evekhm/cms_iom_500 huggingface dataset:
Article - Self-Administered Drug Exclusion List: (A53033)
Basis for Non-CoverageA. Apparent on its FaceB. Presumption: Long-Term Non-Acute AdministrationC. Acceptable Evidentiary Criteria AvailableRoute 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. 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 policyas stated in Medicare Benefit Policy Manual Chapter 15, section 50.2that 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.Note:The drugs represented by HCPCS codes J0801 and J0802 (marked with a double asterisk**) 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 IM administration.CPT/HCPCS ModifiersGroup 1 Paragraph:Claim denials may occur when the appropriate modifier is not applied to a J code/medication, which has more than one route of administration.Group 1 Codes:JAIntravenous administrationJBSubcutaneous administrationProviders are reminded that no form of insulin, regardless of route of administration including intravenous, intramuscular, subcutaneous, or inhalation, is reimbursable by Medicare. [This includes J8499: Insulin, inhaled (Exubera), variable.]
Article - Self-Administered Drug Exclusion List: (A53033)
If a beneficiary's 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 Non-coverage (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 AppealsThe hospital and a physician accepting assignment may appeal a denial under the provisions found in the IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 29, Section 200.Reasonable and NecessaryNoridian will make the determination of reasonable and necessary with respect to the medical appropriateness of the drug to treat the patient's 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 physician's office visit was reasonable and necessary. However, while a physician's 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.Sources IOM, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, Section 50.2, Determining Self-Administration of Drug or Biological Transmittal 123, CR 6950 dated April 30, 2010
Article - Self-Administered Drugs - Process To Determine Which Drugs Are Usually Self-Administered by the Patient (A53034)
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 Contractor"Contractors 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 physician's 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 words"by the patient"mean 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 physician's service for reasons such as:Teaching self-administration,Adjusting or titrating the dose,Monitoring for immediate side effects, andEmergency use.
Article - Self-Administered Drugs - Process To Determine Which Drugs Are Usually Self-Administered by the Patient (A53034)
Teaching self-administration,Adjusting or titrating the dose,Monitoring for immediate side effects, andEmergency use.If a drug has multiple uses, and the drug is administered "incident to" a physician's 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 physician's 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 face"For 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 drug's 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.
Article - Self-Administered Drugs - Process To Determine Which Drugs Are Usually Self-Administered by the Patient (A53034)
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:1.      Select beginning and end dates for the analysis. For consistencytry to use the same dates for all calculations.2.      Calculate the total injections during this period, including anyintravenous or intramuscular injections. This total will be 100%.3.      Drug indications will be sorted by diagnoses and where similarwill be combined to facilitate analysis.4.      Calculate the number of subcutaneous injections, but do notinclude those for courses of treatment consisting of scheduledinjections lasting less than two weeks. (Any indication withscheduled injections lasting less than two weeks is weighted asnot usually self-administered, even if administeredsubcutaneously.)5.      Add to this number (from # 4) those injections for courses oftreatment lasting two weeks or longer and with injections at leastweekly (i.e. those that are both "chronic" and "frequent")6.      If this sum is equal to or less than 50% of the total injectionsduring the period, the drug is not usually self administered andis covered.7.      If this sum is more than 50% of the total injections during theperiod, proceed to Step 3.Step 3Determination of Self-Administration usingEvidentiaryCriteria:When available, evidence of the following types must be considered:Peer-reviewed medical literatureStandards of medical practiceEvidence-based practice guidelinesFDA approved indicationsFDA approved package insert (which is not to be usedbyitself as the onlydetermining factor)Further, evidence of the following typesmaybe considered:Drug compendia referencesReliable patient use dataThe need for physician monitoring to determine each doseOther 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 Usually Self-Administered by the Patient (A53034)
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 beneficiary's 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 IOMMedicare 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 patient's 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 physician's office visit was reasonable and necessary. However, while a physician's 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 Usually Self-Administered by the Patient (A53034)
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.
Social Security Act §1833
html  PUBLIC "-//W3C//DTD HTML 4.01//EN"SSA INTERNET HEAD SCRIPTSSocial Security Act 1833BANNERSkip to main contentSocial SecuritySearchMenuEspaolSign inSITE NAVIGATION#include virtual="/framework/includes/english/navigation.shtml"PAGE TITLECompilation of the Social Security LawsCONTENT
Social Security Act §1833
PAYMENT OF BENEFITS[71]Sec.1833.[42 U.S.C. 1395l](a)Except as providedin section 1876, and subject to the succeeding provisions of this section, thereshall be paid from the Federal Supplementary Medical Insurance TrustFund, in the case of each individual who is covered under the insuranceprogram established by this part and incurs expenses for serviceswith respect to which benefits are payable under this part, amountsequal to(1)in the case ofservices described in section 1832(a)(1)80 percent of thereasonable charges for the services; except that(A)an organizationwhich provides medical and other health services (or arranges fortheir availability) on a prepayment basis (and either is sponsoredby a union or employer, or does not provide, or arrange for the provisionof, any inpatient hospital services) may elect to be paid 80 percentof the reasonable cost of services for which payment may be made underthis part on behalf of individuals enrolled in such organization inlieu of 80 percent of the reasonable charges for such services ifthe organization undertakes to charge such individuals no more than20 percent of such reasonable cost plus any amounts payable by themas a result of subsection (b),(B)with respectto items and services described in section 1861(s)(10)(A), the amounts paidshall be 100 percent of the reasonable charges for such items andservices,(C)with respectto expenses incurred for those physicians services for whichpayment may be made under this part that are described in section 1862(a)(4), theamounts paid shall be subject to such limitations as may be prescribedby regulations,(D)[72]with respect to clinical diagnostic laboratorytests for which payment is made under this part(i)(I)on the basis[73]of a fee schedule under subsection(h)(1) (for tests furnished before January 1, 2017)[74]or section 1834(d)(1), the amount paid shall be equal to 80 percent (or 100 percent, inthe case of such tests for which payment is made on an assignment-relatedbasis) of the lesser of the amount determined under such fee schedule,the limitation amount for that test determined under subsection (h)(4)(B),or the amount of the charges billed for the tests, or
Social Security Act §1833
(II)undersection 1834A (for tests furnished on or after January 1, 2017), theamount paid shall be equal to 80 percent (or 100 percent, in the caseof such tests for which payment is made on an assignment-related basis)of the lesser of the amount determined under such section or the amountof the charges billed for the tests, or(ii)[75]for tests furnished before January 1, 2017,on the basis of a negotiated rate established under subsection (h)(6),the amount paid shall be equal to 100 percent of such negotiated rate[76],(E)with respectto services furnished to individuals who have been determined to haveend stage renal disease, the amounts paid shall be determined subjectto the provisions of section 1881,(F)with respectto clinical social worker services under section 1861(s)(2)(N), the amounts paidshall be 80 percent of the lesser of(i)the actual chargefor the services or(ii)75 percentof the amount determined for payment of a psychologist under clause(L),(G)with respectto facility services furnished in connection with a surgical procedurespecified pursuant to subsection (i)(1)(A) and furnished to an individualin an ambulatory surgical center described in such subsection, forservices furnished beginning with the implementation date of a revisedpayment system for such services in such facilities specified in subsection(i)(2)(D), the amounts paid shall be 80 percent of the lesser of theactual charge for the services or the amount determined by the Secretaryunder such revised payment system,(H)with respectto services of a certified registered nurse anesthetist under section 1861(s)(11), theamounts paid shall be 80 percent of the least of the actual charge,the prevailing charge that would be recognized (or, for services furnishedon or after January 1, 1992, the fee schedule amount provided undersection 1848)if the services had been performed by an anesthesiologist, or thefee schedule for such services established by the Secretary in accordancewith subsection (1),(I)with respectto covered items (described in section 1834(a)(13)), the amounts paid shallbe the amounts described in section 1834(a)(1), and
Social Security Act §1833
(I)with respectto covered items (described in section 1834(a)(13)), the amounts paid shallbe the amounts described in section 1834(a)(1), and(J)with respectto expenses incurred for radiologist services (as defined in section 1834(b)(6)), subjectto section 1848, the amounts paid shall be 80 percent of the lesser of the actualcharge for the services or the amount provided under the fee scheduleestablished under section 1834(b),(K)with respectto certified nursemidwife services under section 1861(s)(2)(L),the amounts paid shall be 80 percent of the lesser of the actual chargefor the services or the amount determined by a fee schedule establishedby the Secretary for the purposes of this subparagraph (but in noevent shall such fee schedule exceed 65 percent of the prevailingcharge that would be allowed for the same service performed by a physician,or, for services furnished on or after January 1, 1992, 65 percent(or 100 per cent for services furnished on or after January 1, 2011)of the fee schedule amount provided under section 1848 for the same serviceperformed by a physician),(L)with respectto qualified psychologist services under section 1861(s)(2)(M), the amounts paidshall be 80 percent of the lesser of the actual charge for the servicesor the amount determined by a fee schedule established by the Secretaryfor the purposes of this subparagraph,(M)with respectto prosthetic devices and orthotics (as defined in section 1834(h)(4)), the amounts paid shallbe the amounts described in section 1834(h)(1),(N)with respectto expenses incurred for physicians services (as defined insection 1848(j)(3)) other than personalized prevention plan services (as defined insection 1861(hhh)(1)), theamounts paid shall be 80 percent of the payment basis determined undersection 1848(a)(1),(O)with respectto services described in section 1861(s)(2)(K) (relating to servicesfurnished by physicians assistants, nurse practitioners, or clinicalnurse specialists), the amounts paid shall be equal to 80 percentof(i)the lesser ofthe actual charge or 85 percent of the fee schedule amount providedunder section 1848, or
Social Security Act §1833
(i)the lesser ofthe actual charge or 85 percent of the fee schedule amount providedunder section 1848, or(ii)in the caseof services as an assistant at surgery, the lesser of the actual chargeor 85 percent of the amount that would otherwise be recognized ifperformed by a physician who is serving as an assistant at surgery,(P)with respectto surgical dressings, the amounts paid shall be the amounts determinedunder section 1834(i),(Q)with respectto items or services for which fee schedules are established pursuantto section 1842(s), the amounts paid shall be 80 percent of the lesser of the actualcharge or the fee schedule established in such section,(R)with respectto ambulance services,(i)the amounts paidshall be 80 percent of the lesser of the actual charge for the servicesor the amount determined by a fee schedule established by the Secretaryunder section 1834(l) and(ii)with respectto ambulance services described in section 1834(l)(8), the amounts paid shallbe the amounts determined under section 1834(g) for outpatient critical accesshospital services ,(S)with respectto drugs and biologicals (including intravenous immune globulin (asdefined in section 1861(zz))) not paid on a cost or prospective payment basisas otherwise provided in this part (other than items and servicesdescribed in subparagraph (B)), the amounts paid shall be 80 percentof the lesser of the actual charge or the payment amount establishedin section 1842(o) (or, if applicable, under section 1847, 1847A, or 1847B),(T)with respectto medical nutrition therapy services (as defined in section 1861(vv)), the amountpaid shall be 80 percent (or 100 percent if such services are recommendedwith a grade of A or B by the United States Preventive Services TaskForce for any indication or population and are appropriate for theindividual) of the lesser of the actual charge for the services or85 percent of the amount determined under the fee schedule establishedunder section 1848(b) for the same services if furnished by a physician,(U)with respectto facility fees described in section 1834(m)(2)(B), the amounts paidshall be 80 percent of the lesser of the actual charge or the amountsspecified in such section,