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TO: All Providers
FROM: Maryland Medicare
DATE: September 21, 2000
SUBJECT: Stem Cell Transplantation


Section 3614, Intermediary Manual, Stem Cell Transplantation, provides claims processing instructions for the coverage of stem cell transplants. It has been updated to include both the covered and noncovered diagnosis and procedure codes for allogeneic and autologous stem cell transplants. In addition to clarifying the current coverage as described in the Coverage Issues Manual 35-30.1, effective 10/01/2000, autologous stem cell transplantation will also be covered for Medicare beneficiaries with multiple myeloma, less than age 78 who have Durie-Salmon stage II or III newly diagnosed or responsive multiple myeloma with adequate cardiac, renal, pulmonary, and hepatic function. The Coverage Issues Manual also includes non-primary amyloidosis as a non-covered condition and primary (AL) amyloidosis as a non-covered condition for Medicare beneficiaries age 64 or older.

Section 3614.1, Allogeneic Stem Cell Transplantation, provides background, coverage, and coding information on Allogeneic stem cell transplantation.

Section 3614.2, Autologous Stem Cell Transplantation, provides background, coverage, and coding information on Autologous stem cell transplantation.

Section 3614.3, Acquisition Costs, provides information on stem cell acquisition charges.

DISCLAIMER: The revision date and transmittal number only apply to the bolded material. All other material was previously published in the manual and is only being reprinted.

All questions regarding this bulletin should be directed to Provider Relations at 410-561-0541.


(Source: Intermediary Transmittal 1805, Coverage Issues Transmittal 125; Change Request 1002)


General Requirements 3600
Claims Processing Timeliness 3600.1
  Time Limitation for Filing Provider Claims 3600.2
  Reviewing Bills for Services After Suspension, Termination, Expiration, or Cancellation of Provider Agreement, or After a SNF is Denied Payment for New Admissions 3600.3
Change of Intermediary 3600.4
Multiple Provider Numbers or Changes in Provider Number 3600.5
Reduction in Payments Due to P.L. 99-177 3600.6

Electronic Data Interchange (EDI)

Electronic Data Interchange Security, Privacy, Audit and Legal Issues 3601
Contractor Data Security and Confidentiality Requirements 3601.1
EDI Audit Trails 3601.2
Security-Related Requirements for Subcontractor Arrangements With Network Services 3601.3
Electronic Data Interchange (EDI) Enrollment Form 3601.4
Information Regarding the Release of Medicare Eligibility Data 3601.5
New Policy on Releasing Eligibility Data 3601.6
Advise Your Providers and Network Service Vendors 3601.7
Network Service Agreement 3601.8
EDI Forms and Formats 3602
Electronic Media Claims (EMC) 3602.1
Requirements for Submission of EMC Data 3602.2
File Specifications, Records Specifications, and Data Element Definitions for EMC Bills 3602.3
Paper Bill 3602.4
Medicare Intermediary Standard Paper Remittance 3602.5
Electronic UB-92 Change Request Procedures 3602.6
Medicare Standard Electronic Remittance 3602.7
Support of Non-Millennium Electronic Formats 3602.8
Frequency of Billing 3603
Requirement That Bills Be Submitted In-Sequence for a Continuous Inpatient Stay 3603.1
Need to Reprocess Inpatient Claims In-Sequence 3603.2

Form HCFA-1450

Review of Form HCFA-1450 for Inpatient and Outpatient Bills 3604
Incomplete and Invalid Claims 3605
Claims Processing Terminology 3605.1
Handling Incomplete and Invalid Claims 3605.2
Data Element Requirements Matrix 3605.3
Form HCFA-l450 Consistency Edits 3606
Hospital Inpatient Bills-General 3610
Charges to Beneficiaries by PPS Hospitals 3610.1
Payment for Ancillary Services 3610.2
Outpatient Services Treated as Inpatient Services 3610.3
Admission Prior to and Discharge After PPS Implementation Date 3610.4
Transfers Between Hospitals 3610.5
Split Bills 3610.6
Outliers 3610.7
Adjustment Bills 3610.8
Waiver of Liability 3610.9
Effects of Guarantee of Payment 3610.10
Remittance Advice to the Hospital 3610.11
Noncovered Admission Followed by Covered Level of Care 3610.12
Repeat Admissions and Leave of Absence 3610.14
Additional Payment Amounts for Hospitals With Disproportionate Share of Low Income Patients 3610.15
Rural Referral Centers (RRCs) 3610.16
Criteria and Payment for Sole Community Hospitals and for Medicare Dependent Hospitals 3610.17
Payment for Blood Clotting Factor Administered to Hemophilia Inpatients 3610.18
Medicare Rural Hospital Flexibility Program 3610.19
Grandfathering of Existing Facilities 3610.20
Requirements for CAH Services and CAH Long-term Care Services 3610.21
Payment for Services Furnished by a CAH 3610.22
Payment for Post-Hospital SNF Care Furnished by a CAH 3610.23
Review of Form HCFA-1450 for the Inpatient 3610.24
Hospital Capital Payments Under PPS 3611
Federal Rate 3611.1
Hold Harmless Payments 3611.2
Blended Payments 3611.3
Capital Payments in Puerto Rico 3611.4
Old and New Capital 3611.5
New Hospitals 3611.6
Capital PPS Exception Payment 3611.7
Outliers 3611.8
Admission Prior to and Discharge After Capital PPS Implementation Date 3611.9
Market Basket Update 3611.10
Kidney Transplant - General 3612
The Standard Kidney Acquisition Charge 3612.1
Billing for Kidney Transplant and Acquisition services 3612.2
Charges for Kidney Acquisition Services 3612.3
Notifying Carriers 3612.4
Heart Transplants 3613
Notifying Carriers 3613.1
Stem Cell Transplantation 3614
Allogeneic Stem Cell Transplantation 3614.1
Autologous Stem Cell Transplantation 3614.2
Acquisition Cost 3614.3
Notifying Carriers 3614.4
Liver Transplants 3615
Standard Liver Acquisition Charge 3615.1
Billing for Liver Transplant and Acquisition Services 3615.2
Charges for Liver Acquisition Services 3615.3
Notifying Carriers 3615.4
List of Approved Liver Transplant Center 3615.5
Prostate Cancer Screening Tests and Procedures 3616
Payments of Nonphysician Services Hospitals Obtain for Hospital Inpatients 3618
Determining Covered/Noncovered Days and Charges 3620
Spell of Illness 3622
Processing No-Payment Bills 3624
Processing Provider Liable Inpatient Bills--Lack of Medical Necessity or Care is Custodial 3625

08-00 BILL REVIEW 3614.1


Stem cell transplantation is a process in which stem cells are harvested from either a patient's or donor's bone marrow or peripheral blood for intravenous infusion. The transplant can be used to effect hematopoietic reconstitution following severely myelotoxic doses of chemotherapy (HDCT) and/or radiotherapy used to treat various malignancies. Allogeneic stem cell transplant may also be used to restore function in recipients having an inherited or acquired deficiency or defect.

Allogeneic and autologous stem cell transplants are covered under Medicare for specific diagnoses. Effective 10/01/90, these cases are assigned DRG 481, Bone Marrow Transplant.

See Coverage Issues Manual, 35-30.1 for a complete description of covered and noncovered conditions.

The Outpatient Code Editor (OCE) will edit stem cell transplant procedure codes against diagnosis codes to determine which cases may meet the specified coverage criteria. Those cases with a diagnosis code for a covered condition will pass (as covered) the OCE noncovered procedure edit. Pay any claims that pass the OCE for eligible beneficiaries. When a stem cell transplant case is selected for review based on the random selection of beneficiaries, the PRO will review the case on a post-payment basis to assure proper coverage decisions. Stem Cell transplants are typically performed in the outpatient setting. Should complications occur, then the procedure would be performed on an inpatient basis. When performed on an inpatient basis, the claim would go through the Medicare Code Editor (MCE), instead of the OCE.

The OCE/MCE classifies procedure code 41.00 (Bone marrow transplant, not otherwise specified) as noncovered. Return the claim to the provider for a more specific procedure code.

3614.1 Allogeneic Stem Cell Transplantation --

  1. General -- Allogeneic stem cell transplantation (ICD-9-CM Procedure Codes 41.02, 41.03, 41.05, and 41.08, CPT-4 Code 38240) is a procedure in which a portion of a healthy donor's stem cells is obtained and prepared for intravenous infusion to restore normal hematopoietic function in recipients having an inherited or acquired hematopoietic deficiency or defect.

    Expenses incurred by a donor are a covered benefit to the recipient/beneficiary but, except for physician services, are not paid separately. Services to the donor include physician services, hospital care in connection with screening the stem cell, and ordinary follow-up care.
  2. Covered Conditions --
    1. Effective for services performed on or after August 1, 1978:
      • For the treatment of leukemia, leukemia in remission (ICD-9-CM codes 204.00 through 208.91), or aplastic anemia (ICD-9-CM codes 284.0 through 284.9) when it is reasonable and necessary; and
    2. Effective for services performed on or after June 3, 1985:
      • For the treatment of severe combined immunodeficiency disease (SCID) (ICD-9-CM code 279.2), and for the treatment of Wiskott - Aldrich syndrome (ICD-9-CM 279.12).
  3. Noncovered Conditions --
    1. Effective for services performed on or after May 24, 1996:
      • Allogeneic stem cell transplantation is not covered as treatment for multiple myeloma (ICD-9-CM codes 203.00 and 203.01 ).

    NOTE: Coverage for conditions other than these specifically designated as covered or non-covered in this section or 35-30.1 of the CIM are left to individual intermediary's discretion.

  4. Billing for Allogeneic Stem Cell Transplants -- The donor is covered for medically necessary inpatient hospital days of care in connection with the stem cell transplant operation. Expenses incurred for complications are covered only if they are directly and immediately attributable to the stem cell donation procedure.

    Hospital services furnished in connection with a stem cell transplant are covered under Part A. Charges are reported on the hospital billing form submitted for the recipient. Days of care used by the donor are not charged against the recipient's utilization record. For purposes of cost reporting, include the covered donor days and charges as Medicare days and charges. Physicians' services are billed under Part B to the carrier, on the account of the recipient, and are paid at 80 percent of reasonable charges.

    Charges for the transplant itself will generally be shown in revenue center code 362, although selection of the cost center is up to the hospital.

3614.2 Autologous Stem Cell Transplantation --

  1. General -- Autologous stem cell transplantation (ICD-9-CM procedure code 41.01, 41.04, 41.07, and 41.09 and CPT-4 code 38241) is a technique for restoring stem cells using the patient's own previously stored cells.
  2. Covered Conditions --
      1. Effective for services performed on or after April 28, 1989:
      • Acute leukemia in remission (ICD-9-CM codes 204.01, lymphoid; 205.01, myeloid; 206.01, monocytic; 207.01, acute erythremia and erythroleukemia; and 208.01 unspecified cell type) patients who have a high probability of relapse and who have no human leucocyte antigens (HLA)-matched;
      • Resistant non-Hodgkin's lymphomas (ICD-9-CM codes 200.00-200.08, 200.10-200.18, 200.20-200.28, 200.80-200.88, 202.00-202.08, 202.80-202.88, and 202.90-202.98) or those presenting with poor prognostic features following an initial response;
      • Recurrent or refractory neuroblastoma (see ICD-9-CM Neoplasm by site, malignant); or
      • Advanced Hodgkin's disease (ICD-9-CM codes 201.00-201.98) patients who have failed conventional therapy and have no HLA-matched donor.
      2. Effective for services performed on or after 10/01/00:
      • Multiple myeloma (ICD-9-CM code 203.00 and 238.6), for beneficiaries less than age 78, who have Durie-Salmon stage II or III newly diagnosed or responsive multiple myeloma and adequate cardiac, renal, pulmonary and hepatic functioning.
      • Primary amyloidosis (ICD-9-CM code 277.3), for beneficiaries under the age of 64, coverage is at the intermediary's discretion.
  3. Noncovered Conditions -- Insufficient data exist to establish definite conclusions regarding the efficacy of autologous stem cell transplantation for the following conditions:
    • Acute leukemia not in remission (ICD-9-CM codes 204.00, 205.00, 206.00, 207.00 and 208.00);
    • Chronic granulocytic leukemia (ICD-9-CM codes 205.10 and 205.11);
    • Solid tumors (other than neuroblastoma) (ICD-9-CM codes 140.0?l99.1);
    • Multiple myeloma (ICD-9-CM code 203.00 and 238.6), through 9/30/00
    • Non-primary (AL) amyloidosis (ICD-9-CM code 277.3), effective 10/01/00; or
    • Primary (AL) amyloidosis (ICD-9-CM code 277.3) for Medicare beneficiaries age 64 or older, effective 10/01/00.

    NOTE: Coverage for conditions other than these specifically designated as covered or non-covered in this section or 35-30.1 of the CIM is left to the intermediary's discretion.

  4. Billing for Autologous Stem Cell Transplants -- Since there are no covered acquisition charges for autologous stem cell transplants, all charges are shown in the usual manner. Charges for the transplant itself are shown in revenue center code 362 or other appropriate cost center.

3614.3 Acquisition Costs -- Stem cell acquisition charges are identified separately in FL 42 of Form HCFA-1450 by using revenue codes 819 (Other Organ Acquisition) and/or 891 (Other Donor Bank, Bone). Do not make separate payment for these acquisition charges as payment is included in the DRG payment.

For allogeneic stem cell transplants (procedure codes 41.02, 41.03, 41.05, or 41.08), where interim bills are submitted, the acquisition charge appears on the billing form for the period during which the transplant took place. Since claims for stem cell transplants are paid using PPS, process an adjustment bill to recover payment if you have already paid the interim bill. Where no interim bills are involved, all charges appear on the transplant bill.

The transplant hospital keeps an itemized statement that identifies the services furnished, the charges, the person receiving the service (donor/recipient), and whether this is a potential transplant donor or recipient. These charges are reflected in the transplant hospital's stem cell/bone marrow acquisition cost center. Include charges for all services required in acquisition of stem cells, i.e., tissue typing and post-operative evaluation, in revenue codes 819 and 891.

For allogeneic stem cell transplants (procedure codes 41.02, 41.03, 41.05, or 41.08), charges for acquisition and any applicable storage charges will appear on the recipient's transplant bill. Acquisition charges do not apply to autologous stem cell acquisitions. The charges, cost report days, and utilization days for the stay in which the stem cells were obtained are reported on the transplant bill.

3614.4 Notifying Carriers -- Carriers will automatically be notified via a CWF trailer.

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