evekhm/cms_iom_500 huggingface dataset:
Article - Billing and Coding: MolDX: Short Tandem Repeat (STR) Markers and Chimerism (CPT® codes 81265-81268) (A54832)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.CMS Internet-Only Manuals, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, 80.1.2 A/B MAC (B) Contacts With Independent Clinical LaboratoriesCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, 50.5 Jurisdiction of Laboratory Claims, 60.1.1 Independent Laboratory Specimen Drawing, 60.2 Travel AllowanceArticle TextPlease note that CPTcodes 81265 and 81266 describe services performed for recipient/donor testingandtwin zygosity. Tests indicated for recipient/donor testing will be considered for payment and tests for twin zygosity will be denied as a statutorily excluded service. The following instructions outline the correct reporting of recipient/donor testing for transplant services.Chimerism analysis to identify appropriate donors and monitor engraftment success or disease reoccurrence is a covered Medicare service.Code 81265 should be reported with one unit of service (UOS). Except in rare cases, this service would only be performed once per lifetime.Code 81266, when used in bone marrow transplants to report an additional double-cord blood sample, is a covered service.Code 81267 should be used post transplantation to confirm successful engraftment or disease reoccurrence. Although the original donor specimen may be referenced, an additional 81265 should NOT be submitted in addition to the 81267 service. For labs that hold the pre-transplant specimen (81265 and/or 81266) until after the transplant occurs, use 81267 plus 81265 and 81266 if necessary.Note:Code 81267 should be reported for the findings of the pre and post-transplant comparison.Code 81268 should be used to report chimerism using a buccal or other germline tissue specimen from the recipient post-transplantation. For labs that hold the pre-transplant specimen (81265 and/or 81266) until after the transplant occurs, use 81267 plus 81265 and 81266 if necessary.
Article - Billing and Coding: MolDX: Short Tandem Repeat (STR) Markers and Chimerism (CPT® codes 81265-81268) (A54832)
MolDX would not expect to see a claim for 81265 pre-transplant and an additional 81265 and 81267 post-transplant or a claim for 81265 pre-transplant and an additional claim for 81268.EXCEPTIONS:Although the initial chimerism testing, code 81265, for engraftment is usually limited to once in a lifetime, MolDX recognizes special circumstances may require an additional service and will consider approval on a case-by-case basis through the appeal process.To report a Molecular Diagnostic Test service, please submit the following claim information:Select appropriate CPTcodeEnter 1 unit of service (UOS)Enter the appropriate DEX Z-Codeidentifier adjacent to the CPTcode in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter the appropriate DEX Z-Codeidentifier adjacent to the CPTcode in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formNOTE:When entering the DEX Z-Codeon the SV101-7 documentation field for Part B claims please do not add additional characters and/or information on the line.
Article - Billing and Coding: MolDX: CDH1 Genetic Testing (A54835)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body memberArticle TextCDH1 testing is utilized in patients with specified cancers as an adjunctive test. CDH1 testing has also been recommended as a screening test for other cancers. However, screening for individuals at risk for cancer is not a Medicare benefit and is statutorily excluded.To receive a CDH1 test denial, please submit the following claim information:CPT 81406 - CDH1, full gene sequenceAn Advance Beneficiary Notice (ABN) is not required for statutorily excluded services.For a voluntary issued ABN, append with GX modifierTo indicate a valid ABN is on file for a known statutorily excluded service, append with a GY modifierEnter the appropriate DEX Z-Codeidentifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter the appropriate DEX Z-Codeidentifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formIn rare cases in which HDGC is suspected in a Medicare beneficiary, MolDX will review the documentation on a case-by-case basis.
Article - Billing and Coding: MolDX: CDH1 Genetic Testing (A54878)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body memberArticle TextCDH1 testing is utilized in patients with specified cancers as an adjunctive test. CDH1 testing has also been recommended as a screening test for other cancers. However, screening for individuals at risk for cancer is not a Medicare benefit and is statutorily excluded.To receive a CDH1 test denial, please submit the following claim information:CPT81406 - CDH1, full gene sequenceAn Advance Beneficiary Notice (ABN) is not required for statutorily excluded services.For a voluntary issued ABN, append with GX modifierTo indicate a valid ABN is on file for a known statutorily excluded service, append with a GY modifierEnter the appropriate DEX Z-codeTMidentifier adjacent to the CPTcode in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter the appropriate DEX-Z-codeTMidentifier adjacent to the CPTcode in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 8371 electronic claimBlock 80 for paper claimIn rare cases in which HDGC is suspected in a Medicare beneficiary, MolDX will review the documentation on a case-by-case basis.
Article - Billing and Coding: Additional Claim Documentation Requirements for Not Otherwise Classified (NOC) Drugs and Biological Products with Specific FDA Label Indications (A54880)
CMS National Coverage PolicyN/AArticle TextGeneral Documentation that is required on every claim for all products:Hospital Part A:Submit the following information for claims involving 'not otherwise classified' or 'unlisted' HCPCS codes for drugs, biological products, and radiopharmaceuticals (J3490, J3590, J9999, A4641, and A9699) with limited or specific indications: The appropriate NOC code The appropriate diagnosis The appropriate revenue codes for the drug and IV infusion Drug name, the National Drug Code (NDC) number and total dosage must be indicatedFor claim submission, the documentation must be included in the remarks field (Field Locator 80) on the UB-04 (CMS 1450 form) or the equivalent 5010 electronic claim field.Part B:Please refer to the following articles on the Palmetto GBA website for general information regarding additional required documentation for NOC drugs, biological products and radiopharmaceuticals:Unclassified or Not Otherwise Classified (NOC) Drug Codes: Rejected if Not Submitted CorrectlyProduct specific information that is required on both Part A and Part B claims:For any new drug not given an assigned specific HCPCS code, Palmetto GBA must be able to ascertain that FDA labeling indications have been met in the use of the drug or radiopharmaceutical. In addition to the documentation listed above, documentation submitted for oncology drugs or oncology radiopharmaceuticals submitted with not otherwise classified codes (NOC) prior to that particular drug or radiopharmaceutical receiving a unique HCPCS code must also include:1. The diagnosis code for the specific FDA label indication for the drug. If no diagnosis code exists that adequately describes or distinguishes the FDA label indication (e.g. the indication is squamous cell carcinoma of the lung and the only available diagnosis code is malignant neoplasm of upper lobe), a specific narrative description (i.e. squamous cell carcinoma) must accompany the appropriate (more general) diagnosis code.2. If applicable, the narrative information must also indicate that any other FDA labeled criteria is met. The following are examples of such conditions:
Article - Billing and Coding: Additional Claim Documentation Requirements for Not Otherwise Classified (NOC) Drugs and Biological Products with Specific FDA Label Indications (A54880)
2. If applicable, the narrative information must also indicate that any other FDA labeled criteria is met. The following are examples of such conditions:a) There must be a statement that the disease is metastatic if the indication is only for a metastatic form of the malignancy in the FDA indication or a statement that the individual patient condition is consistent with any other FDA label criteria, (e.g., bony metastases, but no visceral metastases, etc.).b) If the FDA indication states that the drug is for second or subsequent line treatment after other specific regimens have been employed and/or that the disease is progressive or recurrent after other specific drug regimens or protocols have been employed, a statement to that effect and/or the disease has progressed despite or after those regimens must be included in the narrative.3. If applicable, a statement that any other criteria (not discussed above), required in the FDA label has been met. This requirement would apply to non-oncology drugs, biologic products, or radiopharmaceuticals, as well as, oncology related therapeutic agents with NOC codes.
Article - Billing and Coding: MolDX: Targeted and Comprehensive Genomic Profile Next Generation Sequencing Testing in Cancer (A54901)
CMS National Coverage PolicyN/AArticle Text
Article - Billing and Coding: MolDX: Targeted and Comprehensive Genomic Profile Next Generation Sequencing Testing in Cancer (A54901)
Next Generation Sequencing (NGS)NGS allows identification of somatic and/or germline alterations in multiple genes simultaneously. This guideline focuses on Targeted and Comprehensive Genomic Profile testing for somatic variant detection using tumor-based panels for cancer that may be performed by NGS.Refer toMolDX: Defining panel services in MolDX A59698for further guidance on the distinction between single analyte and panel tests.Definitions:Targeted Tumor PanelsTargeted tumor panels are hereby defined as tests that identify somatic alterations known to occur in certain regions (i.e.,'hotspots') within specific genes of interest for cancer management (i.e., diagnosis, selection of molecularly targeted therapies, prognosis in a context where prognostic classification is essential for treatment selection). Generally, these panels are limited to specific variant types at defined sites, such as single nucleotide variants (SNVs), small insertions or deletions (INDELs), single site copy number variants, or gene fusions. These alterations typically represent response or lack of response to corresponding targeted cancer therapies. The hotspot test should include relevant targets required for companion diagnostic testing and/or known to be necessary for proper patient management.Comprehensive Genomic Profile (CGP) Testing
Article - Billing and Coding: MolDX: Targeted and Comprehensive Genomic Profile Next Generation Sequencing Testing in Cancer (A54901)
Comprehensive Genomic Profile (CGP) TestingCGP testing refers to NGS-based molecular assays that provide additional insight beyond individual gene hotspots; these assays seek to describe the genomic makeup of a tumor and can help identify underlying mechanisms of disease to guide clinical decision making. These tests include not only mutations in individual relevant genes, but also patterns of mutations across related genes in established cancer pathways and often include an assessment of overall mutational burden. These tests typically involve sequencing of entire exonic regions of genes of interest within a comprehensive gene panel or whole exome sequencing and may also include select intronic regions. CGP tests can detect multiple types of molecular alterations (i.e., SNVs, small and large INDELs, copy number variants (CNVs), structural variants (SVs), and splice-site variants) in a single assay. Patterns of mutations seen across multiple genes may be used to infer clinically relevant etiologies, such as DNA mismatch repair deficiency and microsatellite instability (MSI), total mutational load/burden (TMB) and chromosome abnormalities such as loss of heterozygosity (LOH). CGP testing may also include RNA sequencing to detect structural variations, such as translocations or large deletions, and to detect functional splicing mutations. CGP testing is not defined as a targeted panel by MolDX. CGP tests are expected to yield information of clinical relevance beyond a targeted panel, for example, to identify relevant clinical trials for patient management or identify possible therapeutic interventions for off-label use. It is expected that a CGP will identify all clinically relevant information attainable for the type of service performed.CPT coding Instructions:Targeted Tumor PanelsTo bill for DNA-based panels that measure specific SNVs, INDELs, CNVs or rearrangements, review CPT codes 81445 and 81450. If a DNA-based targeted panel meeting the coverage requirements is used, and MSI is also performed, 81457 can be billed. If a DNA-based targeted test meeting coverage requirements is performed that includes MSI and CNVs, 81458 can be billed.
Article - Billing and Coding: MolDX: Targeted and Comprehensive Genomic Profile Next Generation Sequencing Testing in Cancer (A54901)
81449 or 81451 for RNA-based targeted testing may also be billed for the same specimen that received a DNA-based NGS test if complaint with the language of A57503, is non-duplicative, and performed serially to DNA testing as a separate service (with a separate order and report). If only RNA-based testing is reasonable and necessary, 81449 or 81451 may be billed alone if policy requirements are met. If two targeted panels (one for DNA and the other for RNA) are always performed together and meet policy criteria, 81479 should be used for such a service to reduce claims processing errors as this would constitute one service.The unit of service (UOS) for an NGS gene panel is one (UOS=1). Providers must also provide the approved DEX Z-Codeidentifier for the test.Effective July 1, 2017, laboratories with 2 to 4 genes on their targeted NGS panel should use CPT 81479 and one (1) UOS along with their test identifier (DEX Z-Code) to represent this service on their claims.CGPCGP code 81459, based on the inclusion of the comprehensive test components addressed in the definition above, is considered a CGP test by this contractor and may be billed when all stated components of the service have satisfied technical assessment requirements. Because this code includes both DNA-only and DNA/RNA combined services in its description, it is assumed that services that include DNA/RNA combined testing add no additional relevant genomic information beyond that provided by a DNA-only test. For CGP tests that include the use of RNA to interrogate relevant genomic information beyond that captured with DNA-based testing, billing with CPT 81479 is appropriate. Additionally, if a service meets the defintion of a CGP but NOT 81459, CPT code 81479 is appropriate.Therefore, to report a CGP service, test providers should use CPT codes 81459 or 81479, in addition to the approved DEX Z-Codefor the test. Coverage of CGPs is limited to one test per surgical specimen and precludes the use of any further molecular testing on that specimen.
Article - Billing and Coding: MolDX: Targeted and Comprehensive Genomic Profile Next Generation Sequencing Testing in Cancer (A54901)
For NGS-based tests that do not fit under the above definitions of targeted or Comprehensive panels, billing with the Not Otherwise Classified (NOC) code 81479 along with the approved DEX Z-Codeidentifier is appropriate.Tier 1 and/or Tier 2 individual biomarker CPT codes should not be used for a single gene or any combination of genes when testing is performed as part of a NGS or other multiplexing technology panel.Refer toBilling and Coding: MolDX: Next-Generation Sequencing for Solid Tumors A57870for CPT/HCPCS codes and ICD-10 codes relevant for solid tumors.Refer toBilling and Coding: MolDX: Next-Generation Sequencing Lab-Developed Tests for Myeloid Malignancies and Suspected Myeloid Malignancies A57873for CPT/HCPCS codes and ICD-10 codes relevant for myeloid malignancies.
Article - Billing and Coding: Single Chamber and Dual Chamber Permanent Cardiac Pacemakers (A54909)
CMS National Coverage PolicyN/AArticle TextAbstract:The National Coverage Determination (NCD) 20.8.3, Single Chamber and Dual Chamber Permanent Cardiac Pacemakers were revised with an effective date of August 13, 2013. The CMS A/B Medicare Administrative Contractors (MACs) have been instructed to implement the NCD at the local level. The following provides coding and billing instructions for the implementation of NCD 20.8.3. (CMS policy language is initalics.) The NCD Item/Service Description and Indications and Limitations are repeated here.Item/Service DescriptionA. GeneralPermanent cardiac pacemakers refer to a group of self-contained, battery operated, implanted devices that send electrical stimulation to the heart through one or more implanted leads. They are often classified by the number of chambers of the heart that the devices stimulate (pulse or depolarize). Single chamber pacemakers typically target either the right atrium or right ventricle. Dual chamber pacemakers stimulate both the right atrium and the right ventricle.The implantation procedure is typically performed under local anesthesia and requires only a brief hospitalization. A catheter is inserted into the chest and the pacemakers leads are threaded through the catheter to the appropriate chamber(s) of the heart. The surgeon then makes a small pocket in the pad of the flesh under the skin on the upper portion of the chest wall to hold the power source. The pocket is then closed with stitches.The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to conclude that implanted permanent cardiac pacemakers, single chamber or dual chamber, are reasonable and necessary for the treatment of non-reversible symptomatic bradycardia due to sinus node dysfunction and second and/or third degree atrioventricular block. Symptoms of bradycardia are symptoms that can be directly attributable to a heart rate less than 60 beats per minute (for example: syncope, seizures, congestive heart failure, dizziness, or confusion).Indications and Limitations of CoverageB. Nationally Covered IndicationsThe following indications are covered for implanted permanent single chamber or dual chamber cardiac pacemakers:
Article - Billing and Coding: Single Chamber and Dual Chamber Permanent Cardiac Pacemakers (A54909)
Indications and Limitations of CoverageB. Nationally Covered IndicationsThe following indications are covered for implanted permanent single chamber or dual chamber cardiac pacemakers:Documented non-reversible symptomatic bradycardia due to sinus node dysfunction, andDocumented non-reversible symptomatic bradycardia due to second degree and/or third degree atrioventricular block.C. Nationally Non-Covered IndicationsThe following indications are non-covered for implanted permanent single chamber or dual chamber cardiac pacemakers:Reversible causes of bradycardia such as electrolyte abnormalities, medications or drugs, and hypothermia,Asymptomatic first degree atrioventricular block,Asymptomatic sinus bradycardia,Asymptomatic sino-atrial block or asymptomatic sinus arrest,Ineffective atrial contractions (e.g., chronic atrial fibrillation or flutter, or giant left atrium) without symptomatic bradycardia,Asymptomatic second degree atrioventricular block of Mobitz Type I unless the QRS complexes are prolonged or electrophysiological studies have demonstrated that the block is at or beyond the level of the His Bundle (a component of the electrical conduction system of the heart),Syncope of undetermined cause,Bradycardia during sleep,Right bundle branch block with left axis deviation (and other forms of fascicular or bundle branch block) without syncope or other symptoms of intermittent atrioventricular block,Asymptomatic bradycardia in post-myocardial infarction patients about to initiate long-term beta-blocker drug therapy,Frequent or persistent supraventricular tachycardias, except where the pacemaker is specifically for the control of tachycardia, andA clinical condition in which pacing takes place only intermittently and briefly, and which is not associated with a reasonable likelihood that pacing needs will become prolonged.D. OtherMedicare Administrative Contractors will determine coverage under section 1862(a)(1)(A) of the Social Security Act for any other indications for the implantation and use of single chamber or dual chamber cardiac pacemakers that are not specifically addressed in this national coverage determination.(This NCD last reviewed August 2013.)
Article - Billing and Coding: Single Chamber and Dual Chamber Permanent Cardiac Pacemakers (A54909)
Please note:The Decision Memo for Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemaker (CAG-00063R3) states:CMS initiated this current national coverage analysis to reconsider coverage indications for single chamber and dual chamber cardiac pacemakers. The scope of this reconsideration and this decision memorandum does not address biventricular pacemakers, pacemakers that stimulate more than two heart chambers, those devices used to treat tachyarrhythmias and cardiac dyssynchrony, cardiac resynchronization therapy, cardiac pacemaker evaluation services, or self-contained pacemaker monitors.Medicare Administrative Contractors will determine coverage under section 1862(a)(1)(A) of the Social Security Act for any other indications for the implantation and use of single chamber or dual chamber cardiac pacemakers that are not specifically addressed in this national coverage determination.The coding and billing guidelines only apply to those CPT codes for the initial insertion of cardiac pacemakers:33206 Insertion of new or replacement of permanent pacemaker with transvenous electrode(s); atrial33207 ventricular33208 atrial and ventricularThe NCD does not address replacement of pacemaker generators. CPT codes 33227, 33228 and 33229 or 33233 are therefore not addressed in this coding article.CMS NCD Covered Conditions and Diagnosis Codes  Group IClinical Conditions:Documented non-reversible symptomatic bradycardia due to sinus node dysfunctionDocumented non-reversible symptomatic bradycardia due to second degree and/or third degree atrioventricular blockDiagnosis Codes (ICD-10-CM) (Attest with Modifier - KX):Atrioventricular (AV) block (I44.2)Mobitz (type II) AV block (I44.1)Other second degree AV block (I44.1)Sinoatrial node dysfunction/Sick sinus syndrome (I49.5)Congenital heart block (Q24.6)Contractor (Additional) Diagnosis Codes (ICD-10-CM) Allowed by the NCD  Group II (Attest with Modifier - KX)