evekhm/cms_iom_500 huggingface dataset:
Article - Urological Supplies - Policy Article (A52521)
Adhesive strips or tape used with code A4349 (MALE EXTERNAL CATHETER, WITH OR WITHOUT ADHESIVE, DISPOSABLE, EACH) should not be billed separately.Adhesive catheter anchoring devices that are used with indwelling urethral catheters are billed using codes A4333 and A4334, respectively. An anchoring device used with a percutaneous catheter/tube (e.g., suprapubic tube, nephrostomy tube) is billed using code A5200.Replacement leg straps (A5113, A5114) are used with a urinary leg bag (A4358, A5105, or A5112). These codes are not used for a leg strap for an indwelling catheter.When codes A4217, A4450, and A4452 are used with Urological Supplies, they must be billed with the AU modifier. For this policy, codes A4217, A4450, and A4452 are the only three codes for which the AU modifier may be used.An external catheter that contains a barrier for attachment should be coded using A4335.Codes for ostomy barriers (A4369 and A4371) should not be used for skin care products used in the management of urinary incontinence.A percutaneous catheter/tube anchoring device (A5200) is a dressing with adhesive that is designed to be applied directly over the cutaneous opening through which the catheter/tube passes. This dressing has a hole through which the catheter/tube passes and a mechanism for firmly anchoring the catheter/tube to the dressing.
Article - Urological Supplies - Policy Article (A52521)
For claims with date of service (DOS) July 26, 2020 through September 30, 2020, the inFlow Intraurethral Valve-Pump system (Vesiflo, Inc.) must be billed using HCPCS code A4335 (INCONTINENCE SUPPLY; MISCELLANEOUS). Code A4335 is billed as 1 unit of service (UOS) at initial issue, and is all inclusive (catheter, activator, charging base). Code A4335 must also be used on separate claim lines for replacement of any of the individual components of the inFlow Intraurethral Valve-Pump system (catheter, activator, charging base).For claims with DOS October 1, 2020 through March 31, 2021, the inFlow system must be billed using HCPCS code(s): K1010 (Indwelling intraurethral drainage device with valve, patient inserted, replacement only, each), K1011 (Activation device for intraurethral drainage device with valve, replacement only, each) and/or K1012 (Charger and base station for intraurethral activation device, replacement only).For claims with DOS April 1, 2021 through March 31, 2023, the inFlow Intraurethral Valve-Pump system (Vesiflo, Inc.) must be billed using HCPCS code A4335 (INCONTINENCE SUPPLY; MISCELLANEOUS). Code A4335 is billed as 1 unit of service (UOS) at initial issue (see below), and is all-inclusive (catheter, activator, charging base). For replacement of individual components, code A4335 must be used on separate claim lines for any of the individual components of the inFlow Intraurethral Valve-Pump system (catheter, activator, charging base).For claims with DOS on or after April 1, 2023, the inFlow Intraurethral Valve-Pump system (Vesiflo, Inc.) must be billed using HCPCS code A4341 (INDWELLING INTRAURETHRAL DRAINAGE DEVICE WITH VALVE, PATIENT INSERTED, REPLACEMENT ONLY, EACH).
Article - Urological Supplies - Policy Article (A52521)
The initial sizing and insertion of the inFlow device is performed by the treating practitioner in their office. Claims for these services must be billed to the Part B MAC. Replacement of the indwelling intraurethral drainage device with valve is done by a trained caregiver or the beneficiary at home and may be billed on a monthly basis. If a replacement of the indwelling intraurethral drainage device with valve is performed by the treating practitioner, claims for this service must be billed to the Part B MAC.Since the activator and charging base are provided at the time of initial issue in the treating practitioner's office to the beneficiary, these may only be billed to the DME MAC as a replacement using HCPCS code A4342 (ACCESSORIES FOR PATIENT INSERTED INDWELLING INTRAURETHRAL DRAINAGE DEVICE WITH VALVE, REPLACEMENT ONLY, EACH).Payment for items listed in Column II are included in the payment for the Column I code. In the following table, when providing the items listed in Column II, the Column I code must be used instead of billing separate Column II codes when the items are provided at the same time.
Article - Urological Supplies - Policy Article (A52521)
Column IColumn IIA4310A4332A4311A4310, A4332, A4338A4312A4310, A4332, A4344A4313A4310, A4332, A4346A4314A4310, A4311, A4331, A4332, A4338, A4354, A4357A4315A4310, A4312, A4331, A4332, A4344, A4354, A4357A4316A4310, A4313, A4331, A4332, A4346, A4354, A4357A4354A4310, A4331, A4332, A4357A4357A4331A4358A4331, A5113, A5114A5105A4331, A4358, A5112, A5113, A5114A5112A5113, A5114If a code exists that includes multiple products, that code should be used in lieu of the individual codes.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.
Article - Self-Administered Drug Exclusion List: and Biologicals Excluded from Coverage - Medical Policy Article (A52527)
CMS National Coverage PolicyN/AArticle TextThe 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 not all. Information about drugs not separately reimbursed or not covered for reasons other than "usually self-administered," is found in other Part A and Part B MAC publications and sites.In the interest of consistent Medicare, the CGS Administrators Part A MAC will follow the coverage decision for self-administered drugs as determined by the Part B MAC in each respective state. HCPCS codes for the same drugs that apply only to providers that bill the Part A MAC (e.g., HCPCS codes used for drugs billable under the Outpatient Prospective Payment System [OPPS]) are included when applicable.The 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.Claims billed with the JA modifier are not part of the SAD exclusion. The Contractor will process claims with the JA modifier applying the policy that not only the drug is medically reasonable and necessary, but also that the route of administration is medically reasonable and necessary.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.And mark all applicable drugs with *.
Article - Process for Determining Self-Administered Drug Exclusions – Medical Policy Article (A52535)
CMS National Coverage PolicyN/AArticle TextThe Centers for Medicare and Medicaid Services (CMS) published guidelines instructing contractors to develop a process to determine whether a drug or biological is usually self-administered and excluded from payment. (See CMS Publication 100-02,Medicare Benefit Policy Manual, Chapter 15, Section 50.2). These instructions include the following:The Medicare program provides limited benefits for outpatient prescription drugs. The program covers drugs that are furnished "incident to" a physician's service provided that the drugs are not usually self-administered by the patients who take them. Section 112 of the Benefits, Improvements & Protection Act of 2000 ( BIPA) amended sections 1861 (s)(2)(A) and 1861 (s)(2)(B) of the[Social Security]Act to redefine this exclusion. The prior statutory language referred to those drugs "which cannot be self administered." Implementation of the BIPA provision requires interpretation of the phrase "not usually self-administered by the patient."The term "administered" refers only to the physical process by which the drug enters the patient's body. It does not refer to whether the process is supervised by a medical professional (for example, to observe proper technique or side-effects of the drug). Injectable drugs, including intravenously administered drugs, are typically eligible for inclusion under the "incident to" benefit. With limited exceptions, other routes of administration including, but not limited to, oral drugs, suppositories, topical medications are considered to be usually self-administered by the patient. For the purpose of applying this exclusion, the term "usually" means more than 50 percent of the time for all Medicare beneficiaries who use the drug.Contractors are further instructed to make this determination on a drug-by-drug basis, not on a beneficiary-by-beneficiary basis."Apparent on its face"For certain injectable drugs, it will be apparent due to the nature of the condition(s) for which they are administered or the usual course of treatment for those conditions, they are, or are not, usually self-administered. On the other hand, an injectable drug, administered at the same time as chemotherapy, used to treat anemia secondary to chemotherapy is not usually self-administered.Evidence Criteria for applying the Medicare Self-Administered Drug Exclusion:
Article - Process for Determining Self-Administered Drug Exclusions – Medical Policy Article (A52535)
Evidence Criteria for applying the Medicare Self-Administered Drug Exclusion:Peer reviewed medical literatureStandards of medical practiceEvidence-based practice guidelinesFDA approved labelPackage insertDrug compendia referencesSelf-administration utilization statisticsAcute:For the purpose of determining whether a drug is usually self-administered, an acute condition means a condition that begins over a short time period, is likely to be of short duration and/or the expected course of treatment is for a short, finite interval. A course of treatment consisting of scheduled injections lasting less than two weeks, regardless of frequency or route of administration, is considered acute.Usually:For the purposes of applying this exclusion, the term "usually" means more than 50 percent of the time for all Medicare beneficiaries who use the drug. Therefore, if a drug is self-administered by more than 50 percent of Medicare beneficiaries, the drug is excluded from coverage and you may not make any Medicare payment for it.Drugs NOT Usually Self-administered:Drugs delivered intravenously may usually be presumed not usually self-administeredDrugs delivered intramuscularly may usually be presumed not usually self-administeredDrug Usually Self-administered:Drugs delivered subcutaneously may be usually presumed self-administeredDrugs delivered by other routes of administration such as oral, suppositories, and topical medications are all considered to be usually self-administeredNotice of Non-Covered DrugsContractors must provide notice 45 days prior to the date that these drugs will not be covered. During the 45-day time period, contractors will maintain existing medical review and payment procedures. After the 45-day notice, contractors may deny payment for the drugs subject to the notice.
Article - Process for Determining Self-Administered Drug Exclusions – Medical Policy Article (A52535)
CMS further provided that Part A intermediaries or Part A MACs may opt to adopt the determinations of the Part B MACs within their jurisdiction(s). In the interest of providing consistent coverage for all providers within each state, the CGS Administrators, LLC Part A MACs will adopt the coverage decisions for injectable drugs subject to the self-administered drug exclusion as determined by the Part B MAC in each respective state. HCPCS codes for the same drugs that apply only to providers that bill the Part A MAC (e.g., HCPCS codes used for drugs billable under the Outpatient Prospective Payment System [OPPS]) are included when applicable. The list of drugs excluded from Medicare coverage as self-administered drugs can be accessed on our contractor Web site at www.cgsmedicare.com. It can also be found on the Medicare Coverage Database at www.cms.gov/mcd.
Article - Traumeel Injections (A52537)
CMS National Coverage PolicyN/AArticle TextCGS has determined that the injection of Traumeel, a homeopathic formulation, into the soft tissues, ligaments or other structures of the foot or ankle is not medically necessary. There are no published studies on Traumeel injections in humans in the peer-reviewed literature.CPT codes 20550-20553 will be denied if the material injected is determined to be Traumeel.HCPCS code J3490 will be denied when used to denote Traumeel.
Article - Self-Administered Drug Exclusion List: (A52571)
CMS National Coverage PolicyN/AArticle TextBackgroundThe Social Security Act does not provide a comprehensive drug benefit for Medicare beneficiaries. For Part A (inpatient), drugs provided during acute inpatient stays and qualified skilled nursing facility stays are generally covered if Medicare requirements are met. For Part B (outpatient, including outpatient hospital such as the emergency room), drugs and biological coverage is generally limited to the type of drugs that cannot be self-administered (SA), are medically necessary and reasonable, are Food and Drug Administration (FDA) approved, and are incident to the services of physicians in the treatment of patients as defined in the Carrier, Intermediary and Hospital manuals. Payment for drugs and supplies used in the performance of procedures is included in the fee for the procedure and are not separately billable to Medicare or the beneficiary.Congress changed the Medicare definition of the type of drugs that cannot be self-administered with passage of the Medicare, Medicaid, and State Childrens Health Insurance Program (SCHIP) Benefits Improvement and Protection Act (BIPA) of 2000 to usually not self-administered. As a result of this benefit structure, SA drugs and biologicals (pill form or injection form) in the outpatient setting are usually not covered except where Congress has provided for additional coverage. Examples of such coverage include specific blood clotting factors, drugs used in immunosuppressive therapy, renal dialysis related erythropoietin, osteoporosis drugs for certain homebound patients, some oral anti-cancer drugs, and some anti-nausea drugs in combination with oral or intravenous chemotherapy.The Centers for Medicare and Medicaid Services (CMS) has published two Program Memorandums on this issue. Transmittal AB-02-072, Change Request 2200, which was released on May 15, 2002, provides clarification of Section 112 of the BIPA. Change Request 2200 supersedes the following program instructions:- Medicare Carriers Manual, Section 2049.2- Intermediary Manual, Sections 3112.4B & 3660.11- Hospital Manual, Sections 230.4, E205 & 422.
Article - Self-Administered Drug Exclusion List: (A52571)
- Medicare Carriers Manual, Section 2049.2- Intermediary Manual, Sections 3112.4B & 3660.11- Hospital Manual, Sections 230.4, E205 & 422.This transmittal instructs contractors to define usually not self-administered as more than 50 percent of the time for all Medicare beneficiaries who use the drug. A drug self-administered by more than 50 percent of Medicare beneficiaries is excluded from coverage. This definition and other criteria in the transmittal will necessitate an evaluation process by Carriers and Intermediaries prior to applying the exclusion. Transmittal AB-02-139 Change Request 2311, which was released on 10/11/2002, provided additional guidance for applying the Medicare Self-Administered Drug Exclusion.The Medicare exclusion is clear for oral drugs, suppositories and topical medications. For drugs that have previously been covered as an integral part of the procedure, (e.g., a topical ophthalmic anesthetic is not separately reimbursed but is considered part of the fee for the procedure), there is no change. The issues arise with the drugs that are given by intravenous (IV), intramuscular (IM), subcutaneous (SQ) or multiple routes of administration.These transmittals instruct each individual contractor to develop a process for the determination on each drug. For drugs that have multiple indications and routes of administration, contractors will consider all of the indications and routes of administration when making a single determination for a drug.Contractors must continue to apply the policy that not only is the drug medically reasonable and necessary for any individual claim, but also that the route of administration is medically reasonable and necessary. In making the determination, the contractor must use the guidelines in the transmittals, as well as to the extent available, any peer reviewed medical literature; standards of medical practice; FDA approval language, package inserts, other drug compendia as appropriate; evidence-based practice guidelines; and other information submitted by interested individuals or groups.Terms Defined by the CMSAcute Condition: a condition that is likely to be of short duration and/or the expected course of treatment is for a short, finite interval (usually less than 2 weeks).Chronic Condition: a condition that is expected to last longer than 2 weeks.
Article - Self-Administered Drug Exclusion List: (A52571)
Chronic Condition: a condition that is expected to last longer than 2 weeks.Infrequent Use: less than once per week (e.g., once per month).Frequent Use: once or more per week (e. g., once per week).Administered: the term administered refers to the physical process by which the drug enters the patients body. It does not refer to whether the process is supervised by a medical professional (for example, to observe proper technique or side-effects of the drug). Only injectable (including intravenous) drugs are eligible for inclusion under the incident to benefit.Apparent on its Face: For certain injectable drugs, it will be apparent due to the nature of the condition(s) for which they are administered or the usual course of treatment for those conditions, they are, or are NOT, usually self-administered. For example, an injectable drug used to treat migraine headaches is usually self-administered. On the other hand, an injectable drug, administered at the same time as chemotherapy, used to treat anemia secondary to chemotherapy is not usually self-administered.By the Patient: the term by the patient means Medicare beneficiaries as a collective whole, which includes the patients themselves, and not other individuals who may assist with the administration of the drug. The contractor is not to consider individual beneficiaries who do not have the capacity to SA any drug due to a condition other than the condition for which they are taking the drug in question.Frequency: to determine frequency, consider how often the drug is administered. For example, if the drug is administered once per month, it is less likely to be SA. If the drug is administered once or more per week, it is likely that the drug is SA.Usually: for the purposes of applying this exclusion, the term usually means more than 50 percent of the time for all Medicare beneficiaries who use the drug, regardless of the indication or route of administration.Process For Determining List of Excluded Injectable Drugs
Article - Self-Administered Drug Exclusion List: (A52571)
Process For Determining List of Excluded Injectable DrugsDuring the implementation of this new process for determining coverage of drugs and biologicals, First Coast Service Options (FCSO), Inc.s current medical review and payment policies will continue to be in effect. Providers will be given a 45-day notice period if a previously covered drug is determined to be non-covered. Also, providers and beneficiaries will have the usual and customary appeal rights for denied coverage. Interested parties who wish to comment on the list should address their comments to First Coast Service Options Medical Affairs, 2020 Technology Parkway, Suite 100, Mechanicsburg, PA 17050-9419 or you may email the comments toMedicalAffairs@guidewellsource.com.The Process for Determining the List of Excluded Injectable Drugs involves a 10 step process.Step 1 represents the Apparent on its Face DeterminationIs it apparent on its face that the drug is self-administrable?Yes Presumed to be usually self-administered (USA), non-covered.No Go to Steps 2-6.Steps 2-6 represent the Presumptive Factors for the Determination of Self-AdministrationIs the drug administered orally, topically, or by suppository?Yes Presumed to be usually self-administered (USA), non-covered.No Go to question #3.Is it always administered IV? Absent evidence to the contrary, drugs delivered IV are presumed to not usually be self-administered (NUSA).Yes Presumed to be NUSA, covered, if other requirements are met.No Go to question #4.Is it always administered IM? Absent evidence to the contrary, drugs delivered IM are presumed to not usually be self-administered (NUSA).Yes Presumed to be NUSA, covered, if other requirements are met.No Go to question #5.Is it always administered SQ? Absent evidence to the contrary, drugs delivered SQ are presumed to be self-administered (SA) by the patient.Yes Presumed to be SA, excluded from coverage.No Go to steps 6-10.Steps 6-10 represents the Evidentiary Factors in the Determination Process (These steps are to be used when data exists to support the coverage determination of a drug.)List the outpatient clinical indication(s) (frequency, chronic/acute conditions as listed in the package insert).Determine % utilization by clinical indication and route of administration.Estimate the % SA
Article - Self-Administered Drug Exclusion List: (A52571)
List the outpatient clinical indication(s) (frequency, chronic/acute conditions as listed in the package insert).Determine % utilization by clinical indication and route of administration.Estimate the % SA(> or < 50%) by indication. Use a variety of sources/factors which include: acute/chronic, setting, clinical parameter, FDA/drug inserts, pharmacy data, hospital data, health plan data, formulary data, etc.Review claims data for setting, specialty, provider, clinical indication, etc.Review information from interested parties and prioritize all available levels of evidence and make the final determination.Was drug determined to be USA by more than 50% of Medicare beneficiaries?Yes Non-covered service, 45-day notice period if previously covered, notify via web site.No Covered service.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 JA modifier for the intravenous infusion of the drug or billed with the JB modifier for subcutaneous form of administration. Absent evidence to the contrary, the Contractor presumes that drugs delivered intravenously are not usually self-administered by the patient. The Contractor will process claims with the JA modifier still applying the policy as stated in theMedicare Benefit Policy Manual, Chapter 15, Section 50.2 that not only must the drug be medically reasonable and necessary, but also that the route of administration is medically reasonable and necessary. 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.The drugs represented by HCPCS codes J0801 and J0802 are administered by IM or SQ, therefore they require the JB modifier to be reported for SQ administration and they should not have any modifier reported for the IM administration.