Where this LCD applies
Each contract number is a jurisdiction on the remittance; the policy binds claims processed under these contracts and no others.
Billing and coding: diagnoses and procedure codes
Since 2019 the codes live in the companion article rather than the LCD. Billing and Coding A57558 (Billing and Coding: BDX-XL2) 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.
A57558: Billing and Coding: BDX-XL2 (Billing and Coding, effective 2023-03-30)
- Covered ICD-10-CM codes
- 2
- 2 groups
- Non-covered ICD-10-CM codes
- 0
- Procedure codes listed
- 1
- Full article
- cms.gov record
| ICD-10-CM | Description (FY2027) |
|---|---|
| R91.1 | — |
| R91.8 | — |
Procedure codes: 0080U.
Coverage indications, limitations and medical necessity
This Medicare contractor will provide limited coverage for the (BDX-XL2) test (Biodesix, Boulder, CO and Seattle, WA) for the management of a lung nodule, between 8 and 30mm in diameter, in patients 40 years or older, and with a pre-test cancer risk (as assessed by the Mayo Clinic Model for Solitary Pulmonary Nodules) of 50% or less. The intended use of the test is to assist physicians in the management of lung nodules by identifying those lung nodules with a high probability of being benign. These lung nodules would then be candidates for non-invasive computed tomography (CT) surveillance instead of invasive procedures.
Summary of evidence (opening)
Lung nodules are rounded densities, under 30mm in diameter, detected by chest radiograph (CXR) or CT scan. Nodules are mostly surrounded by lung tissue and are also called coin lesions, solitary pulmonary nodules or lesions, or a “spot” on the lung. The edges of a nodule can be described as smooth or irregular (stellate or spiculated) with irregular edges somewhat more indicative for cancer. Heavily calcified nodules with smooth edges are generally benign and solid nodules that have not shown growth over time are considered benign. For a comprehensive review of nodules and their evaluation, see the 2-part series by Patel, et al. 1,2
Lung nodules are detected incidentally or through lung cancer screening. Lung cancer screening now has Medicare coverage in the United States (US). As of April 26, 2016, there were 806 sites registered for screening. 22 The estimated number of new lung nodules incidentally detected annually in the US is 1.57 million, whereas it is anticipated that another 1.5 million are detected by screening annually in the US. 3
Early detection of lung nodules is an opportunity to reduce lung cancer mortality, but it comes with significant risks. These risks are both for patients and health care delivery networks. For patients, a major problem is the risk of unnecessary invasive procedures to find the minority of nodules that are cancer. For health care delivery, the risks are both costs and overloading the health care system.
Of the expected 3 million nodules per year found incidentally or by lung cancer screening, the majority will be Medicare age. Four recent studies underscore the importance of lung cancer evaluations to the Medicare population:
The contractor cites 22 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2017-09-16
- Current revision effective
- 2023-03-30
- Last reviewed by the contractor
- 2023-03-02
- MCD version
- 23
Other related documents: A55644 (Response to Comments).
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 Wisconsin Physicians Service Insurance Corporation 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.
Frequently asked questions
What does LCD L37216 cover?
This Medicare contractor will provide limited coverage for the (BDX-XL2) test (Biodesix, Boulder, CO and Seattle, WA) for the management of a lung nodule, between 8 and 30mm in diameter, in patients 40 years or older, and with a pre-test cancer risk (as assessed by the Mayo Clinic Model for Solitary Pulmonary Nodules) of 50% or less. The intended use of the test is to assist physicians in the management of lung… 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 L37216 apply to?
Wisconsin Physicians Service Insurance Corporation applies it to Medicare claims in AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. 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 L37216?
The companion billing and coding article A57558 lists 2 ICD-10-CM codes in 2 groups that support medical necessity; the first 2 appear on this page and the complete list is in the article on cms.gov.
How do I appeal a denial under LCD L37216?
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.
- Medicare Coverage Database, current LCD exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file lcd.csvSHA-256 2fcc4251b6ddd1eb…
- Medicare Coverage Database, current Billing and Coding Articles exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file article.csvSHA-256 f31932f1df3b4035…
- ICD-10-CM FY2027 code descriptionsVersion FY2027 · effective 2026-10-01 · file icd10cm_codes_2027.txtSHA-256 3c0583a38ee0e848…
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.