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 Part D does not cover a (1) drug used for anorexia, weight loss or weight gain; (2) drug used topromote fertility; (3) drug used for cosmetic purposes or to promote hair growth; (4) drug used for thesymptomatic relief of coughs and colds; (5) prescription vitamin and mineral product; (6) non-prescriptionor over-the-counter drug; (7) drug subject to manufacturer tying arrangements; and (8) drug used to treatsexual or erectile dysfunction or (9) sexual or erectile dysfunction drug used to treat a condition other thansexual or erectile dysfunction for which the drug has not been approved by the FDA. Social Security Act,Sections 1860D-2(e)(2)(A), 1927(d)(2) and 1927(d)(4)(C).The Part D Plan does not cover those drugs excluded from Medicare Part D coverage. The Plan may offersupplemental (additional) coverage to cover excluded drugs. Sildenafil 100 mg is not covered under thePlan's formulary. The Part D Plan offers supplemental drug coverage for Sildenafil 100 mg. Thesupplemental coverage has a quantity limit of #6 tablets per 30 days. Please refer to the Plan's Evidence ofCoverage (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 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).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).
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 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.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 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).
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 is permitted to use a number of different tools to manage its formulary. One of these tools is known as prior authorization. This process requires an enrollee to obtain coverage approval for a drug before 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 requires prior approval (also called prior authorization) before covering some prescription drugs. If prior approval 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.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).
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 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.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 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).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.
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). Coverage is available under Medicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary who has received an organ transplant, provided the beneficiary receiving the drug was enrolled in Medicare Part A at the time of the organ transplant. 42 CFR Section 410.30; Medicare Benefit Policy Manual, Chapter 15, Section 50.5.1. Medicare Part B local policy states that prescription drugs used in immunosuppressive therapy are covered if they are prescribed following a kidney transplant, the transplant met Medicare coverage criteria in effect with respect to the facility being approved for a kidney transplant, the patient was enrolled in Medicare Part A at the time of the transplant, the patient is enrolled in Medicare Part B at the time the drugs are dispensed and the drugs are furnished on or after the date of discharge. Assuming criteria I, II and III are met, a transplant is considered a covered transplant for purposes of this Medicare policy whether payment for the transplant was made by Medicare or another insurer. You can find this rule at Noridian Healthcare Solutions, LLC, Policy Article for Immunosuppressive Drugs (A52474) or CGS Administrators, LLC, Policy Article for Immunosuppressive Drugs (A52474).A Part D plan is permitted to use a number of different tools to manage its formulary, including prior authorization, step therapy and dose restriction, or quantity limits. 70 Federal Register No. 18, issued January 28, 2005 (Preamble to Final Rule); 42 CFR Section 423.578(b).For certain drugs, the Part D Plan has additional requirements for coverage or limits on its coverage. These additional requirements include prior authorization, step therapy and quantity limits. 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.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. A Part D drug is a prescription drug that is 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). Current FDA law requires a manufacturer to prove that its drug is both safe and effective. Some drugs currently on the market were FDA approved for safety only. These drugs were approved prior to the passing of current FDA law. The FDA reviews these drugs to determine which are less than effective (LTE) for their labeled indications. This review process is known as the Drug Efficacy Study Implementation (DESI) program. This program has resulted in the FDA classifying some of these drugs as LTE DESI drugs. Medicare Part D does not pay for prescription drug products classified by the FDA's DESI program as LTE for their labeled indications. Medicare Part D also does not pay for prescription drug products that are Identical, Related or Similar (IRS) to drugs that are classified as LTE drugs. See Social Security Act, Sections 1860D-2(e)(1) and 1927(k)(2)(A)(i)-(iii); and Prescription Drug Benefit Manual, Chapter 6, Section 10.9.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.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 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 orillness; commonly furnished without charge or included in the bill of a physician; of a type that arecommonly furnished in the office or clinic of a physician; and furnished under the direct supervision of thephysician. In order to meet all the general requirements for coverage under the incident-to provision, anFDA approved drug or biological must be of a form that is not usually self-administered. 42 CFR Section410.26(b); Medicare Benefit Policy Manual, Chapter 15, Section 50.3.
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 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 find abbreviated 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 the annual deductible, the initial coverage limit, the coverage gap and catastrophic coverage. For the initial coverage 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 (including tiered 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 a copayment or coinsurance. The amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. If an enrollee pays the full cost of a prescription, the enrollee may submit a request for reimbursement with proof of payment to ask the Plan to pay its share of the cost. The Plan required a $60 copayment amount for up to a 90 day supply of a Tier 2 drug purchased in 2019 from a standard re-tail pharmacy. Verapamil ER 100 mg was on the Plan's 2019 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.Medicare Part D does not cover a (1) drug used for anorexia, weight loss or weight gain; (2) drug used topromote fertility; (3) drug used for cosmetic purposes or to promote hair growth; (4) drug used for thesymptomatic relief of coughs and colds; (5) prescription vitamin and mineral product; (6) non-prescriptionor over-the-counter drug; (7) drug subject to manufacturer tying arrangements; and (8) drug used to treatsexual or erectile dysfunction or (9) sexual or erectile dysfunction drug used to treat a condition other thansexual or erectile dysfunction for which the drug has not been approved by the FDA. Social Security Act,Sections 1860D-2(e)(2)(A), 1927(d)(2) and 1927(d)(4)(C).The Part D Plan does not cover those drugs excluded from Medicare Part D coverage. In addition, the Plandoes not offer supplemental (additional) coverage for it. If you purchase drugs that are excluded, you mustpay 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.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 Plan does not cover drugs/items excluded from Medicare Part D coverage. If you purchase drugs/itemsthat are excluded, you must pay for them yourself. Please refer to the Plan's Evidence of Coverage (EOC).