Will Medicare cover Stem Cell Tx for Amyloidosis?

February 14, 2006

Good morning,

We have a patient scheduled for a potential Autologous Stem Cell

Transplant after being diagnosed with Amyloidosis.

Will Medicare cover it?

Thanks and Happy Valentine to all,

Fahmy

February 14, 2006

Below are the CMS guidelines for

Autologous stem cell transplant.

I found it on the CMS website.

Publication # 100-3; Manual Section # 110.8.1; Version # 3

2. Autologous Stem Cell Transplantation (AuSCT)

Autologous

stem cell transplantation (AuSCT) is a technique for restoring stem cells using

the patient's own previously stored cells.

a. Covered Indications

Effective for services performed on or after April 28,

1989,

AuSCT is considered reasonable and necessary under §l862(a)(1)(A) of the

Social Security Act for the following conditions and is covered under Medicare

for patients with:

§

Acute leukemia in remission

who have a high probability of relapse and who have no human leucocyte antigens

(HLA)-matched;

§

Resistant non-Hodgkin's

lymphomas or those presenting with poor prognostic features following an

initial response;

§

Recurrent or refractory

neuroblastoma; or

§

Advanced Hodgkin's disease

who have failed conventional therapy and have no HLA-matched donor.

Effective

October 1, 2000, single AuSCT is only covered for Durie-Salmon Stage II or III

patients that fit the following requirements:

§

Newly diagnosed or

responsive multiple myeloma. This includes those patients with previously

untreated disease, those with at least a partial response to prior chemotherapy

(defined as a 50% decrease either in measurable paraprotein [serum and/or

urine] or in bone marrow infiltration, sustained for at least 1 month), and

those in responsive relapse; and

§

Adequate cardiac, renal,

pulmonary, and hepatic function.

Effective for services performed on or after March 15,

2005, when recognized clinical risk factors are employed to select patients for

transplantation, high dose melphalan (HDM) together with AuSCT is reasonable

and necessary for Medicare beneficiaries of any age group with primary amyloid

light chain (AL)

amyloidosis who meet the following criteria:

§

Amyloid

deposition in 2 or fewer organs; and,

§

Cardiac

left ventricular ejection fraction (EF) greater than 45%.

b. Noncovered Indications

Insufficient

data exist to establish definite conclusions regarding the efficacy of AuSCT

for the following conditions:

§

Acute leukemia not in

remission;

§

Chronic granulocytic

leukemia;

§

Solid tumors (other than

neuroblastoma);

§

Up to October 1, 2000,

multiple myeloma;

§

Tandem transplantation

(multiple rounds of AuSCT) for patients with multiple myeloma;

§

Effective October 1, 2000,

non primary AL

amyloidosis; and,

§

Effective October 1,

2000, thru March 14, 2005,

primary AL

amyloidosis for Medicare beneficiaries age 64 or older.

In these

cases, AuSCT is not considered reasonable and necessary within the meaning of

§l862(a)(1)(A) of the Act and is not covered under Medicare.

B. Other

All other indications for stem cell transplantation not

otherwise noted above as covered or noncovered nationally remain at local

contractor discretion

Hope that helps,

Sue Milner, BIDMC, Boston

From:

TxFinancialCoordinators

[mailto:TxFinancialCoordinators ] On Behalf Of Fahmy Farid

Sent: Tuesday, February 14, 2006

9:17 AM

To: TxFinancialCoordinators

Subject:

Will Medicare cover Stem Cell

Tx for Amyloidosis?

Good morning,

We have a patient scheduled for a potential

Autologous Stem Cell

Transplant after being diagnosed with Amyloidosis.

Will Medicare cover it?

Thanks and Happy Valentine to all,

Fahmy

February 14, 2006

Great. Thank you!

>>> smilner@... 2/14/2006 9:33:05 AM >>>

Below are the CMS guidelines for Autologous stem cell transplant.

I found it on the CMS website. Publication # 100-3; Manual Section # 110.8.1;

Version # 3

2. Autologous Stem Cell Transplantation (AuSCT)

Autologous stem cell transplantation (AuSCT) is a technique for restoring stem

cells using the patient's own previously stored cells.

a. Covered Indications

Effective for services performed on or after April 28, 1989, AuSCT is

considered reasonable and necessary under §l862(a)(1)(A) of the Social Security

Act for the following conditions and is covered under Medicare for patients

with:

* Acute leukemia in remission who have a high

probability of relapse and who have no human leucocyte antigens (HLA)-matched;

* Resistant non-Hodgkin's lymphomas or those presenting

with poor prognostic features following an initial response;

* Recurrent or refractory neuroblastoma; or

* Advanced Hodgkin's disease who have failed

conventional therapy and have no HLA-matched donor.

Effective October 1, 2000, single AuSCT is only covered for Durie-Salmon Stage

II or III patients that fit the following requirements:

* Newly diagnosed or responsive multiple myeloma. This

includes those patients with previously untreated disease, those with at least a

partial response to prior chemotherapy (defined as a 50% decrease either in

measurable paraprotein [serum and/or urine] or in bone marrow infiltration,

sustained for at least 1 month), and those in responsive relapse; and

* Adequate cardiac, renal, pulmonary, and hepatic

function.

Effective for services performed on or after March 15, 2005, when recognized

clinical risk factors are employed to select patients for transplantation, high

dose melphalan (HDM) together with AuSCT is reasonable and necessary for

Medicare beneficiaries of any age group with primary amyloid light chain (AL)

amyloidosis who meet the following criteria:

* Amyloid deposition in 2 or fewer organs; and,

* Cardiac left ventricular ejection fraction (EF)

greater than 45%.

b. Noncovered Indications

Insufficient data exist to establish definite conclusions regarding the efficacy

of AuSCT for the following conditions:

* Acute leukemia not in remission;

* Chronic granulocytic leukemia;

* Solid tumors (other than neuroblastoma);

* Up to October 1, 2000, multiple myeloma;

* Tandem transplantation (multiple rounds of AuSCT) for

patients with multiple myeloma;

* Effective October 1, 2000, non primary AL amyloidosis;

and,

* Effective October 1, 2000, thru March 14, 2005,

primary AL amyloidosis for Medicare beneficiaries age 64 or older.

In these cases, AuSCT is not considered reasonable and necessary within the

meaning of §l862(a)(1)(A) of the Act and is not covered under Medicare.

B. Other

All other indications for stem cell transplantation not otherwise noted above as

covered or noncovered nationally remain at local contractor discretion

Hope that helps,

Sue Milner, BIDMC, Boston

________________________________

From: TxFinancialCoordinators

[mailto:TxFinancialCoordinators ] On Behalf Of Fahmy Farid

Sent: Tuesday, February 14, 2006 9:17 AM

To: TxFinancialCoordinators

Subject: Will Medicare cover Stem Cell Tx for

Amyloidosis?

Good morning,

We have a patient scheduled for a potential Autologous Stem Cell

Transplant after being diagnosed with Amyloidosis.

Will Medicare cover it?

Thanks and Happy Valentine to all,

Fahmy

February 14, 2006

I believe that as of !0/1/00 non-primary (AL) amyloidosis (ICD-9-CM 277.3) is non covered by Medicare.

Thank You,

Clarice S. Zess

Transplant Financial Coordinator

St. Luke's Medical Center

Abdominal Transplant Clinic

POB Suite 525

Transplant Services

Phone:

Fax:

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Thank You. .

" Fahmy Farid "

Sent by: TxFinancialCoordinators

02/14/2006 08:17 AM

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