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 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 may be covered under Part D. A covered prescription drug must be used for a medically accepted indication. A medically accepted indication means a use that is approved by the Food and Drug Administration (FDA), or a use supported by one or more citations in the drug compendia approved by Medicare. Medically accepted indications do not include uses in research or uses described 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 drug must be used for a medically accepted indication that facilitates the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member (except for Part D vaccines). Consequently, if a drug works on medical equipment or devices and is not used for a medically accepted indication of therapeutic value on the body, it cannot satisfy the definition of a Part D drug. For example, a Heparin flush is not used to treat a patient for a medically accepted indication, but rather to dissolve possible blood clots around an infusion line. Therefore, Heparin's use in this instance is not therapeutic but is, instead, necessary to make durable medical equipment work. It would therefore not be a Part D drug when used in a Heparin flush. Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.6.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 find abbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.The Medicare Coverage Gap Discount Program provides manufacturer discounts on brand name prescription drugs to Part D enrollees who have reached the coverage gap. These are enrollees who are in the donut hole and are not participating in the Extra Help program with Medicare. However, brand name drugs are only eligible for coverage under Part D if their manufacturers have signed agreements with the Centers for Medicare & Medicaid Services (CMS) to provide a discount on all of their brand name drugs. If a drug manufacturer does not sign a discount agreement with CMS, its brand name drugs will not be covered under Part D. Social Security Act, Sections 1860D-14A and 1860D-43.For a drug to be covered under Medicare Part D, it must meet the definition of a Part D drug. The Social Security 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 Prescription Drug Benefit Manual, Chapter 6, Section 10.1. The definition of a Part D drug includes only those prescription drugs that are approved by the FDA for safety and effectiveness. For a drug to be approved by the FDA, the manufacturer of the drug must file a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) with the FDA's Center for Drug Evaluation and Research (CDER). Medicare Part D does not pay for drugs that are not FDA approved prescription drugs. See Social Security Act, Sections 1860D-2(e)(1), 1927(k)(2), and 1927(b)(3).The Plan does not cover drugs/items excluded from Medicare Part D coverage. If you purchase drugs/items that are excluded, you must pay for them yourself. 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 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 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 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 find abbreviated 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 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.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 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 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.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.The Part D Plan can only cover drugs prescribed for a medically accepted indication. The Plan does notcover drugs/items excluded from Medicare Part D coverage. If you purchase drugs/items that are excluded,you must pay for them yourself. 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 may establish tiered cost-sharing for drugs on its formulary. The Plan groups covered drugsinto different cost-sharing levels or tiers. Higher tiers have higher copayments. Medicare rules permit anenrollee to request a tiering exception for a higher tier drug to be covered at the cost-sharing level thatapplies for lower tier drugs. An enrollee may request a tiering exception to cover a higher tier drug at alower tier cost-sharing level so long as there is a drug on the eligible lower tier that is approved for treatingthe same condition that the requested higher tier drug is being used to treat. A Plan is not required to grant atiering exception for a brand drug if the lower tier or tiers only contain generic drugs. 42 CFR ??423.4,423.100, 423.578(a), 423.578(c)(4)(iii); Medicare Prescription Drug Benefit Manual, Chapter 18, ?30.2.1.Each drug on the Plan's formulary is assigned to a cost-sharing tier. The Part D Plan contract allows anenrollee to request an exception to the Plan's cost-sharing structure to pay less for a drug. This is called atiering exception. The prescriber must provide medical reasons to support a tiering exception. The Plancannot grant a tiering exception for any drug in the specialty cost-sharing tier. The Plan cannot grant atiering exception for a non-formulary drug being covered under an exception to the formulary. Please referto 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 may establish tiered cost-sharing for drugs on its formulary. The Plan groups covered drugsinto different cost-sharing levels or tiers. Medicare rules permit an enrollee to request a tiering exception tocover a higher cost-sharing tiered drug at a lower cost-sharing tier level so long as there is a drug on alower cost-sharing tier that is approved for treating the same condition that the requested higher costsharingtiered drug is being used to treat. However, Medicare rules also permit a Plan to design its tieringexception procedures so that a Plan does not have to grant a tiering exception for brand or biologic drugs ifthe lower cost-sharing tier or tiers only contain generic drugs approved for treating the same condition. 42CFR Sections 423.4; 423.578(a); 423.578(a)(6); 423.578(c)(3)(ii); Parts C & D Grievances,Organization/Coverage Determinations, and Appeals Guidance Manual, Section 40.5.1.The prescription drug benefit offered by the Part D Plan must meet criteria requirements pertaining to theannual deductible, the initial coverage limit, the coverage gap and catastrophic coverage. For the initialcoverage limit, the rules provide for a benefit of shared coverage of costs between the enrollee and Plan.An enrollee in a Part D Plan may be subject to annual deductibles, coinsurance and copayments (includingtiered copayments) specified by the Plan. 42 CFR Section 423.104.Each drug on the Plan's formulary is assigned to a cost-sharing tier. The Part D Plan contract allows an enrollee to an exception to the Plan's cost-sharing structure to pay less for a drug. This is called a tiering exception. The prescriber must provide medical reasons to support a tiering exception. The Plancannot grant a tiering exception for any drug in the specialty cost-sharing tier. The Plan cannot grant atiering exception for a non-formulary drug being covered under an exception to the formulary. 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.The prescription drug benefit offered by the Part D Plan must meet certain requirements pertaining to theannual deductible, the initial coverage limit, the coverage gap and catastrophic coverage. For the initialcoverage limit, the rules provide for a benefit of shared coverage of costs between the enrollee and plan. Anenrollee in a Part D Plan may be subject to annual deductibles, coinsurance, and copayments (includingtiered copayments) specified by the plan. 42 CFR Section 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. If an enrollee pays the full cost of a prescription, the enrollee may submit arequest for reimbursement with proof of payment to ask the Plan to pay its share of the cost. The Planrequired a $30 copayment for up to a 90 day supply of a Tier 2 drug purchased in 2020 from a standardretail pharmacy. Naproxen DR 500 mg is on the Plan's 2020 formulary and was classified as a Tier 2 drug.Please refer to the Plan's Evidence of Coverage (EOC) and formulary.
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.The prescription drug benefit offered by the Part D Plan must meet certain requirements pertaining to theannual deductible, the initial coverage limit, the coverage gap and catastrophic coverage. For the initialcoverage limit, the rules provide for a benefit of shared coverage of costs between the enrollee and plan. Anenrollee in a Part D Plan may be subject to annual deductibles, coinsurance, and copayments (includingtiered copayments) specified by the plan. 42 CFR Section 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 (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 be used for a medically accepted indication A medically accepted indication means a use that is approved by 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 number of doses that may be dispensed during a specific period of time (usually per month). A plan must grant an exception 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 available under a dose restriction has been or is likely to be ineffective in treating the enrollee or adversely impacts the drug's effectiveness or patient compliance. 42 CFR 423.578(b).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 available under a dose restriction has been or is likely to be ineffective in treating the enrollee or adversely impacts the 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 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 step therapy to manage its formulary. This is the process of beginningdrug therapy for a medical condition with preferred (or more cost-effective) non-formulary drugalternative(s) and progressing to other drug therapies only as necessary. A plan must grant an exception toits step therapy rules if it determines that the requested drug is medically necessary, consistent with theprescriber's statement. The statement must show that the step therapy drug(s): has been ineffective in thetreatment of the enrollee's disease or medical condition or, based on both sound clinical evidence andmedical and scientific evidence and the known relevant physical or mental characteristics of the enrolleeand known characteristics of the drug regimen, is likely to be ineffective or adversely affect the drug'seffectiveness or patient compliance; or has caused or based on sound clinical evidence and medical andscientific evidence, is likely to cause an adverse reaction or other harm to the enrollee. 42 CFR Section423.578(b)(5)(ii).The Plan requires certain drugs be tried first before it will cover the requested drug. This is called steptherapy. However, the Part D Plan contract allows an enrollee to request an exception. The Plan will coverthe requested drug without requiring step therapy 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 findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 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 can only cover drugs prescribed for a medically accepted indication. The Plan requiresprior approval (also called prior authorization) before covering some prescription drugs. If prior approval isnot obtained, the Plan may not cover the drug. Please refer to the Plan's Evidence of Coverage (EOC).A Part D Plan may establish tiered cost-sharing for drugs on its formulary. The Plan groups covered drugsinto different cost-sharing levels or tiers. Medicare rules permit an enrollee to request a tiering exceptionfor a higher cost-sharing tiered drug to be covered at the cost-sharing level that applies for lower costsharingtiered drugs. If a Part D Plan maintains a formulary tier in which it places very high costs andunique items (i.e., specialty tier), the Part D Plan may design its exception process so that very high cost orunique drugs are not eligible for a tiering exception. 42 CFR Section 423.4; Parts C & D Grievances,Organization/Coverage Determinations, and Appeals Guidance Manual, Section 40.5.1.Each drug on the Plan's formulary is assigned to a tier. The Part D Plan contract allows an enrollee torequest an exception to the Plan's cost-sharing structure to pay less for a drug. This is called a tieringexception. The Plan does not allow a tiering exception for any drug in the specialty tier. 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 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 Section 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. When requesting reimbursement, the enrollee may submit a request forreimbursement with proof of payment to ask the Plan to pay its share of the cost. Please refer to the Plan'sEvidence of Coverage (EOC).