evekhm/cms_iom_3000 huggingface dataset:
Article - Billing and Coding: Therapy Driving Evaluations (A52772)

CMS National Coverage PolicyN/AArticle TextMedicare does not reimburse evaluations performed solely to assess a beneficiary's ability to drive a vehicle. In order for a service to be covered, the service must have a benefit category in the statute Title 18 of the Social Security Act (SSA), it must not be excluded, and it must be reasonable and necessary. There is no benefit category for driving evaluations.In addition, both screening (except as specifically exempted by statute) and routine physical examinations are excluded from coverage. 42 United States Code (USC) 1395y (a) describes routine physical checkups as:1. Examinations performed for a purpose other than treatment or diagnosis of a specific illness, symptom, complaint, or injury.2. Examinations required by insurance companies, business establishments, government agencies or other third parties.For Medicare purposes, when services provided are related solely to driving, they are not reasonable or necessary for the diagnosis or treatment of an illness or injury and are excluded from coverage under the program by SSA 1862(a)(1).This is a statutory exclusion. The beneficiary is liable for the charges and no Advance Beneficiary Notice of Noncoverage (ABN) is required. However, providers are encouraged to provide a voluntary ABN. Append modifier GX (Notice of Liability Issue, Voluntary under Payer Policy) to any billed line item.Sources: CMS Internet Only Manual (IOM), Medicare Claims Processing Manual, Publication 100-04, Chapter 1 Section 60 Social Security Act (SSA) Sections 1861 and 1862(a)(1) 42CFR 411.15(a)
(Medicare Benefit Policy Manual)

09/03/2004 Revised Requirements for Chiropractic Billing of Active/Corrective Treatment and Maintenance Therapy.  Full Replacement of CR 3063 10/04/2004 3449 R17BP 06/18/2004 Providing Information for Incident to Services. - Replaced by Transmittal 20 -CR 3460. 10/04/2004 3242 Rev #  Issue Date  Subject  Impl Date  CR#  R13BP  05/28/2004 Diabetes Self Management Training Services  06/28/2004 3185 R12BP  05/28/2004 Chiropractors Services  10/04/2004 3063 R09BP  04/23/2004 Arrangements for Physical, Occupational, and Speech Language Pathology Services (PT, OT, SLP)  05/24/2004 3134 R06BP 01/23/2004 Intravenous Immune Globulin 04/05/2004 3059 R05BP  01/09/2004 Coverage of Outpatient Physical Therapy, Occupational Therapy and Speech -Language Pathology Services Under Medical Insurance  03/15/2004 2859 & 2779 R04BP 01/02/2004 Dentists, podiatrists, and optometrists are added to the definition/list of physicians who may opt out of Medicare 02/02/2004 3016 R03BP 12/19/2003 Coverage of iFOBT 01/05/2004 2996 R01BP  10/01/2003 Introduction to the Benefit Policy Manual  N/A N/A Back to top of chapter
Article - Investigational Device Exemption Requests - Medical Policy Article (A52841)

CMS National Coverage PolicyN/AArticle TextClinical Study RequestCompliance with the instructions contained in the Medicare Claims Processing Manual (Publication 100-04, chapter 32, sections 68 and 69) is a requirement for both National Government Services and our providers. Providers are required to notify Medicare about clinical studies under four conditions:Effective for dates of service on or after January 1, 2015, providers that participate in an IDE clinical study may file claims for CMS category B IDEs approved by CMS (or its designated entity) and listed on the CMS Coverage Website. This applies to all IDEs assigned an identifying number beginning with a G and a CMS category B (B1, B2, B3, or B4) by the Food and Drug Administration (FDA).Effective for dates of service on or after January 1, 2015, Institutional providers and practitioners shall submit claims only for routine care items and services in Category A IDE device studies approved by CMS (or its designated entity) and listed on the CMS Coverage Website.Effective for dates of service on or after January 1, 2015, providers participating in post-market approval studies or registries of carotid stents may file claims for studies approved by CMS (or its designated entity) and listed on the CMS Coverage Website.Effective for dates of service on or after January 1, 2015, poviders participating in studies for proximal embolic protection devices (EPDs) in carotid artery stenting (CAS) procedures may file claims for studies approved by CMS (or its designated entity) and listed on the CMS Coverage Website.Effective for Category A and B IDE studies approved by the FDA on or after January 1, 2015, interested parties (i.e., study sponsors) that wish to seek Medicare coverage in Category A or B IDE studies must submit a request for review and approval via email to clinicalstudynotification@cms.hhs.gov or via hard copy to the following address:Centers for Medicare and Medicaid Services Center for Clinical Standards and Quality Director, Coverage and Analysis Group ATTN: Clinical Study CertificationMail Stop: S3-02-017500 Security Blvd. Baltimore, MD 21244National Government Services will review renewal or modified clinical study requests from hospitals and physicians in Connecticut, Illinois, Maine, Massachusetts, Minnesota, New Hampshire, New York, Rhode Island, Vermont, and Wisconsin. Clinical coverage determinations are applied uniformly across these regions. If a study has been reviewed for another facility you may not be required to submit study specific information. To reduce the amount of information you are required to submit, please send the following inquiry to National Government Services electronically prior to submitting a request for authorization.Send email to: NGS-IDE-Request@wellpoint.com OR fax to 315-442-4257.E-mail or FAX Subject line should include the type of request (Renewal or Modifications) and the IDE Number.
Article - Billing and Coding: Drugs and Biologicals (A52855)

CMS National Coverage PolicyN/AArticle TextThis article contains coding and other guidelines that complement the Local Coverage Determination (LCD) forDrugs and Biologicals, Coverage of, for Label and Off-Label Uses.Coding Information:General InformationProcedure 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.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.Intravenous in Lieu of Oral FormulationWhen billing for an IV drug which has an available oral form, please also report an additional ICD-10-CM code to indicate that the oral route is not appropriate, for example:K91.2POSTSURGICAL MALABSORPTION, NOT ELSEWHERE CLASSIFIEDK90.9INTESTINAL MALABSORPTION UNSPECIFIEDT50.995AADVERSE EFFECT OF OTHER DRUGS, MEDICAMENTS AND BIOLOGICAL SUBSTANCES, INITIAL ENCOUNTERY63.6UNDERDOSING AND NONADMINISTRATION OF NECESSARY DRUG, MEDICAMENT OR BIOLOGICAL SUBSTANCEY63.8FAILURE IN DOSAGE DURING OTHER SURGICAL AND MEDICAL CAREZ87.19PERSONAL HISTORY OF OTHER DISEASES OF THE DIGESTIVE SYSTEMDocumentation Requirements:The patient's medical record must contain documentation that fully supports the medical necessity for services included within the LCD. (See "Indications and Limitations of Coverage.") This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.The medical record must include the following information:The name of the drug or biological administered;The route of administration;The dosage (e.g., mgs, mcgs, cc's or IU's);The duration of the administration (for CPT codes that are time based); andWhen modifier JW is used to report that a portion of the drug or biological is discarded, from single use vials, the medical record must clearly document the amount administered and the amount wasted or discarded. Effective July 1, 2023 (CR 13056) JZ Modifier is required on all claims that bill for drugs separately payable under Medicare Part B when there are no discarded amounts from single-dose containers or single-use packages.For claims submitted to the Part B MAC:Drugs with No ChargesEffective for dates of service on or after 05/07/2018,when a drug is purchased by the beneficiary, or when the drug was supplied without charge by the manufacturer, the drug should be billed using the appropriate HCPCS code with a billed amount of $0.01.Fordates of service prior to 05/07/2018,drugs with no charge will be accepted by Medicare even with a submitted charge of $0.00. However, the name and dosage of the drug should be listed in the narrative record of the claim, to avoid requests for additional information on the claim.
Article - Coverage of Foot Care Services (A52918)

CMS National Coverage PolicyN/AArticle TextNoridian has noted, through Medical Review, billing of foot care services as non-covered when documentation supports the patient has complaints of associated foot pain. The purpose of this educational article is to clarify coverage of foot care services related to pain.The Medicare Benefit Policy Manual (MBPM) Chapter 15 section 290.C.1(http://www.cms.hhs.gov)states, "In certain circumstances, services ordinarily considered to be routine may be covered if they are performed as a necessary and integral part of otherwise covered services, such as diagnosis and treatment of ulcers, wounds, or infections." In this regard, foot care services associated with a patient's complaints of pain wouldnotbe considered routine in nature. Pain may indicate a problem, such as an ulcer or infection, which is necessary to evaluate. If pain is associated with the reason for the foot care, it is reasonable and necessary for the medical professional to assess and evaluate the pain, and subsequently treat both the pain and the cause of the pain if possible.For all other covered indications for foot care services, including presumption of coverage guidelines, as well as foot care excluded from Medicare coverage, refer to the MBPM Chapter 15 section 290.Source:Medicare Benefit Policy Manual (MBPM) Chapter 15 section 290Social Security Act (SSA) Title XVIII section 1862(a)(1)(A)
Article - Sipuleucel-T (Provenge®) - Coverage Criteria for Prostate Cancer – Clarification (A52926)

CMS National Coverage PolicyN/AArticle TextSipuleucel-T (Provenge) is an autologous cellular immunotherapy, FDA-approved for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.The production of Sipuleucel-T involves collection of the patients own cells (leukapheresis), culture with a proprietary antigen complex, and re-infusion of the antigen-activated patient cells back to the donor. Provenge is administered as three intravenous infusions, generally two weeks apart. When infused back into the patient, usually three days after leukapheresis, the patient-specific medication (autologous cellular therapy) stimulates a positive immunogenic response against the prostate cancer.For coverage, patient records must document that the product is being used according to the NCD 110.22.If the documentation does not describe the criteria above, does not meet all the requirements of the NCD on sipuleucel-T,is inconsistent with the FDA label and/or is not received, the services will be denied. Off-label use of this treatment is not covered unless it meets the requirements for off-label use of chemotherapeutic drugs in the Internet Only Manual 100-02 (Benefit Policy), Chapter 15 (Covered Services), Section 50.4.5.Noridian may coversipuleucel-Tfor the above condition when all requirements are met including the following coding instructions. (NOTE: Noridian will not allow payment for any off-label use of this treatment):For dates of service on/after July 1, 2011, use the following HCPCS code: Q2043 Sipuleucel-T auto CD54+.For dates of service prior to July 1, 2011, use one of the following HCPCS code: J3490, J3590 or C9273 (being replaced by Q2043).The payment of HCPCS Q2043 includes collection of patients cells, activation with PAP-CM-CSF, including leukapheresis and all other preparatory procedures associated withsipuleucel-T. The code Q2043 does not include theadministrationof the treatments. CPT code 96365, intravenous infusion for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to one (1) hour will be allowed for the administration of Q2043.Medicare will allow a maximum of three (3) infusions per lifetime.Sources: Internet Only Manual (IOM) Medicare National Coverage Determinations (NCD) Manual, Publication 100-03, Chapter 1, Section 110.22, IOM Medicare Claims Processing Manual, Publication 100-04, Chapter 32, Section 280; Transmittal 133, Change Request (CR)7431 dated July 8, 2011; Transmittal 2254, CR 7431 dated July 8, 2011.
Article - Sterilization (A52960)

CMS National Coverage PolicyN/AArticle TextSterilization means any medical procedure, treatment or operation for the sole purpose of rendering an individual permanently incapable of reproducing and not related to the repair of a damaged/dysfunctional body part.Under the Medicare Program guidelines the coverage of sterilization is limited to necessary treatment of an illness or injury. An example of necessary treatment is the removal of a uterus or removal of diseased ovaries (bilateral oophorectomy) because of a tumor, or bilateral orchiectomy in the case of prostate cancer.Elective hysterectomy, tubal ligation and vasectomy in the absence of a disease for which sterilization is considered an effective treatment is not covered. In addition, no payment would be made for sterilization procedures if it is a preventive measure e.g., a physician believes pregnancy would cause overall endangerment to a woman's health, or as a measure to prevent the possible development of, or effect on a mental condition, should pregnancy occur. (Section 1862(a)(1)(A) of the Social Security Act and 42 CFR 411.15(k).Claims will be denied on postpay review and payment recouped if the pathological evidence of the necessity to perform any of these procedures to treat an illness or injury is absent and/or when the primary objective is to achieve sterilization.
Article - Billing and Coding: Biomarkers for Oncology (A52986)

Part B claims:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for the paper claimThe claim must contain one of the corresponding ICD-10-CM codes listed in the ICD-10-CM Codes that Support Medical Necessity Group 2 below.11. Colvera test (BCAT1/IKZF1 promoter hypermethylation)Intended use of ColveraColvera is a diagnostic laboratory test used to detect the presence of colorectal cancer circulating tumor DNA. Colvera is intended to be used to detect residual disease following surgery or treatment for primary or recurrent colorectal cancer, and to surveil for recurrence of a previously treated colorectal cancer. Testing is covered when all the following are met:The patient has been previously diagnosed with an AJCC stage I, II, III or IV colorectal cancer, or a recurrence of colorectal cancer, within the previous five years.The patient has no evidence of neoplastic disease at the time the test is ordered. (If the patient is known to be with cancer or presumed to have cancer, this testing is not indicated).The patient is able to tolerate surgery or adjuvant chemotherapy for residual or recurrent colorectal cancer.Testing may be ordered no more than four times per 12-month period.To report a Colvera service, please submit the following claim information:CPT code 0229UEnter Colvera in the comment/narrative field for the following claim/field types:Part A claims:Loop SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formPart B claims:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for the paper claimThe claim must contain one of the corresponding ICD-10-CM codes listed in the ICD-10-CM Codes that Support Medical Necessity Group 1 below.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.The medical record documentation must support the medical necessity of the services as stated in the LCD. Specifically, the medical record should reflect whether any biomarker ordered is diagnostic, prognostic or predictive, as well as be able to clearly correlate any test result with given interventions(e.g., particular selection of chemotherapy).
Article - Billing and Coding: Non-Invasive Cerebrovascular Arterial Studies (A52992)

CMS National Coverage PolicyPlease refer to the related LCD, L35397.Article TextCoding GuidelinesPlease refer to the Novitas Local Coverage Determination (LCD), Non-Invasive Cerebrovascular Arterial Studies, L35397 for reasonable and necessary requirements and frequency limitations.The HCPCS/CPT code(s) may be subject to National Correct Coding Initiative (NCCI) edits. This information does not take precedence over NCCI edits. Please refer to NCCI for correct coding guidelines and specific applicable code combinations prior to billing Medicare.Note:When an uninterpretable study results in performing another type of study, only the successful study should be billed.When billing these proceduresafter a carotid endarterectomy, provide in the narrative the date of the surgery and the verbiage "carotid endarterectomy."Duplex post-interventional follow-up studies are typically limited in scope and unilateral in nature. The "complete/bilateral" duplex scan codes should seldom be used, while the "unilateral or limited study" codes should be used (except for the patient who had bilateral intervention).Do not report procedure codes 93890-93893 in conjunction with code 93888.All non-invasive vascular study CPT codes are considered bilateral codes unless otherwise indicated in the CPT definition. The 150% payment adjustment for bilateral procedures does not apply. Modifier -50 and/or the anatomic modifiers, -LT/-RT should not be used.Append the modifier 52 to report a unilateral study as appropriate. Information explaining the reduced service should be included in Item 19 of the CMS-1500 form or the electronic equivalent. Any appropriate documentation may be submitted with the claim to support the reduced service.
Article - Billing and Coding: Routine Foot Care (A52996)

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) L35138 (Routine Foot Care). Please refer to the LCD for reasonable and necessary requirements.Coverage 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.It is not appropriate to report procedure codes 11305-11308 for the removal of corns and calluses of the feet. Removal of these lesions is considered to be routine foot care and must be reported with procedure codes 11055-11057, paring or cutting of benign hyperkeratotic lesion (e.g., corn or callus). Services must be reported using the procedure code that most accurately describes the procedure performed.When reporting routine foot care services that needs to meet one of the exclusions, one of the following applicable Q modifiers identifying the class findings must be included on the claim.Q7  1 Class A findingsQ8  2 Class B findingsQ9  1 Class B and 2 Class C findingsFor all claims for foot-care services, report a foot/toe location modifier (when appropriate). The following are valid HCPCS modifiers:Left foot - LTFirst toe, left foot - TASecond toe, left foot - T1Third toe, left foot - T2Fourth toe, left foot - T3Fifth toe, left foot - T4Right foot - RTFirst toe, right foot - T5Second toe, right foot - T6Third toe, right foot - T7Fourth toe, right foot - T8Fifth toe, right foot - T9If a significant separately identified evaluation and management service is provided on the same day as routine foot care, the -25 modifier should be appended.Report only one of CPT codes 11055-11057 for each date of service. Total the number of keratotic lesions debrided and select the most appropriate CPT code. Example: if one lesion is debrided on the right foot and two lesions are debrided on the left foot, code 11056 (two to four lesions) would be the most appropriate CPT code.When reporting one of the ICD-10-CM codes that fall under the "active care requirement", the date that the beneficiary was last seen by the M.D., D.O., or qualified NPP, responsible for treating the underlying condition must be reported in line 19 of the CMS-1500 claim form or the electronic equivalent.
Social Security Act §1862

html  PUBLIC "-//W3C//DTD HTML 4.01//EN"SSA INTERNET HEAD SCRIPTSSocial Security Act 1862BANNERSkip to main contentSocial SecuritySearchMenuEspaolSign inSITE NAVIGATION#include virtual="/framework/includes/english/navigation.shtml"PAGE TITLECompilation of the Social Security LawsCONTENT
Article - Billing and Coding: Hemorrhoid Artery Ligation (A53006)

CMS National Coverage PolicyTitle XVIII of the Social Security Act 1833(e)Article TextEffective 08/11/2011, Palmetto GBA will reimburse services for doppler-guided hemorrhoid artery ligation with or without retroanal repair for Grade II or III hemorrhoids that have failed rubber band ligation or conservative treatment, such as behavior modification, high fiber diets to control constipation, and hydrocortisone cream/suppositories.To submit claims for this service, submit code 46948.According to CPTcoding references, it is not appropriate to submit the following codes with a46948 service:46020, 46221, 46250, 46255, 46257, 46258, 46260, 46261, 46262, 46600, 46945, 46946, 76872, 76942, and 76998.
Article - Self-Administered Drug Exclusion List: Medical Policy Article (A53021)

CMS National Coverage PolicyN/AArticle TextCoverage for self-administered drugs for both Part A and Part B is determined by the MAC Contractor in each jurisdiction. HCPCS codes used under Outpatient Prospective Payment System (OPPS) are included, in addition to the codes used for Part B claims, when appropriate.The table below lists drugs that are not covered by Medicare, the effective date of non-coverage, and the rationale. (Please see Process for Determining Self-Administered Drug Exclusions  Medical Policy Article). The column, Brand Names, provides one or more examples but may not include all brand names.Information about drugs not separately reimbursed or not covered for reasons other than usually self-administered, is detailed in Part A and Part B MAC publications and postings available elsewhere.Route of Administration ModifierThe use of the JA and JB modifiers is required for drugs which have one HCPCS Level II (J or Q) code but multiple routes of administration. Drugs that fall under this category will be marked with an asterisk (*) and must be billed with the JA modifier for the intravenous infusion of the drug or billed with the JB modifier for the subcutaneous injection form of administration. Subcutaneously administered drugs listed on the Usually Self-Administered list will be denied as a benefit exclusion. Claims for drugs marked with an asterisk (*) billed without either a JA or JB modifier will also be denied.