Hammer LabsHL-CVG-001MEDICARE COVERAGE COMMENT RECORD
REV 20260831

What happens when you comment on a Medicare coverage policy

Draft Local Coverage Determinations open for comment right now, and the public record of every comment period that has already closed — what was argued, and what the contractor wrote back. Every line links to its CMS source.

Generated 2026-08-31 · coverage database vintage 2026-08-27 · comment record vintage 2026-08-31

01

Open for comment

5 policies are accepting comment. After a window closes, 42 CFR 426.320 limits review to a Medicare beneficiary with a denied service and a treating physician’s documentation — not the manufacturer.

External Breast Prostheses

5 days leftcloses 2026-09-05CGS Administrators · Noridian Healthcare Solutions

Oxygen and Oxygen Equipment

5 days leftcloses 2026-09-05CGS Administrators · Noridian Healthcare Solutions
documentationWhen applicable, the beneficiary’s medical record must have documentation that describes any concerns for variations in oxygen measurements that may result from such factors as the patient's age, the patient’s skin pigmentation, the altitude level, or a decrease in oxygen carrying capacity.
evidence barA medical condition with distinct physiologic, cognitive, and/or functional symptoms documented in high-quality, peer-reviewed literature to be improved by oxygen therapy, such as cluster headaches (not all inclusive).
population limitIt does not include oximetry results done as part of other overnight testing such as polysomnography or home sleep testing.
population limitOvernight oximetry does not include oximetry obtained during polysomnography or other sleep testing for sleep apnea, regardless of the location the testing was performed.
population limitBeneficiaries that qualify for oxygen therapy and oxygen equipment based on testing conducted only during the course of a sleep test are eligible only for reimbursement of stationary equipment.

MolDX: Genome-Wide Molecular Methodologies for the Detection of Copy Number Alterations and Structural Variants in Hematologic Neoplasms

41 days leftcloses 2026-10-11CGS Administrators · Noridian Healthcare Solutions · Palmetto GBA

Criteria across these 3 contractors: they differ — check which policies each cross-references

documentationdiagnosis in accordance with current expert or professional guidelines (e.g., World Health Organization Classification of Haematolymphoid Tumours (WHO), International Consensus Classification of Myeloid and Lymphoid Neoplasms (ICC)), and other reasonably possible causes have been considered and excluded, as documented in the medical record;
prior test requiredTesting for CNAs and SVs has not already been performed and is not in the process of being performed by another genome-wide molecular methodology or by multiple (>1) other chromosomal and/or molecular methodologies (e.g., chromosome banding analysis, CBA;
prior test requiredThe patient previously had an oncologic workup for the same indication utilizing standard chromosomal/molecular assays (as above) that was negative, and presents with further signs or symptoms (e.g., worsening blood counts) suggestive of malignancy or progression of malignancy in accordance with expert or professional guidelines (as above) and as documented in the medical record.
evidence barThe test has satisfactorily completed a Technical Assessment (TA) by the Molecular Diagnostic Services Program (MolDX ® ) to ensure analytical validity (AV), clinical validity (CV) and clinical utility (CU) standards are met.
evidence barThe test demonstrates detection accuracy for targeted analytes comparable or superior to current gold standards for testing.

Codes in the proposed billing articles: 0299U, 0300U, 0331U, 0413U, 81195, 81479

MolDX: Next-Generation Sequencing for Hematologic Malignancies and Suspected Hematologic Malignancies

41 days leftcloses 2026-10-11CGS Administrators · Noridian Healthcare Solutions · Palmetto GBA

Criteria across these 3 contractors: identical

documentationan undiagnosed but highly suspected hematologic malignancy in accordance with current national or international consensus guidelines (as above), AND a standard evaluation to rule out benign or reactive causes (e.g., infectious, inflammatory etiology) has been performed, as documented in the medical record.
evidence barBecause these genes and variants will change as the literature and drug indications evolve, they are listed separately in associated documents such as the MolDX ® Technical Assessment (TA) forms.
evidence barThe test has completed a Technical Assessment (TA) by MolDX ® to verify that analytical validity (AV), clinical validity (CV), and clinical utility (CU) standards are met for the stated indications of the test.

Codes in the proposed billing articles: 81450, 81451, 81455, 81456, 81479

MolDX: Transcriptional Biomarkers for Therapeutic Decision-Making in Renal Carcinoma

41 days leftcloses 2026-10-11CGS Administrators · Noridian Healthcare Solutions · Palmetto GBA

Criteria across these 3 contractors: they differ — check which policies each cross-references

evidence barIf the test relies on an algorithm, the algorithm must be validated in a cohort that is not a development cohort for the algorithm.
evidence barThe analytes measured have demonstrated clinical validity and clinical utility in the peer-reviewed published literature, establishing a clear and significant biological basis for stratifying patients and subsequently selecting (either positively or negatively) their clinical management decision within a clearly defined population.
evidence barAnalytical validity, clinical validity, and clinical utility are assessed as part of a successful technical assessment (TA) by the Molecular Diagnostic Services Program (MolDX ® ).
population limitDiagnostic tests using next-generation sequencing (NGS) for tumor mutation profiling are not within scope of this policy and are governed according to the criteria in LCD L38045, MolDX:
02

What the record shows

3,768comments with a contractor response
339comment periods on the record
247draft policies commented on
6median comments per draft

Contractors answer every comment — 3,747 of 3,768. But most responses do not announce a decision: of 708 distinct substantive responses, 192 state a change and 42 state a refusal, while 446 restate the policy or explain its basis.

A comment period is also rarely crowded. 99 of 339 drafts drew three comments or fewer.

These counts are of what contractors published. They are not a success rate: no comparison exists against drafts that were revised for reasons unrelated to any comment.

03

Closed comment periods

The 60 most recent of 339 on the record, newest first. Quotes are the contractor’s own words about what it did.

closed 2026-02-28 · 9 comments · DL40328 · effective 2026-09-27
mixedThank you for your comments. We acknowledge the broader clinical utility of total serum IgE testing, including its role in the diagnostic evaluation of conditions that extend beyond traditional IgE‑mediated allergy testing (i.e. IgE-mediated and delayed hypersensitivities to external allergens upon exposure) and for the additional conditi…
maintainedThank you for your comments. With respect to the request for additional ICD‑10‑CM diagnosis codes, several additional diagnoses will be added to the Billing and Coding Article as they relate to traditional allergy diagnostic testing (i.e. IgE‑mediated and delayed hypersensitivity reactions to external allergens following exposure). Certai…
closed 2025-11-22 · 2 comments · DL40259 · effective 2026-10-12
Named commenters: Association for Molecular Pathology
closed 2025-11-22 · 10 comments · DL40199 · effective 2026-08-10
Named commenters: Advanced Medical Technology Association, American Clinical Laboratory Association, Association for Molecular Pathology, Roche Diagnostics
movedThank you for your suggestions. The intent of Criterion 5 is to preclude blood-based testing in patients with unequivocal findings on biopsy that would not reasonably be expected to change significantly in the interval before retesting. This has been reworded to “Testing is not performed more than once within a 12-month period nor within …
movedThank you for your careful review. The Evaluation of liver fibrosis section in the Summary of Evidence recognizes that FIB-4 has limitations. Although the original draft LCD listed quantitative FIB-4 result as an example, not necessarily a requirement, language has been added to Criterion 2 to include clinical evaluation as a component of…
closed 2025-11-08 · 26 comments · DL40205 · effective 2026-07-05
closed 2025-11-08 · 9 comments · DL40244
movedOur coverage indications were based on careful review of available evidence. The covered indications and associated diagnosis codes with adequate evidence where patients would be expected to be symptomatic are already included in the policy’s coverage criteria. The LCD is intentionally structured around the clinical purpose of monitoring …
movedAdditional diagnosis codes which fit with established coverage outlined in the policy, and with adequate supporting evidence have been added to the policy and Billing & Coding article. Sleep apnea diagnoses (e.g., G47.33) were considered; however, obstructive sleep apnea alone is not a covered indication under this LCD. TNACMD coverage re…
closed 2025-11-08 · 9 comments · DL40257 · effective 2026-06-21
movedOur coverage indications were based on careful review of available evidence. The covered indications and associated diagnosis codes with adequate evidence where patients would be expected to be symptomatic are already included in the policy’s coverage criteria. The LCD is intentionally structured around the clinical purpose of monitoring …
movedAdditional diagnosis codes which fit with established coverage outlined in the policy, and with adequate supporting evidence have been added to the policy and Billing & Coding article. Sleep apnea diagnoses (e.g., G47.33) were considered; however, obstructive sleep apnea alone is not a covered indication under this LCD. TNACMD coverage re…
closed 2025-11-08 · 9 comments · DL40255
movedOur coverage indications were based on careful review of available evidence. The covered indications and associated diagnosis codes with adequate evidence where patients would be expected to be symptomatic are already included in the policy’s coverage criteria. The LCD is intentionally structured around the clinical purpose of monitoring …
movedAdditional diagnosis codes which fit with established coverage outlined in the policy, and with adequate supporting evidence have been added to the policy and Billing & Coding article. Sleep apnea diagnoses (e.g., G47.33) were considered; however, obstructive sleep apnea alone is not a covered indication under this LCD. TNACMD coverage re…
closed 2025-11-08 · 8 comments · DL40228 · effective 2026-04-12
maintainedThank you for your comments. The rationale for adding “only” is to allow for coverage that is both reasonable and necessary per SSA 1862(a)(1)(A) . The use of the word only is to cover both reasonable and necessary. The examples given represent the majority of the potential reasons and others may be considered on a case-by-case basis for …
maintainedThank you for your comments. See Response 4F. In addition, the guidelines or requirements for SET or GDMT are based upon peer review published literature. The published literature does not differentiate between types of claudication and therefore these requirements will be maintained for this category of coverage. See Response 1C above. S…
closed 2025-10-12 · 2 comments · DL40274 · effective 2026-10-12
Named commenters: Association for Molecular Pathology
closed 2025-10-12 · 13 comments · DL40278 · effective 2026-10-12
Named commenters: American Academy of Dermatology Association, American Clinical Laboratory Association, Association for Molecular Pathology, OncoHost
mixedThank you for your comment and support of this LCD. We respond as follows: Criterion 2: We have modified “Required by national consensus guidelines” for clarity and to more accurately reflect the language of the guidelines. The concept of a “rapid result” is further defined in the criterion (“less than the ASCO-recommended 10 business day…
movedThank you for your comment and support of this LCD. We respond as follows: To better align with the recommendation by the professional bodies as noted in the Summary of evidence, we have amended the language to “less than the ASCO-recommended 10 business days from sample receipt in the laboratory.” We agree that not all NGS tests provide …
closed 2025-10-12 · 13 comments · DL40226 · effective 2026-10-12
Named commenters: American Academy of Dermatology Association, American Clinical Laboratory Association, Association for Molecular Pathology, OncoHost
mixedThank you for your comment and support of this LCD. We respond as follows: Criterion 2: We have modified “Required by national consensus guidelines” for clarity and to more accurately reflect the language of the guidelines. The concept of a “rapid result” is further defined in the criterion (“less than the ASCO-recommended 10 business day…
movedThank you for your comment and support of this LCD. We respond as follows: To better align with the recommendation by the professional bodies as noted in the Summary of evidence, we have amended the language to “less than the ASCO-recommended 10 business days from sample receipt in the laboratory.” We agree that not all NGS tests provide …
closed 2025-10-12 · 13 comments · DL40222 · effective 2026-10-12
Named commenters: American Academy of Dermatology Association, American Clinical Laboratory Association, Association for Molecular Pathology, OncoHost
mixedThank you for your comment and support of this LCD. We respond as follows: Criterion 2: We have modified “Required by national consensus guidelines” for clarity and to more accurately reflect the language of the guidelines. The concept of a “rapid result” is further defined in the criterion (“less than the ASCO-recommended 10 business day…
movedThank you for your comment and support of this LCD. We respond as follows: To better align with the recommendation by the professional bodies as noted in the Summary of evidence, we have amended the language to “less than the ASCO-recommended 10 business days from sample receipt in the laboratory.” We agree that not all NGS tests provide …
closed 2025-10-12 · 13 comments · DL40210 · effective 2026-10-12
Named commenters: American Academy of Dermatology Association, American Clinical Laboratory Association, Association for Molecular Pathology, OncoHost
mixedThank you for your comment and support of this LCD. We respond as follows: Criterion 2: We have modified “Required by national consensus guidelines” for clarity and to more accurately reflect the language of the guidelines. The concept of a “rapid result” is further defined in the criterion (“less than the ASCO-recommended 10 business day…
movedThank you for your comment and support of this LCD. We respond as follows: To better align with the recommendation by the professional bodies as noted in the Summary of evidence, we have amended the language to “less than the ASCO-recommended 10 business days from sample receipt in the laboratory.” We agree that not all NGS tests provide …
closed 2025-10-12 · 2 comments · DL40242 · effective 2026-10-12
Named commenters: Association for Molecular Pathology
closed 2025-10-12 · 2 comments · DL40238 · effective 2026-10-12
Named commenters: Association for Molecular Pathology
closed 2025-10-12 · 10 comments · DL40197 · effective 2026-08-10
Named commenters: Advanced Medical Technology Association, American Clinical Laboratory Association, Association for Molecular Pathology, Roche Diagnostics
movedThank you for your suggestions. The intent of Criterion 5 is to preclude blood-based testing in patients with unequivocal findings on biopsy that would not reasonably be expected to change significantly in the interval before retesting. This has been reworded to “Testing is not performed more than once within a 12-month period nor within …
movedThank you for your careful review. The Evaluation of liver fibrosis section in the Summary of Evidence recognizes that FIB-4 has limitations. Although the original draft LCD listed quantitative FIB-4 result as an example, not necessarily a requirement, language has been added to Criterion 2 to include clinical evaluation as a component of…
closed 2025-10-12 · 10 comments · DL40187 · effective 2026-08-10
Named commenters: Advanced Medical Technology Association, American Clinical Laboratory Association, Association for Molecular Pathology, Roche Diagnostics
movedThank you for your suggestions. The intent of Criterion 5 is to preclude blood-based testing in patients with unequivocal findings on biopsy that would not reasonably be expected to change significantly in the interval before retesting. This has been reworded to “Testing is not performed more than once within a 12-month period nor within …
movedThank you for your careful review. The Evaluation of liver fibrosis section in the Summary of Evidence recognizes that FIB-4 has limitations. Although the original draft LCD listed quantitative FIB-4 result as an example, not necessarily a requirement, language has been added to Criterion 2 to include clinical evaluation as a component of…
closed 2025-10-12 · 10 comments · DL40272 · effective 2026-08-10
Named commenters: Advanced Medical Technology Association, American Clinical Laboratory Association, Association for Molecular Pathology, Roche Diagnostics
movedThank you for your suggestions. The intent of Criterion 5 is to preclude blood-based testing in patients with unequivocal findings on biopsy that would not reasonably be expected to change significantly in the interval before retesting. This has been reworded to “Testing is not performed more than once within a 12-month period nor within …
movedThank you for your careful review. The Evaluation of liver fibrosis section in the Summary of Evidence recognizes that FIB-4 has limitations. Although the original draft LCD listed quantitative FIB-4 result as an example, not necessarily a requirement, language has been added to Criterion 2 to include clinical evaluation as a component of…
closed 2025-09-06 · 4 comments · DL38549 · effective 2025-12-14
maintainedThe Contractors make coverage decisions based on evidence. There is evidence to support the current coverage volumes in the LCD, based on several studies. Water I and II limited the volumes of prostates ultimately in the ranges noted in the LCD. The LCD reviews a number of studies that suggest there may be more complications for those wit…
closed 2025-08-31 · 44 comments · DL40249 · effective 2026-08-30
Named commenters: American Society of Transplantation, Coalition for 21st Century Medicine, College of American Pathologists, International Society for Heart and Lung Transplantation, Verici Dx, many heart transplant recipients who have benefitted from access to multimodality
mixedThank you for your comments. Please note that comments from multiple stakeholders that involve the same topics are addressed together here as a single response. Additionally, we have added a qualifying statement to the section on the 2022 CAC meetings, acknowledging the additional evidence that has been developed since then, and have incl…
maintainedThank you for your comment. Please see Response #1. Additionally – We have chosen to keep “protocol” included in the “Surveillance” testing definition, to further denote that this testing is used per protocol (i.e. is not for-cause).…
closed 2025-08-31 · 44 comments · DL40058 · effective 2026-08-30
Named commenters: American Society of Transplantation, Coalition for 21st Century Medicine, College of American Pathologists, International Society for Heart and Lung Transplantation, Verici Dx, many heart transplant recipients who have benefitted from access to multimodality
mixedThank you for your comments. Please note that comments from multiple stakeholders that involve the same topics are addressed together here as a single response. Additionally, we have added a qualifying statement to the section on the 2022 CAC meetings, acknowledging the additional evidence that has been developed since then, and have incl…
maintainedThank you for your comment. Please see Response #1. Additionally – We have chosen to keep “protocol” included in the “Surveillance” testing definition, to further denote that this testing is used per protocol (i.e. is not for-cause).…
closed 2025-08-31 · 44 comments · DL40058 · effective 2026-08-30
Named commenters: American Society of Transplantation, Coalition for 21st Century Medicine, College of American Pathologists, International Society for Heart and Lung Transplantation, Verici Dx, many heart transplant recipients who have benefitted from access to multimodality
mixedThank you for your comments. Please note that comments from multiple stakeholders that involve the same topics are addressed together here as a single response. Additionally, we have added a qualifying statement to the section on the 2022 CAC meetings, acknowledging the additional evidence that has been developed since then, and have incl…
maintainedThank you for your comment. Please see Response #1. Additionally – We have chosen to keep “protocol” included in the “Surveillance” testing definition, to further denote that this testing is used per protocol (i.e. is not for-cause).…
closed 2025-08-31 · 44 comments · DL40060 · effective 2026-08-30
Named commenters: American Society of Transplantation, Coalition for 21st Century Medicine, College of American Pathologists, International Society for Heart and Lung Transplantation, Verici Dx, many heart transplant recipients who have benefitted from access to multimodality
mixedThank you for your comments. Please note that comments from multiple stakeholders that involve the same topics are addressed together here as a single response. Additionally, we have added a qualifying statement to the section on the 2022 CAC meetings, acknowledging the additional evidence that has been developed since then, and have incl…
movedThank you for your comment. Please see Response #1. Additionally – The LCD states that “Clinical validity (CV) of any analytes (or expression profiles) measured must be established through a study published in the peer-reviewed literature for the intended use of the test in the intended population. The degree of validity must be similar o…
closed 2025-08-31 · 44 comments · DL40062 · effective 2026-08-30
Named commenters: American Society of Transplantation, Coalition for 21st Century Medicine, College of American Pathologists, International Society for Heart and Lung Transplantation, Verici Dx, many heart transplant recipients who have benefitted from access to multimodality
mixedThank you for your comments. Please note that comments from multiple stakeholders that involve the same topics are addressed together here as a single response. Additionally, we have added a qualifying statement to the section on the 2022 CAC meetings, acknowledging the additional evidence that has been developed since then, and have incl…
movedThank you for your comment. Please see Response #1. Additionally – The LCD states that “Clinical validity (CV) of any analytes (or expression profiles) measured must be established through a study published in the peer-reviewed literature for the intended use of the test in the intended population. The degree of validity must be similar o…
closed 2025-07-12 · 4 comments
maintainedThe Contractors make coverage decisions based on evidence. There is evidence to support the current coverage volumes in the LCD, based on several studies. Water I and II limited the volumes of prostates ultimately in the ranges noted in the LCD. The LCD reviews a number of studies that suggest there may be more complications for those wit…
closed 2025-07-12 · 4 comments
maintainedThe Contractors make coverage decisions based on evidence. There is evidence to support the current coverage volumes in the LCD, based on several studies. Water I and II limited the volumes of prostates ultimately in the ranges noted in the LCD. The LCD reviews a number of studies that suggest there may be more complications for those wit…
closed 2025-06-28 · 37 comments · DL40189 · effective 2026-03-01
maintainedThank you for your support of the LCD. We do not agree with the need for clarification. We appreciate your review of the LCD and the suggested clarificatory language.…
maintainedThank you for your comments. See response to comment #1 and 27. This contractor acknowledges clinical experience and cited studies. We maintain LCD conclusions are consistent with guidelines, which still do not endorse EBT as standard. Exclusion remains; reconsideration requires prospective trials/registries with mature data.…
04

Three things a summary would miss

Every finding below is checkable against the CMS pages linked above. They are here because each one was missed by an obvious shortcut, and each changes what a commenter would write.

1. Identical length is not identical text

The three Genome-Wide Molecular Methodologies drafts carry indication sections of 5,123 characters each and analysis sections of 5,934 each. Comparing those counts says the drafts are the same. Comparing the text says otherwise.

Criterion incorporatesPalmetto & Noridian citeCGS cites
Non-NGS tests, BCR-ABL negative myeloproliferative neoplasmsL39919L40000
NGS lab-developed tests, myeloid malignanciesL38047L38070
Minimal residual disease testing for cancerL38779L38822

Palmetto and Noridian are identical. CGS differs, and every difference is a cross-referenced policy number. A letter citing L38047 to CGS cites a policy CGS does not have.

2. The constraint is not in the draft you are reading

Those criteria bind by incorporation: the draft says non-NGS testing “must also fulfill criteria outlined in L39919”. So the rules that decide whether a test is covered live partly in three other policies — and those are different documents at each contractor.

Assessing one code against one draft means reading six documents per contractor. That is invisible to anyone reading a single page, and it is most of the work.

3. A two-sentence ask, granted four times

The Association for Molecular Pathology wrote to four contractors about solid organ allograft rejection. Among a short letter’s asks: use dd-cfDNA rather than cfDNA, because the general term is not specific to the donor-derived form.

the contractors, at articles 60438, 60439, 60446 and 60447Thank you for your comment. Please see Response #1. Additionally, we have revised “cfDNA” to “dd-cfDNA” in the LCD.

One ask, four contractors, four changes — published on both sides. The cheapest asks are the ones that get granted, and almost nobody makes them.

05

What this cannot tell you

Each limit below is a measurement, not a disclaimer. The number that establishes it is given so you can decide whether to believe the rest.

QuestionAnswerWhy
How many of my patients does this criterion affect?Cannot sayCPT 81195 returns zero rows from every Medicare utilisation source published. New codes have no published utilisation — which is the same fact that makes the coverage decision matter.
Will my comment succeed?Cannot sayAcross the record, zero of fifteen pairwise comparisons between ask types separate at 95% confidence. Coverage-expansion asks reduce to ten decided responses. There is no hit rate to quote.
Will this code be covered?Will not sayThis page reports the record and the diff. Forecasting a contractor’s adjudication is a different act and we do not perform it.
Is my test better than the incumbent?Not oursThat is a clinical evidence question. It is what actually moves a contractor, and it belongs to medical affairs.

Counts above are of what contractors published. None is a causal claim: drafts are revised for reasons unrelated to any comment, and no comparison against that exists.

Watch your codes

Draft policies are published without notice and comment windows run about 45 days. Tell us which codes you bill and we will email you when a draft names one — with the sentences that narrow it, as above.

Set up a watch

Free. The record above stays open to everyone, signed in or not.

What this page does not do