Persius/hicric huggingface dataset:
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law defines those drugs that are eligible to be covered under the prescription drug benefit.Medicare law specifically excludes coverage for any drug for which payment would be available underParts A or B of Medicare for that individual. Social Security Act, Section 1860D-2(e)(2)(B).Medicare Part B pays for durable medical equipment (DME) if the equipment is used in the patient's homeor in an institution that is used as a home. Payment may be made for supplies necessary for the effectiveuse of DME. Such supplies include those drugs and biologicals which must be put directly into theequipment in order to achieve the therapeutic benefit of the DME. 42 CFR Section 410.38(a); MedicareBenefit Policy Manual, Chapter 15, Section 110.3.Medicare Part B local policy states that a small volume nebulizer, related compressor and FDA-approvedinhalation solutions are covered when medically necessary to administer albuterol, arformoterol (Brovana),budesonide, cromolyn, formoterol, ipratropium, levalbuterol, or metaproterenol for the management ofobstructive pulmonary disease (Reference the Diagnosis Codes that Support Medical Necessity Group 8Codes section of this rule for applicable diagnoses). You can find this rule at Noridian HealthcareSolutions, LLC, Local Coverage Determination (LCD) for Nebulizers (L33370) or CGS Administrators,LLC, Local Coverage Determination (LCD) for Nebulizers (L33370) and Local Coverage Article (LCA)for Nebulizers (A52466).Medicare law defines those drugs that may be covered under Part D. A covered prescription drug must beused for a medically accepted indication. A medically accepted indication means a use that is approvedby the Food and Drug Administration (FDA), or a use supported by one or more citations in the drugcompendia approved by Medicare. Medically accepted indications do not include uses in research or usesdescribed in peer-reviewed medical literature. Please refer to Social Security Act, Sections 1860D-2(e)(1)and 1927(k)(6); and 42 CFR Section 423.100.A Part D plan is permitted to use a number of different tools to manage its formulary. One of these tools isknown as prior authorization. This process requires an enrollee to obtain coverage approval for a drugbefore the drug is dispensed and covered by the plan. 70 Federal Register No. 18, issued January 28, 2005(Preamble to Final Rule).The Part D Plan contract states that the Plan cannot cover drugs that would be covered under Medicare PartA or Part B. The Part D Plan can only cover drugs prescribed for a medically accepted indication. The Planrequires prior approval (also called prior authorization) before covering some prescription drugs. If priorapproval is not obtained, the Plan may not cover the drug. Please refer to the Plan's Evidence of Coverage(EOC).
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law defines those drugs that may be covered under Part D. A covered prescription drug must beused for a medically accepted indication. A medically accepted indication means a use that is approvedby the Food and Drug Administration (FDA), or a use supported by one or more citations in the drugcompendia approved by Medicare. Medically accepted indications do not include uses in research or usesdescribed in peer-reviewed medical literature. Please refer to Social Security Act, Sections 1860D-2(e)(1)and 1927(k)(6); and 42 CFR Section 423.100.A Part D plan must grant an exception for a drug that is not on its formulary whenever it determines thatthe drug is medically necessary, consistent with the prescriber's statement, and that the drug would becovered but for the fact that it is not on the formulary. The statement must show that all of the covereddrugs on any tier of the plan's formulary for treatment of the enrollee's condition would not be a s effectiveas the non-formulary drug or would have adverse effects for the enrollee. 42 CFR Section 423.578(b).If a drug is not on the formulary (drug list), an enrollee can ask the Plan to make an exception and cover thedrug. The Plan will make an exception for coverage if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Please refer to the Plan's Evidence of Coverage(EOC).
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will find abbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law defines a covered prescription drug as a drug available only by prescription, approved by the FDA, used and sold in the United States, and used for a medically accepted indication. In general, for Part D drugs used in an anticancer chemotherapeutic regimen, a 'medically accepted indication' means a use that is:-Approved by the FDA, or -Supported by citation in one of several specified drug compendia, including the American Hospital Formulary Service-Drug Information (AHFS-DI), National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium, Thomson Micromedex DrugDex, and Clinical Pharmacology; or -Supported by clinical research that appears in the peer reviewed medical literature, specifically in journals or publications as specified by the Centers for Medicare and Medicaid Services (CMS). Social Security Act, Sections 1860D-2(e)(1) and 1861(t)(2)(B); and Medicare Benefit Policy Manual, Chapter 15, Section 50.4.5.The Part D Plan can only cover drugs prescribed for a medically accepted indication. Please refer to the Plan's Evidence of Coverage (EOC).
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.A Part D plan must grant an exception for a drug that is not on its formulary whenever it determines thatthe drug is medically necessary, consistent with the prescriber's statement, and that the drug would becovered but for the fact that it is not on the formulary. The statement must show that all of the covereddrugs on any tier of the plan's formulary for treatment of the enrollee's condition would not be as effectiveas the non-formulary drug or would have adverse effects for the enrollee. 42 CFR Sections 423.578(b) and423.578(b)(5)(i).If a drug is not on the formulary (drug list), an enrollee can ask the Plan to make an exception and cover thedrug. The Plan will make an exception for coverage if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Please refer to the Plan's Evidence Coverage (EOC).
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will find abbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law defines those drugs that are eligible to be covered under the prescription drug benefit. Medicare law specifically excludes coverage for any drug for which payment would be available under Parts A or B of Medicare for that individual. Social Security Act, Section 1860D-2(e)(2)(B). Pursuant to 42 CFR Section 410.26(b) Medicare Part B pays for services and supplies incident to the service of a physician (or other practitioner). Services and supplies must be furnished in a noninstitutional setting to noninstitutional patients; an integral, though incidental, part of the service of a physician in the course of diagnosis or treatment of an injury or illness; commonly furnished without charge or included in the bill of a physician; of a type that are commonly furnished in the office or clinic of a physician; and furnished under the direct supervision of the physician. See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices-Items/CMS-1715-F regarding billing services associated with intranasal esketamine.The Part D Plan contract states that the Plan cannot cover drugs that would be covered under Medicare Part A or Part B. Please refer to the Plan's Evidence of Coverage (EOC).
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will find abbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law defines those drugs that are eligible to be covered under the prescription drug benefit. Medicare law specifically excludes coverage for any drug for which payment would be available under Parts A or B of Medicare for that individual. Social Security Act, Section 1860D-2(e)(2)(B). Medicare Part B pays for durable medical equipment (DME) if the equipment is used in the patient's home or in an institution that is used as a home. Payment may be made for supplies necessary for the effective use of DME. Such supplies include those drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the DME. 42 CFR Section 410.38(a); Medicare Benefit Policy Manual, Chapter 15, Section 110.3. Medicare Part B local policy states that a small volume nebulizer, related compressor and FDA-approved inhalation solutions are covered when medically necessary to administer albuterol, arformoterol (Brovana), budesonide, cromolyn, formoterol, ipratropium, levalbuterol, or metaproterenol for the management of obstructive pulmonary disease (Reference the Diagnosis Codes that Support Medical Necessity Group 8 Codes section of this rule for applicable diagnoses). You can find this rule at Noridian Healthcare Solutions, LLC, Local Coverage Determination (LCD) for Nebulizers (L33370) or CGS Administrators, LLC, Local Coverage Determination (LCD) for Nebulizers (L33370) and Local Coverage Article (LCA) for Nebulizers (A52466).The Part D Plan contract states that the Plan cannot cover drugs that would be covered under Medicare Part A or Part B. Please refer to the Plan's Evidence of Coverage (EOC).A Part D plan must grant an exception for a drug that is not on its formulary whenever it determines that the drug is medically necessary, consistent with the prescriber's statement, and that the drug would be covered but for the fact that it is not on the formulary. The statement must show that all of the covered drugs on any tier of the plan's formulary for treatment of the enrollee's condition would not be as effective as the non-formulary drug or would have adverse effects for the enrollee. 42 CFR Sections 423.578(b) and 423.578(b)(5)(i).If a drug is not on the formulary (drug list), an enrollee can ask the Plan to make an exception and cover the drug. The Plan will make an exception for coverage if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Please refer to the Plan's Evidence of Coverage (EOC).
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law defines those drugs that may be covered under Part D. A covered prescription drug must beused for a medically accepted indication. A medically accepted indication means a use that is approvedby the Food and Drug Administration (FDA), or a use supported by one or more citations in the drugcompendia approved by Medicare. Medically accepted indications do not include uses in research or usesdescribed in peer-reviewed medical literature. Please refer to Social Security Act, Sections 1860D-2(e)(1)and 1927(k)(6); and 42 CFR Section 423.100.A Part D Plan is permitted to use dose restriction to manage its formulary. This process limits the numberof doses that may be dispensed during a specific period of time (usually per month). A plan must grant anexception to its dose restriction rules if it determines that the requested dosage is medically necessary,consistent with the prescriber's statement. The statement must show that the number of doses availableunder a dose restriction has been or is likely to be ineffective in treating the enrollee or adversely impactsthe drug's effectiveness or patient compliance. 42 CFR Sections 423.578(a), 423.578(b), and423.578(b)(B)(iii).The Part D Plan may cover limited quantities of some drugs. However, the Plan allows an exception for agreater amount of the drug if it determines that the requested dosage is medically necessary, consistent withthe prescriber's statement. Please refer to the Plan's Evidence of Coverage (EOC).
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law defines those drugs that are eligible to be covered under the prescription drug benefit.Medicare law specifically excludes coverage for any drug for which payment would be available underParts A or B of Medicare for that individual. Social Security Act, Section 1860D-2(e)(2)(B).Medicare Part B provides coverage of intravenous immune globulin (IVIG) for the treatment of primaryimmune deficiency diseases (ICD-10 diagnosis codes D80.0, D80.2, D80.3, D80.4, D80.5, D80.6, D80.7,D81.0, D81.1, D81.2, D81.5, D81.6, D81.7, D81.89, D81.9, D82.0, D82.1, D82.4, D83.0, D83.1, D83.2,D83.8, D83.9, G11.3) in the home. IVIG is covered under this benefit when the patient has a diagnosedprimary immune deficiency disease, it is administered in the home of a patient with a diagnosed primaryimmune deficiency disease, and the physician determines that administration of the derivative in thepatient's home is medically appropriate. Medicare Benefit Policy Manual, Chapter 15, Section 50.6; CignaGovernment Services Article for Intravenous Immune Globulin (A52509). National Government ServicesArticle for Intravenous Immune Globulin (A52509). Noridian Administrative Services Article forIntravenous Immune Globulin (A52509).The Part D Plan contract states that the Plan cannot cover drugs that would be covered under Medicare PartA or Part B. Please refer to the Plan's Evidence of Coverage (EOC).Medicare law defines those drugs that may be covered under Part D. A covered prescription drug must beused for a medically accepted indication. A medically accepted indication means a use that is approvedby the Food and Drug Administration (FDA), or a use supported by one or more citations in the drugcompendia approved by Medicare. Medically accepted indications do not include uses in research or usesdescribed in peer-reviewed medical literature. Please refer to Social Security Act, Sections 1860D-2(e)(1)and 1927(k)(6); and 42 CFR Section 423.100.The Part D Plan can only cover drugs prescribed for a medically accepted indication. Please refer to thePlan's Evidence of Coverage (EOC).
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will find abbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law defines those drugs that are eligible to be covered under the prescription drug benefit. Medicare law specifically excludes coverage for any drug for which payment would be available under Parts A or B of Medicare for that individual. Social Security Act, Section 1860D-2(e)(2)(B). Medicare Part B pays for durable medical equipment (DME) if the equipment is used in the patient's home or in an institution that is used as a home. Payment may be made for supplies necessary for the effective use of DME. Such supplies include those drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the DME. 42 CFR Section 410.38(a); Medicare Benefit Policy Manual, Chapter 15, Section 110.3. Medicare Part B local policy states that a small volume nebulizer, related compressor and FDA-approved inhalation solutions are covered when medically necessary to administer dornase alfa to a beneficiary with cystic fibrosis (refer to the Group 9 Codes in the LCD-related Policy Article for applicable diagnoses). You can find this rule at Noridian Healthcare Solutions, LLC, Local Coverage Determination (LCD) for Nebulizers (L33370) or CGS Administrators, LLC, Local Coverage Determination (LCD) for Nebulizers (L33370) and Local Coverage Article (LCA) for Nebulizers (A52466).The Part D Plan contract states that the Plan cannot cover drugs that would be covered under Medicare Part A or Part B. Please refer to the Plan's Evidence of Coverage (EOC).
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.A Part D plan must have enough contracted retail pharmacies in its network to ensure that enrollees haveadequate access to covered prescription drugs. Access to covered drugs from an out-of-network pharmacyis required when enrollees: (1) cannot reasonably be expected to obtain such drugs at a network pharmacyand (2) do not access covered drugs at out-of-network pharmacies on a routine basis. A plan is required toestablish reasonable rules to appropriately limit out-of-network access to covered prescription drugs. 42CFR Sections 423.120(a) and 423.124; Medicare Prescription Drug Benefit Manual, Chapter 5, Section60.1.Vaccines administered in a physician's office or by other non-network providers may be covered under theout-of-network access rules. A Part D enrollee may self-pay for the vaccine cost and its administration andsubmit a paper claim for reimbursement to his or her Part D sponsor. 42 CFR Section 423.124; PrescriptionDrug Benefit Manual, Chapter 5, Section 60.3.4.The Part D Plan covers a number of vaccines (including vaccine administration) under the Part D benefit.The Plan's coverage of a vaccine depends on the type of vaccine, where the enrollee gets the vaccine andwho administers the vaccine. Note that in some cases, an enrollee may receive a vaccine outside of thePlan's pharmacy network, and may have to pay for the entire cost of the vaccine and its administration. Theenrollee can then ask the Plan to pay its share of the vaccine costs. For detailed information on howvaccines are reimbursed, please refer to the Plan's Evidence of Coverage (EOC).
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law defines those drugs that are eligible to be covered under the prescription drug benefit.Medicare law specifically excludes coverage for any drug for which payment would be available underParts A or B of Medicare for that individual. Social Security Act, Section 1860D-2(e)(2)(B).Effective January 1, 2011, Medicare law requires that all drugs and biologicals used in the treatment of endstage renal disease (ESRD) be included in the ESRD prospective payment system (PPS) payment bundle,including drugs formerly paid under Medicare Part D. The law identifies categories of drugs that either are,or may be, ESRD-related. Drugs that are always considered ESRD-related include access managementdrugs, anemia management drugs, anti-infectives to treat site access infection, bone and mineralmetabolism drugs and cellular management drugs. Social Security Act, Section 1881(b)(14); 42 CFRSection 413.171; Medicare Benefit Policy Manual, Chapter 11, Section 20.3; and 75 Federal Register No.155, issued August 12, 2010 (Preamble to Final Rule).Effective February 20, 2018, Medicare law also provides coverage of related drugs under the PPS bundlefor treatment of acute kidney injury (AKI). Medicare Benefit Policy Manual, Chapter 11, Section 100.6.For drugs that are always considered ESRD-related, it is important to note that the ESRD bundle includesall ESRD-related drugs and biologicals, regardless of whether or not these are furnished by a dialysisfacility. Thus, effective January 1, 2011, any claims for a drug included in the five categories of drugs thatare always considered renal dialysis drugs when furnished to an ESRD patient and used as specified inTable 4 of the Preamble to the Final Rule would not be payable under Part D when the beneficiary is anESRD patient in dialysis, regardless of why the drug is being furnished. Medicare Program; End-StageRenal Disease Prospective Payment System, 75 Fed. Reg. 49030, 49050 (August 12, 2010); CMS memo:Clarification of Exclusion of Part D Payment for Drugs included in the End-Stage Renal DiseaseProspective Payment dated February 17, 2011.The Part D Plan contract states that its Part D drug coverage cannot cover a drug that would be coveredunder Medicare Part A or Part B. Please refer to the Plan's Evidence of Coverage
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.An enrollee in a Part D plan may be subject to annual deductibles, coinsurance, and copayments (includingtiered copayments) specified by the plan. 42 CFR ?423.104.The Part D Plan enrollee may pay part of the cost of a covered drug during the initial coverage period as acopayment or coinsurance. The amount of the copayment or coinsurance will vary depending on the drug'stier and place of purchase. There may be situations in which an enrollee will pay the full cost of the drug atthe time of purchase or an enrollee may pay more than expected under the coverage rules of the Plan. Ineither case, an enrollee can ask the Plan to pay its share of the cost of the drug by sending the Plan a requestfor reimbursement along with the enrollee's prescription receipt(s) documenting proof of purchase. Pleaserefer to the Plan's Evidence of Coverage.
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.For a drug to be covered under Medicare Part D, it must meet the definition of a Part D drug. The SocialSecurity Act generally defines a Part D drug as a drug product that meets the following requirements:-It requires a prescription for dispensing; and-It is approved by the Food and Drug Administration (FDA) for safety and effectiveness; and-It is prescribed for a medically accepted indication; and-It is not otherwise excluded from coverage under Part D law and rules.See Social Security Act, Sections 1860D-2(e)(1) and 1927(k)(2)(A)(i)-(iii); and Medicare PrescriptionDrug Benefit Manual, Chapter 6, Section 10.1.The definition of a Part D drug does not include over-the-counter (OTC) products. OTC drug products arethose drugs that are available to consumers without a prescription. The FDA's Center for Drug Evaluationand Research (CDER) is the entity that oversees the designation and marketing of OTC drugs. MedicarePart D does not pay for OTC drug products. See rules noted above; and Medicare Prescription Drug BenefitManual, Chapter 6, Section 10.10 and Chapter 7, Section 60.2.