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 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 ?1860D-2(e)(2)(b) and 42 CFR ?423.100.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 ?410.30; Medicare Benefit Policy Manual, Chapter 15, ?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 transplant, II) the transplant met Medicare coverage criteria in effect with respect to the facility being approved for 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. CGS Administrators, LLC, Policy Article for Immunosuppressive Drugs (A52474).Medicare Part B local policy states that immunosuppressive drugs are covered only for the specific labeled indications and approval for marketing by the FDA (bp 102 c15, ?50.5.1). Parenteral Belatacept (Nulojix) is not proven to be safe when administered in the home setting and therefore will be denied as not medically necessary when provided in that setting. CGS Administrators, LLC, Local Coverage Determination for Immunosuppressive Drugs (L33824).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 contract states that its Part D drug coverage cannot cover a drug that would be covered under Medicare Part A or Part B. 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.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.
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). Formulary use includes the application of cost utilization tools, including step-therapy, dosage limitations and therapeutic substitution. 42 CFR Section 423.578(b)(iii). The exceptions process extends to coverage requests to set aside cost utilization rules for non-formulary drugs. A Part D plan must grant an exception 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 subject to cost utilization rules. 42 CFR Section 423.578(b). 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 drug at issue or would have adverse effects for the enrollee. Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance Manual, Section 40.5.3.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. A Plan must grant an exception to prior approval rules 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.
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 rules set forth the requirements and limitations for payments by and on behalf of low-income Medicare beneficiaries who enroll in a Part D Plan. In general, an individual that meets requirements under Medicare's low income subsidy (LIS) rules is entitled to a reduction or elimination in the premium, a reduction or elimination in the annual deductible, a reduction in cost-sharing for all covered Part D drugs below the out-of-pocket limit, and a reduction or elimination in cost-sharing for covered Part D drugs above the out-of-pocket limit. The extent of reduction in these benefits depends on an individual's income and resources. Determinations of eligibility for subsidies are made either by the State (if the individual applies with the Medicaid agency) or by the Social Security Administration (if the individual applies with that agency). 42 CFR ?423.771 to 42 CFR ?423.782.According to enrollment records from the Centers for Medicare & Medicaid Services (CMS), you were determined to be entitled to a low-income subsidy (LIS), copay level 2, effective October 1, 2019 through December 31, 2019. For copay level 2, an enrollee is required to pay $1.25 and $3.80 copayments.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 ?423.104.Part D sponsors are required to coordinate with other providers of prescription drug coverage with respect to the payment of premiums and coverage, as well as coverage supplementing the benefits available under Part D. The Medicare Modernization Act (MMA) specified that these coordination requirements must relate to the following elements: (1) enrollment file sharing; (2) claims processing and payment; (3) claims reconciliation reports; (4) application of the protection against high out-of-pocket expenditures by tracking true out-of-pocket (TrOOP) expenditures; and (5) other processes that CMS determines. Medicare Prescription Drug Benefit Manual (CMS Pub. 100-18) Chapter 14, ?20, Medicare Prescription Drug Benefit Manual, Chapter 14, Appendix E.The Part D Plan contract states that Medicare provides extra help to pay prescription drug costs for people who have limited income and resources. If you qualify you will get help paying for any Medicare drug Plan's prescription copayments.The Plan contract states that they are required to follow rules set by Medicare to make sure that the enrollee is using all of their coverage in combination when they get covered drugs from the Plan. This is called coordination of benefits because it involves coordinating the drug benefits the enrollee gets from the Plan with any other drug benefits available. 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.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 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.
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 indicationmeans 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.The Part D Plan can only cover drugs prescribed for a medically accepted indication. 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.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 to request 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 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.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 pancreas transplant, II) the transplant met Medicare coverage criteria in effect with respect to the facility being approved for pancreas 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.
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 Pancreas transplant, II) the transplant met Medicare coverage criteria in effect with respect to the facility being approved for Pancreas 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.
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). With regard to Hepatitis B vaccine, Medicare Part B pays for vaccines such as hepatitis B vaccinations provided they are reasonable and necessary for the prevention of illness for those individuals who are at high or intermediate risk of contracting Hepatitis B. 42 CFR Section 410.63(a).
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 an organ transplant, II) the transplant met Medicare coverage criteria in effect with respect to the facility being approved for an organ 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).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 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 contract states that the Plan cannot cover drugs that would be covered under Medicare Part A or Part B. 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.
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 $50 copayment amount for up to a 30 day supply and a $125 copayment amount for up to a 90 day supply of a Tier 3 drug purchased in 2019 from a mail order pharmacy. Fenofibrate 50 mg 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 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.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 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. The Plan does not cover drugs/items excluded from Medicare Part D coverage. If you purchasedrugs/items that are excluded, you must pay for them yourself. Please refer to the Plan's Evidence ofCoverage.