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Limitations for Provenge HCPCS code Q2043 and ICD requirements


HCPCS code Q2043Sipuleucel-T, minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, including leukapheresis and all other preparatory procedures, per infusion; short descriptor, Sipuleucel-T auto CD54+.

Effective for claims with dates of service on or after July 1, 2011, processed on and after July 2, 2012, CWF shall only allow a frequency of three (3) services of nationally covered PROVENGE® for asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer, Q2043, in a patient’s lifetime.

Contractors shall use the following messages when denying claims for PROVENGE®, Q2043, that exceed three (3) services in a patient’s lifetime:

Claim Adjustment Reason Code (CARC) 149 - “Lifetime benefit maximum has been reached for this service/benefit category.”

Remittance Advice Remark Code (RARC) N362 - “The number of Days or Units of Service exceeds our acceptable maximum.”

Medicare Summary Notice (MSN) 20.5 – “These services cannot be paid because your benefits are exhausted at this time.”

ICD 9 Coding for On-Label PROVENGE® Services

Effective for claims with dates of service on and after July 1, 2011, contractors shall allow payment for nationally covered PROVENGE®, the on-label indication of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer according to NCD 110.22, provided the claim contains the following: HCPCS code Q2043, AND, ICD-9 code 185, malignant neoplasm of prostate, AND, At least one of the following ICD-9 codes:

196.1 Secondary and unspecified malignant neoplasm of intrathoracic lymph nodes

196.2 Secondary and unspecified malignant neoplasm of intra-abdominal lymph nodes

196.5 Secondary and unspecified malignant neoplasm of lymph nodes of inguinal region and lower limb

196.6 Secondary and unspecified malignant neoplasm of intrapelvic lymph nodes

196.8 Secondary and unspecified malignant neoplasm of lymph nodes of multiple sites

196.9 Secondary and unspecified malignant neoplasm of lymph node site unspecified - The spread of cancer to and establishment in the lymph nodes.

197.0 Secondary malignant neoplasm of lung – Cancer that has spread from the original (primary) tumor to the lung. The spread of cancer to the lung. This may be from a primary lung cancer, or from a cancer at a distant site.

197.7 Malignant neoplasm of liver secondary - Cancer that has spread from the original (primary) tumor to the liver. A malignant neoplasm that has spread to the liver from another (primary) anatomic site. Such malignant neoplasms may be carcinomas (e.g., breast, colon), lymphomas, melanomas, or sarcomas.

198.0 Secondary malignant neoplasm of kidney - The spread of the cancer to the kidney. This may be from a primary kidney cancer involving the opposite kidney, or from a cancer at a distant site.

198.1 Secondary malignant neoplasm of other urinary organs

198.5 Secondary malignant neoplasm of bone and bone marrow – Cancer that has spread from the original (primary) tumor to the bone. The spread of a malignant neoplasm from a primary site to the skeletal system. The majority of metastatic neoplasms to the bone are carcinomas.

198.7 Secondary malignant neoplasm of adrenal gland

198.82 Secondary malignant neoplasm of genital organs

Contractors shall use the following messages when denying claims for the on-label indication for PROVENGE®, HCPCS Q2043, submitted without ICD-9-CM diagnosis code 185 and at least one diagnosis code from the ICD-9 table in Section 280.2 above:

MSN 14.9 - Medicare cannot pay for this service for the diagnosis shown on the claim.

RARC 167 - This (these) diagnosis (es) are not covered. Note: Refer to the 835 Healthcare Policy Identification segment (loop 2110 Service Payment Information REF), if present.

ICD 9 Coding for Off-Label PROVENGE® Services

The use of PROVENGE® off-label for the treatment of prostate cancer is left to the discretion of the Medicare Administrative Contractors. Claims with dates of service on and after July 1, 2011, for PROVENGE® paid off-label for the treatment of prostate cancer must be billed using either ICD-9 code 233.4 (carcinoma in situ of prostate), or ICD-9 code 185 (malignant neoplasm of prostate) in addition to HCPCS Q2043. Effective with the implementation date for ICD-10 codes, off-label PROVENGE® services must be billed with either ICD-10 code D075(carcinoma in situ of prostate), or C61 (malignant neoplasm of prostate) in addition to HCPCS Q2043.

Contractors shall use the following messages when denying claims for the off-label indication for PROVENGE®, HCPCS Q2043, submitted without either ICD-9-CM diagnosis code 233.4 or ICD-9-CM diagnosis code 185:

MSN 14.9 - Medicare cannot pay for this service for the diagnosis shown on the claim.

RARC 167 - This (these) diagnosis (es) are not covered. Note: Refer to the 835 Healthcare Policy Identification segment (loop 2110 Service Payment Information REF), if present.

Reference(s):

http://www.cms.gov/transmittals/downloads/R2380CP.pdf

http://www.cms.gov/transmittals/downloads/R2394CP.pdf

http://www.cms.gov/transmittals/downloads/R140NCD.pdf
 

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