evekhm/cms_iom_500 huggingface dataset:
Article - Self-Administered Drugs - Process to Determine Which Drugs Are Not Usually Self-administered By the Patient (A53893)
CMS National Coverage PolicyN/AArticle TextThis process applies only to medications described in the program instructions of the Internet Only Manual (IOM)Medicare Benefit Policy Manual, Chapter 15, Section 50.2 athttp://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf.IntroductionThis process applies only toinjectable drugsused in anoutpatient settingforMedicare beneficiariesforreasonable and necessary indications.Generic or otherwise equivalent drugs with separate J codes may be treated separately or as one drug.CMS Instructions to Each ContractorContractors must describe the process they will use to determine whether a drug is usually self-administered by the patient and as such cannot be covered as incident to a physicians service. Contractors must continue to assure 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.The wordsby the patientmean for Medicare beneficiaries as a collective whole. If the drug is not covered, it is not covered forallpatients and forallroutes of administration. For example, if a drug is usually self-administered based on the frequency of its subcutaneous injections, and therefore is not covered, the less-frequent intravenous form of the drug also will not be covered, even when administered by a physician (e.g. insulin, even if for an emergency indication). Even if a specific patient couldneverself-administeranyinjectable drug (because of cognitive impairment, blindness, paralysis, other mental or physical disability, etc.) if a particular drug is usually self-administered by most of the Medicare population, the drug would not be covered for this individual. If a drug has multiple uses and the drug is self-administered more than 50% of the time for the total of all uses, then the drug would not be covered even for uses that require physician administration.When a drug is usually self-administered, and therefore not covered, no payment may be made even when the drug is given incident to a physicians service for reasons such as: Teaching self-administration, Adjusting or titrating the dose, Monitoring for immediate side effects, and Emergency use.
Article - Self-Administered Drugs - Process to Determine Which Drugs Are Not Usually Self-administered By the Patient (A53893)
If a drug has multiple uses, and the drug is administered "incident to" a physicians service for its most frequent uses, and therefore covered, then the drug is covered even for uses that can be self-administered. However, when a drug is thereby covered, payment still requires that the drug is actually administered incident to a physicians service and is reasonable and necessary for the condition treated.No payment may be made for an otherwise-covered drug that is self-administered.Noridian will use the following process to determine coverage:Step 1Determination of Self-Administration:Apparent on its faceFor certain injectable drugs, the nature of the condition(s) for which it is administered will be sufficient to determine that the drug is or is not usually self-administered.When the predominant use is for a condition that is recurrent, identifiable by the patient, given for an immediate effect and provided with self-administration instructions in the drugs package insert approved by the United States Food and Drug Administration (FDA), the drug is usually self-administered. Examples include sumatriptan to treat migraine headaches, insulin to treat diabetes and alprostadil to treat erectile dysfunction.On the other hand, a drug that a reasonably prudent patient would not be expected to self-administer is not usually self-administered, and is therefore covered. Examples include a drug usually requiring clinical expertise to administer (e.g. a drug given intravenously or for use in an implanted intravenous or intrathecal pump), a drug usually administered during a procedure (e.g. a local anesthetic or an injected releasing hormone to measure a hormonal response) and a drug usually requiring a physician to titrate the next dose (e.g. erythropoietin alfa for chemotherapy support).Further, a drug generally used only for an acute condition such that the course of scheduled injections lasts less than two weeks, is not usually self-administered.If, and only if, you are unable to make a determination from step 1, go to step 2.Step 2If there arenotmultiple indications for a drug or there is no reliable usable data, skip directly to step 3.UsingPresumptive Evidenceto Combine Information When a Drug Has Multiple Indications and there is Reliable Usable Data:
Article - Self-Administered Drugs - Process to Determine Which Drugs Are Not Usually Self-administered By the Patient (A53893)
Step 2If there arenotmultiple indications for a drug or there is no reliable usable data, skip directly to step 3.UsingPresumptive Evidenceto Combine Information When a Drug Has Multiple Indications and there is Reliable Usable Data:1. Select beginning and end dates for the analysis. For consistency try to use the same dates for all calculations.2. Calculate the total injections during this period, including any intravenous or intramuscular injections. This total will be 100%.3. Drug indications will be sorted by diagnoses and where similar will be combined to facilitate analysis.4. Calculate the number of subcutaneous injections, but do not include those for courses of treatment consisting of scheduled injections lasting less than two weeks. (Any indication with scheduled injections lasting less than two weeks is weighted as not usually self-administered, even if administered subcutaneously.)5. Add to this number (from # 4) those injections for courses of treatment lasting two weeks or longer and with injections at least weekly (i.e. those that are both chronic and frequent)6. If this sum is equal to or less than 50% of the total injections during the period, the drug is not usually self administered and is covered.7. If this sum is more than 50% of the total injections during the period, proceed to Step 3.Step 3Determination of Self-Administration usingEvidentiary Criteria:When available, evidence of the following types must be considered: Peer-reviewed medical literature Standards of medical practice Evidence-based practice guidelines FDA approved indications FDA approved package insert (which is not to be used byitselfas the onlydetermining factor)Further, evidence of the following typesmaybe considered: Drug compendia references Reliable patient use data The need for physician monitoring to determine each dose Other relevant parameters according to contractor discretionThe above data will be used for each indication to supplement available utilization data on the percentage of self-administered injections. Where it appears more reliably available, utilization data on the percent of beneficiaries receiving a drug by self-administration may be used as an alternative to percent of injections.
Article - Self-Administered Drugs - Process to Determine Which Drugs Are Not Usually Self-administered By the Patient (A53893)
Provider Notice of Non-Covered DrugsAfter making determinations by the above three-step process, Noridian will provide notice on our web site,http://www.noridianmedicare.com, 45 days prior to the date that any drug will change from current covered status to being not covered. During the 45-day period, the Noridian existing medical review and payment procedures will remain in effect. After the 45-day period, we may deny payment for the drug(s) subject to the notice.Beneficiary AppealsIf a beneficiarys claim for a particular drug is denied because the drug is subject to the self-administered drug exclusion, the beneficiary may appeal the denial. Because it is a benefit category denial and not a denial based on medical necessity, an Advance Beneficiary Notice of Noncoverage (ABN) is not required. A benefit category denial (i.e., a denial based on the fact that there is no benefit category under which the drug may be covered) does not trigger the financial liability protection provisions of Limitation On Liability [under Section 1879 of the Act]. Therefore, physicians or providers may charge the beneficiary for such an excluded drug.Provider and Physician AppealsA physician accepting assignment and the hospital may appeal a denial under the provisions found in the IOM Medicare Claims Processing Manual, Publication 100-04, Chapter 29, Appeals of Claims Decisions athttp://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c29.pdfReasonable and NecessaryNoridian will make the determination of reasonable and necessary with respect to the medical appropriateness of a drug to treat the patients condition, and will continue to make the determination of whether the intravenous or injection form of a drug is appropriate as opposed to the oral form. We will also continue to make the determination as to whether a physicians office visit was reasonable and necessary. However, while a physicians office visit may not be reasonable and necessary in a specific situation, the medical necessity of the injection will still be determined on its own merits based on this process for determining which drugs are usually self administered.
Article - Self-Administered Drugs - Process to Determine Which Drugs Are Not Usually Self-administered By the Patient (A53893)
Sources: IOMMedicare Benefit Policy Manual,Publication 100-02, Chapter 15, Covered Medical and Other Health Services, Section 50.2, Determining Self-Administration of Drug or Biological; IOMMedicare Claims Processing Manual,Publication 100-04, Chapter 29, Appeals of Claims Decisions.
Article - Dropless Cataract Surgery (A53916)
CMS National Coverage PolicyN/AArticle TextNoridian Healthcare Solutions has become aware of a relatively new technique where a retrozonular or intravitreal injection of compounded antibiotics and or steroids are administered at the conclusion of cataract surgery (CPT 66984 or 66982 or related codes) as a means of reducing or eliminating the need for post-operative topical medications ("dropless" cataract surgery).Noridian states that such injections are integral to the surgery being performed and are bundled with the cataract surgery code for both the physician and facility. Therefore, billing either Medicare or the patient for these services separately is not appropriate. Furthermore, because they are considered integral to and bundled with these codes, it is inappropriate to include such services when performed  as a separately itemized part of a "package" related to the insertion of a premium intraocular lens.There may be rare cases where services represented by intravitreal injection code (67028) and a drug code (J-series) need to be provided in the contralateral eye. In such cases the surgical code and the injection and drug codes should be appended with either a RT or a LT to reflect which eye the cataract surgery was performed on and which eye received the injection. Do not use modifier -59 in such cases as the claim will deny.
Article - Dropless Cataract Surgery (A53918)
CMS National Coverage PolicyN/AArticle TextNoridian Healthcare Solutions has become aware of a relatively new technique where a retrozonular or intravitreal injection of compounded antibiotics and or steroids are administered at the conclusion of cataract surgery (CPT 66984 or 66982 or related codes) as a means of reducing or eliminating the need for post-operative topical medications ("dropless" cataract surgery).Noridian states that such injections are integral to the surgery being performed and are bundled with the cataract surgery code for both the physician and facility. Therefore, billing either Medicare or the patient for these services separately is not appropriate. Furthermore, because they are considered integral to and bundled with these codes, it is inappropriate to include such services when performed as a separately itemized part of a "package" related to the insertion of a premium intraocular lens.There may be rare cases where services represented by intravitreal injection code (67028) and a drug code (J-series) need to be provided in the contralateral eye. In such cases the surgical code and the injection and drug codes should be appended with either a RT or a LT to reflect which eye the cataract surgery was performed on and which eye received the injection. Do not use modifier -59 in such cases as the claim will deny.
Article - Fracture of Ribs with Internal Fixation (A53931)
CMS National Coverage PolicyN/AArticle TextMost injuries to the chest wall do not result in long-term respiratory dysfunction and operative indications for chest wall injuries are rare. Recent studies have explored the option of internal fixation of rib fracture for treatment of complex rib fractures, including flail chest, open fracture, symptomatic nonunion, and thoracotomy for other indications. Flail chest is diagnosed when multiple, consecutive ribs are fractured in two or more places, creating an incompetent region of the chest wall.Internal Fixation is indicated to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs. The Modular RibLoc System consists of plates and screws for fractures, fusions, and osteotomies. The plates are pre-contoured to minimize bending that is done intra-operatively. Instrumentation is supplied with the implants to aid in the insertion of the plates and screws. All plates and screws are manufactured from titanium or titanium alloy.Palmetto GBA will cover CPT codes 21812 and 21813. CPT 21811 is not covered, as in most instances fractures involving 1-3 ribs do not require internal fixation.
Article - Billing and Coding: Spinal Fusion Services: Documentation Requirements (A53972)
CMS National Coverage PolicyN/AArticle TextNoridian Medical Review team and CERT contractor has identified multiple errors regarding documentation to support the medical necessity of spinal fusion procedures. This article clarifies medical necessity and documentation requirements regarding spinal fusion procedures.Medical NecessityHistory and PhysicalDuration/character/location/radiation of painActivity of daily living (ADL) limitationsPhysical examinationEvidence/support of prior conservative treatment measure(s) attempted*Imaging reports pertinent to performed procedureOperative report(s)Outpatient records before, during and after the procedure that support the medical necessity of performed procedures*Note: physician statement that conservative treatment measures were completed is not supportive in and by itself; contractors do require the documentation of these measures.Documentation ErrorsThe most common reason for denial of spinal fusion services is lack of specific information regarding conservative treatment measures which were attempted and failed prior to surgery. The statement "failed conservative/outpatient treatment" is not sufficient evidence of medical necessity for the procedure or inpatient admission. A detailed medical record will help to support the reasonableness of the claim.Conservative treatment modalities include but are not limited to:Physical TherapyOccupational TherapyJoint Injections/Epidural InjectionsAnti-inflammatory/Analgesic medicationsAssistive device useActivity modificationExerciseSituations arise where a fusion is approved without conservative treatment being documented clearly when an emergent situation such as "cauda equina syndrome" is present. Also if an imaging report showing severe cord compression, osteophyte formation impinging on the spinal cord, loose pedicle screws affecting stability, severe fibrosis or formation of scar tissue compressing cord or nerves, and the patient's history and physical findings correlate to the imaging the surgeon should clearly document these findings and the reasons that such findings require imminent intervention.
Article - Billing and Coding: Spinal Fusion Services: Documentation Requirements (A53975)
CMS National Coverage PolicyN/AArticle TextNoridian Medical Review team and CERT contractor has identified multiple errors regarding documentation to support the medical necessity of spinal fusion procedures. This article clarifies medical necessity and documentation requirements regarding spinal fusion procedures.Medical NecessityHistory and PhysicalDuration/character/location/radiation of painActivity of daily living (ADL) limitationsPhysical examinationEvidence/support of prior conservative treatment measure(s) attempted*Imaging reports pertinent to performed procedureOperative report(s)Outpatient records before, during and after the procedure that support the medical necessity of performed procedures*Note: physician statement that conservative treatment measures were completed is not supportive in and by itself; contractors do require the documentation of these measures.Documentation ErrorsThe most common reason for denial of spinal fusion services is lack of specific information regarding conservative treatment measures which were attempted and failed prior to surgery. The statement "failed conservative/outpatient treatment" is not sufficient evidence of medical necessity for the procedure or inpatient admission. A detailed medical record will help to support the reasonableness of the claim.Conservative treatment modalities include but are not limited to:Physical TherapyOccupational TherapyJoint Injections/Epidural InjectionsAnti-inflammatory/Analgesic medicationsAssistive device useActivity modificationExerciseSituations arise where a fusion is approved without conservative treatment being documented clearly when an emergent situation such as "cauda equina syndrome" is present. Also if an imaging report showing severe cord compression, osteophyte formation impinging on the spinal cord, loose pedicle screws affecting stability, severe fibrosis or formation of scar tissue compressing cord or nerves, and the patient's history and physical findings correlate to the imaging the surgeon should clearly document these findings and the reasons that such findings require imminent intervention.
Article - Billing and Coding: Percutaneous Ventricular Assist Device (A53986)
CMS National Coverage PolicyTitle XVIII of the Social Security Act (SSA) 1833(e) prohibits Medicare payment for any claim lacking the necessary documentation to process the claimArticle TextPercutaneous insertion of an endovascular cardiac assist device will be covered under limited conditions. Until the literature clearly demonstrates the efficacy of the treatment approach, coverage may be made only in the following three life-threatening situations and only when external counterpulsation (intra-aortic balloon pump, IABP) is not expected to be sufficient:Cardiogenic shock ICD-10-CM code R57.0; orSevere decompensated heart failure with threatening multi-organ failure, represented by one of the following ICD-10 codes: I50.21, I50.23, I50.41, I50.43, I97.110, I97.111, I97.130, I97.131; orComplications/disturbances of the circulatory system intra-operatively or postoperatively: I97.790, I97.791, I97.88 and I97.89.This service will only be covered when the FDA approval guidelines are strictly adhered to.
Article - Billing and Coding: Percutaneous Ventricular Assist Device (A53988)
CMS National Coverage PolicyTitle XVIII of the Social Security Act (SSA) 1833(e) prohibits Medicare payment for any claim lacking the necessary documentation to process the claimArticle TextPercutaneous insertion of an endovascular cardiac assist device will be covered under limited conditions. Until the literature clearly demonstrates the efficacy of the treatment approach, coverage may be made only in the following three life-threatening situations and only when external counterpulsation (intraaortic balloon pump, IABP) is not expected to be sufficient:Cardiogenic shock ICD-10-CM code R57.0; orSevere decompensated heart failure with threatening multi-organ failure, represented by one of the following ICD-10 codes: I50.21, I50.23, I50.41, I50.43, I97.110, I97.111, I97.130, I97.131; orComplications/disturbances of the circulatory system intra-operatively or postoperatively: I97.790, I97.791, I97.88 and I97.89.This service will only be covered when the FDA approval guidelines are strictly adhered to.Part A Providers: ICD-10-PCS codes:5A02116 - Assistance with Cardiac Output using Other Pump, Intermittent5A0211D -Assistance with Cardiac Output using Impeller Pump, Intermittent5A02216 - Assistance with Cardiac Output using Other Pump, Continuous5A0221D - Assistance with Cardiac Output using Impeller Pump, ContinuousFor Part A Services only, the provider should bill the appropriate procedure code on the UB-04 as this is an inpatient only procedure.
Article - Billing and Coding: MolDX: FDA-Approved BRAF Tests (A54018)
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 TextTwo tests have met the FDA criteria for BRAF genetic testing:Effective 09/07/2012cobas 4800 BRAF V600to detect the presence of a mutation in the BRAF gene in melanoma cells and determine if a patient is eligible for Zelboraf (vemurafenib), a treatment indicated for a melanoma that cannot be surgically excised or has spread in the body.Effective 5/29/13ThxID BRAF V600/Kto detect the BRAF V600E and V600K mutations in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with dabrafenib [Tafinlar] and as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib [Mekinist].To report an FDA approved or laboratory developed test (LDT) BRAF V600 test kit service, please submit the following claim information:CPTcode 81210Enter the appropriate DEX Z-Codeidentifier adjacent to the CPTcode in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter the appropriate DEX Z-Codeidentifier adjacent to the CPTcode in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formSelect the appropriate ICD-10-CM diagnosis.NOTE: MolDX will apply NPI to ID editing on FDA approved BRAF kits. All labs that submit claims for a BRAF V600 test kitMUSTregister the test and confirm theUNMODIFIEDuse of the kit. Tests may be registered on theDEX Diagnostics Exchangehttps://app.dexzcodes.com/loginThis article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.