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Friday, June 11, 2010 8:55:46 AM
indebt2, there's so much to look forward to here. Without the Patient Protection & Affordable Care Act this would be a slow mover simply because the debate of what works best would still be a debate. The FDA's announcement that family-related stems works best in a Trillion Dollar health care industry is pretty big for CBAI private family-related storage. Clinical Trials have proven the science and now we have medically necessary language added to insurance policies to mobilize the capture of private cord blood allogeneics to cure.
We are a cog in the gear but a very important one.
Read this new 2010 CMS Medicare insurance policy. It will cheer you up even more. Keep in mind that CorCell V59.02 CPT code that is displayed on their website... and follow what I have highlighted for you. Give me some feedback if you see what I see going forward... thanks
Subject Draft - Granulocyte-Macrophage Colony-Stimulating Factor
Source Medicare A Bulletin
Publication Medicare Part A Policy Pinnacle
Effective Date Apr 1, 2010
Publish Date Apr 1, 2010
Contractor Name
Pinnacle Business Solutions Inc.
Contractor Number
00233
Contractor Type
FI
LCD Information
LCD ID Number
DL31020
LCD Title
Granulocyte-Macrophage Colony-Stimulating Factor
Contractor's Determination Number
PBSI-A-10-031
AMA CPT / ADA CDT Copyright Statement
CPT codes, descriptions and other data only are copyright 2009 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.
CMS National Coverage Policy
Title XVIII of the Social Security Act, section 1862(a)(1)(A). This section allows coverage and payment for only those services that are considered to be medically reasonable and necessary.
Title XVIII of the Social Security Act,§ section 1833(e). This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim.
Title XVIII of the§ Social Security Act, section 1862(a)(7) excludes routine physical evaluations and screening tests performed in the absence of signs or symptoms from coverage
Primary Geographic Jurisdiction
Louisiana
Mississippi
Oversight Region
Region IV
Projected Determination Effective Date
For services performed on or after 08/01/2010
Original Determination Ending Date
Revision Effective Date
Revision Ending Date
Indications and Limitations of Coverage and/or Medical Necessity
1. Neutropenia, chemotherapy-induced (V58.69, V67.51, E933.1, 288.03)
? In patients with malignancies receiving myelosuppressive antineoplastic therapy in an attempt to increase neutrophil counts and decrease the risk of infectious complications.
2. Autologous or allogeneic bone marrow transplantation (BMT) (V42.81):
? Acceleration of myeloid recovery in patients with non-hodgkin?s lymphomas, acute lymphoblastic (lymphocytic) leukemia, and Hodgkin?s disease undergoing autologous bone marrow transplantation (BMT).
? Acceleration of myeloid recovery in patients undergoing allogeneic BMT from HLA-matched related donors.
? Acceleration of myeloid recovery in patients undergoing autologous or allogeneic BMT following myeloablative chemotherapy for non-myeloid or myeloid malignancies.
? Prolonging survival in patients who have undergone allogeneic or autologous BMT in whom engraftment is delayed or has failed, in the presence or absence of infection3. Peripheral progenitor cell yield transplantation (V59.02, V42.82):
? Mobilize hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and to accelerate myeloid engraftment following autologous peripheral blood progenitor cell (PBCP) transplantation.
** What do umbilical cord stems do according to this new CMS transplant policy?
4. Myeloid engraftment following hematopoietic stem cell transplantation, promotion of (V42.82):
? Acceleration of myeloid recovery in patients who have undergone hematopoietic stem cell transplantation following myeloablative chemotherapy.
? Prolonging survival in patients who have undergone autologous or allogeneic hematopoietic stem cell transplantation in whom engraftment is delayed or has failed, in the presence or absence of infection
**Are these stems also now considered a source to correct HIV according to CMS?
5. Neutropenia associated with HIV infection (042):
? To correct or minimize HIV-associated neutropenia and/or for the treatment of drug-induced neutropenia (e.g., neutropenia associated
with use of zidovudine, interferon alfa, and/or cytotoxic chemotherapy) in HIV-infected patients.
6. Myelodysplastic syndromes (238.72, 238.73, 238.74, 238.75):
? Enhance neutrophil function in patients with MDS and a history of infection.
7. Congenital, Cyclic and Acquired Neutropenias (288.01, 288.02, 288.04, 288.09)
? To increase neutrophil counts in patients with various primary neutropenia.
8. Neutropenia, drug induced (288.03):
? Drug induced neutropenia.
9 Other Uses:
? Used effectively in several patients to hasten recovery from sulfasalazine-associated agranulocytosis; (288.09)
? Neutropenia associated with Felty?s syndrome or large granular lymphocytic leukemia in patients with rheumatoid arthritis.
LIMITATIONS:
Use of Sargramostim, as a single agent or in combination therapy, for the treatment of melanoma has not been established. (USPDI)
Coding Information
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 policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
85x
Special facility or ASC surgery-rural primary care hospital (eff 10/94)
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 policy 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 policy should be assumed to apply equally to all 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 policy 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 policy should be assumed to apply equally to all Revenue Codes.
0250
Pharmacy-general classification
0636
Drugs requiring specific identification-detailed coding (eff 3/92)
CPT/HCPCS Codes
The following short descriptors are in accordance with the AMA copyright. Please refer to the current CPT book for full descriptions.
J2820
Sargramostim injection
ICD-9 Codes that Support Medical Necessity
042
HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE
238.72
LOW GRADE MYELODYSPLASTIC SYNDROME LESIONS
238.73
HIGH GRADE MYELODYSPLASTIC SYNDROME LESIONS
238.74
MYELODYSPLASTIC SYNDROME WITH 5Q DELETION
238.75
MYELODYSPLASTIC SYNDROME, UNSPECIFIED
288.00 - 288.09
NEUTROPENIA, UNSPECIFIED - OTHER NEUTROPENIA
E933.1
ANTINEOPLASTIC AND IMMUNOSUPPRESSIVE DRUGS CAUSING ADVERSE EFFECTS IN THERAPEUTIC USE
V42.81
BONE MARROW REPLACED BY TRANSPLANT
V42.82
PERIPHERAL STEM CELLS REPLACED BY TRANSPLANT
V58.69
LONG-TERM (CURRENT) USE OF OTHER MEDICATIONS
V59.02
BLOOD DONORS STEM CELLS
** the same ICD-9 Code that has been on the CorCell website is for billing the insurance companies - CMS/HMO...short-term storage of autologous and family-related allogeneics**
V67.51
FOLLOW-UP EXAMINATION FOLLOWING COMPLETED TREATMENT WITH HIGH-RISK MEDICATION NOT ELSEWHERE CLASSIFIED
Diagnoses that Support Medical Necessity
ICD-9 Codes that DO NOT Support Medical Necessity
ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation
Diagnoses that DO NOT Support Medical Necessity
General Information
Documentation Requirements
1. Documentation supporting the medical necessity of this item, such as ICD-9-CM codes coded to the highest level of specificity, must be submitted with each claim. Claims submitted without such evidence will be denied as being not medically necessary.
2. Office records should clearly document the reason for the use of the drug(s), its frequency and its purpose.
** Remember Allogeneics are now classified as a drug.
This information and an appropriate history and physical exam must be available if requested by the carrier to determine coverage.
3. Three Phase III studies from CMS accepted literature (specified in PM AB-94-2 and Pub 100-2, Chapter 15, section 50.4) must be submitted at the review level to justify any indication not listed above.
**Studies? Clinical Trial Data
4. HCPCS code J2820 is per 50 mcg. The dose administered should be divided by 50 to reach the units of service to be billed.
5. Sargramostim is administered by IV infusion or subcutaneous infusion.
Appendices
Utilization Guidelines
Sources of Information and Basis for Decision
1. Adoption of the Arkansas policy, ARA-03-024
2. AHFS 2003; 1471-1480.
3. USPDI 2003; 863-869.
4. FDA Approved Package Labeling. **Allogeneics are a drug
5. CMS Manual System, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, section 50.4.
6. Individual Local Medical Review Policies:
? Arkansas - Granulocyte-Macrophage Colony-Stimulating Factor(Sargramostim) Rev 6;
? Louisiana - Leukine (Sargramostin, Granulocyte-Macrophage Colony Stimulating Factor);
? Missouri - Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor (#36); and
7.? Oklahoma and New Mexico - Sargramostim, #060
Advisory Committee Meeting Notes
?This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which includes representatives from allergy and dermatology, and from a Carrier Medical Director Workgroup which developed a model policy on this subject.?
Start Date of Comment Period
04/01/2010
End Date of Comment Period
05/15/2010
Start Date of Notice Period
Revision History Number
#14 ? 03/09/2010
#13 - 06/02/2008
#11 - 03/06/2008
#8, #9 & 10 - 09/24/2006
#6 - 03/15/2006, 02/09/2006
#4 - 03/31/2005
Revision History Explanation
#14. 03/09/2010 adoption of policy from AR (ARA-03-024) open for comment 04/01/2010 ? 05/15/2010
In accordance with the 2007 ICD-9 update, expanded 288.0 and 238.7 to allow 288.01, 288.02, 288.03, 288.04, 288.09, 238.72, 238.73, 238.74, and 238.75 effective 10/01/2006.
Removed administration codes 90780 and 90781 from policy. Policy is outlining the guidelines for drug coverage and not to outline the route of administration. Please sue the route appropriate for the dug. Added CCI statement to CPT/HCPCs section.
Eleted "since Sargramostim is not a chemotherapy agent, the therapeutic or diagnostic infusion codes are appropriate for the administration" from documentation requirement #5.
Added ICD-9 code 288.0 to allow for the sesignation of chemotherapy induced anemia.
Revised I & L to include a LIMITATIONS section and moved previous denial re regarding use in melanoma to this section.
Moved previous Coding GL #2 and #2 to Doc Req #4 and #5 respectively. Replaced MCM 2049.C in #3 with Pub 100-2, Chapter 15, section 50.4. Replaced injection in Doc Req#5 with "infusion"
Revised Sources to include Pub 100-2, Chapter 15 section 50.4 (#4) and to reflect individual state LMRPS (#5).
Revised Advisory Committe Notes section by replacing "in cooperation with advisory groups" with "through a Part B Carrier Advisory Committee". Added informational paragraph.
Reason for Change
Last Reviewed On Date
03/17/2010
Related Documents
This LCD has no Related Documents.
LCD Attachments
There are no attachments for this LCD.
Draft Contact
Amanda Tart - TriSpanLCD@lamsmedicare.com
P. O. Box 23046
Jackson, MS 39225-3046
http://www.codeitrightonline.com/reader/article_print/224193
We are a cog in the gear but a very important one.
Read this new 2010 CMS Medicare insurance policy. It will cheer you up even more. Keep in mind that CorCell V59.02 CPT code that is displayed on their website... and follow what I have highlighted for you. Give me some feedback if you see what I see going forward... thanks
Subject Draft - Granulocyte-Macrophage Colony-Stimulating Factor
Source Medicare A Bulletin
Publication Medicare Part A Policy Pinnacle
Effective Date Apr 1, 2010
Publish Date Apr 1, 2010
Contractor Name
Pinnacle Business Solutions Inc.
Contractor Number
00233
Contractor Type
FI
LCD Information
LCD ID Number
DL31020
LCD Title
Granulocyte-Macrophage Colony-Stimulating Factor
Contractor's Determination Number
PBSI-A-10-031
AMA CPT / ADA CDT Copyright Statement
CPT codes, descriptions and other data only are copyright 2009 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.
CMS National Coverage Policy
Title XVIII of the Social Security Act, section 1862(a)(1)(A). This section allows coverage and payment for only those services that are considered to be medically reasonable and necessary.
Title XVIII of the Social Security Act,§ section 1833(e). This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim.
Title XVIII of the§ Social Security Act, section 1862(a)(7) excludes routine physical evaluations and screening tests performed in the absence of signs or symptoms from coverage
Primary Geographic Jurisdiction
Louisiana
Mississippi
Oversight Region
Region IV
Projected Determination Effective Date
For services performed on or after 08/01/2010
Original Determination Ending Date
Revision Effective Date
Revision Ending Date
Indications and Limitations of Coverage and/or Medical Necessity
1. Neutropenia, chemotherapy-induced (V58.69, V67.51, E933.1, 288.03)
? In patients with malignancies receiving myelosuppressive antineoplastic therapy in an attempt to increase neutrophil counts and decrease the risk of infectious complications.
2. Autologous or allogeneic bone marrow transplantation (BMT) (V42.81):
? Acceleration of myeloid recovery in patients with non-hodgkin?s lymphomas, acute lymphoblastic (lymphocytic) leukemia, and Hodgkin?s disease undergoing autologous bone marrow transplantation (BMT).
? Acceleration of myeloid recovery in patients undergoing allogeneic BMT from HLA-matched related donors.
? Acceleration of myeloid recovery in patients undergoing autologous or allogeneic BMT following myeloablative chemotherapy for non-myeloid or myeloid malignancies.
? Prolonging survival in patients who have undergone allogeneic or autologous BMT in whom engraftment is delayed or has failed, in the presence or absence of infection3. Peripheral progenitor cell yield transplantation (V59.02, V42.82):
? Mobilize hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and to accelerate myeloid engraftment following autologous peripheral blood progenitor cell (PBCP) transplantation.
** What do umbilical cord stems do according to this new CMS transplant policy?
4. Myeloid engraftment following hematopoietic stem cell transplantation, promotion of (V42.82):
? Acceleration of myeloid recovery in patients who have undergone hematopoietic stem cell transplantation following myeloablative chemotherapy.
? Prolonging survival in patients who have undergone autologous or allogeneic hematopoietic stem cell transplantation in whom engraftment is delayed or has failed, in the presence or absence of infection
**Are these stems also now considered a source to correct HIV according to CMS?
5. Neutropenia associated with HIV infection (042):
? To correct or minimize HIV-associated neutropenia and/or for the treatment of drug-induced neutropenia (e.g., neutropenia associated
with use of zidovudine, interferon alfa, and/or cytotoxic chemotherapy) in HIV-infected patients.
6. Myelodysplastic syndromes (238.72, 238.73, 238.74, 238.75):
? Enhance neutrophil function in patients with MDS and a history of infection.
7. Congenital, Cyclic and Acquired Neutropenias (288.01, 288.02, 288.04, 288.09)
? To increase neutrophil counts in patients with various primary neutropenia.
8. Neutropenia, drug induced (288.03):
? Drug induced neutropenia.
9 Other Uses:
? Used effectively in several patients to hasten recovery from sulfasalazine-associated agranulocytosis; (288.09)
? Neutropenia associated with Felty?s syndrome or large granular lymphocytic leukemia in patients with rheumatoid arthritis.
LIMITATIONS:
Use of Sargramostim, as a single agent or in combination therapy, for the treatment of melanoma has not been established. (USPDI)
Coding Information
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 policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
85x
Special facility or ASC surgery-rural primary care hospital (eff 10/94)
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 policy 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 policy should be assumed to apply equally to all 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 policy 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 policy should be assumed to apply equally to all Revenue Codes.
0250
Pharmacy-general classification
0636
Drugs requiring specific identification-detailed coding (eff 3/92)
CPT/HCPCS Codes
The following short descriptors are in accordance with the AMA copyright. Please refer to the current CPT book for full descriptions.
J2820
Sargramostim injection
ICD-9 Codes that Support Medical Necessity
042
HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE
238.72
LOW GRADE MYELODYSPLASTIC SYNDROME LESIONS
238.73
HIGH GRADE MYELODYSPLASTIC SYNDROME LESIONS
238.74
MYELODYSPLASTIC SYNDROME WITH 5Q DELETION
238.75
MYELODYSPLASTIC SYNDROME, UNSPECIFIED
288.00 - 288.09
NEUTROPENIA, UNSPECIFIED - OTHER NEUTROPENIA
E933.1
ANTINEOPLASTIC AND IMMUNOSUPPRESSIVE DRUGS CAUSING ADVERSE EFFECTS IN THERAPEUTIC USE
V42.81
BONE MARROW REPLACED BY TRANSPLANT
V42.82
PERIPHERAL STEM CELLS REPLACED BY TRANSPLANT
V58.69
LONG-TERM (CURRENT) USE OF OTHER MEDICATIONS
V59.02
BLOOD DONORS STEM CELLS
** the same ICD-9 Code that has been on the CorCell website is for billing the insurance companies - CMS/HMO...short-term storage of autologous and family-related allogeneics**
V67.51
FOLLOW-UP EXAMINATION FOLLOWING COMPLETED TREATMENT WITH HIGH-RISK MEDICATION NOT ELSEWHERE CLASSIFIED
Diagnoses that Support Medical Necessity
ICD-9 Codes that DO NOT Support Medical Necessity
ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation
Diagnoses that DO NOT Support Medical Necessity
General Information
Documentation Requirements
1. Documentation supporting the medical necessity of this item, such as ICD-9-CM codes coded to the highest level of specificity, must be submitted with each claim. Claims submitted without such evidence will be denied as being not medically necessary.
2. Office records should clearly document the reason for the use of the drug(s), its frequency and its purpose.
** Remember Allogeneics are now classified as a drug.
This information and an appropriate history and physical exam must be available if requested by the carrier to determine coverage.
3. Three Phase III studies from CMS accepted literature (specified in PM AB-94-2 and Pub 100-2, Chapter 15, section 50.4) must be submitted at the review level to justify any indication not listed above.
**Studies? Clinical Trial Data
4. HCPCS code J2820 is per 50 mcg. The dose administered should be divided by 50 to reach the units of service to be billed.
5. Sargramostim is administered by IV infusion or subcutaneous infusion.
Appendices
Utilization Guidelines
Sources of Information and Basis for Decision
1. Adoption of the Arkansas policy, ARA-03-024
2. AHFS 2003; 1471-1480.
3. USPDI 2003; 863-869.
4. FDA Approved Package Labeling. **Allogeneics are a drug
5. CMS Manual System, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, section 50.4.
6. Individual Local Medical Review Policies:
? Arkansas - Granulocyte-Macrophage Colony-Stimulating Factor(Sargramostim) Rev 6;
? Louisiana - Leukine (Sargramostin, Granulocyte-Macrophage Colony Stimulating Factor);
? Missouri - Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor (#36); and
7.? Oklahoma and New Mexico - Sargramostim, #060
Advisory Committee Meeting Notes
?This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which includes representatives from allergy and dermatology, and from a Carrier Medical Director Workgroup which developed a model policy on this subject.?
Start Date of Comment Period
04/01/2010
End Date of Comment Period
05/15/2010
Start Date of Notice Period
Revision History Number
#14 ? 03/09/2010
#13 - 06/02/2008
#11 - 03/06/2008
#8, #9 & 10 - 09/24/2006
#6 - 03/15/2006, 02/09/2006
#4 - 03/31/2005
Revision History Explanation
#14. 03/09/2010 adoption of policy from AR (ARA-03-024) open for comment 04/01/2010 ? 05/15/2010
In accordance with the 2007 ICD-9 update, expanded 288.0 and 238.7 to allow 288.01, 288.02, 288.03, 288.04, 288.09, 238.72, 238.73, 238.74, and 238.75 effective 10/01/2006.
Removed administration codes 90780 and 90781 from policy. Policy is outlining the guidelines for drug coverage and not to outline the route of administration. Please sue the route appropriate for the dug. Added CCI statement to CPT/HCPCs section.
Eleted "since Sargramostim is not a chemotherapy agent, the therapeutic or diagnostic infusion codes are appropriate for the administration" from documentation requirement #5.
Added ICD-9 code 288.0 to allow for the sesignation of chemotherapy induced anemia.
Revised I & L to include a LIMITATIONS section and moved previous denial re regarding use in melanoma to this section.
Moved previous Coding GL #2 and #2 to Doc Req #4 and #5 respectively. Replaced MCM 2049.C in #3 with Pub 100-2, Chapter 15, section 50.4. Replaced injection in Doc Req#5 with "infusion"
Revised Sources to include Pub 100-2, Chapter 15 section 50.4 (#4) and to reflect individual state LMRPS (#5).
Revised Advisory Committe Notes section by replacing "in cooperation with advisory groups" with "through a Part B Carrier Advisory Committee". Added informational paragraph.
Reason for Change
Last Reviewed On Date
03/17/2010
Related Documents
This LCD has no Related Documents.
LCD Attachments
There are no attachments for this LCD.
Draft Contact
Amanda Tart - TriSpanLCD@lamsmedicare.com
P. O. Box 23046
Jackson, MS 39225-3046
http://www.codeitrightonline.com/reader/article_print/224193
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