evekhm/cms_iom_500 huggingface dataset:
Article - Billing and Coding: Implantable Infusion Pump (A56695)
The information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) forImplantable Infusion Pump L33461.Compounded medications are created by a pharmacist in accordance with the Federal Food, Drug and Cosmetic Act and may be covered under Medicare when their use meets all other criteria for services incident to a physicians service.Compounded medications do not have a National Drug Code (NDC) number, an average sales price (ASP) or an average wholesale price (AWP). Accordingly, the specific HCPCS J codes for the drugs in the compounded formulation may not be submitted. Instead, providers must use HCPCS code J7999-KD (compounded drug, not otherwise classified) for reimbursement of the compound medications.The use of compounded drugs has been especially prevalent in the filling of implantable infusion pumps. Whether a single agent or a combination of agents is used, the compounded medication must be submitted with HCPCS code J7999-KD, even though the compound is similar to or includes a drug with a specific HCPCS code (e.g., HCPCS code J2274 for preservative free morphine). Non-compounded drugs administered via durable medical equipment (DME), are reimbursed based on Centers for Medicare and Medicaid Services (CMS) ASP methodology. Providers who document and use the true off-the-shelf product without compounding may continue to use the drug specific HCPCS code.When billing compounded medications, submit HCPCS code J7999-KD on a single claim line and enter the quantity billed as '1'. Enter the name and total dose (in mg. or mcg.) of each drug in Box 19 of the CMS 1500 or the appropriate comment loop of electronic claims. Example: Unit of 1 J7999-KD claim line detail: Entered in Box 19/5010 comment field 'Morphine Sulfate XX mg + Fentanyl YY mcg + Clonidine ZZ mcg'. If Box 19 cannot accommodate all of the information, attach the information to the paper claim.
Article - Billing and Coding: Implantable Infusion Pump (A56695)
Separate payment may be made for refilling and/or pump adjustments as clinically appropriate. These services should be submitted using the correct drug refill or maintenance code that accurately describes the service rendered. Evaluation and management services are not separately payable unless the practitioner provides a significant, separately identifiable service.Compounded drugs are priced by the contractor. Palmetto GBA will reimburse compounded drugs for use in implanted infusion pumps by multiplying the price per mcg. or mg. by the total number of mcg. or mg. of each drug used to refill the pump. A pharmacy compounding fee will be allowed, in addition to the calculated amount for the drug(s), in order to arrive at the total Medicare allowable for the refill.Prialt is a drug only available from the pharmaceutical manufacturer. If given as a single drug in the pump, use code J2278-KD. If mixed with other drugs in the pump, consider the mixture a compounded drug and use the HCPCS code J7999-KD. If a portion of a single dose vial of a medication is not used, submit the HCPCS code for the drug on a separate claim line and append the JW modifier.CPT/HCPCS codes used for Opioid Drugs for the Treatment of Chronic Intractable Pain are J7999KD, E0782, E0783, E0785, E0786, 62327, 62350, 62351, 62355, 62361, 62362, 62365, 62367, 62368, 62369, 62370, 95990 and 95991.
Article - Billing and Coding: Wound Application of Cellular and/or Tissue Based Products (CTPs), Lower Extremities (A56696)
CMS National Coverage PolicyRelevant CMS manual instructions and policies regarding bioengineered skin substitutes are found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:CMS Internet-Only Manual (IOM), Pub. 100-04, Medicare Claims Processing Manual, Chapter 17, Section 40.CMS Internet-Only Manual (IOM). Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 270.13.CMS Change Request, CR 8213; Autologous Platelet-Rich Plasma (PRP) for Chronic Non-Healing Wounds; issued June 10, 2013Social Security Act (XVIII) Standard References:Title XVIII of the Social Security Act, 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.Article TextThis article gives guidance for billing, coding, and other guidelines in relation to local coverage policy Wound Application of Cellular and/or Tissue Based Products (CTPs), Lower Extremities L36690.General Guidelines for Claims submitted to Part A or Part B MAC:Procedure 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.
Article - Billing and Coding: Wound Application of Cellular and/or Tissue Based Products (CTPs), Lower Extremities (A56696)
Advance Beneficiary Notice of Non-coverage (ABN) Modifier GuidelinesAn 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: Wound Application of Cellular and/or Tissue Based Products (CTPs), Lower Extremities (A56696)
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 RequirementsAll 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.Medical record documentation must support the medical necessity of the services as directed in this policy.The documentation must support that the service was performed and must be included in the patients medical record. This information is normally found in the history and physical, office/progress notes, hospital notes, and/or procedure report.The medical record must clearly show that the criteria listed under the Indications and Limitations of Coverage and/or Medical Necessity sections have been met, as well as, the appropriate diagnosis and response to treatment.The documentation must support the need for CTP application and the product used.A description of the wound(s) must be documented at baseline (prior to beginning conservative treatment) relative to size, location, stage, duration, and presence of infection, in addition to type of treatment given and response.This information must be updated in the medical record throughout treatment.Wound description must also be documented pre and post treatment with the skin substitute graft being used.If obvious signs of worsening or lack of treatment response is noted, continuing treatment with the skin substitute would not be considered medically reasonable and necessary without documentation of a reasonable rationale for doing so.
Article - Billing and Coding: Wound Application of Cellular and/or Tissue Based Products (CTPs), Lower Extremities (A56696)
Documentation of smoking history, and that the patient has received counseling on the effects of smoking on surgical outcomes and treatment for smoking cessation (if applicable) as well as outcome of counselling must be in the medical record.The amount of utilized and wasted skin substitute must be clearly documented in the procedure note with the following minimum information:Date, time and location of ulcer treated;Name of skin substitute and how product supplied;Amount of product unit used;Amount of product unit discarded;Reason for the wastage;Manufacturers serial/lot/batch or other unit identification number of graft material. When manufacturer does not supply unit identification, record must document such.Note:CGS Administrators expects that where multiple sizes of a specific product are available, the size that best fits the wound with the least amount of wastage will be utilized. Each product material is for a single-use only and is not for use on a multiple patients.Utilization GuidelinesIn accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.It is the expectation that a specific CTP product will be used for the episode of each documented wound, and in compliance with FDA assessments and submitted guidelines for the specific product. Greater than ten (10) applications for the treatment of a single wound within a 12-week period of time, will be considered Not Reasonable and Necessary and will be subject to review.Separately billed repeated use of the skin substitute after 12 weeks for a single wound or episode is non-covered. Alternative or additional skin substitute products used within the 12 week initial wound episode are similarly non-covered when the sum of applications of all Skin Substitutes is greater than ten (10) for a single wound.The utilization of a CTP non-compliant with medical necessity or designated guidelines for that specific product may necessitate review or non-coverage as not medically necessary.Labeling for most skin substitute grafts include language suggesting multiple applications; however, Medicare does not expect that every ulcer in every patient will require the maximum number of applications listed on the product label or allowed for reimbursement.Utilization rates that exceed peer norms, identified through data analysis may prompt prepayment or post payment medical review.
Article - Billing and Coding: Non-Invasive Vascular Studies (A56697)
CMS National Coverage PolicySection 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Code of Federal Regulations:42 CFR, Section 410.32, indicates that diagnostic tests may only be ordered by the treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements).42 CFR, Section 410.33 provides guidelines for independent diagnostic testing facilities (IDTFs) including requirements for technician personnel and supervising physicians.CMS Publications:CMS Publication 100-02,Medicare Benefit Policy Manual, Chapter 11:20.1 Noninvasive Vascular Studies for End Stage Renal Disease(ESRD) PatientsCMS Publication 100-03,Medicare National Coverage Determinations Manual, Chapter 1:20.14 Plethysmography20.17 Noninvasive Tests of Carotid Function220.5 Ultrasound Diagnostic Procedures220.21 ThermographyCMS Publication 100-08,Medicare Program Integrity Manual, Chapter 13:13.5 Content of an LCD13.5.1 Reasonable and Necessary Provisions in LCDsArticle TextThis article gives guidance for billing, coding, and other guidelines in relation to local coverage policy Non-Invasive Vascular Studies L34045.It is the responsibility of the physician/provider to ensure the medical necessity of procedures and to maintain records in the event that records are requested for a post-payment audit.42 CFR 410.32 indicates that diagnostic tests, to be covered, must be ordered by the practitioner who treats the patient. The treating physician is the practitioner responsible for the treatment of the patient. He/she orders the test to use the results in the management of the beneficiarys specific medical problem(s). Consulting physicians may also order tests.A referral for one non-invasive study is not a blanket referral for all studies. A referral must be on record for each non-invasive study performed.Documentation must be provided supporting the need for more than one imaging study [Doppler flow (93990) or vessel mapping (G0365) and arteriogram (75790/75820)].Providers of interpretations and the technical portion of the examination must be capable of demonstrating documented training and experience and maintain documentation for post-payment audit.
Article - Billing and Coding: Non-Invasive Vascular Studies (A56697)
Providers of interpretations and the technical portion of the examination must be capable of demonstrating documented training and experience and maintain documentation for post-payment audit.Frequency of follow-up studies will be carefully monitored for medical necessity and it is the responsibility of the physician/provider to maintain documentation of medical necessity in the patients medical record.Guidelines for follow-up cerebrovascular arterial studies include:Stenosis of 20-49% (diameter reduction), an annual study;Stenosis of 50-79%, every six months;Stenosis of 80-99%, every 6 months if surgery not performed; and/orAfter carotid endarterectomy, repeat ipsilateral/unilateral examinations are allowable at six weeks, six months, and one year. During the first year, follow-up studies should be on the ipsilateral side unless signs and symptoms or previously identified disease in the contralateral carotid artery provide indications for a bilateral procedure.If patients become symptomatic of carotid disease repeat duplex scans are allowed without regard to the above schedule.Pre-surgical conduit mapping of the radial artery(ies) should only be accompanied by vein-mapping studies when the arterial studies demonstrate a non-acceptable conduit or an insufficient conduit is available for multiple bypass procedures.In the immediate post-operative period, patients may be studied if re-established pulses are lost, become equivocal, or if the patient develops related signs and/or symptoms of ischemia with impending repeat intervention.
Article - Billing and Coding: Non-Invasive Vascular Studies (A56697)
In the immediate post-operative period, patients may be studied if re-established pulses are lost, become equivocal, or if the patient develops related signs and/or symptoms of ischemia with impending repeat intervention.With regard to autogenous vein and synthetic lower extremity bypass surgeries, a study may be performed at three-month intervals during the first year, at six-month intervals during the second year, and annually thereafter. The frequency of medically necessary follow-up studies post-angioplasty is dictated by the vascular distribution treated.General Guidelines for Claims submitted to Part A or Part B MAC:Procedure 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.
Article - Billing and Coding: Non-Invasive Vascular Studies (A56697)
Advance Beneficiary Notice of Non-coverage (ABN) Modifier GuidelinesAn 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: Non-Invasive Vascular Studies (A56697)
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 historyResults of pertinent tests/proceduresSigned and dated office visit record/operative report (Please note that all services ordered or rendered to Medicare beneficiaries must be signed.)Other Comments:For claims submitted to the Part A MAC: This coverage determination also applies within states outside the primary geographic jurisdiction with facilities that have nominated CGS Administrators, LLC to process their claims.Bill type codes only apply to providers who bill these services to the Part A MAC: Bill type codes do not apply to physicians, other professionals and suppliers who bill these services to the carrier or Part B MAC.For dates of service on or after April 1, 2010, bill type 77X should be used to report FQHC services.Limitation of liability and refund requirements apply when denials are likely, whether based on medical necessity or other coverage reasons. The provider/supplier must notify the beneficiary in writing, prior to rendering the service, if the provider/supplier is aware that the test, item or procedure may not be covered by Medicare. The limitation of liability and refund requirements do not apply when the test, item or procedure is statutorily excluded, has no Medicare benefit category or is rendered for screening purposes.
Article - Billing and Coding: Non-Invasive Vascular Studies (A56697)
For outpatient settings other than CORFs, references to "physicians" throughout this policy include non-physicians, such as nurse practitioners, clinical nurse specialists and physician assistants. Such non-physician practitioners, with certain exceptions, may certify, order and establish the plan of care as authorized by State law. (See Sections 1861[s][2] and 1862[a][14] of Title XVIII of the Social Security Act; 42 CFR, Sections 410.74, 410.75, 410.76 and 419.22; 58 FR 18543, April 7, 2000.)
Article - Billing and Coding: Stretta Procedure (A56703)
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.Article TextThe information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) forStretta Procedure L34553.