evekhm/cms_iom_500 huggingface dataset:
Article - Billing and Coding: Spinraza® (nusinersen) (A58578)
it was injected on or after the date of the FDA's approval;it is reasonable and necessary for the individual patient and,all other applicable coverage requirements are met."1When provided in accordance with FDA indications and subsequently billing for Medicare reimbursement, use J-codeJ2326along with the appropriate billable units.The medication is injected intrathecally. Therefore, it is expected that this medicationmustbe billed in conjunction with CPT procedure code96450[chemotherapy administration, into central nervous system (CNS) (e.g. intrathecal), requiring spinal puncture] on the same date of service.2Should the provider and facility bill separately for procedure and medication respectively, the facility must bill the administration code as a no pay service and the drug as the presumed covered service.Noridian recognizes the importance of the provider coding to the highest level of specificity. As this medication is clinically indicated for the most specific of diagnoses, the providermustbill with the appropriate primary ICD -10-CM code that identifies the type of Spinal Muscular Atrophy that the Medicare beneficiary has been fully evaluated and diagnosed with.Consequently, it is Noridians expectation that the appropriate primary ICD-10-CM Diagnosis Codemustbe billed, as either:G12.0(Infantile spinal muscular atrophy, type I; Werdnig-Hoffman)orG12.1(Other inherited spinal muscular atrophy) to include:-Adult form spinal muscular atrophy-Childhood form, type II spinal muscular atrophy-Distal spinal muscular atrophy-Juvenile form, type III spinal muscular atrophy (Kugelberg-Welander)-Progressive bulbar palsy of childhood (Fazio-Londe)-Scapuloperoneal from spinal muscular atrophy
Article - Billing and Coding: Spinraza® (nusinersen) (A58578)
Frequency Limitations:The drug SPINRAZA (nusinersen) is also FDA indicated for a specific dosing requirement.Currently, FDA has approved the dosage of 12 mg (5mL) per administration.3For the first 12 months of treatment, no more than six (6) intrathecal injections of (SPINRAZA) nusinersen (HCPCS code J2326) may be reported.After the first 12 months of treatment, no more than three (3) intrathecal injections of (SPINRAZA) nusinersen (HCPCS code J2326) may be reported in a rolling 12-month period of time.Any other associated primary ICD 10 diagnosis code billed, or any dosage or frequency other than what is FDA approved, will be reviewed on a claim by claim basis for medical necessity and payment.References:Internet Only Manual (IOM), Medicare Benefit Policy Manual (Pub. 100-02), Chapter 15, Section 50.4.1CPT Assistant-Reporting Intrathecal Injection of Nusinersen (March 2021, Volume 31, Issue 3, page 3)FDA Label SPINRAZA (nusinersen)
Article - Billing and Coding: Spinraza® (Nusinersen) (A58579)
CMS National Coverage PolicyN/AArticle TextNoridian has received numerous billing and coding queries regarding J2326, Nusinersen, (Brand name SPINRAZA). This code became effective 01/01/2018.This article is not a coverage determination, but rather guidance on the appropriate billing and coding when utilizing this medication.As a reminder, the Internet Only Manual (IOM), Medicare Benefit Policy Manual (Pub. 100-02), Chapter 15, Section 50.4.1 Approved Use of Drug states,"Use of the drug or biological must be safe and effective and otherwise reasonable and necessary. Drugs or biologicals approved for marketing by the Food and Drug Administration (FDA) are considered safe and effective for purposes of this requirementwhen used for indications specified on the labeling.Therefore, the programmaypay for the use of an FDA approved drug or biological, if:it was injected on or after the date of the FDA's approval;it is reasonable and necessary for the individual patient and,all other applicable coverage requirements are met."1
Article - Billing and Coding: Spinraza® (Nusinersen) (A58579)
it was injected on or after the date of the FDA's approval;it is reasonable and necessary for the individual patient and,all other applicable coverage requirements are met."1When provided in accordance with FDA indications and subsequently billing for Medicare reimbursement, use J-codeJ2326along with the appropriate billable units.The medication is injected intrathecally. Therefore, it is expected that this medicationmustbe billed in conjunction with CPT procedure code96450[chemotherapy administration, into central nervous system (CNS) (e.g. intrathecal), requiring spinal puncture] on the same date of service.2Should the provider and facility bill separately for procedure and medication respectively, the facility must bill the administration code as a no pay service and the drug as the presumed covered service.Noridian recognizes the importance of the provider coding to the highest level of specificity. As this medication is clinically indicated for the most specific of diagnoses, the providermustbill with the appropriate primary ICD -10-CM code that identifies the type of Spinal Muscular Atrophy that the Medicare beneficiary has been fully evaluated and diagnosed with.Consequently, it is Noridians expectation that the appropriate primary ICD-10-CM Diagnosis Codemustbe billed, which includes either:G12.0(Infantile spinal muscular atrophy, type I; Werdnig-Hoffman)or,G12.1(Other inherited spinal muscular atrophy) to include:-Adult form spinal muscular atrophy-Childhood form, type II spinal muscular atrophy-Distal spinal muscular atrophy-Juvenile form, type III spinal muscular atrophy (Kugelberg-Welander)-Progressive bulbar palsy of childhood (Fazio-Londe)-Scapuloperoneal from spinal muscular atrophy
Article - Billing and Coding: Spinraza® (Nusinersen) (A58579)
Frequency Limitations:The drug SPINRAZA (nusinersen) is also FDA indicated for a specific dosing requirement.Currently, FDA has approved the dosage of 12 mg (5mL) per administration.3For the first 12 months of treatment, no more than six (6) intrathecal injections of (SPINRAZA) nusinersen(HCPCS code J2326) may be reported.After the first 12 months of treatment, no more than three (3) intrathecal injections of (SPINRAZA) nusinersen(HCPCS code J2326) may be reported in a rolling 12-month period of time.Any other associated primary ICD 10 diagnosis code billed, or any dosage or frequency other than what is FDA approved, will be reviewed on a claim by claim basis for medical necessity and payment.References:Internet Only Manual (IOM), Medicare Benefit Policy Manual (Pub. 100-02), Chapter 15, Section 50.4.1CPT Assistant-Reporting Intrathecal Injection of Nusinersen (March 2021, Volume 31, Issue 3, page 3)FDA Label SPINRAZA (nusinersen)
Article - Billing and Coding: Off-label Use of Rituximab and Rituximab Biosimilars (A58582)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim lacking the necessary documentation to process the claimCMS Manual System, Pub 100-04, Medicare Claims Processing Manual, Change Request 10530, Transmittal 3996 dated March 9, 2018CMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 17, 40 Discarded Drugs and BiologicalsArticle TextThis article gives guidance for billing, coding, and other guidelines in relation to local coverage policy Rituximab and biosimilars (DL38920) which addresses off-label use of Rituximab. Labeled indications are not included in this policy. FDA labeled indications include: chronic lymphocytic leukemia, non-Hodgkin lymphomas, pemphigus vulgaris, rheumatoid arthritis, Antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (which includes microscopic polyangiitis, granulomatosis with polyangiitis (GPA) (formally Wegener's Granulomatosis) and eosinophilic GPA (formally ChurgStrauss syndrome).General Guidelines for Claims submitted to Part A or Part B MACProcedure codes may be subject to National Correct Coding Initiative (NCCI) edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing Medicare. For services requiring a referring/ordering physician, the name and NPI of the referring/ordering physician must be reported on the claim. A claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as an incomplete claim under Section 1833(e) of the Social Security Act. The diagnosis code(s) must best describe the patient's condition for which the service was performed. For diagnostic tests, report the result of the test if known; otherwise the symptoms prompting the performance of the test should be reported.Advance Beneficiary Notice of Non-coverage (ABN) Modifier Guidelines:
Article - Billing and Coding: Off-label Use of Rituximab and Rituximab Biosimilars (A58582)
Advance Beneficiary Notice of Non-coverage (ABN) Modifier Guidelines:An ABN may be used for services which are likely to be non-covered, whether for medical necessity or for other reasons. Refer to CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 30, for complete instructions.Effective from April 1, 2010, non-covered services should be billed with modifier GA, -GX, -GY, or GZ, as appropriate.The GA modifier (Waiver of Liability Statement Issued as Required by Payer Policy) should be used when physicians, practitioners, or suppliers want to indicate that they anticipate that Medicare will deny a specific service as not reasonable and necessary and they do have an ABN signed by the beneficiary on file. Modifier GA applies only when services will be denied under reasonable and necessary provisions, sections 1862(a)(1), 1862(a)(9), 1879(e), or 1879(g) of the Social Security Act. Effective April 1, 2010, Part A MAC systems will automatically deny services billed with modifier GA. An ABN, Form CMS-R-131, should be signed by the beneficiary to indicate that he/she accepts responsibility for payment. The -GA modifier may also be used on assigned claims when a patient refuses to sign the ABN and the latter is properly witnessed. For claims submitted to the Part A MAC, occurrence code 32 and the date of the ABN is required.Modifier GX (Notice of Liability Issued, Voluntary Under Payer Policy) should be used when the beneficiary has signed an ABN, and a denial is anticipated based on provisions other than medical necessity, such as statutory exclusions of coverage or technical issues. An ABN is not required for these denials, but if non-covered services are reported with modifier GX, will automatically be denied services.
Article - Billing and Coding: Off-label Use of Rituximab and Rituximab Biosimilars (A58582)
The GZ modifier should be used when physicians, practitioners, or suppliers want to indicate that they expect that Medicare will deny an item or service as not reasonable and necessary and they have not had an ABN signed by the beneficiary. If the service is statutorily non-covered, or without a benefit category, submit the appropriate CPT/HCPCS code with the -GY modifier. An ABN is not required for these denials, and the limitation of liability does not apply for beneficiaries. Services with modifier GY will automatically deny.Documentation RequirementsThe patients medical record should include but is not limited to: The assessment of the patient by the ordering provider as it relates to the complaint of the patient for that visit, Relevant medical history Results of pertinent tests/procedures Signed and dated office visit record/operative report (Please note that all services ordered or rendered to Medicare beneficiaries must be signed.) Previous treatments including dosing and frequency of treatments, duration of treatment and documentation of response Duration of disease course and response to previous treatment if applicableIf use is due to lack of efficacy of prior treatments must document prior treatment(s), dosing, frequency of dosing, duration of treatment(S) and documentation of response(s)If use is due to adverse reaction to first-line therapydocumentation must include the event which absolutely contraindicates further use of the medication, or side effects that are not likely to be transient and resolve with further treatment, or that impair functional capacity and/or activities of daily living.If use for refractory diseasemust document all first-line treatment(s), dosing, frequency of dosing, duration of treatment(S) and documentation of response(s)If use is due to relapse in disease coursemust document prior first-line treatment(s), dosing, frequency of dosing, duration of each treatment(s), and duration of improvement on prior treatment(s). Pertinent clinical history, exam findings and test results that support relapse in disease course should be documented. Documentation of response treatment(s) at time of relapse, including duration, dosing and response to subsequent treatment(s).If use is for re-treatmentthen documentation of positive response to prior treatment must be included.
Article - Billing and Coding: Cataract Extraction (including Complex Cataract Surgery) (A58592)
CMS National Coverage PolicySocial 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.Article TextThis Billing and Coding Article provides billing and coding guidance for Local Coverage Determination (LCD) L38926, Cataract Extraction (including Complex Cataract Surgery). 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.The primary diagnosis submitted by the physician performing the preoperative ophthalmologic evaluation must be cataract (ICD-10-CM codes listed in the "ICD-10 Codes that Support Medical Necessity" section of this article).The diagnoses submitted by the physician performing the evaluation and management component of the preoperative workup, when it is medically necessary, should indicate cataract (ICD-10-CM codes listed in the "ICD-10 Codes that Support Medical Necessity" section of this article) as the primary or secondary diagnosis.Complex cataract extraction should require devices or techniques not generally used in routine cataract surgery.Documentation RequirementsAll documentation must be maintained in the patient's 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.When complex cataract procedures are reported the medical record must support that devices or techniques not generally used in routine cataract surgery were used, for example:
Article - Billing and Coding: Cataract Extraction (including Complex Cataract Surgery) (A58592)
Insertion of iris retractors through additional incisionsMechanical expansion of the pupil using iris hooksCreation of a sector iridectomy with subsequent suture repair of iris sphincterUse of intraoperative iris expansion device to maintain pupil dilation (i.e., Malyugin ring), iris sphincterotomies created with scissorsThe need to support the lens implant with permanent intraocular suturesPlacement of a capsular support ring is necessary to allow secure placement of an intraocular lens
Article - Billing and Coding: Platelet Rich Plasma (A58609)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Article TextThe information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for Platelet Rich Plasma.
Article - Billing and Coding: IDTFs and Low Dose CT Scan for Lung Cancer Screening for CPT Code 71271 (A58641)
CMS National Coverage PolicyCMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 35, 50 Therapeutic ProceduresCMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 18, 220.4 Preventive and Screening ServicesCMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 13, 20.3 Anti-Markup Payment LimitationArticle TextThe Centers for Medicare & Medicaid Services (CMS) has authorized a screening benefit for lung cancer using low dose computed tomography (LDCT) scanning.There are two CPT/HCPCS codes associated with this benefit: G0296 for the initial visit and 71271 for the scan and subsequent intervention. The descriptions for these codes are:G0296 - Counseling visit to discuss need for lung cancer screening using LDCT (service is for eligibility determination and shared decision making)71271 - Computed tomography, thorax, low dose for lung cancer screening, without contrast material(s)Independent Diagnostic Testing Facilities (IDTFs) are enrolled for diagnostic testing only and are not permitted to perform therapeutic activities (CMS Internet-Only Manual, Pub 100-04, Chapter 35). IDTFs may perform the LDCT scan associated with this benefit (when all requirements for coverage, including a physicians order, are met; see Change Request 9246). However, since the code 71271 also includes a therapeutic activity(smoking cessation interventions must be made available for current smokers), this service must be billed by a physician. The physician and IDTF must have a business arrangement for cooperatively providing this portion of the benefit and the IDTF shall look to the physician for payment. Physicians billing for a purchased service, such as the CT scan, should be aware of the anti-markup provisions summarized in the CMS Internet Only-Manual 100-04, Chapter 13, Section 20.3.
(Medicare Claims Processing Manual)
Medicare Claims Processing Manual  Chapter 13 - Radiology Services and Other Diagnostic Procedures   Table of Contents  (Rev. 12364, 11- 16-23)  Transmittals for Chapter 13  10 - ICD Coding for Diagnostic Tests  10.1 -  Billing Part B Radiology Services and Other Diagnostic Procedures  20 - Payment Conditions for Radiology Services  20.1 -  Professional Component (PC)  20.2 -  Technical Component (TC)  20.2.1 -  Hospital and Skilled Nursing Facility (SNF) Patients  20.2.2 -  Services Not Furnished in Hospitals  20.2.3 -  Services Furnished in Leased Departments  20.2.4  Services That Do Not Meet the National Electrical Manufacturers Association (NEMA) Standard XR -29-2013 20.2.5 -  Special Rule to Incentivize Transition from Traditional X -Ray Imaging to Digital Radiography  20.2.5.1 -  Remittance Advice Remark Codes (RARCs), Claim Adjustment Reason Codes (CARCs), and Medicare Summary Notice (MSN)
(Medicare Claims Processing Manual)
20.2.6 - Special Rule to Incentivize Transition from X -rays taken using Computed Radiography to Digital Radiography  30 - Computerized Axial Tomography (CT) Procedures  30.1 -  Low Osmolar Contrast Media (LOCM) (HCPCS Codes Q9945- Q9951)  30.1.1 -  Payment Criteria  30.1.2 -  Payment Level  30.1.3 -  SNF Billing and A/B MAC (A)  Payment for Contrast Material Other Than Low Osmolar Contrast Material (LOCM) (Radiology)  30.1.3.1 -  A/B MAC (A) Payment for Low Osmolar Contrast Material (LOCM) (Radiology)  40 - Magnetic Resonance Imaging (MRI) Procedures  40.1  Magnetic Resonance Angiography (MRA)  40.1.1 -  Magnetic Resonance Angiography (MRA) Coverage Summary  40.1.2 -  HCPCS Coding Requirements  40.1.3 -  Special Billing Instructions for RHCs and FQHCs  40.1.4 -  Payment Requirements  40.2 -  Medicare Summary Notices (MSN), Reason Codes, and Remark Codes  50 - Nuclear Medicine (CPT 78000 -  79999)  50.1 -  Payments for Radionuclides  50.2 -  Stressing Agent  50.2.1 - A/B MAC (A) Payment for IV Persantine  50.2.2 -  A/B MAC (A) Payment for Adenosine  50.3 -  Application of Multiple Procedure Policy (CPT Modifier  -51) 50.4 -  Generation and Interpretation of Automated Data  60 - Positron Emission Tomography (PET) Scans - General Information  60.1 -  Billing Instructions  60.2 -  Use of Gamma Camera and Full and Partial Ring PET Scanners for PET Scans  60.2.1 -  Coverage for Myocardial Viability  60.3 -  PET Scan Qualifying Conditions and HCPCS Code Chart  60.3.1 -  Appropriate CPT Codes Effective for PET Scans for Services Performed on or After January 28, 2005  60.3.2 -  Tracer Codes Required for Positron Emission Tomography (PET) Scans  60.3.3 -  Denial Messages for Noncovered PET Services  60.4 -  PET Scans for Imaging of the Perfusion of the Heart Using Rubidium 82 (Rb 82)  60.5 -  Expanded Coverage of PET Scans
(Medicare Claims Processing Manual)
(PET) Scans  60.3.3 -  Denial Messages for Noncovered PET Services  60.4 -  PET Scans for Imaging of the Perfusion of the Heart Using Rubidium 82 (Rb 82)  60.5 -  Expanded Coverage of PET Scans for Solitary Pulmonary Nodules (SPNs)  60.6 -  Expanded Coverage of PET Scans Effective for Services on or After July 1, 1999 60.7 -  Expanded Coverage of PET Scans Effective for Services on or After July 1, 2001 60.8 -  Expanded Coverage of PET Scans for Breast Cancer Effective for Dates of Service on or After October 1, 2002  60.9 -  Coverage of PET Scans for Myocardial Viability 60.10 -  Coverage of PET Scans for Thyroid Cancer  60.11  - Coverage of PET Scans for Perfusion of the Heart Using Ammonia N -13 60.12 -  Coverage for PET Scans for Dementia and Neurodegenerative Diseases  60.13 -  Billing Requirements for PET Scans for Specific Indications of Cervical Cancer for Services Performed on or After January 28, 2005  60.14 -  Billing Requirements for PET Scans for Non- Covered Indications  60.15 -  Billing Requirements for CMS -  Approved Clinical Trials and Coverage With Evidence Development Claims for PET Scans for Neurodegenerative Diseases, Previously Specified Cancer Indications, and All Other Cancer Indications Not Previously Specified 60.16  Billing and Coverage Changes for PET Scans  60.17  Billing and Coverage for PET Scans for Cervical Cancer Effective for Services on or After November 10, 2009 60.18  Billing and Coverage Changes for PET (NaF -18) Scans to Identify Bone Metastasis of Cancer Effective for Claims With Dates of Services on or After February 26, 2010 60.19  Local Coverage Determination for PET Using New, Proprietary Radiopharmaceuticals for their FDA -Approved Labeled Indications for Oncologic Imaging Only  70 - Radiation Oncology (Therapeutic Radiology)  70.1 -  Weekly Radiation Therapy Management (CPT 77419 -  77430)  70.2 -  Services Bundled Into Treatment Management Codes  70.3 -  Radiation Treatment Delivery (CPT 77401 -  77417)  70.4 -  Clinical Brachytherapy (CPT Codes 77750 -  77799)  70.5 -  Radiation Physics Services (CPT Codes 77300 -  77399)  80 - Supervision and Interpretation (S&I) Codes and Interventional Radiology  80.1 -  Physician Presence 80.2 -  Multiple Procedure Reduction 90 - Services