(Medicare Claims Processing Manual)

270.2  Billing Requirements for Patients Enrolled in a Data Collection System  (Rev.11759, Issued:12- 21-2022, Effective:01 -23-2023, Implementation:01- 23-2023)   Effective for dates of service on or after April 1, 2005, Medicare required that patients receiving a defibrillator for the primary prevention of sudden cardiac arrest be enrolled in a qualifying data collection system.  Providers shall use modifier Q0 to identify patients whose data is being submitted to a data collection system.   The following diagnosis codes identify non -primary prevention (secondary prevention) patient or replacement implantations (e.g. due to recalled devices):   If ICD -9-CM is applicable, select from the following diagnosis codes:   427.1 Ventricular tachycardia   427.41 Ventricular fibrillation  427.42 Ventricular flutter   427.5 Cardiac arrest   427.9 Cardiac dysrhythmia, unspecified   V12.53 Personal history of sudden cardiac arrest   996.04 Mechanical complication of cardiac device, implant, and graft, due to automatic implantable cardiac defibrillator   V53.32 Fitting and adjustment of other device, automatic implantable cardiac defibrillator   If ICD -10-CM is applicable, select from the following list:  I47.0 Re -entry Ventricular Arrhythmia  I47.2 Ventricular Tachycardiaselect -  end date September 30, 2022  I47.20 Ventricular Tachycardia, unspecified - effective October 1, 2022  I47.21 Torsades De Pointes -  effective October 1, 2022 I47.29 Other Ventricular Tachycardia - effective October 1, 2022   I49.3 Ventricular Premature depolarization  I49.01 Ventricular Fibrillation I49.02 Ventricular Flutter  I46.2 Cardiac arrest due to underlying cardiac condition  I46.8 Cardiac arrest due to other underlying condition I46.9 Cardiac arrest, cause unspecified  I49.9 Cardiac arrhythmia, unspecified  T82.110A Breakdown (mechanical) of cardiac electrode, initial encounter  T82.111A Breakdown (mechanical) of cardiac pulse generator (battery), initial encounter  T82.118A Breakdown (mechanical) of other cardiac electronic device, initial encounter  T82.119A Breakdown (mechanical) of unspecified cardiac electronic device, initial encounter  T82.120A Displacement of cardiac electrode, initial encounter  T82.121A Displacement of cardiac pulse generator (battery), initial encounter  T82.128A Displacement of other cardiac electronic device, initial encounter  T82.129A Displacement of unspecified cardiac electronic device, initial encounter  T82.190A Other mechanical complication of cardiac electrode, initial encounter  T82.191A Other mechanical complication of cardiac pulse generator (battery), initial encounter  T82.198A Other mechanical complication of other cardiac electronic device, initial encounter  T82.199A Other mechanical complication of unspecified cardiac device, initial encounter  Z86.74 Personal history of sudden cardiac arrest  Z45.02 Encounter for adjustment and management of automatic implantable cardiac defibrillator  When any of the above codes appear on a claim, the Q0 modifier is not required.  The Q0 modifier may be appended to claims for secondary prevention indications when data is being entered into a qualifying data collection system.   280 - Autologous Cellular Immunotherapy Treatment of Prostate Cancer  (Rev. 2380, Issued: 01- 06-12, Effective: 06 -30-11, Implementation: 08- 08-11)  280.1 - Policy  (Rev. 2380, Issued: 01- 06-12, Effective: 06 -30-11, Implementation: 08- 08-11)  Effective for services furnished on or after June 30, 2011, a National Coverage Determination (NCD) provides coverage of sipuleucel -T (PROVENGE) for patients with asymptomatic or minimally symptomatic metastatic, castrate -resistant (hormone refractory) pr ostate cancer.  Conditions of Medicare Part A and Medicare Part B coverage for sipuleucel -T are located in the Medicare NCD Manual, Publication 100- 03, section 110.22.  280.2 - Healthcare Common Procedure Coding System (HCPCS) Codes 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 sarcom as. 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 ca ncer 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   280.3 - Types of Bill (TOB) and Revenue Codes  (Rev. 2380, Issued: 01- 06-12, Effective: 06 -30-11, Implementation: 08- 08-11)  The applicable TOBs for PROVENGE are: 12X, 13X, 22X, 23X, 71X, 77X, and 85X.    On institutional claims, TOBs 12X, 13X, 22X, 23X, and 85X, use revenue code 0636 -  drugs requiring detailed coding.  280.4 - Payment Method  (Rev. 2380, Issued: 01- 06-12, Effective: 06 -30-11, Implementation: 08 -08-11)  Payment for PROVENGE is as follows:    TOBs 12X, 13X, 22X and 23X -  based on the Average Sales Price (ASP) + 6%,   TOB 85X  based on reasonable cost,   TOBs 71X and 77X  based on all -inclusive rate.  For Medicare Part B practitioner claims, payment for PROVENGE is based on ASP + 6%.   Contractors shall not pay separately for routine costs associated with PROVENGE, HCPCS Q2043, except for the cost of administration. (Q2043 is all -inclusive and represents all routine costs except for its cost of administration).   280.5 - Medicare Summary Notices (MSNs), Remittance Advice Remark Codes (RARCs), Claim Adjustment Reason Codes (CARCs), and Group Codes (Rev. 2394, Issued: 01- 25-12, Effective: 06 -30-11 for -(claims with dates of service on or after 07 -01- 11 processed on or after July 02- 12, Implementation: 07- 02-12)  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.