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Re: indebt2 post# 32506

Friday, 06/11/2010 8:55:46 AM

Friday, June 11, 2010 8:55:46 AM

Post# of 105534
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


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