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

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law defines those drugs that may be covered under Part D. A covered prescription drug must beused for a medically accepted indication. A medically accepted indication means a use that is approvedby the Food and Drug Administration (FDA), or a use supported by one or more citations in the drugcompendia approved by Medicare. Medically accepted indications do not include uses in research or usesdescribed in peer-reviewed medical literature. Please refer to Social Security Act, Sections 1860D-2(e)(1)and 1927(k)(6); and 42 CFR Section 423.100.The Part D Plan can only cover drugs prescribed for a medically accepted indication. Please refer to thePlan's Evidence of Coverage.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.
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.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 for a higher cost-sharing tiered drug to be covered at the cost-sharing level that applies for lower cost-sharing tiered drugs. If a Part D Plan maintains a formulary tier in which it places very high costs and unique items (i.e., specialty tier), the Part D Plan may design its exception process so that very high cost or unique 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 tiering exception. 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 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).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).The Part D Plan contract states that the Plan cannot cover drugs that would be covered under Medicare Part A or Part B. 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.
Appeal type: unknown
Decision: unknown

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

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will find abbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law defines those drugs that are eligible to be covered under the prescription drug benefit. Medicare law specifically excludes coverage for any drug for which payment would be available under Parts A or B of Medicare for that individual. Social Security Act, Section 1860D-2(e)(2)(B).Medicare Part B pays for durable medical equipment (DME) if the equipment is used in the patient's home or in an institution that is used as a home. Payment may be made for supplies necessary for the effective use of DME. Such supplies include those drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the DME. 42 CFR Section 410.38(a); Medicare Benefit Policy Manual, Chapter 15, Section 110.3.Medicare Part B local policy states that an external infusion pump is covered for administration of chemotherapy of the treatment of primary hepatocellular carcinoma or colorectal cancer where this disease is unresectable or where the beneficiary refuses surgical excision of the tumor. 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).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 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. 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). Medicare Part B coverage includes oral anti-cancer drugs. For an oral anti-cancer drug to be covered, all of the following criteria (1-4) must be met (Medicare Claims Processing Manual, Chapter 17, Section 80.1): 1. It is a drug or biological that has been approved by the Food and Drug Administration (FDA), and 2. It has the same active ingredients as a non-self-administrable anti-cancer chemotherapeutic drug or biological that is covered when furnished incident to a practitioner's service. The oral anti-cancer drug and the non-self-administrable drug must have the same chemical/generic name as indicated by the FDA's Approved Drug Products (Orange Book), Physician's Desk Reference (PDR), or an authoritative drug compendium, or it is a prodrug which, when ingested, is metabolized into the same active ingredient which is found in the non-self-administrable form of the drug, and 3. It is used for the same anti-cancer chemotherapeutic indications, including unlabeled or off-label uses, as the non-self-administrable form of the drug, and 4. It is prescribed by a practitioner licensed under state law to prescribe such drugs as anti-cancer chemotherapeutic agents. If criteria 1-4 are not met, the drug will be denied as non-covered. A claim denied for the reason that the diagnosis does not fall in the covered diagnosis section of the Policy Article, titled ICD-10 Codes that Support Medical Necessity, will receive a statutory denial as non-covered, but may be covered at appeal if and only if it can be shown to be allowed under Medicare Benefit Policy Manual, Chapter 15, Section 50 and under the Social Security Act, Section 1861(s)(Q). Medicare Benefit Policy Manual, Chapter 15, Section 50.5.3; CGS Administrators, LLC, Local Coverage Article for Oral Anticancer Drugs (A52479) or Noridian Healthcare Solutions, LLC, Local Coverage Article for Oral Anticancer Drugs (A52479).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.A Part D plan must have enough contracted retail pharmacies in its network to ensure that enrollees have adequate access to covered prescription drugs. To ensure that beneficiaries have access to negotiated prices for covered Part D drugs, a Part D Plan must issue and reissue, as necessary, a card or other type of technology that may be used by enrollees. A Part D plan must require its network pharmacies to submit claims to the Part D Plan or its intermediary whenever the card issued by the Plan is presented or is on file at the pharmacy unless the enrollee specifically requests that a particular claim not be submitted to the Part D Plan. A Part D Plan should establish policies and procedures to ensure that claims are submitted online in real time and restrict the use of beneficiary-submitted paper claims to those situations in which online claims processing is not available to the beneficiary at the point-of-sale (such as out-of-network pharmacies). For cash purchases made at in-network pharmacies an enrollee will be responsible for the difference between the cash price and the Part D Plan's negotiated price. There may be situations when a cash purchase of a covered drug is reasonable. Social Security Act ?1860D-2(d); 42 CFR ?423.120(a); 42 CFR ?423.120(c)(1) and ?423.120(c)(3); Medicare Prescription Drug Benefit Manual, Chapter 14, Coordination of Benefits, ?50.4.3.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. There may be situations in which an enrollee will pay the full cost of the drug at the time of purchase or an enrollee may pay more than expected under the coverage rules of the Plan. In either case, an enrollee can ask the Plan to pay its share of the cost of the drug by sending the Plan a request for reimbursement along with the enrollee's prescription receipt(s) documenting proof of purchase. Please refer to the Plan's Evidence of Coverage.Pursuant to guidelines issued by the Centers for Medicare and Medicare Services (CMS), as of February 1, 2014, the Plan has enacted a policy in which an enrollee is responsible for the difference between the cash price paid and the Plan's contracted negotiated rate for a drug for any purchases made at an in-network pharmacy that are not automatically submitted online through the pharmacy.
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 $360, 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. Shingrix vaccine and its administration fee 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 has the authority to establish a formulary to designate specific drugs that will be available for coverage and the ability to have a cost-sharing structure other than the standard Medicare drug benefit. An enrollee may be subject to annual deductibles, coinsurance, and copayments (including tiered copayments). 42 CFR ?423.104.The Plan will pay part of the costs for covered drugs and the enrollee will pay the other part during the initial coverage period. The amount an enrollee pays when filling a covered prescription is called the copayment or coinsurance. The copayment or coinsurance will vary depending on the drug and where the prescription is filled. The Plan may also have other rules regarding issues such as when a refill will be covered. 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. 42 CFR Section 423.104.The Plan will pay its share of the cost for covered drugs and the enrollee will pay the other part during the initial coverage stage. The enrollee stays in this stage until drug payments for the year plus the Plan's payments total $3,820. Once total drug costs reach this amount, the enrollee enters the coverage gap stage. During the coverage gap stage, the enrollee pays 25% for brand name drugs or 37% for generic drugs. Once total out-of-pocket costs reach $5,100, the enrollee will qualify for catastrophic coverage. 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). Effective January 1, 2011, Medicare law requires that all drugs and biologicals used in the treatment of end stage renal disease (ESRD) be included in the ESRD prospective payment system (PPS) payment bundle, including drugs formerly paid under Medicare Part D. The law identifies categories of drugs that either are, or may be, ESRD-related. Drugs that are always considered ESRD-related include access management drugs, anemia management drugs, anti-infectives to treat site access infection, bone and mineral metabolism drugs and cellular management drugs. Social Security Act, Section 1881(b)(14); 42 CFR Section 413.171; Medicare Benefit Policy Manual, Chapter 11, Section 20.3; and 75 Federal Register No. 155, issued August 12, 2010 (Preamble to Final Rule). Effective February 20, 2018, Medicare law also provides coverage of related drugs under the PPS bundle for treatment of acute kidney injury (AKI). Medicare Benefit Policy Manual, Chapter 11, Section 100.6. For drugs that are always considered ESRD-related, it is important to note that the ESRD bundle includes all ESRD-related drugs and biologicals, regardless of whether or not these are furnished by a dialysis facility. Thus, effective January 1, 2011, any claims for a drug included in the five categories of drugs that are always considered renal dialysis drugs when furnished to an ESRD patient and used as specified in Table 4 of the Preamble to the Final Rule would not be payable under Part D when the beneficiary is an ESRD patient in dialysis, regardless of why the drug is being furnished. Medicare Program; End-Stage Renal Disease Prospective Payment System, 75 Fed. Reg. 49030, 49050 (August 12, 2010); CMS memo: Clarification of Exclusion of Part D Payment for Drugs included in the End-Stage Renal Disease Prospective Payment dated February 17, 2011. 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. 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. Please refer to the Plan's Evidence of Coverage.