I'm such a CMS nerd that every year or two I used to scan the CMS Office of Hearings and Appeals (OMHA) for interesting cases. (Back-when, there were some gems involving HeartFlow).
I'm not sure if OMHA still posts as many cases. But I asked Chat GPT to search CMS and the web for legal cases involving MolDx. I show the results below.
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AI Corner
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The publicly available MolDX appeal record is limited and dominated by Agendia’s disputes over BluePrint and TargetPrint breast-cancer assays. Several OMHA ALJs initially found the tests reasonable and necessary, but the Medicare Appeals Council repeatedly reversed favorable decisions for insufficient deference to MolDX LCDs and technical assessments. Later ALJs generally upheld noncoverage, finding that physician testimony, post-service publications, or evidence of clinical benefit did not adequately establish incremental clinical utility.
Federal courts ultimately sustained the MolDX framework, rejecting challenges to LCD authority and contractor delegation. Overall, the cases show that overcoming MolDX requires a strong, beneficiary-specific evidentiary record rather than generalized scientific disagreement.
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I found 13 useful decisions: one officially published HHS LCD-challenge decision, eight claim-level ALJ/Council decisions recovered from federal-court appendices or opinions, and four federal judicial-review decisions.
A caution at the outset: HHS now publishes only selected Medicare Appeals Council decisions, and there does not appear to be a comprehensive public database of ordinary OMHA claim decisions. Accordingly, this is a substantial but not necessarily exhaustive MolDX set. (HHS.gov)
I. Published HHS ALJ decision involving a MolDX LCD
1. In re LCD Complaint: MolDX Genetic Testing for Hypercoagulability/Thrombophilia
Case: In re LCD Complaint: MolDX: Genetic Testing for Hypercoagulability/Thrombophilia (Factor V Leiden, Factor II Prothrombin, and MTHFR) (L36159)
Number: DAB CR5997; Docket No. C-22-13
Date: December 9, 2021
Created title: MolDX Thrombophilia LCD Challenge Dismissed at the Threshold
A physician attempted to challenge MolDX LCD L36159 on behalf of a Medicare beneficiary. The ALJ dismissed the complaint without reaching the scientific validity of the LCD because the complainant failed to document timeliness, representative authority, the challenged provisions, supporting evidence, and other mandatory elements after being given an opportunity to amend. (HHS.gov)
Live link:
https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2021/alj-cr5997/index.html
II. Agendia BluePrint and TargetPrint administrative appeals
2. Agendia Inc.—Initial favorable ALJ decision
Case: Appeal of Agendia Inc.
Number: ALJ Appeal No. 1-2560274302
Date: August 22, 2018
Created title: ALJ Finds BluePrint and TargetPrint Reasonable and Necessary
After a hearing involving claims for 86 beneficiaries, the ALJ found Agendia’s BluePrint and TargetPrint breast-cancer tests medically reasonable and necessary. The later Council decision records the favorable result but then reverses it. (Supreme Court)
Live link—the ALJ result is described beginning in the Council decision at Appendix page 60:
https://www.supremecourt.gov/DocketPDF/21/21-584/196865/20211019163324354_Agendia%20Appendix.pdf
3. Agendia Inc.—Medicare Appeals Council reversal
Case: Agendia Inc., Appellant
Number: Medicare Appeals Council Docket No. M-19-123; underlying ALJ Appeal No. 1-2560274302
Date: January 7, 2019
Created title: Council Reverses Agendia Victory for Failure to Defer to MolDX
Acting on a CMS referral, the Council reversed the favorable ALJ decision. It found BluePrint and TargetPrint not reasonable and necessary, emphasizing that the ALJ had not adequately respected the applicable LCD, policy article, and MolDX technical findings and that Agendia was financially responsible for the noncovered charges. (Supreme Court)
Live link—Council decision begins at Appendix page 60:
https://www.supremecourt.gov/DocketPDF/21/21-584/196865/20211019163324354_Agendia%20Appendix.pdf
4. Agendia Inc.—ALJ Scott Tews
Case: Appeal of Agendia Inc.
Number: OMHA Appeal No. 1-2376151948
Date: November 3, 2021
Created title: ALJ Upholds MolDX Noncoverage and Assigns Liability to Agendia
ALJ Scott Tews found the BluePrint and TargetPrint services not medically reasonable and necessary and entered an unfavorable decision. He concluded that Agendia knew or should have known of noncoverage because it had submitted the tests to MolDX and was familiar with the governing LCDs, articles, and technical-assessment results. (Supreme Court)
Live link:
Note concerning the next four ALJ dates
The public D.D.C. opinion reproduces the appeal numbers, judges, services, evidence, and holdings, but not the exact dates printed on the decisions. It states that these decisions were issued after the first Agendia federal litigation began and before Agendia filed the second lawsuit on October 24, 2022—thus sometime between January 14, 2019 and October 24, 2022. I have not substituted guessed dates. (Justia Law)
5. Agendia Inc.—ALJ Fuller I
Case: Appeal of Agendia Inc.
Number: OMHA Appeal No. 1-2899285920
Date: Exact date not reproduced publicly; between January 14, 2019 and October 24, 2022
Created title: Clinical Testimony Does Not Overcome the MolDX Record—Tranche I
In a combined hearing covering two claim tranches, Agendia’s medical director described the tests’ use in representative patients. ALJ Fuller nevertheless found that the testimony did not provide a sufficient reason to disregard the LCD or question MolDX’s conclusions concerning clinical utility. (GovInfo)
Live link—discussion begins under “ALJ Fuller’s Decisions”:
https://www.govinfo.gov/content/pkg/USCOURTS-dcd-1_22-cv-03242/pdf/USCOURTS-dcd-1_22-cv-03242-2.pdf
6. Agendia Inc.—ALJ Fuller II
Case: Appeal of Agendia Inc.
Number: OMHA Appeal No. 1-2806373709
Date: Exact date not reproduced publicly; between January 14, 2019 and October 24, 2022
Created title: Clinical Testimony Does Not Overcome the MolDX Record—Tranche II
This was the second tranche adjudicated at the same combined Fuller hearing. The ALJ again concluded that testimony concerning selected beneficiaries did not justify departing from the applicable LCD and the MolDX assessment that BluePrint and TargetPrint lacked demonstrated incremental clinical utility. (GovInfo)
Live link:
https://www.govinfo.gov/content/pkg/USCOURTS-dcd-1_22-cv-03242/pdf/USCOURTS-dcd-1_22-cv-03242-2.pdf
7. Agendia Inc.—ALJ Conway
Case: Appeal of Agendia Inc.
Number: OMHA Appeal No. 3-2912323743
Date: Exact date not reproduced publicly; between January 14, 2019 and October 24, 2022
Created title: Patient Benefit Shown, but Evidence Insufficient to Depart from MolDX
ALJ Conway found that the record demonstrated that BluePrint and TargetPrint had benefited the course of treatment for 150 beneficiaries. Nevertheless, he denied coverage because Agendia had not placed sufficient supporting evidence beyond hearing testimony into that particular record to justify departure from established CMS and MolDX policy. (GovInfo)
Live link—discussion appears under “ALJ Conway’s Decision”:
https://www.govinfo.gov/content/pkg/USCOURTS-dcd-1_22-cv-03242/pdf/USCOURTS-dcd-1_22-cv-03242-2.pdf
8. Agendia Inc.—ALJ Smibert
Case: Appeal of Agendia Inc.
Number: OMHA Appeal No. 3-3935618441
Date: Exact date not reproduced publicly; between January 14, 2019 and October 24, 2022
Created title: Post-Service Studies and Uncertain Outcomes Fail to Displace MolDX
The appeal ultimately concerned BluePrint after Agendia withdrew the TargetPrint claims. ALJ Smibert declined to depart from the LCD, questioning the relevance and independence of submitted studies and noting Agendia’s acknowledgment that it did not receive patient follow-up results and therefore could not establish the beneficiaries’ ultimate clinical outcomes. (GovInfo)
Live link—discussion appears under “ALJ Smibert’s Decision”:
https://www.govinfo.gov/content/pkg/USCOURTS-dcd-1_22-cv-03242/pdf/USCOURTS-dcd-1_22-cv-03242-2.pdf
9. Agendia Inc.—Council reversal of ALJ Amendola
Case: Agendia Inc., Appellant
Number: Medicare Appeals Council Decision No. M-22-4685
Date: 2022; exact day not reproduced in the accessible court opinion
Created title: Council Again Reverses a Favorable ALJ for Insufficient Deference to MolDX
ALJ Amendola had found BluePrint and TargetPrint covered without conducting a hearing, although he dismissed nine untimely appeals. On its own motion, the Council reversed, holding that the ALJ materially erred by neither giving substantial deference to the LCD nor explaining a beneficiary-specific reason for departing from it; the Council denied coverage without remand. (Justia Law)
Live link—discussion appears under “Council Decision (No. M-22-4685)”:
https://www.govinfo.gov/content/pkg/USCOURTS-dcd-1_22-cv-03242/pdf/USCOURTS-dcd-1_22-cv-03242-2.pdf
III. Federal judicial review of the MolDX administrative decisions
10. Agendia, Inc. v. Azar
Case: Agendia, Inc. v. Azar
Number: No. 8:19-cv-00074-DOC-JDE; 420 F. Supp. 3d 985
Date: October 29, 2019
Created title: District Court Initially Invalidates the MolDX-Based Denial Process
The Central District of California granted summary judgment to Agendia and remanded to the Medicare Appeals Council. It held that the LCD and related policies established a substantive payment standard and therefore could not be used against Agendia without the notice-and-comment procedure required by the Medicare Act, although it rejected Agendia’s constitutional nondelegation theory. (bakerdonelson.com)
Live link:
https://www.bakerdonelson.com/webfiles/Publications/Agendia-v-Azar-Document-1.pdf
11. Agendia, Inc. v. Becerra—Ninth Circuit
Case: Agendia, Inc. v. Becerra
Numbers: Nos. 19-56516 and 20-55041; 4 F.4th 896
Date: July 16, 2021
Created title: Ninth Circuit Restores the LCD and MolDX Framework
The Ninth Circuit reversed Agendia’s district-court victory. The majority held that LCDs do not establish or change the statutory “reasonable and necessary” standard and therefore need not undergo Medicare Act notice-and-comment rulemaking; it also rejected the claim that allowing contractors to develop LCDs constituted an unconstitutional private delegation. (Justia Law)
Live link:
https://law.justia.com/cases/federal/appellate-courts/ca9/19-56516/19-56516-2021-07-16.html
12. Agendia, Inc. v. Becerra—District of Columbia
Case: Agendia, Inc. v. Becerra
Number: Civil Action No. 22-3242 (JDB); No. 1:22-cv-03242
Date: Revised opinion July 26, 2024; original opinion March 29, 2024
Created title: Second Agendia Challenge Fails on Preclusion and Substantial Evidence
The D.D.C. held that Agendia’s renewed structural challenges to the LCD and substantial-deference framework were largely barred by the earlier Ninth Circuit litigation. It separately reviewed the Fuller, Conway, Smibert, and Council decisions and concluded that each denial was supported by substantial evidence. (Justia Law)
Live link:
https://www.govinfo.gov/content/pkg/USCOURTS-dcd-1_22-cv-03242/pdf/USCOURTS-dcd-1_22-cv-03242-2.pdf
13. Agendia, Inc. v. Kennedy—D.C. Circuit
Case: Agendia Inc. v. Robert F. Kennedy, Jr., Secretary of HHS
Number: No. 24-5180
Date: May 22, 2025
Created title: D.C. Circuit Affirms MolDX Decisions and Closes the Second Agendia Appeal
The D.C. Circuit affirmed the district court in an unpublished judgment. It held that Agendia’s renewed facial challenge to the substantial-deference regulation was claim-precluded and rejected the preserved challenges to ALJ Conway’s decision and the Council’s reversal of ALJ Amendola, in substantial part because Agendia had forfeited or insufficiently developed the relevant arguments. (GovInfo)
Live link:
https://www.govinfo.gov/content/pkg/USCOURTS-caDC-24-05180/pdf/USCOURTS-caDC-24-05180-0.pdf
Overall impression
The publicly recoverable MolDX appellate record is surprisingly narrow and unusually concentrated in one laboratory’s long-running dispute. Apart from the procedurally dismissed thrombophilia-LCD complaint, nearly all identifiable claim decisions involve Agendia’s BluePrint and TargetPrint breast-cancer assays. This probably reflects publication bias rather than the absence of other MolDX appeals: HHS posts only selected Council decisions, ordinary OMHA claim decisions are not systematically published, and these Agendia decisions became visible largely because they were incorporated into federal-court records. (HHS.gov)
Substantively, the cases show how a formally nonbinding LCD can become practically very difficult to overcome. Under 42 C.F.R. § 405.1062, an ALJ or the Council must give an applicable LCD “substantial deference” or explain why it is not being followed. In the two Agendia tranches where ALJs initially found coverage, the Council reversed because the ALJs did not adequately explain a departure from the LCD and MolDX findings. The message is not that an ALJ can never disagree with MolDX, but that disagreement must be tied to a clearly developed record and preferably to facts particular to the beneficiaries under appeal. (Supreme Court)
The decisions also distinguish plausible clinical usefulness from evidence sufficient to establish Medicare clinical utility. ALJ Conway expressly accepted that the tests benefited treatment for the beneficiaries, yet still found that testimony alone did not overcome the MolDX policy. Other adjudicators discounted publications because they postdated the services, did not isolate the incremental contribution of the contested test, involved financially interested authors, or did not provide actual follow-up outcomes. In practical terms, the burden shifted to Agendia not merely to show that physicians used or valued the tests, but to establish why the assays added actionable value beyond covered alternatives and why that evidence justified departure from MolDX for the particular claims.
Finally, the federal cases substantially strengthened the institutional position of MolDX.
Agendia briefly prevailed in 2019, when the district court treated the LCD as a substantive payment rule requiring notice and comment. The Ninth Circuit reversed that holding, and the later D.D.C. and D.C. Circuit proceedings rejected renewed structural challenges through preclusion while sustaining the individual coverage decisions under deferential substantial-evidence review. The resulting lesson is that, once MolDX noncoverage is embodied in an applicable LCD or article, the more promising appeal strategy is likely a meticulously beneficiary-specific evidentiary showing—not a generalized attack on the legality or scientific currency of the MolDX framework.
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I feel like it used to be easy to find fun CMS legal decisions - not anymore?
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Your memory is almost certainly real—but I think the enjoyable site was the HHS Departmental Appeals Board’s searchable Medicare Appeals Council compendium, rather than a comprehensive library of OMHA ALJ opinions.
What happened?
The Council page still exists and still says it will be “supplemented periodically,” but it is essentially a fossilized collection. HHS began posting selected “significant” Council decisions in 2003, organized them by topic, and provided keyword searching. Yet the page was last substantively reviewed on October 23, 2018, and the newest decision visibly listed appears to be from January 21, 2016. That explains your impression that there used to be something interesting and now there is almost nothing new. (HHS.gov)
The old/familiar searchable site:
https://www.hhs.gov/about/agencies/dab/decisions/council-decisions/index.html
It remains the best official place to browse curated Medicare coverage and payment appeals—but it is Council-level, not a general OMHA ALJ database.
Why ordinary OMHA decisions are hard to find
OMHA issues Level 3 decisions in large numbers, but those decisions are individualized claim determinations, generally contain beneficiary medical information, and ordinarily have no precedential force outside the particular appeal. HHS therefore has never maintained anything resembling PACER for all OMHA opinions. The Council may now designate selected Council decisions as precedential, but routine OMHA ALJ decisions remain claim-specific. (HHS.gov)
There are also two easily confused species of “HHS ALJ decision”:
OMHA ALJ decisions: Medicare Part A, B, C and D claim appeals—the cases you mean.
DAB ALJ decisions: enrollment revocations, exclusions, civil money penalties, nursing-facility sanctions and similar Part 498 matters. These are actively published and searchable, but they are not ordinary OMHA coverage appeals. (HHS.gov)
Current DAB decisions gateway:
https://www.hhs.gov/about/agencies/dab/decisions/index.html
Current places to look
1. DAB Medicare Appeals Council decisions
The tightly curated, mostly older collection:
https://www.hhs.gov/about/agencies/dab/decisions/council-decisions/index.html
This is probably the site you remember.
2. AASIS—OMHA appeal-status lookup
AASIS lets someone check the status of a specific OMHA appeal that they filed. It is not a case-law search engine, generally requires the appeal number, and closed appeals disappear after 180 days. (HHS.gov)
https://www.hhs.gov/about/agencies/omha/filing-an-appeal/appeals-status-lookup/index.html
Direct system:
3. The OMHA e-Appeal Portal
Parties can file and manage their own appeals and submit documents. It does not provide public browsing of other parties’ decisions. (HHS.gov)
https://www.hhs.gov/about/agencies/omha/filing-an-appeal/index.html
4. Requesting a decision or record
A party or authorized representative can request the record in its own case using Form HHS-719. A third party with the appellant’s consent can use HHS-720 and HHS-721. Those mechanisms do not create a public topical research library. (HHS.gov)
https://www.hhs.gov/about/agencies/omha/filing-an-appeal/forms/index.html
A broader FOIA request is theoretically possible, but it would need to be reasonably defined and would probably involve privacy review and extensive redaction because OMHA records contain beneficiary identifiers and medical information. OMHA’s own manual emphasizes protection of personal, tax and health information when responding to requests. (HHS.gov)
Is there a pay service?
Westlaw: yes, but only partially
HHS itself says that some Medicare Appeals Council decisions are available on Westlaw in the Federal Health Law database, identifier:
FHTH-HHS
That is a commercial route to selected Council material, not a complete collection of underlying OMHA ALJ decisions. (HHS.gov)
Westlaw, Lexis and Bloomberg Law
These are useful primarily for:
Federal district and appellate cases reviewing Medicare administrative decisions.
Briefs, petitions and appendices containing otherwise unpublished ALJ or Council decisions.
Searching by laboratory, supplier, judge, appeal number, LCD number or test name.
They do not appear to offer a comprehensive, systematically collected OMHA opinion database. I found no current commercial product equivalent to “all OMHA decisions, searchable by service, CPT code, LCD or contractor.”
PACER and CourtListener/RECAP
PACER is sometimes the best paid source because federal complaints, administrative records and appellate appendices may reproduce the complete OMHA and Council decisions.
CourtListener’s RECAP archive provides many PACER documents free when another user has previously downloaded them:
https://www.courtlistener.com/recap/
For MolDX specifically, this indirect federal-court route is why the Agendia decisions were recoverable.
My conclusion
You are not overlooking a wonderful replacement website. The appealing old resource was probably the DAB’s selected Medicare Appeals Council decisions page, and HHS has allowed it to become effectively dormant. There is still an enormous stream of OMHA adjudication, but public visibility has collapsed into three narrow channels:
A stale, curated Council collection.
Status access for parties through AASIS and the e-Appeal Portal.
Decisions that happen to escape into federal-court records, FOIA productions or private party files.
Westlaw improves searching of the selected Council material and federal litigation, but it does not solve the fundamental problem: ordinary OMHA decisions are not routinely published or centrally obtainable, free or paid. For serious topical research—MolDX, molecular pathology, statistical extrapolation, inpatient status—the practical method is now to combine the old DAB collection with Westlaw/PACER/RECAP searches for administrative-record appendices.
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When I asked you to look for MolDx cases, did you include DAB? And explain DAB, OMHA, MAC.
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Yes, but only partly. The MolDX results I gave you did not primarily come from the searchable DAB decision collection, and I should have labeled the sources more precisely.
What I actually found
The thrombophilia case, DAB CR5997, came directly from the DAB website. But it was a DAB Civil Remedies Division ALJ decision involving a direct LCD challenge under 42 C.F.R. Part 426—not an ordinary OMHA Level 3 claim appeal. (HHS.gov)
The several Agendia ALJ decisions were ordinary OMHA Level 3 claim decisions, recovered indirectly from federal-court opinions and administrative-record appendices.
The two Agendia Medicare Appeals Council decisions were Level 4 decisions by the Council, which is housed inside DAB. Those also were recovered principally from court appendices rather than from DAB’s curated online Council compendium.
The remaining Agendia entries were federal district or appellate court decisions reviewing the administrative proceedings.
So the answer is: I searched the DAB environment, but the useful MolDX material mostly surfaced through federal-court records because the pertinent OMHA and Council decisions were not posted in the ordinary DAB compendium.
DAB versus Medicare Appeals Council
The simplest formulation is:
DAB is the umbrella organization; the Medicare Appeals Council is one component within DAB.
HHS’s DAB has several separate adjudicatory branches. Its website accordingly lists three different kinds of decisions:
DAB Board decisions
DAB Administrative Law Judge decisions
Medicare Appeals Council decisions
The Council expressly describes itself as a component of the Departmental Appeals Board. (HHS.gov)
| Entity | What it is | Principal Medicare role |
|---|---|---|
| OMHA | A separate HHS office | Conducts Level 3 Medicare claim appeals before OMHA ALJs |
| Medicare Appeals Council | A component of DAB | Conducts Level 4 review of OMHA ALJ decisions |
| DAB Civil Remedies Division ALJs | Another component of DAB | Handles enrollment, sanctions, exclusions, CMPs and certain direct LCD complaints—not routine Medicare claim appeals |
| DAB Appellate Division or “Board” | Another DAB adjudicatory branch | Reviews certain DAB ALJ matters and other HHS disputes, but generally not routine OMHA claim appeals |
OMHA describes itself as the third level of Medicare claims appeals. A party dissatisfied with the OMHA ALJ decision may seek review by the Medicare Appeals Council (MAC) at DAB; a final Council decision may then proceed to federal court if jurisdictional requirements are met. (HHS.gov)
The ordinary pathway is therefore:
MAC contractor determination → QIC reconsideration → OMHA ALJ → DAB Medicare Appeals Council → federal district court
Why “DAB decision” is ambiguous
People often use DAB in two different senses:
Broadly: the entire Departmental Appeals Board organization, including the Medicare Appeals Council.
Narrowly: a numbered “DAB No. ####” Board decision, usually involving provider enrollment, sanctions, nursing facilities, exclusions or grants.
Likewise, “DAB ALJ decision” usually does not mean an OMHA ALJ decision. A decision labeled DAB CR5997, for example, is a Civil Remedies Division decision. It happens to concern MolDX because direct LCD challenges are assigned there, but it is not Level 3 review of an individual laboratory claim. The decision itself identifies the tribunal as the DAB Civil Remedies Division. (HHS.gov)
One final nomenclature trap: MAC can mean either:
Medicare Administrative Contractor, such as Palmetto or Noridian; or
Medicare Appeals Council.
HHS generally calls the latter simply “the Council,” which is much safer.
Thus, for future searching, the precise target should be:
OMHA Level 3 ALJ decisions and DAB Medicare Appeals Council Level 4 decisions involving MolDX, plus direct Part 426 LCD challenges before DAB Civil Remedies Division ALJs.
That is more exact than simply asking for “DAB cases.”
