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.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 dru gbefore the drug is dispensed and covered by the plan. 70 Federal Register No. 18, issued January 28, 2005(Preamble to Final Rule).Formulary use includes the application of cost utilization tools, including step-therapy, dosage limitationsand therapeutic substitution. 42 CFR Section 423.578(b)(iii). The exceptions process extends to coveragerequests to set aside cost utilization rules for non-formulary drugs. A Part D plan must grant an exceptionwhenever it determines that the drug is medically necessary, consistent with the prescriber's statement, andthat the drug would be covered but for the fact that it is subject to cost utilization rules. 42 CFR Section423.578(b). The statement must show that all of the covered drugs on any tier of the plan's formulary fortreatment of the enrollee's condition would not be as effective as the drug at issue, or would have adverseeffects for the enrollee. Parts C & D Enrollee Grievances, Organization/Coverage Determinations, andAppeals Guidance Manual, Section 40.5.3.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. A Plan must grant an exception to prior approval rules if itdetermines that the requested drug is medically necessary, consistent with the prescriber's statement. 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 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 deductible stage is the first payment stage of the enrollee's drug coverage. During the deductible stage, the Plan requires that the enrollee pays the full cost of Tier 3, Tier 4 and Tier 5 drugs before the Plan will pay a share of the cost. Once the enrollee has met the deductible amount of $415, the enrollee moves into the initial coverage stage. 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 Shingrix vaccine was on the Plan's 2019 formulary and was classified as a Tier 3 drug. Please refer to the Plan's Evidence of Coverage 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 find abbreviated 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 drugs into different cost-sharing levels or tiers. Medicare rules permit an enrollee to request a tiering exception to cover a higher cost-sharing tiered drug at a lower cost-sharing tier level so long as there is a drug on a lower cost-sharing tier that is approved for treating the same condition that the requested higher cost-sharing tiered drug is being used to treat. However, Medicare rules also permit a Plan to design its tiering exception procedures so that a Plan does not have to grant a tiering exception for brand or biologic drugs if the lower cost-sharing tier or tiers only contain generic drugs approved for treating the same condition. 42 CFR 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 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.Each drug on the Plan's formulary is assigned to a cost-sharing tier. The Part D Plan contract allows an enrollee to request 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 Plan cannot grant a tiering exception for any drug in the specialty cost-sharing tier. The Plan cannot grant a tiering 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.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.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.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 Plan will generally cover prescriptions only if they are filled at a Plan network pharmacy. Prescriptionsfilled at an out-of-network pharmacy may only be covered when a network pharmacy is not available. ThePlan will typically cover prescriptions filled at an out-of-network pharmacy when the prescription is for amedical emergency or urgent care, when there are no 24-hour network pharmacies within a reasonabledriving distance or when the prescription is for a drug that is out of stock at an accessible networkpharmacy. 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 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 I) they are prescribed following a Kidney transplant, II) the transplant met Medicare coverage criteria in effect with respect to the facility being approved for Kidney transplant, III) the patient was enrolled in Medicare Part A at the time of the transplant, IV) the patient is enrolled in Medicare Part B at the time the drugs are dispensed and V) 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).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.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, including priorauthorization, step therapy and dose restriction, or quantity limits. 70 Federal Register No. 18, issuedJanuary 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. Theseadditional requirements include prior authorization, step therapy and quantity limits. 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 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).
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 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 Sections 423.578(a), 423.578(b), and 423.578(b)(B)(iii).The Part D Plan may cover limited quantities of some drugs. However, the Plan allows an exception for a greater 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 find abbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.A Part D Plan must cover the prescription drug benefits described in its subscriber agreement. A Plan is permitted to manage its prescription drug benefit by establishing a formulary that identifies specific drugs that are covered through the Plan. A Plan is permitted to use a number of different tools or approaches to manage the coverage of drugs on 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). 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 an external infusion pump is covered for administration of subcutaneous immune globulin if the subcutaneous immune globulin preparation is a pooled plasma derivative which is approved for the treatment of primary immune deficiency disease; and the patient has a diagnosis of primary immune deficiency disease. You can find this rule at CGS Administrators, LLC, Local Coverage Determination (LCD) for External Infusion Pumps (L33794) and (A52507) or Noridian Healthcare Solutions, LLC LCD for External Infusion Pumps (L33794) and (A52507).
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 certain drugs, or classes of drugs, or their medical uses. Medicare does not cover drugs used to treat sexual or erectile dysfunction (unless used to treat a condition other than sexual or erectile dysfunction for which the drug has been approved by the FDA). Social Security Act ?1860D-2(e)(2)(A), ?1927(d)(2) & (4)(C) and 42 CFR 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. Nothing in the rules regarding exceptions may be construed to allow an enrollee to use the exceptions processes set out in that section to request or be granted coverage for a prescription drug that does not meet the definition of a Part D drug. 42 CFR ?423.578(b) & (e).The Part D Plan does not cover certain types of drugs. The Plan may offer supplemental (additional) coverage to cover excluded drugs. Vardenafil is not covered under the Plan's formulary. The Part D Plan offers supplemental drug coverage for Vardenafil. The supplemental coverage has a quantity limit of 6 per 23 days. 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 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 $141 copayment for up to a long-term (up to 90 days) supply day supply of a Tier 3 drug purchased in 2020 from a retail pharmacy. Duloxetine was on the Plan's 2020 formulary and was classified as a Tier 3 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 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 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 Sections 423.578(a), 423.578(b), and 423.578(b)(B)(iii).The Part D Plan may cover limited quantities of some drugs. However, the Plan allows an exception for a greater 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).