CMS Pub. 100-04, ch. 32, § 280.2

and Diagnosis Coding

(Rev. 2380, Issued: 01-06-12, Effective: 06-30-11, Implementation: 08-08-11)

HCPCS Codes

Effective for claims with dates of service on June 30, 2011, Medicare providers shall report

one of the following HCPCS codes for PROVENGE®:

• C9273 - Sipuleucel-T, minimum of 50 million autologous CD54+ cells activated with

PAP-GM-CSF, including leukapheresis and all other preparatory procedures, per infusion,

or

• J3490 – Unclassified Drugs, or

• J3590 – Unclassified Biologics.

NOTE: Contractors shall continue to process claims for HCPCS code C9273, J3490, and

J3590, with dates of service June 30, 2011, as they do currently.

Effective for claims with dates of service on and after July 1, 2011, Medicare providers shall

report the following HCPCS code:

• Q2043 – Sipuleucel-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+.

ICD-9 Diagnosis Coding

For claims with dates of service on and after July 1, 2011, for PROVENGE®, the on-label

indication of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone

refractory) prostate cancer, must be billed using ICD-9 code 185 (malignant neoplasm of

prostate) and at least one of the following ICD-9 codes:

ICD-9

code

Description

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

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.

ICD-10 Diagnosis Coding

Contractors shall note the appropriate ICD-10 code(s) that are listed below for future

implementation. Contractors shall track the ICD-10 codes and ensure that the updated edit is

turned on as part of the ICD-10 implementation effective October 1, 2013.

ICD-10 Description

C61 Malignant neoplasm of prostate (for on-label or off-label indications)

D075 Carcinoma in situ of prostate (for off-label

indications only)

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

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