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LCD L36464: MolDX: HLA-DQB1*06:02 Testing for Narcolepsy

LCD L36464, MolDX: HLA-DQB1*06:02 Testing for Narcolepsy, is the Local Coverage Determination that Palmetto GBA applies to claims from 7 states (AL, GA, NC, SC, TN, VA, WV), effective 2023-08-24 and first in force 2016-02-15. The policy text runs 472 words. 2 other contractors publish a policy with the same title, so the criteria that apply depend on where the service is furnished.

QuickIntell editorial content · Legacy registry date · Review not verified

Data effective
Data currency: Medicare Coverage Database LCD export release of September 24, 2026 (effective September 20, 2026). Next CMS release: weekly (Thursdays) for the MCD.
Contractor
Palmetto GBA
States and territories
7
AL GA NC SC TN VA WV
Revision effective
2023-08-24
Original effective
2016-02-15
Policy text
472 words
Covered ICD-10 codes (articles)
0

Where this LCD applies

Each contract number is a jurisdiction on the remittance; the policy binds claims processed under these contracts and no others.

Contracts that apply LCD L36464
ContractContractorTypeStates
11201Palmetto GBAA and B and HHH MACSC
11301Palmetto GBAA and B and HHH MACVA
11401Palmetto GBAA and B and HHH MACWV
11501Palmetto GBAA and B and HHH MACNC
11202Palmetto GBAA and B and HHH MACSC
11302Palmetto GBAA and B and HHH MACVA
11402Palmetto GBAA and B and HHH MACWV
11502Palmetto GBAA and B and HHH MACNC
10111Palmetto GBAA and B MACAL
10211Palmetto GBAA and B MACGA
10311Palmetto GBAA and B MACTN
10112Palmetto GBAA and B MACAL
10212Palmetto GBAA and B MACGA
10312Palmetto GBAA and B MACTN

Billing and coding: diagnoses and procedure codes

Since 2019 the codes live in the companion article rather than the LCD. Billing and Coding A56857 (Billing and Coding: MolDX: HLA-DQB1*06:02 Testing for Narcolepsy) carries the diagnosis and procedure lists the contractor loads as the claims edit. CPT codes are shown as bare numbers because the descriptors are licensed by the AMA; HCPCS Level II descriptors are public and shown.

A56857: Billing and Coding: MolDX: HLA-DQB1*06:02 Testing for Narcolepsy (Billing and Coding, effective 2021-07-08)

Covered ICD-10-CM codes
0
0 groups
Non-covered ICD-10-CM codes
4
Procedure codes listed
1
Full article
cms.gov record

Procedure codes: 81383.

Coverage indications, limitations and medical necessity

Indications and Limitations of Coverage

Based upon currently available information, HLA-DQB1*06:02 typing (81383) for the diagnosis or management of narcolepsy is considered experimental/investigational/unproven for all populations. Although research suggests a strong association between HLA-DQB1*06:02 and narcolepsy risk, HLA-DQB1*06:02 typing is insufficient to confirm a diagnosis of narcolepsy, rule out a diagnosis of narcolepsy or quantify risk for narcolepsy. Therefore, at this time there is no clinical utility for genetic testing or HLA-DQB1*06:02 typing in the diagnosis or treatment of narcolepsy.

Background

Narcolepsy is a sleep disorder characterized by excessive daytime sleepiness, cataplexy (sudden loss of voluntary muscle tone), and uncontrollable sleep episodes. Most cases of narcolepsy are sporadic, with symptoms beginning around the time of adolescence.

According to the International Classification of Sleep Disorders, Third Edition (ICSD-3) and the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition (DSM-5), narcolepsy is diagnosed by a combination of physical exam, medical history, polysomnogram, multiple sleep latency testing (MSLT), and low CSF hypocretin-1 levels. Current recommended treatment options include stimulants and antidepressants. At this time, treatment is aimed towards the control of symptoms and is not curative. 12

Narcolepsy has a multifactorial etiology, likely caused by the interaction between genetic risk factors and environmental exposures. Research efforts to identify the genetic contributors to narcolepsy have focused on an association between certain human leukocyte antigen (HLA) haplotypes and narcolepsy risk. The HLA complex encodes greater than 200 genes responsible for the recognition of foreign antigens. These genes are highly polymorphic, and certain alleles have long been known to confer risk for autoimmune disorders.

A variation of the HLA-DQB1 gene called HLA-DQB1*06:02 has been strongly associated with narcolepsy, particularly in individuals who also have cataplexy and a loss of hypocretins. Several genetic association studies in ethnically diverse populations have found a robust association between narcolepsy and the HLA-DQB1*06:02 allele. However, 15 to 25% of unaffected individuals in the general population also carry this risk haplotype, suggesting that it is necessary but not sufficient for the development of narcolepsy. 6 Additionally, persons with narcolepsy and cataplexy have been identified without the HLA-DQB1*06:02 marker. 4 More recent studies further suggest that predisposition to narcolepsy may be the result of complex genetic associations between multiple risk alleles. 11

Despite multiple studies replicating the association between HLA-DQB1*06:02 and narcolepsy in different ethnic groups, the overall contribution of HLA variation to disease risk is low. Monozygotic twin studies have shown only partial concordance (25-31%), indicating that environmental factors play a large role in the etiology of narcolepsy. 8 Recent studies have suggested that exposure to streptococcus, H1N1, and the H1N1 vaccine may also increase the risk for narcolepsy, specifically among individuals with the HLA-DQB1*06:02 allele. 3,14,4

Although research suggests a strong association between HLA-DQB1*06:02 and narcolepsy risk, at this time there is no evidence for any diagnostic utility of HLA typing. 5

Summary of evidence (opening)

N/A

The contractor cites 15 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.

Dates, lineage and related policies

Original determination effective
2016-02-15
Current revision effective
2023-08-24
Last reviewed by the contractor
2023-07-05
MCD version
27

Using this policy on a claim

Match the documented indication to the covered indications above before the service is scheduled, carry a diagnosis from the article's covered list on the claim line, and keep the elements the documentation section asks for in the record, because the contractor can request it later through medical review. A denial under this policy arrives as CARC 50 with remark N115; the LCD lookup guide walks through the appeal path and the Advance Beneficiary Notice rules, and the Palmetto GBA hub lists every other active policy from the same contractor.

The same policy title at other contractors

Contractors often adopt each other's policies and then revise them separately, so the criteria and the diagnosis lists drift apart. The topic comparison lines up every version.

L36551
Noridian Healthcare Solutions, LLC · 18 states · revised 2026-01-22 · 1 covered codes
L37003
Wisconsin Physicians Service Insurance Corporation · 48 states · revised 2023-08-24

Frequently asked questions

What does LCD L36464 cover?

Based upon currently available information, HLA-DQB1*06:02 typing (81383) for the diagnosis or management of narcolepsy is considered experimental/investigational/unproven for all populations. Although research suggests a strong association between HLA-DQB1*06:02 and narcolepsy risk, HLA-DQB1*06:02 typing is insufficient to confirm a diagnosis of narcolepsy, rule out a diagnosis of narcolepsy or quantify risk for… The full indications and limitations are reproduced on this page from the CMS Medicare Coverage Database export of September 24, 2026.

Which states does LCD L36464 apply to?

Palmetto GBA applies it to Medicare claims in AL, GA, NC, SC, TN, VA, WV. A Local Coverage Determination binds only the contractor that wrote it; the same service in another jurisdiction is judged under that contractor's own policy or, where none exists, claim by claim.

Which diagnosis codes support medical necessity under LCD L36464?

The current export links no billing and coding article with a diagnosis list to this LCD, so coverage is decided on the indications in the policy text and the documentation in the record rather than by an automated diagnosis edit.

How do I appeal a denial under LCD L36464?

The remittance carries claim adjustment reason code 50 with remark code N115, naming the LCD. Compare the documented indication with the policy's covered indications and the article's diagnosis list, then file a redetermination within 120 days with the record attached; if the service genuinely falls outside the policy, the patient can be billed only when a valid Advance Beneficiary Notice was obtained before the service.

Sources

Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-02. Verify against the primary file before billing or contracting decisions.

Disclaimer

The policy text and code lists are reproduced from the CMS Medicare Coverage Database export as an operational reference. Verify against the current LCD and article on cms.gov before billing; coverage depends on the full record and the contractor. Not legal, clinical or billing advice.