evekhm/cms_iom_500 huggingface dataset:
Article - Off-Label Use of Chemotherapeutic Drugs and Biologicals for Non-Cancer Indications (A59217)
CMS National Coverage PolicyN/AArticle TextThis article addresses the off-labeled use of chemotherapeutic drugs and biologicals for non-cancer indications.Definitions:Off-label (unlabeled) drug use is defined as a non-FDA approved indication that is not listed on the drug's official label/prescribing information. Off-label use is further defined as giving the drug in a way that deviates significantly from the labeled prescribing information for a particular indication. This includes but is not necessarily limited to, dosage, route of administration, duration, and frequency of administration, and population to whom the drug would be administered.An indication is defined as a diagnosis, illness, injury, syndrome, condition, or other clinical parameter for which a drug may be given.Guidance:For the off-label (unlabeled) use of drugs and biologicals for indications that are not part of an anti-cancer chemotherapeutic regime, NGS will consider coverage on case by case basis per CMS internet only manual (IOM), 100-02, Chapter 15, 50.4.2 Unlabeled Use of Drugs. Inclusion of these drugs and biologicals in a compendium does not guarantee coverage, but the compendium recommendation will be considered as part of the review.The following may be submitted to support the coverage with the claim:Submission of compendium reference if availableFull text support articles for use of the agent for the indicationSocietal recommendationsThe medical records must document the rationale for the off-label use of the agent.If a cancer chemotherapy drug/biologic use is identified as not indicated by the Centers for Medicare and Medicaid Services (CMS) or the FDA or if NGS determines that peer-reviewed medical literature does not support the off-label usage, the drug/biologic is not covered.Not Otherwise Classified (NOC) Drug Billing:
Article - Off-Label Use of Chemotherapeutic Drugs and Biologicals for Non-Cancer Indications (A59217)
List the appropriate J or Q HCPCS code to indicate the drug being billed. When a specific HCPCS code does not exist, list the appropriate NOC code J3490, J3590, or J9999 with the drug name, and dose in the remarks field of the claim Item 19 of the CMS-1500 form for claims billed to the Part B MAC.For Part A, claims with C9399 are suspended, and remarks should be placed on the claim in field locator 80 for the UB04 claim form or SV202-7 for 837I electronic claim.Facilities under the hospital OPPS may use code C9399, billed as one unit, for drugs that do not have an assigned HCPCS code or the assigned HCPCS code is not yet effective.Note:Claims billed to the Part B MAC with C9399 will be rejected.Claims billed with a NOC drug code are suspended and the following information should be provided on the claim in the following fields:Field locator 80 for paper claims /line SV202-7 for electronic claims for Part A.Box 19 for paper claims/loop 2400 or SV101-7 for Part B.Claims billed with a NOC drug code need to include the following information in the fields listed above:Name of the drugDose administered (mg, cc, etc.)Route of administration (IV, IM, SC, PO, etc.)NDC number if availableThe invoice price (for new drugs if the wholesale acquisition cost (WAC) is unavailable, or for compounded drugs).The JW modifier is required for wastage in single-dose vials; this modifier does not apply to multi-dose vials per CMS Internet-Only Manual, Pub 100-04, Chapter 17, Section 40 Discarded Drugs and Biologicals (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c17.pdf).
Article - Off-Label Use of Drugs and Biologicals for Anti-Cancer Chemotherapeutic Regimen (A59218)
CMS National Coverage PolicyN/AArticle TextThis article addresses the off-labeled use of drugs and biologicals for anti-cancer chemotherapeutic regimens.Definitions:
Article - Off-Label Use of Drugs and Biologicals for Anti-Cancer Chemotherapeutic Regimen (A59218)
Off-label (unlabeled) drug use is defined as a non-FDA approved indication that is not listed on the drug's official label/prescribing information. Off-label use is further defined as giving the drug in a way that deviates significantly from the labeled prescribing information for a particular indication. This includes but is not necessarily limited to, dosage, route of administration, duration, and frequency of administration, and population to whom the drug would be administered.An indication is defined as a diagnosis, illness, injury, syndrome, condition, or other clinical parameter for which a drug may be given.Guidance:The general utilization of any cancer chemotherapy drug or biological will be covered for a use that is not FDA approved (unlabeled) if used for anti-neoplastic conditions, and if the use is listed as acceptable in one of the Medicare-approved drug compendia and the use is not listed as "not indicated" or unfavorably evaluated in any of the compendia per the Centers for Medicare and Medicaid Services (CMS) Internet-Only Manual (IOM), Pub 100-02, Chapter 15, 50.4.5 Off Label Use of Anti-Cancer Drugs and Biologicals.NGS may also identify off-label uses for anti-cancer drugs and biologicals as part of an anti-cancer chemotherapeutic regimen that are not listed as supported/recommended in medically accepted compendia (NCCN, Micromedex Drug DEX, Lexi-Drugs, AHFS or Clinical Pharmacology). Coverage will be determined for off-label use if supported by clinical research under the conditions identified in the CMS IOM, Pub 100-02, Chapter 15, Section 50.4.5 Off-Label Use of Anti-Cancer Drugs and Biologicals. For a review of medications under this process, please submit full articles, not abstracts, for consideration.Consistent with CMS IOM, Pub 100-02, Chapter 15, Section 50.4.5 D, if a cancer chemotherapy drug/biologic use is identified as not indicated by CMS or the FDA, or the use is specifically identified as not indicated in one or more of the compendia, or if NGS determines that peer-reviewed medical literature does not support the off-label usage, the drug/biologic is not covered.
Article - Off-Label Use of Drugs and Biologicals for Anti-Cancer Chemotherapeutic Regimen (A59218)
Not Otherwise Classified (NOC) Drug Billing:
Article - Off-Label Use of Drugs and Biologicals for Anti-Cancer Chemotherapeutic Regimen (A59218)
List the appropriate J or Q HCPCS code to indicate the drug being billed. When a specific HCPCS code does not exist, list the appropriate NOC code J3490, J3590, or J9999 with the drug name, and dose in the remarks field of the claim Item 19 of the CMS-1500 form for claims billed to the Part B MAC.For Part A, claims with C9399 are suspended, and remarks should be placed on the claim in field locator 80 for the UB04 claim form or SV202-7 for 837I electronic claim.Facilities under the hospital OPPS may use code C9399, billed as one unit, if it does not have an assigned HCPCS or the assigned HCPCS is not yet effective.Note: Claims billed to the Part B MAC with C9399 will be rejected.Claims billed with a NOC drug code are suspended and the following information should be provided on the claim in the following fields:Field locator 80 for paper claims /line SV202-7 for electronic claims for Part A.Box 19 for paper claims/loop 2400 or SV101-7 for Part B.Claims billed with a NOC drug code need to include the following information in the fields listed above:Name of the drugDose administered (mg, cc, etc.)Route of administration (IV, IM, SC, PO, etc.)NDC number if availableThe invoice price (for new drugs if the wholesale acquisition cost (WAC) is unavailable, or for compounded drugs).The JW modifier is required for wastage in single-dose vials; this modifier does not apply to multi-dose vials per CMS Internet-Only Manual, Pub 100-04, Chapter 17, Section 40 Discarded Drugs and Biologicals (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c17.pdf).
Draft Article - Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DA54117)
CMS National Coverage PolicyInternet-Only Manuals (IOMs):CMS IOM Publication 100-02,Medicare Benefit Policy Manual,Chapter 15, Section 50.4.1 Approved Use of DrugCMS IOM Publication 100-04,Medicare Claims Processing Manual,Chapter 17, Section 40 Discarded Drugs and BiologicalsSocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period.Code of Federal Regulations (CFR) References:CFR, Title 21, Volume 8, Chapter 1, Subchapter L, Part 1271.10 Human cells, tissues, and cellular and tissue-based productsArticle Text
Draft Article - Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DA54117)
This Billing and Coding Article provides billing and coding guidance for Proposed Local Coverage Determination (LCD) DL35041 Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. Please refer to the LCD for reasonable and necessary requirements.Coding GuidanceNotice:It is not appropriate to bill Medicare for services that are not covered (as described by the entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.Per the Current Procedural Terminology (CPT) codebook definition, skin substitute grafts include non-autologous human skin (dermal or epidermal, cellular and acellular) grafts (e.g., homograft, allograft), non-human skin substitute grafts (i.e., xenograft), and biological products that form a sheet scaffolding for skin growth. Skin substitute graft application codes are not to be reported for application of non-graft wound dressings (e.g., gel, powder, ointment, foam, liquid) or injected skin substitutes.Do not report non-graft wound dressings or injected skin substitute HCPCS codes with skin substitute graft application codes as this would be considered incorrect coding. Such products are bundled into other standard management procedures if medically necessary and are not separately payable.Removal of a current graft and/or simple cleansing of the wound and other surgical preparation services are included in the skin substitute graft application codes. Active wound care management (CPT code 97602) procedures should never be reported in conjunction with skin substitute graft application codes.One would not expect an evaluation and management (E/M) service with each skin replacement surgical procedure (application of skin substitute graft) in an episode of care unless the patients condition required a separately identified service.If reporting a skin substitute product with HCPCS code Q4100 (Skin substitute, not otherwise specified) or HCPCS code A4100 (Skin substitute, FDA cleared as a device, not otherwise specified), the product name, package size purchased, amount applied and amount wasted must be reported in the claim narrative/remarks or the claim will be returned to the provider.Skin substitute HCPCS codes included in Group 2 below reported with any application or administration service NOT included in Group 1 below will be denied.
Draft Article - Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DA54117)
Skin substitute HCPCS codes included in Group 2 below reported with any application or administration service NOT included in Group 1 below will be denied.Application codes billedmustuse the appropriate modifier (e.g., RT, LT) to identify the location where the skin substitute was applied, or the service will be denied.The appropriate application code must be reported on the same claim as the skin substitute graft code. When the skin substitute graft is denied, the related application code will also be subject to denial.Satisfactory Evidence of FDA Regulatory Requirements
Draft Article - Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DA54117)
Satisfactory evidence of the U.S. Food and Drug Administration (FDA) regulatory requirements for the skin substitute grafts or cellular and/or tissue-based products (CTPs) included in this billing and coding article includes:A copy of the FDAs letter to the drugs manufacturer approving the new drug application (NDA),A listing of the drug or biological in the FDAs Approved Drug Products or FDA Drug and Device Product Approvals,A copy of the manufacturers package insert approved by the FDA as part of the labeling of the drug, containing its recommended uses and dosage, as well as possible adverse reactions and recommended precautions in using it, orInformation from the FDAs Website.For skin substitute grafts or CTPs classified as human cells, tissues, and cellular and tissue-based products (HCT/Ps), a letter from the FDA indicating that the HCT/P has met regulatory guidance is acceptable evidence of the FDA regulatory compliance for HCT/Ps regulated under section 361 of the Public Health Service Act and/or the Federal Food, Drug, and Cosmetic Act.It is recommended that the manufacturer of the particular skin substitute graft or CTP product obtain the appropriate information for FDA regulatory compliance and send to the MAC along with evidence-based literature, if available. Once this information has been received by the MAC, the product will be considered for coverage and placed into the appropriate Code Group.Utilization ParametersApplication frequency must follow the product labeling. A maximum of two skin substitute graft product applications per wound will be allowed for the episode of skin replacement surgery for wound care (defined as 12-weeks from the first application of a skin substitute graft) for those products recommended per the labeling to require a second application.Application of a skin substitute graft product beyond the 12-week episode of skin replacement wound care will not be allowed.Documentation Requirements
Draft Article - Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DA54117)
All documentation must be maintained in the patients medical record and made available to the contractor upon request.Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.The medical record must clearly document that the criteria listed in the LCD has been met, as well as the appropriate diagnosis and response to treatment. Description of the wound(s) must be documented at baseline (prior to beginning conservative wound care measures) relative to size, location, stage, duration, and presence of infection, in addition to the type of conservative treatment given and the response. This information must be updated in the medical record throughout the episode of skin replacement surgery for wound care. The wound description must also be documented pre- and post- treatment with the skin substitute graft being used. The reason(s) for any repeat application should be specifically addressed in the medical record.Documentation must include an assessment outlining the plan for skin replacement surgery and the choice of skin substitute product for the 12-week period as well as any anticipated repeat applications within the 12-week period. An operative note must support the procedure (e.g., application of skin substitute graft to legs) for the relevant date of service (first application starts the 12-week episode of care) and include the reason for the procedure and a complete description of the procedure including product used (with identifying package label in the chart), and relevant findings.Any amount of wasted skin substitute must be clearly documented in the procedure note with ALL of the following information (at a minimum): Date, time and location of ulcer(s) treated; Name of skin substitute and package size; Approximate amount of product unit used; Approximate amount of product unit discarded; Reason for the wastage (including the reason for using a package size larger than was necessary for the size of the wound, if applicable); Manufacturers serial/lot/batch or other unit identification number of graft material. When the manufacturer does not supply unit identification, the record must document such.
Draft Article - Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DA54117)
The HCPCS code of the applicable skin substitute and the units billed must be consistent with the medical record regarding wound description and size.
Draft Article - Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DA57680)
CMS National Coverage PolicyInternet-Only Manuals (IOMs):CMS IOM Publication 100-02,Medicare Benefit Policy Manual,Chapter 15, Section 50.4.1 Approved Use of DrugCMS IOM Publication 100-04,Medicare Claims Processing Manual,Chapter 17, Section 40 Discarded Drugs and BiologicalsSocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period.Code of Federal Regulations (CFR) References:CFR, Title 21, Volume 8, Chapter 1, Subchapter L, Part 1271.10 Human cells, tissues, and cellular and tissue-based productsArticle Text
Draft Article - Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DA57680)
This Billing and Coding Article provides billing and coding guidance for Proposed Local Coverage Determination (LCD) DL36377 Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. Please refer to the LCD for reasonable and necessary requirements.Coding GuidanceNotice:It is not appropriate to bill Medicare for services that are not covered (as described by the entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.Per the Current Procedural Terminology (CPT) codebook definition, skin substitute grafts include non-autologous human skin (dermal or epidermal, cellular and acellular) grafts (e.g., homograft, allograft), non-human skin substitute grafts (i.e., xenograft), and biological products that form a sheet scaffolding for skin growth. Skin substitute graft application codes are not to be reported for application of non-graft wound dressings (e.g., gel, powder, ointment, foam, liquid) or injected skin substitutes.Do not report non-graft wound dressings or injected skin substitute HCPCS codes with skin substitute graft application codes as this would be considered incorrect coding. Such products are bundled into other standard management procedures if medically necessary and are not separately payable.Removal of a current graft and/or simple cleansing of the wound and other surgical preparation services are included in the skin substitute graft application codes. Active wound care management (CPT code 97602) procedures should never be reported in conjunction with skin substitute graft application codes.One would not expect an evaluation and management (E/M) service with each skin replacement surgical procedure (application of skin substitute graft) in an episode of care unless the patients condition required a separately identified service.If reporting a skin substitute product with HCPCS code Q4100 (Skin substitute, not otherwise specified) or HCPCS code A4100 (Skin substitute, FDA cleared as a device, not otherwise specified), the product name, package size purchased, amount applied and amount wasted must be reported in the claim narrative/remarks or the claim will be returned to the provider.Skin substitute HCPCS codes included in Group 2 below reported with any application or administration service NOT included in Group 1 below will be denied.
Draft Article - Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DA57680)
Skin substitute HCPCS codes included in Group 2 below reported with any application or administration service NOT included in Group 1 below will be denied.Application codes billedmustuse the appropriate modifier (e.g., RT, LT) to identify the location where the skin substitute was applied, or the service will be denied.The appropriate application code must be reported on the same claim as the skin substitute graft code. When the skin substitute graft is denied, the related application code will also be subject to denial.Satisfactory Evidence of FDA Regulatory Requirements
Draft Article - Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DA57680)
Satisfactory evidence of the U.S. Food and Drug Administration (FDA) regulatory requirements for the skin substitute grafts or cellular and/or tissue-based products (CTPs) included in this billing and coding article includes:A copy of the FDAs letter to the drugs manufacturer approving the new drug application (NDA),A listing of the drug or biological in the FDAs Approved Drug Products or FDA Drug and Device Product Approvals,A copy of the manufacturers package insert approved by the FDA as part of the labeling of the drug, containing its recommended uses and dosage, as well as possible adverse reactions and recommended precautions in using it, orInformation from the FDAs Website.For skin substitute grafts or CTPs classified as human cells, tissues, and cellular and tissue-based products (HCT/Ps), a letter from the FDA indicating that the HCT/P has met regulatory guidance is acceptable evidence of the FDA regulatory compliance for HCT/Ps regulated under section 361 of the Public Health Service Act and/or the Federal Food, Drug, and Cosmetic Act.It is recommended that the manufacturer of the particular skin substitute graft or CTP product obtain the appropriate information for FDA regulatory compliance and send to the MAC along with evidence-based literature, if available. Once this information has been received by the MAC, the product will be considered for coverage and placed into the appropriate Code Group.Utilization ParametersApplication frequency must follow the product labeling. A maximum of two skin substitute graft product applications per wound will be allowed for the episode of skin replacement surgery for wound care (defined as 12-weeks from the first application of a skin substitute graft) for those products recommended per the labeling to require a second application.Application of a skin substitute graft product beyond the 12-week episode of skin replacement wound care will not be allowed.Documentation Requirements