CMS Pub. 100-04, ch. 32, § 90.6

for Myelodysplastic Syndrome (MDS)

(Rev. 11035, Issued:10-13-21, Effective: 11-17-21; Implementation: 11-21)

Myelodysplastic Syndrome (MDS) refers to a group of diverse

blood disorders in which the bone marrow does not produce

enough healthy, functioning blood cells. These disorders are

varied with regard to clinical characteristics, cytologic and

pathologic features, and cytogenetics.

On August 4, 2010, the Centers for Medicare & Medicaid

Services (CMS) issued a national coverage determination

(NCD) stating that

CMS believes that the evidence does not demonstrate that the

use of allogeneic hematopoietic stem cell transplantation (HSCT)

improves health outcomes in Medicare beneficiaries with MDS.

Therefore, allogeneic HSCT for MDS is not reasonable and

necessary under

§1862(a)(1)(A) of the Social Security Act (the Act).

However, allogeneic HSCT for MDS is reasonable and

necessary under

§1862(a)(1)(E) of the Act and therefore covered by Medicare

ONLY if provided pursuant to a Medicare-approved clinical

study under Coverage with Evidence Development (CED). Refer

to Pub.100-03, National Coverage Determinations Manual,

Chapter 1, section 110.8.1, for more information about this

policy, and Pub. 100-04, Medicare Claims Processing Manual,

Chapter 3, section 90.3.1, for information on CED.

B Adjudication Requirements

Payable Conditions. For claims with dates of service on and

after August 4, 2010, contractors shall pay for claims for HSCT

for MDS when the service was provided pursuant to a

Medicare-approved clinical study under CED; these services

are paid only in the inpatient setting (Type of Bill (TOB) 11X),

as outpatient Part B (TOB 13X), and in Method II critical

access hospitals (TOB 85X). Contractors shall require the

following coding in order to pay for these claims:

• Existing Medicare-approved clinical trial coding conventions,

as required in Pub. 100-04, Medicare Claims Processing

Manual, Chapter 32, section 69, and inpatient billing

requirements regarding acquisition of stem cells in Pub. 100-

04, Medicare Claims Processing Manual, Chapter 3, section

90.3.3.

• If ICD-10-CM is applicable, ICD-10-PCS, procedure codes

30230C0, 30230G0, 30230Y0, 30233G0, 30233C0,

30233Y0, 30240C0, 30240G0, 30240Y0, 30243C0,

30243G0, and30243Y0

• If Outpatient Hospital or Professional Claims: HCPCS procedure code 38240

• If ICD-10-CM is applicable, ICD-10-CM diagnosis codes, D46.A, D46.B,

D46.C, D46.Z, D46.0, D46.1, D46.20, D46.21, D46.22, D46.4, D46.9, and

Z00.6

• Professional claims only: place of service codes 21 or 22.

Denials. Contractors shall deny claims failing to meet any of

the above criteria. In addition, contractors shall apply the

following requirements:

• Providers shall issue a hospital issued notice of non-coverage

(HINN) or advance beneficiary notice (ABN) to the

beneficiary if the services performed are not provided in

accordance with CED.

• Contractors shall deny claims that do not meet the criteria

for coverage with the following messages:

CARC 50 - These are non-covered services because this is not deemed a 'medical necessity' by the payer.

NOTE: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information

REF), if present.

RARC N386 - This decision was based on a National Coverage Determination (NCD). An NCD provides a

coverage determination as to whether a particular item or service is covered. A copy of this policy is available at

http://www.cms.hhs.gov/mcd/search.asp. If you do not have web access, you may contact the contractor to

request a copy of the NCD.

Group Code – Patient Responsibility (PR) if HINN/ABN issued, otherwise Contractual Obligation (CO)

MSN 16.77 – This service/item was not covered because it was not provided as part of a qualifying trial/study.

(Este servicio/artículo no fue cubierto porque no estaba incluido como parte de un ensayo clínico/estudio

calificado.)