

28

Lupron Depot 3-Month & Eligard 22.5 mg

3

84

Breast/Ovarian Cancer; Endometriosis; Uterine Fibroids

J1950

Lupron Depot 1-Month 3.75 mg

1

28

Lupron Depot 3-Month 11.25 mg

3

84

Central Precocious Puberty

J1950/ J3490/ J1951

Lupron Depot-Ped 7.5 mg

2

28

Lupron Depot-Ped 11.25 mg

3

28

Lupron Depot-Ped 15 mg

4

28

Lupron Depot-Ped 30 mg

8

84

Fensolvi 45 mg Kit

180

168

  1. Initial Approval Criteria

Coverage is provided in the following conditions:

  • Patient is 18 years or older (unless otherwise specified); AND

Central Precocious Puberty (CPP) 3,6,11,17-19Ф (J1950, J3490 and J1951 [Fensolvi] only])

  • Patient is less than 13 years old; AND
  • Onset of secondary sexual characteristics earlier than age 8 for girls and 9 for boys associated with pubertal pituitary gonadotropin activation; AND
  • Diagnosis is confirmed by a pubertal gonadal sex steroid level and a pubertal LH response to stimulation by native GnRH; AND
  • Bone age advanced greater than 2 standard deviations (SD) beyond chronological age; AND
  • Tumor has been ruled out by lab tests such as diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), and human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor) ; AND
  • Will not be used in combination with growth hormone

Endometriosis 1,2,9 †  (J1950 only)

  • Documentation patient’s diagnosis has been confirmed by a workup/evaluation (versus presumptive treatment)

Uterine leiomyomata (fibroids) 1,2,10(J1950 only)

  • Documentation patient’s diagnosis has been confirmed by a workup/evaluation (versus presumptive treatment); AND
  • Documentation patient is receiving iron therapy

Breast Cancer 7,8,12,13(J9217 and J1950)

  • Patient is pre-menopausal or is a male with suppression of testicular steroidogenesis; AND
  • Disease is hormone receptor positive; AND
    • Used in combination with adjuvant endocrine therapy; OR
    • Endocrine therapy for recurrent or metastatic disease

Ovarian cancer 7,8,15,16(J9217 and J1950)

  • Used as a single agent; AND
    • Patient has a diagnosis of stage II-IV granulosa cell tumors of the ovary; AND
      • Patient’s disease has relapsed; OR
    • Patient has a diagnosis of Epithelial Ovarian Cancer OR Fallopian Tube Cancer OR Primary Peritoneal Cancer; AND
      • Patient’s disease is persistent or recurrent (excluding immediate treatment of biochemical relapse)

Prostate Cancer 4,5,7,8,14(J9217 only)

Head and Neck Cancer 7,8(J9217 only)

  • Patient has a diagnosis of androgen-receptor positive recurrent salivary gland tumor; AND
    • Patient has distant metastases with a performance status score of 0-3; OR
    • Patient has unresectable locoregional recurrence or second primary with prior radiation therapy

FDA Approved Indication(s); Compendia recommended indication(s); Ф Orphan Drug

  1. Renewal Criteria

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet the indication-specific relevant criteria identified in section III; AND

Prostate cancer and Salivary Gland tumors (J9217 only);

Breast and Ovarian Cancer (J9217 or J1950 only)

  • Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: tumor flare, hyperglycemia/diabetes, cardiovascular disease (myocardial infarction, sudden cardiac death, stroke), QT/QTc prolongation, convulsions, etc.

Central Precocious Puberty (CPP)  3,6,11,17-19 (J1950 and J3490/J1951-[Fensolvi] only)

  • Patient is less than 13 years old; AND
  • Disease response as indicated by lack of progression or stabilization of secondary sexual characteristics, decrease in growth velocity and bone age advancement, and improvement in final height prediction; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: convulsions, development or worsening of psychiatric symptoms, etc.; AND
  • Will not be used in combination with growth hormone

Endometriosis (J1950 only)

  • Patient has not received a total of 12 months of therapy of a GnRH-agonist (i.e., leuprolide acetate, etc.); AND
  • Patient continues to have symptoms of endometriosis or symptoms recur after the initial 6-month course of therapy; AND
  • Patient will have bone density assessment prior to retreatment; AND
  • Patient will use in combination with add-back therapy in combination with norethindrone

Uterine leiomyomata (fibroids) (J1950 only)

  • May not be renewed
  1. Dosage/Administration

Indication

Dose

Endometriosis

Administer, intramuscularly,  3.75 mg monthly or 11.25 mg every 3 months for a duration of 6 months only.

Breast/Ovarian Cancer

Administer, intramuscularly or subcutaneously,  3.75 mg every/7.5 mg monthly or 11.25 mg/22.5 mg every 3 months.

Central Precocious Puberty (CPP)

  • Fensolvi subcutaneous kit
  • Administer 45 mg subcutaneously once every six months.
  • Lupron Depot-Ped intramuscular injection:
  • Weight based
  • >37.5 kg: 15 mg every 4 weeks
  • >25-37.5 kg: 11.25 mg every 4 weeks
  • ≤ 25 kg: 7.5 mg every 4 weeks; OR
  • Ages 2 to 11 yrs: 11.25 mg or 30 mg every 12 weeks

Uterine leiomyomata (fibroids)

Administer, intramuscularly, 3.75 mg monthly or 11.25 mg every 3 months.

The recommended duration of therapy is 3 months or less; retreatment depends on return of symptoms.

Prostate Cancer

Administer, intramuscularly or subcutaneously, 7.5 mg every 4 weeks, 22.5 mg every 12 weeks, 30 mg every 16 weeks, or 45 mg every 24 weeks

Salivary Gland tumors of the Head and Neck

Administer, intramuscularly or subcutaneously, 7.5 mg every 4 weeks, 22.5 mg every 12 weeks

  • Lupron Depot is administered intramuscularly (IM), Eligard and Fensolvi are administered subcutaneously (SQ)
  • Do not use concurrently a fractional dose, or a combination of doses of this or any depot formulation due to different release characteristics.
  1. Billing Code/Availability Information

Drug Name

Strength

HCPCS*

NDC

Lupron Depot 1-Month

3.75 mg

J1950

00074-3641-xx

Lupron Depot 1-Month

7.5 mg

J9217

00074-3642-xx

Lupron Depot 3-Month

11.25 mg

J1950

00074-3663-xx

Lupron Depot 3-Month

22.5 mg

J9217

00074-3346-xx

Lupron Depot 4-Month

30 mg

J9217

00074-3683-xx

Lupron Depot 6-Month

45 mg

J9217

00074-3473-xx

Lupron Depot-Ped

7.5 mg

J1950

00074-2108-xx

Lupron Depot-Ped

11.25 mg

J1950

00074-2282-xx

Lupron Depot-Ped 3-Month

11.25 mg

J1950

00074-3779-xx

Lupron Depot-Ped

15 mg

J1950

00074-2440-xx

Lupron Depot-Ped 3-Month

30 mg

J1950

00074-9694-xx

Eligard

7.5 mg

J9217

62935-0753-xx

Eligard

22.5 mg

J9217

62935-0223-xx

Eligard

30 mg

J9217

62935-0303-xx

Eligard

45 mg

J9217

62935-0453-xx

Fensolvi

45 mg

J3490, J1951

62935-0153-xx

*J1950: Injection, leuprolide acetate (for depot suspension), per 3.75 mg

*J9217: Leuprolide acetate (for depot suspension), 7.5 mg

*J3490: Unclassified drugs (Fensolvi only – discontinue 07/01/21)

*J1951: Injection, leuprolide acetate for depot suspension (fensolvi), 0.25 mg (Effective 07/01/21)

  1. References
  1. Lupron Depot GYN 3 Month 11.25 mg [package insert]. North Chicago, IL; Abbvie Inc.; March 2020. Accessed March 2021.
  2. Lupron Depot GYN 3.75 mg and 3 Month 11.25 mg [package insert]. North Chicago, IL; Abbvie Inc.; February 2021. Accessed March 2021
  3. Lupron Depot-Ped [package insert]. North Chicago, IL; Abbvie Inc.; March 2021. Accessed March 2021.
  4. Lupron Depot URO [package insert.]. North Chicago, IL; Abbvie Inc.; March 2019.  Accessed March 2021.
  5. Eligard [package insert]. Fort Collins, CO; Tolmar Therapeutics, Inc; April 2019.  Accessed March 2021.
  6. Fensolvi [package insert]. Fort Collins, CO; Tolmar Therapeutics, Inc; May 2020.  Accessed March 2021.
  7. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Leuprolide acetate. National Comprehensive Cancer Network, 2021.  The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed March 2021.
  8. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Leuprolide acetate for depot suspension. National Comprehensive Cancer Network, 2021.  The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org.  Accessed March 2021.
  9. Dlugi AM, Miller JD, Knittle J, et al: Lupron depot (leuprolide acetate for depot suspension) in the treatment of endometriosis: a randomized, placebo-controlled, double-blind study. Fertil Steril 1990; 54:419-427.
  10. Friedman AJ, Barbieri RL, Doubilet PM, et al: A randomized, double-blind trial of a gonadotropin-releasing hormone agonist (leuprolide) with or without medroxyprogesterone acetate in the treatment of leiomyomata uteri. Obstet Gynecol Surv 1988; 43:484-485.
  11. Lee PA & Page JG: The Leuprolide Study Group: Effects of leuprolide in the treatment of central precocious puberty. J Pediatr 1989; 114:321-324.
  12. Harvey HA, Lipton A, Max DT, et al: Medical castration produced by the GnRH analogue leuprolide to treat metastatic breast cancer. J Clin Oncol 1985; 3:1068-1072.
  13. Boccardo F, Rubagotti A, Amoroso D, et al, “Endocrinological and Clinical Evaluation of Two Depot Formulations of Leuprolide Acetate in Pre- and Perimenopausal Breast Cancer Patients,” Cancer Chemother Pharmacol, 1999, 43(6):461-6.
  14. National Collaborating Centre for Cancer. Prostate cancer: diagnosis and treatment. London (UK): National Institute for Health and Clinical Excellence (NICE); 2008 Feb. 146 p. (NICE clinical guideline; no. 58)
  15. Fishman A, Kudelka AP, Tresukosol D, et al. Leuprolide acetate for treating refractory or persistent ovarian granulosa cell tumor. J Reprod Med. 1996;41(6):393-396.
  16. Kavanagh JJ, Roberts W, Townsend P, et al: Leuprolide acetate in the treatment of refractory or persistent epithelial ovarian cancer. J Clin Oncol 1989; 7:115-118.
  17. Beccuti G, Ghizzoni L. Normal and Abnormal Puberty. Endotext. De Groot LJ, Chrousos G, Dungan K, et al., editors, South Dartmouth (MA): MDText.com, Inc.; 2000-. Accessed at: https://www.ncbi.nlm.nih.gov/books/NBK279024/.
  18. Brito VN, Spinola-Castro AM, Kochi C, et al. Central precocious puberty: revisiting the diagnosis and therapeutic management. Arch Endocrinol Metab. 2016 Apr;60(2):163-72
  19. Carel JC, Eugster E, Rogol A, et al. Consensus statement on the use of gonadotropin-releasing hormone analogs in children. Pediatrics. 2009 Apr;123(4):e752-62. doi: 10.1542/peds.2008-1783. Epub 2009 Mar 30.
  20. First Coast Service Options, Inc.  Local Coverage Article:  Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (A57655).  Centers for Medicare & Medicaid Services, Inc.  Updated on 11/21/2019 with effective date 10/03/2018.  Accessed March 2021.
  21. National Government Services, Inc. Local Coverage Article: Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (A52453).  Centers for Medicare & Medicaid Services, Inc.  Updated on 04/24/2020 with effective date 05/01/2020. Accessed March 2021.
  22. Novitas Solutions, Inc.  Local Coverage Article: Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (A56776).  Centers for Medicare & Medicaid Services, Inc.  Updated on 11/08/2019 with effective date 11/14/2019.  Accessed March 2021.

Appendix 1 – Covered Diagnosis Codes

J1950 & J3490/J1951 [Fensolvi]

ICD-10

ICD-10 Description

C48.1

Malignant neoplasm of specified parts of peritoneum

C48.2

Malignant neoplasm of peritoneum, unspecified

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

C50.019

Malignant neoplasm of nipple and areola, unspecified female breast

C50.021

Malignant neoplasm of nipple and areola, right female breast

C50.022

Malignant neoplasm of nipple and areola, left female breast

C50.029

Malignant neoplasm of nipple and areola, unspecified female breast

C50.111

Malignant neoplasm of central portion of right female breast

C50.112

Malignant neoplasm of central portion of left female breast

C50.119

Malignant neoplasm of central portion of unspecified female breast

C50.121

Malignant neoplasm of central portion of right male breast

C50.122

Malignant neoplasm of central portion of left male breast

C50.129

Malignant neoplasm of central portion of unspecified 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

C50.219

Malignant neoplasm of upper-inner quadrant of unspecified 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

C50.229

Malignant neoplasm of upper-inner quadrant of unspecified 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

C50.319

Malignant neoplasm of lower-inner quadrant of unspecified 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

C50.329

Malignant neoplasm of lower-inner quadrant of unspecified 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

C50.419

Malignant neoplasm of upper-outer quadrant of unspecified 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

C50.429

Malignant neoplasm of upper-outer quadrant of unspecified 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

C50.519

Malignant neoplasm of lower-outer quadrant of unspecified 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

C50.529

Malignant neoplasm of lower-outer quadrant of unspecified male breast

C50.611

Malignant neoplasm of axillary tail of right female breast

C50.612

Malignant neoplasm of axillary tail of left female breast

C50.619

Malignant neoplasm of axillary tail of unspecified female breast

C50.621

Malignant neoplasm of axillary tail of right male breast

C50.622

Malignant neoplasm of axillary tail of left male breast

C50.629

Malignant neoplasm of axillary tail of unspecified male breast

C50.811

Malignant neoplasm of overlapping sites of right female breast

C50.812

Malignant neoplasm of overlapping sites of left female breast

C50.819

Malignant neoplasm of overlapping sites of unspecified female breast

C50.821

Malignant neoplasm of overlapping sites of right male breast

C50.822

Malignant neoplasm of overlapping sites of left male breast

C50.829

Malignant neoplasm of overlapping sites of unspecified male breast

C50.911

Malignant neoplasm of unspecified site of right female breast

C50.912

Malignant neoplasm of unspecified site of left female breast

C50.919

Malignant neoplasm of unspecified site of unspecified female breast

C50.921

Malignant neoplasm of unspecified site of right male breast

C50.922

Malignant neoplasm of unspecified site of left male breast

C50.929

Malignant neoplasm of unspecified site of unspecified male breast

C56.1

Malignant neoplasm of right ovary

C56.2

Malignant neoplasm of left ovary

C56.9

Malignant neoplasm of unspecified ovary

C57.00

Malignant neoplasm of unspecified fallopian tube

C57.01

Malignant neoplasm of right fallopian tube

C57.02

Malignant neoplasm of left fallopian tube

C57.10

Malignant neoplasm of unspecified broad ligament

C57.11

Malignant neoplasm of right broad ligament

C57.12

Malignant neoplasm of left broad ligament

C57.20

Malignant neoplasm of unspecified round ligament

C57.21

Malignant neoplasm of right round ligament

C57.22

Malignant neoplasm of left round ligament

C57.3

Malignant neoplasm of parametrium

C57.4

Malignant neoplasm of uterine adnexa, unspecified

C57.7

Malignant neoplasm of other specified female genital organs

C57.8

Malignant neoplasm of overlapping sites of female genital organs

C57.9

Malignant neoplasm of female genital organ, unspecified

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

E30.8

Other disorders of puberty

N80.0

Endometriosis of uterus

N80.1

Endometriosis of ovary

N80.2

Endometriosis of fallopian tube

N80.3

Endometriosis of pelvic peritoneum

N80.4

Endometriosis of rectovaginal septum and vagina

N80.5

Endometriosis of intestine

N80.6

Endometriosis in cutaneous scar

N80.8

Other endometriosis

N80.9

Endometriosis, unspecified

J9217

ICD-10

ICD-10 Description

C06.9

Malignant neoplasm of mouth, unspecified

C07

Malignant neoplasm of parotid gland

C08.0

Malignant neoplasm of submandibular gland

C08.1

Malignant neoplasm of sublingual gland

C08.9

Malignant neoplasm of major salivary gland, unspecified

C48.1

Malignant neoplasm of specified parts of peritoneum

C48.2

Malignant neoplasm of peritoneum, unspecified

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

C50.019

Malignant neoplasm of nipple and areola, unspecified female breast

C50.021

Malignant neoplasm of nipple and areola, right female breast

C50.022

Malignant neoplasm of nipple and areola, left female breast

C50.029

Malignant neoplasm of nipple and areola, unspecified female breast

C50.111

Malignant neoplasm of central portion of right female breast

C50.112

Malignant neoplasm of central portion of left female breast

C50.119

Malignant neoplasm of central portion of unspecified female breast

C50.121

Malignant neoplasm of central portion of right male breast

C50.122

Malignant neoplasm of central portion of left male breast

C50.129

Malignant neoplasm of central portion of unspecified 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

C50.219

Malignant neoplasm of upper-inner quadrant of unspecified 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

C50.229

Malignant neoplasm of upper-inner quadrant of unspecified 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

C50.319

Malignant neoplasm of lower-inner quadrant of unspecified 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

C50.329

Malignant neoplasm of lower-inner quadrant of unspecified 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

C50.419

Malignant neoplasm of upper-outer quadrant of unspecified 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

C50.429

Malignant neoplasm of upper-outer quadrant of unspecified 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

C50.519

Malignant neoplasm of lower-outer quadrant of unspecified 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

C50.529

Malignant neoplasm of lower-outer quadrant of unspecified male breast

C50.611

Malignant neoplasm of axillary tail of right female breast

C50.612

Malignant neoplasm of axillary tail of left female breast

C50.619

Malignant neoplasm of axillary tail of unspecified female breast

C50.621

Malignant neoplasm of axillary tail of right male breast

C50.622

Malignant neoplasm of axillary tail of left male breast

C50.629

Malignant neoplasm of axillary tail of unspecified male breast

C50.811

Malignant neoplasm of overlapping sites of right female breast

C50.812

Malignant neoplasm of overlapping sites of left female breast

C50.819

Malignant neoplasm of overlapping sites of unspecified female breast

C50.821

Malignant neoplasm of overlapping sites of right male breast

C50.822

Malignant neoplasm of overlapping sites of left male breast

C50.829

Malignant neoplasm of overlapping sites of unspecified male breast

C50.911

Malignant neoplasm of unspecified site of right female breast

C50.912

Malignant neoplasm of unspecified site of left female breast

C50.919

Malignant neoplasm of unspecified site of unspecified female breast

C50.921

Malignant neoplasm of unspecified site of right male breast

C50.922

Malignant neoplasm of unspecified site of left male breast

C50.929

Malignant neoplasm of unspecified site of unspecified male breast

C56.1

Malignant neoplasm of right ovary

C56.2

Malignant neoplasm of left ovary

C56.9

Malignant neoplasm of unspecified ovary

C57.00

Malignant neoplasm of unspecified fallopian tube

C57.01

Malignant neoplasm of right fallopian tube

C57.02

Malignant neoplasm of left fallopian tube

C57.10

Malignant neoplasm of unspecified broad ligament

C57.11

Malignant neoplasm of right broad ligament

C57.12

Malignant neoplasm of left broad ligament

C57.20

Malignant neoplasm of unspecified round ligament

C57.21

Malignant neoplasm of right round ligament

C57.22

Malignant neoplasm of left round ligament

C57.3

Malignant neoplasm of parametrium

C57.4

Malignant neoplasm of uterine adnexa, unspecified

C57.7

Malignant neoplasm of other specified female genital organs

C57.8

Malignant neoplasm of overlapping sites of female genital organs

C57.9

Malignant neoplasm of female genital organ, unspecified

C61

Malignant neoplasm of prostate

Z85.46

Personal history of malignant neoplasm of prostate

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs) and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA):

Lupron Depot/Lupron Depot-Ped (J1950) & Lupron Depot/Eligard (J9217)

Jurisdiction(s):  N

NCD/LCD Document (s): A57655

https://www.cms.gov/medicare-coverage-database/search/document-id-search-results.aspx?DocID=A57655&bc=gAAAAAAAAAAA&  

Jurisdiction(s): 6, K

NCD/LCD Document (s): A52453

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID=A52453&bc=gAAAAAAAAAAA  

Jurisdiction(s):  H

NCD/LCD Document (s): A56776

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID=A56776&bc=gAAAAAAAAAAA

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC

 

 

 

LEUPROLIDE SUSP (Lupron Depot®, Lupron Depot-Ped®, Eligard®, Fensolvi®) Prior Auth Criteria
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