Header: A dissatisfied beneficiary can appeal his denied claim, OR, challenge the offending NCD or LCD as a whole. Let's see what's current on the CMS website.
##
AI CORNER
##
Medicare beneficiaries may challenge an LCD as unreasonable under 42 C.F.R. Part 426, but the process is obscure and procedurally demanding.
Fifteen recent DAB cases show an active yet largely unsuccessful docket: all were dismissed, eleven for threshold or jurisdictional defects, three after withdrawal, and one after the contractor revised its policy and effectively resolved the dispute. Common failures included unclear standing, failure to identify the precise LCD provision, missing physician documentation, and inadequate scientific evidence.
The cases reveal a mismatch between beneficiary-only standing and the sophisticated evidentiary burden required. NCD challenges remain legally available but appear dormant since 2014.
##
##
The Hidden Docket: Medicare LCD Challenges Are Alive—but Rarely Reach the Merits
Medicare beneficiaries have a little-known statutory right to challenge the validity of a Local Coverage Determination, or LCD. These cases still occur: the Departmental Appeals Board published 12 LCD-related decisions in 2024, six in 2025, and two through June 3, 2026. But they are buried in annual lists containing hundreds of unrelated HHS administrative decisions, and most end before the scientific merits are reached. (HHS.gov)
What is an LCD challenge?
An LCD challenge under 42 C.F.R. Part 426 asks whether a Medicare Administrative Contractor’s coverage policy is itself unreasonable. It is not the same as an ordinary claim appeal arguing that a contractor incorrectly applied an LCD to a particular patient.
The distinction matters:
Claim appeal: “My service should have been covered under the existing rules.” This proceeds through redetermination, reconsideration, OMHA, and potentially the Medicare Appeals Council.
LCD challenge: “The coverage restriction in the LCD is unreasonable.” This is heard initially by an administrative law judge in the HHS Departmental Appeals Board’s Civil Remedies Division.
Only an “aggrieved party”—generally a Medicare beneficiary who needs or received the service and whose coverage is affected by the LCD—may initiate the challenge. A laboratory, manufacturer, physician society, or other commercial organization cannot ordinarily challenge the LCD in its own name. (eCFR)
The complaint must identify the LCD and exact provision challenged, establish beneficiary standing and timeliness, include relevant treating-physician documentation, explain why the policy is unreasonable, and provide supporting clinical or scientific evidence. The ALJ ordinarily gives the complainant one opportunity to correct an unacceptable filing. Failure to cure the deficiencies produces dismissal and generally a six-month bar on refiling. (eCFR)
How to find the cases
There is no polished “LCD challenge database.” The practical route is:
Open the HHS Departmental Appeals Board’s Administrative Law Judge Decisions page.
Select a year.
Search the page for “LCD Complaint.”
Search separately among DAB Board decisions for appeals using “LCD Complaint,” the LCD number, the
CRdecision number, or “Part 426.”
General DAB ALJ decisions page:
https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/index.html
2026 decisions:
https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2026/index.html
2025 decisions:
https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2025/index.html
2024 decisions:
https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2024/index.html
DAB Board decisions, including appeals from LCD rulings:
https://www.hhs.gov/about/agencies/dab/decisions/board-decisions/index.html
An appeal from an LCD ALJ decision goes to the DAB Appellate Division, not to the Medicare Appeals Council. The Appeals Council reviews ordinary Medicare claim appeals; the DAB Board reviews Part 426 LCD proceedings. (HHS.gov)
Fifteen Recent LCD Challenges
The following are 15 representative published decisions from February 2024 through June 2026.
1. Gastrointestinal Pathogen Multiplex Panels
Case: In re LCD Complaint: Gastrointestinal Pathogen (GIP) Panels Utilizing Multiplex Nucleic Acid Amplification Techniques (NAATs) (L38229)
Docket: C-26-432
Decision: DAB CR6894
Date: May 13, 2026
Novitas had denied CPT 87507. The beneficiary’s underlying argument was that the LCD had been incorrectly applied to his individual claim, rather than that the LCD provision itself was unreasonable. The ALJ found no jurisdiction over that question and also concluded that the amended complaint lacked the required scientific and clinical support for an LCD challenge. (HHS.gov)
https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2026/alj-cr6894/index.html
2. Vitamin D Assay Testing
Case: In re CMS LCD Complaint: Vitamin D Assay Testing
Docket: C-26-368
Decision: DAB CR6909
Date: June 3, 2026
The filing did not adequately establish the complainant’s aggrieved-party status, timeliness, the exact LCD and provision challenged, or the clinical and scientific basis for alleging unreasonableness. The complainant did not respond to the ALJ’s order permitting an amended complaint, and the matter was dismissed. (HHS.gov)
https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2026/alj-cr6909/index.html
3. Immune Globulin for Autoimmune Encephalopathy
Case: In re LCD Complaint: Immune Globulins (L34771)
Docket: C-24-215
Decision: DAB CR6782
Date: October 17, 2025
A beneficiary with Hashimoto’s encephalopathy challenged restrictions affecting IVIG coverage. During the proceeding, WPS revised its billing article to add diagnostic codes permitting coverage for autoimmune encephalitis and encephalopathy when documentation requirements were met. The case was formally dismissed, but the contractor’s revision appears to have supplied the practical coverage relief being sought. (HHS.gov)
https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2025/alj-cr6782/index.html
4. Magnesium Testing
Case: In re LCD Complaint: Magnesium (L39400)
Docket: C-25-746
Decision: DAB CR6746
Date: August 11, 2025
The original complaint did not satisfy Part 426’s acceptability requirements. The complainant was offered an opportunity to amend but did not submit a corrected complaint by the deadline, requiring dismissal. (HHS.gov)
https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2025/alj-cr6746/index.html
5. Routine Foot Care and Mycotic Nail Debridement
Case: In re LCD Complaint: Routine Foot Care (L35138) and Debridement of Mycotic Nails (L35013)
Docket: C-25-299
Decision: DAB CR6639
Date: March 13, 2025
The beneficiary sought to reduce the required interval between covered nail-debridement services from nine weeks to six weeks. Although she supplied a podiatrist’s statement, she did not provide qualifying scientific or clinical evidence explaining why the LCD’s interval was unreasonable; a private insurer’s policy was insufficient. (HHS.gov)
https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2025/alj-cr6639/index.html
6. Cataract Surgery and Postoperative Toric Lenses
Case: In re LCD Complaint: Cataract Surgery in Adults (L34203)
Docket: C-24-769
Decision: DAB CR6608
Date: January 22, 2025
The complaint concerned payment for toric contact lenses reportedly needed following cataract surgery. The filing lacked several required elements and supporting evidence, and no amended complaint was submitted after the ALJ identified the deficiencies. (HHS.gov)
https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2025/alj-cr6608/index.html
7. B-Type Natriuretic Peptide Testing
Case: In re LCD Complaint: B-Type Natriuretic Peptide (BNP) (L33573)
Docket: C-25-91
Decision: DAB CR6606
Date: January 16, 2025
The beneficiary adequately demonstrated standing and timeliness, but the complaint did not clearly identify the challenged LCD provision, articulate why it was unreasonable, or supply supporting clinical evidence. No amended complaint followed, and the matter was dismissed. (HHS.gov)
https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2025/alj-cr6606/index.html
8. Cologuard Screening
Case: In re LCD Complaint: Cologuard Screening
Docket: C-25-20
Decision: DAB CR6583
Date: December 5, 2024
A nurse practitioner argued that Cologuard was medically necessary for a particular patient. The ALJ explained that beneficiary-specific medical necessity ordinarily belongs in the claim-appeal system; an LCD challenge instead requires identification of an unreasonable policy provision, appropriate authorization, proof of timeliness, physician documentation, and supporting scientific evidence. None was supplied in an acceptable amended complaint. (HHS.gov)
https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2024/alj-cr6583/index.html
9. Hyaluronic Acid Injections for Knee Osteoarthritis
Case: In re LCD Complaint: Hyaluronic Acid Injections for Knee Osteoarthritis
Docket: C-25-44
Decision: DAB CR6580
Date: December 3, 2024
After the ALJ found the initial complaint unacceptable and allowed amendment, the complainant withdrew the challenge. Part 426 required dismissal; a dismissal following withdrawal generally cannot be appealed and prevents refiling for six months. (HHS.gov)
https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2024/alj-cr6580/index.html
10. Trigger-Point Injections
Case: In re LCD Complaint: Trigger Point Injections (L34211)
Docket: C-24-458
Decision: DAB CR6512
Date: July 25, 2024
The beneficiary corrected certain physician-signature and timeliness defects but still did not identify the precise LCD provision alleged to be unreasonable or provide scientific evidence explaining why it should be invalidated. The amended filing therefore remained unacceptable. (HHS.gov)
https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2024/alj-cr6512/index.html
11. Surgical Treatment of Nails
Case: In re LCD Complaint: Surgical Treatment of Nails (L34887)
Docket: C-24-427
Decision: DAB CR6491
Date: June 17, 2024
The filing expressed concerns about nail-avulsion procedures but did not identify a qualifying aggrieved Medicare beneficiary, demonstrate timeliness, or satisfy the substantive complaint requirements. No acceptable amended complaint was presented. (HHS.gov)
https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2024/alj-cr6491/index.html
12. Pressure-Reducing Support Surfaces
Case: In re LCD Complaint: Pressure Reducing Support Surfaces—Group 1 (L33830)
Docket: C-24-371
Decision: DAB CR6463
Date: April 18, 2024
The challenge concerned coverage of a pressure-reducing support surface. The beneficiary’s representative subsequently asked that the proceeding be closed, which the ALJ treated as a withdrawal and dismissed under Part 426. (HHS.gov)
https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2024/alj-cr6463/index.html
13. Vitamin D Assay Testing
Case: In re LCD Complaint: Vitamin D Assay Testing (L36692)
Docket: C-24-135
Decision: DAB CR6441
Date: March 13, 2024
The complaint concerned magnesium and vitamin D testing but lacked an adequate treating-physician statement, identification of the exact LCD provisions, an explanation of their alleged unreasonableness, and supporting clinical evidence. The beneficiary did not submit a corrected complaint. (HHS.gov)
https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2024/alj-cr6441/index.html
14. CT of the Head
Case: In re LCD Complaint: CT of the Head (L34417)
Docket: C-24-204
Decision: DAB CR6438
Date: February 29, 2024
The filing did not adequately identify the LCD provision challenged, establish aggrieved-party status, or provide supporting medical and scientific evidence. The ALJ also questioned whether the beneficiary was actually seeking review of an individual claim denial rather than challenging the validity of the LCD itself. (HHS.gov)
https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2024/alj-cr6438/index.html
15. Therapeutic Shoes for Persons with Diabetes
Case: In re LCD Complaint: Therapeutic Shoes for Persons with Diabetes (L33369)
Docket: C-24-199
Decision: DAB CR6435
Date: February 26, 2024
The initial complaint was incomplete. Before the deadline for correction, the complainant voluntarily withdrew it, resulting in dismissal and the regulatory six-month restriction on refiling the same complaint. (HHS.gov)
https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2024/alj-cr6435/index.html
Sidebar: The Strange, Nearly Moribund World of NCD Challenges
National Coverage Determination challenges remain authorized under Part 426, but they follow a different route. An acceptable NCD complaint goes directly to the DAB Appellate Division, rather than first being heard by a Civil Remedies Division ALJ. (eCFR)
HHS maintains a dedicated page entitled “Acceptable National Coverage Determination Complaints.” It is less a modern docket than a static historical list:
The most recent accepted complaint publicly listed is a vagus-nerve-stimulation proceeding from 2014. The page also includes the celebrated 2013–2014 challenge to the national noncoverage policy for transsexual surgery, which resulted in DAB No. 2576. No accepted complaint dated after 2014 appears on the public list. (HHS.gov)
Thus, NCD review is legally alive but publicly close to moribund. The page does not prove that nobody has attempted a complaint since 2014; it shows that HHS has not publicly listed a newer complaint as acceptable. The likely explanation is structural: standing is confined to affected beneficiaries, the evidentiary burden is substantial, and CMS can reconsider, withdraw, or revise an NCD while a challenge is pending. Those features make an NCD reconsideration request or conventional claim litigation more manageable for sophisticated stakeholders, although that conclusion is an inference from the regulatory design rather than an announced CMS policy. (HHS.gov)
What the Recent LCD Cases Teach
The first conclusion is stark: none of these 15 cases produced a decision holding an LCD either reasonable or unreasonable on the scientific merits. All 15 were formally dismissed.
The dispositions break down as follows:
11 of 15 were dismissed at the acceptability or jurisdictional stage.
3 of 15 were voluntarily withdrawn.
1 of 15, the immune-globulin case, was dismissed after the contractor revised its policy in a way that appears to have resolved the coverage problem.
0 of 15 generated a completed evidentiary review of the LCD record and a merits ruling.
The recurring procedural defects were remarkably consistent: failure to identify the exact LCD provision, inadequate evidence of beneficiary standing or timeliness, absence of a treating-physician statement, and—most importantly—failure to provide scientific evidence accompanied by an explanation of why the contractor’s policy was unreasonable.
Several complainants also misunderstood the nature of the remedy. They wanted an adjudicator to decide that a service was medically necessary for one patient or that the contractor had applied the LCD incorrectly. Those are ordinary claim-appeal questions. A Part 426 case requires an attack on the validity of the policy itself, supported by evidence addressing the policy’s clinical logic.
This produces an awkward imbalance. The only parties with standing are individual beneficiaries, but the task resembles sophisticated health-policy litigation: the complainant must identify the operative language, understand the evidentiary record, marshal relevant literature, and explain why the contractor’s synthesis is unreasonable. Manufacturers and medical societies may assist, but they cannot simply substitute themselves as the complainant.
The immune-globulin case is therefore especially instructive. A formal dismissal can disguise a substantive success. Once WPS revised the associated article and permitted payment under additional diagnostic codes, there was no longer a live coverage restriction requiring adjudication. Under Part 426, a contractor revision that removes the challenged provision can carry essentially the same practical consequence for the beneficiary’s claim as a favorable invalidity decision. (eCFR)
The docket is consequently neither hidden nor dead. It is poorly indexed, procedurally unforgiving, and dominated by unsuccessful pro se complaints. The scarcity of merits decisions should not be mistaken for proof that LCDs are universally defensible. It more often shows that very few complainants survive the gateway requirements necessary to place the contractor’s scientific record genuinely at issue.
