Oncology & Hematology Coding Alert

You'll also want to highlight the need for a second ICD-9 code.

A recent Medicare announcement revealed the limits of Provenge coverage. Here are the specifics.

Resist Urge to Report Q2043 With Admin Code

CMS announced coverage for Provenge use, finding the immunotherapy reasonable and necessary for beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer." The effective date is June 30, 2011, and the implementation date is Aug. 8, 2011.

HCPCS: As of July 1, a new code for Provenge is available: Q2043 (Sipuleucel-T, minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, including leukapheresis and all other preparatory procedures, per infusion).

Many practices were surprised by CMS's statement that the phrase "all other preparatory procedures" in the HCPCS definition means Q2043 includes:

• Transportation process of collecting immune cells from a patient during a non-therapeutic leukapheresis procedure
• Subsequently sending the immune cells to the manufacturing facility
• Transporting the immune cells back to the site of service to be administered to the patient
• The infusion of the immune cells to the patient.

Key point: Look at that last bullet again. It means that you should not report a CPT® infusion code separately, according to MLN Matters article MM7431, "Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer" (www.cms.gov/MLNMattersArticles/Downloads/MM7431.pdf). For example, you should not report 96365 (Intravenous infusion for therapy, prophylaxis, or diagnosis [specify substance or drug]; initial, up to 1 hour) to represent the Provenge infusion, the article states.

This inclusion sets a dangerous precedent, proclaims Roberta Buell, MBA, of OnPoint Oncology, in her July 22, 2011, E-Reimbursement Newsletter. Why is drug administration considered a "preparatory procedure," and why isn't the sample administration code (which you can't use anyway) the more complex 96413 (Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug)?

Note that the instruction not to code administration separately is in direct contrast to policies some local MACs published before the national rule was established. (For an example, see "Q2043 Is Effective for Provenge, July 1" in Oncology & Hematology Coding Alert, vol. 13, no. 8.)

Double Up on ICD 9 Codes to Prevent Denial

MM7431 indicates that for on-label Provenge use, Q2043 must be paired with 185 (Malignant neoplasm of prostate) and at least one of these additional secondary neoplasm codes:

• 196.1, Secondary and unspecified malignant neoplasm of lymph nodes; intrathoracic lymph nodes
• 196.2, ... intra-abdominal lymph nodes
• 196.5, ... lymph nodes of inguinal region and lower limb
• 196.6, ... intrapelvic lymph nodes
• 196.8, ... lymph nodes of multiple sites
• 196.9, ... site unspecified
• 197.0, Secondary malignant neoplasm respiratory and digestive systems; lung
• 197.7, ... liver, specified as secondary
• 198.0, Secondary malignant neoplasm of other specified sites; kidney
• 198.1, ... other urinary organs
• 198.5, ... bone and bone marrow
• 198.7, ... adrenal gland
• 198.82, ... genital organs.

Your local MAC may pay for off-label prostate cancer Provenge treatment if you use either 233.4 (Carcinoma in situ of prostate) or 185 linked to Q2043. The decision for coverage, however, is at the MAC's discretion, the article notes.

Don't Forget Frequency Limitation

Medicare will cover only one Provenge treatment regimen in a patient's lifetime. The regimen involves three doses. "This will be a hard edit in the CMS system and claims over three treatments will be kicked out," Buell warned. The physician typically administers each dose roughly two weeks apart, but Medicare allows for a treatment period "not to exceed 30 weeks from the first administration," the MLN Matters article states.