LCD Reference Article Article

Sipuleucel-T (Provenge®) - Coverage Criteria for Prostate Cancer – Clarification

A55719

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Draft Article
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.
NOT AN LCD REFERENCE ARTICLE
This article is not in direct support of an LCD.

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General Information

Source Article ID
N/A
Article ID
A55719
Original ICD-9 Article ID
Not Applicable
Article Title
Sipuleucel-T (Provenge®) - Coverage Criteria for Prostate Cancer – Clarification
Article Type
Article
Original Effective Date
10/01/2015
Revision Effective Date
10/19/2018
Revision Ending Date
N/A
Retirement Date
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Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

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CMS National Coverage Policy

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Article Guidance

Article Text

Sipuleucel-T (Provenge®) is an autologous cellular immunotherapy, FDA-approved for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.


The production of Sipuleucel-T involves collection of the patient’s own cells (leukapheresis), culture with a proprietary antigen complex, and re-infusion of the “antigen-activated” patient cells back to the donor. Provenge® is administered as three intravenous infusions, generally two weeks apart. When infused back into the patient, usually three days after leukapheresis, the patient-specific medication (autologous cellular therapy) stimulates a positive immunogenic response against the prostate cancer.

For coverage, patient records must document that the product is being used according to the NCD 110.22.

If the documentation does not describe the criteria above, does not meet all the requirements of the NCD on sipuleucel-T,is inconsistent with the FDA label and/or is not received, the services will be denied. Off-label use of this treatment is not covered unless it meets the requirements for off-label use of chemotherapeutic drugs in the Internet Only Manual 100-02 (Benefit Policy), Chapter 15 (Covered Services), Section 50.4.5.

Noridian may cover sipuleucel-T for the above condition when all requirements are met including the following coding instructions. (NOTE: Noridian will not allow payment for any off-label use of this treatment):

For dates of service on/after July 1, 2011, use the following HCPCS code: Q2043 Sipuleucel-T auto CD54+.

For dates of service prior to July 1, 2011, use one of the following HCPCS code: J3490, J3590 or C9273 (being replaced by Q2043).

The payment of HCPCS Q2043 includes collection of patients’ cells, activation with PAP-CM-CSF, including leukapheresis and all other preparatory procedures associated with sipuleucel-T. The code Q2043 does not include the administration of the treatments. CPT® code 96365, intravenous infusion for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to one (1) hour will be allowed for the administration of Q2043.

Medicare will allow a maximum of three (3) infusions per lifetime.



Sources: Internet Only Manual (IOM) Medicare National Coverage Determinations (NCD) Manual, Publication 100-03, Chapter 1, Section 110.22, IOM Medicare Claims Processing Manual, Publication 100-04, Chapter 32, Section 280; Transmittal 133, Change Request (CR)7431 dated July 8, 2011; Transmittal 2254, CR 7431 dated July 8, 2011.

Response To Comments

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Coding Information

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CPT/HCPCS Codes

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Group 1 Codes
Code Description
Q2043 SIPULEUCEL-T, MINIMUM OF 50 MILLION AUTOLOGOUS CD54+ CELLS ACTIVATED WITH PAP-GM-CSF, INCLUDING LEUKAPHERESIS AND ALL OTHER PREPARATORY PROCEDURES, PER INFUSION
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CPT/HCPCS Modifiers

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ICD-10-CM Codes that Support Medical Necessity

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(1 Code)
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Group 1 Codes
Code Description
C61 Malignant neoplasm of prostate

Group 2

(22 Codes)
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And at least one of the following:

Group 2 Codes
Code Description
C77.1 Secondary and unspecified malignant neoplasm of intrathoracic lymph nodes
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
C77.5 Secondary and unspecified malignant neoplasm of intrapelvic 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
C78.7 Secondary malignant neoplasm of liver and intrahepatic bile duct
C79.00 Secondary malignant neoplasm of unspecified kidney and renal pelvis
C79.01 Secondary malignant neoplasm of right kidney and renal pelvis
C79.02 Secondary malignant neoplasm of left kidney and renal pelvis
C79.10 Secondary malignant neoplasm of unspecified urinary organs
C79.11 Secondary malignant neoplasm of bladder
C79.19 Secondary malignant neoplasm of other urinary organs
C79.51 Secondary malignant neoplasm of bone
C79.52 Secondary malignant neoplasm of bone marrow
C79.70 Secondary malignant neoplasm of unspecified adrenal gland
C79.71 Secondary malignant neoplasm of right adrenal gland
C79.72 Secondary malignant neoplasm of left adrenal gland
C79.82 Secondary malignant neoplasm of genital organs
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ICD-10-CM Codes that DO NOT Support Medical Necessity

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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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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.

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Revision History Information

Revision History Date Revision History Number Revision History Explanation
10/19/2018 R3

Updated to indicate this article is not an LCD Reference Article.

10/19/2018 R2

Article converted to Billing and Coding. No change is coverage was made.

10/19/2018 R1

The article is revised to follow the NCD criteria for this procedure.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
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Related National Coverage Documents
NCDs
110.22 - Autologous Cellular Immunotherapy Treatment
SAD Process URL 1
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SAD Process URL 2
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Statutory Requirements URLs
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Rules and Regulations URLs
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CMS Manual Explanations URLs
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Public Versions
Updated On Effective Dates Status
11/16/2023 10/19/2018 - N/A Currently in Effect You are here
09/29/2020 10/19/2018 - N/A Superseded View
10/17/2018 10/19/2018 - N/A Superseded View
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Keywords

  • Q2043
  • Sipuleucel-T
  • Provenge
  • Prostate Cancer