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.…
closed 2025-06-28 · 4 comments